WTO: Spotlight on the United States at the Trade Policy Review (December 2012)

On 18 December 2012 and 20 December 2012, the World Trade Organization (WTO) undertook a trade policy review of the United States of America. All members of the WTO are subject to review under the Trade Policy Review Mechanism (TPRM). The questions raised by WTO Members during the US TPR touched upon on compulsory licensing (including cases of judicial compulsory licensing following eBay v. MercExchange), copyright (Golan v. Holder), the Special 301 report and the Medicines Patent Pool. On 30 April 2013, the WTO released the records of the meeting including WT/TPR/M/275. Continue Reading

SCOTUS Oral Arguments in AMP v. Myriad Genetics; Court to Determine Answer to Question: Are Human Genes Patentable?

On 15 April 2013, the Supreme Court of the United States heard oral arguments in the case Association for Molecular Pathology, et. al., v. Myriad Genetics, et. al, hearing arguments over the question: are human genes patentable? The case, which has been litigated since 2009, specifically involves two genes, known as the BRCA1 and BRCA2 genes which are associated with an individual’s susceptibility to breast and ovarian cancer. Continue Reading

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R&D costs for Gleevec

In a bid to generate sympathy for its defeat in the Supreme Court of India over efforts to evergreen patent protection for the cancer drug imatinib (trade names Gleevec or Glivec) in developing countries, Novartis has been making increasingly spectacular claims as regards its investments in the development of the drug. Continue Reading

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SCOTUS Oral Arguments in FTC v. Actavis; Court to Decide Legality of Pay-For-Delay (Reverse Payment) Settlement Agreements

On Monday, 25 March 2013, the Supreme Court of the United States heard oral arguments in the case, Federal Trade Commission v. Actavis, Inc., et. al. This case had previously been captioned as Federal Trade Commission v. Watson Pharmaceuticals, et. al., but was recaptioned after the combination of Actavis and Watson. KEI filed an amicus brief in support of the FTC which is available here (along with additional background to the case). Continue Reading

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KEI on Medicines Patent Pool license (and MoU) with ViiV Healthcare

KEI comment on the Medicines Patent Pool license and MoU with ViiV Healthcare
28 February 2013

FYI: James Love (james.love@keionline.org, +1.202.361.3040), Krista Cox (krista.cox@keionline.org, +1.202.332.2670) or Thiru Balasubramaniam (thiru@keionline.org).

The 27 February 2013 agreements between the Medicines Patent Pool (MPP) and ViiV Healthcare, a joint venture of GlaxoSmithKline, Pfizer, and Shionogi will expand access to affordable pediatric formulas for HIV/AIDS.

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KEI’s 2013 Special 301 Comments

On Friday, 8 February 2013, KEI filed comments to USTR on the 2013 Special 301 Review. The comments request support for an extension of the transition period for least-developed countries, issues regarding compulsory licenses, patent linkage, exclusive rights over test data, and standards of patentability. With regard to copyright, KEI submitted comments covering issues of technological protection measures and DMCA-style legislation on notice-and-takedown procedures. KEI also made comments regarding the enforcement of intellectual property rights.

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Abbott and Senator Hatch lambast Global Fund’s policy on generics and compulsory licensing

On 13 April 2011, Senator Orrin Hatch (Republican-Utah) wrote a letter to then-Secretary of State, Hillary Clinton complaining about Global Fund’s policy on generic procurement and compulsory licensing. With respect to procurement, Sen. Hatch asserted that Global Fund monies were used to procure generic drugs “at unnecessary costs in recipient countries” while branded drugs (all Abbott products) were were available at a lower cost. Continue Reading

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KEI files amicus brief in pay-for-delay case; SCOTUS to resolve circuit split on legality of reverse payment settlements

On Monday, 28 January 2013, KEI filed an amicus brief to the Supreme Court of the United States in the case Federal Trade Commission v. Watson Pharmaceuticals**. The case involves a question of whether pay-for-delay settlement agreements, also known as reverse payments (where a branded pharmaceutical company will pay a generic firm to stay off the market for a certain period of time), are per se legal or whether they are presumptively anticompetitive. Continue Reading

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