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10 November 2022Big PharmaStaff Writer

SCOTUS rejects BMS vs Gilead patent clash

Dispute over patent relating to a CAR-T cell therapy shunned by top court | Backing from Amgen, GSK and St. Jude's Children's Research Hospital over “exceedingly narrow” patent protection fails to convince Justices.

The US Supreme Court has refused  BMS’ Juno Therapeutics bid to revive its $1.2 billion win in a patent dispute with  Kite Pharma, a subsidiary of  Gilead.

The US’ highest court rejected BMS’ and Sloan Kettering Institute for Cancer Research’s petition for writ of certiorari, which the drugmaker had filed in June this year after a US Court of Appeals for the Federal Circuit had reversed its victory.

According to BMS, the Federal Circuit’s ruling and other similar rulings were “devastating for innovation”.

In August 2021, the Federal Circuit concluded that claims of US patent 7,446,190 were invalid, overturning 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, claiming that the court had applied a “rigid, formalistic test” for evidence of the inventor's ownership of the “full scope” of the invention.

While several 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, BMS’s petition was denied.

In its petition to the Supreme Court, BMS argued 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”.

It added: “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.

BMS said that the effect of this “judicial embroidery” has been particularly lethal in the biological sector.

“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,” said the petition.

Again, several pharmaceutical companies filed amicus briefs in support of BMS, including Amgen, GSK and St. Jude's Children's Research Hospital.

However, the appeal was rejected on Monday, 7 November.

Also in November, the Supreme Court  agreed to hear Amgen’s attempt to revive patents on its cholesterol drug Repatha (evolocumab) that were invalidated amid a legal wrangle with Sanofi and Regeneron.

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More on this story

Big Pharma
16 June 2022   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.
Americas
7 November 2022   The dispute centres on a section of the Patent Act concerning 'enablement' | The US government had urged the court to deny the petition.

More on this story

Big Pharma
16 June 2022   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.
Americas
7 November 2022   The dispute centres on a section of the Patent Act concerning 'enablement' | The US government had urged the court to deny the petition.

More on this story

Big Pharma
16 June 2022   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.
Americas
7 November 2022   The dispute centres on a section of the Patent Act concerning 'enablement' | The US government had urged the court to deny the petition.