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« GlaxoSmithKline Files Amicus Brief in Amgen v. Sanofi | Main | U.S. Government Files Amicus Brief in Amgen v. Sanofi »

March 21, 2023


The biggest hole I see in this argument is that the “innovation” lies in the validation of a disease theory (e.g. an antibody that competitively binds to PCSK9 receptors can treat high LDL cholesterol). That is increasingly true with biologics. But genus patents do not enable that utility, and if they were endorsed, they could be used by unsuccessful pharmas to discourage competitors who sought to validate the same or related disease theories.

Ideally, bad circuit law on utility and how-to-use enablement (eg Krimmel, Nelson, Fujisawa, Brana, etc.) would be overruled, so that pharma patents would maximally encourage advancing first-in-class candidates to Phase 2 and 3 trials. Then a genus-wide patent would likely be appropriate.

Kyle: while validating disease theories is always a part of pharma development, I think the issue is focused on the molecule and how to protect it. As an example, the basis of antacids is to modify the function of the proton pump in the stomach. This can be achieved by omeprazole or lansoprozole, both distinct molecules having the desired clinical effect. A genus claim to either does not affect patenting or commercializing the other due to the different chemical species within each genus (i.e., they do not overlap).

Very different situation for antibodies, where (in the strictest sense) an antibody having a valine at a particular position in its amino acid sequence is a different antibody than one having an isoleucine at that position, wherein the difference in two molecules having tens of thousands of atoms is three atoms (-CH2-). While this should be addressed under the doctrine of equivalents there is inconsistent application of the doctrine under the best of circumstances.

Amgen's problem is that they claimed their antibody completely by function, which would have been fine 50 years ago because that was the only way to do it (and generally it would be antisera comprising a plurality of antibodies raised to an antigen rather than a monoclonal antibody). But the ability to define antibodies by amino acid sequence has actually reduced the scope of claims to antibodies, an attempted remedy for his being Amgen's claims.

Thanks for the comments.

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