Amgen’s ongoing patent lawsuit
It has been nearly a decade since Amgen sued Sanofi and Regeneron Pharmaceuticals for patent infringement on at least three of its intellectual property portfolio.
The latest development in this saga happened on March 27, when Amgen spoke at the U.S. Supreme Court.
Amgen’s specific IP portfolio, which describes and claims monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 (PCSK9), would eventually become the company’s Repatha treatment.
Sanofi and partner Regeneron have its own cholesterol-lowering monoclonal antibody drug Praluent, which works in a similar way as Repatha.
Amgen has asked for the courts to weigh in on Amgen’s patents for Repatha, which generated sales of $1.5 billion in 2022 and to determine if Praluent infringes on them.
Amgen also wants the court to rule on how much information it and others need to disclose when describing inventions in patents.
Under U.S. patent law, drug companies can get 20 years of market exclusivity for publishing their inventions but must describe them clearly enough so skilled people can copy and use them without too much trial and error.
If they do not and the patent is too broad, the companies run the risk of having their patents canceled.
Amgen is hoping the courts will rule in favor of its “genus claims” argument, which is a patent that covers not just one specific chemical but a group of related chemicals.
If that were the case, then Amgen could claim ownership of all antibodies that inhibit the PCSK9 protein, the mechanism of action for both Repatha and Praluent.
The concern then is that other companies could do the same.
As such, many of the industry’s biggest players are on both sides.
According to Reuters, Sanofi and Regeneron are backed by Johnson & Johnson, Pfizer, Eli Lilly and at least six other companies, arguing that broad patent protection like Amgen is seeking is not allowed by U.S. patent law.
Amgen is backed by Bristol Meyers, AbbVie and GSK.
So far, U.S. courts have so far sided with Sanofi.
A federal appeals court that covers U.S. patent cases invalidated Amgen’s patent claiming ownership of all PCSK9 inhibitors as a whole in 2021.
The Supreme Court is expected to make a decision sometime in June.