KEI Submission to WHO Essential Medicines List – Enzalutamide / Abiraterone Acetate

The WHO Essential Medicines List is a major WHO tool used to expand access to medicines.  In 2017, the WHO issued the 20th Essential Medicines List (EML) which was the 40th anniversary of the list.  The WHO is currently in… Continue Reading

2019: KEI Comments Submitted to USTR Special 301 Review

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

Government Funded Inventions

This page has some broken links, due to some issues with our hosting company. The issues should be fixed soon.—– We have several pages related to the U.S. Bayh-Dole Act here. KEI efforts to address pricing and other public interest… Continue Reading

KEI Statement on House Letter to President Trump on the Protection of Taxpayers’ Rights in Federally-Funded Inventions

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

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NIH to taxpayers — we don’t care about high prices in US for Xtandi

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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Biolyse Pharma offers to supply enzalutamide (Xtandi) for $3 per pill to Medicare and developing countries

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.

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