In Abbott Labs. v. Andrx Pharm., Inc., No. 05-1433, the U.S. Court of Appeals for the Federal Circuit held that a preliminary injunction granted pursuant to plaintiff’s claims alleging infringement of its patents relating to extended release formulations of a broad spectrum antibiotic should be vacated where (a) the plaintiff failed to establish a likelihood of success on the merits; (b) the plaintiff failed to establish that irreparable harm supported the grant of the injunction; and (c) the public interest benefited from a denial of the injunction.

Earlier, Abbott Laboratories brought suit against Teva Pharmaceuticals, Inc. alleging infringement of its patents relating to extended release formulations of clarithromycin. Clarithromycin is a broad spectrum antibiotic from the macrolide family of antibiotics, all of which are derived from erythromycin A.

Abbott asked for a preliminary injunction against Teva on the grounds that Teva was infringing claims 2, 4, and 6 of U.S. Patent No. 6,010,718 (’718 patent) and claim 2 of U.S. Patent No. 6,551,616 (’616 patent). Teva argued that substantial questions existed as to the validity of Abbott’s asserted claims under 35 U.S.C. § 103. The district court granted a preliminary injunction after agreeing that Teva had raised a substantial question as to the validity of claim 2 of the ’616 patent but it rejected Teva’s invalidity arguments as to the asserted claims of the ’718 patent.

In 1997, Abbott filed for a patent claiming an extended release formulation of clarithromycin. The patent describes and claims extended release formulations comprising erythromycin derivatives combined with a pharmaceutically acceptable polymer. The resulting drug-polymer matrix leads to the extended release properties of the formulation. The ER formulation enabled patients to take one pill per day rather than twice, as had been required with the immediate release formulation. That patent issued on January 4, 2000 as the ’718 patent. Further, based on the ’718 patent application, Abbott filed a continuation-in-part application that claims a method of reducing adverse gastrointestinal side effects of erythromycin-derived drug formulations by using extended release formulations. This continuation-in-part issued as the ’616 patent. In 2000, Abbott introduced its ER clarithromycin formulation, Biaxin XL.

A plaintiff seeking a permanent injunction must satisfy a four-factor test before a court may grant such relief: (1) the movant has some likelihood of success on the merits of the underlying litigation; (2) immediate irreparable harm will result if the relief is not granted; (3) the balance of hardships to the parties weighs in the movant’s favor; and (4) the public interest is best served by granting the injunctive relief. These principles apply with equal force to disputes arising under the Patent Act.

In looking at the standard for a preliminary injunction, the court stated that when moving for the extraordinary relief of a preliminary injunction, a patentee need not establish the validity of a patent beyond question. The patentee must, however, present a clear case supporting the validity of the patent in suit.

As to the public interest factor, the court stated that:

Although the public interest inquiry is not necessarily or always bound to the likelihood of success of the merits, in this case absent any other relevant concerns, we agree with the district court that the public is best served by enforcing patents that are likely valid and infringed. As Abbott did not establish a likelihood of success on the merits, we conclude that the public interest is best served by denying the preliminary injunction.

In a split decision, the court said Teva had raised sufficient questions about the validity of Abbott’s patents to make it unfair for a court to keep Teva out of the marketplace for generic versions of Biaxin XL until after a full trial. The court felt that if Abbott ultimately proves its patents for extended release Biaxin are valid, money damages shall be sufficient.

U.S. Circuit Judge Pauline Newman dissented stating that:

Reversal of a preliminary injunction that preserves the status quo requires a clear showing that the district court exceeded its discretionary authority. See We Care, Inc. v. Ultra-Mark Int’l Corp., 930 F.2d 1567, 1570 (Fed. Cir. 1991) (“The court’s determination can be overturned only on a showing that it abused its discretion, committed an error of law, or seriously misjudged the evidence.”) My colleagues do not discuss the trial judge’s careful explanations, but, upon finding that Teva has raised a “substantial question” about patent validity, they hold that Teva should be permitted to practice the Abbott invention before patent validity is decided. With all respect to my colleagues’ concerns, they misapply not only the criteria of the preliminary injunction but also the standard of appellate review.

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