Creative Claiming Strategies

• Published date: 15 September 2022
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Food and Drugs Law
• Law Firm: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
• Author: Mr Thomas Irving and Stacy Lewis

Innovator companies in the biopharmaceutical space are looking to their patent counsel for creative patent claiming strategies to protect their assets. In this article, using the Federal Circuit opinions in Teva Pharms. v. Corcept Therapeutics, Vanda v. West-Ward, and Sanofi v. Watson as a foundation, we describe a strategy of enhancing chances of success against generic or biosimilar challengers by claiming clinical trial protocols and results, and other information that appears on a drug product label, i.e., by claiming what was approved by the FDA. The article will also explore creative claim strategies that take advantage of 35 U.S.C. 112(f)'s means-plus-function terminology. These strategies could help create strong US patents and provide additional protections for biopharmaceutical innovations.

I. CLAIM STRATEGY BASED ON CLAIMING CLINICAL TRIAL RESULTS

The opinion in Sanofi v. Watson, 875 F.3d 636 (Fed. Cir. 2017), showcases intriguing possibilities for patent owners in the biopharma industry whose patent counsel works closely with clinical trial teams and files US patent applications that include and claim innovations arising from clinical trial results.

Under the rationale of Sanofi v. Watson, when a generic or biosimilar manufacturer copies a label to obtain FDA approval, an innovator biopharma company may successfully assert induced infringement of method-of-treatment claims that facially seem very narrow, but closely correspond with what the FDA approved and is included in the label, including the clinical trial results set forth in the label.

For this strategy to work in the US, of course, the patent application must be drafted to include details of the clinical trial information and results and must be filed before any published clinical trial information or results become disabling prior art, as set out under 35 U.S.C. ' 102(a)(1), in the absence of any 35 U.S.C. ' 102(b)(1) exceptions.

Patent teams should therefore coordinate and communicate early and frequently with the clinical trial teams and regulatory teams of the new drug application (NDA) or biologics license application (BLA) holder/reference product sponsors to help facilitate this strategy.

Practitioners should consider including in the patent specification and claims the specific information that cannot be carved out by the generic or biosimilar manufacturer, such as key safety signals, dosage adjustments in methods of treatment, and references to the clinical studies section in the Indication and Usage section of the label.

A. Details of Sanofi v. Watson Opinion

The invention at issue in Sanofi v. Watson, supra, was a method of treating heart rhythm problems in patients with atrial fibrillation by administering dronedarone, an antiarrhythmic agent, which is marketed under the brand name Multaq'.

Sanofi filed a patent application on its dronedarone composition in 1998. After approximately a decade of clinical trials and successful Phase III results, Sanofi obtained FDA approval of Multaq'.

Sanofi later obtained US Patent No. 8,410,167 ("the '167 patent"), which disclosed the Phase III clinical trial results, including details of contraindicated symptoms, severe heart failure dangers, and patient cardiovascular risk factors. Claim one of the '167 patent recited those same details:

A method of decreasing a risk of cardiovascular hospitalization in a...