Category Archives: Uncategorized

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.

FDA Revises Policies and Procedures for Prioritization of ANDAs in New MAPP

On January 30, 2020, the U.S. Food & Drug Administration (FDA) issued a new Manual of Policies & Procedures (MAPP) concerning how it will prioritize internal review of abbreviated new drug applications (ANDAs), amendments and supplements.

Whether a submission qualifies for priority designation can mean a substantial difference in approval time. As the FDA explains, it “may grant an ANDA submission either a shorter review goal date or an expedited review” if the submission satisfies a public health priority (or prioritization factor) described in the MAPP.

View the full Alert on the Duane Morris LLP website.

Spate of FDA and FTC Warning Letters Sets Stage for Wave of False Advertising Consumer Class Action Lawsuits

Since the 2018 Farm Bill passed in December 2018, removing hemp from the Controlled Substances Act and thus legalizing it under federal law, consumer goods containing the hemp-derivative cannabidiol (CBD) have become exceptionally popular. With that growing popularity among consumers has come increased scrutiny by federal regulators whose mission is consumer safety and protection, such as the Food and Drug Administration and Federal Trade Commission, and now by the plaintiffs’ bar, which files consumer class actions based on advertising. As the recent spate of warning letters and consumer class actions demonstrate, hemp-derived CBD product manufacturers and others in the supply chain for those products have to be mindful of the claims they make to consumers about their products.

View the full Alert on the Duane Morris LLP website.

With a Flurry of Warning Letters and a Consumer Update, FDA Signals Commitment to CBD Enforcement Policy

On November 25, 2019, the U.S. Food & Drug Administration (FDA) announced that it had issued warning letters to 15 U.S. businesses engaged in the sale of products containing cannabidiol (CBD); that it had published a revised Consumer Update detailing safety concerns about CBD products; and that it “cannot conclude that CBD is generally recognized as safe (GRAS)” for use in human or animal food. These actions and statements by FDA cut against industrywide hopes that FDA might soon realign its enforcement policy in light of market realities.

View the full Alert on the Duane Morris LLP website.

FDA’s Bark May Be Worse Than Its Bite: Revised Guidance Permits Certain Compounding of Animal Drugs from Bulk Drug Substances

On November 19, 2019, the U.S. Food and Drug Administration (FDA) released revised guidance concerning the compounding of animal drugs from bulk drug substances—in particular, the circumstances under which the FDA would not plan to take enforcement action for certain violations of the Federal Food, Drug, and Cosmetic Act (FDCA) when pharmacists and veterinarians compound or oversee the compounding of animal drugs from bulk drug substances. The guidance is intended to replace a withdrawn draft guidance concerning the compounding of animal drugs initially released in May 2015.

View the full Alert on the Duane Morris LLP website.

In a Regulatory “One-Two,” FDA Modifies Terms of Oversight Concerning Homeopathic Drugs

Late last week, the FDA—in denying a citizen petition and issuing two Federal Register notices—modified published guidance on the manufacture and distribution of homeopathic drugs and declined to convert a current policy guide (CPG) provision into an official regulation. Importantly, the FDA cautioned industry participants and consumers alike that its CPG withdrawal “does not represent a change in the legal obligations that apply to homeopathic drugs”; rather, the CPG—issued in 1988—merely no longer reflects the “current thinking” of the FDA, as it is inconsistent with the agency’s “risk-based approach to enforcement generally.”

View the full Alert on the Duane Morris LLP website.

FDA Proposes Labeling Recommendations for Complications Linked to Breast Implants

On October 24, 2019, the Food and Drug Administration (FDA) announced new draft guidance entitled “Breast Implants—Certain Labeling Recommendations to Improve Patient Communication.” The draft guidance “contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants.”

In its announcement, FDA noted that it has received “new information pertaining to risks associated with breast implants, including breast implant-associated anaplastic large cell lymphoma” and additional illnesses attributed to breast implants. Complications related to breast implants have been widely reported over the last year, with other symptoms, including increased presence of autoimmune disease in women who have received breast implants, as well as muscle and joint pain, fatigue and weakness, and certain cognitive difficulties. These proposed labeling requirements also follow FDA warnings issued to two implant manufacturers who had failed to carry out adequate postmarket surveillance of the implants as a condition of their approval, as well as an FDA request that another manufacturer recall certain textured breast implant products.

View the full Alert on the Duane Morris LLP website.

Federal Agencies Issue Draft Guidance for Drug Master Files for First Time in 30 Years

For the first time since September 1989, federal agencies have issued draft guidance concerning drug master files (DMFs), submissions to the FDA that may be used to provide confidential, detailed information concerning the manufacturing, processing, packaging and storing of human drug products. Notably, the release of this draft guidance comes on the heels of a recent executive order by President Trump aiming to curb the use of agency guidance documents to avoid the formal rule-making process.

View the full Alert on the Duane Morris LLP website.

Discovery Ruling in District of Minnesota May Have Far-Reaching Implications for FCA Defendants

In a concise, six-page discovery order, a federal judge in Minneapolis may have just started the proverbial shifting of tectonic plates undergirding routine defense procedures in False Claims Act (FCA) litigation by requiring a defendant in an FCA lawsuit to produce the information provided to the Department of Justice (DOJ) during the DOJ’s process of determining whether to pursue the matter.

The FCA creates liability for persons or entities found to have knowingly submitted false claims to the government or having caused others to do so. Like some other federal laws, the FCA creates a private right of action; under the act, a private party—a whistleblower or “relator”—may bring a qui tam action on behalf of the government. When initially filed, the court seals the complaint pending the government’s investigation of the case. If the government chooses, it may intervene and pursue the matter. If not, the relator may pursue the case on its own. (In either case, the relator is entitled to a percentage of the government’s recovery.)

View the full Alert on the Duane Morris LLP website.

BYOD and eCOA: A Match Made in Heaven?

This was originally published in the Food and Drug Law Institute’s Update magazine.

Patient-focused drug development and the selection and development of Clinical Outcome Assessments (COA) continue to be a focus for the U.S. Food and Drug Administration (FDA). At the same time, we continue to see an increase in technology available at our fingertips and on our wrists. As electronic capture of data becomes more robust and systems to ensure its integrity are put into place, FDA has started to embrace electronic clinical outcome assessments (eCOA). This increase opens up a plethora of new data sources that can be used to facilitate and enhance clinical trials, including the use of a study subject’s own devices (a/k/a “bring your own device” (BYOD)). This article discusses eCOA, BYOD, and FDA’s guidance on their use in clinical studies.

For the full article by Frederick R. Ball, Carolyn A. Alenci and Sandra Stoneman, visit the Duane Morris LLP website.