(More on government funded inventions here. Other KEI comments on NIH licenses are found here.) Sabarni K. Chatterjee, Ph.D., M.B.A. Senior Licensing and Patenting Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892-9702… Continue Reading →
Sanofi $9.3 Billion Medivation Bid 28 April 2016. Ben Hirschler and Leigh Thomas. Sanofi launches $9.3 billion fight for U.S. cancer firm Medivation. Reuters. 28 April 2016. Helen Thomas. Sanofi / Medivation: Deal-Making Déjà Vu Comes With Added Competition. WSJ.… Continue Reading →
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.
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.
Frequency of disclosure of federal funding in patents, 2000 to 2011
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 Reading →