Insights

New York – July 13, 2023: The National Law Journal has named Crowell & Moring partner Anne Elise Herold Li to its 2023 list of Emerging Therapies/Life Sciences Trailblazers. The list features lawyers who are “agents of change” and have made significant marks on their sector.

Washington – June 26, 2023: Intellectual Asset Management recognized Crowell & Moring in its IAM Patent 1000 – The World’s Leading Patent Practitioners guide, awarding the firm a gold band ranking as one of the top four firms handling patent litigation and transactions in Belgium, and a silver ranking for the firm’s Chicago office. The firm was also recommended nationally in the United States for trade secrets litigation. This marks the tenth consecutive year that the firm has been ranked in the guide in Belgium.

Washington – June 1, 2023: Crowell & Moring earned 82 rankings for 68 lawyers across 48 categories, as well as 37 national and statewide practice area rankings, in the Chambers USA 2023 guide. The rankings are driven by independent interviews of clients and lawyers at peer firms.

In Vanda Pharmaceuticals, Inc. v. United States, No. 23-629C (Fed. Cl. 2024), 2024 WL 201890, the Court of Federal Claims (COFC) addressed whether government disclosure of a company’s trade secrets and commercial information could create a viable claim for a taking under the Fifth Amendment or for breach of an implied-in-fact contract.  The company, Vanda Pharmaceuticals (Vanda), claimed that the government’s disclosure of its confidential trade secrets—including its trademarked drugs’ dissolution rates—to competitors seeking U.S. Food and Drug Administration (FDA) approval of generic drug alternatives was an unlawful regulatory taking that diminished the value of Vanda’s brand name drugs and infringed upon Vanda’s right to exclude generics from the market.  The government moved to dismiss Vanda’s claims for lack of subject matter jurisdiction and for failure to state a claim.  The COFC denied the government’s motion in part, holding as a matter of first impression that Vanda adequately stated a takings claim based on the government’s disclosures but failed to state a claim for breach of an implied-in-fact contract.  The COFC also held that Vanda’s claims involving one generic drug manufacturer were outside the Tucker Act’s six-year statute of limitations and were time barred. 

On November 7, 2023, the Federal Trade Commission (“FTC”) announced it is challenging over 100 patents as improperly listed in the Food and Drug Administration’s (“FDA”) publication titled “Approved Drug Products with Therapeutic Equivalence Evaluations,” which is commonly known as the Orange Book. The FTC sent warning letters to ten drug and medical device manufacturers identifying patents for inhalers, autoinjectors and anti-inflammatory multi-dose bottles that the FTC believes are improperly listed. In the letters, the FTC indicated it is using the FDA’s regulatory dispute process to challenge the listing of these patents in the Orange Book because improperly listing patents may violate antitrust laws and impede competition. The FTC’s actions appear to be consistent with its recent and increased scrutiny of the healthcare and pharmaceutical industries.

The case of Juno Therapeutics, Inc. v. Kite Pharma, Inc.[1]has captured the attention of the legal community and beyond, as it delves into the complex world of written description in patent law.  The Supreme Court recently made a significant decision in Juno by denying certiorari on appeal from the Federal Circuit.  On January 9, 2023, the Supreme Court denied Juno’s petition for rehearing.

More companies than ever before are launching smart medical devices and industry growth seems endless as new products and technologies are announced daily. However, before companies push products to market, it’s crucial to understand key aspects of device approval, and company and patient protection. In this webinar, our speakers will outline intellectual property strategies, U.S. Food and Drug Administration considerations, and data cybersecurity concerns that are inherent to all smart medical devices. They will explore the legal issues that can significantly decrease the risk profile and potential liabilities throughout a product's lifecycle and create safer, more reliable products for consumers.

This is a joint program between the Pauline Newman IP American Inn of Court and the Hon. William C. Conner American Inn of Court.

Listen on Apple Podcasts, Spotify and YouTube.