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18 November 2021AmericasMuireann Bolger

Gilead ruling ‘threatens life-saving research’, says St Judes

The US Court of Appeals for the Federal Circuit should revisit a ruling in favour of Gilead Sciences that invalidated a cancer drug patent because the decision jeopardises research, according to St Judes Children’s Research Hospital.

The hospital filed the amicus curie jointly with the  Albert Einstein College of Medicine, and The University of Texas MD Anderson Cancer Center on November 10 in a bid to reverse the August decision.

Back in October 2017, a subsidiary of Bristol Myers Squibb, Juno Therapeutics, accused Gilead’s Kite Pharma of infringing US patent number 7,446,190—which covers “Nucleic acids encoding chimeric T cell receptors”—through the sale of immunotherapy treatment Yescarta (axicabtagene ciloleucel).

The patent is owned by Sloan Kettering Institute for Cancer Research, which licenses it exclusively to Juno. In response to the suit, Kite countered that the patent was invalid.

In April 2020, a California federal judge found that Kite had infringed and issued a final award of $1.2 billion in damages to Juno.

But this decision was later reversed by the Federal Circuit panel, which held the patent was invalid because “a claim reciting a groundbreaking biotechnology innovation (here, an intracellular domain for CARs), and further generically reciting the well-established, readily-made targeting domain of a CAR (particularly including an “scFv” binding molecule), could never satisfy the written description requirement—unless the 6 specification describes all ‘known and unknown’ embodiments of the prior-art technology element”.

‘Exemplar of patent protection’

According to St Jude and its fellow amici, the patent-in-suit should be considered valid because “it stands as an exemplar of what patent protection can provide to institutions dedicated to cutting-edge research to eradicate the real-world toll levied by cancer”.

They further argued the panel’s decision caught them “in an impossible bind for their ongoing and future innovation efforts with chimeric antigen receptors and other lifesaving biotechnologies”.

This decision, they contended, left them with no other option but to pursue exceedingly narrow, ineffective patent protection readily evaded by copycats using routine, pre-existing technology.

This position would prevent further investment towards developing treatments for patients; and would require research institutions expending their limited resources and time attempting to satisfy the panel’s super-heightened description standard by exhaustively identifying, making, and testing innumerable embodiments of old technology, said the filing.

They wrote that: “Amici are deeply concerned that the panel’s decision morphs the written description requirement into an unattainable standard—aimed (perhaps exclusively) at cutting-edge innovations in the biotechnology and pharmaceutical fields—that significantly threatens the lifesaving efforts of amici and their research collaborators.”

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