By James DeGiulio --
Jury Awards Abbott $16M in Tarka Patent Suit Against Glenmark
Abbott Laboratories has been awarded $16 million in its suit against Glenmark Pharmaceuticals over a generic version of the blood pressure drug, Tarka, after a federal jury found Glenmark liable for infringement. In October 2007, Glenmark notified Abbott and Sanofi that it had filed an Abbreviated New Drug Application (ANDA) with the FDA to make a generic drug containing trandolapril and verapamil hydrochloride, the active ingredients in Tarka. Sanofi and Abbott responded by filing the current lawsuit in December 2007, alleging that Glenmark was planning to infringe U.S. Patent No. 5,721,244, which covers Tarka (see "Court Report," December 16, 2007). In June 2010, Sanofi and Abbott failed to block Glenmark's launch of its generic version of Tarka after their motion for a preliminary injunction and temporary restraining order was denied (see "Biotech/Pharma Docket," June 10, 2010). Glenmark subsequently launched its generic Tarka at-risk in June. In July, the plaintiffs succeeded in getting sanctions against Glenmark on the grounds that the generic-drug company had destroyed evidence relevant to the likely litigation that would follow the filing of its ANDA.
On January 14, the jury handed down its verdict in the U.S. District Court for the District of New Jersey, confirming the validity of the Sanofi-owned and Abbott-licensed '244 patent. Glenmark has been ordered to pay Abbott $16 million in damages, out of which about $15.2 million were awarded by the jury for lost profits and the balance for higher prices that Abbott could have charged had Glenmark not infringed the '244 patent. Glenmark is expected to appeal.
Mylan Settles with Pfizer in Lipitor and Caduet Patent Suits
Pfizer has entered into a deal with Mylan that permits the generic producer to sell versions of the cholesterol drug Lipitor and the combination blood pressure/cholesterol treatment Caduet. Pfizer first filed suit against Mylan in June 2009, accusing Mylan of infringing U.S. Patent Nos. 5,969,156; 6,087,511; and 6,274,440, covering Lipitor, by filing its ANDA (see "Court Report," June 22, 2009. The asserted patents, owned by Pfizer subsidiary Warner-Lambert, expire in July 2016, and Lipitor was granted a further period of exclusivity until January 2017. In February 2010, Pfizer sued Mylan for infringement of U.S. Patent No. 6,455,574 over Mylan's attempt to make a generic version of Caduet (see "Court Report," February 8, 2010).
On January 25, in separate press releases covering the Lipitor and Caduet settlements, Mylan announced that it had entered into agreements with Pfizer that will resolve both infringement cases. Under the terms of the Caduet settlement, Mylan can begin marketing and selling a generic version of Caduet on November 30, 2011. The terms of the Lipitor settlement remain confidential. Both settlement agreements are subject to review by the U.S. Department of Justice and the Federal Trade Commission.
Sanofi-Aventis Uroxatral Patent Found Valid and Infringed by Apotex
Apotex was found to infringe the patent covering Sanofi-Aventis' prostate drug Uroxatral after a District Court judge followed his earlier ruling upholding the validity of the patent. Sanofi brought an infringement suit against Apotex, Mylan, Aurobindo, Torrent, and others in 2007 following the generics' ANDA filings, alleging that each defendant's generic alfuzosin hydrochloride infringed U.S. Patent No. 4,661,491 (see "Court Report," October 14, 2007). After the actions were consolidated in the U.S. District Court for the District of Delaware, Sanofi and Apotex stayed their claims. Apotex agreed in October 2009 that if a judgment was entered in favor of Sanofi and against any defendant, the stay would be lifted and a similar judgment would be entered against it. However, Apotex also indicated in the October 2009 stipulation that it could appeal any judgment siding with Sanofi. Mylan attempted to invalidate Sanofi's patent by asserting that the '491 patent was obvious in view of three pieces of prior art. In May, Judge Sleet issued an opinion upholding the patent, disagreeing with the defendant's argument that the patent was invalid due to obviousness (see "Biotech/Pharma Docket," May 27, 2010). The District Court in August upheld the validity of the asserted claims of the patent-in-suit, found that Mylan's proposed generic infringed the '491 patent, and enjoined Mylan from making and selling the generic in the U.S. until after the patent's expiration.
On January 11, Judge Gregory Sleet signed off on a stipulation to enter judgment against Apotex, holding that the defendant's proposed product violated the patent and blocked the effective date of its ANDA until after the expiration of the patent-in-suit. Sanofi proposed the stipulation to Apotex in December, based on Judge Sleet's earlier ruling against Mylan. Judge Sleet's judgment can be found here.
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