On Tuesday, the Supreme Court denied Centocor’s (now “Janssen”) petition for cert. and so let stand a ruling that Centocor’s patents on humanized monoclonal antibodies (covering Abbott’s Humira) are invalid for failure to meet the written description requirement (WDR) of s. 112(1). Since cert. was not requested following the en banc decision in Ariad v. Lilly, which essentially reached the same conclusion on drugs — not yet discovered — that might alter the NF-kB pathway, this was the first good chance the Supreme Court had to weigh in on the heightened WDR that has been applied with regularity by panels of the Fed. Cir. to invalidate biotech patents claiming early stage inventions since it was articulated by Judge Lourie in the 1997 U. of Cal. v. Lilly decision. As I have written in a number of posts on subsequent decisions, this new and improved WDR has led biotech patentees down a trail of legal tears as, with few exceptions, their patents have failed the WDR – even if the claims were arguably enabled by the specification—a question that the Fed. Cir. has increasingly refused even to consider once the increasingly easy button of the WDR has been used to invalidate the patent.
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Certified Licensing Professionals, Inc., 2021 Disclaimer
This blog, Patents4Life, does not contain legal advice and is for informational purposes only. Its publication does not create an attorney-client relationship nor is it a solicitation for business. This is the personal blog of Warren Woessner and does not reflect the views of Schwegman Lundberg & Woessner, or any of its attorneys or staff. To the best of his ability, the Author provides current and accurate information at the time of each post, however, readers should check for current information and accuracy.
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Warren D. Woessner
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