Amgen Antibody Appeal Pits Patent Rights Against Competition

Amgen Inc. will ask the Federal Circuit at argument Wednesday to revive its patents for the cholesterol drug Repatha, which were invalidated in a long-running dispute with Sanofi and Regeneron Pharmaceuticals Inc.

The case could have implications for drugmakers and biotechnology companies that produce pioneering antibody-based drugs, including those being developed to treat and prevent Covid-19.

The appeal comes in the wake of the U.S. Court of Appeals for the Federal Circuit’s 2017 decision narrowing the patents companies can claim for the antibodies they discover. The decision called into question many existing biotech patents.

Amgen v. Sanofi could add new restrictions on patent rights. But allowing patents to cover a whole class of antibodies could stifle innovation and competition, opponents argue.

Amgen has been fighting Sanofi and Regeneron over their competing drug Praluent since 2014, before either drug was on the market. Last year, a federal trial court found Amgen’s two Repatha patents were invalid because they weren’t detailed enough to enable an expert to recreate the invention.

Ping Pong

The dispute has been batted between the district court and Federal Circuit for six years.

Amgen sued Sanofi and Regeneron, alleging their drug infringed its two patents for Repatha. Amgen’s patents are related to a genus of antibodies called PCSK9 inhibitors, which help patients with ultra-high bad, or LDL, cholesterol who have difficulty getting their condition under control with widely used statins such as Pfizer Inc.’s Lipitor.

A federal jury in March 2015 said Praluent would infringe the Amgen patents. The U.S. District Court for the District of Delaware 2017 took the rare step of ordering Praluent pulled off the market. The Federal Circuit almost immediately put the sales ban on hold and granted Sanofi’s and Regeneron’s request for a new trial. Amgen won again in February 2019, when a jury upheld two patents for Repatha.

The district court judge later threw out the verdict, saying the patents cover a “vast” genus of antibodies and don’t enable a person skilled in the field to make or use the inventions without undue experimentation. That cleared Sanofi and Regeneron to continue selling Praluent. Amgen appealed.

Sanofi and Regeneron argue the patent language covers millions of possible antibodies, and is, at best, a starting point for trial-and-error experimentation. Amgen argues the scope is narrower, encompassing 400 variants with predictable activity.

High Stakes for Biotech

Neither Repatha nor Praluent has lived up to expectations, as insurance companies balked at paying high prices for a new class of treatments for chronic diseases when cheaper drugs are available. The drugs initially cost $14,000 a year each, while generic statins can cost less than $100 a year.

The dispute has drawn amicus briefs for both sides concerning its broader implications on the future of antibody-based drugs.

Bristol-Myers Squibb Co. and Merck Sharp & Dohme Corp. filed a brief in support of Amgen arguing the lower court’s ruling holds owners of antibody patents to an “impossibly high standard.” Pioneers of therapeutic antibodies will have a much harder time getting meaningful patent protection for their expensive, time-consuming work, they argue.

Two briefs in support of Sanofi-Regeneron argue Amgen’s position will stifle competition.

Pfizer Inc. argues the breadth of Amgen’s patent is a “deliberate strategy designed to capture any and every anti-PCSK9 antibody that a competitor might develop.”

Eli Lilly & Co. challenges the patent’s attempt to cover “anything that works,” arguing “Amgen seeks to coopt an entire class of medicines, therapeutic antibodies, and block the target’s use in antibody drug discovery and development.”

Lilly put the case in the context of the current pandemic, imagining a patent directed to all antibodies to the virus. “Such a patent would, in violation of laws intended to promote science, preempt the more than a dozen pharmaceutical companies developing therapeutic antibodies to combat this viral pandemic,” it said.

Jeffrey Lamken of MoloLamken LLP in Washington will argue for Amgen. Matthew Wolf of Arnold & Porter Kaye Scholer LLP in Washington will argue for Sanofi-Regeneron.

The case is Amgen Inc. v. Sanofi, Fed. Cir., No. 20-1074, argument 12/9/20.