Senator Angus King proposed an amendment to National Defense Authorization Act (NDAA) that would require the Department of Defense (DoD) to authorize third parties to use inventions that benefited from DoD research funding, when prices exceed the median price charge in the seven largest economies with per capita incomes at least half the per capita income in the United States.
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
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.
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On March 10, 2017, KEI filed our 3rd set of comments with the U.S. Army Medical Research and Material Command (USAMRMC) on their proposed grant of an exclusive license on Zika virus vaccine patents to the French pharmaceutical company Sanofi.
On Monday, 12 December 2016, Knowledge Ecology International (KEI) delivered its opening statement to the 25th session of WIPO’s Standing Committee on the Law of Patents (SCP).
KEI Opening Statement, for SCP 25
12 December 2016KEI will discuss two topics. The first concerns government rights in patented inventions, when the government funds or partly funds the research.
KEI will host a conference call at 11:00 A.M. today to brief interested stakeholders and the press on issues related to NIH patent policy, including the recent decision in KEI’s Xtandi petition (additional background here: /xtandi), the grant of exclusive licenses on government-owned inventions (/nih-licenses), and transparency of decision-making at NIH more broadly.
For call-in information, please contact Zack Struver at zack.struver@keionline.org. Continue Reading
In the wake of the NIH’s letter to KEI declining to use the government’s rights in the federally-funded patents on Xtandi under the Bayh Dole Act, it is interesting to consider that even the Gates Foundation, hardly the anti-patent group, maintains certain programs and policies to ensure that Gates-funded inventions are used for charitable purposes, with limitations on pricing.
(More on government funded inventions here. Other KEI comments on NIH licenses are found here.) On May 18th, 2016 the NIH posted a notice on the Federal Register stating it is contemplating the grant of an exclusive license to Chimeron… Continue Reading
On May 24th, 2016 the NIH posted a notice on the Federal Register stating it is contemplating the grant of an exclusive license to Dimension Therapeutics, Inc. for the development of an Adeno-Associated Virus Vectors for the Treatment of Glycogen… Continue Reading