5 Key Takeaways | Best Practices in Patent Drafting: Addressing 112 and Enablement after Amgen
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 availability of post-grant proceedings at the Patent Trial and Appeal Board (PTAB) has changed the face of patent litigation. This periodic digest is designed to keep you up-to-date by highlighting interesting PTAB,...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 January 10, 2024, the USPTO published guidelines for assessing enablement in view of Amgen v. Sanofi and other recent court cases (“the Guidelines”). The Guidelines state that they are not intended to “announce any major...more
On January 10, 2024, the United States Patent and Trademark Office (USPTO) issued "Guidelines for Assessing Enablement in Utility Applications and Patents in View of the U.S. Supreme Court Decision in Amgen Inc. et al. v....more
On January 10, 2024, the United States Patent and Trademark Office (USPTO) published Guidelines, applicable to any technology, for ascertaining compliance with the enablement requirement in view of the U.S. Supreme Court...more
The USPTO has issued “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.” The Guidelines set forth the U.S. Patent and Trademark...more
In the wake of the U.S. Supreme Court’s decision in Amgen Inc. v. Sanofi, 598 U.S. 594 (2023) (Amgen), in which the Court addressed whether Amgen’s functional antibody genus claims satisfy the enablement requirement, the U.S....more
In Baxalta, Inc. v. Genentech, Inc., the Court of Appeals for the Federal Circuit upheld a summary judgment finding from the District of Delaware (Judge Timothy B. Dyk) that claims 1-4, 19 and 20 of Baxalta’s patent directed...more
On May 18, 2023, the Supreme Court affirmed the Federal Circuit’s (CAFC) decision on enablement in Amgen Inc. v. Sanofi, 987 F.3d 1080 (CA Fed. 2021). The Court thus left in place a significant CAFC decision making it more...more
The Supreme Court's consideration of the standards for satisfying the enablement provisions of 35 U.S.C. § 112(a) has been occasioned for the first time in over a century by the Court's granting certiorari in Amgen v....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
Long before the AIA, declarations were a tool that was available during patent prosecution to put evidence, e.g., post-filing data and expert opinions, in front of an Examiner to rebut obviousness or lack of enablement...more
Addressing the issue of whether an anticipatory prior art reference was enabling, the U.S. Court of Appeals for the Federal Circuit affirmed the judgment of the U.S. Patent Trademark Office (USPTO) Board of Patent Appeals and...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 Biogen Idec, Inc. v. GlaxoSmithKline LLC, the Federal Circuit upheld a narrow claim interpretation based on prosecution history disclaimer. The court held that the applicants’ arguments against an enablement rejection...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
On April 5, 2013, in In re Morsa, the U.S. Court of Appeals for the Federal Circuit (Rader, Lourie, O'Malley*) affirmed-in-part, vacated-in-part and remanded the USPTO Board of Patent Appeals and Interferences decision...more