5 Key Takeaways | Best Practices in Patent Drafting: Addressing 112 and Enablement after Amgen
In the biotechnology and chemical spaces, genus claims are often sought by patent applicants to protect not only a specific product of interest, but also as a means to protect against others making related products that...more
The concept of the "person of ordinary skill in the art" (POSITA) remains pivotal in patent law, particularly in evaluating obviousness under 35 U.S.C. § 103 and compliance with enablement and written description requirements...more
Recently, a Director Review was granted where Director Vidal vacated the Patent Trial and Appeals Board’s (“PTAB”) Final Written Decision and remanded back to the PTAB for further consideration of enablement. Duration Media...more
The Federal Circuit recently reversed a district court decision that found a patent that did not describe after-arising technology failed to satisfy the written description requirement. In so doing, the Federal Circuit...more
The US Court of Appeals for the Federal Circuit reversed a district court’s ruling of invalidity for lack of written description, finding that the district court erred in its analysis of written description because patents...more
In a Jan. 10 precedential ruling by the United States Court of Appeals for the Federal Circuit, the validity of the U.S. patent covering Novartis’s blockbuster drug Entresto was upheld, reversing an earlier decision by the...more
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 Supreme Court’s lone patent case from last term does not break new ground on enablement law. The Court’s core holdings—that a patent specification must enable the full scope of the claimed invention and therefore that...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
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
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 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
In Baxalta Incorporated v. Genentech, Inc., 2022-1461, the Federal Circuit affirmed the district court’s decision granting Genentech’s motion for summary judgment that claims 1-4, 9, and 20 of U.S. Patent No. 7,033,590 (“the...more
Baxalta Inc. v. Genentech, Inc., Appeal No. 22-1461 (Fed. Cir. Sept. 20, 2023) Our Case of the Week focuses on the enablement requirement. It’s the first case to come before the Federal Circuit following the Supreme...more
In its recent decision in Baxalta Inc. v. Genentech, Inc., No. 2022-1461, 2023 WL 6135930 (Fed. Cir. Sept. 20, 2023), the Federal Circuit applied the Supreme Court’s decision in Amgen Inc. v. Sanofi to affirm the District of...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
Patent offices may reject a patent application with claims reciting using a composition to treat a disease, based on the requirement that the claimed treatment is not fully supported by the application. In the U.S., such...more
The US Court of Appeals for the Federal Circuit affirmed a district court’s holding that the asserted method of treatment patent was valid and infringed because safety and efficacy are not patent concerns. The Federal Circuit...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
The Federal Circuit’s recent decision in United Therapeutics Corp. v. Liquidia Techs., Inc., No. 2022-2217, 2023 WL 4695903 (Fed. Cir. July 24, 2023), provides an interesting discussion on the written description and...more
The U.S. Supreme Court recently struck down broad patent claims covering a “genus” of antibodies, reaffirming in a 9-0 decision that a patent must “enable” the full scope of its claims (Amgen Inc. v. Sanofi). Amgen, Inc.,...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