Rick Ball and Coleen Hill to Speak at MassMedic Regulatory Roundup Event

Duane Morris attorneys Rick Ball and Coleen Hill will speak at the MassMedic Regulatory Roundup Event webinar on February 16, 2023, starting at 9 a.m. Their presentation is titled “Recent Developments on the ‘Fraud on the FDA’ Theory of False Claim Liability” at 10:45 a.m.

This program is designed to give RA, QA and C-level executives updates on the global and domestic regulatory issues facing the industry. The agenda includes comprehensive presentations by CDRH, industry representatives and regulatory experts.

For  more information or to register, please visit the MassMedic website.

Year-End Appropriations Bill Overhauls FDA Cosmetics Authority

On December 23, 2022, Congress significantly expanded the FDA’s regulatory authority over cosmetics as part of its year-end Consolidated Appropriations Act of 2023, the first major statutory change to the Food, Drug and Cosmetics Act regarding the regulation of cosmetics since 1938. Passed with bipartisan support and garnering industry approval, the Modernization of Cosmetics Regulation Act contains a number of key provisions, requirements and dates for compliance.

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

Board Directors Beware: U.S. Antitrust Agencies Ramp Up Enforcement of Interlocking Directorates

The Antitrust Division of the Department of Justice (DOJ) has indicated a recent interest in enforcing Section 8 of the Clayton Act, which prohibits individuals from serving on boards of competing corporations, known as “interlocking directorates.” (See 15 U.S.C. § 19.) Assistant Attorney General Jonathan Kanter has called Section 8 an “important but underenforced” antitrust law. After DOJ announced a focus on Section 8, the agency reported that seven board members announced their resignations in response. Since then, DOJ has continued its focus on Section 8, issuing civil investigative demands and confidential investigation letters to firms, including private equity funds and investors. Life sciences companies, and companies that invest in the life sciences industry, should be on the lookout for interlocking directorates, as there is empirical evidence suggesting that the industry is particularly at risk of a Section 8 investigation.

Read the full text of this Alert on the firm website.

DOJ Announces an Enhanced Approach to Corporate Criminal Enforcement

On September 15, 2022, Deputy Attorney General Lisa O. Monaco of the Department of Justice (DOJ) delivered a speech at New York University addressing new guidance on corporate criminal enforcement. Her speech made it clear that DOJ is prioritizing investigations and prosecutions against corporate entities. DOJ’s approach in this area is fundamentally grounded in individual accountability and corporate responsibility. Building off those ideas, the new guidance provides for: (1) increased focus on individual liability; (2) consideration of the full criminal, civil and regulatory record of any company when deciding the appropriate resolution; (3) expanding voluntarily self-disclosure programs across DOJ; and (4) the consideration of compensation systems that reward or deter compliance when evaluating the strength of a company’s compliance program. Monaco also announced increased transparency and consistency by DOJ when determining issues related to monitors. DOJ intends these policies to communicate to corporate entities that it is “not accepting business as usual” and that personal liability and the specifics of a corporation’s cooperation and integration of compliance programs will be heavily scrutinized in criminal corporate prosecutions.

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

Broad Patent Prosecution Bars Risk Effectively Decoupling Complementary Patent Litigation and Prosecution Practices

Parties in the discovery phase of litigation often exchange confidential documents and information, which may contain proprietary information such as the technical aspects and know-how behind a party’s intellectual property. To facilitate the exchange of confidential information and prevent its misuse by parties to the litigation, courts often use an agreed protective order, which outlines the disclosure and dissemination of confidential information, proper use of such information (e.g., prosecuting or defending the instant action) and the return of confidential information following the conclusion of litigation and any appeals taken.

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

DOJ Filing Reawakens Fraud-On-The-FDA Theory Of Liability

On June 3, the U.S. Department of Justice Civil Division’s Washington, D.C., office filed a statement of interest in a relator’s action, arguing that “[c]onduct giving rise to a regulatory violation can also give rise to” False Claims Act liability.

The case is U.S. ex rel. Patricia Crocano v. Trividia Health Inc., before the U.S. District Court for the Southern District of Florida.

Specifically, the DOJ requested “that the ruling not foreclose the possibility that, under certain circumstances,” conduct that violates the Federal Food, Drug and Cosmetic Act or U.S. Food and Drug Administration regulations “could be material to the government’s payment decisions and provide a basis for FCA liability assuming all necessary FCA elements are demonstrated,”[3] colloquially known as “fraud on the FDA.”

This filing makes clear the DOJ’s decision to reawaken a theory of liability thought to be dead.

To read the full text of this article by Duane Morris attorneys Eric Breslin, Frederick R. Ball and Brittany Pagnotta, originally published in Law360, please visit the firm website.

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.

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

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.

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

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.

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

FTC Publishes Proposed Changes to Guides Concerning the Use of Endorsements and Testimonials in Advertising

The Federal Trade Commission (FTC) has announced proposed changes to its Endorsement Guides, 16 CFR Part 255, which assist entities in conforming endorsements and testimonials in advertising to the requirements of Section 5 of the FTC Act. FTC continues to review the guides, first published in 1980, as part of its ongoing regulatory review process.

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