By James DeGiulio --
Drug Wholesalers Secure Injunction Blocking Braintree from Terminating MiraLAX Supply
Direct purchasers of MiraLAX, who have brought a class action suit headed by Rochester Drug Cooperative ("RDC") against drugmaker Braintree Laboratories Inc., were successful in obtaining a preliminary injunction blocking Braintree from terminating its sales to the drug wholesaler plaintiffs. In the original action, Braintree filed a patent infringement suit against Schwarz Pharma in 2003, after the company submitted an ANDA to manufacture a generic version of MiraLAX. The suit and prior Paragraph IV filing, which concerned U.S. Patent No. 5,710,183, triggered a 30-month stay on the FDA's approval of Schwarz's ANDA. Braintree eventually dismissed its claims against Schwarz Pharma, thus waiving the remainder of the 30-month stay, and the ANDA was approved in July 2004.
In March of 2007, RDC filed this putative class action suit on behalf of drug wholesalers who purchase MiraLAX directly. RDC claimed that the original ANDA litigation was a ploy to extend Braintree's monopoly on MiraLAX because Braintree knew or should have known the patent it asserted against Schwarz Pharma was invalid. The plaintiffs claim Braintree engaged in an anti-competitive scheme that allowed it to charge supracompetitive prices for MiraLAX, or polyethylene glycol 3350, and the delay of generic competition caused them to overpay for MiraLAX by millions of dollars. In lieu of an answer, Braintree filed a motion to dismiss the action, which was denied. In March 2011, Braintree sent letters to the plaintiffs, stating that they would no longer sell products to them due to their allegedly meritless antitrust litigation. RDC then moved for a preliminary injunction to force Braintree to continue to supply MiraLAX to the plaintiffs.
On July 7, Judge Sue Robinson issued a memorandum opinion granting the request for a preliminary injunction from plaintiffs RDC, Louisiana Wholesale Drug Co., and Meijer Inc., forcing Braintree to stop its retaliatory action and resume its supplier relationships with the companies. After Braintree cut off its supply, RDC said the move threatened the plaintiffs' ability to obtain and retain customers, and forced them to switch to other suppliers that charged them higher prices. Judge Robinson analyzed the four eBay factors, and was persuaded by plaintiff's authority Bergen Drug Company Inc. v. Parke, Davis & Co., 307 F.2d 725 (3d Cir. 1962). Judge Robinson agreed to issue the injunction, but she said the plaintiffs would have to agree to post a bond for the cost of the litigation. The plaintiffs have shown only possible harm, not any specific harm, caused by Braintree's decision to terminate its business relationships with the plaintiffs. This is because ultimate relief sought by the plaintiffs is to be reimbursed for the cost of Braintree's branded MiraLAX product. Judge Robinson said the plaintiffs must bear the risk of costs going forward if the plaintiffs seek the extra relief of Braintree's continued business.
Takeda Agrees to Drop Mylan Inc. from Prevacid Patent Litigation, But Mylan Subsidiary Remains
Takeda Pharmaceutical Co. Ltd. has agreed to drop Mylan Inc. as a defendant in Takeda's lawsuit over Mylan's generic version of the acid reflux drug Prevacid, but subsidiary Mylan Pharmaceuticals Inc. remains in the suit to litigate the generic maker's position. Takeda brought suit in May 2011, accusing Mylan of infringing its two patents covering Prevacid, U.S. Patent Nos. 6,328,994 and 5,464,632, by filing an ANDA for a generic version of the drug (see "Court Report - Part II," May 23, 2011). Ethypharm SA, which owns the '632 patent and licenses it to Takeda, joined Takeda as a plaintiff. According to the complaint, the plaintiffs claimed the generic's release would cause irreparable harm, and asked the District Court to block approval of Mylan's generic drug. Takeda also requested that the case be declared exceptional so that Mylan would be forced to cover its attorneys' fees. After Takeda filed its complaint, Mylan filed counterclaims seeking declaratory judgment that the two patents were invalid and that Mylan's drug did not infringe either patent.
On July 11, Judge Joel Pisano signed off on a stipulation dismissing Mylan Inc. as a defendant. However, the dismissal may not have a significant impact, for Mylan Inc. subsidiary Mylan Pharmaceuticals Inc. remains in the suit. In exchange for the dismissal, Mylan and Matrix Laboratories agreed to abide by the District Court's final judgment relating to any damages, as well as any court orders against it. Mylan also agreed to make any documents or information relevant to the alleged infringement and validity of Takeda's patents available for discovery as if the generics maker were still party to the suit.
Astellas Settles Adenoscan Patent Suit with Sagent and Strides Arcolab
After just a few weeks, Astellas Pharma US Inc. has settled a lawsuit against Sagent Pharmaceuticals Inc. and Strides Arcolab Ltd., who were accused of infringing Astellas' patent covering the pharmacologic stress agent Adenoscan. In June 2011, Astellas and Item Development AB brought suit against Sagent Strides, a joint venture between the two defendant companies, alleging infringement of U.S. Patent No. 5,731,296 (see "Court Report," June 26, 2011). Astellas was notified in May that Sagent Strides had filed papers seeking FDA approval for an Adenoscan generic. Sagent Strides asserted that the '296 patent was invalid and unenforceable. Astellas has vigorously defended the '296 patent, which is set to expire in March 2015, bringing several suits against generic makers seeking to enter the market for its Adenonscan product. However, Astellas entered into a settlement with Teva in 2007, which provides Teva with a license to market and sell its Adenoscan generic in September 2012.
On July 11, Judge Mary Cooper signed off on an order dismissing the case against Sagent Strides without prejudice. The action can be reopened if there is no settlement within 60 days, and the District Court retains jurisdiction over the matter to enforce the terms of the settlement, which were not disclosed. It is not clear whether the settlement included a provision that would allow Sagent Strides to market and sell its generic Adenoscan product before the expiration of the patent.
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