Specific Intent to Induce Patent Infringement Inferred from Pharmaceutical Label

Federal CircuitSanofi v. Watson Labs., No. 2016-2726, 2017 (Fed. Cir. Nov. 9, 2017) (Before Prost, C.J., Wallach, and Taranto, J.) (Opinion for the court, Taranto, J.)

Sanofi is the owner of two patents claiming compositions and uses of the cardiovascular drug dronedarone. The ‘167 patent claims methods of reducing cardiovascular hospitalization by administering dronedarone to patients meeting specific conditions that mirror those of a clinical study conducted by Sanofi between 2005 and 2008 (“ATHENA”). In 2009, Sanofi received approval for a New Drug Application for 400 mg tables of dronedarone, sold as Multaq®. Hoping to market generic versions of the drug, Watson Laboratories Inc. (“Watson”) and Sandoz Inc. (“Sandoz”) filed abbreviated new drug applications with the FDA, claiming invalidity and/or non-infringement of the two patents. The label they proposed using with the generic version did not differ materially from the label used by Sanofi.

Sanofi sued Watson and Sandoz for infringement under 35 U.S.C. § 271(e)(2)(A). The district court held, first, that Watson and Sandoz induced infringement of the ‘167 patent. Their sales of the proposed generic drugs, with the proposed labels, would induce physicians to infringe all but one of the asserted claims. The inducing act, here, is the marketing of the generic dronedarone drugs with the proposed label and the induced act is the administration of dronedarone by medical providers to patients meeting specific criteria described in the ’167 patent claims.

The court also held that the ‘167 patent is not invalid for obviousness. Finally, the court held that the asserted claims do not exclude compositions containing polysorbate surfactants. Watson and Sandoz appealed; the Federal Circuit affirmed the judgment in full.

Under 35 U.S.C. § 271(b), “[w]hoever actively induces infringement of a patent shall be liable as an infringer.” Specific intent to encourage another’s inducement is necessary for a finding of induced infringement. When a label is claimed to be the culprit of inducement, it must “encourage, recommend, or promote infringement.” Here, the proposed label shows specific intent to encourage physicians to infringe the ‘167 patent by directing them to prescribe dronedarone to patients with at least one of the risk factors claimed in the patent. The “Indications and Usage” section of the label not only states that dronedarone “is indicated to reduce the risk of hospitalization for atrial fibrillation” and identifies the specific patients covered by this indication but also explicitly references Clinical Studies Section 14, which features the ATHENA study. This reference thus expressly directs the reader to the class of patients who have risk factors written into the ’167 patent, thereby encouraging physicians to administer the drug in a way that infringes the patent.

Next, the Court found no clear error in the court’s determination that the ‘167 claims were not obvious based on the factual finding that a person of ordinary skill in the art in 2008 would not have had a reasonable expectation that dronedarone would reduce the risk of cardiovascular hospitalization and hospitalization for the specific class of patients.

Finally, the Court rejected Watson’s and Sandoz’s prosecution disclaimer argument for limiting the scope of the other patent (the ’800 patent), based on the adoption of claim-narrowing language excluding polysorbate surfactants in the prosecution of the parent application “In general, a prosecution disclaimer will only apply to a subsequent patent if that patent contains the same claim limitation as its predecessor.” Regents of Univ. of Minn. v. AGA Med. Corp., 717 F.3d 929, 943 (Fed Cir. 2013). The express limitation included in the parent application does not appear in ‘800 patent claims; the asserted claims thus do not exclude compositions containing polysorbate surfactants.

Take Away

Specific intent to induce infringement may be inferred from a pharmaceutical label. Marketing a drug with a label worded to direct medical professionals to administer a drug in a way that reads on a patent claim may be sufficient for purposes of induced infringement. Adoption of claim-narrowing language in a parent application is not enough to establish prosecution disclaimer in a subsequent application lacking the same claim limitations.  

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Robert Schaffer

Robert Schaffer is an intellectual property partner at Troutman Sanders. Bob applies more than 30 years of experience to IP counseling and litigation. His work includes patent procurement, strategic planning and transactional advice, due diligence investigations, district court patent cases, and Federal Circuit appeals. He regularly handles complex and high-profile domestic and international patent portfolios, intellectual property agreements and licensing, IP evaluations for collaborations, mergers, and acquisitions. In disputed court cases Bob’s work includes representing and counseling client in ANDA litigations, complex patent infringement cases and appeals, and multidistrict and international cases. In disputed Patent Office matters his work includes representing and counseling clients in interferences, reexaminations, reissues, post-grant proceedings, and in European Oppositions. For more information and to contact Bob please visit his profile page at the Troutman Sanders website.

Robert Schaffer

Joseph Robinson has over 20 years of experience in all aspects of intellectual property law. He focuses his practice in the pharmaceutical, life sciences, biotechnology, and medical device fields. His practice encompasses litigation, including Hatch-Waxman litigation; licensing; counseling; due diligence; and patent and trademark prosecution. He has served as litigation counsel in a variety of patent and trademark disputes in many different jurisdictions, and has also served as appellate counsel before the Court of Appeals for the Federal Circuit. Joe also focuses on complex inter partes matters before the U.S Patent and Trademark Office, inventorship disputes, reexaminations and reissues. His experience includes numerous interferences, a particular advantage in new U.S. Patent and Trademark Office post-grant proceedings. He also counsels on patent–related U.S. Food and Drug Administration issues, including citizen petitions, Orange Book listing, and trademark issues. For more information and to contact Joe please visit his profile page at the Troutman Sanders website.

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