By Suresh Pillai --
Settlement Announced in Oxycontin® Litigation
KV Pharmaceutical Co. announced a settlement in its litigation with Purdue Pharma LP over the painkiller Oxycontin® (see "Court Report," June 11, 2007). The settlement resolves three lawsuits filed by Purdue in the U.S. District Court for the Southern District of New York. Purdue launched the first of these lawsuits in January 2007 on the heels of KV's filing of an ANDA with the FDA in which KV sought to launch generic versions of oxycodone controlled-released tablets. KV's ANDA also included a Paragraph IV certification claiming that the patents-in suit, U.S. Patent Nos. 5,508,042, 5,656,295, 5,549,912, and 5,266,331, were invalid and unenforceable and would not be infringed by the generic versions under development.
Purdue filed another suit soon after KV amended its ANDA to include the sale of additional dosage strengths of generic Oxycontin®. In response, KV countersued Purdue, claiming that the patents-in-suit were unenforceable on the basis of fraud committed during prosecution (i.e., failing to disclose relevant prior art and making misrepresentations to the USPTO). However, in January 2008 in related antitrust case, the District Court held that Purdue's patents were valid and enforceable (see "In re OxyContin Antitrust Litigation").
Under the terms of the settlement agreement, Purdue has consented to granting KV limited rights, which are nontransferable, nonexclusive, and royalty-bearing, to sell generic versions of Oxycontin® for a set period of time so long as KV pays sales royalties. In return, KV has agreed to acknowledge that the patents-in-suit are valid and were infringed by KV. For more information on the settlement, please see KV's press release.
Medicis Files Suit Against Ranbaxy over Solodyn® Patents
As previously reported on Patent Docs, Medicis Pharmaceutical Corp. has filed suit against India-based Ranbaxy Laboratories Ltd. in the U.S. District Court for the District of Delaware, alleging infringement of the patent covering the Medicis product Solodyn®, U.S. Patent No. 5,908,838. Solodyn® is currently the only approved oral antibiotic for the treatment of acne in patients aged 12 and older. Medicis' lawsuit was filed upon its receipt of a Paragraph IV notice letter from Ranbaxy, Inc. (based in Princeton, N.J.) in which Ranbaxy alleged that the patent was invalid. This lawsuit is the latest in a series of suits filed by Medicis against generic drugmakers seeking to manufacture and market generic versions of Solodyn®. To date, Medicis has reached settlements with Impax Laboratories, Inc.; Teva Pharmeceutical Industries, Ltd. (see "Biotech/Pharma Docket," March 24, 2009); and Barr Laboratories Inc. over the manufacture and marketing of generic versions of Solodyn®.
In the current complaint against Ranbaxy, Medicis is seeking a permanent injunction, a court order denying Ranbaxy ANDA approval until the patent's expiration, and costs.
DuPont Countersues Monsanto in Dispute over Roundup Ready Technology
In answer to Monsanto Co.'s infringement suit alleging DuPont Co's infringement of U.S. Patent No. RE39,247, the reissue of U.S. Patent No. 5,633,435, DuPont filed counterclaims alleging that the '247 patent was not infringed and that the suit itself was part of a larger plan on the part of Monsanto to establish an anticompetitive monopoly on certain agricultural products. The original suit, filed in May in the U.S. District Court for the Eastern District of Missouri (see "Court Report," May 10, 2009), alleged that DuPont combined Monsanto's Roundup Ready and Pioneer Hi-Bred International, Inc.'s Optimum GAT traits into its own soybean and corn plants. Dupont countered Monsanto's claim of infringement by arguing that its use of Monsanto's patented trait was within DuPont's rights under a 2002 licensing agreement between DuPont and Monsanto.
In its counterclaims, DuPont alleged that Monsanto's patents were granted in part through fraud and inequitable conduct on the part of Monsanto during prosecution. DuPont claimed that this inequitable conduct allowed Monsanto to procure patent rights that prevent other companies from stacking competitor traits with those of Monsanto, thereby illegally extending Monsanto's monopoly.
Pfizer Adds Second Patent to Lyrica® Infringement Suit Against Sun Pharma
This week, Pfizer Inc. and Northwestern University, already embroiled in litigation with Sun Pharma over the nerve pain treatment Lyrica®, amended their complaint by adding a second patent to the suit. The original complaint, filed in the U.S. District Court for the District of Delaware (see "Court Report," May 3, 2009), alleged that, through Sun's filing of an ANDA to make and market a generic version of Lyrica®, Sun infringed Pfizer's and Northwestern's rights in U.S. Patent No. 6,197,819. The '819 patent is owned by Northwestern and exclusively licensed to Pfizer's subsidiary, Warner-Lambert Co. LLC. The amended complaint added U.S. Patent No. 5,563,175 to the litigation; this patent is jointly owned by Northwestern and Warner-Lambert.
The amended complaint alleges that Pfizer received a letter from Sun that informed Pfizer that Sun's ANDA contained a Paragraph IV certification that the '819 patent was invalid, unenforceable, and not infringed by Sun's proposed product. Six weeks after receipt of the first letter, Pfizer received a second letter that made similar claims about the '175 patent. Pfizer and Northwestern are seeking judgments of infringement for both patents-in-suit, injunctive relief that would bar Sun from marketing and manufacturing generic versions of Lyrica® prior to patent expiration, monetary relief if Sun were to sell its generic product, and fees and costs.
This lawsuit is the latest to be filed in Pfizer's and Northwestern's efforts to prevent generic makers from making generic versions of Lyrica®. The two partners currently have lawsuits pending against Sandoz Inc., Actavis Inc., Cobalt Laboratories Inc., Wockhardt Ltd., Teva Pharmaceuticals Industries Ltd., Lupin Ltd., and Mylan Pharmaceuticals Inc.
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