By James DeGiulio --
Pozen Secures Injunction Blocking Par's Generic Treximet
Earlier this month, Pozen obtained a preliminary injunction blocking Par Pharmaceutical from marketing a generic version of Pozen's migraine drug Treximet until an infringement suit over the drug is resolved. The dispute between the parties began in November 2008 when Pozen brought suit in the U.S. District Court for the Eastern District of Texas against Par and the generic drugmakers Alphapharm, Teva, and Dr. Reddy's (see "Court Report," November 23, 2008). All four defendants had submitted ANDAs seeking to market generic versions of Treximet. Pozen claimed that the generic drugmakers infringed U.S. Patent Nos. 6,060,499; 6,586,458; and 7,332,183. In April 2010, Teva was dismissed without prejudice from the consolidated litigation. The case against the other three defendants was tried on October 12-15, 2010, and a decision is still pending. However, in early 2011, Par received approval from the FDA to market its generic version of Treximet, allowing Par to launch its product once Pozen's three years of regulatory exclusivity expires on April 15. After Par refused to reveal whether it planned to launch at-risk, Pozen then asked the court for a preliminary injunction until the court issues a final decision.
In an April 14 opinion, Judge Leonard Davis granted a preliminary injunction ordering Par not to make, use, sell, offer to sell, or import into the United States a generic version of sumatriptan and naproxen sodium. Judge Davis focused his analysis on two asserted claims of the '458 patent, finding that Pozen had sufficiently shown that it was likely to succeed against Par on the merits of its infringement claim. The court also rejected Par's arguments that it raised a substantial question regarding the enforceability of the '458 patent. The injunction will remain in effect until a final decision is issued in the pending patent litigation.
Wyeth and Orchid Enter Licensing Agreement in Effexor XR Suit
Wyeth has entered into a licensing deal with Orchid Chemicals & Pharmaceuticals, thereby ending the parties' patent infringement litigation over Effexor XR. The dispute between Wyeth and Orchid began in July 2009, when Wyeth filed suit in the U.S. District Court for the District of New Jersey against Orchid after its submission of an ANDA for a generic extended release version of venlafaxine HCl (see "Court Report," July 12, 2009). Wyeth asked the court to declare that Orchid had infringed U.S. Patent Nos. 6,274,171; 6,403,120; and 6,419,958 and enjoin the generic drugmaker from making or selling its proposed generic. Orchid responded by asserting that that patents were invalid. In October, Wyeth was ordered to produce its prior Effexor patent settlement and licensing agreements after the court decided the agreements might be relevant to Orchid's patent misuse defense. Wyeth has filed at least sixteen suits over Effexor XR since the drug was approved, and has settled with eleven generic companies to date.
On April 14, Judge Freda L. Wolfson signed an order approving the settlement. Under the settlement, Orchid agreed not to manufacture its generic product until the expiration of the three patents at issue, except as permitted by a confidential licensing agreement. The settlement requires each party to bear its own court costs. Further details of the agreement were not revealed.
Takeda Agrees to Dismiss One Actos Infringement Suit against Apotex
After filing its complaint just one month ago, Takeda Pharmaceutical has requested a voluntary dismissal of its patent infringement suit against Apotex, centered around Apotex's efforts to manufacture a generic version of the diabetes medication Actos. On March 22, Takeda brought suit against Apotex in the U.S. District Court for the Southern District of Florida, claiming that Apotex's ANDA infringed U.S. Patent Nos. 5,965,584; 6,329,404; 6,166,043; 6,172,090; 6,211,205; 6,271,243; and 6,303,640 (see "Court Report," March 27, 2011) Apotex sought approval for generic pioglitazone tablets to be used for both monotherapy and in combination with a diabetes drug. Takeda also alleged willfull infringement and inducing infringement, claiming Apotex was likely to advertise the Actos name on its website, thus inviting customers to follow the Actos treatment systems but substitute the Apotex version of the drug.
On April 13, Judge Ursula Ungaro entered an order dismissing the case without prejudice, based on Takeda's request and notice of voluntary dismissal. Takeda did not disclose its reasoning for requesting dismissal, but both parties are currently litigating a nearly identical infringement suit in the U.S. District Court for the Southern District of New York.