In In re Entresto (Sacubitril/Valsartan) Patent Litigation, Judge Richard G. Andrews of the U.S. District Court for the District of Delaware granted MSN Pharmaceuticals Inc. a victory on noninfringement of U.S. Patent No....more
7/16/2025
/ Abbreviated New Drug Application (ANDA) ,
Adverse Inference Instructions ,
Claim Construction ,
Generic Drugs ,
Healthcare ,
Intellectual Property Protection ,
Life Sciences ,
Novartis ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
On May 29, 2025, the U.S. Supreme Court issued a decision in Seven County Infrastructure Coalition v. Eagle County, Colorado, a case concerning the National Environmental Policy Act (NEPA) that limits judicial review of...more
6/12/2025
/ Energy Projects ,
Environmental Impact Report (EIR) ,
Environmental Litigation ,
Environmental Policies ,
Greenhouse Gas Emissions ,
Infrastructure ,
Judicial Review ,
NEPA ,
Oil & Gas ,
Railways ,
Regulatory Reform ,
SCOTUS ,
Seven County Infrastructure Coalition v Eagle County Colorado ,
Trump Administration
Both President Trump’s and President Biden’s administrations have emphasized in executive orders and presidential memoranda the need for objective, science-based decision-making. However, Trump’s May 23, 2025, Executive Order...more
5/29/2025
/ Biden Administration ,
Diversity and Inclusion Standards (D&I) ,
Executive Orders ,
Government Agencies ,
OSTP ,
R&D ,
Regulatory Reform ,
Regulatory Requirements ,
Research and Development ,
Scientific Research ,
Transparency ,
Trump Administration
President Trump’s highly publicized executive order 14297, titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” targets the discrepancy in drug pricing in the United States compared with...more
5/16/2025
/ Antitrust Provisions ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Healthcare ,
International Trade ,
Most-Favored Nations ,
Patient Access ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
Trump Administration ,
U.S. Commerce Department
President Trump’s May 5, 2025, executive order titled “Regulatory Relief to Promote Domestic Production of Critical Medicines” sets out the administration’s goals to increase the domestic manufacture of critical...more
5/8/2025
/ Country of Origin ,
Drug Pricing ,
Environmental Policies ,
Environmental Protection Agency (EPA) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Manufacturers ,
Manufacturing Facilities ,
Patient Access ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Supply Chain ,
Trump Administration
In FDA v. Wages and White Lion Investments LLC, the U.S. Supreme Court’s unanimous decision in favor of the Food and Drug Administration serves as a reminder of the deference still accorded to regulatory agencies post-Loper...more
4/21/2025
/ Administrative Procedure Act ,
Appeals ,
E-Cigarettes ,
FDA Approval ,
FDA v Wages and White Lion Investments LLC ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Popular ,
Regulatory Agencies ,
Rulemaking Process ,
SCOTUS ,
Tobacco Regulations ,
Vaping
Dr. Stephen Thaler’s attempts to obtain intellectual property protection for artificial intelligence were once again shot down by the courts, when the U.S. Court of Appeals for the District of Columbia affirmed that the...more
3/27/2025
/ Appeals ,
Artificial Intelligence ,
Copyright ,
Copyright Office ,
Copyright Registration ,
Intellectual Property Protection ,
Inventions ,
Machine Learning ,
Patent Applications ,
Patents ,
Software ,
The Copyright Act
With the Trump administration’s push to establish America’s global dominance in artificial intelligence (AI), thorny questions of intellectual property rights and fair use are likely to be litigated with greater frequency....more
2/17/2025
/ Artificial Intelligence ,
Copyright ,
Copyright Infringement ,
Copyright Litigation ,
Data Protection ,
Data Security ,
Fair Use ,
Intellectual Property Protection ,
Legal Technology ,
Machine Learning ,
Technology Sector ,
Third-Party Rights ,
Thomson Reuters ,
Training