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16 June 2022Big Pharma

BMS petitions SCOTUS to revive $1.2bn win

BMS unit Juno Therapeutics and the Sloan Kettering Institute for Cancer Research have urged the US Supreme Court to reinstate their $1.2 billion win in a patent clash with Kite Pharma, a subsidiary of Gilead.

In a petition for a writ of certiorari, BMS argued that the US Court of Appeals for the Federal Circuit ruling in August last year—which reversed BMS’ victory—and other similar rulings were “devastating for innovation”.

Gregory Castanias, a partner at Jones Day who is acting for Juno, said: “We’re seeking Supreme Court review because the Federal Circuit’s written description law is contrary to the statute that Congress wrote, it goes against hundreds of years of US Supreme Court precedent, and it is stifling scientific breakthroughs, particularly medical ones like Sloan Kettering’s lifesaving CAR-T therapy. The patent law is supposed to encourage, not discourage, innovation and investment in these kinds of advancements.”

In August last year, the Federal Circuit held that claims of US patent 7,446,190 were invalid, siding with Kite’s contention that “no reasonable jury” could find the patent’s written descriptions sufficient.

The decision overturned the US District Court for the Central District of California’s ruling that Kite had infringed the patent by releasing Yescarta, a CAR-T cell therapy used to treat large B-cell lymphoma.

BMS asked the Federal Circuit to rehear the dispute, arguing that the court had applied a “rigid, formalistic test” for evidence of the inventor's ownership of the “full scope” of the invention.

A flurry of amicus briefs echoed BMS’ sentiment that the decision left “no other option” than to pursue “exceedingly narrow” patent protection that could easily be evaded by copycats.

However, BMS’ petition for rehearing was denied. Now, on appeal to the Supreme Court, BMS has argued that the Federal Circuit had added patent requirements that don’t exist in the Patent Act.

“Even though the statute plainly says that the measure of the ‘written description of the invention’ is whether it allows skilled workers to make and use the invention, that court has burdened the straightforward textual provision with convoluted, judicially crafted requirements that the patent show the inventor ‘possessed the full scope of the claimed invention’, including all ‘known and unknown’ variations of individual components,” said the petition.

According to BMS, the consequences of this “judicial embroidery” have led the Federal Circuit to invalidate many patents by "demanding the impossible”. In particular, said BMS, the effect has been particularly lethal in the biological sector.

BMS claimed: “This case is the poster child for those devastating consequences. It involves the erasure of patent protection for a lifesaving technology in the CAR-T therapy field.”

In asking the Supreme Court to grant certiorari, BMS added that the Federal Circuit’s approach “contravenes the plain statutory text and is erasing vast swaths of patents for failing to satisfy a disclosure standard found nowhere in the statute”.

BMS has asked the court to address the question of whether the adequacy of the “written description of the invention” is to be measured by the statutory standard or under the Federal Circuit’s test.

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