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 …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is proud to announce the firm has been selected to the 2024 edition of Best Law Firms. Firms included in the 2024 Best Law Firms ranking are recognized for professional excellence with persistently impressive ratings from clients and peers. To …
“Human sacrifice! Dogs and cats living together! Mass hysteria!” At least that’s this blogger’s reaction to the recent news that FTC sent out Notice letters to 10 different drug companies about the patent information they list in the Orange Book. It’s so exciting that we …
For years, submitting a Suitability Petition has been like screaming into a void: You’d be lucky if FDA ever responds. This has been a big problem because FDA’s inattentiveness can delay entry of certain types of ANDAs for years—often resulting in the ANDA applicant’s abandonment …
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 …
In January 2023, Vanda Pharmaceuticals, Inc. (Vanda) submitted two interesting and substantially similar citizen petitions (Docket Nos. FDA-2023-P-0313 and FDA-2023-P-0344) regarding its product Hetlioz (tasimelteon). Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the …
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials AND a critical competency for legal and business professionals in the biopharmaceutical arena AT THE American Conference Institute’s (ACI’s) 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA! Attend ACI’s Hatch-Waxman and BPCIA Proficiency …
One of the most important questions FDA has to answer is whether a given product is appropriately characterized as a drug, biologic, device, food, cosmetic, or something entirely different. As we have explained before, that distinction is critical to assigning a particular product to the …
Well, it’s official: The Federal Circuit decision in GSK v. Teva stands, as the Supreme Court has decided not to hear the case on appeal. While the statistics were against the Supreme Court taking up the case given the limited number of cases heard per …
Well, we’re a little late to blogging about this, but the significance of the ongoing Teva v. GSK litigation to Hatch-Waxman aficionados makes this case still ripe for blogging. Six months after the Supreme Court asked the Solicitor General to submit a brief on behalf of …
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 …
On May 2nd, the U.S. Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. That bill is S. 1067, the “Ensuring …
FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. As the Office of Generic Drugs (“OGD”) has stated, “[t]he clarity and transparency provided by PSGs help streamline generic drug product development, …
FDA has not been shy about its distaste for the Catalyst decision; the Agency has published on its website the litany of problems that arise from it and has sent emails and letters to stakeholders essentially urging them to contact Congress to address the decision. …
