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« Conference & CLE Calendar | Main | Infinity Computer Products, Inc. v. Oki Data Americas, Inc. (Fed. Cir. 2021) »

February 21, 2021

Comments


Another, prior, Fed. Cir. decision on 112 non-description for a broad pharmaceutical patent claim: University of Rochester versus G.D. Searle & Co., Case No. 03-1304.

Yes, but that case predates both Noelle, Ariad, and of course all the recent enablement cases. The Court is certainly constraining scope, particularly in antibody claims.

Is it really true though that companies will be dissuaded from developing new biologics because they can’t get a patent essentially owning the mechanism of action? Most biologics (as well as small molecules) do have within class competition, and it doesn’t seem to be compressing returns—eg Humira has plenty of competition among anti-TNF alpha therapeutics.

Usually, I would imagine 1) the other company essentially co-invented a similar drug, which means they had to show efficacy and safety to the FDA, or 2) they are a biosimilar maker, in which case the sponsor gets 12 years of exclusivity; plus, most biosimilars are structurally very like the reference product, so broad genus claims are unnecessary.

Biosimilars are an interesting case, because almost all the litigation has been on patents other than the original molecule patent (due to timing of when the biosimilars pathway became available compared with original FDA approval date and expiration date of the molecule patents). This is one of the reasons Humira (and the other half dozen biologics) have many biosimilar competitors.

The issue isn't owning mechanism of action; it is the impossibility of enabling (legally but not scientifically) production of every amino acid sequence variant and then having competitors piggyback over an innovator's discovery that an antibody to antigen X can be used therapeutically.

Biosimilars are less of a problem due to the 12 year exclusivity FDA approval of the reference product gives the innovator. It will be interesting to see if the biosimilar route is used by competitors for easier regulatory approval or if competitors will use the BLA route for their own 12-year exclusivity.

Thanks for the comment.

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