Sanofi v. Apotex - Case Brief
Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368 (Fed. Cir. 2006).
Generic drug manufacturer Apotex wanted to market a generic form of Sanofi’s Plavix (clopidogrel bisulfate) and filed an ANDA alleging that Sanofi’s patents were invalid.
The two parties worked together to negotiate a settlement. The agreement was not accepted by state attorneys general even after new terms were presented. Under provisions of the agreement, the regulatory denial killed the settlement and the parties resumed litigation.
Sanofi then filed a motion for preliminary injunction to stop Apotex from selling its product. Within 21 days, the district court issued a preliminary injunction. During that time, Apotex shipped six-months of product. Apotex then appealed. In order to be granted a preliminary injunction, a party must show:
- Reasonable likelihood of success on the merits
- Irreparable harm if an injunction is not issued
- Balance of hardships tipped in favor of the party
- Injunction would have no negative impact on the public interest
The major difference between the factors for consideration in preliminary injunctive relief and those for permanent relief is that preliminary relief requires a showing of a likelihood of success while permanent relief requires success on the merits as a precondition. Thus, the final three factors will give some indication of how the court will rule in post-eBay injunction cases.
Likelihood of success on the merits: Apotex argued anticipation based on a broadly worded claim of a prior art patent that was considered by the examiner during prosecution. The court confirmed that this made the burden of proving invalidity at trial “especially difficult.” On obviousness, the CAFC confirmed that the unpredictability of enantiomer activity made the claimed dextrorotatory formation nonobvious even if the molecule as a whole was known.
Irreparable Harm: The settlement agreement between the parties included a provision that capped any damages for infringement by Apotex — seemingly an admission that Sanofi would settle for money damages. The court did not buy-into this argument because the agreement also contemplated an injunction.
Balance of hardships tip in Sanofi’s favor because Apotex chose to launch its product under threat of injunctive relief. It could have avoided the situation altogether and thus should not benefit from this factor.
Public Interest:
The court found no error in the lower court’s conclusion “that the significant public interest in encouraging investment in drug development and protecting the exclusionary rights conveyed in valid pharmaceutical patents” outweighs the public interest concerns offered by generic manufacturers and amici, including possible deaths due to patients opting to forgo purchasing medicine because of the lack of a less expensive alternative.