Xtandi 2016 March-In Request

Today Knowledge Ecology International and the Union for Affordable Cancer Treatment (UACT) petitioned the Department of Health and Human Services, the Department of Defense, and the National Institutes of Health, asking that they exercise either their royalty-free, non-exclusive license or federal “march-in” rights to end the monopoly on an expensive prostate cancer drug, enzalutamide, marketed as Xtandi by Astellas, a Japanese pharmaceutical company.

Xtandi was invented at UCLA on federal grants from the NIH and DoD.

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Patents with government interests, by disease, 2010 to 2013

The attached PDF file provides counts on the number of patents with various search terms in the specification (spec/”search term”), and the number of those patents that declare either government rights in the patents (govt/government), an assignment to the US government (an/”united states of america”), or both. The complete counts are in the PDF file. The queries were done by Claire Cassedy on December 5, 2014.

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Birch Bayh’s competing interests and evolving views

The 1980 Bayh-Dole Act is named after two former US Senators, Birch Bayh and Bob Dole. In 2002 both claimed the Bayh-Dole Act march-in provisions were not intended to address cases where prices for inventions are unreasonable, and Senator Bayh repeated this view during a 2004 march-in case involving Abbott patents on ritonavir.

Among the provisions of the Act that suggest otherwise are the following:

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WTO disputes- Intellectual property dimensions of the Boeing case (WT/DS353)

“Roma locuta causa finita est” (Rome has spoken, therefore the case has been decided) was the maxim employed by medieval jurists to describe the absolute irrevocability of papal judgements in canon law. Today, in modern international trade law, the World Trade Organization’s (WTO) Appellate Body fulfills a similar function as the international trading system’s “Supreme Court”. In the words of the WTO,

[t]he Appellate Body was established in 1995 under Article 17 of the Understanding on Rules and Procedures Governing the Settlement of Disputes (DSU). Continue Reading

Statements by KEI and others on NIH rejection of Fabrazyme March-In Request

For background on the Fabrazyme case, see: https://www.keionline.org/fabrazyme

The following statements were made today by civil society on the NIH rejection of the Fabrazyme March-in Request Petition. Contact Judit Rius at judit.rius@keionline.org if your organization would like to submit an statement.

Statement by James Love, Director of Knowledge Ecology International (KEI) (Contact: 1.202.361.3040)

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The Energy Independence and Security Act of 2007 Innovation Inducement Prizes

On December 19, 2007, the The Energy Independence and Security Act of 2007 was enacted as Public Law 110-140. The Act created two new innovation inducement prizes to stimulate innovation in the field of energy:

  • The H-Prize, which is designed to advance the research, development, demonstration, and commercial application of hydrogen energy technologies.
  • The Bright Tomorrow Lighting Prizes, which deal with energy efficient solid state lighting.

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Written submission U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) Hearing on Treating Rare and Neglected Pediatric Diseases: Promoting the Development of New Treatments and Cures

Written submission U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) Hearing on Treating Rare and Neglected Pediatric Diseases: Promoting the Development of New Treatments and Cures, On the topic of Direct funding, subsidies and incentives for the development… Continue Reading