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 …
Earlier this month, the Association for Accessible Medicines and its Biosimilars Council (“AAM”) announced (here and here) the release of a report, titled “Assessment of the Impact of Settlements,” examining the effects of patent litigation settlements on patient savings and access to generic drugs and …
It was about a year and a half ago that we first proclaimed mass hysteria when FTC crossed streams into FDA territory, but perhaps our cries were premature. As we mentioned last year, a large number of the drug companies targeted by FTC in its …
In yet another installment of the drama that is Jazz v. Avadel, the Federal Circuit recently reviewed a decision from the U.S. District Court for the District of Delaware that addressed the scope of an injunction under the patent safe harbor imposed on Avadel’s Lumryz …
The FDA Reduction-in-Force (Termination)—or “RIF(T)”—announced last week has resulted in countless stories in the press and on personal LinkedIn accounts from those RIF’d. As the dust begins to settle and we all assess what this means for the future of FDA and the public health, …
Come together with leaders from the pharmaceutical, biotechnology, and diagnostic industries to unpack huge changes at the American Conference Institute’s 23rd Advanced Summit on Life Sciences Patents, which is scheduled to take place from May 19-20, 2025 at the New York Bar Association in New York, …
Last week, U.S. Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) announced the introduction of two bills we’ve seen before: (1) S. 1096, the Preserve Access to Affordable Generics and Biosimilars Act; and (2) S. 1095, the Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation …
Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product. Even though the PTE provisions established in the Drug Price Competition and …
The American Conference Institute’s 21st Annual Paragraph IV Disputes is scheduled to take place from April 29-30, 2025 at The Altman Building in New York, NY. Widely recognized as the industry gold standard, the conference unites leaders from brand-name and generic drug companies, alongside federal judges, the …
Whether a patent can be listed in the Orange Book is a critical issue for both brand and generic manufacturers, and, of particular interest in the last few years is whether patents claiming just the device constituent of a combination product is eligible for listing. …
Since the induced infringement finding in GSK v. Teva, the generic industry has feared the death of the skinny label (admittedly stoked by alarmist headlines like my own, see Ding Dong is the Skinny Label (Effectively) Dead?). This is because, at a minimum, if a …
We learned earlier this week that an allision (a runner-up to Merriam-Webster’s 2024 Word of the Year, polarization) may be poised to occur—perhaps within a fortnight (another runner-up to Merriam-Webster’s 2024 Word of the Year thanks to Taylor Swift)—as Congress considers various pieces of healthcare …
On August 30, 2024, we posted on what was then the most recent version of S. 142, the Preserve Access to Affordable Generics and Biosimilars Act. Some version of the bill, which addresses patent settlement agreements (pejoratively referred to as “reverse payment agreements” by their …
