By James DeGiulio --
Allergan and Hi-Tech Settle Combigan Patent Dispute
Allergan has resolved its dispute with Hi-Tech Pharmacal over the latter's bid to market a generic version of Allergan's glaucoma treatment Combigan. In June 2009, Allergan sued Hi-Tech in the U.S. District Court for the Eastern District of Texas, claiming that Hi-Tech's ANDA filing infringed U.S. Patent Nos. 7,030,149; 7,320,976; 7,323,463; and 7,642,258 (see "Court Report," June 14, 2009). Allergan sought injunctive relief as well as an order prohibiting approval of Hi-Tech's ANDA until the allegedly infringed patents expire. Allergan has also brought similar infringement suits against generic-drug makers Sandoz, Apotex, and Watson, which are still pending.
On May 31, in accordance with a May 20 settlement, Judge T. John Ward signed off on an Order dismissing all claims in Allergan's suit against Hi-Tech. The dismissal stipulated that all four Allergan patents related to Combigan were valid and infringed by the generic product described in Hi-Tech's ANDA. According to the stipulation, Allergan's claims are dismissed with prejudice, and each party shall bear its own costs, expenses, and attorneys' fees.
Novartis and Sun Settle Focalin Patent Suit
Novartis Pharma has resolved a patent infringement suit with Sun Pharmaceutical Industries over Sun's proposed generic version of Novartis' attention deficit disorder drug Focalin. In July 2010, licensee Novartis and patent owner Celgene brought suit in the U.S. District Court of New Jersey, claiming that Sun's ANDA for its proposed generic Focalin would infringe U.S. Patent Nos. 5,908,850; 6,355,656; and 6,528,530 (see "Court Report," July 11, 2010). The plaintiffs asked to be given access to the ANDA, but Sun would not agree to provide it on reasonable terms, instead sending Novartis and Celgene a statement that acknowledged that the proposed generic version would infringe two of the three patents for Focalin. With respect to the third patent, Sun stated that the generic would not infringe. In March 2011, the parties notified the District Court that they had reached a settlement and requested a stay pending regulatory approval.
On June 10, after counsel for the parties notified the District Court that regulatory review of the settlement had been completed, Judge Susan D. Wigenton signed off on the agreement dismissing the case without prejudice. The litigation over Focalin continues, however, as manufacturer Elan has brought suit against Intellipharmaceutics, Par Pharmaceuticals, and Teva over a planned generic Focalin. All three of these cases remain pending.
Antitrust Sanctions Upheld Against Pfizer in Neurontin Case
Sanctions for a witness testimony violation were upheld on appeal in a case involving accusations that Pfizer used patent litigation to delay generic competition for the epilepsy drug Neurontin. The plaintiffs, which include CVS Pharmacy, Rite Aid Corp., Louisiana Wholesale Drug Co., and Meijer, first brought suit in March 2002 alleging that Pfizer and Warner-Lambert engaged in an overarching anti-competitive scheme to acquire and maintain monopoly power in the market for gabapentin products in violation the Sherman Act. The plaintiffs allege that Pfizer improperly listed two patents in the Orange Book, manipulated the patent approval process so a third patent could delay generic entry, initiated multiple sham suits over the patents, and engaged in fraudulent off-label promotion. In October 2002, the case was stayed pending resolution of the infringement action. In February 2008, following the remand by the Federal Circuit (see "In re Gabapentin Patent Litigation (Fed. Cir. 2007)"), the stay was lifted and the antitrust case continued. Sanctions were imposed after Pfizer produced two witnesses who were not prepared to discuss why Pfizer had denied promoting Neurontin for off-label uses in the antitrust suit, despite having pled guilty to doing so in a separate criminal case in 2004.
On June 9, Judge Faith S. Hochberg issued an Opinion and Order rejecting Pfizer's appeal of the sanctions and affirmed the Order handed down by Magistrate Judge Shwartz. The Order gave the plaintiffs an opportunity to redepose the witnesses, banned Skadden Arps Slate Meagher & Flom LLP from appearing at the new deposition, and struck all objections at the original deposition. During the deposition that led to the sanctions, the witness who was brought in to testify after the District Court deemed Pfizer's first witness inadequate simply recited an outline of responses Skadden had prepared. The judge ruled that this was equivalent to failure to appear. The judge's Order also required Pfizer to pay all attorneys' fees and costs associated with the matter.
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