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28 April 2020AmericasRory O'Neill

Pfizer fails to establish standing for patent challenge

Pfizer has been rebuked by judges for filing thin evidence in support of what the pharma company called its ‘self-evident’ standing to bring a patent challenge.

In a  decision issued today, April 27 the US Court of Appeals for the Federal Circuit rejected Pfizer’s request to cancel two  Chugai Pharmaceutical patents covering a method of removing DNA contaminant from protein samples.

Pfizer said it was “self-evident” that it had a product, Ruxience (rituximab), that was blocked from coming to market by the patents.

Ruxience is a biosimilar of a rituximab drug sold by Pfizer’s rival  Genentech which, like Chugai, is a subsidiary of  Roche.

Pfizer filed for inter partes review (IPR) of the two patents at the Patent Trial and Appeal Board. The PTAB instituted IPR, but ruled for Chugai, a subsidiary of Roche, prompting Pfizer to appeal to the Federal Circuit.

But according to the Federal Circuit, “it appears that Pfizer’s ‘self-evident’ theory stems from the fact that Pfizer listed “rituximabIPR@winston.com” in its petitions as its service email address for the IPR proceedings”.

“Chugai, in turn, listed Genentech as a potential real party in interest in the IPR proceedings and subsequent appeals because Genentech sells a rituximab product and Pfizer’s service email suggested that Pfizer believed the litigation related to rituximab,” it added.

This, the court said, was not sufficient to establish standing to bring the claims.

“Pfizer’s service email address and Chugai’s response do not tell the court anything useful about Pfizer’s plans for its biosimilar, Ruxience, as of the beginning of 2019, when this appeal began,” the judges said.

While Pfizer said it was at risk of an infringement action by Chugai, it did not specify in its evidence when that risk arose, the court also found.

The judges said they could not establish standing based on the evidence provided, and dismissed Pfizer’s appeal.

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