In the immediate wake of the Belcher v. Hospira case where the patent holder made contradictory statements to the USPTO and the FDA regarding prior art, Senators Leahy and Tillis called for “the creation of a smooth, predictable, and regular channel of information from other federal agencies to the Patent Office” in a letter to then-acting USPTO Director Hirschfeld. FDA Commissioner Woodcock immediately followed with another letter to Mr. Hirschfeld where the FDA offered “training on FDA’s public information and databases that may help USPTO locate pertinent references and determine whether particular documents constitute prior art.”

While these calls for the USPTO to draw on the resources of other federal agencies are new, federal agencies such as the EPA have mined the USPTO’s databases since at least 2017. During the course of litigation over the Enlist Duo® herbicide mix, the EPA discovered patent application claims of synergy they had not considered and successfully requested that the court remand the mixture’s use registration to the EPA. Following this episode, the EPA in 2017 elected to “begin pesticide interaction evaluation with the USPTO patents” and “developed a process for rapidly searching and screening USPTO data for interaction claims” applicable to both new chemicals and genetically modified crops.

The response of the USPTO to calls for increased cooperation with other federal agencies will most likely fall on newly nominated USPTO Director Kathi Vidal. In fairness to the USPTO, developing processes for patent examiners to sift through voluminous and largely irrelevant submissions to regulatory agencies may be more complicated than searching patent databases given advanced patent literature search tools, the public accessibility of most patent literature, and the “applicable laws governing disclosure” of certain regulatory agency submissions mentioned in FDA Commissioner Woodcock’s letter. Nonetheless, providing USPTO patent examiners with efficient search tools for identifying admissions of patent applicants in submissions to other federal agencies would clearly provide for more rigorous examination.

As noted in the accompanying MVS Filewrapper post: The great dichotomy: patent protection vs. regulatory approval, a patent applicant’s goal of proving novelty and non-obviousness may conflict with a regulatory submission’s goal of proving that a product is similar to well-known products and is thus safe. Patent applicants and patent holders seeking product approvals from other federal agencies such as the FDA, EPA, and USDA should do their best to ensure that the statements that they make to the USPTO and the federal agencies are consistent.  Such consistency is important in large companies where individuals in regulatory, R&D, and patent law groups may be siloed and unaware of other group’s submissions.  In small companies where one person such as a Chief Scientific Officer may have both a duty to disclose to the USPTO all information known to them that is “material to patentability” and direct involvement in submissions to other federal agencies, such inconsistencies can lead to court holdings of inequitable conduct fatal to a patent and all related patents in its family. Patent applicants of any size can also consider providing copies of suitably redacted or unredacted copies of any material federal agency submissions to the USPTO in Information Disclosure Statements to meet their duty to disclose obligations and protect their patent application filings.

Charles P. Romano, Ph.D. is a Senior Patent Agent in the MVS Biotechnology & Chemical Practice Group. To learn more, visit our MVS website, or contact Charley directly via email.

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