ass=”alignleft size-full wp-image-3003″ title=”80px-Baseball_umpire_2004″ src=”https://www.patentspostgrant.com/wp-content/uploads/2010/07/80px-Baseball_umpire_2004.jpg” alt=”80px-Baseball_umpire_2004″ width=”80″ height=”120″ />In the world of pharmaceuticals, every day counts. Indeed, when the subject matter is a block-buster drug like Bristol-Myers/Sanofi’s anti-blood clot drug Plavix® every day of U.S. sales averages nearly $15.5 million dollars (reported U.S. sales for 2009 of $5.6 billion). So, it comes as no surprise that Apotex Inc., a Canadian manufacturer of a generic version of the drug, refuses to sit on the side-lines waiting for the Plavix® patent (U.S. 4,847,265) to expire. However, the playing field has not been so kind to Apotex. Strike 1: Apotex was enjoined from sale of a generic Plavix® until after the patent expires following Apotex’s losing effort to invalidate the Plavix® patent at the District Court (Sanofi-Synthelabo v. Apotex Inc., 492 F. Supp. 2d 353 (S.D.N.Y. 2007)) and at the U.S. Court of Appeals for the Federal Circuit (Sanofi-Synthelabo v. Apotex Inc., 550 F.3d 1075, 89 USPQ2d 1370 (Fed. Cir. 2008)). Apotex subsequently pursued a dual track involving petitioning the U.S. Supreme Court for a writ of certiorari and filing a request for ex parte reexamination at the U.S. Patent and Trademark Office (USPTO). The Supreme Court denied Apotex’s petition. Strike 2: In August 2009 the USPTO ordered reexamination of Sanofi’s patent (U.S. 90/009,474) in response to Apotex’s request for reexamination. However, in March 2010, we reported that Plavix® escaped unscathed from the reexamination challenge by Apotex. Strike 3: On April 5, 2010, Apotex filed a second request for reexamination (U.S. 90/009,721) of the Plavix® patent. In the second Request, Apotex argued to the USPTO that two substantial new questions of patentability based on prior art printed publications, admissions under oath by Sanofi employees and experts, and other literature, sworn testimony and documents not previously applied by or available to the USPTO rendered the Plavix® patent invalid. Apotex also argued that Sanofi mischaracterized the district court evidentiary record and failed to present a full and accurate picture of the evidence and prior art. Although the second request contained 138 references including patents, journal articles, affidavits, deposition testimony and trial testimony, both the first request and the second request relied mainly on the disclosure of U.S. 4,529,596. Seizing upon reliance of U.S. 4,529,596 in the second request, the USPTO has now denied this second request finding that no substantial new question of patentability (SNQ) has been raised. Specifically, the USPTO found that no SNQ was presented because the main reference relied upon in the request (U.S. 4,529,596) had previously formed the basis of an anticipation rejection in the original prosecution and in a double patenting rejection in the first request. You’re Out!? The second request was yet another attempt by Apotex to dislodge the injunction prior to expiration of the patent. As a result of the successfully concluded first reexamination and the denied second request for reexamination, it appears Apotex will just have to wait for expiration (2012). Of course, this may only be the first out of the inning with a new hitter stepping up to the plate.
