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Following the U.S. Supreme Court’s impactful decision in Amgen v. Sanofi, the United States Patent and Trademark Office (USPTO) has published guidelines on the enablement of patent claims. In the Amgen case, the Supreme Court found that Amgen’s claims covering potentially millions of antibodies were too broad, causing uncertainty as to the treatment of such claims going forward. The USPTO’s guidelines clarify that the basic principles of enablement will remain the same, while acknowledging the importance of providing enough description to enable each claim.

Panitch Schwarze attorneys Travis W. Bliss, Ph.D. and Ava E. Lutz authored an article in The Legal Intelligencer examining these new guidelines. They highlight the Supreme Court’s explanation of enablement as describing an invention “in such full, clear, concise, and exact terms as to enable any person skilled in the art’ to ‘make and use’ the invention.” Patent applicants must meet this standard, but they should also ensure their claims are broad enough to make it difficult to design around the patent.

The Amgen case has shown that inventors and practitioners should limit their claims to a narrower set of antibodies and tie these claims together by structure and function. By following USPTO’s practical guidelines, innovators in biotechnology are more likely to avoid pitfalls and successfully claim the patents they seek.

Read the full article here: In the Wake of ‘Amgen v. Sanofi,’ the USPTO Clarifies the Patent Enablement Requirement (Subscription is required.)

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