The U.S. Court of Appeals for the Federal Circuit (CAFC) recently considered a novel question regarding calculation of the regulatory review period for patent term extension (PTE) under 35 USC § 156 for reissued patents....more
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
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
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
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 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
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
The USPTO will be hosting a “public listening session” on January 19, 2023, focusing on USPTO-FDA collaboration initiatives proposed pursuant to President Biden's Executive Order on “Promoting Competition in the American...more
Patent holders have the right to exclude others from making, using, selling, or offering to sell an invention—but only during the time a patent is in force....more
In Biogen International GmbH v. Banner Life Sciences LLC, the Federal Circuit construed language of the Hatch-Waxman patent term extension statute in a manner Biogen argued was inconsistent with the “active moiety” focus of...more
In a recent decision, the issue before the Federal Circuit was the meaning of the term “product” in a patent term extension statute. Biogen Int'l GmbH v. Banner Life Scis. LLC, 956 F.3d 1351 (Fed. Cir. 2020). Section 156 of...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
A. Introduction - A prodrug is a medication or compound that after administration is metabolized (i.e., converted in the body) into a pharmacologically active drug (e,g., a metabolite). Often, the prodrug has no function...more
This is the fourth article in our five-part series on PTE. When applying for a patent term extension (PTE), due diligence matters. If an applicant did not act with due diligence during the testing phase or the approval...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
There have been many voices raised in recent years against the patent system for a variety of political, policy, or personal reasons. Indeed, there is even a book entitled Don't File a Patent that sets out the authors'...more