Sanofi-Synthelabo, et al. v. Apotex, Inc., et al.
470 F.3d 1368 (2006)
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Rule of Law:
A preliminary injunction is properly granted to a patent holder when it demonstrates a likelihood of success on the merits by showing the challenger's invalidity claims lack substantial merit, and that it will suffer irreparable harm, such as irreversible price erosion, which outweighs the hardships to the infringing party who launched their product at-risk.
Facts:
- Sanofi developed and markets Plavix®, a drug whose active ingredient is clopidogrel bisulfate.
- Clopidogrel bisulfate is a specific stereoisomer (the dextrorotatory enantiomer, or 'd-enantiomer') of a chemical compound, and it is covered by Sanofi's U.S. Patent 4,847,265 ('the '265 patent').
- A prior patent, U.S. Patent 4,529,596 ('the '596 patent'), disclosed a broader category of related compounds, including the racemic mixture (a 50/50 mix of the d- and l-enantiomers) of the base chemical, but not the specific d-enantiomer as a bisulfate salt.
- Apotex, a generic drug manufacturer, sought to manufacture and sell a generic version of clopidogrel bisulfate.
- Sanofi and Apotex entered into settlement negotiations to resolve the patent dispute, but the proposed settlement failed to receive required approval from state attorneys general.
- Following the failure of the settlement, Apotex launched its generic clopidogrel bisulfate product 'at-risk' on August 8, 2006, while patent litigation was pending.
- Between the launch and the court's subsequent injunction order, Apotex shipped a six-month supply of its generic product to distributors in the United States.
Procedural Posture:
- In November 2001, Apotex filed an Abbreviated New Drug Application (ANDA) with the FDA, including a Paragraph IV certification that Sanofi's '265 patent was invalid.
- Sanofi sued Apotex for patent infringement in the U.S. District Court for the Southern District of New York on March 21, 2002.
- Apotex filed a counterclaim asserting the '265 patent was invalid and unenforceable.
- The FDA approved Apotex's ANDA on January 20, 2006.
- After Apotex launched its generic product, Sanofi filed a motion for a preliminary injunction in the district court on August 15, 2006.
- The district court (trial court) granted Sanofi's motion for a preliminary injunction on August 31, 2006.
- Apotex appealed the district court's grant of the preliminary injunction to the U.S. Court of Appeals for the Federal Circuit.
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Issue:
Did the district court abuse its discretion by granting a preliminary injunction to enjoin Apotex's sale of a generic drug where it found Sanofi was likely to succeed on the merits of its patent infringement claim and would suffer irreparable harm?
Opinions:
Majority - Lourie, Circuit Judge.
No. The district court did not abuse its discretion in granting the preliminary injunction because its findings on the four requisite factors were not based on a clear error of judgment, an error of law, or clearly erroneous factual findings. The district court correctly found that Sanofi established a likelihood of success on the merits, as Apotex failed to raise a substantial question regarding the '265 patent's validity. Apotex's anticipation defense failed because the prior art ('596 patent) did not disclose every limitation of the claimed invention, specifically the bisulfate salt of the d-enantiomer. The obviousness defense also failed because the unexpected properties of clopidogrel bisulfate and the extensive experimentation required to develop it were objective indicia of nonobviousness. The court also properly found that Sanofi would suffer irreparable harm from irreversible price erosion, that the balance of hardships tipped in Sanofi's favor because Apotex's harm was self-inflicted from its at-risk launch, and that the public interest in protecting valid patents to encourage innovation outweighed the interest in a lower-priced generic at this stage.
Analysis:
This case reinforces the high bar for overturning a district court's decision on a preliminary injunction, which is reviewed for abuse of discretion. It provides a classic application of the four-factor test in the context of pharmaceutical patent litigation under the Hatch-Waxman Act. The decision underscores the significance of an 'at-risk launch' by a generic manufacturer, treating the resulting harm to the generic company as self-inflicted and weighing it heavily against them in the balance of hardships. Furthermore, the court's treatment of irreparable harm solidifies price erosion and market share loss as key factors that money damages cannot easily remedy, justifying injunctive relief.
