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14 June 2022

Takeda unit urges Fed Circ to revive antibody patent

Baxalta, a subsidiary of Japan-headquartered pharmaceutical company Takeda, has asked the US Court of Appeals for the Federal Circuit to overturn a decision that invalidated its antibody patent.

In its opening brief, filed Friday, June 10, Baxalta claimed that the ruling—handed down by Judge Timothy Dyk at the District Court the US District Court for the District of Delaware—was based on two factual errors: the field of antibodies is “inherently unpredictable” and that the only way to practice the teachings of the patent is by trial-and-error.

In January this year, Genentech emerged victorious in a suit filed by Baxalta which claimed that Genentech’s haemophilia treatment Hemlibra infringed a patent.

Dyk dismissed Baxalta’s suit and awarded Genetech summary judgment. He said that the relevant claims of Baxalta's patent related to blood-clotting antibodies are invalid for lack of enablement.

On appeal against the decision, Baxalta has now argued that while certain aspects of the field of antibodies are unpredictable, other aspects are predictable.

Turning to its own patent, Baxalta claimed that “a skilled artisan could engineer antibodies into the full scope of claimed isotypes and formats—a process involving a predictable aspect of the field of antibodies”.

Secondly, Baxalta argued that practising the claims doesn’t involve ‘trial-and-error’ or “randomly synthesising antibodies while hoping to discover one that practices the claims”, but instead includes a specification which describes a two-step process to practice the claims.

“This process is reliable, not trial-and-error, and requires no undue experimentation,” said the brief.

Baxalta continued: “The district court failed to heed this court’s direction to consider each case, even those involving genus claims, ‘based on the facts of that case and the evidence presented there’.

“On the record here, a reasonable jury could find facts establishing that the claims are enabled. The district court’s grant of summary judgment was erroneous.”

In addition to asking the Federal Circuit to address the issues of whether the district court erred in its ‘unpredictable art’ and ‘trial-and-error’ conclusions, the Takeda-subsidiary set out two further issues.

Baxalta’s first issue was whether the district court failed to hold Genentech to its “burden to prove by clear-and-convincing evidence the facts underlying non-enablement and to construe the evidence in the light most favourable to Baxalta”.

Additionally, the court was asked to consider whether the Delaware court applied the wrong legal standard for enablement by “(a) requiring a patent claiming a novel quality to enable every possible measurement of that quality; (b) requiring enablement of antibodies outside the scope of the claims; and (c) focusing on development of the accused product, without evidence that its development followed the patent’s teachings”.

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More on this story

Americas
17 January 2022   Genentech has gained a win in a suit claiming that its haemophilia treatment Hemlibra infringes a patent owned by Takeda subsidiary, Baxalta, after a US federal judge held that parts of the patent were invalid.

More on this story

Americas
17 January 2022   Genentech has gained a win in a suit claiming that its haemophilia treatment Hemlibra infringes a patent owned by Takeda subsidiary, Baxalta, after a US federal judge held that parts of the patent were invalid.

More on this story

Americas
17 January 2022   Genentech has gained a win in a suit claiming that its haemophilia treatment Hemlibra infringes a patent owned by Takeda subsidiary, Baxalta, after a US federal judge held that parts of the patent were invalid.