Orange Book Blog

At the intersection of Patent and FDA Law

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Category: Paragraph IV Cases

  • Barr and Caraco Win Summary Judgment that Ortho-McNeil’s Formulation Patent on Ultracet is Invalid

    Ortho-McNeil Pharm. v. Kali Labs., No. 06-CV-3533 (D.N.J.) In a decision released April 17th, the U.S. District Court for the District of New Jersey granted summary judgment that certain claims of U.S. Patent No. RE39,221 are invalid as obvious. The '221 patent claims combinations of acetaminophen and tramadol, marketed by Ortho-McNeil (OMI) as Ultracet.  Barr…

  • District Court Upholds Validity of Takeda’s Patents on Prevacid, Rejecting Teva’s Obviousness Arguments

    Takeda Pharma. v. Teva Pharms. USA, No. 06-033-SLR (D. Del. 2008) Following a week-long bench trial held last year, the U.S. District Court for the District of Delaware released an opinion on March 31st stating that Takeda’s patents on Prevacid (lansoprazole) are valid and that Teva’s ANDA for a generic version of Prevacid capsules infringes one of…

  • OBB News Briefs

    Last Monday, the Federal Circuit affirmed a district court decision in McNeil-PPC v. Perrigo, concerning a generic version of Pepcid Complete.  The decision was affirmed without an opinion, under Rule 36. Tuesday, AstraZeneca and Ranbaxy announced a settlement of their patent litigation over generic Nexium (esomeprazole), with Astra granting Ranbaxy exclusive rights to sell a…

  • Federal Circuit Finds Declaratory Judgment Jurisdiction Despite Covenant Not to Sue

    Caraco Pharm. Labs. v. Forest Labs., No. 2007-1404 (Fed. Cir. 2008) In a 2-1 decision, the Federal Circuit held today that an ANDA applicant’s declaratory judgment action for noninfringement meets Article III’s "case or controversy" requirement notwithstanding that the patentee has granted the applicant a covenant not to sue.  Today’s decision will likely bring a…

  • Federal Circuit Affirms Topamax Decision in Favor of Ortho-McNeil and Against Mylan and Cobalt

    Ortho-McNeil v. Mylan, No. 2007-1223 (Fed. Cir. 2008); Ortho-McNeil v. Cobalt, Nos. 2007-1258, -1259 (Fed. Cir. 2008) U.S. Patent No. 4,513,006 is listed in the Orange Book as protecting Topamax (topiramate), Ortho-McNeil’s blockbuster anticonvulsant for the treatment of migraines and epilepsy.  Mylan and Cobalt seek to market generic versions of Topamax before the ‘006 patent…

  • Eisai Wins Preliminary Injunction Against Teva’s Generic Aricept

    Eisai Co. v. Teva Pharms. USA, No. 05-5727 (D.N.J. 2008) Eisai Co., Ltd., the Japanese manufacturer of Aricept (donepezil hydrochloride), has won a preliminary injunction against Teva Pharmaceuticals USA, Inc., keeping Teva’s generic version of Aricept off the market for the time being.  Aricept, which accounts for $1.6 billion in annual U.S. sales, is reportedly…

  • District Court Upholds Validity of P&G’s Actonel Patent, Rejecting Teva’s Obviousness Arguments

    Proctor & Gamble v. Teva Pharms. USA, No. 04-940 (D. Del. 2008) Late last month, the U.S. District Court for the District of Delaware (J. Farnan) upheld the validity of Proctor & Gamble’s U.S. Patent No. 5,583,122, which claims risedronate sodium, the active ingredient in Actonel.  Teva had challenged the ‘122 patent in a paragraph…

  • Federal Circuit Invalidates Pfizer’s Latest-Expiring Patent on Celebrex, for Double Patenting

    Pfizer v. Teva Pharms. USA, No. 2007-1271 (Fed. Cir. 2008) Pfizer owns three Orange Book-listed patents protecting its blockbuster arthritis drug Celebrex (celecoxib): U.S. Patent Nos. 5,466,823; 5,563,165; and 5,760,068.  As we previously reported, last year a district court held that Teva's ANDA infringes all three patents, and enjoined Teva from marketing its generic version…

  • Barr Labs Prevails in Yasmin Case; Bayer’s Patent Held Invalid for Obviousness

    Bayer Schering Pharma AG v. Barr Labs., No. 05-2308 (D.N.J. 2008) On Monday, the U.S. District Court for the District of New Jersey invalidated Bayer's U.S. Patent No. 6,787,531 on grounds of obviousness, relying heavily on KSR.  The '531 patent, claiming pharmaceutical formulations of micronized drospirenone and ethinylestradiol, protects Bayer's Yasmin birth control pill.  Barr…

  • OBB News Briefs

    The New York Times had another article Thursday on the investigation into the Chinese supply of heparin.  Pharmalot had this related post Friday. FTC Commissioner Jon Leibowitz wrote an editorial for the Washington Post Monday on "reverse-payment" settlements (or "pay-for-delay" settlements), and the FTC’s recently filed case against Cephalon, in particular. Dow Jones reported Monday…