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Category Archives: International Trade & Investment

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Customs Rescinds Proposal to Extend Payment of Duties in Response to COVID-19 Pandemic; Requires Payment of Deferred Duties Not Granted Extension

US Customs and Border Protection (“Customs”) rescinded its proposal to grant extensions on all customs duty payments for 90 days in response to the COVID-19 Pandemic.  While Customs has conducted a limited case-by-case review of some requests for extensions of duty payments, Customs notified the trade community it was no longer accepting case-by-case requests for

Industrial policy strikes again: Germany announces further tightening of Foreign Investment Control rules

For M&A transactions in Germany and beyond, Foreign Investment Control screenings have become an indispensable standard element to assess when structuring deals and planning for regulatory review. Similarly to merger control, acquirers and sellers need to consider the impact of the increasing number of jurisdictions that might want to review their proposed transaction. In the

Federal Circuit Acetris Decision Changes Procurement Country of Origin Landscape

On Monday, in the much-anticipated decision in Acetris Health, LLC v. U.S. 18-2399, the Court of Appeals for the Federal Circuit (the “Federal Circuit”) ruled that U.S. manufacture of a drug is sufficient to confer U.S. origin under the Trade Agreements Act (“TAA”) – regardless of the origin of its main component, the Active Pharmaceutical

National Security Commission on AI issues interim report

The National Security Commission on Artificial Intelligence (the “Commission”), established by the John S. McCain National Defense Authorization Act for Fiscal Year 2019, issued an interim report providing the Commission’s preliminary assessment of foreign threats to U.S. national security in the current AI era; how AI can improve the government’s ability to defend the U.S.,

CFIUS Regulations Released for Public Inspection

The long-anticipated foreign investment review regulations were released for public inspection on 13 January, 2020. The regulations, scheduled to appear in the Federal Register on 17 January, 2020, are in two Federal Register notices: In connection with 31 CFR Parts 800 and 801, the Office of Investment Security at the Department of the Treasury issued

Will FDA be forced to implement a drug importation program?

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of developing a broad drug importation program. Instead, the working group’s remit was specifically limited to considering potential

A New European Deal?

German Minister of Economics suggests revising EU and German merger control regulations to enable the creation of European champions – and keeps FDI options on the table to prevent acquisitions by non-European players

Pharma Companies May Benefit from Proposed Patent Law Changes in China; Public Comment Invited

On January 4, China’s National People’s Congress (NPC) released draft amendments to the Chinese Patent Law, proposing expanded and enhanced protections that may provide real benefits to companies that develop new drugs.  A potentially important condition to one of the key proposed changes specific to new drugs is that it would be available only for

China Takes Significant Steps to Consolidate Generic Drug Industry and Lower Prices

With the opportunity for global pharmaceutical companies to gain new access to the Chinese market presenting itself like never before (see our previous blog posts here and here), significant news broke on December 7, 2018, regarding a newly implemented pilot centralized drug procurement program (the “program”) that will have significant ramifications for global pharmaceutical companies. 

USTR Requests Input on Impact of Trade Agreements on Government Procurement

On August 21, 2017, the Department of Commerce (Commerce) and the Office of the United States Trade Representative (USTR) issued a request for public comment on the impact of government procurement provisions of U.S. trade agreements on U.S. manufacturers and suppliers. Prompted by President Trump’s “Buy American and Hire American” Executive Order (E.O.), the request seeks to understand how domestic preference laws affect participation of U.S. manufacturers and suppliers in the Federal procurement process.

Trump Administration Re-Certifies Iranian Compliance with Nuclear Agreement; Imposes Sanctions on Additional Entities for Other “Malign” Activities

On July 17, the Department of State communicated to Congress that Iran remains in compliance with its obligations under the Joint Comprehensive Plan of Action (JCPOA), the nuclear agreement reached over Iran’s nuclear program by the world’s major powers that went into effect in January 2016.

U.S. Treasury Secretary Mnuchin Urges Amending CFIUS Reviews

On Thursday, May 18, U.S. Treasury Secretary Steven Mnuchin waded further publicly into efforts on Capitol Hill to amend the authorizing statute underlying the Committee on Foreign Investment in the U.S. (CFIUS), a U.S. Government interagency committee that conducts national security reviews.  Munchin reportedly told a gathering of business executives at the U.S. Chamber of

CFIUS Reform Turns to Food Security

Congressional efforts to reform the Committee on Foreign Investment in the United States (CFIUS), a U.S. Government interagency committee that conducts national security reviews, continue apace. This week saw the introduction of bipartisan legislation in the U.S. Senate that would (i) give federal agriculture and food officials permanent representation on CFIUS and (ii) amend the statute to allow the Committee to consider agriculture and food-related criteria when reviewing transactions that could result in control of a U.S. business by a foreign person.

Seeking to Restrict Chinese Investment in the U.S., Congress Considering CFIUS Reforms

Lawmakers in both the U.S. House of Representatives and Senate are examining ways to restrict Chinese investment in the United States by reforming national security reviews conducted by the Committee on Foreign Investment in the United States (CFIUS), a U.S. Government interagency committee.

Border Adjustability Tax in Peril?

The future of the Border Adjustment Tax (BAT) proposal, a critical element of the House Republican tax reform plan, is in doubt after signs of Republican opposition in the Senate emerged last week. Senator David Perdue (R-GA) became the most prominent Republican to overtly criticize the BAT, expressed in a Dear Colleague letter to his

Commerce Department Relaxes Restrictions on Certain Defense-Related and Other Exports to India; Tightens Hong Kong Documentation Requirements

On January 19, 2017, the U.S. Commerce Department’s Bureau of Industry and Security (“BIS”) issued several amendments to the Export Administration Regulations (“EAR”) to implement the India-U.S. Joint Statement of June 7, 2016, recognizing the U.S. and India as Major Defense Partners, and making certain technical changes regarding Hong Kong’s Import and Export (Strategic Commodities)

How National Security Concerns Can Impact a Global Transaction: President Obama Blocks Chinese Acquisition of a German-U.S. Business

On December 2, 2016, President Obama blocked a Chinese-owned German company, Grand Chip Investment GmbH (“Grand Chip”), from acquiring the U.S. business of German company Aixtron SE (Aixtron), a semiconductor equipment manufacturer with a U.S. subsidiary headquartered in Sunnyvale, California.

Data Without Borders: Hogan Lovells Winnik Forum Addresses International Considerations for the Growth and Development of a Connected World

The Internet of Things (“IoT”) connects markets and supply chains around the world.  Industry, governments and consumers around the world are embracing IoT technologies to improve research and public policy, to accelerate service delivery and to monitor global development programs across healthcare, agriculture, natural resource management, climate, and energy sectors.  Industry experts project that between

CFIUS under the Trump Administration

The incoming Trump administration’s approach to foreign direct investment (FDI) in the United States and to national security reviews conducted by the Committee on Foreign Investment in the United States (CFIUS) is difficult to predict. Mr. Trump has criticized certain foreign investments in the United States, but his trade-related critiques have focused largely on U.S. free trade agreements and the loss of U.S. manufacturing jobs to foreign countries.