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Biogen’s Rehearing Denial Lays New Hurdles for Pharma Patents

March 18, 2022, 9:10 AM

A recent dissent from three Federal Circuit judges signals that a potential Supreme Court petition might be on the horizon in a case that opened up a new avenue for challenging pharmaceutical patents.

Two denials of full court rehearings for pharmaceutical patents that hit March 16 are the latest examples of how the U.S. Court of Appeals for the Federal Circuit is grappling with the standard for written description support. Judge Alan D. Lourie authored a dissent in one of the decisions, saying that the opinion in Biogen International GmbH v. Mylan Pharmaceuticals Inc. will have a “muddying effect” on case law.

Emer Simic, a patent attorney at Neal Gerber Eisenberg LLP in Chicago, said the dissent is significant, especially as Biogen and others move forward with the broader standard established by the panel opinion.

“Potentially, Biogen could take this case up to the Supreme Court,” Simic said. “Oftentimes when we see a dissent like this that’s very strong, it signals that this is a potential case that could be taken up to the court for a higher review.”

‘Up in the Air’

Lourie’s dissent, joined by Chief Judge Kimberly A. Moore and Judge Pauline Newman, shows the tension between the different schools of thought around the requirement among the judges, Shashank Upadhye of Upadhye Tang LLP said.

The patent act requires that a patent owner provide a precise definition of what is claimed to establish that the inventor possesses the invention.

The Federal Circuit should have taken up the en banc petition so the court could clarify the proper bounds of written description analysis, Lourie said. The panel majority and district court made four errors, Lourie wrote, including by finding that a claim lacked written description because it only appeared in the specification. “Once is enough,” Lourie wrote.

Lourie’s view of the standard exemplifies an interpretation of the law where patent owners just need to list ingredients and methods to satisfy the requirement, Upadhye said. That practice could lead to pharmaceutical companies that are aggressive about pursuing patent claims suing for infringement of claims that aren’t necessary for the original invention, Upadhye said. The result, he said, would be more suits over unrelated patents with the same ingredients.

“The panel opinion is trying to move toward a rule of law that merely putting words down might not be enough to satisfy the requirement,” Upadhye added, saying the challenge he had with Lourie’s dissent is that it can be interpreted to mean patent owners can list a catalog of items to stitch together to meet the written description standard.

The original 2-1 majority ruled that Biogen’s method of treatment patent doesn’t show the company possessed the claimed therapeutically effective dose to treat multiple sclerosis at the time it filed the patent application.

The panel’s opinion broadened the written description requirement beyond the need to list ingredients and methods. The decision meant that patent owners must prove both therapeutic efficacy, which was set in an earlier case, and clinical efficacy to meet the written description requirement.

Attacks on the previous standard were limited to claims drafted in functional terms and claims lacking literal support in the specification, said Dmitry Karshtedt, a law professor at George Washington University.

Written description practice “really is up in the air,” now, Upadhye said.

More Challenges Expected

The Federal Circuit’s ruling in Biogen, now settled by the denial of the full rehearing, presents concerns for patent drafters and the pharmaceutical industry that more pharmaceutical patents will be challenged based on potential lack of support for written description, Simic said.

“It does signal to patent challengers that written description is now potentially a more attractive basis to challenge pharmaceutical patents than what was previously considered,” Simic said. “For patents that were considered to be sound at least with respect to potential written description challenges, now there may not be the same confidence.”

The appeals court also denied a full panel reconsideration of another split decision where the judges disagreed over the standard for written description support. Lourie wrote the majority opinion in that case, which upheld the invalidation of part of a Indivior UK Ltd. patent on the opioid cessation drug Suboxone.

Last year, the Federal Circuit unraveled a $1.2 billion award won by Bristol-Myers, saying the patents didn’t adequately describe the invention. The heightened standard applied for written description there possibly threatens research, according to research institutions.

“It’s an area where I have alerts set up for every written description precedential opinion coming out because they’re so impactful for my clients,” said Matthew A. Chivvis of Morrison & Foerster LLP. “It doesn’t matter what side they think they’re going to be on. They want to know what’s going on here just because it’s become the center of a bunch of big decisions recently.”

To contact the reporter on this story: Samantha Handler in Washington at shandler@bloombergindustry.com

To contact the editors responsible for this story: Renee Schoof at rschoof@bloombergindustry.com; Jay-Anne B. Casuga at jcasuga@bloomberglaw.com