Practice Note on Reissue Applications

| July 14, 2010

People who follow the CAFC will undoubtedly recall the decision Pfizer v. Ranbaxy in which the CAFC found that claim 6 was invalid as an improper dependent claim under 35 U.S.C. § 112, ¶ 4 because it covered embodiments outside the scope of the claim on which it depended.  457 F.3d 1284, 1291 (Fed. Cir. 2006).   The loss was especially painful for Pfizer because the patent – U.S. Patent No. 5,273,995 – claimed its extremely successful cholesterol-controlling composition, Lipitor®.

Pfizer sought to overcome its problem with claim 6 by filing a reissue application where it corrected claim 6 and added two new claims, and by later filing a second reissue application (as a continuation of Pfizer’s first reissue application) where it deleted claim 6 altogether and added one new claim.  In March 2009, the PTO allowed Pfizer’s first reissue application as the ‘667 reissue patent in which claim 6 was rewritten in independent form.  Pfizer’s second reissue application is still pending at the PTO.

A few months earlier, Apotex had filed an ANDA seeking FDA approval for Atorvastatin, Apotex’s generic version of Lipitor®, asserting that Pfizer’s original ‘995 patent was invalid and uninfringed.  Pfizer replied by suing Apotex for infringement of the ‘995 patent.

Apotex moved that Pfizer’s complaint be dismissed for lack of subject matter jurisdiction and for failure to state a claim.  Apotex argued that as a matter of law, Pfizer “surrendered” the ‘995 patent when the PTO issued the ‘667 reissue patent.  Accordingly, Apotex asserted, there is no enforceable ‘995 patent on which to base a complaint.  Pfizer replied that there is no surrender until the PTO issues the second reissue patent.

Judge Robert Dow has now denied Apotex’s motion.  Pfizer v. Apotex, 2010 U.S. Dist. LEXIS 65448 (N.D. Ill. June 30, 2010).  He framed the question as “when the surrender of the original patent takes effect (thereby rendering the original patent unenforceable), where an applicant seeks multiple reissue patents which do not issue at the same time” (emphasis added).

Judge Dow began his analysis by observing that “in the case of a single reissue patent, surrender and reissuance go hand-in-hand, and the original patent is invalid after the date of reissue.”  In a case where there are multiple reissue applications, however, he found nothing in the statutory reissue provisions stating whether surrender should accompany the first reissue patent or the final reissue patent.  On the other hand, he found that the legislative history of the reissue provisions revealed a Congressional intent to “preserve an inventor’s property right … where a mere error in drafting requires reissuance of the patent.”

Judge Dow therefore concluded that the remedy of reissue should be applied liberally so that surrender is required only after the PTO issues the final reissue patent.  He further cited certain PTO Board decisions and MPEP passages as persuasive support for his conclusion in favor of Pfizer to deny Apotex’s motion.  Judge Dow’s only concern was the possibility of multiple patents owned by different companies, but covering the same invention – he therefore required that Pfizer file a terminal disclaimer stating that the reissue patent and the original ‘995 patent remain commonly owned.

The lesson is that a reissue patentee seeking to enforce its original patent may wish to review Pfizer’s reissue strategy in this case.

Category: CAFC, PTO Board, Stays/District Courts

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