Amgen v Sanofi: The enablement of Sisyphean tasks?

On March 27, the oral arguments for Amgen v. Sanofi were presented before the Supreme Court of the United States. The outcomes: concerning, particularly for industries like the pharmaceutical sector where functional claims are so crucial.

The case, which began in 2014, involves Amgen, Inc., et al as plaintiffs, Sanofi, et al as defendants, and the United States government as amicus curiae in support of the defendants. It revolves around the genus claim in an Amgen patent for a monoclonal antibody, with a scope that is—seemingly—too broad.

In their arguments, the plaintiffs' defense asserts: "It's been getting clearer and clearer what the Federal Circuit's doing in its basic hostility to the breadth of claims, and I think that this is basically the apogee; we've reached an endpoint where, frankly, the industry can't take it any longer because you can't invest $2.6 billion if the breadth of your claims is such that it means you can't get adequate protection. Because, if you cover everything you invented, then it's invalid because it's too hard to make them all."

On the other hand, the defendants' defense argues: "The more you claim, the more you need to enable. If you claim a lot and enable a little, the public is short-changed and the patent is invalid. The Federal Circuit has long enforced that basic principle by requiring the patentee to enable the full scope of the patent without undue experimentation."

The United States, in its capacity as amicus curiae, contended: "If an antibody has already been created, a scientist who wants to make that antibody is not going to go into a laboratory and inoculate a mouse. They're going to use the amino acid sequence. That is the recipe for making an antibody. That is why the government says that, for the 26 exemplars within the patents, where Amgen had actually listed the amino acid sequence, those antibodies are enabled, because if a scientist wants to go into the lab and make that antibody, they have the recipe, they have the amino acid sequence.”

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