Engagement announcement: USPTO and Regulatory Agencies Tie the KnotJuly 29, 2022

After many years of casual data sharing between agencies, the USPTO has formally announced its intentions to marry the duty of disclosure for patent prosecution with the regulatory process.  Today’s notice clarifies the scope of duties of inquiry and disclosure to the Patent Office, including for statements made to the FDA and other regulatory agencies that are inconsistent with statements submitted to the USPTO.

Traditionally inventors focus on points of novelty in patent applications, with data supporting the message that the invention is different from anything seen before.  However, when the product is regulated, converse arguments are often made with government agencies.  The invention in commercial form may be positioned to be substantially equivalent to what is already in the market. For the regulatory agencies, the story to be told from a risk perspective is that there is nothing new to see here – with supporting data as proof, comparing the new product side by side to existing products.  

With today’s notice, the Patent Office emphasizes that each individual with a duty of inquiry and duty to disclose should ensure that the statements made to the USPTO and regulatory agencies regarding claimed subject matter, are consistent. See Belcher Pharms., LLC v. Hospira, Inc., 11 F.4th 1345 (Fed. Cir. 2021) (affirming a district court’s determination of inequitable conduct because the patent owner’s Chief Science Officer failed to provide to the USPTO submissions he made to the FDA about the prior art that were inconsistent with positions taken before the USPTO during the prosecution of a pending patent application).

Specifically, providing material information to regulatory agencies such as the FDA, while simultaneously withholding the same information from the USPTO, undermines and is a clear violation of the duty of disclosure. See Bruno Independent Living Aids, Inc. v. Acorn Mobility Services, Ltd., 394 F.3d 1348, 1354 (Fed. Cir. 2005) (the U.S. Court of Appeals for the Federal Circuit inferred intent to deceive, and found inequitable conduct occurred when a party involved in both the FDA and the USPTO submissions chose to disclose material prior art to the FDA but not to the USPTO).

Today’s notice calls out that each individual with a duty of inquiry and duty to disclose should review documents it submits and receives from other government agencies, to determine whether the information should be submitted to the USPTO. Further, it states that simply choosing to separate patent from regulatory accountability does not relieve the applicant of this duty of disclosure: “walling off the patent prosecution practitioners from the attorneys seeking FDA approval, as a way to prevent material information from being exchanged between the practitioners and attorneys, is inappropriate.” (Notice, p. 45767 col. 1).

In addition, this duty is retroactive and an applicant must disclose to the USPTO any information that refutes, or is inconsistent with, a position the applicant takes in asserting an argument of patentability, or opposing an argument of unpatentability. If a party to a USPTO proceeding discovers that an earlier position taken in a submission to the USPTO or another regulatory agency was incorrect or inconsistent with other statements made by the party, the party must promptly correct the record. See, e.g., In re Tendler, Proceeding No. D2013-17 (USPTO Jan. 1, 2014) (suspending a practitioner for four years for failure to correct the written record after learning of inaccuracies in a declaration the practitioner had filed).

With today’s notice, the coordination of regulatory and patent strategies throughout the product lifecycle becomes more critical than ever.  The consequences of making inconsistent statements between the Patent Office and regulatory agencies, or failing to disclose to the USPTO information material to patentability that is submitted to/sent from regulatory agencies, are severe. Failing to abide by this new union between the Patent Office and regulatory agencies may result in patent application rejection, patent invalidity, a finding of fraud and/or inequitable conduct, and disciplinary action against the patent practitioner.

Cassie J. Edgar, Patent Attorney and Chair of the Regulatory Law practice group, advises clients in intellectual property, regulatory law, crisis management, compliance, stewardship, lobbying, and matters with USDA, FDA, EPA, and FTC. Cassie is also Co-Chair of the Data Privacy and Cybersecurity practice group. For additional information, please visit MVS or contact Cassie directly via email at cassie.edgar@ipmvs.com.

← Return to Filewrapper

Stay in Touch

Receive the latest news and updates from us and our attorneys.

Sign Up