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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
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
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
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 a unanimous ruling, the Supreme Court of the United States (SCOTUS) addressed the enablement requirement under Section 112 of the Patent Act, placing this into sharper focus with the Amgen v. Sanofi case. This landmark...more
In a unanimous opinion in Amgen Inc. v. Sanofi, the Supreme Court held that two functional genus patent claims were not enabled under 35 U.S.C. § 112(a).1 In doing so, it affirmed both the Federal Circuit’s previous decision...more
The Supreme Court heard arguments this week in Amgen v. Sanofi, the closely-watched case involving the enablement standard for patent claims, particularly as applied to functionally-defined genus claims. The question raised...more
On Monday, March 27, 2023, at 10:00 a.m. EDT, the Supreme Court of the United States will hear oral arguments in Amgen Inc. v. Sanofi, No. 21-757. William H. Milliken, a director in Sterne Kessler’s Trial & Appellate Practice...more
High Court Will Tackle Proper Enablement Standard - Constituting something of a surprise, the Supreme Court on Friday, November 3rd granted Amgen's petition for certiorari on the second of the Questions Presented in its...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
A recent post-grant review decision once again reminds patentees of the increasing scrutiny that claims are facing under the written description and enablement requirements under 35 U.S.C. § 112 (a). In this case,...more
PACIFIC BIOSCIENCES OF CALIFORNIA v. OXFORD NANOPORE TECHNOLOGIES - Before Lourie, Taranto, and Stoll. Appeal from the United States District Court for the District of Delaware. Summary: Enablement is required for...more
A recent Supreme Court petition for certiorari alleges that genus claims are no longer viable under the Federal Circuit’s recent application of enablement and written description law.The petition has huge ramifications not...more
UPDATE: On September 30, 2020, Eli Lilly appealed both decisions by Justice St-Louis: Eli Lilly v Apotex (A-234-20 and A-239-20); Eli Lilly v Pharmascience and Riva (A-236-20); Eli Lilly v Mylan (A-237-20); and Eli Lilly v...more
In a case relating to compounds for the treatment of the Hepatitis C virus (HCV), the US Court of Appeals for the Federal Circuit upheld a district court’s grant of judgment as a matter of law (JMOL) for lack of enablement...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
IDENIX PHARMACEUTICALS LLC v. GILEAD SCIENCES INC. Before Prost, Newman, and Wallach. Appeal from the United States District Court for the District of Delaware. Summary: Synthesizing and screening tens of thousands of...more
Ericsson Inc. v. Intellectual Ventures I LLC (No. 2017-1521, 8/27/18) (Reyna, Taranto, Chen) Reyna, J. - Vacating and remanding the PTAB’s IPR decision because the PTAB erred in not considering portions of the petitioner’s...more
In an opinion addressing enablement under 35 USC 112, the US Court of Appeals for the Federal Circuit concluded that an asserted claim was invalid because the specification failed to enable its full scope, even though...more
Federal Circuit Summary - Before Prost, Moore, and Reyna. Appeal from the United States District Court for the District of Massachusetts Summary: A patent claim having multiple permutations is only enabled if each and...more
In a hard-fought patent battle involving “groundbreaking” work by both parties, Chief Judge Stark of the U.S. District Court for the District of Delaware ruled that plaintiff Idenix’s patent for treating Hepatitis C virus...more
One-E-Way, Inc. v. ITC, Fed. Cir. Case 2016-2105 (June 12, 2017) - A divided panel reverses a determination of indefiniteness by the ITC, ruling that under Nautilus, the claim language, in combination with the...more
Addressing the issues of indefiniteness and non-infringement for both utility and design patents, the U.S. Court of Appeals for the Federal Circuit reversed and vacated in part the district court’s grant of summary judgment...more
Addressing obviousness issues, the U.S. Court of Appeals for the Federal Circuit affirmed a lower court’s finding that patents were valid and infringed, despite undeniably including recitations falling within a prior art...more