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Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368, 81 U.S.P.Q.2d 1097

Facts

Sanofi markets Plavix®, a drug used to reduce thrombotic events, with clopidogrel bisulfate as its active ingredient, covered by U.S. Patent 4,847,265. Apotex filed an ANDA seeking FDA approval to manufacture a generic version, asserting that the patent was invalid. Sanofi sued Apotex for infringement, leading to a preliminary injunction after Apotex launched its generic product. The district court found that Apotex's defenses against the patent's validity lacked substantial merit.

Sanofi markets Plavix®, a platelet aggregation inhibiting agent used to reduce thrombotic events such as heart attacks and strokes. The active ingredient in Plavix® is clopidogrel bisulfate, which is covered by Sanofi's patent, U.S. Patent 4,847,265 (“the ′265 patent”), which will expire on November 17, 2011.

Issue

The main legal issues were whether Sanofi's patent was valid and enforceable, and whether Apotex's ANDA filing constituted infringement.

The Court of Appeals, Lourie, Circuit Judge, held that: 1 patentee was likely to succeed in its defense against competitor's challenge to validity of patent based on alleged anticipation; 2 patentee was likely to succeed in its defense against competitor's obviousness challenge to patent; 3 patentee was likely to succeed in its defense against competitor's challenge to enforceability of patent; 4 patentee's entry of settlement agreement with competitor did not contract away patentee's right to prove irreparable harm; 5 balance of hardships tipped in patentee's favor; 6 public interest supported injunction; 7 competitor was not entitled to assert claim of unclean hands in opposition to patentee's request for preliminary injunction; and 8 injunction bond in amount of $400 million was adequate.

Rule

The court applied a four-factor test for preliminary injunctive relief, which includes likelihood of success on the merits, irreparable harm, balance of hardships, and public interest.

A decision to grant or deny a preliminary injunction pursuant to 35 U.S.C. § 283 is within the sound discretion of the district court, and we review such a decision for an abuse of discretion.

Analysis

The court found that Sanofi was likely to succeed in proving that Apotex's product infringed the patent and that Apotex's challenges to the patent's validity and enforceability lacked substantial merit. The court noted that Apotex conceded infringement and failed to raise a substantial question regarding the patent's anticipation or obviousness. Additionally, the court determined that the balance of hardships favored Sanofi and that the public interest supported the injunction.

In reaching its decision, the district court applied the established four-factor test for preliminary injunctive relief, and found that the factors weighed in favor of an injunction. Regarding the likelihood of success on the merits, the court noted that Apotex conceded that its accused products infringe claim 3 of the ′ 265 patent.

Conclusion

The Court of Appeals affirmed the district court's decision to grant the preliminary injunction, concluding that the district court did not abuse its discretion in its findings.

We conclude that the district court did not abuse its discretion in granting the preliminary injunction, we affirm.

Who won?

Sanofi prevailed in the case because the court found that they were likely to succeed on the merits of their patent claims and that the balance of hardships favored them.

Sanofi, as the moving party, may be entitled to a preliminary injunction if it establishes four factors: “(1) a reasonable likelihood of its success on the merits; (2) irreparable harm if an injunction is not granted; (3) a balance of hardships tipping in its favor; and (4) the injunction's … impact on the public interest.”

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