Duane Morris Life Sciences Law

July 22, 2022 by Duane Morris

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.

July 7, 2022 by Duane Morris

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.

June 28, 2022 by Duane Morris

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.

June 28, 2022 by Duane Morris

DOJ Clarifies Position on Fraud-on-the-FDA Theory of False Claims Act Liability

On June 3, 2022, the Civil Division of the Department of Justice filed a statement of interest in a relator’s action in the Southern District of Florida, arguing that “[c]onduct giving rise to a regulatory violations can also give rise to [False Claims Act] liability.” Specifically, requesting “that the ruling not foreclose the possibility that, under certain circumstances, conduct giving rise to violations of the [Federal Food, Drug and Cosmetic Act] or FDA regulations could be material to the government’s payment decisions and provide a basis for FCA liability assuming all necessary FCA elements are demonstrated,” also known as “fraud on the FDA.”

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

April 21, 2022 by Duane Morris

FDA’s Guidance Creates Administrative Burden for Animal Drug Compounding Documentation

On April 13, 2022, the FDA issued Guidance for Industry #256 about the enforcement policy regarding the compounding of animal drugs from bulk drug substances by or under the direct supervision of veterinarians or pharmacists in either state-licensed pharmacies or federal facilities. FDA has spent several years and gone through multiple iterations trying to develop new industry guidance on compounding animal medications. While changes have been made from previous iterations, FDA has implemented significant administrative burdens for documentation of clinical need and limitations on drug substances that can be compounded for office use.

FDA has taken the current position that drugs compounded from bulk substances violate the Federal Food, Drug and Cosmetic Act (FD&C Act) because they are not approved or indexed, are not made according to current good manufacturing practice and cannot satisfy the FD&C Act’s adequate directions for use provision. However, FDA has generally refrained from taking enforcement action against animal drugs compounded from bulk drug substances under certain circumstances when no other medically appropriate treatment options exist. Especially for animal drugs, compounding plays a crucial role in providing medically appropriate treatments for a wide variety of species of all different shapes and sizes―specifically, those for whom a single dosage form or level will not be medically appropriate.

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

April 11, 2022 by Duane Morris

Rick Ball to Speak at FDLI’s Introduction to Drug Law and Regulation Event

Duane Morris partner Rick Ball will be a speaker at FDLI’s “Introduction to Drug Law and Regulation,” a virtual course to be held on April 28, 2022. Mr. Ball’s topic will be “Violations and Enforcement.”

About the Program

Explore the essentials of drug law and regulation and gain a comprehensive understanding of the administrative agencies that impact this industry. Learn about patent and exclusivity issues, Rx to OTC switches, Good Manufacturing Practices (GMP), advertising and promotion, compliance, enforcement, and related issues. Case studies, hypotheticals, and ample time for Q&A are provided.

To learn more about this program and register, please visit the FDLI website.

March 16, 2022March 16, 2022 by Duane Morris

FDA Final Guidance on Initiating Voluntary Recalls: Be “Recall Ready”

On March 4, 2022, FDA issued a final guidance to industry and FDA staff regarding the initiation of voluntary recalls under 21 CFR part 7, subpart C. The guidance applies to voluntary recalls of products subject to FDA’s jurisdiction, including any:

1. Food, drug and device (human or animal use);
2. Cosmetic and biological product (human use);
3. Tobacco product;
4. Item subject to a quarantine regulation under 21 CFR part 1240; and
5. Devices that are electronic products regulated as radiology devices (subject to 21 CFR part 892) but not electronic products subject to 21 CFR parts 1003 and 1004.

In short, the final guidance clarifies FDA’s recommendations on how a firm should be prepared to facilitate the timely initiation of voluntary recalls, steps a firm should take if there is an indication of a problem with a distributed product and how to initiate voluntary recalls. The final guidance also explains how FDA works with firms to initiate a voluntary recall.

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

February 10, 2022 by Duane Morris

District Court of Delaware Rules for Generic Pharma’s Use of Skinny Label, but Permits Induced Infringement Suit to Proceed Against Insurer

In the recent opinion of Amarin Pharma v. Hikma Pharms. U.S., the District Court of Delaware dismissed Amarin’s complaint against Hikma for induced infringement of three patents when Hikma used a skinny label to carve out a patented indication. However, the court held that Amarin sufficiently pled to proceed with the complaint against an insurer, Health Net, for induced infringement.

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

January 13, 2022January 13, 2022 by Duane Morris

Pharmaceutical Research and Manufacturers of America’s Revised Code Takes Effect

On January 1, 2022, the updated Code on Interactions with Health Care Professionals, published by the Pharmaceutical Research and Manufacturers of America (PhRMA), became effective. The updates reflect fraud and abuse concerns voiced by the Department of Health and Human Services’ Office of Inspector General in its November 2020 Special Fraud Alert. While it is not a legal document, companies that adopt the code’s rules are more likely to comply with federal fraud and abuse laws like the Anti-Kickback Statute.

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

December 13, 2021 by Duane Morris

DOJ Reinstates and Augments Prior Corporate Criminal Enforcement Policies

On October 28, 2021, Deputy United States Attorney General Lisa Monaco issued a memorandum marking the first major announcement on corporate criminal enforcement from the Department of Justice (“DOJ”) under the Biden Administration (“Monaco Memo”). Most notably, this memorandum: (1) reinstates the Individual Accountability Policy originally announced in the Yates Memo and (2) guides prosecutors to look at all prior misconduct, not just those instances similar to the misconduct at issue in the present investigation.

To read the full text of this post by Duane Morris attorneys Rick Ball, Eric Breslin and Brittany Pagnotta, please visit the Duane Morris White-Collar Criminal Law Blog.