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 …
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. …
After waiting with bated breath for more than a week since posting spicy Part 1 and Part 2 of our three-part series on recent U.S. Patent and Trademark Office (“PTO”) Patent Term Extension (“PTE”) decisions under 35 U.S.C. § 156 for certain FDA-regulated products, we …
Earlier this week, we posted Part 1 of our three-part series on U.S. Patent and Trademark Office (“PTO”) Patent Term Extension (“PTE”) decisions under 35 U.S.C. § 156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. Part 1 focused on both the …
It’s been a while since we last blogged on Patent Term Extension (“PTE”) issues of interest. And with 2024 (September 24th) being the 40th anniversary of the enactment of the 1984 Hatch-Waxman Amendments—the statute that amended Title 35 of the United States Code to create …
While the Biologics Price Competition and Innovation Act (“BPCIA”) is inherently distinct from the Hatch-Waxman Act, many of the fundamental concepts FDA adopted as it enacted the Hatch-Waxman Act made their way into FDA’s implementation of the BPCIA. This of course, make sense—after decades of …
The House Committee on Energy and Commerce Subcommittee on Oversight and Investigations invited Hyman, Phelps & McNamara, P.C. Counsel John Claud to testify yesterday about FDA’s foreign inspection program. Mr. Claud frequently counsels foreign and domestic clients on issues relating to inspections and cGMP remediations. We’ve …
In September 2022, while the world was still in the midst of the COVID-19 epidemic and dealing with significant supply chain woes, President Biden issued an Executive Order—Executive Order 14081—titled “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.” Section 1 …
Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. On the heels of its powerful (and unprecedented) amicus brief in Paragraph IV litigation between Jazz and Avadel concerning a patent …
On the day I was born The nurses all gathered ‘round And they gazed in wide wonder At the joy they had found The head nurse spoke up Said, “Leave this one alone” She could tell right away That I was bad to the bone As we noted in our post yesterday, on …
