By James DeGiulio --
Cephalon's Fentora Patent Found Valid, Infringed by Watson
Cephalon enjoyed a needed victory in its patent dispute with Watson over Fentora after one of the patents at issue in the case was upheld and Watson's proposed generic of Fentora was found to infringe that patent. The dispute between the parties began in June 2008, when Cephalon filed suit against Watson in the U.S. District Court for the District of Delaware over Watson's ANDA filing covering a generic version of Fentora (see "Court Report," June 8, 2008). Cephalon alleged infringement of U.S. Patent Nos. 6,200,604 and 6,974,590. In September 2009, Cephalon brought suit for infringement of U.S. Patent No. 6,264,981 (see "Court Report," October 4, 2009). The cases were consolidated for purposes of discovery and a bench trial, which was held between May 10 and 17, 2010. In early March, 2011 Judge Robinson found that Watson had established that the asserted claims of the '604 and '590 patents were invalid for lack of enablement (see "Biotech/Pharma Docket," March 15, 2011).
In an opinion issued on March 24, Judge Sue L. Robinson effectively ended Watson's efforts to market a generic version of Fentora for the time being after determining that the proposed generic drug infringes four claims of the '981 patent. Watson contended that its proposed fentanyl buccal tablets were not covered by the '981 patent because they contained an amorphous rather than a solid solution, but the District Court agreed with Cephalon's argument that fentanyl cannot be completely in amorphous form. The Court also held that the proposed generic contained a buffer system and absorption mechanism protected by the '981 patent. Judge Robinson subsequently denied Watson's motion to vacate a previously entered injunction preventing Watson from marketing its generic drug.
Abbott Laboratories and WARF Settle Zemplar Patent Suit with Anchen Pharmaceuticals
Abbott Laboratories and the Wisconsin Alumni Research Foundation (WARF) entered into an agreement with Anchen Pharmaceuticals, thus ending a patent infringement dispute over a generic version of the kidney disease treatment Zemplar. In October 2010, Abbott and WARF sued Anchen in the U.S. District Court for the District of Delaware, alleging that Anchen infringed U.S. Patent No. 5,587,497 when it filed an ANDA seeking approval to market generic Zemplar (see "Court Report," October 31, 2010). WARF owns the '497 patent and exclusively licenses the patent to Abbott. In their complaint, Abbott and WARF asked the court to prohibit the approval of Anchen's ANDA, enjoin the generics maker from marketing or selling paricalcitol capsules, and award the plaintiffs costs and attorneys' fees.
In January, the parties notified the District Court that Anchen was engaged in talks with the plaintiffs about the possibility of a settlement. The Court agreed to grant Anchen a few months extra time to respond to the complaint, so the defendant could allocate resources to negotiating a settlement. On March 23, Judge Gregory M. Sleet approved a joint stipulation filed by the parties, which agreed to dismiss all claims, counterclaims, and affirmative defenses in the suit without prejudice. The parties also indicated that each would cover its own costs and attorneys' fees.
Pronova Settles with Apotex in Lovaza Patent Dispute
Pronova and Apotex have reached an agreement settling their litigation over Lovaza, agreeing to allow Apotex to enter the market for the triglyceride-lowering drug beginning in 2015. In April 2009, Pronova brought suit against Apotex in the U.S. District Court for the District of Delaware, alleging infringement of U.S. Patent Nos. 5,502,077 and 5,656,667 following Apotex's ANDA filing (see "Court Report," May 3, 2009). Pronova filed an amended complaint adding infringement claims with respect to U.S. Patent Nos. 7,678,930 and 7,718,698. In January, Pronova filed a new infringement suit in the District of Delaware over U.S. Patent No. 7,732,488 (see "Court Report," January 9, 2011). These suits were combined with Pronova's similar suits against generic makers Teva Pharmaceuticals USA and Par Pharmaceutical. The first trial against all three defendants with respect to the '077 and '667 patents was set for March 29.
On March 29, Pronova and Apotex agreed to voluntarily drop Pronova's two infringement suits that were scheduled to begin that same day, with each party bearing its own attorneys' fees and costs. Judge Robinson signed off on the settlement that day, issuing a stipulated order, which did not contain details on market entry. However, on March 30, Pronova and GlaxoSmithKline announced in separate press releases that the parties' settlement grants Apotex a license to enter the U.S. market with a generic version of Lovaza in the first quarter of 2015, or earlier depending on certain undisclosed circumstances. The '077 patent expires in March 2013, while the '667 patent expires in April 2017. Pronova's allegations against Teva and Par are still pending.
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