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16 November 2021Big PharmaAlex Baldwin

Amgen asks Fed Circ to rehear $1.1bn Juno patent suit

Amgen and two research centres have thrown their support behind Bristol Myers Squibb subsidiary Juno Therapeutics to help restore a $1.1 billion patent judgment against Kite Pharma that was overturned by the US Court of Appeals for the Federal Circuit.

The three parties published their statement of interest on the case on November 10, asking the circuit to grant Juno’s petition for an en banc rehearing.

Kite Pharma successfully persuaded the Federal Circuit to reverse the win for Juno over a cancer treatment patent in August.

The three-judge panel unanimously ruled that claims of US patent 7,446,190 were invalid, backing Kite’s argument that “no reasonable jury” could find the patent’s written descriptions sufficient.

It was one of several Federal Circuit decisions covering written description and enablement requirements of 35 USC §112.

These decisions have left antibody practitioners “uncertain” about just how much support is required in a patent application, according to Benjamin Pelletier, partner at Haynes & Boone.

Amgen’s proposed brief

In its motion for leave to file an amicus brief, Amgen claims that “the issues involved in this case may have far-reaching and unintended consequences for life science innovation”.

It added that the Federal Circuit had “erroneously” interpreted Section 112(a), by holding that the doctrine “contains two separate description requirements, a written description of the invention... and the manner and process of making and using the invention”

The creation of two tests for description requirements means that an infringer can challenge the validity under each standard, “taking two bites at the apple… Creat[ing] an unfair and unworkable standard for patent holders”.

Amgen also holds that the en banc review is necessary to correct the panel’s “overreach” into the “province of the jury”. It added: “Written description is a question of fact reserved for juries, whose findings are entitled to more deference than the panel gave here”.

Research perspective

The City of Hope motion argues that the Federal Circuit’s interpretation of the written description requirement will have the unintended effect of “jeopardising the development of biopharmaceutical therapies at the City of Hope and over research institutions, to the ultimate detriment of patients”.

St Jude’s Hospital, who also submitted a proposed amicus brief, claimed that it was  “concerned that the panel’s decision morphs the written description requirement into an unattainable standard”, claiming that this particularly impacts the biotechnology and pharmaceutical fields.

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