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« USPTO Unveils Examiner Guidance on Searching Drug-related Applications | Main | CVS Pharmacy Inc. v. Forest Laboratories Inc. (2d Cir. 2024) »

June 11, 2024


Excellent post, thank you. My understanding is that some manufacturers had sought guidance on this issue (listing of devices) from the FDA but had never received a response--I wonder if that would make a difference to the FTC's analysis.

Also I was struck by the phrase "there needs to be something to copy in the first place for the generics regime to be effective." Perhaps using the terminology "copy" rather than "generic" would better help the public understand the benefits that innovator pharma companies are providing by developing new drugs in the first place.


There is a cycle. Pro patent Phase lasts decades: As you known, generally the US Government was pro-patent since 1975. Also, there was beneficial Senators Hatch and Waxman Act to facilitate patent litigations by the drug innovator if it listed it’s compound and formulation drug patents in the FDA Orange Book. This controlled Generic drug company copycats from causing havoc by their doing t a very small human clinical bioequivalence study comparing their generic formulation of the innovator drug versus the FDA licensed Big Pharma innovator drug formulation.
Anti patent (the antitrust mentality of the FTC) is a mindless political-driven attack of drug patents by pro-generic companies (who now also innovate with drugs). All the big genetic drug companies are now Big Pharma drug companies). The FTC periodically harms Big Pharma patenting.
So Kevin you described what the FTC is starting again. The trigger is unclear….
At the same time the USPTO is also in dysfunctional crisis regarding Sections 101, 103, 103, and 112. The USPTO is also driven by politics. The current decline of the USPTO can be traced back to the bogus AIA changes which just complicated patenting. Frankly patenting is no longer a predictable process.
The pretense of improvement by FTC or USPTO or FDA goes through phases of tolerance and phases of obstructionism. We are now in the later phase. It’s just cycling political games.

Dear Karl:

I agree with the cycle point - it happens, human nature and politics.

Thanks for the comment.

Update: the district court judge today ordered on Thursday a 30-day stay on his order to delist five Teva patent from the Orange Book, to enable the Third Circuit to review the order.

🤞but don't hold your breath.

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