Blogs

How Sanofi Prices Its MS Drug Aubagio (Teriflunomide) in the U.S. and Five Reference Countries

The U.S. Army recently rejected requests by public interest groups, Senator Bernie Sanders, and almost a dozen House Democrats to refuse to grant Sanofi an exclusive license on patents on a Zika virus vaccine, or, alternatively, to ensure that the license included terms assuring that U.S. taxpayers would not pay a higher price than other high-income countries. Specifically, KEI proposed the following terms to be included in the contract:

Sanofi fines for fraud, kickbacks, etc

April 3, 2017. Sanofi agreed to pay $19.9 million to resolve allegations under the False Claims Act that the company overcharged the U.S. Department of Veterans Affairs (VA) for drugs under two contracts between 2002 and 2011. According to the DOJ press release:

U.S. Army Rejects Pricing Concerns in Grant of Exclusive Patent License to Sanofi on Zika Vaccine

Today, KEI received a letter from the U.S. Army dated April 21, 2017, signed by Barry M. Datlof, in which the Army largely rejected concerns raised in comments submitted by KEI and various other public interest groups related to the proposed grant of an exclusive license to the French drug company Sanofi on a U.S. Army-invented vaccine for Zika virus.

2017: KEI, UACT Request that Trump Administration Reevaluate Xtandi Petition

Knowledge Ecology International and the Union for Affordable Cancer Treatment sent a letter to Secretary Tom Price of the Department of Health and Human Services, and to Secretary Jim Mattis of the Department of Defense, requesting that the Trump Administration reevaluate the January 2016 Xtandi petition that the government use its rights in patents under the Bayh Dole Act (35 U.S.C.

KEI Statement on House Letter to President Trump on the Protection of Taxpayers’ Rights in Federally-Funded Inventions

4 APRIL 2017
FOR IMMEDIATE RELEASE
CONTACT: Zack Struver, zack.struver@keionline.org or +1 (202) 332-2670

In a letter sent today, Representative Lloyd Doggett, D-Texas, and 50 other democratic members of Congress requested that President Donald J. Trump issue guidance for the use of Bayh-Dole Act march-in rights in order to protect taxpayer’s rights in federally-funded patented inventions.

The following statement should be attributed to James Love, Director of Knowledge Ecology International (KEI):

“The letter from members of Congress on the need to protect taxpayer's rights in the inventions they fund is important, timely, and directly related to the challenge of providing affordable health care to everyone. Federally-funded inventions are now routinely placed on the market at extremely high prices. Astellas charges more than $350 per day for the prostate cancer drug Xtandi, and BioGen is charging $1.125 million for the first two years of Spinraza, which is used to treat spinal muscular atrophy in mostly young children. The notion that the federal government will not engage on the pricing of these products runs counter to the explicit provisions in the Bayh-Dole Act that require inventions be made ‘available to the public on reasonable terms.’ The President can curb high prices for these drugs without new legislation, and without putting patients at risk.”

KEI filed the most recent march-in request with the federal government on the prostate cancer drug Xtandi.

The letter is available as a PDF here and below in plain text.

Representative Doggett’s office issued the following press release: https://doggett.house.gov/media-center/press-releases/congressional-democrats-trump-we-re-calling-your-hand-lower-prescription

Democrats in House and Senate introduce new drug pricing bill

The House version is HR 1776. Attached below. The Senate bill is identical, and also attached.

Senator Franken's press release is here.
Representative Schakowksy's press release is here:
Senator Franken's facebook statement is here.

KEI statement: 21st meeting of the WHO Expert Committee on the Selection and Use of Essential Medicines

On Monday, 27 March 2017, Knowledge Ecology International (KEI) delivered the following oral statement to the Open Session of the 21st Meeting of the WHO Expert Committee on the Selection and Use of Essential Medicines. The program for the open session can be found here.

Dr. Elias Zerhouni defends Sanofi/Army proposed license on Zika patents, and KEI responds

On March 21, 2017, the New York Times published a letter signed by Dr. Elias Zerhouni, defending the proposed Sanofi monopoly on the US Army patents to the Zika virus. The letter is available from the NYT from the following link, and also reprinted here, followed by commentary.

https://www.nytimes.com/2017/03/21/opinion/developing-a-zika-vaccine.html

To the Editor:

Re “Trump Should Avoid a Bad Zika Deal” (Op-Ed, March 11):

Maryland House of Delegates passes bill on prescription drug price gouging by vote of 137 to 4

On March 20, 2017, the Maryland House of Delegates approved a prescription drug price gouging bill by a vote of 137-4. A copy of the bill, as it passed the House, is attached.

This is a March 20, 2017 Report by Erin Cox, published in the Baltimore Sun:

Maryland's attorney general could sue drug companies for price gouging under a bill approved by the House of Delegates Monday.

Leaked document: March 15, 2017 Note by Switzerland on India EFTA TEPA IP Chapter

Attached is a March 15, 2017 note by Switzerland on the India EFTA TEPA IP Chapter.

The EFTA is the The European Free Trade Association. The EFTA member states are Iceland, Liechtenstein, Norway and Switzerland. The document refers to a proposed "Trade and Economic Partnership Agreement," or TEPA, between India and the four members of the EFTA. The EFTA page on this negotiation is here.

Patients, Members of Congress Ask Chilean Government to Issue Compulsory Licenses on Prostate Cancer and HCV Drug Patents

21 MARCH 2017
PRESS ADVISORY
FOR IMMEDIATE RELEASE

CONTACT: Zack Struver, zack.struver@keionline.org, +1 (202) 332-2670 (office) / +1 (914) 582-1428 (cell)
Luis Villarroel, info@innovarte.cl, +56 9 9827 9673

Santiago, Chile — Members of the Chilean Congress and a group of 6 patients visited the Chilean Ministry of Health yesterday to ask that the government use its authority under Chilean law to end patent monopolies on the prostate cancer drug enzalutamide (U.S. brand name Xtandi) and on sofosbuvir-based combination drugs for the treatment of hepatitis C virus (HCV).

The patients and members submitted a petition that outlined the legal authority and public policy rationale for the grant of compulsory licenses on the patents for the drugs described in the petition. Those compulsory licenses would allow prescription drug manufacturers to produce affordable generic versions of the drugs, subject to a reasonable royalty.

Leaked: Three documents from RCEP negotiations

The Regional Comprehensive Economic Partnership (RCEP) is a proposed trade agreement involving 16 countries in the Asia/Pacific region, that have a combined population of 3.5 billion persons, and about 30 percent of world GDP. They include the members of the Association of Southeast Asian Nations (ASEAN) (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, Vietnam), and six additional countries: Australia, China, India, Japan, South Korea and New Zealand.

14 March 2017 - Senate Finance Committee grills Robert Lighthizer (USTR nominee) on trade and IPR policies

On 14 March 2017, the U.S. Senate Finance Committee held confirmation hearings for Robert Lighthizer, President Donald Trump's appointee for United States Trade Representative. During the Reagan administration, Lighthizer served as Deputy US Trade Representative with the rank of Ambassador (Source: http://www.presidency.ucsb.edu/ws/?pid=41174). Prior to his tenure as Deputy USTR, from 1981 to 1983, Lighthizer served as Chief Counsel for the U.S. Senate Finance Committee. Currently, he is a partner at Skadden Arps.

KEI Testifies in Maryland on Drug R&D Cost Transparency Bill (HB666/SB437)

James Love and Andrew Goldman represented KEI on March 16, 2017, in a working group meeting of a subcommittee of the Maryland General Assembly House of Delegates Health & Government Operations Committee, where they testified on HB666/SB437, a bill that would establish transparency of R&D costs for prescription drugs sold in Maryland.

Vincent DeMarco of at Health Care for All! and Dr. Reshma Ramachandran of the Johns Hopkins Bloomberg School of Public Health also testified at the hearing.

HHS Office of Inspector General Declines to Investigate Failure to Disclose Federal Funding in Ionis Pharmaceuticals' Spinraza

The Department of Health and Human Services Office of Inspector General (OIG) informed KEI that it would not move forward with an investigation into whether Isis Pharmaceuticals, now known as Ionis Pharmaceuticals, failed to report federal funding in patents on Spinraza.

In a letter dated March 13, 2017, Matthew Charette, the Special Agent in Charge of the Investigations Branch of OIG, explained that OIG counsel believes that OIG has limited authority, and that the obligation to "monitor[] invention reporting and remedy[] noncompliance" "rests with NIH's Office of Policy for Extramural Research Administration (OPERA)."

On January 18, 2017, KEI submitted a 22-page letter to OIG containing evidence that the patents on Spinraza benefited from federal grants. KEI did not just ask OIG to investigate Isis' alleged failure to report this funding, in violation of the Bayh-Dole Act and federal regulations, but also urged the OIG "to investigate whether the National Institutes of Health failed to conduct proper oversight in administering its grants" and to "recommend appropriate action to remedy the situation in line with the statute and prior decisions with regard to failure to disclose a subject invention."

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