By James DeGiulio --
Pfizer Settles Lipitor Patent Suits with Aurobindo, Kremers
Pfizer has settled separate cases with Aurobindo and Kremers, ending its patent infringement actions over the generic companies' efforts to enter the market for the cholesterol drug Lipitor. On June 27, 2011, Pfizer sued Aurobindo in response to the generic's filing of an ANDA for atorvastatin calcium, claiming infringement of U.S. Patent No. 5,969,156, issued in 1999, and its reexamination certificate, issued in 2006 (see "Court Report," July 4, 2011). Aurobindo's May 17 letter informed Pfizer of its intent to seek FDA approval to sell 10 mg, 20 mg, and 80 mg dosages of generic Lipitor. The '156 patent's expiration date is July 8, 2016, but the patent has been granted a further period of pediatric exclusivity running through January 8, 2017.
On November 7, Judge Leonard P. Stark signed off on a joint motion to dismiss filed by the parties under Federal Rule 41(a)(2). The joint motion indicated that Pfizer and Aurobindo had entered into a settlement agreement on November 2, thus prompting their request for dismissal of all claims and counterclaims. The dismissal is without prejudice and shall not act as an adjudication on the merits.
On November 18, in another Lipitor case pending since December 2009 (see "Court Report," December 7, 2009), Kremers Urban Pharmaceuticals Inc. also entered into a settlement agreement with Pfizer over 10 mg, 20 mg, 40 mg, and 80 mg dosages, known generically as atorvastatin calcium tablets. The terms of this agreement are confidential, and the agreement remains subject to review by the U.S. Department of Justice and the Federal Trade Commission.
Mylan and Novartis Settle Patent Suit over Vivelle-Dot
Mylan has settled both of its patent litigations with Novartis related to the estrogen therapy drug Vivelle-Dot, opening the door to begin manufacturing a generic version of the estrogen replacement patch. In February, Novartis filed two lawsuits against Mylan, one in the U.S. District Court for the District of Vermont and one in the U.S. District Court for the Southern District of New York. The suits allege that Mylan's ANDA covering a generic Vivelle-Dot infringes U.S. Patent Nos. 5,656,286 and 6,024,976. Mylan asserted that these patents were invalid or unenforceable, and would not be infringed by the generic estradiol transdermal system the company proposed. Novartis requested a permanent injunction barring Mylan from manufacturing the drug and damages if the company produced its proposed generic before the two patents expired.
On November 23, New York District Judge Katherine B. Forrest issued a stipulation and order staying the case pending approval of the settlement by the U.S. Department of Justice and the Federal Trade Commission. According to the agreement, Mylan will receive a patent license to begin selling generic versions of the product on December 16, 2013, or earlier under certain circumstances. Additional details of the settlement are confidential. The agreement allows Mylan to begin manufacturing a generic version of the estrogen replacement patch, and Mylan can enter the market first as the first ANDA filer. Vivelle-Dot generated $240 million in U.S. sales over the past year.
Teva and Bayer Settle Dispute over Levitra Patents
Bayer reached a settlement with Teva over two patents directed to Levitra, and Teva agreed not to produce the generic drug until a settled date following a consent judgment for the plaintiffs. Teva notified Bayer in May 2009 that it had filed an ANDA seeking to market generic vardenafil hydrochloride. In response, Bayer filed five related but separate cases in 2009 and 2010, alleging infringement of U.S. Patent Nos. 6,362,178 and 7,696,206 based on Teva's ANDA (see "Court Report," April 19, 2010 and July 25, 2010). Teva asserted that Bayer's patents were invalid and would not be infringed. Bayer argued that Teva's Paragraph IV notice letter provided no valid basis for these assertions regarding the patents-in-suit.
On November 17, Judge Sleet signed off on a consent judgment and order, entering judgment in favor of Bayer and against Teva on Bayer's claims of infringement of the '178 and '206 patents. Under the judgment, claims 1-5, 7, and 8 of the '178 patent and claims 1-6 of the '206 were deemed valid, the patents were declared enforceable, and Teva's ANDA was found to infringe the same claims. Teva agreed not to make, offer for sale, or sell the products that are described in its ANDA prior to the date set forth in the Settlement Agreement. The parties waived any right to appeal the judgment.