Litigators in the life sciences field are no doubt familiar with the so-called “artificial” act of infringement established by 35 U.S.C. § 271(e)(2)(A)-(B): namely, that a party can be sued for patent infringement by merely filing an Abbreviated New Drug Application (“ANDA”) for a generic drug or a Biologics License Application (“BLA”) for a biosimilar drug. The filing of such an action can allow for, among other things, the resolution of patent infringement disputes before the generic (or biosimilar) drug enters the market. 

The concept sounds simple enough, and in many cases, it is not a source of contention despite being prevalent in nearly all pharmaceutical litigations. But, of course, the devil is in the details. For example, if a company submits an ANDA seeking to market a generic drug only for unpatented uses, is that company nonetheless liable based on the “artificial” act of infringement under 35 U.S.C. § 271(e)(2)?  Some have tried to argue that the answer to this question is “yes” under the language of 35 U.S.C. § 271(e)(2)(A), which makes it an act of infringement to seek approval to market a generic drug “the use of which is claimed in a patent before the expiration of such patent.” (Emphasis added.)   

The Federal Circuit recently issued a precedential opinion addressing this very question. In the case at issue, the plaintiffs (who developed and patented the drug) held only expired patents on the drug compound itself, but owned several active patents related to specific methods of treatment (the “Method of Treatment Patents”). The defendants’ ANDA sought approval to market a generic version of the drug only for uses not covered by the Method of Treatment Patents. 

Despite the prohibition on marketing the drug for claimed uses, applicable law allows medical practitioners to prescribe the generic version however they deem appropriate, even if the prescription would infringe the Method of Treatment Patents. As such, according to the plaintiffs, under 35 U.S.C. § 271(e)(2)(A), “it makes no difference that the drug is proposed to be sold for a use not covered by” the Method of Treatment Patents because “the drug could be prescribed for those patented uses.”    

The Federal Circuit rejected plaintiffs’ analysis of the “artificial” act of infringement, ruling that the “use . . . claimed in a patent” under 35 U.S.C. § 271(e)(2)(A) “must be the use for which an applicant is seeking marketing approval.” According to the Federal Circuit, a contrary result would allow a brand to “maintain its exclusivity merely by regularly filing a new patent application claiming a narrow method of use not covered by its NDA.” 

As such, the Federal Circuit clarified that 35 U.S.C. § 271(e)(2)(A) does not provide “an independent basis of infringement” separate from those set forth in other sections of 35 U.S.C. § 271. Because defendants were not seeking approval to market the drug at issue for a patented use, the Federal Circuit held that they did not infringe the Method of Treatment Patents. 

The case is H. Lundbeck A/S et al. v. Lupin Ltd. et al.., appealed from C.A. No. 18-cv-00088, in the District of Delaware—a copy of which can be found here

Print:
Email this postTweet this postLike this postShare this post on LinkedIn
Photo of Gourdin Sirles Gourdin Sirles

Gourdin W. Sirles is an associate in the Litigation Department, where he focuses on patent and intellectual property litigations.  From large pharmaceutical litigations (including litigations related to the Biologics Price Competition and Innovation Act and Hatch-Waxman Act), to patent litigations related to electronics…

Gourdin W. Sirles is an associate in the Litigation Department, where he focuses on patent and intellectual property litigations.  From large pharmaceutical litigations (including litigations related to the Biologics Price Competition and Innovation Act and Hatch-Waxman Act), to patent litigations related to electronics, software, Microelectromechanical systems and components thereof, and financial services products, Gourdin’s intellectual property litigation experience has covered a broad variety of technologies and specialties.

Gourdin has experience in all aspects of the litigation process, including trials, Markman hearings, fact and expert discovery, depositions, case preparation and strategy, motion practice, and settlement negotiation. Gourdin is also well-versed in e-discovery, including forensic document collections, e-discovery platforms, management of contract attorney teams, document review, and production.

In addition to patent and intellectual property litigations, Gourdin’s practice has also encompassed a variety of other legal matters, including pro bono immigration matters, bankruptcy law, toxic tort, employment litigation, commercial disputes, and campaign finance compliance and other election-related laws on the state and federal level.

Photo of Baldassare Vinti Baldassare Vinti

Baldassare (“Baldo”) Vinti heads Proskauer’s Intellectual Property Litigation Group.

Baldo’s practice focuses on litigating patent, false advertising, trade secret, life sciences, trademark and contractual matters in federal and state courts and before the International Trade Commission. He is a seasoned trial attorney responsible…

Baldassare (“Baldo”) Vinti heads Proskauer’s Intellectual Property Litigation Group.

Baldo’s practice focuses on litigating patent, false advertising, trade secret, life sciences, trademark and contractual matters in federal and state courts and before the International Trade Commission. He is a seasoned trial attorney responsible for all aspects of litigation, including Markman hearings, appeals before the Federal Circuit, case preparation and strategy, depositions, motion practice, and settlement negotiations. He has represented clients in high-stakes matters involving a broad range of technologies, including medical devices, diagnostics, immunoassays, prosthetics, pharmaceuticals, dental implants, electronic medical records systems, encryption technology, wound dressings, digital video compression, electronic book delivery and security systems, mobile media technologies, navigation and location-based services, bandwidth management, bar code scanning, lasers , and other technologies. Baldo has represented numerous major corporations, including Arkema S.A., British Telecommunications PLC, Church & Dwight Co., Inc., Henry Schein, Inc., Maidenform Brands Inc., Mitsubishi Electric Corp., Ossur North America Inc., Panasonic Corp., Sony Corp., Welch Foods, Inc., and Zenith Electronics LLC.

In addition, Baldo regularly handles transactional work, including intellectual property due diligence, licensing, intellectual property structural transactions, patentability studies, infringement/non-infringement opinions, and client counseling in intellectual property matters.

Baldo is an author and frequent commentator on patent issues pertaining to medical devices and a host of other intellectual property topics, and has been quoted in the National Law Journal, Bloomberg BNA, Law360, Westlaw Journal and Inside Counsel magazine. He is also a regular contributor of articles published in Medical Product Outsourcing magazine that deal with the medical device industry.

Baldo served as a judicial intern for Hon. John E. Sprizzo of the United States District Court for the Southern District of New York and for Hon. Charles A. LaTorella of the New York Supreme Court.