U.S. injunction cases, involving medical technologies

Patent infringement cases where injunctions were denied

2006. September 9: Voda v. Cordis Corp., No. CIV-03-1512-L, 2006 WL 2570614 (W.D. Okla. Sept. 5, 2006), aff’d, 536 F.3d 1311 (Fed. Cir. 2008)

Patents 5,445,625, ′213 and ′195, claim an angioplasty guide catheter, a medical device, and methods of use. The patent holder brought infringement action against a competitor. A jury held that the defendant infringed the plaintiff’s patents, and determined that plaintiff was entitled to a reasonable royalty of 7.5% of defendant’s gross sales of the infringing catheters. Following the jury verdict, the plaintiff requested a permanent injunction barring defendant, “its officers, agents servants, directors, employees and all those in active concert or participation with them … from infringing, inducing the infringement of, and contributorily infringing any one or more claims” of the patents-in-suit. The Court found that the plaintiff failed to demonstrate either irreparable injury or that monetary damages are inadequate. The Court of Appeals affirmed the district court’s denial of plaintiff’s request for a permanent injunction. (Voda v. Cordis Corp., 536 F.3d 1311, 1329 (Fed. Cir. 2008)

Plaintiff argues irreparable harm is presumed whenever validity and continuing infringement have been established. Brief in Support of Plaintiff’s Request for Permanent Injunction at 5 (Doc. No. 350). This argument, however, runs afoul of the court’s reasoning in eBay where the Court clearly held the right to exclude does not, standing alone, justify a general rule in favor of injunctive relief. eBay Inc., 126 S.Ct. at 1840. Moreover, other than the presumption of irreparable harm, plaintiff identifies no harm to himself; rather, he relies on alleged harm to a non-party, Scimed. See Brief in Support of Plaintiff’s Request for Permanent Injunction at 6-12. The court concurs with defendant that such harm is irrelevant because Scimed elected not to sue to enforce the patent rights. As patents have “the attributes of personal property”, the person seeking a permanent injunction must demonstrate harm from infringement of those rights that is personal as well.

The court also finds plaintiff has not established that monetary damages are inadequate to compensate him. Plaintiff argues he granted Scimed an exclusive license to his patented inventions and defendant’s continuing infringement will damage his relationship with Scimed. This argument, however, is simply the other side of the right-to-exclude coin and is not sufficient to justify granting injunctive relief. Plaintiff’s request for a permanent injunction is therefore denied.

2007. September 6: Altana Pharma AG v. Teva Pharm. USA, Inc., 532 F. Supp. 2d 666, 682–83 (D.N.J. 2007), aff’d, 566 F.3d 999 (Fed. Cir. 2009)

Patent 4,758,579 claims the compound pantoprazole, a pharmaceutical drug which inhibits the secretion of gastric acid in the stomach. This drug is prescribed to treat various gastrointestinal disorders including gastroesophageal reflux disease, which causes heartburn and chronic, erosive ulcers in the esophagus. The patent holder and the exclusive licensee brought infringement action against a competitor, and the patent holder filed a motion for preliminary injunction after . The Court found that the plaintiffs’ claim of irreparable harm based on the argument that their businesses will be financially crushed by the launch of generic versions was exaggerated. In reaching this finding the Court took into consideration that the plaintiffs knew that the defendant filed ANDA applications, stayed until August and September 2007. The Court found it hard to believe that the plaintiffs did not had a business plan in place to deal with the introduction of a generic version by the defendant.

This Court finds that Plaintiffs have failed to establish irreparable harm. First, it appears that Plaintiffs’ argument that their businesses will be financially crushed by the launch of generic versions of Protonix is exaggerated. With respect to Wyeth, Plaintiffs’ counsel admitted during oral argument that Protonix makes up only 8.8% of Wyeth’s annual sales. See Oral Argument Transcript (July 31, 2007) at 57:24–58:4. Although Protonix makes up a large portion of Altana’s sales, Altana has known for over three years, since the generic drug companies filed their ANDA applications, that the Hatch–Waxman Act stays as to Teva and Sun would be expiring in August and September 2007. It is difficult to accept that Altana does not have a business plan in place to deal with the introduction of a generic version of Protonix, whether that includes Altana’s marketing of its own authorized generic version of Protonix or some other business strategy. The ′579 patent expires in July 2010. If one accepts Altana’s argument, the company will essentially cease to exist upon expiration of the ′579 patent. This cannot be the case. Additionally, it is unreasonable to believe that Nycomed, which clearly knew of this litigation and the expiration of the Hatch–Waxman Act stays as to Teva and Sun in August and September 2007 when it purchased Altana last year, sought out and approved a corporate transaction that would cripple the company upon expiration of such stays only several months after the acquisition.

Furthermore, the Federal Circuit, as well as courts in this district, have declared that the types of harms advanced by Plaintiffs in the instant lawsuit are not irreparable and thus, cannot form the basis for granting an injunction. In Eli Lilly and Co. v. American Cyanamid Co., 82 F.3d 1568, 1578 (Fed.Cir.1996), the Federal Circuit held that a movant does not establish irreparable harm by arguing loss of revenue and loss of research and development opportunities where money damages are calculable and the defendants have the ability to pay any damages award.

Two recent decisions from this district are in line with Eli Lilly and Nutrition 21. See Novartis v. Teva, Nos. 04–4473, 06–1130, 2007 WL 1695689, at *26–28 (D.N.J. June 11, 2007) (finding that plaintiff failed to establish irreparable harm because the damages were calculable, Teva had the ability to pay any monetary damages judgment, and the possibility of a loss of market share, irreversible price erosion, and lost research opportunities do not constitute irreparable harm); In re Gabapentin Patent Litigation, Nos. 00–2931, 01–1537 (D.N.J. Aug. 20, 2004(JCL)), Transcript at pp. *684 12–14 (“Loss of market share, of price erosion, lost sales, and even lost market opportunities in my view can be reduced to dollars, not easily, but feasibly. And as Ivax well knows, it enters the market at its peril, if there is a finding of infringement and validity, and it is entitled to take that risk.”).

2007. September 12: Tiber Labs., LLC v. Hawthorn Pharm., Inc., 527 F. Supp. 2d 1373, 1381–82 (N.D. Ga. 2007)

Patent 6,979,689 claims a three-ingredient pharmaceutical composition for the treatment of upper respiratory and oral pharyngeal congestion and related symptoms in pediatric patients. Assignee brought two separate actions against alleged infringers, thirteen and seventeen months after the ′689 patent was issued. The Court determined that this delay by the plaintiff warranted strongly against the finding of irreparable harm. Plaintiff seemed to be willing to negotiate with defendant during pre-litigation discussions, which similarly suggested that plaintiff was not going to be irreparably harmed absent a preliminary injunction. Plaintiff failed to demonstrate that a monetary remedy will not adequately compensate it in this case should it prove its infringement claims. The Court found that the public interest favors maintaining the status quo in the supply of those medications to pediatric patients, and weighs strongly against disrupting that supply and potentially misinforming pharmaceutical consumers concerning their use of prescription medication.

The patent at issue in this case was issued on December 27, 2005. At that time, both accused products, Hydro–DP and Dytan–HC, had already been introduced in the market. Tiber, who is charged with its predecessor-assignee’s dilatory conduct, brought its action against Cypress in February of 2007, over thirteen months after the ′689 Patent was issued. It brought its action against Hawthorne in June of 2007, over seventeen months after the ′689 Patent was issued. This delay in both cases warrants strongly against the finding of irreparable harm.

Furthermore, as the Federal Circuit has recognized, a patentee’s willingness to “forgo its patent rights for compensation” by offering to licensee its patent further militates against the existence of irreparable harm. See High Tech Med. Instrumentation, 49 F.3d at 1557 (finding that patentee’s “apparent willingness to grant a license” under its patent to alleged infringer was inconsistent with allegation of irreparable harm); see also T.J. Smith & Nephew Ltd., 821 F.2d at 648 (stating that licensing is “incompatible with the emphasis on the right to exclude that is the basis for the presumption in a proper case”). Tiber’s apparent willingness to grant a license to Cypress during its pre-litigation discussions further undercuts its suggestion that it will be irreparably harmed absent a preliminary injunction.

Finally, despite its conclusory argument to the contrary, Tiber has not demonstrated that a monetary remedy will not adequately compensate it in this case should it prove its infringement claims.

In the Court’s view, the public interest favors maintaining the status quo in the supply of those medications to pediatric patients, and weighs strongly against disrupting that supply and potentially misinforming pharmaceutical consumers concerning their use of prescription medication. Without specific evidence in the record alleviating these concerns, the Court declines to award the relief requested.


2008. January 8: Respironics, Inc. v. Invacare Corp.
, No. CIV.A. 04-0336, 2008 WL 111983, (W.D. Pa. Jan. 8, 2008)

Four patents related to medical devices for sleep therapy. Patent holder brought infringement action against a competitor. Following a jury verdict in his favor, the plaintiff filed a motion for a permanent injunction to stop defendant from using, making, or selling the medical devices. The plaintiff was described as the industry leader in the field of sleep therapy, a fact that was not disputed in this case. Based on this, the Court did not find a new entrant in the market to be a serious threat to the plaintiff’s reputation for innovation. 

As Respironics itself points out, the vast majority of Invacare’s sales is in its traditional product lines, such as wheelchairs, walkers and oxygen. Only a “small fraction” of Invacare’s sales come from “its recent foray into sleep products.” [doc. no. 313, p. 8]. On the other hand, Respironics consistently describes itself as the leader in the field of sleep therapy. The status of Respironics as the industry leader was not disputed in this case. Under these facts, we do not find a new entrant in the market, with what Respironics itself describes as a side business in the field of sleep therapy, to be a serious threat to the industry leader’s reputation for innovation.

Second, although it is true that the protection of patent rights generally fosters innovation, that, in itself, is insufficient to justify permanent injunctive relief. As the Supreme Court has cautioned us, we must consider the facts of each patent case on its own merits, and not grant permanent injunctive relief based on broad principles, and generalities, of patent law. Here, where the device found to be infringing is no longer on the market, has never been on the market, and was last displayed more than four years ago, general statements regarding innovation do not support entry of a permanent injunction.

2008. January 8: Siemens Med. Sols. USA, Inc. v. Saint-Gobain Ceramics & Plastics, Inc., No. CIV.07-190-SLR, 2008 WL 114361, at *6 (D. Del. Jan. 8, 2008)

Patent 4,958,080 claims a gamma or x-ray detector that incorporates a particular scintillator, which has been described as a breakthrough in the field of medical imaging. Plaintiff, an exclusive licensee of this patent, filed a motion for a preliminary injunction. Plaintiff failed to demonstrate any compelling reason why monetary damages would be insufficient to compensate it for this loss in market share.

The most compelling and non-speculative of these arguments, that money damages are inadequate to compensate plaintiff for its 15% loss of market share, without more, does not establish irreparable injury. See Nutrition 21 v. U.S., 930 F.2d 867, 871 (Fed.Cir.1991) (“[T]he district court’s reliance on possible26 market share loss would apply in every patent case where the patentee practices the invention.”); Illinois Tool Works, Inc. v. Grip–Pak, Inc., 906 F.2d 679, 683 (Fed.Cir.1990) (“Application of a concept that every patentee is always irreparably harmed by an alleged infringer’s pretrial sales would equally disserve the patent system.”). Plaintiff has not adduced any compelling reason why monetary damages would be insufficient to compensate it for this loss in market share. The fact that the ′080 patent is set to expire on October 6, 2008 neither mitigates against nor amplifies this failure of proof.27 Absent special circumstances that could justify relief at this early stage, the court would have no occasion to enjoin defendant’s sale of LYSO under its ′420 patent license, even if infringement were more clear in this case.

2008. September 26: Advanced Cardiovascular Sys., Inc. v. Medtronic Vascular, Inc., 579 F. Supp. 2d 554, 560 (D. Del. 2008), dismissed, 356 F. App’x 389 (Fed. Cir. 2009)

Patents 5,514,154, 6,066,167, 6,066,168, and 6,432,133 claim a second generation stent devices and methods for delivery and manufacture of several versions those devices. The patent holder filed a motion for a permanent injunction after a trial for infringement returned a jury verdict in its favor. Noting the plaintiff’s willingness to forego its patent rights for compensation, the Court concluded that the plaintiff will not suffer irreparable harm absent an injunction. The Court suggested that permanent injunctions are typically granted in two-competitor situations where the patentee has demonstrated an unwillingness to part with the exclusive right. The Court also concluded that the public interest favors the denial of a permanent injunction in this case considering the strong public interest in maintaining diversity in the coronary stent market.

ACS has not addressed the fact that BSC holds a larger market share than Medtronic. Moreover, ACS has not identified any specific customers it has lost, or stands to lose, directly as a result of Medtronic’s continued sales of infringing stents. ACS admits that it has recaptured nearly all of the market share lost to Medtronic, and is currently the leading producer of bare-metal stents. The court finds no irreparable harm on this record.

The court also notes that ACS’s willingness to forego its patent rights for compensation supports the court’s conclusion that ACS will not suffer irreparable harm absent an injunction. ACS has licensed the Lau patents to both Cordis (in April 2000) and BSC (in May 2000). ACS asserts that it has not licensed its patents simply for money—to do so would violate its “general policy”—but in exchange for cross-licenses and to settle litigations. (D.I. 805 at 7–8) The fact that ACS was selective regarding its licensing compensation—exchanging its technology only for other licenses to competing technology—does not rectify the fact that ACS was willing, ultimately, to forego its exclusive rights for some manner of compensation. Money damages are rarely inadequate in these circumstances; rather, permanent injunctions are typically granted in two-competitor situations where the patentee has demonstrated an unwillingness to part with the exclusive right. Compare Novozymes, 474 F.Supp.2d at 613 (D.Del.2007) (finding irreparable harm where patentee only licensed its patent to its subsidiary who competed head-to-head with the infringer) (granting permanent injunction), with Voda v. Cordis Corp., No. Civ. A. 03–1512, 2006 WL 2570614 at *6 (W.D.Okla. Sept. 5, 2006) (denying permanent injunction where plaintiff was a willing licensor, rejecting plaintiff’s argument that “ongoing infringement will damage his relationship with [plaintiff’s exclusive licensee]” as “simply the other side of the right-to-exclude coin”).

Finally, the court notes that the public interest favors the denial of a permanent injunction in this case. A strong public interest in maintaining diversity in the coronary stent market has been previously recognized by this court and the Federal Circuit. See Cordis Corp. v. Boston Sci. Corp., 99 Fed.Appx. 928, 935 (Fed.Cir.2004) (unpublished) (“[A] strong public interest supports a broad choice of drug-eluting stents, even though no published study proves the superiority of either Cordis’s Cypher of BSC’s Taxus stent.”); Cordis Corp. v. Boston Scientific Corp., Nos. Civ. A. 03–027, 03–283, 2003 WL 22843072, *2 (D.Del. Nov. 21, 2003) (noting the “obvious concern of depriving the public of the best and safest medical devices by limiting competition”).

2009. July 16: Medtronic Sofamor Danek USA, Inc. v. Globus Med., Inc., 637 F. Supp. 2d 290, 314 (E.D. Pa. 2009), aff’d sub nom. Warsaw Orthopedic, Inc. v. Globus Med., Inc., 416 F. App’x 67 (Fed. Cir. 2011)

Patents 6,530,929 and 7,008,422 claim devices and methods used by spinal surgeons to stabilize bony structures. The patent holder and licensees brought action against defendant, alleging infringement. Following jury verdict of infringement, the parties stipulated to bench trial on issues of damages and injunctive relief. The plaintiff did not presented evidence of potential loss of market share or good will absent the grant of a permanent injunction, therefore failing to demonstrate irreparable harm. 

Medtronic USA presented evidence of “[irreparable] harms that defy monetary quantification and that controvert [Medtronic USA’s] long-term goals, including loss of access to surgeons, loss of the opportunity to sell other products for use in the same Sextant surgeries …, loss of the opportunity to use these flagship products to sell surgeons other products for use in non-Sextant surgeries, eroded market share, loss of goodwill, and injury to [Medtronic USA]’s reputation as an innovator in the area of minimally invasive surgeries.” Pls. Post–Trial Brief at 12. But Warsaw is a manufacturer of medical devices, not a distributor; it is unlikely that Warsaw suffers the same irreparable injuries as Medtronic USA. There is no evidence that Warsaw would have had access to surgeons or the opportunity to sell the Sextant System (or other products) to hospitals that purchase surgical equipment. Warsaw presented no evidence of its market share or the loss of good will. The evidence of record does not support entry of a permanent injunction. Warsaw failed to present evidence of irreparable harm, so the court cannot consider the balance of hardships between Warsaw and Globus. The parties presented evidence on whether issuance of an injunction would be contrary to the public interest, but since no injunction will issue for lack of evidence of irreparable harm to Warsaw, the only plaintiff with standing, the court need not decide the matter.

2010. April 27: Johnson & Johnson Vision Care, Inc., v. CIBA Vision Corp., 712 F. Supp. 2d 1285, 1289–90 (M.D. Fla. 2010)

Patents pertaining to extended-wear contact lenses and related methods. Competitor brought action against the patent holder seeking declaratory judgment that competitor did not infringe those patents, and claiming that certain of those patents were invalid. Patent holder counterclaimed alleging infringement of its patents by the competitor. After the Court determined that competitor infringed two of the patents, the patent holder moved for permanent injunction prohibiting competitor from future sales of infringing product. The Court found that the patent owner failed to prove that it will be irreparably harmed if a permanent injunction does not enter or that monetary damages are inadequate to compensate it for future injuries due to continued infringement. To reach this conclusion of lack of irreparable harm the Court took into consideration the patent holder’s licensing behaviour, whom either offered or actually entered into licensing agreements with its three major domestic competitors and also entered into licenses with two foreign manufacturers. The Court was also convinced that innocent contact lens wearers will suffer real adverse consequences if sale of this product was enjoined. An injunction would have created consequential medical, practical and economic issues for large numbers of these lenses.

Looking at CIBA’s licensing behavior and the specific facts of this case, the Court, as it did at the preliminary injunction stage (see Doc. 49 at 15), finds compelling that CIBA has been willing to share the Nicolson patents with so many of its competitors (again, including J & J itself). This conduct, taken in its totality, is inconsistent with CIBA’s assertion that only enforcement of its right to exclude J & J from using the Nicolson patents will redress the harm that CIBA will suffer in the future on account of J & J’s infringement. The Court finds that CIBA has failed to prove that it will be irreparably harmed if a permanent injunction does not enter or that monetary damages are inadequate to compensate CIBA for future injuries due to J & J’s continued infringement.6 See e.g. Advanced Cardiovascular Sys., Inc. v. Medtronic Vascular, Inc., 579 F.Supp.2d 554, 560 (D.Del.2008), appeal dismissed, 356 Fed.Appx. 389 (Fed.Cir.2009) (patent owner’s willingness to forego its patent rights for compensation supports the court’s conclusion that patent owner will not suffer irreparable harm absent an injunction; “[t]he fact that ACS [patent owner] was selective regarding its licensing compensation—exchanging its technology *1290 only for other licenses to competing technology—does not rectify the fact that ACS was willing, ultimately, to forego its exclusive rights for some manner of compensation”); see also MercExchange, 500 F.Supp.2d at 577 (“decisions subsequent to the Supreme Court’s opinion [in eBay ] have rejected the broad classification that direct competitors always suffer irreparable harm from infringement”); Praxair, Inc. v. ATMI, Inc., 479 F.Supp.2d 440, 444 (D.Del.2007) (permanent injunction denied despite infringer being patentee’s sole competitor).

This evidence convinces the Court that millions of innocent contact lens wearers will suffer real adverse consequences if sale of ACUVUE®OASYS is enjoined. These are not just issues of comfort or cosmetics, as CIBA argues, but rather deal with the more substantive concerns of proper vision and eye care. There will also be significant disruption, confusion and cost (estimated to be in the hundreds of millions of dollars) caused by ACUVUE®OASYS patients being abruptly told that the contact lens for which they have been fitted and with which they are satisfied, is no longer available. Choosing a new lens will at minimum require refitting and the new lens may not prove as efficacious as the ACUVUE®OASYS lens. Moreover, patients may have to be refitted more than once until an appropriate lens is found. An undefined number will not be able to be refitted appropriately at all. CIBA’s answer that “they can just wear glasses” is no answer, in this Court’s view.

The preponderance of the evidence convinces the Court that an injunction will create consequential medical, practical and economic issues for large numbers of ACUVUE®OASYS users. The deleterious effects of the injunction on the general public would simply be too great to permit. Thus, CIBA has failed to carry its burden of proving that the public interest would not disserved by the entry of a permanent injunction.

The Court understands that the product in Bard Peripheral involved “potentially life saving technologies.” Id. Here, the consequences of enjoining the ACUVUE®OASYS are not so grave; nevertheless, this Court, sitting in equity, finds those consequences to be sufficiently important and adverse to millions of ACUVUE®OASYS patients that the public interest would be disserved if an injunction were to be entered.

2011. February 7: Edwards Lifesciences AG v. CoreValve, Inc., No. C.A. 08-91-GMS, 2011 WL 446203, at *14 (D. Del. Feb. 7, 2011), aff’d in part, remanded in part, 699 F.3d 1305 (Fed. Cir. 2012)

Patent 5,411,552 claims a valve prosthesis that can be implanted in the body without the need for surgical intervention, but rather through use of a catheter. Following a jury verdict of infringement plaintiff filed a motion for permanent injunction. The Court found that the harm alleged by the plaintiff would continue even if a permanent injunction were issued, because it stems from the defendant’s past conduct. Plaintiff failed to make allegations of prospective lost customers or harms that are truly irreparable unless the Court issues a permanent injunction.  Since the defendant is able to move its manufacturing operations from the United States to Mexico, it would remain in the market with little or no interruption even if the court were to enjoin its infringing manufacturing operations in the United States, and an injunction thus would not affect the alleged harm. The Court denied the motion for permanent injunction but granted the plaintiff’s request for an accounting of the number of relevant devices made, used, sold, offered for sale, imported or supplied in or from the United States by the defendant, and corresponding revenue from March 16, 2010 through the date of the order accompanying this memorandum.

In this case, the irreparable harm factor weighs against granting a permanent injunction for several closely-related reasons. First, the “irreparable” component of the injury that Edwards alleges stems from CoreValve’s past conduct, and would continue even if a permanent injunction were issued. Edwards makes no allegations of prospective lost customers or harms that are truly irreparable unless the court issues a permanent injunction. On the contrary, the court concludes that with respect to the irreparable harms that Edwards alleges, Edwards would not benefit substantially from an injunction being issued at this stage, several years after CoreValve’s accused product entered the market.

Second, Edwards’ allegations of irreparable harm are undercut because CoreValve’s infringement stems not from sales of the accused product, all of which occurred outside the United States, but rather from the manufacturing of the accused product in the United States. Thus, Edwards must establish that CoreValve’s manufacturing operations in the United States are continuing and will continue to cause irreparable harm if not enjoined. Edwards, however, does not appear to dispute that CoreValve would be able to move its remaining manufacturing operations to Mexico almost immediately if the court enjoined it from continuing to manufacture its products in the United States. (See, e.g., D.I. 402 at 1 (“Even now, CoreValve admits that it has been moving off shore to Mexico since January 2010 and could immediately ramp up manufacturing there.”); id. at 7–8; D.I. 357 at 15.) Thus, CoreValve would remain in the market with little or no interruption even if the court were to enjoin its infringing manufacturing operations in the United States, and an injunction thus would not affect the alleged harm.

As it did in this case, Edwards can bring suit against CoreValve and seek damages if CoreValve continues its infringing manufacturing operations in spite of the judgment of infringement. Moreover, Edwards has licensed the ′ 552 Patent to a competitor, 3F Therapeutics, for a field of use that overlaps significantly with that of Edwards’ Sapien product. (See A116.) While not determinative, such licensing activity is further evidence that monetary damages would be adequate to compensate Edwards for any future infringing manufacturing operations by CoreValve.15 See, e.g., Telcordia, 592 F.Supp.2d at 748 n. 10.

The court will grant, however, Edwards’ request for an accounting of the number of CoreValve Revalving System devices made, used, sold, offered for sale, imported or supplied in or from the United States and corresponding revenue from March 16, 2010 through the date of the order accompanying this memorandum.

2011. April 21: B. Braun Melsungen AG v. Terumo Med. Corp., 778 F. Supp. 2d 506, 524 (D. Del. 2011)

Patent 7,264,613 claims intravenous (IV) catheters, a medical device. Following a jury verdict in his favor, the patent holder filed for a motion seeking permanent injunction for the immediate, complete removal of defendant’s device from the United States market. The defendant opposed to the scope of the injunction proposed by the plaintiff, and instead proposed a limited injunctive relief allowing defendant to continue to sell the device in the smaller (30%) alternative care market segment where it was already being sold, for a period of fifteen months. Considering that the plaintiff’s argument of irreparable harm heavily relied on the possibility that the defendant’s infringing device could expand to the larger (70%) acute care market, the Court determined that there was little reason to believe that this expansion would happen under a limited permanent injunction. The Court also found that the public interest favors the limited injunction proposed by the defendant considering the public interest in access to competing alternatives to medical devices.

Braun seeks immediate entry of a permanent injunction that would result in the immediate, complete removal of Terumo’s Surshield device from the U.S. market. While Terumo objects to such broad, immediate relief, it does not oppose injunctive relief entirely. Instead, Terumo proposes “the Court should provide for a ‘sunset’ period of fifteen months, allowing Terumo to continue to sell the Surshield in the smaller (30%) alternative care market segment where it is presently sold. This will allow Terumo time to introduce a new, non-infringing safety I.V. catheter product prior to any injunction taking effect in the alternative care market segment. (D.I. 382 at 1) Furthermore, “[a]s part of a court-approved ‘sunset’ provision, Terumo is willing to agree to refrain from selling the Surshield in the acute care market, and also to refrain from offering the Surshield as part of any GPO contract bids directed to existing Braun GPO contracts up for renewal.” (Id. at 2)

Other factors, however, favor the more limited relief proposed by Terumo. First, any fair reading of Braun’s opening brief—prepared before Braun knew of Terumo’s proposal for injunctive relief—reveals that the great bulk of irreparable harm Braun fears is from improper competition by Terumo in the acute (hospital) care market, which accounts for 70% of the market in which the companies compete. (See D.I. 365 at 12; Trial Tr. at 537:6–25) In particular, Braun observed in its opening brief that, without injunctive relief, Terumo’s fledgling non-acute limited competition would expand to the acute market, particularly as large, GPO contracts opened up for renewal. (See D.I. 365 at 12; Trial Tr. at 272:6–16) Terumo’s proposal directly addresses these legitimate concerns of Braun by agreeing to refrain from competing in the acute market with the infringing Surshield device. (See D.I. 382 at 1–2, 9, 11–13) To date, Terumo’s competition with Braun has been limited to the non-acute market, and even here Braun has limited Terumo to approximately a 1% market share. (See D.I. 365 at 5 (citing Trial Tr. at 1009:24–1010:8), 11 (“Surshield, 0.0%” (citing D.I. 366 Ex. 9, PTX–431)); D.I. 382 at 2, 12) There is little reason to believe that additional cabined competition, until June 2012, by a product Terumo will be phasing out, under the auspices of a Court-imposed permanent injunction, will expand to such an extent as to impose substantial, irreparable harm to Braun.

[Considering balance of hardships] The Court finds that this factor weighs heavily in favor of Terumo’s proposed injunctive relief, as opposed to Braun’s much more expansive proposal. If the Court were to immediately and entirely exclude Terumo’s Surshield from the market, medical professionals who are currently using Terumo’s device would be required to stop doing so. In at least some instances, this would result in medical professionals being abruptly deprived of a device for which they have expressed a preference, and have been specifically trained to use. (See, e.g., D.I. 385, Omiecinski Decl., ¶¶ 10–11) Terumo’s reputation would also be harmed to a degree disproportionate to the infringement found by the jury. What would appear to many to be an urgent, “recall-like” decree from this Court is simply not warranted under the circumstances presented here. (See id. ¶ 14)

The Court concludes that the public interest likewise favors entry of the more limited injunctive relief proposed by Terumo, as opposed to the injunction sought by Braun. The Court reaches this conclusion largely for the reasons already described, primarily the impact of Braun’s requested relief on medical professionals currently using Terumo’s Surshield, Again, the Court does not minimize the importance of the competing considerations relied on by Braun—including, especially, the public interest in strong and consistent enforcement of patent rights. See Callaway, 585 F.Supp.2d at 622 (finding insufficient evidence “to counter the strong public policy favoring the enforcement of patent rights recognized by the courts.”) (internal quotation marks omitted). However, in the overall circumstances presented here, particularly the public interest in access to competing alternatives to safe medical devices, see, e.g., Cordis Corp. v. Boston Scientific Corp., 2003 WL 22843072, at *6 (D.Del. Nov. 21, 2003) (denying preliminary injunction in part due to “the obvious concern of depriving the public of the best and safest medical devices by limiting competition”), the public interest favors the more limited injunction proposed by Terumo.

2012. January 9: Conceptus, Inc. v. Hologic, Inc., No. C 09-02280 WHA, 2012 WL 44064, at *2 (N.D. Cal. Jan. 9, 2012)

Patent 6,634,361 claims an intrafallopian contraceptive, a medical devices. Following a jury verdict in his favor, the patent holder filed a motion for permanent injunction. The Court found that monetary award for ongoing infringement will adequately compensate for the harm suffered by the plaintiff. The Court also considered that public health has benefited from having a choice of products for transcervical hysteroscopic sterilization. Taking this into consideration, the Court found that the public interest would undoubtedly be harmed by an injunction because it would leave only one product for transcervical hysteroscopic sterilization. Since the products commercialized by the plaintiff and the defendant were different, removing the defendant’s product from the market would have eliminated an important alternative for patients.

Even though Hologic is a larger and more diversified company, it has identified substantial hardship that would occur if a permanent injunction is imposed. As discussed above, a monetary award for ongoing infringement will adequately compensate for Conceptus’s harm. This factor weighs against a permanent injunction.

Essure is the core of Conceptus’s business because it is the company’s sole product. Harm to the core of a patentee’s business also supports a finding of irreparable harm. See Bosch, 659 F.3d at 1152. This factor weighs in favor of a permanent injunction.

Conceptus would not have to re-litigate the entire action if it sought to collect damages for the period after the last damages period litigated. And Conceptus does not dispute that Hologic can pay the judgment and ongoing damages. Because Conceptus can be adequately compensated for its harm, this factor weighs against a permanent injunction.

Even though Hologic is a larger and more diversified company, it has identified substantial hardship that would occur if a permanent injunction is imposed. As discussed above, a monetary award for ongoing infringement will adequately compensate for Conceptus’s harm. This factor weighs against a permanent injunction.

The public interest would undoubtedly be harmed by an injunction. Enjoining the sale of Adiana would leave only one product for transcervical hysteroscopic sterilization. Public health has benefitted, and will continue to benefit, from having a choice of products for transcervical hysteroscopic sterilization. This is especially important because the products are different. Removing Adiana from the market would have eliminated an important alternative for patients.

Essure and Adiana are not interchangeable products and procedures. With Essure, there is a risk of perforations because of its long corkscrew-like tail. Evidence at trial also showed that some patients do not want Essure because it is metallic. For example, Essure is not available to patients who have nickel allergies. With Essure, there is a concern that the trailing coils could interfere with certain types of endometrial ablation procedures. There is also the possibility of pain after placement of Essure coils (TX 137 at 9976–78).

On the other hand, Adiana is not a metallic coil but is a small foam cylinder. It is not screwed into the fallopian tube. Instead, the fallopian tube is “burned” slightly by radiofrequency energy. As the tube heals, the healing tissue grows into the foam insert. The insert itself infringes nothing. The procedure for inserting it was found by the jury to infringe the method claims in suit. Nonetheless, the precise mechanism of action has important advantages over Essure, such as a non-metalic body, no risk of perforation, and use of radiofrequency energy.

In this action, the public benefit of having two products with different qualities in the transcervical hysteroscopic sterilization market militates strongly against an injunction.

2012. July 9: Valeant Int’l (Barbados) SRL v. Watson Pharm., Inc., No. 10-20526-CIV, 2012 WL 12844756, at *2–3 (S.D. Fla. July 9, 2012)

Patents 7,569,610, 7,563,823, 7,649,019, 7,553,992 claim bupropion hydrobromide, a pharmaceutical drug used as antidepresan. Following a final judgement in his favor, the patent owner filed a motion to amend the final judgement to permanently enjoin the defendant from the commercial manufacture or sale of its generic drug before the expiration of the patents in June 2026. The Court found that generic competition does not, in itself, establish irreparable harm to the plaintiff. The final judgement prohibits the defendant from marketing its bupropion hydrobromide products prior to the expiration of the plaintiff Orange Book patents, which prevents the defendant from directly competing with the plaintiff, or usurping any market share until the plaintiff patents’ expire.

By contrast, Plaintiff Valeant relies on a line of cases granting injunctive relief to patentees in Hatch-Waxman cases. See Eli Lilly & Co. v. Sicor Pharms., Inc., 705 F. Supp. 2d 971, 1011 (S.D. In. 2010), aff’d, 426 Fed. Appx. 892 (Fed. Cir. 2011); Otsuka Pharm. Co., Ltd. v. Sandoz, Inc., No. 07-1000, 2010 WL 4596324, at *36 (D.N.J. Nov. 15, 2010). Plaintiff argues that all Hatch-Waxman cases involve a direct competitor attempting to take market share by selling a cheaper generic version of the patented drug product, which would create irreparable harm to the prevailing patentee were an injunction not to issue. While this may be true, given the procedural posture of this case, the Court agrees with the analysis of the Alcon, Inc. court. After the eBay decision, the Federal Circuit and district courts repeatedly have required that such evidence must be presented before an injunction may issue in cases, including pharmaceutical cases, involving generic competition. See, e.g., Abbott Labs. v. Andrx Pharms., Inc., 452 F.3d 1331, 1347-48 (Fed. Cir. 2006) (vacating district court’s decision granting a preliminary injunction, stating that “[W]e do not doubt that generic competition will impact Abbott’s sales of Biaxin XL, but that alone does not establish that Abbott’s harm will be irreparable.”) Under Abbott, it is unclear that Plaintiffs showing of generic competition, without more, would establish irreparable harm.

Even if the Court were to find that the evidence of competition establishes irreparable harm, Plaintiff Valeant still does not meet the eBay standard for injunctive relief. The Court agrees that its findings of fact, rulings, and declaratory judgment under 35 U.S.C. § 271 (e)(4)(A) render injunctive relief unnecessary in this case. The Court’s February 22, 2012 Second Amended Final Judgment prohibits Watson from marketing its proposed bupropion hydrobromide products prior to the expiration of Valeant’s Orange Book patents, which currently are set to expire on the same day as Valeant’s 992 patent, or June 27, 2026. This prevents Watson from directly competing with Valeant or usurping any market share from Valeant’s Aplenzin® products until Valeant’s patents expire. In the event there is a violation of the Court’s February 22, 2012 Declaratory Judgment, Valeant may file another case in the Southern District of Florida and note this related case.

2013. March 28: Tyco Healthcare Grp. LP v. Ethicon Endo-Surgery, Inc., 936 F. Supp. 2d 30, 62 (D. Conn. 2013), aff’d in part, vacated in part, rev’d in part, 774 F.3d 968 (Fed. Cir. 2014)

Patents 6,063,050, 6,468,286, 6,682,544 claim ultrasonic surgical devices employing ultrasonic energy to cut and coagulate vessels in surgery. The patent holder brought actions alleging infringement of patents. The Court made a finding of infringement by the defendant, and awarded damages to plaintiff, but nevertheless found that the plaintiff did not met his burden of proving that injunctive relief was warranted. The Court took into consideration the fact that, throughout trial, the plaintiff emphatically sought monetary awards for lost profits and a certain royalty. According to the Court, this supported the position that monetary damages were fully adequate to compensate the plaintiff. In its analysis of the public interest, the Court noted that a permanent injunction would pull many devices that are presently used in surgery off the market. For the purpose of royalty damages the Court took into account a licensing agreement previously conducted by the plaintiff, the fact that the defendant had its own ultrasonic technology, and the fact that the infringing products were far more successful than other products commercialized by the defendant. The royalty damages were set at eight percent of the infringing sales from April 2004 and March 2012.

Most importantly, the Court finds that Plaintiff did not prove the first prong, as Philip Roy, the first witness who testified at trial, and who spoke on the subject of Tyco’s ultrasonic devices in relation to Ethicon’s, spoke of “irreparable harm” suffered by Tyco in terms of the damage to its reputation, but was unable to articulate why if Tyco has endured infringement and harm to its reputation since 2004, it never sought preliminary injunctive relief. (2012 Tr. at 209–210.) Throughout trial, Tyco has been emphatic as to its entitlement to lost profits and to a certain royalty rate, which further supports the position that “remedies available at law, such a monetary damages,” are fully adequate to compensate for Tyco’s injury.

The Court finds that the public interest prong cuts both ways, as there is certainly an interest in “protecting the rights of patent owners,” see Smith & Nephew, Inc. v. Synthes (U.S.A.), 466 F.Supp.2d 978, 985 (W.D.Tenn.2006), as well as an important consideration that a permanent injunction would pull many devices that are presently used in surgery off the market. See, e.g., Bard Peripheral Vascular, Inc. v. W.L. Gore & Associates, Inc., CV–03–0597–PHX–MHM, 2009 WL 920300, at *9 (D.Ariz. Mar. 31, 2009) aff’d, 670 F.3d 1171, opinion vacated in part on reconsideration, 682 F.3d 1003 (Fed.Cir.2012) vacated in part on reh’g en banc, 476 Fed.Appx. 747 (Fed.Cir.2012)(“Given the utility of Gore’s infringing products, both Counterpart and Non–Counterpart, the important role that these products play in aiding vascular surgeons who perform life saving medical treatments, sound public policy does not favor removing Gore’s items from the market. The risk is too great. Placing Gore’s infringing products out of reach of the surgeons who rely on them would only work to deny many sick patients a full range of clinically effective and potentially life saving treatments. The Court finds that the strength of this factor alone precludes it from imposing a permanent injunction.”).

The Court has also considered the “balance of hardships” and concludes that a “remedy in equity” is not warranted. These parties, self-described as the Coke and Pepsi of the surgical tool market, are both giants in the industry, and the balance of hardships does not tip sufficiently in Plaintiff’s favor to warrant such an extreme remedy.

2013. June 27: Smith & Nephew, Inc. v. Interlace Med., Inc., 955 F. Supp. 2d 69, 78 (D. Mass. 2013)

Patent 7,226,459 and 8,061,359 claim an arthroscopic surgical instrument and a surgical endoscopic cutting device and method for its use, respectively. The patent holder brought action alleging infringement of patents, and moved for permanent injunction. The Court found that, because the defendant tracks the sales of its infringing products separately, it should be easy to calculate an appropriate ongoing royalty. The Court also found that the potential harm to the plaintiff can be remedied at least partially by monetary damages, but if a permanent injunction was issued the defendant would lose millions of dollars in investment and its employees would lose their jobs. In examining whether the public interests would be disserved by an injunction the Court considered that at least some doctors and their patients will suffer a negative impact if the defendant is enjoined from selling its medical device. Given the importance of optimal patient care, the Court found that the public interest weighted against granting a permanent injunction. The Court ultimately allowed the motion for a permanent injunction, but stayed that permanent injunction until the reexamination of the patents at the USPTO. The Court ordered the parties to agree on a sunset royalty rate for the defendant to pay the plaintiff while the permanent injunction is stayed.

Considering all of these circumstances, it appears that S & N has suffered some injury from Hologic’s infringement based on the injury to its right to exclude, the harm from direct competition, and its lost customers and lost opportunities. These injuries are irreparable and favor granting a permanent injunction. However, I find the weight of this factor is somewhat diminished by the possibility that S & N’s asserted patent claims will be invalidated upon reexamination, and by the fact that Hologic apparently increased the total size of the market.

Here, S & N has shown evidence that it has lost market share and lost business opportunities as the result of Hologic’s infringement. In addition, it has suffered the intangible harm associated with the violation of its right to exclusivity. See Douglas Dynamics, LLC v. Buyers Prods. Co., 717 F.3d 1336, 1344–45 (Fed.Cir.2013). Monetary damages are not adequate to fully compensate these injuries, and so this second part of the eBay test also favors entering a permanent injunction. At the same time, although such damages cannot fully repair the harm S & N will suffer from continued infringement, they can nevertheless substantially mitigate S & N’s losses. Moreover, it should be easy to calculate an appropriate ongoing royalty because Hologic tracks the sales of its infringing products separately. So although the inadequacy of monetary damages weighs in favor of a permanent injunction, it does not weigh heavily.

Under these circumstances, I find that the balance of hardships weighs against a permanent injunction. While S & N will suffer if a permanent injunction is denied, its injuries can be at least partially remedied by monetary damages. On the other hand, if a permanent injunction issues, Hologic will immediately lose its $266 million investment—and 159 of its employees will lose their jobs. That hardship is substantially more severe than any faced by S & N. Even considering the fact that Hologic’s investment was (unintentionally) built on infringement, the equities here favor compensating S & N with damages rather than destroying Hologic’s intrauterine device business.

The final part of the eBay test looks to whether a permanent injunction would disserve the public interest. On the one hand, the public interest generally favors protecting the rights of patentees and enforcing the patent system. See ActiveVideo Networks, Inc. v. Verizon Commc’ns, 694 F.3d 1312, 1341 (Fed.Cir.2012); see also Douglas Dynamics, 717 F.3d at 1345–46. But here, there is a strong countervailing public interest in making Hologic’s device available for medical treatment. Hologic has presented evidence showing that at least some doctors consider its product more effective than S & N’s for intrauterine tissue removal. Of course, S & N disputes that evidence; it correctly points out that there is no controlled clinical study showing any advantage for Hologic’s product over S & N’s, and emphasizes that anecdotal evidence about physician preference is not enough to prove an issue of patient safety. See Mallinckrodt, Inc. v. Masimo Corp., 147 Fed.Appx. 158, 177–78 (Fed.Cir.2005). I am nevertheless convinced that at least some doctors and their patients will suffer a negative impact if Hologic is enjoined from selling its medical device. Because different doctors may find one device or the other more suitable for particular intrauterine tissue procedures, health providers and patients benefit substantially from having both products available in the market. Given the importance of optimal patient care, the public interest weighs against granting a permanent injunction here.

The decision here is extremely close. The first two factors of the eBay test weigh somewhat in favor of a permanent injunction, while the third and fourth factors each weigh against it. Importantly, the balance among the four factors is substantially affected by the ongoing reexamination proceedings, which weaken the arguments favoring an injunction and strengthen the arguments against it.8 Balancing the eBay factors as detailed above, I find that S & N will be entitled to a permanent injunction if the reexamination proceedings and any subsequent appeals are eventually resolved in S & N’s favor.9 At present, however, the unresolved PTO reexaminations tip the balance against immediately enjoining Hologic. I therefore allow S & N’s motion for a permanent injunction, but stay that injunction until the reexaminations and any subsequent appeals therefrom are concluded. See Standard Havens Prods. v. Gencor Indus., 996 F.2d 1236, 1993 WL 172432 (Fed.Cir.1993) (table).10 The parties shall *81 confer and agree on an appropriate sunset royalty rate for Hologic to pay S & N while the permanent injunction is stayed. If the parties are unable to agree, the court will determine an appropriate rate.

2016. December 28: Bayer Pharma AG v. Watson Labs., Inc., No. CV 12-1726-LPS, 2016 WL 7468172, at *2 (D. Del. Dec. 28, 2016)

Patent 8,071,577 claims a combined oral contraceptive, a pharmaceutical drug. The patent holder brought action against the defendant pursuant to the Hatch–Waxman Act. The Court found that the proposed product subject to a ANDA application filed by the defendant would infringe the patent held by the plaintiff. Following this judgement, the parties agreed to reset the date of the ANDA procedure to a date not earlier than the date of the expiration of the patents. Nevertheless, the plaintiff moved for additional injunctive relief, seemly to limit the defendant solely to research activities regarding the patented product and prevent the defendant from engaging in pre-commercialization activities that could precede a launch of a generic product. The Court found that the plaintiff failed to show irreparable harm or that the remedies available at law are inadequate, considering that if the defendant launches a generic product during the life of the patent without the FDA approval the defendant will risk civil and criminal sanctions. A prospective harm caused by the launch of products without FDA approval was an unfounded speculation, and the civil and criminal litigation that type of action would be subject to was quantifiable.

Effectively, the parties’ dispute seems to be whether to limit Defendant solely to research activities that are within the Hatch–Waxman Act’s “safe harbor,” 35 U.S.C. § 271(e)(1), or whether instead to allow Defendant to engage in all research and pre-commercialization activity that could precede a launch of a generic product. While there may be valid reasons to limit Defendant’s activities to the extent Plaintiffs request, here Plaintiffs have failed to create a record which would justify such relief.

It is true, as Bayer contends, that Watson seeks to be a direct competitor of Bayer in the market for Natazia® and has committed an “act of infringement” (albeit an “artificial” act) by filing an ANDA. (D.I. 162 at 1–2) But these facts alone are insufficient to establish irreparable harm in all ANDA cases. See generally Alcon, 2010 WL 3081327, at *2. Bayer presents little evidence to support its claim that it will be irreparably harmed in the absence of an injunction. As Watson correctly observes, “Bayer does not submit any data to explain the general magnitude of potential lost revenues or establish any harm to itself as a company.” (D.I. 161 at 4) Although Bayer suggests that it has already been harmed due to changing its marketing plans for Natazia®, Bayer has not proven that Watson’s ANDA filing caused those changes. See Apple Inc. v. Samsung Elecs. Co., 735 F.3d 1352, 1363 (Fed. Cir. 2013) (“[T]he purpose of the causal nexus requirement is to show that the patentee is irreparably harmed by the infringement.”). Indeed, the testimony Bayer relies on suggests that other factors, such as the timing of FDA approval of indications, played a significant role in Bayer’s marketing decisions. (See D.I. 160 Ex. A at 337) While Defendant’s launch of a generic product during the life of the patent is the type of activity that could result in irreparable harm to Bayer, Plaintiffs’ speculation that Defendant will risk criminal sanctions by launching its generic product into the market without FDA approval strikes the Court as entirely unfounded, and FDA approval will not happen until after the expiration of the patent. Moreover, the possible necessity of future litigation with Defendants is slight, and litigation costs cannot support a finding of irreparable harm. See ActiveVideo Networks, Inc. v. Verizon Comm., Inc., 694 F.3d 1312, 1337 (Fed. Cir. 2012) (“Reliance on litigation costs to support a determination of irreparable harm [is] legal error.”). Further support for the conclusion that Bayer has failed to prove irreparable harm is the evidence of the relatively small sales of Natazia®, and the drug’s seemingly close-to-inconsequential place in Bayer’s overall portfolio of corporate activities. (See generally id. at 1–2) (summarizing evidence) Generally, the record lacks evidence of irreparable harm.

Bayer has also failed to show that the remedies available to it at law are inadequate. The costs of litigation, including any future litigation, are quantifiable and can be compensated by money damages. As with the irreparable harm factor, Bayer hypothesizes there could be “a premature product launch,” by which Watson would “flood the market with lower priced generics” before FDA approval. (D.I. 160 at 3) However, as Bayer acknowledges, this would subject Watson “to significant penalties.” (Id. at 3 n.1) Watson contends, without contradiction, that such penalties would be both civil and criminal. (D.I. 161 at 3) It seems unlikely that if Watson—which is in the business of developing and marketing drug products in the United States, all of which require FDA approval—proves willing to risk its relationship with the FDA in order to prematurely and unlawfully launch its generic version of this one product, Natazia®, that an additional order from this Court would prove to be the dispositive deterrent to such unlawful conduct. Thus, Plaintiffs have not demonstrated that legal remedies are inadequate. See also Alcon, 2010 WL 3081327, at *3 (explaining that § 271(e)(4)(A) relief, delaying FDA approval of ANDA, “effectively precludes practice of the [patent-in-suit] outside the context of experimentation … until after the patent’s expiration,” supporting a finding that adequate legal remedies for harm to patentee do exist).

Bayer has succeeded in showing that the balance of hardships favors its requested additional injunctive relief. Bayer stands to lose some of the value of its patent if “infringing activity” is permitted to occur during the life of the patent. By contrast, there would be little, if any, harm to Watson were the Court to grant Bayer’s requested injunction. Watson suggests that the requested injunction would “prevent[ ] Watson from making or using or experimenting with its ANDA product,” which could “chill further experimentation on the product.” (D.I. 161 at 4–5) But Watson does not address whether some of these activities would fall within the safe harbor of § 271(e)(1). Also, the record contains no evidence as to how much more quickly, if at all, Watson could launch its proposed generic product (following FDA approval) without the injunction as compared to with the injunction in place. Thus, while there is little evidence of harm on either side of the balance, the Court concludes from the record that the balance of hardships slightly favors Bayer.

Finally, the public interest also appears, slightly, to favor Bayer. Here, the public has an interest in having what could be a somewhat earlier launch of a generic drug, which favors Watson, but the public also has an interest in protecting valid patents and encouraging investment in new pharmaceutical products. Neither side presented evidence on these points. However, given that the FDA already must delay approval of the product until after the expiration of the patent, the Court finds that the public interest would not be disserved by an additional injunction of equal duration being directed to Watson.

In sum, Bayer has failed to show irreparable harm or that the remedies available at law are inadequate, although Bayer has succeeded in showing that the balance of harms and the public interest do support the additional requested injunction. Weighing all of the pertinent considerations, the Court has determined that the most reasonable exercise of its discretion is to deny the requested permanent injunction.

 

Patent infringement cases where injunctions were granted

2006. September 28: Smith & Nephew, Inc. v. Synthes (U.S.A.), 466 F. Supp. 2d 978, 983 (W.D. Tenn. 2006), amended in part, No. 02-2873 MA/A, 2006 WL 8435285 (W.D. Tenn. Oct. 27, 2006)

Patents 5,167,663 and 5,312,406 claim intramedullary nails, a medical device, and the methods used in the treatment of intertrochanteric femoral fractures using interfragmentary compression. Patent holder brought action against a competitor for patent infringement, and requested a permanent injunction. Following the finding of infringement, both parties briefed the Court on the issue of a permanent injunction. The Court found that lost of profits and loss of brand name recognition suffered by the plaintiff due to sales of infringing product by the defendant constitute injuries that are both incalculable and irreparable. In its analysis of the balance of hardship and the public interest, the Court took into consideration the availability of other, similar products in the market – which weighted in favor of the grant of a permanent injunction.

The loss of market share and the resulting lost profits and loss of brand name recognition which Smith & Nephew suffered because of Synthes’ continued sale of the infringing products constitute injuries that are both incalculable and irreparable. The court finds no support for Synthes’ assertions that Smith & Nephew has not been irreparably harmed because of the limited competition between the primary Smith & Nephew product covered by the ′663 and the ′406 patents and the infringing products made by Synthes.

Relief in the form of monetary damages alone would not meet the ends of justice here because this remedy would allow the infringement to continue. Monetary damages generally are not an adequate remedy against future infringement because the central value of holding a patent is the right to exclude others from using the patented product. Telequip Corp. v. The Change Exchange et al., 2006 WL 2385425, *2, 2006 U.S. Dist. LEXIS 61469, at *4 (N.D.N.Y., Aug. 15, 2006) (citing Honeywell Int’l Inc. v. Universal Avionics Sys. Corp., 397 F.Supp.2d 537, 546 (D.Del.2005)).

No considerable hardship will be imposed on physicians or patients when the injunction is imposed because other competing products would fill any temporary void created by the injunction.

Any minor disruption to the distribution of the infringing products will not negatively affect the public or those involved in the chain of distribution because none of the data on the record establishes undisputed and enormous public reliance on Synthes’ products and because other, similar products are available in the market.

2007. October 30: Martek Biosciences Corp. v. Nutrinova Inc., 520 F. Supp. 2d 537, 558–59 (D. Del. 2007), aff’d in part, rev’d in part, 579 F.3d 1363 (Fed. Cir. 2009)

Patents 6,451,567, 5,340,594, and 6,410,281 claim a process for production of microbial products with a high concentration of highly unsaturated fatty acids and processes for growing microorganisms. Patent holder brought action against a competitor for patent infringement. Following a jury verdict in his favor, the patent holder filed a motion for permanent injunction. The Court found that the plaintiff suffered and would continue to suffer irreparable harm absent a permanent injunction against the infringement of the relevant patents by the defendant, as it is likely to lose market share that it may not be able to recapture. In its analysis of the balance of hardship the Court took into consideration that while microbial products were only a small percentage of the defendant’s total business, the sale of nutritional oils, including microbial products, were the primary source of revenue for the defendant.

Turning to the four-factor test, the court finds that entry of a permanent injunction with respect to the ′594 and ′281 patents is warranted.15 The court first concludes that Martek has suffered irreparable harm because of Lonza’s infringement of Martek’s right to exclude others from practicing the ′594 and ′281 patents. Here, Martek paid approximately $60 million to acquire Omega Tech, Inc. and its patents, which include the ′594 and ′281 patents. (D.I. 305, Ex. A ¶¶ 2–4.) In addition, Lonza is Martek’s only competitor in the vegetarian DHA market for adult foods and beverages, and is targeting Martek’s customers in that industry. (Id. ¶ 18.) License and supply agreements with food and beverage manufacturers are long-term. (Id. ¶ 19–20.) Accordingly, Martek expects to exclude Lonza from marketing and selling DHA food and beverages in order to increase its value by securing contracts with companies in the adult food and beverage industry. Based on these circumstances, Martek has suffered irreparable harm. Martek will continue to suffer such harm if Lonza is not enjoined from infringing the ′594 and ′281 patents, as it is likely to lose market share that it may not be able to recapture.

The court next finds that legal remedies are not adequate to compensate Martek for the infringement of the ′594 and ′281 patents. The statutory right to exclude represents a tangential benefit associated *559 with patent rights that cannot be quantified in monetary damages. Fisher–Price, Inc. v. Safety 1st, Inc., 279 F.Supp.2d 526, 528 (D.Del.2003) (citation omitted). Indeed, as previously mentioned, Lonza is Martek’s only competitor in the food and beverage vegetarian DHA market, and Martek has a right to exclude its rival from using its proprietary technology. Novozymes A/S v. Genencor Intern., Inc., 474 F.Supp.2d 592, 613 (D.Del.2007).

The balance of hardships also favors Martek. While DHA represents only a small percentage of Lonza’s total business, Martek’s primary source of revenue is the sale of nutritional oils, including DHA. (D.I. 305, Ex. A ¶¶ 7; D.I. 305, Ex. J.) Additionally, Lonza makes no argument with respect to this factor. Thus, it appears as though Lonza agrees that the balance of hardships tips in Martek’s favor.

Finally, Lonza has presented no evidence nor made any argument that a permanent injunction would harm the public. Moreover, as this court has previously explained, “it is almost redundant to note the substantial interest in enforcing valid United States patents, while the court perceives no countervailing harm to the public [—such as that the infringing products are medically necessary or that their removal from the stream of commerce would harm the public—] in granting the requested injunctive relief.” Fisher–Price, 279 F.Supp.2d at 528. Accordingly, after having analyzed the four factors articulated in eBay, the court concludes that Lonza should be enjoined from infringing the ′594 and ′281 patents.

2008. October 2: Amgen, Inc. v. F. Hoffman-La Roche Ltd., 581 F. Supp. 2d 160, 168 (D. Mass. 2008), aff’d in part, vacated in part, remanded sub nom. Amgen Inc. v. F. Hoffman-La Roche Ltd, 580 F.3d 1340 (Fed. Cir. 2009)

Patents 5,441,868, 5,547,933, 5,618,698, 5,621,080, 5,756,349, and 5,955,422 claim recombinant erythropoietin (EPO), a naturally occurring protein that stimulates the production of red blood cells. The patent holder brought infringement actions against a competitor. Following a jury verdict in its favor, the plaintiff filed a motion for a permanent injunction. The the Court found that the value of the patents at issue, the plaintiff stock price, and its ability to attract investment for research and development would be greatly diminished absent the grant of a permanent injunction. According to the Court, these harms were potentially immense and unquantifiable, while monetary damage was inadequate. In its analysis of the public interest, the Court determined that it was not clear whether the competing product commercialized by the defendant offered an advantage that would justify the denial of a permanent injunction. The Court considered that ‘ any marginal health or economic benefits would be outweighed by the potential harm to the incentives for innovation underlying the patent system’.

Amgen has satisfied all four factors necessary for a permanent injunction set forth in eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388, 126 S.Ct. 1837, 164 L.Ed.2d 641 (2006). Failure to issue a permanent injunction would cause irreparable, immeasurable harm, for which there is no adequate remedy at law. Given that Roche infringes Amgen’s valid patents, and in light of the harms that will be discussed, the balance of hardships clearly favors Amgen. Moreover, the Court has concluded that “the public interest would not be disserved by a permanent injunction.” Id. at 391, 126 S.Ct. 1837. The *168 record compiled over the course of a four-day evidentiary proceeding reveals no benefit to patient health or the public coffers so great as to outweigh the public’s interest in a robust patent system.

Roche’s entry into the market, despite a judgment of infringement, could encourage other would-be infringers to attempt to gain access, resulting in significant litigation expenses and uncertainty about the value of Amgen’s patents. Simply put, the value of the patents at issue, which are admittedly “the foundation of Amgen’s business,” see Pl.’s Mem. Supp. Perm. Inj. [Doc. 1578] at 12, would be greatly diminished. Amgen’s stock price would fall along with its ability to attract investment for research and development. In addition, producing and marketing MIRCERA would enable Roche to develop infrastructure that would make Roche a viable competitor not only in the ESA market, but also in markets for future drugs.
In view of these potentially immense and unquantifiable harms, the Court concludes that failure to enter a permanent injunction would result in irreparable harm for which monetary damages are inadequate. Furthermore, because Amgen’s patents are valid, enforceable, and infringed, and in light of the potential harms described above, there can be little doubt that the balance of hardships favors Amgen. Thus, the first three eBay factors strongly favor an injunction.

First, although an additional choice would undoubtedly benefit patients and doctors, it is not clear that MIRCERA offers an advantage so appreciable that it would justify abrogation of Amgen’s monopoly privilege. Any conclusions regarding a potential savings to Medicare are too speculative to justify the denial of a permanent injunction. In fact, the warped economic incentives created by Medicare reimbursement and speculation about changes in regulation mean that MIRCERA’s presence on the market might actually result in more expensive drugs for consumers. Finally, any marginal health or economic benefits would be outweighed by the potential harm to the incentives for innovation underlying the patent system. In short, the Court cannot conclude that granting a permanent injunction disserves the public interest.

2009. June 1: Haemonetics Corp. v. Baxter Healthcare Corp., No. CV 05-12572-NMG, 2009 WL 10692802, at *3 (D. Mass. June 1, 2009), modified, No. CV 05-12572-NMG, 2009 WL 10692829 (D. Mass. June 24, 2009)

Patent 6,705,983 claims instruments and related equipment used to collect blood and separate whole blood into its three main components (plasma, platelets and red blood cells). Patent holder brought infringement action. Following a jury verdict in its favor, the plaintiff filed a motion for a permanent injunction against future infringement by the defendant or, in the alternative, a royalty -of 15% and 20, depending on the field of use- on the gross sales revenue of infringing products. The Court found that absent an injunction, the sale of infringing products by the defendant will irreparably harm the plaintiff by capturing market share that would otherwise belong to the plaintiff. 

Absent an injunction, Fenwal will continue to infringe the ‘983 patent by making and selling the Alyx system. Haemonetics argues that Fenwal, as Haemonetics’ sole competitor in the market for portable automated systems for collecting red blood cells, will irreparably harm Haemonetics by capturing market share that would otherwise belong to Haemonetics (if there were no Alyx). See Acumed LLC v. Stryker Corp., 551 F.3d 1323, 1328 (Fed. Cir. 2008); Amgen, Inc. v. F. Hoffman–La Roche Ltd., 581 F. Supp. 2d 160, 212 (D. Mass. 2008) (finding that allowing an infringer to be a direct competitor would irreparably cause harm to the patentee through “lost profits, market share, and good will”).

Haemonetics’ injury stems, in fact, from the loss of its “right to exclude competitors from infringing the patent.” See Acumed, 551 F.3d at 1328. Money damages cannot compensate for Haemonetics’ inability to assert that right. Id. The fact that Haemonetics has asked for a royalty in the event that an injunction is not entered does not preclude it from seeking money damages in any event, despite the defendants’ argument to the contrary.

Haemonetics contends that its potential losses absent an injunction counterbalance any harm Fenwal would suffer if an injunction were entered, particularly in light of the fact that hardship incurred from merely ceasing operations is insufficient to tilt the scale in Fenwal’s favor. See Smith & Nephew, Inc. v. Synthes (U.S.A.), 466 F. Supp. 2d 978, 984 (W.D. Tenn. 2006). The defendants respond that the cost of having to design around the ‘983 patent would be very costly and thus cause them tremendous hardship. That hardship, however, is also insufficient to tip the scale. See Callaway Golf Co. v. Acushnet Co., 585 F. Supp. 2d 600, 622 (D. Del. 2008) (“The court is not in the business of making defendants’ infringements easier to unravel.”). Accordingly, the third eBay factor does not weigh against the entry of an injunction.

Thus, rather than hypothesize about what royalty the jury may have awarded Haemonetics, the Court will proceed to consider the relevant factors set forth in Georgia–Pacific Corp. v. U.S. Plywood–Champion Papers, Inc., 446 F.2d 295 (2d Cir. 1971), upon which both Haemonetics’ damages expert at trial and defendants’ expert Dr. Bergin relied. First, it is notable that Haemonetics did not license the ‘983 patent to anyone (regardless of whether it considered doing so), suggesting that it placed a high value on the patent. Next, Haemonetics and Fenwal are direct and nearly exclusive competitors in the market for red blood cell collection. Fenwal’s use of the ‘983 patent thus prevents Haemonetics from maintaining a monopoly on products covered by that patent. Moreover, Fenwal has found the Alyx to be so successful that it is expanding its use to markets other than for the collection of two units of red blood cells (involving the collection of plasma and platelets). All of those factors weigh in favor of a higher royalty.


The 15% royalty sought by Haemonetics does, however, appear to be excessive, especially considering that, 1) pursuant to its purchase agreement, Haemonetics agreed to pay the inventor of the ‘983 patent a royalty of approximately two percent and 2) Haemonetics itself has not used the patent. Accordingly, the Court will award a royalty of ten percent (10%) to Haemonetics.

Haemonetics requests that the Court require the payment of a royalty for every infringing sale of an Alyx disposable kit and “ancillary product” (including a cart and work station for the Alyx system) made after the verdict. The defendants reject Haemonetics’ proposed application of a royalty to “ancillary products” because those products were not found to infringe the ‘983 patent. The Court will not impose a royalty on all products associated with the Alyx centrifugal device because it is reasonable to assume that Fenwal will develop a non-infringing device that works with the other non-infringing components of the Alyx system. Accordingly, the royalty will apply only to sales of the Alyx disposable kits.
*7 Furthermore, the defendants contend that any royalty should be calculated on the basis of “net sales,” which the defendants suggest and the Court hereafter will define as gross sales less returns, discounts and other price reductions, not on the basis of gross sales as Haemonetics proposes. The defendants contend that the gross sales figure bears no relation to the amount of money Fenwal actually collects. That contention is reasonable and, accordingly, the royalty will be calculated on the basis of net sales.

 

2009. September 4: Spectralytics, Inc. v. Cordis Corp., 650 F. Supp. 2d 900, 921 (D. Minn. 2009), aff’d in part, vacated in part, 649 F.3d 1336 (Fed. Cir. 2011)

Patent 5,852,277 claims an apparatus for cutting a piece of metal tubing with a laser to make a stent, a medical device. Patent holder brought an infringement action against a competitor. Following a jury verdict in its favor, the plaintiff filed a motion for a permanent injunction to forbid the defendant from infringing the patent in the future. The defendant asserted that they no longer use the technology covered by the relevant patent, and based on this assertion the Court found that the hardship on the defendant was minimal and that the public interest will not be disserve with the grant of a permanent injunction.

 

The Court finds that Spectralytics has satisfied this test with respect to any possible future use by Cordis and Noble of the ′277 patent. In particular, the balance of hardships and the public interest tip decidedly in Spectralytics’s favor. From Cordis and Noble’s assertion that they no longer use the ′277 patent, it follows that an injunction will impose no great hardship on them and will not disserve the public interest. The Court therefore grants Spectralytics’s request for injunctive relief.

2009. September 10: Fresenius Med. Care Holdings, Inc. v. Baxter Int’l, Inc., No. C 03-1431 SBA, 2008 WL 928496, at *1 (N.D. Cal. Apr. 4, 2008), aff’d in part, rev’d in part sub nom. Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288 (Fed. Cir. 2009)

Patents 5,247,434, 5,744,027, and 6,284,131 claim a hemodialysis machine integrated with a touch screen user interface, a medical device. A competitor brought a declaratory judgment action against the patent holder, and the patent holder filed a counterclaim for infringement. Following a jury verdict in its favor, the plaintiff filed a motion for a permanent injunction. The Court found that the harm to the plaintiff’s reputation as an innovator resulting from the defendant’s infringing actions was an injury not compensable by damages. The Court also considered that the loss of reputation, goodwill, and the loss of the right to exclude are forms of injury that cannot be easily quantified, which weighs against the adequacy of monetary damage as remedy for future infringement. The Court also took into consideration, in its analysis of the balance of hardship, that the defendant could easily implement alternatives to the patented technology.

Additionally, the harm to Baxter’s reputation resulting from Fresenius’s wrongful appropriation of Baxter’s technology forms a basis for injunctive relief. It is well-established that harm to reputation as an innovator is an injury “not compensable by damages .” Muniauction,502 F.Supp.2d at 483 (“such a harm is not compensable in damages, and is irreparable, making equitable relief appropriate”); Black & Decker Inc. v. Robert Bosch Tool Corp., 2006 WL 3446144 at *4 (N.D.Ill.2006) (reputation as an innovator harmed by continued selling of infringing product); Wald v. Mudhopper Oilfield Servs., Inc., 2006 WL 2128851 at *5-6 (W.D.Okla.2006) (patentee’s “reputation for innovation” was damaged as a result of defendant’s infringement).

Allowing Fresenius to continue to infringe would irreparably harm Baxter’s reputation and goodwill as an innovator, threaten Baxter’s extensive investments in research and development, and potentially encourage other companies to infringe Baxter’s intellectual property. The evidence at trial showed that Baxter annually invests over half a billion dollars each year on research and development, purchases new technology to expand its reach into new markets, and spends tens of millions of dollars to license technology from other companies. See Oct. 24, 2007 Tr. 169:5-170:9; Oct. 25, 2007 Tr. 12:17-19. This investment will be largely for naught, and Baxter’s reputation as an innovator and the associated goodwill will be tarnished, if Fresenius, Baxter’s arch-rival in the renal field, is allowed to market and sell a product that Baxter, and not Fresenius, invented. Accordingly, this factor favors an injunction.

Here, the loss of goodwill, reputation for innovation, the legal right to exclude, including the right to control the terms of any licensing arrangement, are all forms of irreparable injury that cannot be easily and readily quantified through a simple monetary award. This factor favors an injunction

The evidence Fresenius offered at trial that it has numerous, easily-implemented alternatives to the patented technology supports a finding that the balance of hardships tips in Baxter’s favor. Fresenius’s CEO has conceded that “there are a lot of ways to approach data input” and an injunction would not be a “big issue.” Mot for New Trial, Ex. 2. Fresenius’ lead engineer even listed some of the many inexpensive, non-infringing alternative designs readily available to Fresenius, such as “a mouse, a touch pad, a keyboard, so on and so forth.” See Oct. 26, 2007 Tr. 472:4-9; see also June 2006 Tr. 390:3-9. Additionally, Daniel Rubinfeld, Fresenius’ damages expert, opined that a “design around” in the year 2000 would have cost between $200,000-$1,000,000 and take about six to nine months to implement. Docket No. 452, Exhibit 1, Rebuttal Expert Report of Daniel L. Rubinfeld, 219. Fresenius’s Chairman testified that a touch screen was only $40 less expensive than using a mouse, keyboard, or scratchpad. Oct. 26, 2007 Tr. 503:24-504:22; see also Oct. 25, 2007 Tr. 199:13-17. Based on these admissions, Fresenius cannot be heard to now argue that implementing another input device would cause it undue hardship or disadvantage. Muniauction, 502 F.Supp.2d at 484 (W.D.Pa.2007) (rejecting hardship arguments where “[a]t trial, defendants presented numerous low-cost, easily executed replacements for the [infringing] system”).

Additionally, in cases where the infringer is capable of selling non-infringing items, the balance of hardships favors the patentee. MGM Well Servs., Inc. v. Mega Lift Sys. LLC, 505 F.Supp.2d 359, 379 (S.D.Tex.2007). Fresenius repeatedly argued that the 2008H is an “excellent machine” and performs hemodialysis just as well as the 2008K. See Oct. 26, 2007 Tr. 462:3-463:3; June 2006 Tr. 263:12-264:4; 310:24-311:21. Having relied upon the 2008H as its “non-infringing alternative” in this litigation, Fresenius cannot now disavow that stance and claim hardship in being made to rely on that machine.

Numerous courts have granted permanent injunctions in cases involving medical devices where, as here, there were alternative products already on the market or available to the infringer. See Innogenetics, N.V. v. Abbott Labs., 2007 U.S. Dist. LEXIS 3148, at * 1-2 (W.D.Wis. Jan. 12, 2007) (granting permanent injunction, where “other diagnostic techniques exist[ed] and would suffice, even if they are not as effective as the patented technique.”); Smith & Nephew, 466 F.Supp.2d 978 (granting permanent injunction enjoining sale of medical related product where, among other things, similar products were available on the market).

2010. September 30: Streck, Inc. v. Research & Diagnostic Sys., Inc., No. 8:06CV458, 2010 WL 11530582, at *3 (D. Neb. Sept. 30, 2010), aff’d, 665 F.3d 1269 (Fed. Cir. 2012)

Patents related to controls for use on hematology instruments. Patent holder brought an infringement action against a competitor. Following a jury verdict in its favor, the plaintiff filed a motion for a permanent injunction. The Court found that sales by the defendant have the potential to greatly impact the market share of the plaintiff in the future, because the defendant undercuts the plaintiff prices. The Court also noted that the defendant competes directly with the plaintiff, targeting its customers. The Court took this as evidence of irreparable injury absent a permanent injunction. The Court also considered that other remedies would be inadequate to compensate the plaintiff for the loss of brand name recognition and goodwill if infringement continues. In its analysis of whether the public interests would be disserved, the Court took into consideration that the plaintiff showed that it has the ability to supply the market with necessary quantities of the product and that other reasonable alternative technology were available.

Although medical care is involved, there has been no showing that restraining R&D from selling integrated controls would implicate public health and safety concerns. Streck has shown it has the ability to supply the market with necessary quantities of the products. If there were any shortage, laboratories, hospitals, and clinics have the reasonable alternative of testing instruments with nonintegrated controls.

The court first finds Streck has demonstrated irreparable injury. R&D directly competes with Streck in the market for integrated reticulocyte controls. Streck and R&D are the only two competitors, so every sale by R&D is a lost sale to Streck. Streck has shown a loss of market share, profits, and potential revenue as a result of R&D’s infringement and there will likely be such loss in the future. Moreover, Streck’s integrated reticulocyte control business, which accounted for about one-third of Streck’s total sales in 2009 is threatened by R&D’s steadily increasing infringing sales. Streck’s exclusive arrangements with instrument manufacturers is an important component of its marketing strategy. R&D competes directly with Streck for Beckman Coulter’s business and Beckman Coulter is the world’s largest hematology instrument manufacturer. R&D’s infringing sales have the potential to greatly impact Streck’s market share in the future because R&D undercuts Streck’s prices. Further, the evidence shows that R&D designed its infringing products to compete directly with Streck’s controls and R&D targets Streck’s customers.

Streck has also demonstrated that legal remedies are inadequate. Although the jury verdict may adequately compensate Streck for its past injuries, the threat of continuing infringement exists, since R&D will continue to sell the infringing products absent an injunction. Loss of brand name recognition and customer goodwill are the types of injuries that are often incalculable and irreparable. Streck has shown that it has excellent name recognition and goodwill and the loss associated with damage to its brand or goodwill is difficult to quantify. The inability to calculate Streck’s future loss with reasonable precision makes legal remedies inadequate in this case.

The court further finds that the court’s assessment of the balance of harms favors granting an injunction to Streck. The evidence shows that R&D will continue to market its infringing products in direct competition with Streck’s products if not enjoined. Without a permanent injunction, Streck will continue to suffer irreparable injury to a significant portion of its business, and will lose future opportunities, goodwill, and potential revenue. In contrast, the integrated control market is a small part of R&D’s overall business and the negligible harm inflicted on R&D by the injunction is outweighed by the potential harm to Streck in denying the injunction. In the context of a permanent injunction, the overall balance of hardships favors Streck. R&D remains free to sell its noninfringing products.

Further, the court finds the public interest will not be disserved by an injunction. Although medical care is involved, there has been no showing that restraining R&D from selling integrated controls would implicate public health and safety concerns. Streck has shown it has the ability to supply the market with necessary quantities of the products. If there were any shortage, laboratories, hospitals, and clinics have the reasonable alternative of testing instruments with nonintegrated controls. An injunction strikes a workable balance between protecting Streck’s rights as a patentee and protecting the public. Both a jury and this court have found that R&D has infringed Streck’s patents. Upholding patent rights against an adjudicated infringer satisfies the public’s interest in a strong patent system. The court thus concludes that the public interest also weighs in favor of Streck.

2011. August 5: Pozen Inc. v. Par Pharm., Inc., 800 F. Supp. 2d 789, 824–25 (E.D. Tex. 2011), aff’d, 696 F.3d 1151 (Fed. Cir. 2012)

Patents 6,060,499, 6,586,458, 7,332,183 claim a pharmaceutical drug and corresponding methods for the treatment of migraine headaches. Patent holder brought infringement action against an ANDA applicant, and requested a permanent injunction. The Court found that the ANDA products infringed the plaintiff’s patents. With regards to the irreparable harm for the purpose of deciding a permanent injunction, the Court found that the launch of a generic product would significantly affect the plaintiff’s revenue stream and the entry of a competitor at a lower price would affect the plaintiff market share.      

As demonstrated by Pozen’s agreement with GSK, the launch of a generic product would significantly affect Pozen’s revenue stream. Such a reduction of revenue would subsequently impact Pozen’s ability to allocate its resources to product development. Likewise, Pozen would be harmed from the introduction of Defendants’ ANDA products, which at a lower cost, would undoubtedly affect Pozen’s market share. Taken together, Pozen has demonstrated that without a permanent injunction, it would suffer irreparable harm. See, e.g., Abbott Labs., 544 F.3d at 1361–62 (affirming the district court’s conclusion that price erosion from current generic competition did not negate irreparable harm from the market share and revenue loss upon the entry of another generic competitor); Sanofi–Synthelabo v. Apotex, Inc., 470 F.3d 1368, 1382–83 (Fed.Cir.2006) (affirming the district court’s finding of irreparable harm based, in part, on price erosion); Purdue Pharma L.P. v. Boehringer Ingelheim GMBH, 237 F.3d 1359, 1368 (Fed.Cir.2001) (likelihood of price erosion and loss of market position are evidence of irreparable harm).

The commercial entry of Defendants’ ANDA products would launch a cascade of consequences that, as provided above, cannot be undone. Defendants’ proposed ANDA products violate the of exclusionary rights of Pozen’s patents-in-suit. Remedies at law, such as monetary damages, are inadequate to compensate for such consequences. Accordingly, monetary damages cannot adequately compensate for the commercialization of Defendants’ infringing products.

The public interest in a permanent injunction does not tip in favor of either party. The importance of the patent system is encouraging innovation, as the “encouragement of investment-based risk is the fundamental purpose of the patent grant, and is based directly on the right to exclude.” See Sanofi–Synthelabo, 470 F.3d at 1383. Nor is the public harmed by a permanent injunction, as Treximet is readily supplied to patients. On the other hand, as Defendants contend, the public would benefit from their lower priced generic ANDA products. However, a reduction of cost to consumers is balanced by the possibility of premature elimination of Pozen’s patent rights.

2011. September 30: Sanofi-Aventis Deutschland GmbH v. Glenmark Pharm. Inc., 821 F. Supp. 2d 681, 694 (D.N.J. 2011), aff’d and remanded sub nom. Sanofi-Aventis Deutschland GmbH v. Glenmark Pharm. Inc., USA, 748 F.3d 1354 (Fed. Cir. 2014)

Patent 5,721,244 claims an angiotensin-converting enzyme inhibitor and calcium antagonist, a pharmaceutical drug used to treat hypertension. The patent holder brought infringement action against a competitor. Following a jury verdict in its favor, the plaintiff filed a motion for a permanent injunction. In its analysis of irreparable harm the Court took into consideration evidence presented by the plaintiff of lost sales, lost market share and price erosion with the entrance of direct competition. The Court also suggested that monetary damages are inadequate because ‘absent an injunction, Plaintiffs are essentially forced into a compulsory licensing arrangement with a direct competitor, and effectively shut out of enforcing their patent rights.’ In its analysis of whether the public interests would be disserved, the Court considered that the lack of lower cost generics with the grant of a permanent injunction is a ‘legitimate concern’, but that it ‘does not outweigh the public interest in protecting and promoting patent rights”

Plaintiffs and Glenmark are direct competitors in the Tarka marketplace, and, at trial, Plaintiffs presented evidence demonstrating lost sales, lost market share and price erosion. Accordingly, this Court finds that Plaintiffs have shown that they have suffered irreparable harm, and this factor weighs in favor of a permanent injunction.

Plaintiffs and Defendants are two head-to-head competitors in the Tarka marketplace; every sale of Defendants’ generic Tarka is a lost sale by Plaintiffs. As discussed above, Plaintiffs have suffered a loss of market share, harm to reputation, and price erosion, all of which are facts that tend to establish the inadequacy of a legal remedy. See PATENT CASE MANAGEMENT JUDICIAL GUIDE Table 9.1 (2009). Additionally, “a patent holder refusal to grant a license and its engagement in lengthy litigation to protect that business decision,” as occurred here, also weighs in favor of finding the remedy at law inadequate. See id. Most importantly, money damages are inadequate because, absent an injunction, Plaintiffs are essentially forced into a compulsory licensing arrangement with a direct competitor, and effectively shut out of enforcing their patent rights. Accordingly, this Court finds that remedies at law are inadequate and this factor weighs in favor of a permanent injunction.

Plaintiffs argue that the public interest weighs in favor of enforcing its patent rights. Pointing to the $290 million dollar payment Abbott made to Sanofi Aventis for exclusive manufacturing rights to Tarka, which included a $151 million dollar payment for the ′244 patent with ongoing royalties for sales, Abbott argues that this investment was made with the expectation that the investment could be recouped by selling, to the exclusion of all others, the patented product. Defendants argue that there is a public interest in making lower cost drugs available to consumers, and that if Defendants are enjoined the public will be harmed because they will no longer enjoy the lower cost generic Tarka but rather would be subject to higher prices set through Abbott’s monopoly on the market.

Although Defendants raise a legitimate concern, this concern does not outweigh the public interest in protecting and promoting patent rights. “[S]elling a lower priced product does not justify infringing a patent,” and although the Hatch–Waxman Act encourages making lower cost generic drugs available to the public, “it does not do so by entirely eliminating the exclusionary rights conveyed by pharmaceutical patents. Nor does the statutory framework encourage or excuse infringement of valid pharmaceutical patents.” Pfizer, Inc. v. Teva Pharms. USA, Inc., 429 F.3d 1364, 1382 (Fed.Cir.2005) (internal citations omitted). Abbott invested significant resources with the expectation that it would be able to recoup its investment, and the patent system is designed to provide incentives for innovative drug companies to continue costly development efforts. See Sanofi–Synthelabo, 470 F.3d at 1383. If generic pharmaceutical companies were free to disregard patent rights and simply piggy back off the innovations of others, then the incentives the patent system is designed to promote, namely those that encourage continued investment in costly drug development, would disappear. Accordingly, this Court finds that this factor weighs in favor of a permanent injunction.

2014. January 13: Allergan, Inc. v. Sandoz Inc., No. 6:11-CV-441, 2014 WL 12622277, at *26–27 (E.D. Tex. Jan. 13, 2014), aff’d, 796 F.3d 1293 (Fed. Cir. 2015)

Patents 7,851,504, 8,278,353, 8,299,118, 8,309,605, and 8,339,479 claim a 0.01% bimatoprost ophthalmic solution, a pharmaceutical drug indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. The patent holder brought infringement action against an ANDA applicant, and requested a permanent injunction. The Court found that the ANDA products infringed the plaintiff’s patents. With regards to the irreparable harm for the purpose of deciding a permanent injunction, the Court found that the launch of a generic product would significantly affect the plaintiff’s market share and the price of the product would be eroded. The Court found that it was difficult, if not impossible, to quantify the potential harms caused by lost sales, price erosion, lack of reinvestment potential, and injury to goodwill and reputation to the plaintiff absent a permanent injunction.

Allergan’s market share would be quickly eroded with the introduction of generic products. Market erosion is expected when generics are introduced, as was the case with Xalatan®. While patented, Xalatan® was the leading drug in the prostaglandin-analog class, controlling approximately 50% of the prostaglandin market. When Xanatan® went off patent, generics flooded the market. Two months after the introduction of generics, Xalatan® lost 90% of its market share, and within 12 months it lost a total of 95% of its market share. Currently, branded Xalatan® maintains only 1% of the market. Lumigan® 0.01% would suffer the same fate if generics entered into the market.

In addition to lost market share, the price of Lumigan® 0.01% would also suffer erosion. Increased competition by cheaply available generics would put downward pressure on Allergan’s price in order for Lumigan® 0.01% to remain competitive in the marketplace.

The Court also finds that the revenue loss from generic entry would directly affect Allergan’s ability to invest in the development of new treatments, harming both Allergan and ailing patients.

It would be difficult, if not impossible, to quantify all these harms from lost sales, price erosion, lack of reinvestment potential, and injury to goodwill and reputation. This further demonstrates the harm is irreparable and could not be later compensated by an award of damages.

2014. August 14: Janssen Prod., L.P. v. Lupin Ltd., 109 F. Supp. 3d 650, 697 (D.N.J. 2014), modified, No. 10-5954 (WHW), 2016 WL 1029269 (D.N.J. Mar. 15, 2016)

Patents 7,126,015, 7,700,645, and 7,772,411 claim darunavir, a human immunodeficiency virus (HIV–1) protease inhibitor. The patent holder brought infringement action against an ANDA applicant, and requested a permanent injunction. The Court found that the ANDA products infringed the plaintiff’s patents. With regards to the irreparable harm for the purpose of deciding a permanent injunction, the Court found that the launch of a generic product would significantly harm the plaintiff in the form of lost sales, price erosion, diminished research and development assets, and having to compete directly with an entity selling a product made by an infringing process.

The Court finds that these four circumstances—lost sales, price erosion, diminished research and development assets, and having to compete directly with an entity selling a product made by an infringing process—together demonstrate that Janssen will be irreparably harmed absent an injunction.

The record shows that Janssen will not only lose sales and be forced to compete with a direct competitor, but that the competition with its direct competitor will lead directly to the destruction of its Prezista business. Monetary compensation can alleviate some of that loss, but it cannot fully account for the harm of being taken out of the market. Even were Lupin able to satisfy a judgment,9 “a defendant’s ability to pay a judgment does not defeat a claim that an award of damages would be an inadequate remedy. Rather, a defendant’s ability to pay merely indicates that a court should look to other considerations to determine whether a damages award will adequately compensate the patentee for the harm caused by continuing infringement.” Apple III, 735 F.3d at 1369. And “[t]here is no reason to believe that [Lupin] will stop infringing, or that the irreparable harms resulting from its infringement will otherwise cease, absent an injunction.” Robert Bosch LLC, 659 F.3d at 1155. The Court finds that remedies available at law would be inadequate.

2014. December 16: Rawcar Grp., LLC v. Grace Med., Inc., No. 13-CV-1105 H (BLM), 2014 WL 12577590, at *9 (S.D. Cal. Dec. 16, 2014)

Patents 8,042,549 and 8,286,637 claim collapsible sterile drapes used to cover certain non-sterile medical instruments for use during surgery, including radiological or imaging units, to maintain a sterile surgical field. The patent holder brought action for infringement against a competitor. The Court found that the defendant willfully infringed the patents, and that a permanent injunction was warranted. In its analysis of irreparable harm, the Court considered the fact that the plaintiff and the defendant were direct competitors. The Court also considered this factor to conclude that monetary damages are not an adequate remedy. The defendant failed to submit evidence of the hardship it would suffer with the issuance of a permanent injunction. The defendant also failed to submit evidence of a critical public interest that would be harmed by the grant of an injunction.

Plaintiff and Defendants are direct competitors in the same market for surgical drapes. (Doc. No. 226 at 23.) Plaintiff’s first amended complaint alleges that Defendants have infringed and continue to infringe Plaintiff’s patents, and that as a direct result of Defendants’ infringement, Plaintiff has suffered irreparable harm. (Doc. No. 69 at ¶¶ 58, 64.) Further, because the parties are direct competitors, monetary damages are not an adequate remedy to compensate Plaintiffs. See Hybritech, Inc. v. Abbott Labs, 849 F.2d 1446, 1456-57 (Fed. Cir. 1988) (“because the principal value of a patent is its statutory right to exclude, the nature of the patent grant weighs against holding that monetary damages will always suffice to make the patentee whole”). In addition, the balance of the hardship weighs strongly in favor of Plaintiff because Plaintiff has suffered irreparable harm from Defendants’ infringement, and the defendants have not submitted any evidence or argument regarding their own harm. The Court also notes that there is a “strong public policy favoring the enforcement of patent rights,” PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1567 (Fed. Cir. 1996), and Defendants have not submitted any evidence of a critical public interest that would be harmed by the grant of an injunction. Finally, “Courts awarding permanent injunctions typically do so under circumstances where plaintiff practices its invention and is a direct market competitor.” Adv. Cardiovascular Sys., Inc. v. Medtronic Vascular, Inc., 579 F. Supp. 2d 554, 558 (D. Del. 2008).

2016. August 25: Vanda Pharm. Inc. v. Roxane Labs., Inc., 203 F. Supp. 3d 412, 435–36 (D. Del. 2016), aff’d sub nom. Vanda Pharm. Inc. v. W.-Ward Pharm. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018)

Patent 8,586,610 claim iloperidone, a pharmaceutical drug, and method for treating patient suffering from schizophrenia with iloperidone. The patent holder brought infringement action against an ANDA applicant, and requested a permanent injunction. The Court found that the ANDA products infringed the plaintiff’s patents. With regard to the irreparable harm for the purpose of deciding a permanent injunction, the Court considered that the plaintiff would suffert harms as a direct results of the proposed ANDA product sales. The Court determined that these harms would be difficult to quantify.

Here, it is clear that Vanda would be irreparably harmed without an injunction. “Where a plaintiff and an infringer directly compete in the same market, an injunction may be warranted to protect the plaintiff from irreparable harm.” Endo Pharm. Inc., 2016 WL 1732751, at *5 (citing Douglas Dynamics, LLC v. Buyers Prods. Co., 717 F.3d 1336, 1345 (Fed.Cir.2013)). Allowing generic products such as Roxane’s into the market will no doubt cause harm to Vanda. Without an injunction, Plaintiffs would suffer an incalculable loss of market share and Roxane’s generic iloperidone would erode the price for Fanapt®. Vanda would also suffer irreparable harm from being unable to use lost Fanapt® revenue to invest in research and development of new clinical indications for and formulations of Fanapt®> and development of other drugs. These irreparable harms would be the direct result of Roxane’s sales. (D.I. 178 at 26.) There is no other adequate remedy because these harms are and would continue to be difficult to quantify. On the other hand, Roxane has not demonstrated it would suffer hardship. Therefore, the balance of hardships weighs in favor of enjoining Roxane. Finally, the court finds that the public interest would not be disserved by a permanent injunction. eBay, 547 U.S. at 391, 126 S.Ct. 1837. Vanda holds a valid patent and the Federal Circuit has “long acknowledged the importance of the patent system in encouraging innovation. Indeed, the ‘encouragement of investment-based risk is the fundamental purpose of the patent grant, and is based directly on the right to exclude.’ ” Sanofi–Synthelabo v. Apotex, Inc., 470 F.3d 1368, 1383 (Fed.Cir.2006) (quoting Patlex Corp. v. Mossinghoff, 758 F.2d 594, 599 (Fed.Cir.1985)).

In conclusion, the four eBay factors weigh in favor of issuing an injunction. The Plaintiffs are entitled to a permanent injunction restraining and enjoining Roxane, their officers, agents, servants, employees, attorneys, affiliates, divisions, subsidiaries, and those persons in active concert or participation with any of them from infringing the ‘610 Patent or inducing anyone to do the same, including the manufacture, use, offer to sell, sale, distribution, or importation of any generic iloperidone product described in the Roxane ANDA, or any amendments or supplements thereto until the expiration of the ‘610 Patent on November 2, 2027.

2017. October 5: Amgen Inc. v. Sanofi, 872 F.3d 1367, 1381 (Fed. Cir. 2017)

Patents 8,829,165 and 8,859,741 claim antibodies that help reduce low-density lipoprotein cholesterol (LDL-C), or “bad cholesterol.” The patent holder brought infringement action against competitors. Following a verdict finding the validity of the asserted patents and a permanent injunction granted by the District Court, the competitors appealed. In its analysis of whether a permanent injunction would disserve the public interest, the Appellate Court stated that ‘eliminating a choice of drugs is not, by itself, sufficient to disserve the public interest. Under such an approach, courts could never enjoin a drug because doing so would always reduce a choice of drugs.’ The Court added that ‘an accused infringer cannot escape an injunction merely by producing infringing drugs. Accordingly, a reduction in choice of drugs cannot be the sole reason for a district court to deny an injunction.’

Here, the district court concluded that issuing a permanent injunction would disserve the public interest. Despite that finding, the court issued a permanent injunction. J.A. 33–34. That was in clear violation of eBay. If a plaintiff fails to show “that the public interest would not be disserved by a permanent injunction,” then the district court may not issue an injunction. eBay, 547 U.S. at 391, 126 S.Ct. 1837.


Second, the district court also erred in its analysis of the “public interest” factor. In reaching its conclusion that the injunction would disserve the public, the district court weighed “being a patent holder and a verdict winner” on the one hand and “taking an independently developed, helpful drug off the market” on the other. J.A. 33. It then “conclude[d] that the public interest of having a choice of drugs should prevail.” J.A. 33–34.


But eliminating a choice of drugs is not, by itself, sufficient to disserve the public interest. Under such an approach, courts could never enjoin a drug because doing so would always reduce a choice of drugs. That, of course, is not the law. See 35 U.S.C. § 271(e)(4)(B) (“[I]njunctive relief may be granted against an infringer to prevent the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of an approved drug, veterinary biological product, or biological product.”). We previously rejected such reasoning in WBIP, LLC v. Kohler Co. and explained that: The district court’s decision is based on its reasoning that having more manufacturers of a lifesaving good in the market is better for the public interest. But this reasoning is true in nearly every situation involving such goods, such that, if it alone is sufficient, it would create a categorical rule denying permanent injunctions for life-saving goods, such as many patented pharmaceutical products. As the Supreme Court has warned, categorical rules regarding permanent injunctions are disfavored. 829 F.3d 1317, 1343 (Fed. Cir. 2016).


Just as a patent owner does not automatically receive an injunction merely by proving infringement, see eBay, 547 U.S. at 394, 126 S.Ct. 1837, an accused infringer cannot escape an injunction merely by producing infringing drugs. Accordingly, a reduction in choice of drugs cannot be the sole reason for a district court to deny an injunction.

2018. May 1: Kaneka Corp. v. Purestar Chem Enter. Co., No. 16CV4861MKBSIL, 2018 WL 3215680, at *5 (E.D.N.Y. May 1, 2018), report and recommendation adopted, No. 16CV4861MKBSIL, 2018 WL 3213281 (E.D.N.Y. June 29, 2018)

Patent 7,145,044 claims nutritional supplement ubiquinol. The patent holder brought action against a competitor for patent infringement, and filed for a permanent injunction. The Court found that, since the defendant is a direct competitor of the plaintiff, continued infringement will likely result in lost sales and market share sufficient to show irreparable harm for the plaintiff. To determine that the monetary damages were inadequate, the Court considered that in the absence of injunctive relief the infringing activities will likely continue. In its analysis of whether a permanent injunction would disserve the public interest noted that this factor may favor an infringer when injunctive relief will result in a socially valuable technology becoming unavailable or substantially more expensive. Nevertheless, the Court did not found an indication that consumers who seek to purchase non-infringing ubiquinol will be unable to do so, or that these consumers would be forced to pay an unreasonable price to purchase the plaintiff’s product.

Here, Kaneka satisfies the first two factors. As set forth in the Complaint, Purestar’s product directly competes with Kaneka Ubiquinol. Indeed, Defendant’s solicitation of Kaneka’s customers by email is direct evidence of that competition. As a result, the Court finds that Defendant’s continued infringement will likely result in lost sales and market share sufficient to show irreparable harm. See Stein Indus., Inc. v. Jarco Indus., Inc., 934 F. Supp. 55, 58 (E.D.N.Y. 1996) (finding, inter alia, unrebutted claims of lost sales and market share sufficient to show irreparable injury). Additionally, monetary damages are inadequate as, in the absence of injunctive relief, there is no indication that Purestar’s unlawful conduct—specifically infringing upon Kaneka’s product—will cease. See Sexy Hair Concepts, LLC v. Sexy Hair Inc., No. 12-cv-3937, 2013 WL 5460629, at *4 (E.D.N.Y. Sept. 30, 2013) (citing Pearson Educ., Inc. v. Vergara, No. 09-cv-6832, 2010 WL 3744033, at *4 (S.D.N.Y. Sept. 27, 2010) ). Accordingly, the Court concludes that Kaneka has suffered irreparable harm and that monetary relief is inadequate to compensate for such an injury.

The Court also concludes that the balance of hardships favors Kaneka. “The balance of hardships clearly tips in plaintiff’s favor … where it has established irreparable harm[,] … [distribution of] the infringing conduct is likely to continue absent injunctive relief … [and] plaintiff has already incurred substantial legal costs in protecting its […] rights….” Hilton v. Int’l Perfume Palace, Inc., No. 12-cv-5074, 2013 WL 5676582, at *13 (E.D.N.Y. Oct. 17, 2013) (internal citations omitted). As set forth above, Plaintiffs have established irreparable harm and that, without injunctive relief, the infringing conduct will likely continue. Further, Plaintiff has incurred legal costs in bringing and prosecuting this case. Thus, the Court concludes that the balance of hardships weighs in Plaintiff’s favor.

Finally, the Court concludes that injunctive relief serves the public interest. In patent infringement cases, there is a “strong public policy favoring the enforcement of patent rights.” See PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1567 (Fed. Cir. 1996). “[T]he touchstone of the public interest factor is whether an injunction, both in scope and effect, strikes a workable balance between protecting the patentee’s rights and protecting the public from the injunction’s adverse effects.” i4i Ltd. P’ship, 598 F.3d at 863. This factor requires a plaintiff to demonstrate that “the public interest would not be disserved by a permanent injunction.” eBay, 547 U.S. at 391, 126 S.Ct. 1837. To that end, the public interest factor may favor an infringer when injunctive relief will result in a socially valuable technology becoming unavailable or substantially more expensive. See Metso Minerals, Inc., 788 F. Supp. 2d at 77 (internal citations omitted). Here, however, there is no indication that consumers who seek to purchase non-infringing ubiquinol will be unable to do so, or that these consumers would be forced to pay an unreasonable price to purchase Kaneka Ubiquinol. Therefore, injunctive relief serves the public interest as any adverse impact is limited to restraining Purestar’s infringing activity and vindicating Kaneka’s patent rights. Accordingly, based on the foregoing analysis, the Court concludes that Plaintiff has established its entitlement to an injunction.

2018. May 16: Endo Pharm. Inc. v. Teva Pharm. USA, Inc., 731 F. App’x 962, 974–75 (Fed. Cir.), vacated in part, 729 F. App’x 936 (Fed. Cir. 2018)

Patents 8,309,122 and 8,329,216 claim a controlled release formulation of the painkiller opioid oxymorphone. Patent holder brought action against a competitor, and filed a motion for a permanent injunction. The District Court granted the request for a permanent injunction, taking into account the fact that absent a permanent injunction the plaintiff would lose market share, reduce promotional expenses, change research and development strategies, among other factors. The Appellate Court affirmed the decision to grant a permanent injunction, concluding that the District Court did not abused its discretion in weighing these factors in favor of the request by the plaintiff.

Actavis mainly argues that the district court abused its discretion in enjoining Actavis’s original formulation of controlled release oxymorphone because Endo presented no evidence at trial of irreparable harm. That is inaccurate. The district court found that Endo will likely suffer irreparable harm relying on, among other things, its subsidiary findings that: (1) Actavis’s generic version of OPANA®ER infringed Endo’s patents; (2) Endo and Actavis are direct competitors in the oxymorphone market; and (3) the introduction of additional generics into the market has led Endo to suffer past harms (losing its market share, cutting its sales force, reducing its promotional expenses, and changing its research and development strategies)—which would continue unabated in the absence of an injunction—and, relatedly, that Endo is also at risk of intangible harms such as “reputational, organizational, and administrative.” J.A. 178–79. Among other evidence, the court credited trial testimony to that end. See J.A. 1272–73; see also J.A. 1306. Indeed, “[i]t was proper for the district court to consider evidence of past harm” to assess irreparable injury to Endo. i4i Ltd. P’ship v. Microsoft Corp., 598 F.3d 831, 861 (Fed. Cir. 2010), aff’d, 564 U.S. 91, 131 S.Ct. 2238, 180 L.Ed.2d 131 (2011); see also Broadcom Corp. v. Emulex Corp., 732 F.3d 1325, 1338 (Fed. Cir. 2013) (“The district court determined that Broadcom and Emulex were competitors and that Broadcom lost market share while Emulex gained it—thus Broadcom established irreparable harm.” (citation omitted) ).

Endo relatedly demonstrated, mainly through trial testimony, that it had to lay off its sales force, which may damage its reputation in the market segment and make the company less attractive to potential new hires. The court found that such irreparable harm cannot be adequately addressed without an injunction. J.A. 179–80. Actavis, on the other hand, made no affirmative argument that it would suffer hardship from an injunction to counter Endo’s likely hardship. J.A. 180–81. Finally, the court also found that public interest favors Endo’s right to exclude others as the rightful patent owner. J.A. 181–82. On balance, it cannot be said that the district court abused its discretion in weighing these factors in Endo’s favor and granting permanent injunctive relief.