On Thursday February 7, 2019, KEI submitted comments and intent to testify at the hearing for the 2019 US Trade Representative’s Special 301 review process. This year’s hearing will take place on Wednesday February 27, 2019 at the Office of… Continue Reading
We have several pages related specifically to the U.S. Bayh-Dole Act here. KEI efforts to address pricing and other public interest issues in more than 30 different NIH licensing cases, involving both patents and data rights, are here: http://keionline.org/nih-licenses KEI… Continue Reading
For more information, contact: (U.S.) James Love, KEI: james.love@keionline.org or +1 (202) 332-2670 (Chile) Luis Villaroel, Innovarte: info@innovarte.cl or +56 9 9827 9673 Chile FAQ What is happening in Chile with regard to HCV medicines and Xtandi, for prostate cancer?… Continue Reading
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
On August 5, 2016, KEI received a response from the Department of the Army to KEI and UACT’s January 14, 2016 request that the Army and the National Institutes of Health (NIH) exercise the governments’ rights in the patents for… Continue Reading
National Institutes of Health Declines to Exercise Authority to Lower Xtandi Price
The National Institutes of Health will not use its rights under the Bayh-Dole Act to end the monopoly on the expensive prostate cancer drug Xtandi and allow low-priced generic versions to compete on the market.
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On April 22, 2016, the President of Biolyse Pharma — a Canadian pharmaceutical company that specializes in the manufacture of oncology drugs — offered to supply the prostate cancer drug enzalutamide (Xtandi) to the Centers for Medicare & Medicaid Services (CMS) for $3 per pill ($12 per day; $4,383 per year). The Biolyse price for enzalutamide is 4-percent of the 2014 Medicare price, $69.41 ($277.64 per day; $101,408.01 per year), and lower than any other price in the world.
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