Expert Analysis

• A Closer Look At Proposed HHS Research Misconduct Rule

  

  The U.S. Department of Health and Human Services' proposed updates to its policies on research misconduct codify many well-known best practices, but also contain some potential surprises for the research community and counsel, say attorneys at Hogan Lovells.

• Incontinence Drug Ruling Offers Key Patent Drafting Lessons

  

  In a long-awaited decision in Astellas v. Teva and Sandoz, an English court found that the patent for a drug used to treat overactive bladder syndrome had not been infringed, highlighting the interaction between patent drafting and litigation strategy, and why claim infringement is as important a consideration as validity, says George McCubbin at Herbert Smith.

• Why Hemp-Synthesized Intoxicants Need Uniform Regs

  

  State laws regulating hemp-synthesized intoxicants are a patchwork with little consistency between any given state, and without the adoption of a uniform regulatory framework, producers and consumers alike will need to be very cautious, say Dylan Anderson and Seth Goldberg at Duane Morris.

• Opinion

  Life Sciences Regulators Must Write Cloud-Specific Guidance

  

  As cloud services continue to revolutionize the life sciences industry's ability to conduct regulated activities, the U.S. Food and Drug Administration and other regulators should update their data management policies to clearly support and encourage use of cloud technology, say Nate Brown and Marlee Gallant at Akin.

• Fed. Circ. Elekta Holding May Make Patent Prosecution Harder

  

  The Federal Circuit's recent analysis of obviousness in its Elekta v. Zap Surgical Systems decision will make prosecuting patents harder, as parties will now need to consider whether to argue that cited patents are nonanalogous, say Sean Murray and Jeremiah Helm of Knobbe Martens.

• Attorneys, Law Schools Must Adapt To New Era Of Evidence

  

  Technological advancements mean more direct evidence is being created than ever before, and attorneys as well as law schools must modify their methods to account for new challenges in how this evidence is collected and used to try cases, says Reuben Guttman at Guttman Buschner.

• Series

  ESG Around The World: The UK

  

  Following Brexit, the U.K. has adopted a different approach to regulating environmental, social and governance factors from the European Union — an approach that focuses on climate disclosures by U.K.-regulated entities, while steering clear of the more ambitious objectives pursued by the EU, say attorneys at Dechert.

• Boeing Opinion Strikes Blow Against Overpayment Theory

  

  The Fifth Circuit's decision in Earl v. Boeing Co. casts doubt on consumers' standing to bring claims of overpayment for products later revealed to have defects — and suggests that it's more likely that those products would have been removed from the market, driving up the price of alternatives, say attorneys at Bush Seyferth.

• Tips For Litigating Against Pro Se Parties In Complex Disputes

  

  Litigating against self-represented parties in complex cases can pose unique challenges for attorneys, but for the most part, it requires the same skills that are useful in other cases — from documenting everything to understanding one’s ethical duties, says Bryan Ketroser at Alto Litigation.

• What Pharma Cos. Must Know About FDA Off-Label Guidance

  

  The U.S. Food and Drug Administration recently issued draft guidance on how pharmaceutical companies should share research on off-label use of medical devices, outlining how firms could avoid enforcement action — especially when disseminating self-created content about their own products, say Jacqueline Berman and Maarika Kimbrell at Morgan Lewis.

• It's Time To Prescribe Frameworks For AI-Driven Health Care

  

  As health care providers begin to adopt artificial intelligence in clinical settings, new legal and regulatory challenges are emerging, with the critical issue being balancing AI's benefits and innovations in health care while ensuring patient safety and provider accountability, say attorneys at Kirkland.

• The Murky World Of IP Protection For Gene-Edited Plants

  

  The recently filed Corteva v. Inari lawsuit, which accuses a plant trait developer of using a front company for commercial development, underscores the legal challenges in protecting and determining the ownership of new, genetically edited plant varieties, and emphasizes why joint development arrangements must be carefully navigated, say Andrew Zappia and Tate Tischner at Troutman Pepper.

• New Initiatives Will Advance Corporate Biodiversity Reporting

  

  Two important recent developments — the launch of the Taskforce on Nature-related Financial Disclosures' framework on nature and biodiversity reporting, and Nature Action 100's announcement of the 100 companies it plans to engage on biodiversity issues — will help bring biodiversity disclosures into the mainstream, say David Woodcock and Maria Banda at Gibson Dunn.

• Opinion

  Alternative Patents Would Solve Many Inventor Woes

  

  A fundamental reform that gives inventors the option of alternative patents tailored to the value of an invention offers a potential solution for resolving patent-system problems, says John Powers of The Powers IP Law Firm.

• Class Action Defense: Don't Give Up On Bristol-Myers Squibb

  

  Federal appellate court decisions in the six years since the U.S. Supreme Court decided Bristol-Myers Squibb show that it's anyone's ballgame in class action jurisdictional arguments, so defendants are encouraged to consider carefully whether, where and when arguing lack of specific personal jurisdiction may be advantageous, say attorneys at K&L Gates.