Confronting a life sciences patentee with its statements to regulatory bodies (such as the FDA) is a textbook defense strategy in patent litigation.  After all, communications with regulatory bodies are often performed by non-attorneys who may not appreciate the consequences of their statements in future litigation. And while in ideal circumstances the patentee’s attorneys will ensure accurate and consistent communications and try to put potentially inconsistent statements in context, it is not always possible to do so once the genie is out of the bottle. Belcher Pharmaceuticals, LLC v. Hospira, Inc., exemplifies the dire consequences that can result from inconsistent communications with regulators—particularly if a defendant can point to a single source for those communications.   

According to the decision, Belcher made an “about-face” to the United States Patent Office (“PTO”) after submitting a New Drug Application (“NDA”) related to a proposed l-epinephrine formulation. For example, in order to expedite FDA approval for its NDA, Belcher represented that its formulation merely removed “preservatives and sulfides” and resulted in a composition having a pH range of 2.8 to 3.3.  The NDA called the process for obtaining this pH range “old,” and Belcher submitted batches from a reference product by Sintetica having a pH range of 3.1 to 3.3.  Notwithstanding this representation, Belcher later sought to patent a formulation having an in-process pH of 2.8 to 3.3. When the PTO rejected the claim based on prior art having a pH range of 2.2 to 5.0, Belcher successfully argued that the claimed range of 2.8 to 3.3 was “unexpectedly found to be critical” to the invention and therefore different from the prior art. The PTO then granted Belcher’s patent (the “’197 Patent”).

Belcher then sued Hospira for patent infringement. As part of its defense, Hospira relied on Belcher’s inconsistent statements to the FDA and PTO to argue unenforceability of the ’197 Patent due to inequitable conduct. Hospira prevailed on this defense largely due to the testimony of Belcher’s Chief Science Officer (“CSO”), who confirmed he was involved in both drafting the NDA and responding to the PTO’s questions during prosecution.  Specifically, the district court found “he knew of Sintetica’s epinephrine formulations that had a pH range of 2.8 to 3.3 and that Belcher’s NDA described that range as ‘old’” and “did not merely withhold this information [from the PTO] but also used emphatic language to argue that the claimed pH range of 2.8 to 3.3 was a ‘critical’ innovation” that produced unexpected results.

The Federal Circuit affirmed, noting that inequitable conduct requires a defendant to “establish both the materiality of the withheld reference and the applicant’s intent to deceive the PTO.”  As to “materiality,” Belcher did not dispute that the withheld information disclosed the claimed pH range, and therefore the Federal Circuit found materiality “necessarily” met.  Belcher, however, argued that the withheld information was merely “cumulative” of information in the PTO’s possession.  The Federal Circuit rejected this argument as “directly at odds with [Belcher’s] argument during prosecution that the claimed range was ‘critical.’”

As to “deceptive intent,” the Federal Circuit found no “direct evidence” of a “specific intent to deceive the PTO . . . .”  Indeed, Belcher’s CSO testified that he believed the omitted information to be irrelevant because “they were different from the asserted claims in certain respects . . . .”  Had the district court merely rejected Belcher’s argument on credibility grounds, the Federal Circuit indicated that there would have been an insufficient basis to uphold the ruling. However, because of the CSO’s “central role in both FDA approval and patent prosecution, and his arguments to the examiner about the ‘criticality’ of the 2.8 to 3.3 pH range despite knowing that Sintetica’s batches used the same range,” the Federal Circuit found sufficient evidence to affirm the district court.

This decision emphasizes the importance of coordinating the efforts of patent attorneys during the FDA approval and patent prosecution processes.  According to the Federal Circuit, while Belcher’s CSO held degrees in medical sciences and business and had responsibilities for “intellectual property matters including patent application drafting,” he was not a registered patent agent or an attorney. Had Belcher synched its representations to FDA and the PTO, Hospira would have been hard pressed to prove the intent prong for inequitable conduct in view of the court’s finding that there was no direct evidence that Belcher specifically intended to deceive the PTO.

The case is Belcher Pharms., LLC v. Hospira, Inc., No. 20-1799, a copy of which can be found here.

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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 Vinti is a partner in the Patent Law and Intellectual Property Groups.

Baldo’s practice focuses on litigating patent, false advertising, trade secret, trademark and contractual matters in federal and state courts and before the International Trade Commission. He is a skilled intellectual…

Baldassare Vinti is a partner in the Patent Law and Intellectual Property Groups.

Baldo’s practice focuses on litigating patent, false advertising, trade secret, trademark and contractual matters in federal and state courts and before the International Trade Commission. He is a skilled intellectual property litigator with extensive experience in all aspects of litigation, including trials (jury and bench), Markman hearings, appeals before the Federal Circuit, case preparation and strategy, depositions, motion practice, and settlement negotiations. In the area of patent litigation, he has worked on cases involving a broad range of technologies, including medical devices, diagnostics, immunoassays, orthotics and prosthetics, proton pump inhibitor pharmaceuticals, dental implants, electronic medical records systems, wound dressings, pharmaceutical capsules, digital video compression, electronic book delivery and security systems, mobile phones and mobile media technologies, ATSC digital television standard, navigation, location-based services, bandwidth management, bar code scanning, irrigation equipment, waste management systems, laser inscription devices, and other related technologies. Baldo has represented numerous major corporations in patent litigations, including British Telecommunications PLC, Church & Dwight Co., Inc., Henry Schein, Inc., Maidenform Brands Inc., Mitsubishi Electric Corp., Ossur North America Inc., Panasonic Corp., Sony Corp., U.S. Philips Corp. and Zenith Electronics LLC.

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