Life Sciences

Expert Analysis

• Series

  Pursuing Wellness: Steps Toward A Supportive Firm Culture

  

  As an early advocate of the American Bar Association's year-old well-being pledge, we launched an integrated program to create and sustain a supportive workplace culture with initiatives focused on raising mental health awareness, embracing creativity and giving back to the community, says Casey Ryan at Reed Smith.

• Stats Show Cannabis Patents Are Underutilized

  

  Recent case law developments and analysis of U.S. Patent and Trademark Office data reveal that the legal status of cannabis in the U.S. may have depressed inventing vis-a-vis Canada and that design patents are a missed opportunity for cannabis companies, says Joshua Glucoft of Irell & Manella. 

• CFIUS Risk Review Rules May Draw Attention To US Biotech

  

  The Committee on Foreign Investment in the United States' critical technologies pilot program has had relatively minor impact on the U.S. biotech industry in the last year, but proposed rules unleashed by the Foreign Investment Risk Review Modernization Act will soon reshape the relationship between the government and the biotech industry, says Richard Matheny of Goodwin.

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  Pursuing Wellness: Mental Health Education As A Firm Priority

  

  Our firm drives a holistic concept of well-being through educational opportunities, such as a series of expert-led workshops intended to address mental health and substance abuse issues that we vowed to fight when we signed the American Bar Association's well-being pledge one year ago, says Krista Logelin at Morgan Lewis.

• GAO Report Illuminates Insurer Influence On Drug Discounts

  

  A recent report by the U.S. Government Accountability Office on Medicare Part D drug prices provides novel insights concerning the variability of negotiated discounts across drugs and insurers, and reveals several factors that may be responsible for the fluctuation in rebating across health insurance plans, say consultants at Analysis Group.

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  Pursuing Wellness: A Firm's Work With Mental Health Experts

  

  Signing the American Bar Association's well-being pledge last year was a natural progression of our firm's commitment to employee wellness, which has included developing partnerships with professionals in the mental health space to provide customized programming to firm attorneys and staff, say Annette Sciallo and Mark Goldberg at Latham.

• Searching For A Legal Pathway For CBD Products

  

  Sales of products containing CBD are booming, but companies selling them are still faced with a regulatory quagmire, struggling to understand how to legally promote, label and distribute CBD consumables in light of gridlock at the U.S. Food and Drug Administration and inconsistent state laws, say attorneys at DLA Piper.

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  Pursuing Wellness: When A Firm Brings Counseling On Site

  

  One year ago, our firm signed the American Bar Association's well-being pledge and embraced a commitment to providing on-site behavioral health resources, which has since become a key aspect of our well-being program, say Meg Meserole and Kimberly Merkel at Akin Gump.

• Outsourcing Facilities Face Rising Drug Compounding Risks

  

  Recent actions by the U.S. Food and Drug Administration and lawsuits filed by drug manufacturers indicate that it is more important than ever for outsourcing facilities to comply with FDA policies regarding bulk drug substances allowed for use in compounding, say attorneys at Ropes & Gray.

• Foreign Patentees, Heed Fed. Circ. Jurisdiction Ruling

  

  As a result of the Federal Circuit's recent holding in Genetic Veterinary Sciences v. Laboklin that consenting to a cease-and-desist letter was sufficient to provide specific personal jurisdiction, foreign patent holders should pay careful attention to their license agreements and their enforcement and commercial activities within the U.S., say Daniel Melman and Sarah Benowich of Pearl Cohen.

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  Pursuing Wellness: Inside A Firm Meditation Program

  

  After our firm signed the American Bar Association’s well-being pledge one year ago, we launched two key programs that included weekly meditation sessions and monthly on-site chair massages to help people address both the mental and physical aspects of working at a law firm, says Marci Eisenstein at Schiff Hardin.

• 2 Fed. Circ. Decisions May Signal Pro-Patentee Swing

  

  The Federal Circuit's recent patent decisions in Ajinomoto v. U.S. International Trade Commission and Eli Lilly v. Hospira — on the tangential relation exception to the doctrine of equivalents — indicate that prosecution history estoppel may be becoming more favorable to patentees, says Sarah Kagan of Banner Witcoff.

• Top 5 Modern Tax Challenges For Digital Health Companies

  

  As jurisdictions around the world adapt and modernize to capture revenue that would otherwise escape taxation under frameworks put in place long before today’s technology existed, digital health companies face rising tax uncertainty, say Kathleen Gregor and Elizabeth Smith of Ropes & Gray.

• Early Sampling Of Electronic Info Is Underutilized In Discovery

  

  The early and prompt provision of samples from all electronically stored information sources as a part of ESI protocol search methodology is consistent with the Federal Rules of Civil Procedure and may allow for significant cost savings during discovery, says Zachary Caplan at Berger Montague.

• Dissent Exposes Flaws In Fed. Circ. ANDA Patent Holding

  

  In Nalpropion v. Actavis — a recent abbreviated new drug application case in the Federal Circuit centered on patent claim interpretation, the written description requirement and the substantial equivalence rule — the dissent reached a conclusion that is more consistent with years of jurisprudence than the majority's, says Daniel Pereira of Oblon McClelland​​​​​​​.