Oklahoma Families for Affordable Health Care’s Post

Patent Thickets Won’t Be Stopped Until FDA and USPTO Collaborate Better, Say Senators and Experts: Congress needs to put more pressure on agencies like the FDA and the US Patent and Trademark Office (USPTO) to collaborate on fighting patent thickets, the multiple patents pharmaceutical companies file after a drug is already on the market to extend the drug’s period of exclusivity and keep generic alternatives off the market. #fda #financial #lifesciences

This 40-second exchange is an important watch. It’s a perfect example of the pharmaceutical industry’s anti-competitive patent tricks. During February’s Senate HELP Committee hearing on drug prices, Senator Ben Ray Luján asked Merck’s CEO, Robert Davis, if he will commit to not blocking generic competition when the primary patents expire on Keytruda. Mr. Davis answered: “I will not try to stop a biosimilar IV version of Keytruda coming on to the market.” Seems like a genuine commitment? Nope. Sen. Luján never mentioned anything about "IV". Mr. Davis slipped in the IV qualifier so that he comes across as telling the truth while concealing the real intention behind his statement, which is to hide Merck’s true business plan. As always with pharma, the devil is in the details. The truth is that Merck plans to switch patients from an IV (intravenous) version of Keytruda over to a subcutaneous (under the skin) version (when it is approved), for which they have additional patent protection. That will let them maintain their market monopoly. This is known as product hopping, and it’s a classic manipulation of the patent system. And in anticipation of the tired argument that patients can get the old “off-patent” IV version, we know that the market does not work like that. Merck will use marketing and promotion strategies to re-capture the market. In essence, patents have become the platform for marketing and promotion strategies for re-monopolising a drug whose patent protection should have ended. A reminder to the pharma industry: We’re watching.

A statistical spotlight on EPO Opposition Divisions vs Boards of Appeal in the pharmaceutical sector... Opponents at the European Patent Office frequently feel like they’re facing a steep challenge when dealing with the opposition divisions (OD). However, they often find this challenge less daunting when they reach the Technical Boards of Appeal (BoA).     Notably in the pharmaceutical sector, the difference between the revocation rate (in red on the attached pie charts) of OD and BoA is:  ·       16% when the decision is based on the set of claims that also formed the basis of the preceding decision (22 versus 38%), and  ·       22% when the decision is based on a set of claims that differs from the claims that formed the basis of the preceding decision (41% versus 63%).    You can see more insights comparing EPO opposition Divisions and Board of Appeals in a recent article written with Dr. Malte Köllner, patent attorney, now available on #epi information: https://lnkd.in/eUxcGDRu

From the emergence of specialty drugs to the effect of patent expirations, here are 8 developing trends in the pharmacy benefits sphere that employers should be aware of. Dive deeper into the topic within our whitepaper 🔗 https://lnkd.in/eyppjZCu #pharmacybenefits #JGSInsurance #InsuranceIsntBoring

From the emergence of specialty drugs to the effect of patent expirations, here are 8 developing trends in the pharmacy benefits sphere that employers should be aware of. Dive deeper into the topic within our whitepaper 🔗 https://lnkd.in/eyppjZCu #pharmacybenefits #AHTInsurance

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I am happy to share that my Note, “Crossing the Thicket Line” has been published in UC Davis Law Review. In it, I explore the problems associated with the pharmaceutical industry pushing the limits of the obviousness requirement to obtain patents for "minor, even cosmetic, tweaks to delivery mechanism, dosages, and formulations." Doing so extends the time of protection on a single drug and increases the protections that competitors have to challenge. I offer two solutions to distinguishing between cosmetic and novel changes: (1) Combining the FDA and USPTO offices to provide input on patent applications jointly; and (2) incorporating the "enhanced or superior efficacy" standard of review set out under the Indian Patent Act Section 3(d). I conclude that both of these solutions help realign the incentives of the U.S. patent system and address the increased transaction costs in the pharmaceutical industry. I am grateful to my advisor, Professor Lee, and the editors of UC Davis Law Review for their feedback and assistance in publishing my Note. A weblink can be found here: https://t.ly/Y9hsu.

From the rise of specialty drugs to the impact of patent expirations, here are 8 evolving trends in #pharmacy benefits that employers need to know. Read more in our whitepaper 🔗 https://lnkd.in/eyppjZCu #TheBaldwinGroup #ProtectingThePossible #EmployeeBenefits

Things may get very interesting if SCOTUS grants cert to reconsider the standard used for obviousness. Check out this article that I wrote with Matthew Murphy and Thomas Hedemann for what's at stake. #SCOTUS #obviousness #pharmaceuticals

Understanding the key factors driving prescription drug costs is the first step to finding effective solutions for reining in rising prices. Read about the 8 trends in our recent whitepaper; https://lnkd.in/eyppjZCu