On March 28, 2016, six Senators and six members of the House of Representatives sent a letter to HHS Secretary Burwell and Director Collins at NIH, calling for an “open and transparent public hearing” to discuss the issues presented in… Continue Reading
For more information on the 2021-2022 Xtandi request please visit: https://www.keionline.org/xtandi2021 (More on government funded inventions here.) On January 14, 2016, Knowledge Ecology International (KEI) and the Union for Affordable Cancer Treatment (UACT) submitted a request to the National Institutes… Continue Reading
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.
This was the release from Representative Doggett’s office:
FOR IMMEDIATE RELEASE
January 11, 2016Contact:
Leslie Tisdale, (202) 225-4865
Over 50 Members of Congress to Obama Administration:
Help End Drug Price Gouging Now
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.
Following our filing of a march-in petition with the NIH, seeking a rule that government funded inventions be no more expensive in the United States than in other high income countries, I was asked about the extent of federal funding of patented inventions.
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:
“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 ReadingStatements 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)
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.