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There now is increased interest about the written description and enablement requirements for patent applications claiming antibodies. This may stem from the recent U.S. Supreme Court decision in Amgen v. Sanofi, finding lack...more
The United States Patent and Trademark Office (USPTO) has published new Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al. ...more
On December 8, Partner Nena Bains and Counsel Yifan Mao presented “Best Practices in Patent Drafting: Addressing 112 and Enablement After Amgen” at the 24th Annual Berkeley-Stanford Advanced Patent Law Institute organized by...more
In earlier times, the Federal Circuit, responding to efforts by the U.S. Patent and Trademark Office to reject patent applications directed to biotechnology-related inventions, held (In re Brana) that utility of such...more
In a unanimous decision, the Supreme Court has affirmed the lower court’s ruling that Amgen’s broad genus claims to cholesterol-lowering antibodies are invalid for lack of enablement....more
ACI’s Advanced Summit on Life Sciences Patents is back in person on June 2–3 in New York City. Our reimagined 2022 conference will provide practical insights on how to implement bullet-proof patent prosecution tactics,...more
In the recent case of Amgen Inc. v. Sanofi, Aventisub LLC, the Federal Circuit affirmed the district court’s invalidation of certain of Amgen’s antibody patent claims, concluding that the claims were not “enable[d]” under 35...more
In today's connected global economy, obtaining patent protection in multiple jurisdictions is the best way for companies to protect their IP on a global scale. But every jurisdiction has different patentability requirements...more
You’ve finished drafting the patent application for a critical, clinical stage invention. The scientific team wrote up the examples and they even included comparative data. You’ve finalized the claims and specification....more
The PTAB Cannot Approve or Deny Certificates of Correction - In Honeywell International, Inc. v. Arkema Inc., Arkema France, Appeal Nos. 2018-1151, -1153, the Patent Trial and Appeal Board (“Board”) does not have the...more
Finding that the number of possible embodiments that could fit within the limitations of the asserted claims numbered in the “tens of thousands,” the US Court of Appeals for the Federal Circuit held that the claims were not...more
In its 2013 decision in In re Morsa, the Federal Circuit vacated an anticipation rejection where “both the Board and the examiner failed to engage in a proper enablement analysis” to establish the enabling quality of the...more
In In re Morsa, the Federal Circuit reversed an anticipation rejection where the applicant had challenged the enabling quality of the cited prior art reference, even though the applicant had not submitted evidence in support...more