The American Conference Institute’s (ACI’s) virtual 6th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA is scheduled to take place from October 20-29, 2026 (Eastern Standard Time). Led by an experienced faculty, the virtual training series is specifically designed for attorneys, regulatory affairs professionals, …
What a year for Hatch-Waxman litigation! With the Supreme Court’s decision in Amarin v. Hikma, it’s already been a big year for the Hatch-Waxman Amendments, but now we have another case from the D.C. Circuit that touches on an important aspect of generic drug incentives: …
Listing patent information in the Orange Book is one of the most important things you can do as an innovator sponsor to ensure that your property rights are respected. And, of course, it’s statutorily required. So that makes the new guidance FDA just issued on …
The skinny label is back from the dead. While back in 2021, it seemed like the skinny label was effectively dead after the Federal Circuit twice held Teva liable for induced infringement of GSK’s labeling in GSK v. Teva, the Supreme Court breathed new life …
Last week, FDA released its Justification of Estimates for Appropriations Committees for the Agency’s Fiscal Year 2027 (“FY2027”) budget request. Prior budget requests included a separate document titled “FDA Legislative Proposals” (see, e.g., here, here, here, and here; and our prior post here). The FY2027 …
Two little mice fell in a bucket of cream. The first mouse quickly gave up and drowned. The second mouse, wouldn’t quit. He struggled so hard that eventually he churned that cream into butter and crawled out. Gentlemen, as of this moment, I am that …
While 3-year new clinical investigation exclusivity has never been the holy grail of exclusivities—we reserve that for 7-year orphan drug exclusivity or 5-year new chemical entity exclusivity (with the plus-5-year GAIN and plus-6-month pediatric exclusivity additions!) because of the different lengths and scopes—it plays an …
The American Conference Institute’s (ACI’s) Annual Paragraph IV Disputes Conference is scheduled to take place from April 21-22, 2026 at The Times Center, New York, NY. Join the nation’s most respected forum for pharmaceutical patent litigation as it returns for its 22nd edition. This is …
As some of you know, tucked inside the Consolidated Appropriations Act of 2026, was some legislation that FDA has been pushing for quite some time. In addition to the incredibly important renewal of the Rare Pediatric Disease Priority Review Voucher program (blog on that forthcoming), …
The American Conference Institute’s (“ACI”) FDA Boot Camp returns March 25-26, 2026, at the New York City Bar, New York, NY. This foundational training brings together life sciences attorneys, in-house counsel, and compliance professionals to dissect FDA law, policy, and enforcement trends. What You’ll Gain: A clear …
The skinny label has hit the big time. Last week, the Supreme Court agreed to hear Hikma v. Amarin to address the burning question of whether a carve-out induces infringement. As of now, the Federal Circuit has been very clear that a carve-out can induce …
Priority Review Vouchers (PRV) are incredibly valuable—several have sold for hundreds of millions of dollars. Which is why it makes sense that Sun Pharma Advanced Research Co. Ltd. and Sun Pharmaceutical Industries, Inc. went to the mat fighting FDA for a PRV for phenobarbital. And …
FDA has long permitted ANDA applicants to “carve-out” patent-protected uses from product labeling, resulting in differences between the Reference Listed Drug and the ANDA. Legal challenges to the carve-out are not new: The GSK v. Teva saga, followed by the Amarin v. Hikma litigation, made …
The American Conference Institute’s (ACI’s) Pharma & Biotech Patent Litigation USA forum is scheduled to take place from October 14-15, 2025 at 3 Times Square in New York, NY. Billed as “the new US Gold Standard event for pharma and biotech patent litigation,” ACI’s Forum …
The American Conference Institute’s (ACI’s) virtual 5th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA is scheduled to take place from October 14-30, 2025 (Eastern Standard Time). The virtual training series is specifically designed for attorneys, regulatory affairs professionals, and industry executives …
