Patent Law

Novo Nordisk Fails to Show Reasonable Likelihood of Success Over Sanofi

By Stephen Albainy-Jenei

In a nonprecedential opinion, the U.S. Court of Appeals for the Federal Circuit gave the thumbs up to a district court decision that Plaintiff-Appellant Novo Nordisk A/S wasn?t getting a preliminary injunction out of Sanofi-Aventis after alleging that Sanofi?s SoloStar product infringed claims of Novo?s U.S. Patent No. 7,241,278.  Novo Nordisk A/S v. Sanofi-Aventis (08-1225).

In order to obtain a preliminary injunction, a patentee must show: ?(1) reasonable likelihood of success on the merits; (2) irreparable harm; (3) that the balance of hardships tips in its favor; and (4) the impact of the injunction on the public interest.?  The denial of a preliminary injunction pursuant to 35 U.S.C. § 283 is within a district court?s discretion.

In this case, the district court denied the preliminary injunction because Novo failed to show a reasonable likelihood of success on the merits.  The district court reasoned that Sanofi ?raised substantial questions regarding whether the specification read as a whole suggests that the very character of the invention.  These substantial questions included whether:

1. the embodiments of the invention set forth in the specification as ?the invention? constitute the invention itself despite claim language that could be interpreted more broadly,
2. the specification expressly disclaims injection pens with rotating piston rods or gearing other than direct gearing,
3. the specification suggests the need to narrowly construe the claims because it distinguishes prior art or clearly expresses an intention to limit the invention?s structure, and
4. Novo?s amendment of the ?278 patent?s claims to import language from the DCA Application affects this Court?s use of the specification, which was not amended, in construing such claims.

The district court ultimately found that these substantial questions precluded a finding that Novo has a likelihood of success on the merits and, accordingly, denied Novo?s motion for a preliminary injunction.

Novo appealed, arguing that the district court?s claim construction is legal error because the claim language is clear, the specification contains no disclaimer, the prosecution history makes clear that Novo abandoned these requirements, and the doctrine of claim differentiation supports Novo?s proposed construction.

The federal Circuit felt that the lower court was well within its discretion:

[N]otwithstanding Novo?s arguments to the contrary, we read the district court?s opinion as generally addressing whether Sanofi raised ?substantial questions,? rather than specifically articulating a claim construction.  While it is true that many of the substantial questions identified by the district court would ultimately be analyzed in the context of construing the claims, some might more appropriately be analyzed in the context of validity (i.e., written description and enablement).

At the preliminary injunction stage, however, it is irrelevant whether this case presents greater issues of claim construction or validity?the existence of one or both of these issues is sufficient to justify the district court?s decision to deny a preliminary injunction.

Full post as published by Patent Baristas on August 08, 2008 (boomark / email).