Akerman Partner Timothy Sendek wrote about a pending U.S. Supreme Court decision that, when decided, will significantly impact the scope or limit of pharmaceutical patents.

Writing for Life Sciences Intellectual Property Review, Sendek looked at the battle over monoclonal antibodies, used to treat Covid-19 and other diseases.  The litigants are Amgen Inc. and Sanofi; the Court agreed in November to hear the case during its current term. 

Sendek wrote:

"The patents at issue in Amgen deal with a special class of drugs (monoclonal antibodies) and a special class of patent claims…This type of claim covers a genus or category of solutions to a problem when the patent describes and enables a subset of such solutions. For example, in Amgen, the patents at issue claimed monoclonal antibodies which bind to a certain naturally-occurring protein."

"The patents identified 26 antibodies which would bind as claimed by the patent, but there are millions of other candidate antibodies that might also function to bind to the claimed protein. This is the basic question before the Supreme Court—does the ’make and use’ language mean that an inventor has to describe how to make and use every possible permutation of 'the invention' if that is what is claimed?"

Sendek concluded: "The court’s decision on Amgen will have significant importance for the pharmaceutical and life sciences industries. A win for Amgen would make it easier for drug companies to obtain broader protection for therapeutic discoveries, while a win for Sanofi would create opportunities for generic manufacturers to challenge such patents."

Sendek is an experienced trial lawyer focusing on patent, trademark, and copyright disputes in U.S. District Courts, the International Trade Commission (ITC), and at the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board. His experience includes numerous Section 337 trials at the ITC, jury and bench trials in District Court, and patent office litigation, including over 60 inter partes review (IPR) proceedings.

 About Akerman

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Akerman’s Intellectual Property Practice Group protects the value of our clients’ assets by aggressively pursuing infringers and defending our clients from accusations of wrongdoing. Members of our team have advanced technical degrees and business experience in disciplines such as electrical engineering, computer science, chemistry, and molecular biology. From software to semiconductors, devices to designs, and biotechnology to business methods, our lawyers and professionals have served innovative companies and research entities across the globe for more than three decades. By coupling industry insights with a keen focus on our clients’ business objectives, we efficiently litigate the full range of intellectual property issues—including patent, trademark, copyright, trade secret, trade dress, and related contract disputes.