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Abbott Laboratories v. Sandoz, Inc.

Citations: 544 F.3d 1341; 89 U.S.P.Q. 2d (BNA) 1161; 2008 U.S. App. LEXIS 21880; 2008 WL 4636167Docket: 2007-1300

Court: Court of Appeals for the Federal Circuit; October 21, 2008; Federal Appellate Court

Original Court Document: View Document

Narrative Opinion Summary

The case of Abbott Laboratories v. Sandoz, Inc. before the United States Court of Appeals for the Federal Circuit involves allegations of patent infringement by Sandoz on Abbott's extended-release clarithromycin formulations. Abbott, the plaintiff-appellee, sought a preliminary injunction to prevent Sandoz from marketing its product during litigation, which was granted by the district court. The patents at issue, U.S. Patent Nos. 6,010,718 and 6,551,616, pertain to extended drug formulations with specific pharmacokinetic properties. Sandoz contested the injunction, arguing invalidity of the patents based on anticipation and obviousness, citing prior art and the Supreme Court's KSR decision. Additionally, Sandoz alleged inequitable conduct by Abbott during patent prosecution. The district court found no abuse of discretion in granting the injunction, concluding that Abbott was likely to succeed on the merits, and evaluated equitable factors such as irreparable harm and public interest. The appellate court affirmed the district court's decision, highlighting that Sandoz failed to demonstrate the invalidity or unenforceability of Abbott's patents sufficiently to overturn the injunction.

Legal Issues Addressed

Claim Construction in Patent Infringement Cases

Application: The court reviews the district court's claim construction regarding the term 'pharmaceutically acceptable polymer,' affirming a broader interpretation.

Reasoning: The district court interpreted 'pharmaceutically acceptable polymer' using the definition outlined in the '718 patent specification, which describes such polymers as compounds suitable for contact with human and animal tissues without causing undue toxicity or irritation.

Equitable Factors for Preliminary Injunctions

Application: The court assesses the balance of hardships and public interest in deciding whether to grant a preliminary injunction.

Reasoning: The district court weighed the hardships faced by both Abbott and Sandoz, determining that the balance favored Abbott.

Inequitable Conduct in Patent Prosecution

Application: The court examines allegations of inequitable conduct by Abbott during patent prosecution but finds no clear evidence of intent to deceive.

Reasoning: Sandoz contended that the '718 and '616 patents were unenforceable due to Abbott’s alleged inequitable conduct before the Patent and Trademark Office (PTO).

Patent Infringement and Preliminary Injunctions

Application: The court examines the propriety of a preliminary injunction to prevent Sandoz from marketing a potentially infringing product during ongoing patent litigation.

Reasoning: The appeal arose from a preliminary injunction granted by the United States District Court for the Northern District of Illinois, under Judge David H. Coar, which was issued to prevent Sandoz from marketing its product while the validity and enforceability of Abbott's patents were being litigated.

Patent Validity - Anticipation

Application: Sandoz argues that prior art anticipates Abbott's patents, but the court finds insufficient evidence to support this claim.

Reasoning: Sandoz claims that European Patent Publication No. 0,280,571 B1 (the '571 Publication) anticipates the '718 patent, citing its description of a sustained release matrix formulation with specific components.

Patent Validity - Obviousness

Application: The court evaluates arguments that the patents are invalid due to obviousness, considering combinations of prior art and the KSR decision.

Reasoning: Sandoz contended that the claims of the '718 and '616 patents are invalid due to obviousness, asserting that the combination of the '571 Publication, PCT Application WO 95/30422, and U.S. Patent No. 5,705,190 renders the patents unpatentable.