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In one of the first Eastern District of Texas interpretations of the Hatch-Waxman Act, the federal law governing the procedure for bringing generic drugs to market, brand-name drug company Allergan Inc. has prevailed against five generic drug makers. On Aug. 22 in Allergan Inc. v. Sandoz Inc., U.S. District Judge T. John Ward ruled that the four Allergan patents were valid and that the four defendants in the consolidated case had infringed upon it. The defendants were seeking U.S. Food and Drug Administration approval to sell generic versions of Allergan’s Combigan, a combination of two glaucoma drugs used to treat glaucoma and ocular hypertension. Ward enjoined four defendants from making or selling the generic drugs until after the last of Allergan’s patents in the suit expired. Under Hatch-Waxman, drug companies may file a so-called abbreviated new drug application (ANDA) with the FDA to seek approval for generic versions of already-approved drugs by submitting bioequivalence studies instead of clinical studies. Generic manufactures must certify one of several things to win FDA approval for an ANDA — that the listed drug is not patented, that the patent has expired or that the patent is invalid or will not be infringed by the generic drug. Allergan sued each of the defendants between April 2009 and September 2010 after they asserted that its patents were invalid or wouldn’t be infringed by their products. Near the end of his 101-page findings of fact and conclusions of law, Ward wrote that “the Court is not persuaded that Defendants have established by clear and convincing evidence that the patents-in-suit are obvious in light of the prior art. The Court finds that there are significant differences between the prior art and the claimed inventions, such that a person of ordinary skill in the art would not have been motivated to create a fixed combination composition of [the two glaucoma drugs in Combigan].” The Allergan ruling closely tailed an Aug. 5 judgment in Pozen Inc. v. Par Pharmaceutical Inc., which Allergan case co-lead counsel Jonathan Singer said might be the only other Eastern District of Texas Hatch-Waxman ruling. Singer is a Minneapolis and San Diego partner who heads Fish & Richardson’s pharmaceutical litigation practice. In Pozen, U.S. District Judge Leonard Davis ruled that defendants Alphapharm Pty Ltd., Dr. Reddy’s Laboratories Inc. and Par Pharmaceutical Inc. infringed at least one of three Pozen patents on its migraine treatment drug Treximet, which combines two other drugs in a single tablet. Davis enjoined the defendants in that case from making, using, selling or offering their infringing products in the United States. All three defendants had filed ANDAs with the FDA seeking approval to sell generic Treximet before Pozen’s patents expire. Although the Eastern District of Texas is known for patent litigation, it’s not a magnet for pharmaceutical cases like the districts of Delaware or New Jersey, Singer said. Following the Allergan and Pozen rulings, “there will be more companies that will take a close look at Texas to litigate Hatch-Waxman cases,” he said. Ward’s ruling in Allergan also recognized the unpredictability and difficulty of formulating combination ophthalmic drugs, Singer said. “All the experts agree that ophthalmic formulation is an unpredictable and complicated art,” Singer said. Allergan started developing Combigan in 1998 and won FDA approval for it in 2007. “If they had lost this case, they would only have three years to sell before the generic competition wiped them out,” Singer said. Stevens, Love, Hill & Holt of Longview, Texas, served as Allergan’s local counsel. Aside from Sandoz, the other defendants were Alcon Laboratories Inc. and related companies Alcon Research Ltd. and Alcon Inc.; Falcon Pharmaceuticals Ltd.; Apotex Inc. and its U.S. affiliate Apotex Corp.; and Watson Laboratories Inc. A fifth defendant, Hi-Tech Pharmacal Co. Inc., admitted before trial that Allergan’s patents were valid and that it had infringed and settled. None of the defendant companies responded to requests for comment. Neither did Alcon’s lawyers at McDonnell Boehnen Hulbert & Berghoff and Rakoczy Molino Mazzochi Siwik in Chicago. Watson’s lawyers at Polsinelli Shughart of Kansas City, Mo., and Siebman, Burg, Phillips & Smith in Sherman, Texas, did not respond. Sandoz’s lawyers at Philadelphia’s Duane Morris and The Davis Firm in Longview, Texas, either did not respond or could not be immediately reached for comment. Katten Muchin Rosenman Chicago patent litigation partner Robert Breisblatt, one of several of the firm’s lawyers who represented Apotex, said “Apotex has no comment.” Gillam & Smith of Marshall, Texas, also represented Apotex. Sheri Qualters can be contacted at [email protected].

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