Expert Analysis

• A Look At FDA's Plans To Establish New OTC Drug Category

  

  The U.S. Food and Drug Administration's recently finalized rule, creating a new over-the-counter pathway for drugs when patients satisfy certain conditions, may be useful for off-patent drugs with established safety records, though switching to OTC comes with additional costs and considerations, say attorneys at Skadden.

• The Fed. Circ. In 2024: 5 Major Rulings To Know

  

  In 2024, the Federal Circuit provided a number of important clarifications to distinct areas of patent law – including design patent obviousness, expert testimony admissions and patent term adjustments – all of which are poised to have an influence going forward, say attorneys at Knobbe Martens.

• Rethinking Litigation Risk And What It Really Means To Win

  

  Attorneys have a tendency to overestimate litigation risk before summary judgment and underestimate risk after it, but an eight-stage litigation framework can clarify risk at different points and help litigators reassess what true success looks like in any particular case, says Joshua Libling at Arcadia Finance.

• Patent Ruling Sheds Light On Printed Matter Doctrine

  

  Patent attorneys should pay attention to the claim language highlighted in Ioengine v. Ingenico, where the Federal Circuit held that program code was not printed matter, but essentially instructions or content, and therefore not subject to the printed matter doctrine for patent challenges, says Irah Donner at Manatt.

• How DOGE's Bite Can Live Up To Its Bark

  

  All signs suggest that the Department of Government Efficiency will be an important part of the new Trump administration, with ample tools at its disposal to effectuate change, particularly with an attentive Republican-controlled Congress, say attorneys at K&L Gates.

• US-China Deal Considerations Amid Cross-Border Uncertainty

  

  With China seemingly set to respond to the incoming U.S. administration's call for strategic decoupling and tariffs, companies on both sides of the Pacific should explore deals and internal changes to mitigate risks and overcome hurdles to their strategic plans, say attorneys at Covington.

• Considering The Status Of The US Doctrine Of Patent Misuse

  

  A recent Ninth Circuit decision and a U.K. Court of Appeal decision demonstrate the impact that the U.S. Supreme Court's 2015 decision in Kimble v. Marvel Entertainment has had on the principle that post-patent-expiration royalty payments amount to patent misuse, not only in the U.S. but in English courts as well, say attorneys at Covington.

• Series

  Playing Rugby Makes Me A Better Lawyer

  

  My experience playing rugby, including a near-fatal accident, has influenced my legal practice on a professional, organizational and personal level by showing me the importance of maintaining empathy, fostering team empowerment and embracing the art of preparation, says James Gillenwater at Greenberg Traurig.

• Opinion

  No, Litigation Funders Are Not 'Fleeing' The District Of Del.

  

  A recent study claimed that litigation funders have “fled” Delaware federal court due to a standing order requiring disclosure of third-party financing, but responsible funders have no problem litigating in this jurisdiction, and many other factors could explain the decline in filings, say Will Freeman and Sarah Tsou at Omni Bridgeway.

• Patent Policy Changes To Track Under New Gov't Leadership

  

  The new federal government will likely bring pivotal shifts in U.S. patent policy through legislation and initiatives that reflect a renewed focus on strengthening intellectual property rights, fostering innovation and enhancing the nation's competitive edge, says PK Chakrabarti at Butzel Long.

• Opinion

  Congress Should Finally Add Clarity To Section 101

  

  With both the U.S. House of Representatives and Senate introducing bills to provide guidance on what qualifies as patentable subject matter under the Patent Act, Congress will hopefully put an end at last to 10 years of uncertainty surrounding the question, says David Carstens at Carstens Allen.

• 5 Advertising Law Trends To Watch In 2025

  

  Although advertisers are encouraged by the incoming Trump administration's focus on deregulation, this year could feel like wading through uncharted waters, and decreased federal government regulation may mean increased state regulation, say attorneys at Reed Smith.

• 5 E-Discovery Predictions For 2025 And Beyond

  

  In the year to come, e-discovery will be shaped by new and emerging trends, from the adoption of artificial intelligence provisions in protective orders, to the proliferation of emojis as a source of evidence in contemporary litigation, say attorneys at Littler.

• 4 Trade Secret Developments To Follow This Year

  

  Significant developments in trade secret law are likely in 2025, and areas to watch include protection of AI-related innovations, the fate of the Federal Trade Commission's noncompete ban, and questions of the federal Defend Trade Secrets Act's extraterritorial reach, say attorneys at Faegre Drinker.

• Republican Trifecta Amplifies Risks For Cos. In 3 Key Areas

  

  Expected coordination between a Republican Congress and presidential administration may expose companies to simultaneous criminal, civil and congressional investigations, particularly with regard to supply chain risks in certain industries, government contracting and cross-border investment, say attorneys at Morgan Lewis.