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18 January 2022AmericasAlex Baldwin

Groups urge Fed Circ to rehear Biogen patent case

Pharma, biotech and chemical industry groups have asked the US Court of Appeals for the Federal Circuit to review its decision to invalidate a Biogen patent for lacking written description.

The law division of the American Chemical Society, the Biotechnology Innovation Organisation (BIO), and the Pharmaceutical Research and Manufacturers of America (PhRMA) have all filed briefs in support of Biogen’s petition for a panel rehearing.

The appellate court refused Biogen’s attempt to revive a key patent for its multiple sclerosis drug Tecfidera (dimethyl fumarate) in a split decision handed down in November.

It affirmed a prior ruling from the US District Court for the Northern District of West Virginia that the claims of US patent 8,399,514 were invalid, clearing the way for Mylan to launch its own generic of the drug.

Biogen submitted a petition for a panel rehearing on 30 December, claiming that the panel majority had misinterpreted prior case law and applied a heightened written description standard which asked Biogen to submit data approving “clinical efficiency”.

The amici submitted briefs in support of Biogen’s petition last week on 12 and 13 December.

The law division of the American Chemical Society agreed broadly with Biogen’s petition, claiming that the panel majority’s decision applied a heightened written description requirement.

Specifically, the society argued that the judgment departs from precedent in similar pharma patent validation cases debating written description in Alcon Research v Barr Labs and Ariad Pharmaceuticals v Eli Lilly & Co.

BIO took issue with a specific requirement of the Federal Circuit’s analysis, arguing that the appellate court “erroneously applied” a “blaze marks” analysis, which is used to determine possession of an invention within a “specific scenario”.

It argued that the court had already held that blaze marks had not previously been required to sufficiently disclose written descriptions in similar cases.

PhRMA members argued that the Federal Circuit’s disclosure requirements were “flatly inconsistent” with “long-settled requirements for the practical utility of human therapeutic inventions”.

PhRMA claimed that two of the Federal Circuit’s arguments—that the inventor had not proven that they had “actually made” the specific invention, nor that it “was effective in humans”—should not have rendered the ‘514 patent invalid.

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More on this story

Americas
18 March 2021   A proposed Teva Pharmaceutical generic drug to treat multiple sclerosis infringes patents relating to Vumerity, according to a lawsuit filed by Biogen and Alkermes.
Americas
2 December 2021   The US Court of Appeals for the Federal Circuit has refused Biogen’s attempt to revive a key patent for its multiple sclerosis drug Tecfidera (dimethyl fumarate), leaving Mylan’s successful challenge intact.

More on this story

Americas
18 March 2021   A proposed Teva Pharmaceutical generic drug to treat multiple sclerosis infringes patents relating to Vumerity, according to a lawsuit filed by Biogen and Alkermes.
Americas
2 December 2021   The US Court of Appeals for the Federal Circuit has refused Biogen’s attempt to revive a key patent for its multiple sclerosis drug Tecfidera (dimethyl fumarate), leaving Mylan’s successful challenge intact.