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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 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
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
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
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
This is the third article in our five-part series on PTE. Calculating a drug’s regulatory review period seems like it should be simple. The FDA even states that its regulatory review period determination is...more
This is the second article in our five-part series on PTE. Everywhere you look, patent term extension (PTE) is described using the “Rule of Ones:” one patent, one product, one PTE. However, the Rule of Ones does not...more