Month: August 2017

2017: Kymriah, the Novartis $475,000 CAR T treatment, received 50 percent Orphan Drug tax credit on trials

Posted on by James Love

Missing in the reporting on the Novartis price for Kymriah, its new $475,000 CAR T treatment, is that Novartis received an Orphan Drug designation in February 3, 2015, and sequently received a tax credit subsidy from the United States equal to 50 percent of the cost of qualifying clinical trials.

From the FDA database on Orphan Designations:
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=463114

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US Federal rights in patents on Probuphine, to treat opioid addiction

Posted on by Kim Treanor

Probuphine is an expensive medication used to treat opioid dependence by providing maintenance treatment and lessening withdrawal symptoms. The U.S. federal government also has considerable leverage over the pricing of this product, because of the federal funding of the the research that lead to the sole Orange Book patent on the product, and phase 3 trials that were used the register the product.

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KEI statement regarding Gilead’s Acquisition of Kite Pharma

Posted on by James Love

KEI statement regarding Gilead’s Acquisition of Kite Pharma.

“Congress should require the NIH to enforce the Bayh-Dole obligation to make the Kite Pharma Chimeric Antigen Receptors Technologies (CAR T) treatments available to the public on reasonable terms.

KEI notes that Kite reported spending $317 million in R&D from 2012 to June 30, 2017, and is selling the company for $11.9 billion.

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Workshop: Patents, the Public Interest and Two New Medical Technologies: CRISPR and CAR T

Posted on by Kim Treanor

Workshop: Patents, the Public Interest and Two New Medical Technologies: Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR), Chimeric Antigen Receptors (CAR) technologies

On September 15th, 2017, Knowledge Ecology International will be hosting a workshop on: “Patents, the Public Interest and Two New Medical Technologies: CRISPR and CAR T.”

If you are unable to attend in person, a livestream of the event will be available here

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USTR Chief Innovation and Intellectual Property Negotiator

Posted on by James Love

In February 2016, the Trade Facilitation and Trade Enforcement Act of 2015 became law, as PL 114-125. Section 609 of the law created a new position in USTR, the “Chief Innovation and Intellectual Property Negotiator.” This position creates a position for a presidential poltical appointee confirmed by the Senate, with the rank of ambassador, replacing the current system where the IP negotiators are civil servants, reporting to political appointees. Continue Reading →

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2017: Salubris Biotherapuetics: Bispecific, Biparatopic Antibody-Drug Conjugate for Human Liver Cancers

Posted on by Kim Treanor

(More on government funded inventions here. Other KEI comments on NIH licenses are found here.) Attached are the August 8, 2017 KEI comments regarding the prospective grant of an exclusive patent license by the NIH to Salubris Biotherapuetics for the development of… Continue Reading →

2017: KEI initial comments on NIH proposed grant of exclusive license on liver cancer treatment to Salubris

Posted on by Kim Treanor

On August 8, 2017, Knowledge Ecology International (KEI) submitted comments on the proposed grant of an exclusive license from the National Institutes of Health (NIH) and Department of Health and Human Services (HHS) to Salubris Biotherapuetics, Inc, a corporation headquartered in Guangdong, China, for an important new technology that could be used Continue Reading →

NIH response to KEI request for NIH policy on on the licensing of federally-funded CRISPR patented inventions.

Posted on by James Love

On June 6, 2017, KEI wrote to Dr. Thomas Price, Secretary of Health and Human Services (HHS), and Dr. Francis S. Collins, Director of the National Institutes of Health (NIH) requesting the HHS develop a policy on the licensing of federally-funded CRISPR patented inventions. A copy of our letter is available here: /node/2801.

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