By Kurt R. Karst – Suppose FDA approves a New Drug Application (“NDA”) – NDA No. 1 – and grants a period of 5-year New Chemical Entity (“NCE”) exclusivity, but there are no patents listed in FDA’s Orange Book for the NDA, and therefore, there is …
By Kurt R. Karst – Last week, Judge Ellen S. Huvelle of the U.S. District Court for the District of Columbia dismissed without prejudice for lack of subject matter jurisdiction a Complaint filed by Cephalon, Inc. (“Cephalon”) on March 15, 2011 challenging FDA’s January 7, 2011 …
By Kurt R. Karst – A recent article in The RPM Report concerning the apparent fate of the only Priority Review Voucher (“PRV”) issued to date by FDA caught our attention. Kudos to The RPM Report team, which took note of some statements made during a …
By Kurt R. Karst – Over the Independence Day holiday, in between the family BBQ and fireworks, we had a few minutes to reflect on what a hectic month June was for FDA and the regulated industry. There were the decisions handed down by the U.S. …
By Kurt R. Karst – A recent unpublished decision out of the U.S. District Court for the District of New Jersey presented an interesting public disclosure issue that we think will be of interest to the Hatch-Waxman community. The case, like so many Hatch-Waxman cases, is …
By Kurt R. Karst – The continuing court battle over a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin) could be derailed if a recent amendment added to the House version of the America Invents …
By Dara Katcher Levy – Last week, FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”) released an Untitled Letter issued to Novartis on May 31st, which alleges the company made unsubstantiated superiority claims in a detail aid for its ADHD drug, Focalin XR. Unlike most …
By Ben Wolf* and Jeff Wasserstein – Justice Kennedy delivered the opinion of the Supreme Court in today’s 6-3 decision in Sorrell v. IMS Healthcare Inc. (Docket No. 10-779). This decision strikes down a Vermont law prohibiting the sale, disclosure, and use of pharmacy records that reveal …
By Kurt R. Karst – Like a young attorney (full of angst) waiting for Bar Exam results to be posted on the Internet, we sat in front of our computer this morning constantly hitting the “refresh” button to update the U.S. Supreme Court’s “2010 Term Opinions …
By Ricardo Carvajal & Riëtte van Laack – When the FDA Nanotechnology Task Force issued its report in 2007, it declined to adopt precise definitions of the terms "nanoscale materials" or "nanotechnology," opting instead to take an inclusive approach. FDA has now issued draft guidance on nanotechnology …
Hyman, Phelps & McNamara, P.C.’s David B. Clissold has been named to the Board of Advisors of Analgesic Clinical Trial Innovations, Opportunities, and Networks (“ACTION”). ACTION is a public-private partnership aligned with FDA’s recently launched Initiative for the Advancement of Regulatory Science. ACTION is designed …
By Kurt R. Karst – Like Yogi Bear, who is always on the lookout for a better way to procure pic-i-nic baskets, we are always on the lookout for innovative strategies companies come up with to protect their market exclusivity. Two strategies have recently come by …
By Kurt R. Karst – Earlier this week, FDA announced the availability of a final guidance document, titled “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act,” explaining the Agency’s interpretation of this statutory provision …
The Food and Drug Law Institute (“FDLI”) will host an intensive one-day, must-attend conference on June 24, 2011, at the Westin City Center in Washington, DC, titled “Brands, Generics and Hatch-Waxman: New Challenges; Unabated Controversy.” The conference will cover myriad Hatch-Waxman issues, including 180-Day Exclusivity, …
By Nisha P. Shah & Kurt R. Karst – The U.S. Government Accountability Office (“GAO”) recently issued a report required by the FDA Amendments Act of 2007 (“FDAAA”) concerning the effects of the Pediatric Research Equity Act (“PREA”) (FDC Act § 505B) and the Best Pharmaceuticals …
