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President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more
While it may seem like the only constant at the United States Patent and Trademark Office (USPTO) is change, that sentiment rings especially true in 2025. With a new presidential administration in the White House and numerous...more
On the heels of the recent reintroduction of the PERA and PREVAIL Acts of 2025, a bipartisan group of lawmakers in Congress has introduced the Leadership in Critical and Emerging Technologies (“CET”) Act. The goal of the...more
Key Takeaway: This article explores the unique procedural and strategic considerations for litigating SEP cases at the ITC, and what to know when navigating this complex and evolving landscape. The U.S. International Trade...more
For the past decade, controversy regarding the laws of patent eligibility has created uncertainty in the minds of inventors and investors, especially in the biotechnology, medical diagnostics, and software industries adjacent...more
Welcome to the latest issue of Blockbuster Biologics Review, which covers the status and developments of post-grant challenges and patent litigations implicating blockbuster biologics and legislative proposals related to...more
In a move that could reshape the U.S. patent landscape, Congress has reintroduced two major pieces of legislation: the Patent Eligibility Restoration Act (PERA) of 2025 and the Promoting and Respecting Economically Vital...more
Welcome to Wilmer Hale's PTAB/USPTO Update for May 2025....more
A bipartisan group of senators and congressional representatives reintroduced the Patent Eligibility Restoration Act (PERA), which aims to reform the law of patent eligibility under 35 U.S.C. § 101. PERA seeks to address the...more
Last week, Sens. Thom Tillis (R-N.C.) and Chris Coons (D-Del.) and Reps. Kevin Kiley (R-Calif.) and Scott Peters (D-Calif.) reintroduced the Patent Eligibility Restoration Act (PERA), a bill Sens. Tillis and Coons first...more
The bipartisan legislative push could create big hurdles for drug development, with concerns mounting over limited patent protections and increased litigation risks, hears Marisa Woutersen. The US pharmaceutical industry...more
On March 14, 2025, EU Member States agreed in the European Council on a common position to move forward with development of new rules for certain genetically modified plants generated using modern precision breeding methods...more
On March 10, John Squires was officially nominated to be Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office....more
Patent eligibility under 35 U.S.C. § 101 remains one of the most hotly contested and unpredictable areas of U.S. patent law. In the years following the Supreme Court’s landmark decisions in Alice Corp. v. CLS Bank Int’l...more
On March 17, 2025, Senators Chuck Grassley (R-IA), John Cornyn (R-TX), Richard Blumenthal (D-CT), and Richard Durbin (D-IL) re-introduced the “Affordable Prescriptions for Patients Act” (“APPA”), which previously passed the...more
With the recent convocation of the 119th Congress, a change in administration, and resignation of USPTO Director Vidal, pharmaceutical patent reform is likely on the minds of many in Washington. Prior to this political...more
The Promoting and Respecting Economically Vital American Innovation Leadership (“PREVAIL”) Act has moved to the Senate for a full vote after passing the Senate Judiciary Committee vote 11-10 on November 21, 2024. In...more
It's that time of the year again – the time to snuggle up by the fire, put on Dominick the Donkey and read this year's Top Section 101 Patent Eligibility Stories. But first, the holiday movies and where they're streaming ...more
On November 12, USPTO Director Kathi Vidal announced in a post on LinkedIn and a letter to friends and colleagues that she would be stepping down the second week in December. Deputy Director Derrick Brent will take over until...more
On November 15, 2024, the US Senate Judiciary Subcommittee on Intellectual Property advanced the Inventor Diversity for Economic Advancement (IDEA) Act, one of three significant bills it considered this year to reform the...more
I have been waiting for developments on the Patent Eligibility Restoration Act (PERA) since I testified before the Subcommittee on Intellectual Property of the Senate Judiciary Committee in January 2024, and in the meantime...more
Today Representatives Kevin Kiley (R-CA) and Scott Peters (D-CA) introduced the Patent Eligibility Restoration Act (PERA), bipartisan legislation mirroring a proposed law introduced last year by Senators Thom Tillis (R-NC)...more
On July 10, the Senate unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S.150), which seeks to increase competition and lower drug prices by imposing limits on patent litigation related to biological...more
It's been a while since I last posted, and I apologize for that. (If interested, here's an alert about what's kept me away: a CFAA trial we wrapped up in late July.) But I am back, so let's look at the latest on the Section...more
On July 7, the Senate passed a resolution “[r]ecognizing the importance of trademarks in the economy and the role of trademarks in protecting consumer safety, by designating the month of July as ‘National Anti-Counterfeiting...more