By James DeGiulio --
Amgen's Bid for Summary Judgment in Neupogen Suit with Teva Falls Short
Amgen has been unsuccessful in its attempt to secure partial summary judgment of infringement against Teva with regard to Amgen's patents covering the blood drug Neupogen. In December 2009, Teva brought a declaratory judgment action in the U.S. District Court for the Eastern District of Pennsylvania, seeking to invalidate claims of U.S. Patent Nos. 5,580,755 and 5,582,823, which cover Neupogen (see "Court Report," December 7, 2009). In January, Amgen responded with a counterclaim for infringement of the '755 and '823 patents. Teva admitted to infringment of the asserted claims in the event they are found valid and enforceable. In September, Amgen filed a motion for partial summary judgment on the pleadings, or in the alternative, for partial summary judgment on its counterclaim that Teva infringed the asserted patents.
On November 19, Judge Stewart Dalzell denied Amgen's bid for partial summary judgment, finding that there is a material question of fact on Amgen's infringement claim. Judge Dalzell determined that it is still unclear whether Teva's human G-CSF generates mature cells in the same way as Amgen's patents. Thus, whether Teva's product infringes remains inconclusive. Judge Dalzell also denied Teva's request for leave to file a second amended complaint until after construction of the claim term "pluripotent," an important term at issue in the case. Judge Dalzell's order can be found here.
Teva and Sunovion Settle Lunesta Patent Suit
Sunovion Pharmaceuticals, which changed its name from Sepracor in October, has reached a consent agreement with Teva, thus settling its infringement suit over the sleep drug Lunesta, and permitting Teva to sell a generic on November 13, 2013. In March 2009, Sepracor (now Sunovion) brought suit in the U.S. District Court for the District of New Jersey against several generic companies intending to make generic versions of the sleep drug Lunesta (see "Court Report," March 29, 2009). Sepracor alleged that the generic makers' ANDAs infringed four patents covering the drug: U.S. Patent Nos. 6,319,926; 6,444,673; 6,864,257; and 7,381,724.
In September, Teva signed a stipulation acknowledging that the proposed drug formulation in its ANDA infringed certain claims of the four patents-in-suit. Similar to earlier agreements with Wockhardt and Glenmark, the agreement allows Teva to enter the market about two and one-half months before the expiration of a patent on the drug. According to the parties, the settlement was reached between the parties to eliminate the substantial litigation costs that would otherwise be incurred by continuing the dispute.
Paddock Fails to Dismiss Novo's Prandin Patent Suit
In the latest development in the five-year dispute over the infringement and validity of the Novo Nordisk patent covering the diabetes drug Prandin, Paddock was unsuccessful in its bid to dismiss Novo's declaratory judgment claim that Novo was not involved in anticompetitive conduct. Novo Nordisk has spent a great deal of effort defending and enforcing U.S. Patent No. 6,677,358, which covers Prandin, with a long-running litigation and eventual patent use code change that ultimately required authorization from the Federal Circuit (see "Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. (Fed. Cir. 2010)").
In May 2010, Novo sued Paddock in the District of Minnesota alleging that Paddock's ANDA infringed the '358 patent (see "Court Report," June 6, 2010). In its letter to Novo providing notice of the ANDA, Paddock contended that Novo's amended use code misrepresents the scope of the '358 patent, and that this amendment was made solely to unlawfully monopolize the market for repaglinide. Paddock threatened an antitrust suit based on this change in the use code if Novo brought suit for infringement. After Novo filed its infringement suit against Paddock, along with a declaratory judgment claim of no anticompetitve conduct, Paddock made good on its promise, filing a counterclaim for antitrust violations against Novo (Novo filed the same suit in the Eastern District of Michigan). Paddock then moved to dismiss Novo's declaratory judgment claim in the Minnesota action, arguing that Novo had not sufficiently alleged an absence of its monopoly power in the relevant market.
On November 30, Judge Donovan W. Frank of the U.S. District Court for the District of Minnesota denied Paddock's motion to dismiss Novo's declaration judgement that it did not engage in anticompetitive conduct, instead finding Novo's conduct involving Prandin as plausibly outside the realm of anticompetitive conduct. Judge Frank also barred Paddock from continuing to litigate the alleged antitrust violations in the pending case in the Eastern District of Michigan. Judge Frank's order can be found here.
Comments