Topic
Biotech
243 published works
Patent Law Weblog
PTAB (Again) Awards Priority of Invention to Broad in Interference No. 106,115
The Decision on Priority By Kevin E. Noonan – On March 26, the Patent Trial and Appeal Board, without holding an oral hearing and despite a rather sharply worded opinion…
BioSlice Blog
EDPB/EDPS Joint Opinion on the European Biotech Act Proposal: Key Data Protection Implications for Pharma and Life Sciences
By Alexander Roussanov, Camille Vermosen, Ana Gonzalez-Lamuno
On 16 December 2025, the European Commission published its Proposal for a Regulation establishing a framework of measures for strengthening the EU's biotechnology and biomanufacturing sectors, particularly in the area…
Bill of Health
Hippocratic Quantum: The Ethics of Biomedical Discovery in the Quantum Age
By Erin Scott
Biotechnology Hippocratic Quantum: The Ethics of Biomedical Discovery in the Quantum Age Quantum technology is increasingly described as the telescope of the 21st century: a scientific instrument that expands what…
Global Policy Watch
The Biotech Act Recognises and Supports “Strategic Projects” And “High Impact Strategic Projects” to Reinforce the Union Biotechnology Sector
By Valeria Sturla, Anna Wawrzyniak, Spiros Drosos
Introduction As discussed in our previous blogpost (link), on 16 December 2025, the European Commission (“Commission”) released its Proposal for the European Biotech Act (“Biotech Act”) (see here). This blogpost…
Inside EU Life Sciences
The Biotech Act Recognises and Supports “Strategic Projects” And “High Impact Strategic Projects” to Reinforce the Union Biotechnology Sector
By Valeria Sturla, Anna Wawrzyniak, Spiros Drosos
Introduction As discussed in our previous blogpost (link), on 16 December 2025, the European Commission (“Commission”) released its Proposal for the European Biotech Act (“Biotech Act”) (see here). This blogpost…
The IPKat
A new way to define T cells and what it means for cell therapy IP
A primary objective of a pharmaceutical patent is to provide robust protection for the drug product itself. Defining a cell therapy product represents a challenge in this respect, given their…
Cleary Foreign Investment and International Trade Watch
New Guidance Issued and Changes Underway for U.S. Outbound Investment Regime as 2026 NDAA Defense Bill Introduces Outbound Investment, Sanctions, and Biotech Updates
By Chase D. Kaniecki, Samuel H. Chang, B.J. Altvater, Alexi T. Stocker
On December 18, 2025, President Trump signed the 2026 National Defense Authorization Act (“NDAA”), a sweeping defense spending bill that brings a number of changes to the U.S. outbound investment…
Government Contracts Law
Feature Comment: Supply Chain Hide-And-Seek: How And Why the FY 2026 NDAA BIOSECURE Act Could Apply To You (Yes, You)
By Alex Major, Franklin Turner
The BIOSECURE Act in the FY 2026 NDAA is a quiet, sweeping shift in federal supply-chain enforcement that reaches beyond “biotech” and into the tools most companies barely think about…
Sanctions & Export Controls Update
The BIOSECURE Act Becomes Law: Implications for Collaborations with “Biotechnology Companies of Concern”
By Janet K. Kim (US), Xin Tao (US), Lise S. Test (US), Bruce J. Linskens (US)
After failing to pass in the previous Congress, a revised version of the “BIOSECURE Act” (“the Act”) was signed into law by President Trump on December 18, 2025, as Section…
Global Policy Watch
New Sanctions Authorities in the FY 2026 NDAA
By Stephen Rademaker, Blake Hulnick
After passing the House the preceding week, the National Defense Authorization Act for Fiscal Year 2026 (FY 2026 NDAA) passed the Senate on December 17 by a vote of 77-20…