By James DeGiulio --
Allergan Secures Infringement Ruling Against Generics in Combigan Patent Suit
Allergan has successfully secured an infringement ruling against Sandoz, Alcon, Apotex, and Watson Laboratories in the consolidated patent suit over four patents covering the glaucoma medication Combigan. Allergan has spent several years aggressively protecting its patents for Combigan, which is used to lower intraocular pressure in patients with glaucoma or ocular hypertension. Four patents have been listed in the Orange Book for Combigan: U.S. Patents Nos. 7,030,149, 7,320,976, 7,323,463, and 7,642,258.
In April 2009, Allergan brought suit in the U.S. District Court for the Eastern District of Texas against Sandoz in response to the ANDA Sandoz filed seeking approval to market a generic version Combigan (see "Court Report," April 12, 2009). More generic drugmakers filed ANDAs over the glaucoma drug, which spurred Allergan suits against Hi-Tech and Alcon in 2009 (see "Court Report," June 14, 2009, November 15, 2009), and Apotex and Watson in 2010 (see "Court Report," June 20, 2010, September 12, 2010). In June 2010, Allergan and Hi-Tech settled their case, resolving the infringement claims (see "Biotech/Pharma Docket," June 20, 2011).
On August 22, after a bench trial, Judge T. John Ward issued a Judgment and Injunction, ruling that Sandoz, Alcon, Apotex, and Watson infringed all four Allergan patents in their efforts to market generic versions of Combigan. Judge Ward also confirmed that the four patents are valid and enforceable. The generics were enjoined from gaining approval of their ANDAs and thus from entering the market with their own versions of brimonidine tartrate/timolol maleate ophthalmic solution until after the last of the '149, '976, '463, and '258 patents expires.
Novartis and Apotex Resolve Patent Dispute over Myfortic
Novartis has resolved an infringement suit against Apotex over the patents covering Myfortic. Novartis' Myfortic is an immunosuppressant drug used to prevent patient's bodies from rejecting transplant organs. These types of drugs have been successfully used to protect against transplant rejection, but have been criticized recently by the FDA for their potential associated side effects, including kidney disease.
On November 3, 2009, Novartis brought suit in the U.S. District Court for the District of New Jersey after Apotex submitted an ANDA in June 2009 seeking approval for delayed-release tablets in 180- and 360-milligram doses (see "Court Report," November 15, 2009). Novartis accused Apotex of infringing U.S. Patent Nos. 6,025,391, 6,172,107, and 6,306,900, which Novartis listed as covering treatments using mycophenolate salts, the active ingredient in Myfortic. Novartis sought to have the District Court permanently enjoin Apotex from marketing and selling its generic version of Myfortic, as well as an order that any approval of Apotex's ANDA would not be effective until after the patents expire in April 2017. Apotex refuted the infringement allegation by challenging the validity of the patents, stating in its claim construction brief, filed in December 2010, that Novartis barely provided any evidence to support its position that its patent claims were valid. Novartis also has a case pending against Teva in Delaware over a generic Myfortic (see "Court Report," May 8, 2011).
The District Court was first notified that the parties had reached a settlement on June 29. On August 18, Judge Peter G. Sheridan granted Novartis' stipulation of dismissal, ending the litigation between the two parties. The parties stipulated to dismissal under Federal Rules 41(a)(1)(A)(ii) and 41(c). Terms of the agreement were not disclosed in the order.
Novartis Settles with Macleods in Famvir Patent Dispute
Novartis has agreed to settle a suit with Macleods Pharmaceutical, ending its infringement dispute with Macleods of its plan to market a generic version of the herpes treatment Famvir. On April 1, 2010, Novartis filed suit in U.S. District Court for the District Of Columbia, alleging that Macleods infringed U.S. Patent No. 5,866,581 when it filed an ANDA seeking approval for a generic version of the herpes treatment (see "Court Report," April 11, 2010). Novartis was also engaged in a Famvir infringement suit against Roxane Laboratories in the District of New Jersey (see "Court Report," May 18, 2008), but that case settled in June. Novartis remains in litigation with Teva over its generic form of Famvir.
On August 22, Judge James E. Boasberg signed an order dismissing the case without prejudice after both parties filed a stipulation of dismissal under Federal Rules 41(a)(1) and 41(c), indicating that they would reach a settlement agreement. Further details about the settlement were not immediately available.
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