Life Sciences

Expert Analysis

• 4 Things FTC Competition Bureau Looks For In White Papers

  

  Most written advocacy to the Bureau of Competition is of an extremely high quality, but sometimes we notice that there’s some room for improvement, says Daniel Francis, an associate director at the Federal Trade Commission's Bureau of Competition.

• Preinstitution Submissions May Limit Certain ITC Probes

  

  Following recent rule changes, U.S. International Trade Commission determinations and decisions by the Federal Circuit, proposed respondents may be able to prevent or limit the scope of ITC Section 337 investigations if they act quickly using various types of preinstitution submissions, says Michael Doane of Miles & Stockbridge.

• Remembering Justice Stevens As A Law Firm Leader

  

  Rothschild Barry's John Coffey, who joined Justice John Paul Stevens' law firm in 1965, shares what it was like to watch Justice Stevens practice law, mentor younger lawyers and land a malfunctioning plane.

• A New Era For Human Genetic Resource Compliance In China

  

  This month, China's new regulations governing the management of human genetic resources came into effect, bringing stronger enforcement measures and much heavier liabilities that will require many companies, medical and research institutions, and universities to upgrade their compliance systems accordingly, say attorneys at Tian Yuan.

• Calif. Privacy Law's 3 Limited Exemptions For Health Cos.

  

  So that health and life sciences companies can better determine whether the information they collect is subject to the California Consumer Privacy Act, Jason Linder and Libby Jelinek of Irell & Manella address the scope of certain CCPA exemptions and identify the main areas of ambiguity.

• What High Court's Kisor Ruling Means For FDA Decisions

  

  The U.S. Supreme Court's decision in Kisor v. Wilkie, weakening Auer deference, gives courts more authority to challenge agency decisions — even those concerning very technical regulations, as many of the U.S. Food and Drug Administration's do, say attorneys at Axinn.

• Answers To Key Legal Finance Ethics Questions

  

  While there is discussion in some quarters about new regulations on commercial legal finance, the hands-off approach taken by the majority of courts and legislatures is an implicit recognition that it is already sufficiently regulated, says Danielle Cutrona of Burford Capital.

• Preemption Vs. Public Nuisance, In Aviation And Opioids

  

  A recent Iowa Supreme Court ruling concerning a local airport commission's authority to condemn a structure declared safe by the Federal Aviation Administration presents many of the same preemption questions that will play out in opioid litigation, says Richard Dean of Tucker Ellis.

• Federal Agencies Need A Uniform Record-Keeping Process

  

  The administrative record is very important to federal agency litigation — as showcased in last month's U.S. Supreme Court decision concerning the addition of a citizenship question to the 2020 census — yet there is no set of consistent principles to guide agencies in compiling these official records, say attorneys at WilmerHale.

• The Role Of Dictionaries In Last Term's High Court Decisions

  

  Since 32 of the 67 decisions issued by the U.S. Supreme Court during its October term cite dictionaries, it’s worth reviewing the opinions to learn which dictionaries the justices consulted and how they used them, say Bruce Wessel and Brian Weissenberg of Irell & Manella.

• How To Evaluate The Rise In Legal Employment

  

  Although the rate of employment for law school graduates — which had been falling steadily — saw a small increase over the last year, other factors, such as fewer graduates overall and potential future job growth stagnation, temper the good news for those pursuing law degrees, say Tiffane Cochran and Tyler Grimm of AccessLex Institute.

• Tips For Patenting And Protecting Wearable Technology

  

  The approach to patents practiced by fashion brands needs to evolve as technology’s integration into fashion becomes more frequent and complex, says Barry Lewin of Gottlieb Rackman.

• Foreign Investment In US Biotech Gets Greater Gov't Scrutiny

  

  Chinese investment in the U.S. biotech industry is attracting increased government oversight, as evidenced by the Committee on Foreign Investment in the United States blocking several such transactions in the last 16 months. Two important proposed rules could materially affect the industry further, say attorneys at Morgan Lewis.

• Biosimilar Patent Litigation Bill Would Change BPCIA Strategy

  

  If passed, the Affordable Prescriptions for Patients Act will limit the number of patents that can be raised in litigation under the Biologics Price Competition and Innovation Act, with significant repercussions for biosimilar applicants deciding whether to engage in a patent dance, say attorneys at Paul Hastings.

• Opinion

  The Business Case For Championing Diverse Legal Teams

  

  Leveraging the collective strengths of a diverse workforce is not only the right thing to do, it’s a strategic imperative for any successful firm or business, says Louise Pentland, executive vice president and chief business affairs and legal officer of PayPal.