A brand-name drug company can’t sue generic drug companies for patent infringement if the generics ask the government to approve only nonpatented uses for the drug, the U.S. Court of Appeals for the Federal Circuit has ruled.
On Feb. 9, a unanimous panel affirmed a December 2010 ruling by Judge Robert Kugler of the District of Delaware dismissing AstraZeneca Pharmaceuticals L.P.’s case against Apotex Corp. and several other generic drug companies.
The case, AstraZeneca v. Apotex, involves AstraZeneca’s patented technology for the cholesterol-lowering drug Crestor. AstraZeneca holds three patents related to the drug.
AstraZeneca and the Brigham and Women’s Hospital Inc. appealed consolidated final orders of their cases against Apotex, Aurobindo Pharma Ltd., Cobalt Pharmaceuticals Inc., Cobalt Laboratories Inc., Glenmark Generics Inc. USA, Mylan Pharmaceuticals Inc., Par Pharmaceuticals Inc., Sun Pharmaceutical Industries Ltd., Teva Pharmaceuticals USA Inc., Torent Pharma Inc., and Torent Pharmaceuticals Ltd.
The defendants are generic pharmaceutical manufacturers that filed abbreviated new drug applications (ANDAs) with the U.S. Food and Drug Administration for permission to market generic versions of the drug.
They sought approval of generic drugs for treating only a genetic condition known as homozygous familial hypercholesterolemia and another condition known as hypertriglyceridemia, but not the uses claimed in AstraZeneca’s patents.
AstraZeneca sued the defendants for infringing one of the patents in December 2007 in the District of Delaware. The court ruled in AstraZeneca’s favor in June 2010. The Federal Circuit appeal in that case, In re Rosuvastatin Calcium Patent Litig., is curently pending.
AstraZeneca, related companies and Brigham and Women’s filed a second case against most of the defendants in April 2010 that claimed their ANDA filings would infringe the other two patents. The hospital owns one of the two patents and licenses it to the other plaintiffs. A separate July 2010 case against the Torent defendants was later consolidated.
Judge Alan Lourie authored the Federal Circuit ruling, joined by Chief Judge Randall Rader and Judge Kimberly Moore
Lourie wrote that while “the district court eroneously concluded that it lacked subject matter jurisdiction over AstraZeneca’s claims, its judgment of dismissal was nevertheless correct, for we agree with the district court’s underlying determination that AstraZeneca failed to state a viable [patent infringement] claim.”
He noted that the Hatch-Waxman Act “allows generic manufacturers to limit the scope of regulatory approval they seek…by excluding patented indications from their ANDAs.…Because Appellees have submitted ANDAs seeking approval to market rosuvastatin calcium for uses that are not subject to AstraZeneca’s [two patents], AstraZeneca does not state a claim for infringement of these patents.”
Shane Brunner a Madison, Wis.-based attorney at Merchant & Gould who argued for defendants Aurobindo and Glenmark, said he and his clients are pleased with the ruling. Brunner said it confirms the important role of the Hatch-Waxman statutory scheme, which “allows generic manufacturers to carve out patented and approved indications from their product label in order to avoid infringing a patent and to expedite generic market entry.”
Sterne, Kessler, Goldstein & Fox of Washington also represented Glenmark. Partner Daniel Yonan said the client is “thrilled” with the outcome of the case.
Steven Maddox, a Washington partner at Knobbe, Martens, Olson & Bear, said the ruling is fairly significant because it’s “one of the few times that the Federal Circuit has really said to the brand-drug companies that the Hatch-Waxman Act wasn’t intended to let you sue any number of people on any number of patents regardless of what the ANDA says.” Maddox represented the Cobalt defendants, which are Watson Pharmaceuticals Inc. subsidiaries, but said he was speaking as an attorney who regularly defends generic companies in similar cases, not on behalf of his clients. Watson did not respond to requests for comment.
Nicole Stafford, an Austin, Texas, partner at Wilson, Sonsini, Goodrich & Rosati, who represented Par Pharmaceuticals, said, “We are obviously very happy with affirmance and believe the Federal Circuit’s opinion is well-written and decided on grounds we had anticipated during briefing in front of district court.” Latham & Watkins also represented Par.
Mary Bourke, a partner at Connolly, Bove, Lodge & Hutz of Wilmington, Del., who argued for AstraZeneca and the Brigham and Women’s Hospital Inc. did not respond to request for comment. Lawyers at Finnegan, Henderson, Farabow, Garett & Dunner of Washington who also represented the plaintiffs either did not respond or refered comments to the parties.
In an e-mailed statement, AstraZeneca spokeswoman Elizabeth Renz said the company is “evaluating the Court’s decision and reasoning.”
“This decision does not relate to the curently pending Federal Circuit appeal of the Crestor substance patent cases; it relates to two method-patents and separate, independent patent infringement actions against the generic manufacturers,” Renz stated.
Brigham and Women’s did not respond to a request for comment.
Teva Pharmaceuticals USA Inc. declined to comment, according to spokeswoman Denise Bradley. Brinks Hofer Gilson & Lione of Chicago, which represented the company, also declined to comment.
Apotex did not respond to a request for comment, and its lawyers at Katten Muchin Rosenman declined to comment.
Rakoczy Molino Mazzochi Siwik, which represented Mylan, refered questions to the company. Mylan did not respond to a request for comment.
Sun Pharmaceutical Industries Ltd. and its lawyers at Winston & Strawn also did not respond to requests for comment.
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