By Suresh Pillai --
Settlement Announced in SOLODYN® Patent Dispute
Last week, Teva Pharmaceutical Industries Ltd. and Medicis Pharmaceutical Corp. entered into a settlement agreement that effectively ends a dispute between the two companies over the patent family covering SOLODYN® (minocycline HCL, used to treat acne) Extended Release Tablets. Medicis' initial complaint, which was filed against Barr Pharmaceuticals (which has since been acquired by Teva) in January (see "Court Report," January 13, 2009), alleged infringement of U.S. Patent No. 5,908,838.
Under the terms of the settlement agreement, Medicis has granted Teva the option to market its generic versions of SOLODYN® 45 mg, 90 mg, and 135 mg tablets beginning in November 2011 or earlier under certain conditions. In exchange for this license and Medicis' release of Teva from liability stemming from Teva's sales of generic SOLODYN®, Teva has agreed to cease all of their SOLODYN® shipments. Additional information regarding the settlement agreement can be found in Teva's press release.
Supreme Court Denies Apotex Appeal in Risperdal® Litigation
On Monday, the Supreme Court denied Apotex's petition for a writ of certiorari seeking review of the Federal Circuit's affirmation of a District Court's dismissal of Apotex's counterclaims of noninfringement. The patents at issue in the case, U.S. Patent Nos. 4,804,663, 5,453,425, and 5,616,587, cover risperidone, the active ingredient in Risperdal®, a drug made by Janssen Pharmaceutica NV and prescribed for the treatment of schizophrenia, bipolar mania, and irritability associated with autistic behavior.
Janssen first filed suit in the U.S. District Court for the District of New Jersey against Apotex in March 2006 (see "Court Report," July 22, 2007), claiming that Apotex's ANDA covering oral Risperdal® infringed the '663 patent. Janssen subsequently filed suit against Apotex, alleging that Apotex's ANDA covering a tablet version of Risperdal® also infringed Janssen's Risperdal® patents. Apotex responded by asserting counterclaims seeking a declaratory judgment of noninfringement for two unasserted patents, the '425 and the '587 patents. The District Court granted Janssen's motion to dismiss the counterclaims, citing an absence of a case or controversy with regard to the unasserted patents. Apotex appealed the decision to the Federal Circuit, which affirmed the lower court's decision. Additional information regarding the Federal Circuit decision can be found in this Patent Docs report.
Federal Trade Commission Declines to Challenge UCB-Generics Deal
In a letter dated March 10, and reported by Dow Jones on March 20, the Federal Trade Commission (FTC) has declined a challenge to UCB SA's legal settlement with Dr. Reddy's Laboratories, Ltd., Cobalt Pharmaceuticals, Inc., and Mylan Inc. to keep generic versions of the UCB anti-epileptic drug, Keppra®, off the market. The UCB patent at issue is U.S. Patent No. 4,943,639. In 2004, Mylan filed an ANDA application seeking FDA approval to manufacture and market generic versions of Keppra®. Mylan also filed a Paragraph IV certification asserting that the '639 patent was invalid and not infringed. Mylan's filing was followed by ANDA filings by Dr. Reddy's and Cobalt; in response to these multiple filings, UCB sued the generic manufacturers in the U.S. District Court for the Northern District of Georgia. In October 2007, UCB settled the dispute with Dr. Reddy's, Mylan, and Cobalt, in which Mylan received a license to market tablets of lev4etiracem, the Keppra® active ingredient, as of November 2008. The rest of the agreement, however, including the dates when Dr. Reddy's and Cobalt could market generic Keppra®, was not disclosed, and the FTC began an antitrust investigation.
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