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 …
By Alan M. Kirschenbaum, Kurt R. Karst & J.P. Ellison – On Thursday morning, the U.S. Senate passed, by a 60-39 vote, H.R. 3590, the Patient Protection and Affordable Care Act. Last weekend, Sen. Harry Reid (D-NV) unveiled a 383-page Manager’s Amendment to the bill. …
By Kurt R. Karst – A recent decision from the U.S. District Court for the Northern District of Illinois (Eastern Division) presents an interesting solution to a concern about the forfeiture of 180-day exclusivity when a company submits an ANDA containing both a Paragraph IV Certification …
By Kurt R. Karst – Tick tock! Tick tock! Like sand through the hourglass so too are the days that The Medicines Company (“TMC”) has to convince Congress or the U.S. Patent and Trademark Office (“PTO”) to allow a Patent Term Extension for U.S. Patent …
By Kurt R. Karst – Although much discussion has been devoted over the past few days to Sen. Byron Dorgan’s (D-ND) proposed amendment (SA 2793) to the Senate Health Care Reform Bill that would let U.S. pharmacies and drug wholesalers import FDA-approved drugs from certain …
By Kurt R. Karst – A recent decision from the Patent and Trademark Office (“PTO”) in which the Office granted an interim Patent Term Extension (“PTE”) for U.S. Patent No. 5,407,914 but denied interim extensions for U.S. Patent Nos. 5,260,273 and 5,789,381 covering the drug product …
