On July 29, 2022, the U.S. Patent and Trademark Office (PTO) published a Notice on the Duties of Disclosure and Reasonable Inquiry During Examination, Reexamination, and Reissue, and for Proceedings Before the Patent Trial and Appeal Board. The notice was part of the PTO's response to President Joe Biden's July 2021 Executive Order on Promoting Competition in the American Economy calling for "help [to] ensure that the patent system, while incentivizing innovation, does not also unjustifiably delay generic drug and biosimilar competition beyond that reasonably contemplated by applicable law." It also answered Congress' call for PTO action following the Federal Circuit's September 2021 ruling that a drug formulation patent was unenforceable based on a drug manufacturer's inconsistent disclosures to both the PTO and the Food and Drug Administration (FDA). In view of the notice, companies should review the interface between their IP and regulatory functions to confirm that their interoperation (or lack thereof) does not run afoul of a patent applicant's duties of disclosure and reasonable inquiry to the PTO.
Belcher Teaches a Hard Lesson
Prefatory to the notice, on September 1, 2021, the Federal Circuit in Belcher Pharm. v. Hospira, Inc., 11 F.4th 1345, affirmed a district court ruling that Belcher Pharmaceuticals' patent for epinephrine formulations was unenforceable. This was due to Belcher withholding reference product information and arguing to the PTO, on the one hand, that its narrower, claimed pH range was a critical, patentable feature distinguishing the invention from the broader range in the prior art before the PTO, while making conflicting disclosures to FDA, on the other hand, of a reference drug with the claimed pH range and asserting to FDA that a change in the in-process pH was a "very minor change." More specifically, while it argued to the PTO that the narrower pH was "critical" for reducing racemization and degradation of the epinephrine, Belcher presented to FDA, in support of its 505(b)(2) NDA application,1 stability studies on a reference product that reported the same pH range (2.8-3.3) as the claimed pH range. Accordingly, the Federal Circuit concluded "Belcher's alleged critical improvement over the prior art was therefore already within the public domain, just not before the examiner"'and failure to disclose the reference product was an omission of material information. See Belcher Pharm., LLC v. Hospira, Inc., Case No. 2020-1799 (Fed. Cir. Sept. 1, 2021) at 14. Significant to the court's conclusion, during prosecution, Belcher failed to disclose the reference product information to the PTO even though Belcher's chief science officer oversaw regulatory approval, product development and intellectual property matters, including patent prosecution. The Federal Circuit held that "the district court did not clearly err in finding that the single most reasonable inference is that [the chief science officer] possessed the specific intent...
