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Pharma Patents Threatened by Federal Circuit, Petitions Say (1)

July 1, 2022, 9:37 AMUpdated: July 1, 2022, 4:22 PM

Pharmaceutical patent owners’ growing frustration with the Federal Circuit’s tightening of Patent Act provisions that require inventors to fully describe what they’ve created has led to multiple Supreme Court petitions seeking to bring the country’s primary patent appeals court to heel.

The US Court of Appeals for the Federal Circuit over the past decade has adopted more stringent standards for meeting the law’s dictates that patents provide a clear written description, and enable others to understand the invention. Three separate petitions for review now ask the high court to examine the tests that have evolved from the statutory language that set benchmarks for how patent owners disclose the full scope of their inventions—tests attorneys say have created a particularly high burden on the life sciences industry.

Recent rulings striking down drug patents owned by Bristol-Myers Squibb Co.’s Juno Therapeutics, Biogen International GmbH, and Amgen Inc. show the difficulty for drug makers and biotechnology companies to satisfy the Federal Circuit’s standards, attorneys said.

“Hopefully the Supreme Court can provide a course correction for the course we’re on now,” said Hailey Bureau, a patent attorney at Birch, Stewart, Kolasch & Birch LLP. “The court has been on this path for the past decade, but now it seems like the past three very recent decisions came to a head in the past year.”

Describing an Invention

Section 112(a) of the Patent Act requires that patent “claims must set forth the subject matter that an inventor or a joint inventor regards as the invention.” Building from there, more specific provisions call for a “a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable” a person skilled in the art to make and use the invention.” The Federal Circuit treats this language as two separate questions, attorneys say: a written description requirement, and an enablement standard.

Both prongs of Section 112 have been improperly strengthened by the Federal Circuit, drugmakers argue, which they say has led to the cancelation of patents for revolutionary cancer treatments and a blockbuster multiple-sclerosis drug.

The full Federal Circuit held in the 2010 Ariad v. Eli Lilly ruling that the written description requirement is separate from enablement. The tests, though, are two sides of the same coin, Bureau said.

“They’re very much enmeshed together. If you can show enablement, then you must have written description,” Bureau said. “The court decided on its own to split these into two requirements of written description and enablement, but whether or not that was the congressional intent, likely it’s not.”

Full Possession

Petitions from Biogen and Juno Therapeutics both center on whether the Federal Circuit has gone too far in what is required to show that an inventor has full possession of the invention, a way to show there’s an adequate written description.

“The question not only is how do we, as the applicant, show possession, [but] how do we show we have enough possession?” Bureau said. “Based on some goalposts that the Federal Circuit has set, that appears to be invisible that no one else can see except for the court.”

Biogen’s patent for the MS drug Tecfidera fell because the patent didn’t show that the invention was “effective,” drawing dissents from multiple judges, who said the decision will muddy case law. Just listing ingredients and methods once, without proving efficacy, should be enough, Judge Alan D. Lourie wrote in a dissent from the full Federal Circuit’s decision not to rehear the case.

“If the written description standard is now going to require proof of efficacy in a patent application, that also creates a problem for pharmaceutical companies in deciding when to file for patent protection,” said Emer Simic, a patent attorney at Neal, Gerber & Eisenberg LLP in Chicago. “This does create a significant worry for pharmaceutical companies pursuing drugs for treatment of various conditions.”

Juno’s patent failed to show how specific antibodies would work in its technique, in which T-cells of a person’s own immune system are modified to attack cancer cells, the Federal Circuit ruled in reversing a $1.2 billion jury verdict. While Juno’s patent offered some examples of antibodies, the Federal Circuit didn’t find it sufficient.

“It really puts a very high burden on the applicant—an incredible burden, maybe even untenable,” Bureau said. “We’ve ended up in a situation that’s not great for applicants or patent holders in these cases.”

Juno said the Federal Circuit has moved beyond the statute and is “erasing vast swaths of patents.” Biogen warned that the ruling nixing its patent would have a “chilling effect on innovation.”

Biogen may have the best shot at a Supreme Court grant, said Simic, pointing to the split among the judges and the high court’s denial of other petitions involving genus claims—patents that cover a group of related substances, rather than one specific compound—like the ones at issue in the Juno and Amgen petitions.

‘Impossible Burden’

Last year, the Federal Circuit found that Amgen’s patents on its cholesterol drug Repatha—which covered hundreds of distinct antibodies—were too broad to be valid, failing to satisfy the enablement requirement.

That decision created a new hurdle for genus claims, Amgen argued in its petition to the Supreme Court, saying the Federal Circuit expanded the test to require that the patent allow a skilled expert to cumulatively identify and make nearly all possible variations of the invention without substantial time and effort. The high court called for the government’s views on Amgen’s petition in April, a signal at least one justice is interested in the case.

Teaching every genus claim that works and doesn’t work would be an impossible burden, said Mark Lemley, a Stanford University law professor.

“It’s gonna make it hard for pretty much anybody in the pharma and bio space to get a genus claim in the future,” Lemley said. “I don’t think the lawyers and pharmaceutical companies that are writing the patents have kind of yet fully focused on the fact that, you know, when these things go to court years later, they’re not going to survive.”

If the Juno and Amgen decisions are left in place by the Supreme Court, no attempt to define an antibody will be enough to satisfy the Federal Circuit, said Jacob S. Sherkow, a professor of law at the University of Illinois, who with Lemley authored a paper on antibody patents falling at the appellate court.

“More importantly, it leaves us in a world where almost every antibody patent covering any major product, any therapeutic, any diagnostic—any patents covering antibodies—they’re all going to be likely to be held invalid under that same standard,” Sherkow said.

“That would just obliterate billions of dollars of intellectual property value.”

(Updates with additional information on Amgen's petition. A previous version corrected the name of Biogen's multiple sclerosis drug Tecfidera.)

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

To contact the editors responsible for this story: Tonia Moore at tmoore@bloombergindustry.com; Adam M. Taylor at ataylor@bloombergindustry.com