Perspectives on Life Sciences

Personalized medicine patent claims have been under assault since the Supreme Court’s Mayo v. Prometheus decision.

Late last month, an advisor to the Court of Justice of the European Union issued an opinion recommending that plants produced using innovative breeding techniques, like gene editing, be regulated like conventionally-bred plants rather than under the EU’s genetically modified organism Directive, the

Arent Fox Health Care partner and co-practice group leader Stephanie Trunk was nominated by corporate counsel to the 2018 Client Choice™ award list for the District of Columbia. Client Choice™ recognizes law firms and partners that stand apart for the excellent client service they provide.

Three Department of Justice memoranda recently emerged that shed light on DOJ enforcement policies.

Karen Carr and Emily Leongini to Present at Q1’s Annual Food Labeling Conference. Arent Fox partner Karen Carr and associate Emily Leongini are scheduled to speak at the Q1 Productions’ 5th Annual Food Labeling Conference.

Arent Fox will host the reception for the New York State Bar Association’s (NYSBA’s) Food, Drug & Cosmetic Law Section Annual Meeting on January 25th, 2018 in its New York office.

A federal district court in Florida earlier this month reversed a jury verdict and vacated a $350 million False Claims Act award, joining the growing number of courts to strictly apply the materiality standard set by the US Supreme Court.

As was widely reported, Congress approved legislation late Monday, January 22, 2018 to provide continuing appropriations for federal agencies through February 8, 2018, ending the government shutdown that began Saturday.

This year brought us very significant changes in patent jurisprudence from the Supreme Court and Federal Circuit affecting Chemical & Life Sciences patent practice.

Recently, the FDA announced that it does not intend to enforce certain provisions in four of the rules that implement the FDA Food Safety Modernization Act. 

The Pharmaceutical Research and Manufacturers of America (PhRMA) filed a lawsuit against the state of California in response to the state’s new drug price law. 

The US Food and Drug Administration recently issued warning letters to four companies.

On November 8, 2017, the Federal Trade Commission held a workshop entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.”

Twenty-two Arent Fox LLP practices have been recognized in the 2018 “Best Law Firms” rankings that are published annually by U.S. News & World Report and Best Lawyers.

When the National Bioengineered Food Disclosure Standard was signed into law last year, it represented the culmination of an extended period of regulatory and legislative activity on food labeling issues.

The US Department of Agriculture needs to strengthen its controls over the approval and oversight of agreements for the import of organic products into the US, according to a recent audit report issued by the Office of the Inspector General at USDA.

The food industry potentially faces a new challenge on disclosure at the local level with the recent passage of a San Francisco ordinance addressing antibiotic use.

In August 2016, the Food and Drug Administration issued a final rule to update and clarify the agency’s drug registration and listing regulations.

While acknowledging some notable challenges, a recent USDA study concluded that most consumers seeking information on their food purchases would be able to access this information, given the proper education and tools to do so.

Last week, FDA Commissioner Gottlieb issued a statement describing the Agency’s “new” policy for regulating stem cell therapies and regenerative medicine. 

Forty-two Arent Fox LLP attorneys have been rated as leaders in their profession by The Best Lawyers in America 2018.

On July 21, the US District Court for the District of Columbia upheld FDA’s authority to regulate e-cigarettes and other electronic nicotine delivery systems (“ENDS”) as though they are tobacco, even though these products do not actually contain tobacco. 

One of the primary reasons the United States lacks a national animal identification system is the fervent perception among farmers and ranchers that such a system would result in government control over their livestock and an invasion of privacy.

On July 18, 2017, FDA held a public meeting to address efforts to ensure a balance between innovation in drug development and accelerating the access of the public to lower-cost alternatives to innovator drug therapies is maintained under the Drug Price Competition and Patent Term Restoration Act.