Apotex Seeks Stay of Sanofi-Aventis Case

Scott Daniels | January 14, 2010

The possibility of an accused infringer attacking the validity of a patent through reexamination, even after an adverse decision from the CAFC, was demonstrated anew last week.

On August 17, 2009, we reported that the PTO had granted Apotex’s request for ex parte reexamination of U.S. Patent No. 4,847,265 owned by Sanofi-Aventis and covering its anti-blood clot drug PLAVIX®. Since then, the PTO has issued a non-final rejection of most of the ‘265 claims as being obvious over each of several prior art references “in view of the state of the art,” as well as being unpatentable for obviousness-type double patenting in view of Sanofi-Aventis’ own U.S. Patent No. 4,529,596.1

Apotex now moves the District Court, on the basis of this rejection, to stay the law suit between Apotex and Sanofi-Aventis, pending completion of the ‘265 reexamination.

Some background regarding the dispute between the parties would be helpful. It began in 2001 when Apotex filed an ANDA for a generic version of Plavix®, and Sanofi-Aventis later sued Apotex for infringement of the ‘265 patent. The District Court ruled in 2007 that claim 3 of the ‘265 patent was valid and enforceable (infringement not being an issue), and in December 2008, the CAFC affirmed those validity and enforceability rulings in favor of the patentee Sanofi-Aventis. The case was then remanded to the District Court for it to determine the amount of damages owed by Apotex to Sanofi-Aventis and to issue an appropriate judgment.

Apotex relied primarily upon the adverse impact of such a judgment, to support its stay request: “the probability that Apotex would be required to pay a judgment of hundreds of millions of dollars on a patent that the PTO now considers invalid, a payment which likely would be unrecoverable.”

Apotex also contended that

(1) a PTO conclusion that claim 3 is unpatentable would not be inconsistent with the earlier CAFC decision upholding the validity of that claim, in view of the fact that there is no presumption of validity or requirement for clear and convincing proof of invalidity, at the PTO;

(2) the next Office Action is likely to contain a final rejection of claim 3;

(3) the reexamination is likely to conclude in a few months – also, since Apotex is not allowed to file any further papers, Sanofi-Aventis largely controls the future pace of the reexamination;

(4) PTO statistics show that in 64% of ex parte reexaminations, there is at least an amendment of the claims; and

(5) there is no possibility of evidence being lost during the stay because relevant evidence has already been disclosed by Apotex to Sanofi-Aventis in discovery.

If the court grants the stay, Apotex stated that it would post a bond of $442,209,362 which is the amount sought by Sanofi-Aventis as damages. Accordingly, Apotex argued that a stay would not pose any risk to Sanofi-Aventis, even if Sanofi- Aventis ultimately prevails at the PTO and the validity of the patent is confirmed.

The case demonstrates the impact of In re Swanson, 40 F.3d 1368 (Fed. Cir. 2008), in permitting an accused infringer to attack at patent in reexamination on the basis of prior art, even after the Federal Circuit has ruled in favor of the patentee on that art.

1Claim 5, however, was determined to be patentable over the art.

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