Background: I began covering this Integrilin® (Eptifibatide) matter on Friday night. So -- after a little digging around in the electronic federal court files in Delaware -- I now know that the most-likely principal generic competitor to Schering-Plough's Integrilin (Eptifibatide) will be manufactured by Teva Pharmaceuticals, headquartered out of Israel. 
I also now know that Teva sent letters to Schering-Plough and Millennium, dated January 8, and February 13, 2009, advising each of Teva's intent to market a generic version of Integrilin (these letters give Teva some procedural advantages, should Schering-Plough and Millennium decide to file patent infringement suits -- as each has). From the lawsuits, then:
[Schering-Plough's Infringement Complaint]
. . . .20. By letter[s] dated January 8, [and February 13,] 2009 (the “Notice Letter”), Teva notified Millennium and Schering that it had submitted to the FDA ANDA No. 90-854, for Teva’s Eptifibatide, Injection, 2 mg/mL, 10 mL Vial and 100 mL Vial, a drug product that is a generic version of INTEGRILIN® (“Teva’s ANDA Product”). The purpose of the submission of the ANDA was to obtain approval under the Federal Food, Drug, and Cosmetic Act (“FDCA”) to engage in the commercial manufacture, use, offer for sale, and/or sale of Teva’s ANDA Product prior to the expiration of the ['447,] ‘825 [and '902] patent[s]. . . .
22. In the Notice Letter, Teva also notified Millennium and Schering that, as a part of its ANDA, Teva had filed certifications of the type described in Section 505(j)(2)(A)(vii)(IV) of the FDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV), with respect to the ‘825 patent. Upon information and belief, Teva submitted ANDA No. 90-854 to the FDA containing a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) asserting that the ‘825 patent is invalid, unenforceable, and/or will not be infringed by the manufacture, use, offer for sale, or sale of Teva’s ANDA Product. . . .
28. Upon information and belief, Teva intends to engage in the manufacture, use, offer for sale, sale, marketing, distributing, and/or importation of Teva’s ANDA Product with its proposed labeling immediately and imminently upon approval of ANDA No. 90-854. . . .
[Teva's Answer to the Complaint]AFFIRMATIVE DEFENSES
Further responding to Plaintiffs’ Complaint, TPM and Teva USA assert the following affirmative defenses and reserve the right to amend their Answer and Affirmative Defenses as additional information becomes available:
1. TPM and Teva USA do not infringe, and have not infringed, any valid and enforceable claim of the ‘825 patent, either literally or under the doctrine of equivalents.
2. The claims of the ‘825 patent are invalid and void for failure to comply with the requirements of Title 35, United States Code, including, but not limited to, one or more of Sections 101, 102, 103, 112, and/or obviousness-type double patenting. . . .
[Emphasis supplied.]
In sum, then, Teva looks to be mounting a very serious counter-claim strategy -- to Schering-Plough's assertion of patent infringement. And that, coupled with the Teva FDA ANDA filing, on balance, would suggest Teva intends to place the generic version on the US market as soon as it receives FDA approval -- and almost certainly, well before the nominal December 2015 expiry date for the US patents. Perhaps within a year's time. We'll see. I'll keep you informed, right here.
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