By Kurt R. Karst – FDA’s recent approval of Nycomed U.S., Inc.’s ANDA No. 78-548 for a generic version of ALDARA (imiquimod) Cream, 5%, appears to be the first instance in which FDA has determined that a first ANDA applicant is eligible for 180-day exclusivity …
By Kurt R. Karst – The U.S. District Court for the Eastern District of Michigan (Southern Division) recently dismissed without prejudice a Complaint filed by Wyeth and granted a Motion to Dismiss filed by Sun Pharmaceutical Industries, Ltd. and Caraco Pharmaceutical Laboratories, Ltd. (“Sun”) in a Lanham Act …
By Kurt R. Karst – Earlier today, the U.S. Court of Appeals for the District of Columbia Circuit handed Teva Pharmaceuticals USA, Inc. (“Teva”) a significant victory in the company’s lawsuit against FDA concerning the availability of 180-day exclusivity for generic versions of Merck & …
By Kurt R. Karst – The Patent and Trademark Office’s (“PTO’s”) recent denial of a Patent Term Extension (“PTE”) for U.S. Patent No. 5,270,305, which was reissued as U.S. Patent No. RE40,045 (“the ‘045 patent”), covering Glaxo’s ADVAIR DISKUS (fluticasone propionate; salmeterol xinafoate) should be the …
By Kurt R. Karst – FDA’s Office of Generic Drugs (“OGD”) has a backlog of Abbreviated New Drug Applications (“ANDAs”) that is nearing 2,000, according to OGD Director Gary Buehler, who presented the data at the recent Generic Pharmaceutical Association (“GPhA”) Annual Meeting. OGD’s median …
By Kurt R. Karst – In yet another setback to the Federal Trade Commission’s (“FTC’s”) battle against settlement agreements between brand name and generic drug companies – so-called “reverse payments” or what the government now calls “pay-for-delay” agreements – the U.S. District Court for the …
By Kurt R. Karst – Two recent rulings out of the U.S. District Court for the Eastern District of Pennsylvania stemming from allegations about antitrust violations from the submission of citizen petitions have once again raised the issue of so-called “sham” citizen petitions and, insofar …
By Kurt R. Karst – Late last month, FDA denied a citizen petition submitted by Graceway Pharmaceuticals, LLC (“Graceway”) requesting that the Agency refuse to approve Abbreviated New Drug Applications (“ANDAs”) for generic versions of Graceway’s ALDARA (imiquimod) Cream, 5%, unless such applications contain, among …
By Kurt R. Karst – As we predicted, Massachusetts-based The Medicines Company (“TMC”) has sued the U.S. Patent and Trademark Office (“PTO”) and FDA in connection with the company’s efforts to obtain a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) …
By Kurt R. Karst – Is an ANDA applicant who cites a 505(b)(2) drug as the Reference Listed Drug (“RLD”) required to certify to Orange Book-listed patents covering the 505(b)(2) RLD drug as well as to Orange Book-listed patents covering the original listed drug approved …
By Kurt R. Karst – Now that we are a little more than six years after the December 8, 2003 enactment of Title XI of the Medicare Modernization Act (“MMA”), which, among other things, amended the FDC Act to create a new 180-day exclusivity regime …
By Kurt R. Karst – Massachusetts-based The Medicines Company (“TMC”) has lost its latest battle with the U.S. Patent and Trademark Office (“PTO”) for a Patent Term Extension for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering ANGIOMAX (bivalirudin), a drug product FDA first …
By Kurt R. Karst – As we reported yesterday, the Federal Trade Commission (“FTC”) held a press conference on January 13, 2010 announcing the release of a report, titled “Pay-for-Delay: How Drug Company Pay-Offs Cost Consumers Billions,” on the effects of pay-for-delay deals in the …
By Kurt R. Karst – Over the past several weeks, proponents of a ban on so-called pay-for-delay settlements have put a full-court press on Congressional leaders to include provisions in the final Health Care Bill. The House bill includes a provision (§ 2573) sponsored by …
By Kurt R. Karst – Following FDA’s decision, reflected in the October 2009 Orange Book Cumulative Supplement (page A-28), to grant 5-year New Chemical Entity Exclusivity (“NCE”) for EMEND (fosaprepitant dimeglumine) Injection, the Agency has issued an exclusivity determination explaining its decision. Fosaprepitant is a …
