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A case that could impact the future of Patenting of Biologics.


Amgen Inc. v. Sanofi case is currently in the Federal Circuit, wherein the validity of the two Amgen patents claiming genus is being argued. Court is evaluating whether these patents meet enablement requirements under Section 112 of the Patent Act or not.

Fight between innovator & generic pharma is over Genus Vs Species claims. Innovator companies are looking to get coverage for discoveries that may lead to important drugs, however the generic Pharma feel such broadness is unfair, as it hinders the competition.

As this dispute is playing out in the court, a group of law professors have published a study titled “Death of Genus Patents”, which is an interesting read and raises some valid questions about “full scope possession” theory and how it threatens innovation in Pharmaceutical, Biotechnology & Chemical industry.

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3668014

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