Bloomberg Law
June 23, 2022, 9:05 AM

Generic Drugmakers Score Big in Rare Federal Circuit Reversal

Samantha Handler
Samantha Handler

An unusual Federal Circuit decision has given generic drugmakers a new way to successfully challenge pharmaceutical patents with specific types of claims.

Novartis Pharmaceuticals Corp.‘s patent on the dosage regimen for the blockbuster multiple sclerosis drug Gilenya didn’t have an adequate description, which the Patent Act requires for a patent to be valid, a US Court of Appeals for the Federal Circuit panel ruled June 21 in a new opinion. Inventors must provide a precise definition of what is claimed to show that they possess the invention.

The ruling outlines a new defense generic drug makers accused of infringing a name-brand drug can raise to attack the patent as invalid, said Michelle Armond, a founding partner at Armond Wilson LLP. The decision, if it stands after likely appeals, will have a big impact on pharmaceutical cases, Armond said, adding that the consequences could also spill outside of life sciences patents.

The opinion creates a framework for what is necessary for a patent to satisfy the written description requirement for claims that show the absence of a feature in a patent, known as a negative claim limitation. Silence—meaning no mention of a feature in the description—can’t generally support negative limitations, except when patent owners show that skilled experts in the field would “always” understand that a feature should be excluded, according to the opinion.

“Written description can often be a significant issue in pharmaceutical cases,” Armond said. “You can expect that other generic drug makers are going to pay attention to this and try similar approaches and strategies on patents in that space that have negative limitations.”

Inventors writing patent applications, as well as patent challengers, now have more certainty, said Shashank Upadhye of Upadhye Tang LLP. Patent drafters know now what is necessary to satisfy the requirement, and companies are more aware of the vulnerabilities of the patents they own.

“It’s not bad to have some rules in place that provide clear guidance for both patent holders and competitors alike,” Upadhye said, “so that both of them can manage their businesses.”

‘Soap Opera’

Patients are often given a higher dosage when starting medication, known as a loading dose. Novartis’s US Patent No. 9,187,405 discloses multiple daily potential doses for Gilenya’s active ingredient fingolimod, with no mention of a loading dose. The original Federal Circuit panel majority concluded that a skilled expert would know that the absence of a loading dose in the patent would be enough to understand that one isn’t needed.

The court’s opinion changed after a rare sequence of events, which could make the case ripe for the full Federal Circuit or the US Supreme Court, attorneys said.

“There aren’t soap operas in patent law, because nothing we do is that sexy,” Upadhye said, “but if there was one, maybe this would be a good candidate for the ‘Patent Law Soap Opera Digest.’”

The Federal Circuit originally issued a ruling siding with Novartis, from a panel composed of judges Kathleen M. O’Malley and Richard Linn in the majority and Kimberly A. Moore as the lone dissenter. O’Malley subsequently retired, and Judge Todd M. Hughes joined the panel for its reconsideration of the case. Hughes sided with Moore to rule against Novartis.

It’s unclear how much impact the Federal Circuit’s new decision will have on the dispute it weighed.

Novartis didn’t initially sue any competitors over the ‘405 patent until after some challenged its validity at the US Patent and Trademark Office. After the PTO found the patent was valid—showing Novartis the patent had more value than expected—in 2018 it sued two dozen generic makers, including HEC, for infringing the patent. Most have now settled.

Whether HEC or any other rival that was previously considering launching a generic version of the drug can do so now is unclear, Upadhye said.

The answer for the other companies depends on the terms of the settlement agreements reached, while HEC could be blocked by an injunction order as the two companies are scheduled to go to trial over the another patent related to Gilenya in April 2023.

If HEC does roll out a drug, it likely faces less competition from companies that settled out but must weigh the risk of the potential payout versus the likelihood the Supreme Court unravels the ruling.

One judge being the difference in the case shows how close it was, Armond said, meaning Novartis will likely appeal.

“This can have a lot of value, especially in the pharmaceutical space,” Armond said. “This case can be very consequential, so you can see there being interest in carrying it forward and seeking clarification from the Supreme Court.”

Bright-Line Rules

In a dissent, Linn took issue with the “heightened standard” of review that the majority applied, saying deference must be given to district courts. The US District Court for the District of Delaware had found that the patent was valid and HEC infringed it. Appellate courts are supposed to review factual determinations deferentially for clear error, Linn said.

The Supreme Court has previously ruled that appellate courts must provide deference to district courts in factual reviews, and the Federal Circuit’s reversal creates unpredictability, said Patrice P. Jean of Hughes Hubbard & Reed LLP. Patent holders likely will cite Linn’s dissent as a defense moving forward, she said.

The tension between the two views comes from the Federal Circuit’s attempt to provide more bright-line rules when the review has previously depended on the case’s specific facts, Armond said.

“They’re trying to provide a framework for more cases,” Armond said, “so it’s going to be really interesting to see where the Federal Circuit goes from here on this.”

To contact the reporter on this story: Samantha Handler in Washington at

To contact the editors responsible for this story: Keith Perine at; Jay-Anne B. Casuga at

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