Merck Sharp & Dohm B.V. v. Aurobindo Pharma USA, Inc. et al (Fed. Cir. March 13, 2025) - The Hatch-Waxman Act seeks to strike a balance in the pharmaceutical industry by incentivizing drugs makers to develop innovative...more
Addressing the calculation of patent term extensions (PTEs) under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit affirmed a district court decision that under the act the issue date of the original...more
The Patent Term Extension (PTE) provisions of 35 U.S.C. § 156 compensate pharmaceutical patent owners for time they are not able to enjoy commercial market exclusivity because their products are not yet approved by the U.S....more
Early last year, Aurobindo, one of the Defendants* in ANDA litigation against Merck, advanced the proposition that in cases where a patent had been reissued patent term extension ("PTE") under 35 U.S.C. § 156 should be...more
On March 13, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed a five-year patent term extension (“PTE”) for Merck’s sugammadex patent, holding that the district court had correctly calculated PTE based on the...more
On March 13, 2025, the Federal Circuit decided in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc. (No. 2023-2254) how patent term extensions (PTEs) apply to reissued patents under the Hatch-Waxman Act....more
The Federal Circuit heard oral argument in Auribundo's appeal of the district court's decision in favor of plaintiff Merck, in a case captioned In re Sugammadex (alternatively, Aurobindo v. Merck Sharp and Dohme). The issue...more
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
The USPTO has announced fee increases and new fees for patents and trademarks to take place on January 18, 2025, for trademarks, and January 19, 2025, for patents. The increase in fees and the introduction of new fees by the...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
In the November 20, 2024 Federal Register Notice, the United States Patent and Trademark Office (USPTO or the “Office”) released its final rule on patent fee adjustments (“Final Rule”). These fee adjustments, set to take...more
Patent term extension (PTE) under 35 U.S.C. § 156 is a statutory program that restores to a patent at least a portion of the term that was effectively lost while the covered product was undergoing regulatory review and could...more
The United States Patent and Trademark Office (USPTO) announced on Wednesday that patent-related fees will be raised starting January 19, 2025 to offset forecasted increases in operating cost....more
Attention, inventors, in-house counsel, and anyone with a vested interest in the world of intellectual property: the USPTO just issued its final rule for patent fees. This is a follow-up to the 2023 proposal—but with a...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
Patent Term Extensions (e.g., in the United States), Supplementary Protection Certificates (e.g., in Europe), and other similar extensions compensate the owner of a patent covering certain approved medical products for the...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
Takeaways: 1. ODP in reexamination and reissue remains unpredictable despite Allergan 2. Patent Owners should carefully review ODP rejections to ensure they are proper Obviousness-type double patenting (ODP) is a legal...more
As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more
The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s refusal to register a mark, finding that an unchallenged, detailed declaration by the opposing company’s director sufficed as...more
On April 30, the USPTO announced a Request for Comments (RFC) seeking public feedback on how AI could affect USPTO evaluations on patentability, including what qualifies as prior art and the assessment of the level 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