The United States Patent and Trademark Office (USPTO) has announced changes to patent fees, which will take effect on Jan 19, 2025. Most current fees are subject to a 7.5% across-the-board increase while other fees are...more
For branded drugmakers, the development of a pharmaceutical product approved by the Food and Drug Administration (FDA) all but assures generic competition. As discussed during the first installment of our Hatch-Waxman series,...more
The USPTO has published its final rule setting patent fees that will take effect January 19, 2025. The final rule steps back from some of the new fee structures proposed in April 2024, but still could have a significant...more
The United States Patent and Trademark Office (USPTO) announced today the finalized fee increases taking effect on January 19, 2025. While applicants can still expect significant increases in certain areas, some proposed fee...more
The US Court of Appeals for the Federal Circuit issued its opinion in Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 24-1061 (Fed. Cir. 2024), holding that “a first-filed, first-issued, later-expiring claim cannot...more
On October 7, 2024, the Supreme Court declined to hear Cellect LLC v. Vidal, No. 23-1231. The case has been followed closely by patent professionals ever since the Federal Circuit upended the judicially-created doctrine of...more
If the U.S. Patent and Trademark Office (USPTO) is going to implement fee changes in January 2025, we should see a Federal Register Notice detailing the proposed fees soon. The USPTO started this round of fee-setting in April...more
On January 19, 2024, the Court of Appeals for the Federal Circuit issued an order denying the Petition for Rehearing En Banc in the much awaited In re Cellect matter. The mandate of the court issued today....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
On Friday, January 19, 2024, the Court of Appeals for the Federal Circuit issued an Order refusing to rehear In re Cellect, LLC en banc. This likely means that the holding in In re Cellect will represent the law regarding...more
The Federal Circuit appeal in Merck Sharp & Dohme B.V., Merck Sharp & Dohme, LLC v. Aurobindo Pharma USA, Inc. et al., concerns whether patent term extension (PTE) for regulatory delay, in particular delay for FDA drug...more
IPR Petitioners Must Be Permitted to Respond to Claim Constructions First Proposed in Patent Owner Response - In Axonics, Inc. v. Medtronic, Inc., Appeal No. 22-1532, the Federal Circuit held that where a patent owner in...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
Addressing for the first time how patent term adjustments (PTAs) interact with obviousness-type double patenting (ODP), the US Court of Appeals for the Federal Circuit concluded that when members of a patent family have...more
In re Cellect, LLC, Appeal Nos. 2022-1293, -1294, -1295, -1296 (Fed. Cir. Aug. 28, 2023) In a significant appeal from ex parte reexamination proceedings before the Patent Trial and Appeal Board, the Federal Circuit...more
In In re Cellect, the Federal Circuit effectively held that Patent Term Adjustment (PTA) awarded under 35 USC § 154 is not protected from obviousness-type double patenting (OTDP) in view of a patent with the same 20-year...more
IN RE CELLECT, LLC - Before Lourie, Dyk, and Reyna. Appeal from the Patent Trial and Appeal Board. Summary: Obviousness-type double patenting analyses for patents with Patent Term Adjustments are based on the...more
In Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc., Novartis scored another obviousness-type double patenting (OTDP) win when the Federal Circuit held that a post-URAA child patent could not be cited as an...more
In Novartis AG v. Ezra Ventures LLC, the Federal Circuit addressed “the interplay between a patent term extension (PTE) granted pursuant to 35 U.S.C. § 156 and the obviousness-type double patenting doctrine.” In upholding the...more