ImClone Loses Patent Decision for Cancer Drug Erbitux

By Leslie Gladstone Restaino, Esq.

ImClone Systems, Inc. is reeling from a court decision Monday invalidating ownership of a significant patent for the company’s cancer drug Erbitux. 

Yeda Research and Development Co., the licensing arm of the Weizmann Institute, filed suit in 2003, alleging that three researchers had not been properly designated as inventors on the patent which claims the use of certain antibodies to block a tumor grown protein, when used in combination with chemotherapy.  Aventis claimed that its scientists had already conceived of the use of the antibodies as tumor inhibitors when one of its scientists asked scientists at the Weismann Institute to test the idea in routine experiments.  Yeda claimed that Aventis scientists volunteered to supply the Weizmann scientists with an ingredient to do the experiments.  The New York District Court agreed with Yeda, crediting the invention solely to the Weizmann researchers.  In order to continue to sell Erbitux, Yeda may likely look to grant a license to ImClone, Aventis’ exclusive licensee of the patents, at a premium to the current terms of ImClone’s pre-existing agreement with Aventis.  Alternatively, Yeda may block ImClone’s ability to sell Erbitux for use in chemotherapy combination therapies.
 
This ruling underscores the need to correctly list patent inventors. Inventorship turns on conception.  Oftentimes however, researchers list all project participants on patent filings, mimicking the procedure used for article publication.  Where incorrect,  ownership can shift, or the patent invalidated. 
 
About the Author:
Leslie Gladstone Restaino is a Member of the Firm of  Sills Cummis Epstein & Gross, P.C in the Intellectual Property and Corporate Practice Groups. She concentrates her practice on the special business and legal needs of public and private life sciences companies. Ms. Restaino represents established pharmaceutical companies and start-ups in the life sciences industry throughout all phases of their life cycle and understands the business concerns of growing and established companies.

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