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Amgen High Court Patent Fight Carries Big Stakes for Drugmakers

Nov. 9, 2022, 9:55 AM

A US Supreme Court review of how broadly Amgen Inc. and other drugmakers can write their patent applications promises to reshape intellectual property protections for the pharmaceutical industry.

The case gives the justices a chance to define the scope of a patent law requirement that patents must contain enough information to enable someone with expertise in the field to make and use the invention.

An eventual decision on whether drug patents have to specify all potential antibodies that could have the same effect—or only spell out some of them to protect the entire category—will impact patent strategies and drug research and development.

The high court’s signal that it will mull patent law’s “enablement” caveat could be a boon to drugmakers wanting to explore competitive areas of research and development, if the court cracks down on broad patent claims.

A decision allowing for broader claims would be a win for Amgen and other companies that have tried to stake out a wide territory around their drugs with functional genus claims.

“I think it’s going to have a huge impact on patents that have already issued, including blockbuster pharmaceuticals and biotechnology inventions,” Michelle Armond, co-founder of Armond Wilson LLP, said. “It’s also going to have a huge impact on how these cases are litigated and what defenses are in play.”

Changing Standard

The justices have agreed to consider reviving two patents covering Amgen’s Repatha cholesterol drug that it asserted against Sanofi and Regeneron Pharmaceuticals Inc.’s rival Praluent medicine.

The court’s interpretation of what constitutes full enablement will affect drugmakers that use functional genus claims to define an invention as a category of things that performs a certain function or achieves a certain result.

The US Court of Appeals for the Federal Circuit previously found that Amgen’s patents—related to antibodies called PCSK9 inhibitors, which help reduce LDL cholesterol levels—covered too broad a swath of possible antibodies with their functional genus claims

Amgen’s competitors, Sanofi and Regeneron, had argued that the patents were, at best, a starting point for trial-and-error experimentation. Amgen said the scope is narrower, and that it was a road map that could be emulated using “well-known screening techniques.”

Robin Feldman, a law professor at the University of California Hastings, likened Amgen’s view to that of Mufasa, a character in the Walt Disney Co.'s “The Lion King,” standing on a cliff and telling his offspring, Simba, their kingdom extends to everything the light touches.

“The question is, can you do that with patents?” Feldman said.

The justices will consider whether inventors should be allowed to benefit from broad patent language, or whether they must specifically list which combinations they aim to protect—or something in between, Paul Schoenhard, a Fried Frank LLP IP litigation partner, said.

“Really, what this is looking to is, ‘Have you actually invented all of this? Do you actually know whether all of this will work?’” Schoenhard said.

Antibody patents cover some of drugmakers’ most valuable properties, including blockbuster treatments like AbbVie Inc.'s Humira and Merck & Co.'s Keytruda. When antibody treatments first came onto the scene in the 1990s, attorneys said the US Patent and Trademark Office was more permissive about allowing broad claims, granting patents in which the inventors didn’t identify every antibody that could perform the listed function.

The explosion of development in the space “was never really contemplated by the original antibody exception,” said Christopher Cowles, a Withers IP partner. “I think these cases are kind of residual from that kind of thinking.”

Effects on Development

A high court ruling could curtail what some practitioners see as Federal Circuit creep, in which the appeals court has gradually required more detail from patent holders. In Amgen’s case, the Federal Circuit found that “undue experimentation would be required to practice the full scope of these claims.”

Under the Federal Circuit’s interpretation that patents must map out how to reach the “full scope” of the claims, “drafters have to be much more careful to make sure they’re hitting that new standard,” said Nathan Mutter of Holland & Hart LLP. “In some cases, it seems like you just don’t know when you’ve hit it.”

If the justices want to define enablement more broadly, the case is “their opportunity to maybe draw some of that back,” Mutter said.

Others see a potential shift toward a less restrictive standard as a setback for research and development.

Broadly enabled claims are akin to a company “sitting on a large plot of land where only they can use it,” Tahir Amin, the co-founder of I-MAK, a group that advocates to curb pharmaceutical patenting abuse, said.

“That’s actually hindering development and research,” Amin said. “But I’d be surprised if the court gave a very restrictive reading. They’ll probably allow these companies to have some of that land, but not as much as they want.”

Ripple Effects

If the court decides companies must be more precise in their claims, patent holders could see more challenges to their long-established patents. Section 112 of the federal patent code, which outlines the requirements for enablement and written description, could become “an important tool for companies to challenge patents with,” Amin said.

Any change in the current case-by-case standard will affect how patents are written and whether previously granted patents will be more vulnerable to invalidation.

“If the court imposes a rigid rule for the enablement requirement, a large number of existing patent claims covering many pharmaceutical products that are active in the industry right now would be at risk of being found invalid,” Schoenhard said.

On the other hand, a looser interpretation than the Federal Circuit’s “would allow patentees to monopolize large swaths of material that would otherwise be available for incremental innovation,” said Mel Bostwick, a partner in Orrick Herrington & Sutcliffe LLP’s Supreme Court and Appellate practice, in an email.

To contact the reporter on this story: Kelcee Griffis in Washington at kgriffis@bloombergindustry.com

To contact the editors responsible for this story: Keith Perine at kperine@bloomberglaw.com; Jay-Anne B. Casuga at jcasuga@bloomberglaw.com