Key Points - Last Tuesday, USTR announced the results of its Section 301 “necessity review.” Today, USTR followed up with a Federal Register notice providing details on the further proposed modifications to the Section 301...more
On January 26, 2024, the Biden-Harris Administration announced that it would place a temporary “pause” on pending decisions to export liquefied natural gas (LNG) to countries with which the United States has not entered into...more
2/2/2024
/ Bilateral Investment Treaties ,
Climate Change ,
Department of Energy (DOE) ,
Energy Policy Act ,
Energy Projects ,
Environmental Impact Statements ,
Exports ,
FERC ,
Free Trade Agreements ,
Greenhouse Gas Emissions ,
Liquid Natural Gas ,
NAFTA ,
NEPA ,
Public Interest ,
Shareholders ,
WTO
Summary -
Last year the World Intellectual Property Organization (WIPO), under a threat of a vote, accelerated negotiations on an international legal instrument related to intellectual property (IP) and genetic resources...more
10/31/2023
/ Biotechnology ,
Comment Period ,
Deadlines ,
Genetic Materials ,
Intellectual Property Protection ,
International Harmonization ,
Life Sciences ,
Patent Law Treaty ,
Patents ,
Pharmaceutical Industry ,
USPTO ,
WIPO
The “African Group” in the World Trade Organization (WTO) is pushing for discussions—and potentially renegotiation of international trading rules—on how developing countries do and can acquire technology to build resilience...more
Key Points -
The EU aims to harmonize patent protection rules and flexibilities with a layer on top of national rules. This is in line with long-term efforts by the EU institutions to harmonize patent rules and motivated,...more
On February 1, the USITC formally announced the opening of its investigation into the merits of expanding the TRIPS Waiver to diagnostics and treatments. The investigation was initially requested by USTR, who had been leading...more
Key Points -
The co-legislators of the EU recently reached a provisional agreement on a regulation for a CBAM.
CBAM will require importers to the EU of covered carbon-intensive products to pay a charge for the carbon...more
Key Points -
On December 6, days before a deadline for WTO members to decide whether to expand the TRIPS waiver for COVID-19 vaccines to cover COVID-19 diagnostics and therapeutics as well, the Office of the USTR...more
12/9/2022
/ Biden Administration ,
Coronavirus/COVID-19 ,
Intellectual Property Protection ,
International Trade Commission (ITC) ,
Onshoring ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
TRIPS Agreement ,
Vaccinations ,
Waivers ,
WTO
On November 1, USTR released a comment form prescribing the submission format for public comments in the “necessity review” process for the Section 301 China tariffs. USTR first announced the public comment phase of the...more
Key Points -
The United States and its allies are banning imports or increasing tariffs on Russia’s top products—crude oil, petroleum, petroleum fuels, oils, liquefied natural gas, coal, fish, seafood, alcohol,...more
Key Points -
On March 11, 2022, USTR and DOC requested public comments on the trade pillar of the Indo-Pacific Economic Framework, with both requests including a focus on digital trade issues. Comments are due to both...more
One of the few remaining opportunities for passage of bipartisan legislation this Congress is legislation to improve America’s competitiveness vis-à-vis China for semiconductor manufacturing and scientific research and...more
On Friday, February 4, 2022, the House passed the America COMPETES Act on nearly a straight party line vote to, among many other priorities, fund domestic semiconductor chip manufacturing, dramatically increase scientific...more
On October 1, 2021, Mexico’s President Andrés Manuel López Obrador submitted to the House of Representatives a bill to amend the Mexican constitution in respect of the electric power sector. The bill aims to reassert the...more
Key Points -
The Department of Commerce initiated a Section 232 national security investigation into NdFeB permanent magnets, which are used in fighter aircraft, missile guidance systems, electric vehicles, wind...more
Yesterday, in the unprecedented “In re Section 301 Cases” litigation, the U.S. Court of International Trade (CIT) entered a preliminary injunction that suspends the liquidation of plaintiffs’ unliquidated entries from China...more
Key Points
- On December 14, 2020, Commerce promulgated a fourth interim final rule to revise certain aspects of the Section 232 steel and aluminum exclusions process.
- One notable change is the creation of GAEs,...more
On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more
8/13/2020
/ Best Practices ,
Coronavirus/COVID-19 ,
Counterfeiting ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
Department of Homeland Security (DHS) ,
E-Commerce ,
Executive Orders ,
Exemptions ,
Food and Drug Administration (FDA) ,
Free Trade Agreements ,
Health and Safety ,
Imports ,
Infectious Diseases ,
Manufacturers ,
Medical Supplies ,
OMB ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Prescription Drugs ,
Procurement Guidelines ,
Public Health ,
Reporting Requirements ,
Section 301 ,
Supply Chain ,
Trump Administration ,
Waivers ,
WTO
On June 30, the Standing Committee of the National People’s Congress (the “Standing Committee”) in the People’s Republic of China (“China”) unanimously passed The Law of the People’s Republic of China on Safeguarding National...more
Following the decision taken by China’s National People’s Congress to adopt a new national security law (the “Security Law”) for the Hong Kong Special Administrative Region (“Hong Kong”) on May 28, the Standing Committee of...more
- The Facility-Specific Rapid Response Labor Mechanism (RRLM) in the United States-Mexico-Canada Agreement (USMCA) establishes an entirely new streamlined approach to labor dispute settlement in free trade agreements under...more
The National People’s Congress in China has today adopted a resolution paving the way for a new national security law to apply to Hong Kong.
The law is expected to focus on the prevention and punishment of secession, the...more
- On May 18, 2020, the government of Brazil submitted its application for accession to the WTO GPA, which will further open the Brazilian government procurement market to foreign producers and foreign service providers and...more
- On April 16, 2020, the Chinese competition authority finally announced its conditional approval of Nvidia’s $6.9 billion acquisition of Mellanox.
- The Chinese SAMR approved the acquisition after a yearlong investigation...more
Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more
1/8/2020
/ Acquisitions ,
Artificial Intelligence ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
CFIUS ,
Department of Health and Human Services (HHS) ,
Digital Health ,
EU ,
Export Controls ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Innovation ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Mergers ,
Office of Foreign Assets Control (OFAC) ,
Patent-Eligible Subject Matter ,
Pharmaceutical Industry ,
Popular ,
Section 101 ,
USPTO