Coordinating IP and Regulatory Filings Can Minimize the Risk of Inequitable Conduct Before the PTO

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. 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 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.

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The Other Side of the Coin: Diligent Patent Prosecution Does Not Lead to Unreasonable Delay and Application of Prosecution Laches

The backlog of pending patent applications at the USPTO is growing. As of May 2022, the USPTO estimates an average pendency of approximately 20 months from filing to the mailing of a first office action. Applicants may be tempted to take advantage of and exploit the patent system to unreasonably delay prosecution and extend the patent term of a patent family member far beyond the lifetime of the original parent application. To prevent this gaming of the patent system in the hopes of extending patent term and to prevent prejudice to others, the equitable affirmative defense of prosecution laches may be raised to render an asserted patent unenforceable.

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Silence Is Not Necessarily Golden for Negative Patent Claim Limitations

During the prosecution of a patent application before the U.S. Patent and Trademark Office, claim amendments that introduce a negative limitation―the exclusion of a particular element or feature from the scope of the claims―may be dispositive in distinguishing the instant application from the prior art and advance the application toward allowance. However, the introduction of negative limitations may raise questions and issues as to whether the claims satisfy the written description requirement under 35 USC §112(a). Recently, the U.S. Court of Appeals for the Federal Circuit elaborated upon what satisfies the written description requirement with respect to the recitation of negative claim limitations.

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Who Watches the Watchmen? Supreme Court to Decide Fate of Administrative Patent Judge Appointments

The Supreme Court of the United States is to decide the fate of administrative patent judges of the Patent Trial and Appeal Board, namely whether the current appointment scheme violates the Appointments Clause of the U.S. Constitution. This case, which may have broad implications on post-grant proceeding process before the USPTO, is being watched by companies around the world.

To read the full text of this Duane Morris Alert, please visit the firm website.

Forum Selection Clause Held Inapplicable for Precluding Inter Partes Review Before the Patent and Trial Appeal Board

Confidentiality agreements or nondisclosure agreements (NDAs) are generally one of the first documents that in-house counsel require teams to execute when exploring licensing and/or research opportunities with third parties. NDAs are meant to protect the confidential information of one or both parties while each party determines whether the collaboration is worth pursuing. However, in a recent case in the Southern District of New York, one party tried to invoke a forum selection clause of an NDA to prevent the other party from challenging patents using inter partes review at the USPTO’s Patent Trial and Appeal Board.

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Numerical Ranges: More Than Just Endpoints in Patent Process

On February 11 and 12, 2020, the United States Patent and Trademark Office held a series of webinars covering the interpretation of ranges during the prosecution of patent applications. The following is a brief report and summary of the covered material.

Numerical ranges provide more than just two particular endpoints for a set of data within patent applications. The interpretation of a claimed numerical range when compared with disclosed numerical ranges in the prior art, assuming the claimed invention recites the other limitations of the prior art, can form the basis for an anticipation rejection based on 35 U.S.C. § 102, an obviousness rejection under 35 U.S.C. § 103, or an alternative grounds rejection under both 35 U.S.C. §§ 102/103.

View the full Alert on the Duane Morris LLP website.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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