zetiaSubsequent to the Ex Parte Tanaka BPAI decision (Appeal No. 2009-000234) on December 9, 2009, Judge Jose L. Linares of the U.S. District Court for the District of New Jersey granted partial summary judgment invalidating four claims in the Zetia Reissue Patent U.S. Reissue Patent No. RE37,721 that were added in the reissue application of U.S. Patent No. 5,767,115.  The reissued claims were directed to the active ezetimibe species, which was already encompassed by the original ‘115 patent claims to a genus of hydroxyl-substituted azetidinone compounds.  As we previously pointed out, reissue patent applications do not fix all errors. Here as in Tanaka, “bullet claiming” via patent reissue is once again disputed as an error that may be corrected by reissue.

The civil action, Schering Corp. et al. v. Glenmark Pharmaceuticals Inc. USA et al., (Case No. 2:07-cv-01334), was filed in 2007, after Mumbai based Glenmark filed an abbreviated new drug application on Schering’s Zetia with the FDA.  The patent at issue, U.S. Patent No. RE37,721 was granted on May 28, 2002, adding four new claims to the single ezetimibe compound [1-(4-fluorophenyl)-3(R)-[3(S)-(4-fluorophenyl)-3-hydroxypropyl)]-4(S)-(2-hydroxyphenyl)-2-azetidinone], a pharmaceutical composition comprising said compound, and a method of treating comprising administering the compound.

The requirements under 35 U.S.C. § 251 for granting a reissue patent are twofold and must be met in a reissue oath or declaration. First, the original patent must be wholly or partly inoperative or invalid because of defects in the specification or drawing, or because the patentee has claimed more or less than he was entitled to claim.  Second, the inoperative or invalid patent must have arose through error without any deceptive intent.

Upon filing its Reissue application on June 15, 2000, Schering described the error as a failure to appreciate the full scope of the invention by not including claims of narrower scope.

In the Summary Judgment opinion, Judge Linares held that the ‘115 patent claims were effective to protect the ezetimibe species, when construing the facts in the light most favorable to Schering.  Following Schering’s concession that the original ‘115 claims are valid, operative, and encompassed the desired active species, Judge Linares found that “the failure to include specific bullet claims to ezetimibe in the ‘115 patent did not, therefore, render the patent ‘wholly or partly inoperative or invalid.” 35 U.S.C. § 251.  Accordingly, Judge Linares granted summary judgment invalidating reissue claims 10-13 as a matter of law.  The litigation has now settled and the summary judgment decision has been vacated.

This opinion is consistent with Tanaka.  In Tanaka, the reissue application sought the addition of a dependent claim to “hedge against the invalidity of one or more of the original claims.” The Appellant in Tanaka relied on In re Handel for the proposition that the addition of narrower claims as a hedge against possible invalidity of the original patent claims was a proper basis for requesting reissue. In re Handel, 136 USPQ 460 (CCPA 1963).

The BPAI was not persuaded despite the Appellant’s reliance on In re Handel in support of its position, which the BPAI did not find to be controlling; finding that it was merely dicta on this point of law.  The BPAI accordingly, determined that the Appellant’s Reissue Declaration was defective essentially, because the error of failing to properly claim the subject matter of the invention in narrow claims is not correctable by reissue, since such an error is not sufficient to render the original patent “inoperative or invalid.” (pg. 24).

In Tanaka, the BPAI did not follow Handel holding that it was mere dicta.  However, in Hewlett the Federal Circuit considered and did not dismiss the remedial principle from Handel that adding bullet claims in a reissue application is permissible to correct an error in the original patent through reissue. Hewlett-Packard Co. v. Bausch & Lomb, Inc., 11 USPQ2d 1750, 1757 (Fed. Cir. 1989)(“The practice of allowing reissue for the purpose of including narrower claims as a hedge against the possible invalidation of a broad claim has been tacitly approved, at least in dicta, in our precedent.  See also E. Lipscomb, Walker on Patents § 14:33 at 479 (3d ed. 1986).  For purpose of this case, we will assume that practice is in accordance with the remedial purpose of the statute”).

Furthermore, it is worth noting that, unlike the Reissue “error” requirements noted above, ex parte reexamination does not require that there be an error in the original patent requiring correction.  Accordingly, the bullet claims invalidated by Judge Linares may be added in a patent owner requested ex parte reexamination.  Yet, such a  reexamination must be pursued by identifying a substantial new question of patentability with respect to the issued claims.

The bullet claim issue is likely to be fleshed out in more detail by the CAFC in the coming months.