Under the FDC Act and FDA’s implementing regulations, a sponsor may qualify for a 3-year period of market exclusivity for a “change” to an approved drug product if the application contains: (1) “reports of new clinical investigations (other than bioavailability studies);” (2) that were “essential …
As we previously reported, in August 2007, FDA issued a letter and started a docket requesting public comment on a variety of 3-year exclusivity issues concerning generic versions of Shire U.S. Inc.’s PROAMATINE (midodrine hydrochloride) Tablets. FDA approved PROAMATINE in September 1996 under the Agency’s …
In the second lawsuit in as many months, the Patent and Trademark Office (“PTO”) has been sued over a decision to deny a Patent Term Extension (“PTE”). As we previously reported, Wyeth sued the PTO and FDA in June 2008 concerning the appropriate PTE regulatory …
An interesting issue is percolating at the U.S. Patent and Trademark Office (“PTO”) concerning Patent Term Extensions (“PTEs”). We hinted at this issue in our recent post concerning the PTO’s decision to deny a PTE with respect to U.S. Patent #5,674,860 (“the ‘860 patent”), which …
In June, the U.S. Patent and Trademark Office (“PTO”) determined that AstraZeneca’s U.S. Patent No. 5,674,860 (“the ‘860 patent”), which covers the drug product SYMBICORT (budesonide; formoterol fumarate dihydrate) Inhalation Aerosol, is ineligible for a Patent Term Extension (“PTE”). The PTO’s decision is important in …
On June 23, 2008, Representative William Delahunt (D-MA) introduced, and the U.S. House of Representatives quickly passed by voice vote, H.R. 6344 – the Responsive Government Act of 2008. The 12-page bill includes several provisions, including the latest iteration of the so-called “Dog Ate My …
On June 6, 2008, Wyeth Holdings Corporation and its Fort Dodge Animal Health Division (collectively “Wyeth”) filed a complaint in the U.S. District Court for the District of Columbia against FDA and the U.S. Patent and Trademark Office (“PTO”) requesting declaratory and injunctive relief with …
Title XI (§ 1112) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”) requires pharmaceutical applicants (both brand and generic) to file with the Federal Trade Commission (“FTC”) and the Assistant Attorney General certain agreements executed on or after January 7, 2004. …
Valeant Pharmaceuticals International’s (“Valeant’s”) EFUDEX (fluorouracil) Topical Cream, 5%, (also known as 5-FU) is a locally-acting antineoplastic drug product FDA first approved in July 1970 for the topical treatment of multiple actinic or solar keratoses (“AK”). In 1976, FDA approved the drug for a second …
We previously reported (here and here) on FDA’s efforts to resolve 180-day exclusivity forfeiture issues concerning generic versions of Bayer Pharmaceuticals’ (“Bayer’s”) diabetes drug PRECOSE (acarbose) Tablets by establishing a public docket. (FDA has also taken similar actions to resolve 180-day exclusivity issues concerning ramipril …
On May 7, 2008, the U.S. Court of Appeals for the Federal Circuit is scheduled to hear oral argument in Lupin Ltd. v. Abbott Labs. This is a patent infringement action concerning U.S. Patent #4,935,507 (“the ‘507 patent”) with respect to Abbott’s antibiotic drug product …
Under Title II of the Hatch-Waxman Act, certain patents related to products regulated by FDA are eligible for extension by the U.S. Patent and Trademark Office (“PTO”) if patent life was lost during a period when the product was undergoing regulatory review. The “regulatory review …
On April 11, 2008, we reported that Judge Royce C. Lamberth of the U.S. District Court for the District of Columbia issued a 2-page order in Teva Pharmaceuticals USA, Inc. v. Leavitt siding with Teva over the reslisting of U.S. Patent #5,158,952 (“the ‘952 patent”) …
Earlier this month, we reported on the status of litigation in the U.S. Court of Appeals for the District of Columbia Circuit concerning Nu-Pharm Inc.’s efforts to get FDA to approve the company’s ANDA for a generic version of Abbott Laboratories’ DEPAKOTE (divalproex sodium) Delayed-Release …
Earlier today, Judge Royce C. Lamberth of the U.S. District Court for the District of Columbia issued a 2-page order in Teva Pharmaceuticals USA, Inc. v. Leavitt siding with Teva. This case concerns the relisting of U.S. Patent #5,158,952 (“the ‘952 patent”) in the Orange …
