Patent law in the life sciences industry evolves rapidly, with several recent Federal Circuit decisions showing how those shifts can impact intellectual property strategy. The cases discussed below touch on everything from...more
On 11 December 2025, the European Union (EU) institutions reached an agreement on the “Pharma Package”. This milestone follows several years of legislative work, beginning with the European Commission’s proposal in April...more
Two and a half years after the initial proposal, agreement has been reached by the EU institutions on the so-called EU Pharma Package. The Package represents a comprehensive overhaul of the European Union’s pharmaceutical...more
Summary - In a landmark unanimous decision, the Full Court of the Federal Court of Australia in Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd [2025] FCAFC 161 (Otsuka FC) held that patent claims directed to...more
On Tuesday, December 9, 2025, the U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) hosted its 19th Annual IP Attaché roundtable in Washington, D.C....more
In the United States, medical device regulation and intellectual property (IP) protection are governed by complex statutory and regulatory frameworks that are distinct from—but closely related to, and in some cases...more
In 1999, Congress created a system of patent term adjustment (PTA) that adds additional time to patent terms to remedy certain delays caused by the U.S. Patent and Trademark Office (USPTO) in issuing a patent. Why Review...more
The federal government entered a shutdown on October 1, 2025. The following update provides a summary of the resulting impact on the U.S. Patent and Trademark Office (USPTO), the U.S. International Trade Commission (ITC), and...more
Patent term extensions (PTE) are crucial for medical device innovators to recover patent life lost during lengthy FDA regulatory reviews. While more common in pharmaceuticals, recent cases show significant PTE benefits for...more
On May 27, 2025, the Intellectual Property High Court of Japan awarded plaintiff Toray Industries, Inc. ("Toray") ¥21.76 billion (US$151 million; €133 million) in damages for patent infringement by defendants Sawai...more
ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more
As noted in the first article in our Medtech Coming to America series, “US Emerging as Top Global Medtech Destination,” perceived regulatory advantages are prompting European medtechs to enter the US market earlier in their...more
The intersection of patent strategy and FDA regulatory strategy is a critical consideration for medical device companies. A well-integrated approach can create powerful barriers to entry, strengthen intellectual property (IP)...more
The Federal Circuit recently affirmed a district court’s holding that patent term extension (PTE) for a reissued patent was properly based on the issue date of the original patent and not that of the reissued patent. The...more
Bridion® (sugammadex) - Case Name: Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., No. 2023-2254, 2025 WL 795317 (Fed. Cir. Mar. 13, 2025) (Circuit Judges Dyk, Mayer, and Reyna presiding; Opinion by Dyk, C.J.) (Appeal...more
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
The Federal Circuit held in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., 23-2254 that a reissued patent receives patent term extension (PTE) based on the issue date of the original patent, not the reissue patent,...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
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