By Suresh Pillai --
Settlement Announced in Eloxatin® Suit
The U.S. District Court for the District of New Jersey has issued an order announcing a settlement of all outstanding litigation between Sanofi-Aventis and Ebewe Pharma over Eloxatin®, a colon cancer drug marketed and distributed by Sanofi. This settlement puts an end to two years of litigation that commenced when Sanofi and Debiopharm, the patent holder of U.S. Patent Nos. 5,338,874 and 5,716,988, filed suit against Ebewe alleging patent infringement (see "Court Report," December 28, 2008). Ebewe had earlier filed ANDAs for Eloxatin®. In response to Sanofi's and Debiopharm's complaint, Ebewe counterclaimed that both patents were invalid and further alleged that the '874 patent was unenforceable on the grounds of inequitable conduct on the part of Debiopharm during prosecution.
As part of the findings of fact included with the order, the District Court stated that Ebewe had infringed both patents upon the filing of the ANDAs. Under the terms of the settlement, Ebewe agreed to the dismissal, with prejudice, of all Ebewe defenses and counterclaims. Ebewe has also stipulated that it infringed both patents and agreed to a permanent injunction barring it from marketing, manufacturing, or importing into the United States both theoxaliplatin and oxaliplatin for injection during the lives of both patents-in-suit.
Although this puts an end to Sanofi and Debiopharm's litigation with Ebewe, its Eloxatin® suits against Abraxis BioScience Inc., Par Pharmaceutical Inc., Sun Pharmaceutical Industries Ltd., and Barr Laboratories Inc. are ongoing.
Forest and Sun Settle Lexapro® Patent Suit
Sun Pharmaceutical Industries, Ltd. and Forest Laboratories Inc. jointly announced the settlement of litigation between the companies over the antidepressant drug Lexapro®. The settlement includes a licensing deal under which Sun would license several Lundbeck A/S patents, including patents-in-suit U.S. Patent Nos. 6,916,941, RE 34,712, and 7,420,069. If approved by the U.S. District Court for the Eastern District of Michigan, the settlement would end years of litigation between the two companies (see "Court Report," March 11, 2007).
Under the terms of the settlement agreement, when any third party generics drug manufacturer enters the market with final approval from the FDA, Forest will provide licenses to Caraco Pharmaceutical Laboratories Ltd., a Sun subsidiary, for any patents related to Lexapro®. A separate assets agreement provides that Caraco will purchase products from Forest's Inwood Line of products, which consists of generic equivalents of Forest's branded products. As part of this agreement, Caraco is to pay Forest advances against royalties as well as royalties on net sales of products. Forest has also agreed to reimburse Caraco with a portion of the costs related to litigation.
Settlement Announced in Everett Dispute with Breckenridge over Vitafol®-OB and Strovite® Advance Patents
The U.S. District Court for the District of New Jersey has dismissed pending lawsuits and entered a jointly-filed Consent Judgment and Permanent Injunction against Breckenridge Pharmaceutical, Inc. in its dispute against Everett Laboratories Inc. over Breckenridge's alleged infringement of Everett's patents covering the prescription multivitamins Vitafol®-OB (U.S. Patent Nos. 6,814,983 and 7,390,509) and Strovite® Advance (U.S. Patent Nos. 6,660,293 and 6,893,904) (see "Biotech/Pharma Docket," March 16, 2009). Under the terms of the settlement, Breckenridge has acknowledged that the patents-in-suit are valid and enforceable and would be infringed by the unlicensed sale of Breckenridge products covered by the patents and previously offered for sale.
Purdue Pharma Loses Bid for Dismissal in Oxycontin® Dispute
Purdue Pharma Inc. has failed in its bid to have the U.S. District Court for the Western District of Virginia dismiss Alpharma Inc.'s lawsuit against Purdue on the grounds of lack of subject matter jurisdiction. Alpharma filed suit last November over the right to market ALO-01, an opiod painkiller related to Oxycontin®, marketed and distributed by Purdue (see "Court Report," November 23, 2008). Purdue has threatened to assert its rights in patents covering Oxycontin®, which Purdue claims would be infringed by Alpharma should Alpharma attempt to market ALO-01. The patents-in-suit include U.S. Patent Nos. 6,277,384, 6,375,957, 6,475,494, 6,696,066, 7,172,767, 7,419,686, 6,228,863, 6,627,635, and 6,696,088.
In its motion to dismiss, Purdue argued that the dispute was not ripe for adjudication because the dispute between the parties was not concrete and definite. The District Court disagreed, however, and noted that in a 2007 meeting with Alpharma, a high-level Purdue official had asserted that Alpharma's product was covered by Purdue's patents. Although Purdue insisted that this assertion was not a threat of litigation, the Court stated that so long as the defendant asserted rights that would force plaintiff to pursue possible illegal behavior or abandon a product that plaintiff may have had the right to market and manufacture, the plaintiff had a cause of action. In reaching this decision, the Court also noted Purdue's aggressive litigation strategy in other similar cases.
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