CRU Denies Apotex Petition Challenging Denial of Second Request for Reexamination of PLAVIX® Patent

Scott Daniels | December 3, 2010

The PTO’s refusal last week to grant Microsoft’s second request for reexamination of i4i’s U.S. Patent No. 5,878,449 because no substantial new question of patentability (SNQ) had been raised, reminds us that we need to update our report regarding Bristol-Myers/Sanofi’s U.S. Patent No. 4,847,265. 

The ‘265 patent is the subject of an infringement suit between Apotex and Bristol in the Southern District of New York and is of even greater commercial significance than i4i’s ‘449 patent. It covers a chemical isomer clopidogrel bisulfate which is the active agent in the anti-blood clot drug, PLAVIX®.  And as we reported in July, the examiner denied a second request filed by Apotex for reexamination of the ‘265 patent, finding no SNQ.  Dissatisfied with the result, Apotex petitioned the Central Reexamination Unit (CRU) to reverse the examiner and to hold that Apotex’s request did, in fact, raise an SNQ regarding the patentability of the ‘265 patent.

The CRU has now denied Apotex’s petition.  The CRU began its analysis with the definition of an SNQ: “when there is a substantial likelihood that a reasonable examiner would consider the prior art or printed publication important in deciding whether or not the claim is patentable.”  Old art may be relied upon if presented “in a new light” as compared with previous examination, as opposed to art presenting “the same question of patentability” as before. 

The earlier examination of the ‘265 claim had focused on the issue of whether the claimed chemical isomer would have been obvious over a prior art Bristol patent: essentially, would one skilled have predicted that the claimed clopidogrel isomer would have the good anti-blood clot properties coupled with low toxicity, as found by the ‘265 inventors. 

Apotex’s petition asserted 15 SNQs, mostly attempting to show that the relevant art was predictable and that the claimed clopidogrel isomer was obvious.  Apotex relied upon the previously considered Bristol patent in combination of a series of new references.  But the CRU refused to accept any of the proposed SNQs, finding that the compounds disclosed in the new references were insufficiently related to the claimed isomer to allow one skilled in the art to predict the properties of that isomer. “[T]here is no correlation between these drugs and clopidogrel and the references do not tend to show that the art is predictable.”  For other references cited by Apotex, the CRU determined that they contained no disclosure that had not been considered in the previous examination.  The CRU summarized that “[n]othing in the newly cited references would have led the skilled artisan to predict” the properties found by the ‘265 inventors.

Apotex also argued that the examiner in the earlier examination of the ‘265 patent misapplied the law of obviousness-type double patenting.  The CRU rejected this argument as well, for failing to raise new technical issues, “‘[E]xaminer error’ can not serve as the basis for a SNQ.” 

The CRU therefore found no SNQ and denied Apotex’s petition. 

Apotex has no right to further appeal the PTO’s refusal to grant reexamination, for instance to the PTO Board or to the CAFC.   35 U.S.C. § 303(c); 37 CFR § 1.927.

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