Pharmaceutical patents under fire from the federal circuit, according to the petitions

Growing frustration among pharmaceutical patentees over the Federal Circuit’s tightening of patent law provisions that require inventors to describe in detail what they have created has led to multiple Supreme Court petitions seeking to put the country’s leading patent appeals court.

Over the past decade, the United States Court of Appeals for the Federal Circuit has adopted higher standards to meet the requirements of the law that patents provide a clear written description and enable others to understand the invention. Three separate petitions for review are now asking the High Court to look at tests that have evolved from statutory language that set benchmarks for how patent holders fully disclose their inventions – the tests say lawyers have created a particularly heavy burden on the life sciences industry.

Recent decisions invalidating pharmaceutical patents held by Bristol-Myers Squibb Co. Juno Therapeutic, Biogen International GmbHand Amgen Inc. show how difficult it is for drugmakers and biotech companies to meet federal circuit standards, the attorneys said.

“I hope the Supreme Court can make a correction to the course we are currently on,” said Hailey Bureau, patent attorney at Birch, Stewart, Kolasch & Birch LLP. “The court has been going down this road for the past decade, but now it looks like the last three very recent decisions have come to a head in the last year.”

Describe an invention

Section 112(a) of the Patent Act requires that “patent claims must state what an inventor or co-inventor considers to be the invention”. From there, more specific provisions require a “written description of the invention, and of the manner and process of making and using it, in full, clear, concise and accurate terms enabling” a skilled person in the art of making and using the invention. The Federal Circuit treats this language as two separate issues, the lawyers say: a written description requirement and a clearance standard.

Both prongs of Section 112 were improperly enforced by the federal circuit, drugmakers claim, which they say led to the invalidation of patents for breakthrough cancer treatments and a blockbuster cancer drug. multiple sclerosis.

The Complete Federal Circuit held in 2010 Ariad vs. Eli Lilly ruling that the written description requirement is distinct from the authorization. Testing, however, is two sides of the same coin, Bureau said.

“They are very intertwined. If you can show clearance, you should have a written description,” Bureau said. “The court decided on its own initiative to split them into two requirements of written description and enabling, but whether or not that was Congress’s intention, it probably isn’t.”

full ownership

The Biogen and Juno Therapeutics petitions both address whether the Federal Circuit went too far in what is necessary to show that an inventor has full possession of the invention, a way of showing that there is an adequate written description.

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

Biogen’s patent for the drug MS Gilenya fell because the patent failed to show the invention was “effective”, prompting dissent from several judges, who said the ruling would cloud case law. Simply listing ingredients and methods once, without proving efficacy, should suffice, 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, it also creates a problem for pharmaceutical companies to decide when to file for patent protection,” said patent attorney Emer Simic. at Neal, Gerber & Eisenberg. LLP in Chicago. “This creates significant concern for pharmaceutical companies researching drugs for the treatment of various conditions.”

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

“It really places a very heavy burden on the plaintiff — an incredible, perhaps even untenable burden,” Bureau said. “We have found ourselves in a situation that is not ideal for patent applicants or patentees in these cases.”

Juno said the Federal Circuit went beyond the law and “erases vast swathes of patents.” Biogen warned that the decision revoking its patent would have a “chilling effect on innovation”.

Bigoen may be in the best position to win a Supreme Court grant, Simic said, pointing to the split between judges and the High Court’s denial of other petitions involving gender claims – patents that cover a group of related substances, rather than a specific compound – such as those 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 the clearance requirement .

The ruling created a new hurdle for gender claims, Amgen argued in its Supreme Court petition, saying the Federal Circuit expanded the test to require the patent to allow a qualified expert to identify and make cumulatively almost all possible variants of the invention without substantial. time and effort.

Teaching every gender assertion which works and which doesn’t would be an impossible burden, said Stanford University law professor Mark Lemley.

“This is going to make it difficult for almost everyone in the pharma and bio space to get a gender claim in the future,” Lemley said. “I don’t think the lawyers and the pharmaceutical companies who are writing the patents have somehow fully focused on the fact that, you know, when these things come 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 University of Illinois law professor Jacob S. Sherkow, who with Lemley wrote an article about antibody patents falling in court of appeal.

“Most importantly, it leaves us in a world where almost all antibody patents covering any major product, any treatment, any diagnostics – any patent covering antibodies – will all be subject to ‘be invalidated under that same standard,’ Sherkow said. said.

“It would only erase billions of dollars worth of intellectual property.”

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