Tech Transfer eNews Blog

USPTO to formally share data with other agencies to ensure consistency in claims


By Jesse Schwartz
Published: August 3rd, 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 in agencies such as the FDA, according to a post from Cassie Edgar of law firm McKee Voorhees & Sease.

The USPTO notice should serve as a caution to patentees that any claims of novelty made will need to be consistent with FDA and other regulatory filings, where the incentive is to argue for substantial similarity to previously approved drugs or devices.

“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,” Edgar points out.

Shirking the duty to disclose when filing for a patent – and making inconsistent claims to other agencies – will be viewed in a context of inequitable conduct, the USPTO notice states. It warns

That each individual with a 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,” the USPTO states.

In addition, this duty is retroactive. “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,” Edgar says.

She says the new notice is not to be taken lightly. “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,” Edgar stresses. “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.”

Source: Lexology

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