Back in July, the United States Supreme Court turned the world of administrative law on its head, adding new layers of judicial oversight to what might have previously been thought of as fairly non-descript Federal agency functions. One of those cases was Loper Bright v. …
Further talks of the Skinny Label’s demise may be premature, as demonstrated by a new decision from the District Court for the District of Columbia upholding FDA’s interpretation of the “same labeling” provisions of the Hatch-Waxman Amendments. That is not to say that concerns about …
If you monitor Regulations.gov dockets and litigation dockets on PACER like we do, then you know that one company name—more than any other over the past several years—pops up: Vanda Pharmaceuticals, Inc. But unlike the fictitious Vandelay Industries of Seinfeld that George Costanza claims to …
In the Hatch-Waxman Community there are certain folks who are viewed as “the Founders” or pioneers of the law. There are, of course, the names Representative Henry Waxman and Senator Orrin Hatch, but there were several other Founders. One of them—who was said to have …
Forty years ago today—on a sunny Monday, September 24, 1984 at approximately 3:30 PM Eastern Time in the Rose Garden at the White House—President Ronald Reagan signed into law Public Law 98-417, the Drug Price Competition and Patent Term Restoration Act of 1984, stating that …
“Inter Partes Review” and “Section 101” are not terms you typically run into on this all-things-FDA blog, but we have talked about such patent-related issues before (here and here), and they are important legal (patent) principles, particularly in the context of drug and biological products …
Tell me doctor, where are we going this time? Is this the 90s, or 2025? Apologies to both Robert Zemeckis, who directed the 1985 classic “Back to the Future,” and to Huey Lewis and the News, which played “Back in Time” for the feature film, …
As readers of this blog know (see, e.g., here), the Affordable Generics (and Biosimilars) Act has been floating around in Congress for the better part of two decades. That bill, addressing drug (and later biological product) patent settlement agreements (pejoratively referred to as “reverse payment …
The American Conference Institute (“ACI”) will hold (virtually) its 4th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA from October 8-24, 2024. This virtual three-week program is designed to give new lawyers and executives a solid foundation in the essentials and intricacies of …
In the world of patent term extensions, every day considered part of the regulatory review period is important, as that day—either in whole or in part—gets added back to the patent upon approval of the product. In the veterinary world, where rolling applications are common, …
Increasingly the subject of induced infringement litigation, the viability of the carve-out has been questioned for several years now. But recently, a new challenge was filed in the District Court for the District of Columbia questioning whether modifications to labeling as a result of patent …
The American Conference Institute (“ACI”) is holding its 10th Anniversary Paragraph IV Disputes Master Symposium from October 15-16, 2024, at the Hyatt Regency McCormick Place in Chicago, Illinois. Each fall, leading pharmaceutical patent litigators for brand-name and generic drug companies gather at the Paragraph IV …
The Supreme Court’s recent decision in Loper Bright v. Raimondo has done away with Chevron deference to federal agencies’ interpretation of ambiguous statutes, including the FDA. The decision commands that federal judges must make their own decisions in suits against FDA, considering—but not deferring to—the …
As we have noted for the last year or so, the FTC has been on a mission to clean up the Orange Book by removing what it deems to be “improper” patents. The FTC has put out policy statements, challenged patent listings, tapped Congress, appeared …
If you’ve been following this blog since the early days, then you know we fervently followed the more-than-decade-long soap opera that was The Medicines Company’s efforts to obtain a Patent Term Extension (“PTE”) from the U.S. Patent and Trademark Office (“PTO”) for U.S. Patent No. …
