Expert Analysis

• How AstraZeneca Ruling Could Change Dosage Patent Claims

  

  If affirmed on appeal, the rationale employed by the Delaware federal court in Wyeth v. AstraZeneca to find "unit dosage"-related patent claims invalid could lead to a significant paradigm shift in how active-ingredient-focused patent applications are drafted and litigated, say Matthew Zapadka and John Schneible at Arnall Golden.

• Failed W.Va. Patent Challenge Reveals Secret Prior Art's Risks

  

  A West Virginia federal court's recent ruling — that references used by a patent challenger to establish an ordinarily skilled artisan's existing knowledge must be published before a patent's filing — may discourage claim construction challenges based on secret prior art and steer drafters away from externally defined terms, says Brianna Potter at Baker Botts.

• Navigating Decentralized Clinical Trials With FDA's Guidance

  

  The U.S. Food and Drug Administration's recently finalized guidance on conducting decentralized clinical trials, while not legally binding, can serve as a road map for sponsors, investigators and others to ensure trial integrity and participant safety, say attorneys at Phillips Lytle.

• The Bar Needs More Clarity On The Discovery Objection Rule

  

  Almost 10 years after Federal Rule of Civil Procedure 34 was amended, attorneys still seem confused about what they should include in objections to discovery requests, and until the rules committee provides additional clarity, practitioners must beware the steep costs of noncompliance, says Tristan Ellis at Shanies Law Office.

• How Patent Landscape Analysis Drives Business Growth

  

  Keegan Caldwell at Caldwell Law explores how patent landscape analysis serves as a key driver of sustainable growth — examining how its components, strategic advantages and implementation best practices are reshaping innovation leadership.

• In Terror Case, DC Circ. Must Weigh Justices' Twitter Ruling

  

  When the D.C. Circuit hears oral argument in AstraZeneca UK v. Atchley, how the court interprets the U.S. Supreme Court's 2023 ruling in Twitter v. Taamneh will have a significant impact on future claims brought under the Anti-Terrorism Act and Justice Against Sponsors of Terrorism Act, say attorneys at Lewis Baach.

• Marching In On Orange Book Drugs May Have Limited Effect

  

  Statistical analysis shows that marching in on Orange Book drug patent holders to require additional licensees would have a relatively minimal impact on drug prices, and should be weighed against the harms it could have on pharmaceutical innovation, say researchers at Competition Dynamics.

• Series

  Being A Navy Reservist Makes Me A Better Lawyer

  

  Serving this country in uniform has not only been one of the greatest honors of my life, but it has also provided me with opportunities to broaden my legal acumen and interpersonal skills in ways that have indelibly contributed to my civilian practice, says Phillip Smith at Weinberg Wheeler.

• Incoming Admin May Shake Up Life Sciences Regulation

  

  Though President-elect Donald Trump has not yet articulated policy priorities regarding the life sciences industry, the sector is positioned to see significant changes that could affect everything from drug exclusivity and generic drug approvals, to the availability of over-the-counter drugs, to laboratory-developed tests and digital health, say attorneys at Morgan Lewis.

• Next Steps In The $2.8B Blue Cross Payout To Providers

  

  Healthcare providers deciding whether to participate in Blue Cross Blue Shield network's recent $2.8 billion antitrust class action settlement must weigh key recovery factors, including provider type and litigation cost, say attorneys at Hall Render.

• So You Want To Move Your Law Practice To Canada, Eh?

  

  Google searches for how to move to Canada have surged in the wake of the U.S. presidential election, and if you’re an attorney considering a move to the Great White North, you’ll need to understand how the practice of law differs across the border, says David Postel at Henein Hutchison.

• What To Expect Next From Federal Health Tech Regulation

  

  Healthcare organizations should pay close attention to federal health information technology regulators' recent guidance concerning barriers to accessing electronic health information, which signals that more enforcement in this area is likely forthcoming, say attorneys at Ropes & Gray.

• Trump Rollback Of Biden Enviro Policies: What To Expect

  

  Donald Trump's upcoming second presidential term will usher significant shifts in U.S. environmental and natural resource law and policy — and while the Biden administration is racing to secure its legacy, the incoming Trump administration is making plans to dramatically roll back most, if not all, of Biden's environmental initiatives, say attorneys at Beveridge & Diamond.

• Takeaways From State Votes On Abortion In The 2024 Election

  

  Attorneys at Epstein Becker discuss how 10 states voted on ballot initiatives to either protect or restrict access to abortion in the 2024 general election, and analyze overarching trends.

• Key Territory-Split Licensing Lessons For Life Sciences Cos.

  

  Territory-split deals can allow life sciences companies to maximize products' potential across a range of geographic areas, but these deals also present unique challenges requiring highly bespoke structures that can make or break the value of an asset, say attorneys at Covington.