By Kurt R. Karst - FDA has issued a draft guidance document, titled "Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act," explaining the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 new statutory provision. FDC Act § …
By Kurt R. Karst – We previously reported on the Patent and Trademark Office’s (“PTO’s”) determination that U.S. Patent #5,817,338 (“the ‘338 patent”), which covers AstraZeneca’s PRILOSEC OTC (omeprazole magnesium) Delayed-Release Tablets, is not eligible for a Patent term Extension (“PTE”) because the PRILOSEC OTC New …
By Kurt R. Karst – Late last week while those of us in the U.S. were still digesting our turkey dinners, FDA issued a draft guidance document describing the Agency’s current thinking on the implementation of § 4(b)(1) of the Q1 Program Supplemental Funding Act …
By Kurt R. Karst - On November 25, 2008, FDA granted in full a citizen petition (petition supplements are available here and here) submitted by Osmotica Pharmaceutical Corp. earlier this year requesting that FDA determine that any company with a pending Abbreviated New Drug Application ("ANDA") …
By William T. Koustas & Kurt R. Karst – We previously reported that the Federal Trade Commission (“FTC”) is planning a Roundtable on Follow-on Biologics (“FOBs”) to be held on November 21, 2008 in Room 432 at FTC Headquarters in Washington, D.C. The Roundtable was …
By Kurt R. Karst – Earlier today, the U.S. Court of Appeals for the District of Columbia Circuit issued its opinion in Teva Pharmaceuticals USA, Inc. v. Leavitt. The case concerns the availability of 180-day exclusivity for a generic version of Janssen Pharmaceutica’s schizophrenia drug …
By Kurt R. Karst – Answer: "October 24, 2008" . . . . queue Jeopardy! think music . . . . Question: "What is the date on which patent information was first listed in the Orange Book covering an old antibiotic drug product?" Alex Trebek: "Correct!" On …
By Kurt R. Karst – Further cementing FDA’s position that a generic applicant can forfeit 180-day exclusivity after patent information is "withdrawn" by the NDA holder, FDA ruled earlier today that Hi Tech Pharmacal Co., Inc. (“Hi Tech”) forfeited 180-day exclusivity after the information on two exclusivity-qualifying Orange …
BNA, a leading provider of expert information and analysis, is holding a one-day, information-packed conference, titled “Pharmaceutical Patent Laws: A prescription for Success in Challenging Times.” Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will be on a panel discussion of Non-Patent Marketing Exclusivity with …
Section 920 of the FDA Amendments Act (“FDAAA”) amended the FDC Act to create new § 505(t) – “Database for Authorized Generic Drugs” – that requires FDA to compile and publish a complete list of all authorized generic drugs identified in annual reports submitted to …
Yesterday, the U.S. Senate passed S. 3560, the “QI Program Supplemental Funding Act of 2008.” Section 4 of the bill would amend the FDC Act to add new subsection 505(v) – “Antibiotic Drugs Submitted Before November 21, 1997” – to create Hatch-Waxman benefits for so-called …
Over the past several months, FDA has responded to or companies have submitted citizen petitions to FDA requesting that the Agency refrain from approving ANDAs for generic drugs with less than complete labeling – so-called “skinny labeling.” That got us thinking – what is the …
On September 12, 2008, the U.S. Court of Appeals for the District of Columbia heard oral argument and ruled in Teva Pharmaceuticals USA, Inc. v. Leavitt, which concerns the availability of 180-day exclusivity for a generic version of Janssen Phaemaceutica’s schizophrenia drug RISPERDAL (risperidone) Tablets …
2009 is shaping up to be a big year for debate on Follow-On Biologics (“FOBs”). Earlier this year, Representative Anna Eshoo introduced FOB legislation and the House Energy and Commerce Committee Subcommittee on Health requested comment on various FOB issues. The legislation and comments submitted …
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 …
