Webinar: Orange Book listing sheets under the microscope
Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
The foundational comic premise of walk-into-a-bar jokes is the underlying differences among the characters walking in. The three characters—in this case a chess player, a hockey player, and a patent litigator—may appear...more
On June 10, 2024, Judge Stanley R. Chesler of the United States District Court for the District of New Jersey granted the Amneal defendants’ motion for partial judgment on their counterclaims in a Hatch-Waxman dispute, and...more
The Federal Trade Commission (FTC) has called attention in the past year to its perception of the influence that branded pharmaceutical companies have over the price of beneficial drugs. Most recently, the agency has asserted...more
In recent months, the issue of whether certain patents are appropriately listed in the Food and Drug Administration (FDA) Orange Book, associated with the Hatch-Waxman Act, has garnered the attention of the Federal Trade...more
Second Circuit Affirms “Pay for Delay” Dismissal: On May 13, 2024, the Second Circuit affirmed dismissal of antitrust claims brought by wholesalers, retailers, and employee benefit funds that alleged they overpaid for the...more
On January 18, 2024, the USPTO rejected a "contingent" terminal disclaimer filed by Acadia Pharmaceuticals Inc. (Acadia) for a patent it owns that is being challenged in a pending litigation as invalid for obviousness-type...more
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more
This week’s case of the (recent) week could serve as a crash course in several areas of patent law. It touches on Hatch-Waxman litigation and the Orange Book, claim construction, anticipation/obviousness, written description...more
On February 24, 2023, in Jazz Pharms., Inc., v. Avadel CNS Pharms., LLC, the U.S. Court of Appeals for the Federal Circuit affirmed the United States District Court for the District of Delaware’s grant of an injunction...more
On February 24, 2023, the U.S. Court of Appeals for the Federal Circuit issued a precedential opinion in Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC that affirmed a district court’s injunction requiring Jazz...more
Procedural History - Jazz Pharms., Inc., v. Avadel CNS Pharms., LLC, Case No. 2023-1186 (Fed. Cir. February 24, 2023) is an appeal by Jazz Pharmaceuticals, Inc. (Jazz) from a District of Delaware order granting a motion...more
JAZZ PHARMACEUTICALS, INC. v. AVADEL CNS PHARMACEUTICALS, LLC - Before Lourie, Reyna, and Taranto. Appeal from the United States District Court for the District of Delaware. Summary: A patent directed to a system to reduce...more
Case Name: Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, No. 21-691-GBW, 2022 WL 17084371 (D. Del. Nov. 18, 2022) (Williams, J.) Drug Product and Patent(s)-in-Suit: Xyrem® (sodium oxybate); U.S. Patent No. 8,731,963 (“the...more
High Stakes: Hatch-Waxman Litigation Comes for Cannabis - GW Pharma, now a subsidiary of Jazz Pharmaceuticals, is no stranger to patent litigation. It previously found itself on the receiving end of a patent infringement...more
Thank you for reading the January 2023 issue of Sterne Kessler's MarkIt to Market® newsletter. This month, we discuss an ongoing trademark dispute between the band OK Go and cereal company Post, how to stay vigilant about...more
On December 27, 2022, Haug Partners LLP and Gibbons PC obtained a key victory as to all counts for its client, plaintiffs Takeda Pharmaceutical Co. Ltd. and Takeda Pharmaceuticals U.S.A., Inc., defeating a generic challenge...more
The consequences of expressly recited claim limitations and how patentees can be held to these limitations was illustrated in the Federal Circuit's recent decision in Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc. ...more
On March 16, 2022, the Court of Appeals for the Federal Circuit denied Biogen International GmbH and Biogen MA, Inc.’s (“Biogen”) combined petition for panel rehearing and rehearing en banc in Biogen International GmbH v....more
In June 2021, the US Patent and Trademark Office (USPTO) published an update to its study of America Invents Act (AIA) trials involving challenges to Orange Book-listed and biologic patents from September 16, 2012, through...more
[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more
Case Name: Jazz Pharms., Inc. v. Avadel Pharms. Plc, Civ. No. 21-691 (MN), 2021 WL 4860682 (D. Del. Oct. 19, 2021) (Noreika, J.) - Drug Product and Patent(s)-in-Suit: Xyrem® (sodium oxybate); U.S. Patent No. 8,731,963 (“the...more
On December 8, 2021, the Federal Circuit in AztraZeneca AB v. Mylan Pharms. Inc. held that the claim construction of a percentage term should “‘most naturally align[] with the patent’s description of the invention,’ as...more
As is well-known, Congress established the Federal Circuit as a circuit court of appeals to harmonize U.S. patent law in an environment where regional Circuit Courts had developed their own judicial interpretations of the...more
USPTO Leadership - ..Drew Hirshfeld is still performing the functions and duties of Director. The Biden Administration has not made an announcement as to who will be nominated to become the next Director. ...more
Earlier this month, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed (2-1) upon rehearing its October 2020 decision that a labeling...more