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FDA Statements and Patent Disclosures


Medical Device companies often need the U.S. Food and Drug Administration (FDA) to approve “indications for use” of their products–for use selling them in the U.S.  Those same companies often seek U.S. patent protection so that they can profit from their inventions underlying those same products.  In both cases, the companies seek to persuade federal government agencies to approve their requests.  However, at a high level, these requests can seem to conflict.  For example, many times a company will seek to persuade the FDA that the product for which approval is sought is similar to previous products, reducing the amount of new safety testing required.  On the other hand, the company may seek to persuade the U.S. Patent and Trademark Office (USPTO) that any inventions underlying the product are different from previous products and inventions.  Recognizing the interests of companies seeking their approval, leaders of the FDA and USPTO exchanged letters to address how the two federal agencies could coordinate their work.

The main result for patent applicants was a federal register notice, where the USPTO emphasized that patent filers have a duty to disclose to the USPTO information “material to patentability.”  The notice stated that to uphold this duty a reasonable inquiry “may comprise reviewing documents that are submitted to or received from other Government agencies, including the FDA. If any reviewed document is material to the patentability of a pending matter before the Office . . . the party has a duty to submit the information to the USPTO.” 37 CFR 1.56.  By submitting a copy of FDA materials to the USPTO, the companies and their counsel can show “any statements made on their behalf to other Government agencies regarding the claimed subject matter, are consistent.”  87 Fed. Reg. 45766 (July 29, 2022).

For medical device companies, the action item is this: consider putting FDA counsel in touch with patent counsel so that FDA submissions can be reviewed and potentially submitted to the USPTO, if sufficiently relevant.  Cases cited in the same federal register notice indicate that courts have held company personnel–not just counsel–responsible, summarizing two cases as follows:

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). . . .

In 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 an official involved in both the FDA and the USPTO submissions chose to disclose material prior art to the FDA but not to the USPTO.

87 Fed. Reg. 45766 (July 29, 2022).  The notice continues with a reminder that “Activities or documents associated with market testing, marketing, or commercialization by the patent applicant can also be material to patentability, and therefore, when material, should be disclosed to the USPTO.”  Id.  In view of these cases and because materiality may be somewhat subjective, it may be safer to disclose even more than a company considers truly material to the patent process.

Notwithstanding the benefits of both FDA and patent approvals, medical device companies should tread cautiously (and provide consistent information) when seeking benefits from different federal government agencies.

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Philip Nelson

Philip Nelson counsels clients in all stages of growth, from startups to established public companies. To jump-start young portfolios, Mr. Nelson pioneered use of special programs to cut through red tape for rapid patent allowance. For those wanting to preserve options at minimal cost, he has a tested protocol. He especially enjoys laying sophisticated patent minefields, protecting core assets with an eye to the future concept and product pipeline. No matter when he joins the team, he quickly grasps the technology and points to the best options to support the business.

Mr. Nelson builds value for investment and acquisition by working with company visionaries and scientists to describe and protect their ideas. Although the patent office likes to say “no,” he works through the objections, often speaking to patent examiners in person to negotiate for better claims. Collegial persistence and technical tutorials tend to persuade examiners, getting them to “yes.”

Mr. Nelson drafts and negotiates technology agreements and advises on big-picture strategy. When opposing diligence counsel is just pasting in a pat phrase from a template, he uses his experience from the trenches (prosecuting, negotiating, and litigating) to correct the meaning and serve his clients.

Mr. Nelson advises on contested matters, drafts litigation briefs, and works closely with litigator colleagues. He negotiates with his clients’ adversaries to avoid suit or improve litigation positions. When a competitor claimed to own his client’s invention in chemistry lab instruments, he won two patent office “interferences”—and a Federal Circuit appeal—to preserve his client’s ownership rights. He handles complex patent office trials such as interferences, derivations, and inter-partes reviews. He did reexaminations and inter-partes reexaminations back before they were cool (before the America Invents Act popularized Board proceedings).

His physics background and widely varied experience at a top intellectual property boutique for almost 20 years has created a sophisticated advocate for his clients. Mr. Nelson looks forward to helping you assess the field, build your defenses, close your deal, and rain fire on your IP problems and adversaries.

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