In the mid-2000s, the U.S. Patent Office (USPTO) determined that reexaminations would be more consistent and legally correct if performed by a centralized set of experienced and specially trained Examiners. As a result, the...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
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
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
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
The Federal Circuit denied Cellect, LLC's petition for rehearing en banc of the In re Cellect case, which held that the expiration of a patent for obviousness-type double patenting ("ODP") purposes is the expiration date...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
The US Court of Appeals for the Federal Circuit’s recent decision in In re Cellect confirmed that, when considering whether a reference patent invalidates for obviousness-type double patenting (ODP) a patent having a term...more
Case Name: In re Sugammadex, No. 20-CV-2576 (CCC/LDW), 2023 WL 3966146 (D.N.J. June 13, 2023) (Cecchi, J.) Drug Product and Patent(s)-in-Suit: Bridion® (sugammadex sodium); U.S. Patent No. RE44,733 (“the ’733 patent”)....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
Last week, the Federal Circuit held that obviousness-type double patenting trumps patent term adjustment, opening the door for invalidity attacks that to date had been questionable. In re Cellect was an appeal from a...more
The USPTO has commenced the fee-setting process for fee adjustments it expects to implement in January 2025. While many fee changes are modest (~5%), the USPTO proposes significant increases to design patent fees and PTAB...more
Allele v. Pfizer – The Basics. On April 23, 2021 Pfizer, Inc., BioNTechSE, and BioNTech US, Inc. (“Pfizer and BioNTech”) filed a joint reply supporting of their previously filed motion to dismiss a patent infringement...more
In an earlier post, we discussed the patent linkage system implemented in the Fourth Amendment to the Chinese Patent Law, which will come into effect on June 1, 2021. Another important change in the amendment is the...more
Most of us were thrilled to see the calendar turn to 2021 on January 1, closing the chapter on what was an extremely challenging year around the globe. Now that we are a month into the new year, and the fireworks have faded...more
On 17 October 2020, China's NPC adopted amendments to the Patent Law, which will take effect on 1 June 2021. The highlights are the adoption of a patent linkage system, a patent term extension for pharmaceutical patents,...more
On 6 July 2020, China's National People’s Congress (NPC) released its latest Draft Patent Law for public comment, proposing, amongst other things, a patent linkage system, patent term extension for pharmaceutical patents,...more
USPTO and JPO Issue Joint Message - Yesterday, Director Andrei Iancu of the U.S. Patent and Trademark Office and Commissioner Akira Matsunaga of the Japan Patent Office issued a joint message to express the Offices' "most...more
Case Name: Biogen Int’l GmbH v. Banner Life Sciences LLC, No. 18-2054-LPS, 2020 U.S. Dist. LEXIS 3639 (D. Del. Jan. 7, 2020) (Stark, J.)....more