By James DeGiulio --
Sanofi and BMS Awarded $442M in Plavix Patent Suit
Apotex has been ordered to pay $442.2 million in damages to sanofi-aventis and Bristol-Myers Squibb Co. for infringing their patent covering the blood thinner Plavix.
Sanofi sued Apotex in the U.S. District Court for the Southern District of New York in 2002, shortly after the generics maker filed an Abbreviated New Drug Application (ANDA) to market a generic version of clopidogrel bisulfate, the active ingredient in Plavix. Apotex asserted that U.S. Patent No. 4,847,265 was invalid due to obviousness, but both the District Court and the Federal Circuit ruled against Apotex, upholding the patent claims (see "Sanofi-Synthelabo v. Apotex, Inc. (Fed. Cir. 2008)"). The Federal Circuit denied Apotex's request for rehearing, and the U.S. Supreme Court denied Apotex's petition for certiorari in November 2009. Apotex sought to stay the District Court infringement action in April, pending the results of the reexamination by the U.S. Patent and Trademark Office, but this motion was denied. In June, the USPTO denied Apotex's second request for reexamination after finding no substantial new question of patentability (see "Biotech/Pharma Docket," July 8, 2010). Only the damages portion of the case remained unresolved.
On October 19, Judge Sidney H. Stein granted the plaintiffs' request for half of Apotex's net sales of the drug during the three-week period of infringement in August 2006, as well as prejudgment interest. Both sides agreed that the net sales during that three-week period totaled $884.4 million. Judge Stein noted that Sanofi had lowered the price for branded Plavix, not produced a generic, which was relevant in the damage calculation per the settlement agreement. Further, the District Court rejected Apotex's contention that it was not liable for prejudgment interest, since the parties' settlement agreement did not restrict interest awards. Judge Stein's Order can be found here.
Novartis and Watson End Enablex Patent Suit
Novartis has ended its patent infringement suit against Watson over Watson's plans to market a generic version of Enablex.
Novartis sued Watson in the U.S. District Court for the District of Delaware in April 2009, claiming infringement of U.S. Patent No. 6,106,864 covering darifenacin, the active ingredient in the overactive bladder drug Enablex (see "Court Report," May 3, 2009). Watson has yet to file an answer to Novartis' complaint or any dispositive motions.
On October 27, Judge Sue L. Robinson approved the dismissal of the case without prejudice. Details of the settlement were not revealed. Judge Robinson's Order can be found here.
Hikma Pharmaceuticals and Mutual Pharmaceutical Settle Patent Suit over Colcrys
Hikma Pharmaceuticals and Mutual Pharmaceutical have agreed to settle a lawsuit over the gout treatment Colcrys, after Hikma agreed to stop selling its own competing colchicine medication until receiving regulatory approval from the Food and Drug Administration.
Mutual obtained FDA approval for Colcrys in July 2009 for the treatment of gout, and subsequently filed suit against Hikma the next month in the U.S. District Court for the Central District of California. The lawsuit claimed Hikma and co-defendants Watson, Vision Pharma, Qualitest Pharmaceuticals, and Excellium Pharmaceutical violated the Lanham Act by advertising their drugs in competition with Colcrys. Mutual's colchicine drug was the only drug that had FDA approval, and Mutual claimed the defendants' advertisements were likely to confuse patients about the unapproved status of the competing products and their interchangeability with Colcrys. The case was transferred to the District Court for the District of New Jersey in October 2009.
On October 19, Judge Garrett E. Brown Jr. of the District of New Jersey signed off on a stipulation of dismissal between Hikma and Mutual. Hikma agreed to stop selling colchicine tablets until it receives approval for its new drug application from the FDA, which in September ordered unapproved versions off the market. Judge Brown's Order can be found here.
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