Scott Daniels | March 30, 2010

As we reported January 14, 2010, Apotex has moved to stay Sanofi-Aventis et al. v. Apotex, in which Apotex is accused of infringing U.S. Patent No. 4,847,265.  The ‘265 patent is owned by Sanofi and covers its anti-blood clot drug PLAVIX®.

Apotex’ motion is based upon a December 18th non-final rejection of the claims in dispute.  The trial judge has not yet ruled on the motion, but Sanofi has replied to the rejection, asserting at length that the prior art does not render the claimed compositions obvious, but rather teaches away from those compositions.

What makes Sanofi’s reply to the rejection of more general interest, however, are its two legal arguments:

(1)   that a 2006 CAFC decision finding the ‘265 claims non-obvious over the currently-cited prior art, is binding on the reexamination requester, and precludes the PTO from rejecting those claims or even from granting a reexamination (see Sanofi-Synthelabo v. Apotex Inc., 470 F.3d 1368, 1378 (Fed. Cir. 2006)); and

(2)   that a 2008 CAFC holding of non-obviousness is binding because the CAFC affirmed the trial judge’s finding that Sanofi had rebutted Apotex’ prima facie case of obviousness (see Sanofi-Synthelabo v. Apotex Inc., 550 F.3d 1075, 1087-1090 (Fed. Cir. 2008)).

Sanofi acknowledges the case law holding that an earlier CAFC decision does not preclude a later reexamination based on the same prior art that was before the CAFC, because the legal issue before the PTO is different from the legal issue before the CAFC – specifically, there is no statutory presumption of validity at the PTO and the burden of proof is lower at the PTO than in the courts.  See In re Swanson, 540 F.3d 1368 (Fed. Cir. 2008).

Sanofi nonetheless argues that the 2006 CAFC decision involved a grant of a preliminary injunction where it, not the accused infringer, bore the burden of establishing patentability.  Sanofi asserts that the obviousness issue in the 2006 case is therefore sufficiently close to the obviousness issue raised in the present request for reexamination, so that the 2006 CAFC decision of non-obviousness is binding on the PTO and Apotex.

Sanofi also argues that the CAFC’s 2008 decision involving the same issue raised in the December 18th Office Action – whether Sanofi can rebut the prima facie case of obviousness – is binding on the PTO and Apotex, precluding the present reexamination.

We will report the examiner’s response.

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