Insights

Washington – September 5, 2023: The Lawyers’ Committee for Civil Rights Under Law, with legal support of Crowell & Moring, has filed an amicus brief in American Alliance for Equal Rights vs. Fearless Fund Management LLC. The brief defends remedial programs designed to combat longstanding, systemic discrimination, pushing back on claims that such programs constitute unlawful racial discrimination against white business owners.

Orlando, Fla.– June 22, 2023: The Florida Commission on Offender Review has denied parole to Crosley Green, ruling that his tentative parole release date will be in 2054, when he will be 97 years old. The 65-year-old grandfather has already served 32 years in prison, including 19 years on death row, for a Brevard County murder that he did not commit.

On July 3, 2019, in United States ex rel. Johnson v. Raytheon Co., the U.S. District Court for the Northern District of Texas granted the government’s motion to dismiss a qui tam suit over the objections of the relator. The Johnson case is just the latest example of the Department of Justice (DOJ) using its authority under Section 3730(c)(2)(A) of the False Claims Act to seek dismissal of meritless qui tam suits, consistent with a January 2018 DOJ Memorandum emphasizing the importance of that authority (the “Granston memo”).

On Monday, DOJ moved to dismiss ten kickback-related FCA complaints against thirty-eight major pharmaceuticals companies and commercial-outsourcing vendors. The number of motions is striking in itself, because DOJ has rarely used that authority in the past, moving to dismiss approximately thirty FCA cases from 1986 to 2011. Monday’s filings reinforce a trend of increased dismissals since the Granston Memo. And they follow on the heels of a high-profile announcement that DOJ is prepared to seek dismissal in Gilead Sciences, Inc. v. United States ex rel. Campie, on which we reported here. The motions demonstrate that the Granston Memo has teeth and suggest a narrower interpretation of the Anti-Kickback Statute that may offer some relief to the pharmaceutical industry, which has long been a primary target of FCA enforcement.

Last Tuesday, the Federal Circuit unanimously held that all biosimilar companies – even companies that participate in the so called “patent dance” – must notify brand-name rivals of their intent to sell a biosimilar drug 180 days before marketing the drug. The case, Amgen Inc., v. Apotex Inc. could have major implications for the timing of when biosimilar companies launch their drugs.

Several litigation trends set in motion by recent  events continued in 2018 and have now become the “new normal.” In 2018, D. Delaware, as predicted, overtook E.D. Texas for the largest number of patent cases filed, a trend set in motion by the May 2017 Supreme Court decision in T.C. Heartland, which made personal jurisdiction for corporations a driving force in patent litigation forum selection. Another continuing trend: trade secret litigation has skyrocketed—tripled since 2016. This is no anomaly. Macro trends like the digitization of intellectual property, surging employee mobility, and reduced patent protection for software and business methods have combined with the Defend Trade Secrets Act of 2016 to make trade secret litigation an increasingly popular and effective tool for protecting high-tech assets. D. New Jersey has the most product liability filings, in large part due to the Johnson & Johnson Talcum Powder Products Liability Litigation multidistrict litigation (MDL) filed in the last months of 2017. But D. New Jersey is also the most frequent venue for non-MDL medical device and pharmaceutical product cases, due to the large number of device and drug manufacturers headquartered in that venue, again based on T.C.Heartland.

While past events are no guarantee of the future, certain litigation trends can be useful barometers. For example, the national downward trend for patent litigation has continued since the advent of the America Invents Act. But while the overall trend is downward, E.D. Texas still maintains its place as the most popular location for new patent cases—at least for now. But that trend may not hold. Patent case filings in D. Delaware have exploded due to the Supreme Court’s May 2017 decision in TC Heartland, and Delaware is now a close second to E.D. Texas. N.D. California also saw a dramatic rise in patent filings. Instead of flocking to E.D. Texas, patent owners are pivoting to D. Delaware and N.D. California, where venue can be established based on corporate headquarters. While E.D. Texas may still have more total IP filings due to its pre-TC Heartland head start, since that decision, Delaware has had the most filings and that trend will continue. Another trend is the dramatic increase in antitrust filings in E.D. Pennsylvania, which is largely due to the many pharmaceutical companies based there, and the In re: Generic Pharmaceuticals Pricing Antitrust Litigation, which is ongoing.

Crowell & Moring’s Advertising & Product Risk Management Group presents our second annual seminar on crisis management.  Legal, business and public relations professionals will examine ways to reduce, and in some cases, eliminate the risk of a product crisis throughout the product lifecycle. From concept design through product launch, our panelists will discuss their approaches to minimizing the risk of product defects, port seizures, advertising claims, and class action litigation.

Join us in celebrating 22 years of commitment to diversity and inclusion in California’s legal profession at our upcoming 22nd Annual Business Conference, October 5th-6th, 2011 at the Marriott Hotel, Downtown Los Angeles.

Keith Harrison is one of the speakers at this symposium. The topic is "New US Patient Protection and Affordable Care Act: What’s in for Biosimilars?"

Courthouses across the country are restarting and rethinking trials amid the coronavirus pandemic. This webinar will address what actions judges and courts are taking to conduct safe trials, including all virtual proceedings. Crowell & Moring’s experienced trial attorneys will discuss both best practices and important considerations to consider as matters navigate through the system. This panel of experts will weigh in on: