News & Analysis as of

Life Sciences China Pharmaceutical Industry

DLA Piper

Navigating China's Healthcare Compliance Landscape: New Guidelines to Mitigate Commercial Bribery Risks

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China's State Administration for Market Regulation (SAMR) has released the draft Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (Draft Guidelines) for public comment. The Draft Guidelines,...more

Goodwin

Life Sciences M&A Trends for 2023 and 2024 (Through End of Q3) in Greater China

Goodwin on

Goodwin is presenting a two-part publication series covering life sciences trends involving license deals, M&A, and financing for Greater China’s life sciences sector. ...more

Morgan Lewis

Shanghai’s 2024 Enforcement Framework on Healthcare Practices – Key Takeaways and How to Prepare

Morgan Lewis on

The Shanghai Health Commission, together with 13 other governmental authorities in Shanghai, jointly published on October 10, 2024 the Shanghai version of the 2024 Notice on Issuing the Key Points of Correcting Improper...more

Morgan Lewis

Understanding the NewCo Model: A Trending Approach of Chinese Pharmaceutical Companies

Morgan Lewis on

Inventive deal structures are on the rise within China’s life sciences industry, with the “NewCo” model having garnered significant interest among Chinese pharmaceutical companies in recent years. In 2024, several landmark...more

Foley & Lardner LLP

The Rise of GenAI in Personalized Medicine and Beyond

Foley & Lardner LLP on

GenAI, or Generative AI, has seen a surge in patenting activity with China leading the way in filing patent applications for this technology. The landscape analysis by WIPO reveals Tencent, Ping An Insurance Group, and Baidu...more

Hogan Lovells

Top legal issues to think about in China-related licensing transactions

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This article provides a general overview of certain Chinese legal considerations for licensing and collaboration deals in the life sciences industry. In particular, this article focuses on two types of transactions...more

Lowenstein Sandler LLP

The BIOSECURE Act: Proposed New Legislation Could Affect U.S. Companies’ Plans to Contract With Chinese Biotechnology Companies

Lowenstein Sandler LLP on

The U.S. Senate and the U.S. House of Representatives are both considering legislation that could have a serious impact on the ability of U.S. biotechnology, drug, and medical device companies to do business with...more

Morgan Lewis

How China’s Detailed Human Genetic Resources Rules May Impact Multinational Life Science Companies

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China’s Ministry of Science and Technology (MOST) officially announced on June 1, 2023 the release of the “Detailed Implementation Rules for the Management Regulations of Human Genetic Resources” (the Detailed HGR Rules)....more

Linda Liu & Partners

CNIPA’s Requirements on Supplementary Experimental Data and Inventiveness Evaluation of CN Patent Application in Biology and...

Linda Liu & Partners on

On December 14, 2020, the China National Intellectual Property Administration released “Announcement about Amendments to the Guidelines for Patent Examination (Announcement No. 391)” on its website, showing that the amended...more

Goodwin

Year in Review: Top Biosimilars-Related Regulatory Developments of 2022

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As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year...more

Hogan Lovells

Spotlight on Greater China: out-licensing to Chinese counterparties

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As part of a new Asia-Pacific (APAC) Life Sciences and Health Care webinar program designed both for companies with commercial interests in APAC and for companies based in the region, Hogan Lovells is hosting a special...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more

Hogan Lovells

China's draft implementation rules on human genetic resources: potential changes on HGR Supervision?

Hogan Lovells on

The Ministry of Science and Technology of China has finally issued the draft of Implementation Rules for the Regulations of Human Genetic Resources Administration for public comments on March 21, 2022, which gives more...more

Akin Gump Strauss Hauer & Feld LLP

America’s Pharmaceutical Supply Chain: An Overview of the Policy Landscape and Potential Path Forward

For several years, policy-makers and commentators have expressed concern about the resilience of the United States’ pharmaceutical supply chain. Current U.S.-based manufacturing capabilities have been at the forefront of...more

Jones Day

Patent Linkage and Article 76 Proceedings in China: A Litigator's Perspective

Jones Day on

China has recently unveiled its own version of a patent linkage system that has been highly watched by stakeholders and industry observers.  This new system will also create a new form of pharmaceutical patent litigation in...more

A&O Shearman

Patent Linkage in China: up, running and with Chinese characteristics

A&O Shearman on

As one of the most significant IP developments in China, the Fourth Amendment to the PRC Patent Law introduced patent linkage for pharmaceutical patent litigation in China. A full set of rules implementing the patent linkage...more

Morgan Lewis

China Amends Regulation Governing Medical Devices

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China recently amended its primary regulation governing medical devices, the Regulation on Supervision and Administration of Medical Devices (2021 RSAMD), which will replace its previous 2014 version and become effective on...more

Rothwell, Figg, Ernst & Manbeck, P.C.

China’s Hatch-Waxman Act: Patent Linkage System Implemented in the 4th Amendment to the Chinese Patent Law

The Standing Committee of the 13th National People’s Congress, China’s top legislature, adopted the Fourth Amendment to the 1984 Chinese Patent Law on October 17, 2020. The Fourth Amendment follows a series of amendments that...more

Hogan Lovells

The TGA and the Iron Mask

Hogan Lovells on

In 2020, heightened demand for health care resulted in an influx of therapeutic goods being included on the Australian Register of Therapeutic Goods (ARTG). A large portion of these goods are manufactured in China however,...more

Kilpatrick

What to Watch in 2021 - Big Changes for Drug Companies in China

Kilpatrick on

For several years, China has been evaluating changes to its drug approval system to promote drug innovation and patient access to medicines. The year 2020 saw China begin taking steps towards adopting some of those changes....more

Womble Bond Dickinson

China Announces Long-Awaited—and Significant—Updates to Intellectual Property Protections

Womble Bond Dickinson on

For months, global patent practitioners have been expecting China to announce sweeping, significant changes to the nation’s system of intellectual property laws—and they were not disappointed. On Oct. 17, the Standing...more

Fish & Richardson

Legal Alert: New Hatch-Waxman-Style Patent Law Formally Adopted by China’s National People’s Congress; to Take Effect June 1, 2021

Fish & Richardson on

On October 17, China’s National People’s Congress (NPC) formally adopted a revised patent law that makes significant changes to that country’s legal framework for pharmaceutical patents. The regulation, promulgated by China’s...more

A&O Shearman

China: Patent Law Amendment brings sea change to pharmaceutical patent regime

A&O Shearman on

Article 76 of the Amendment establishes the longanticipated patent linkage scheme in China. It aims to allow early resolution of patent disputes between innovators and generic companies during the drug review and approval...more

Hogan Lovells

China adopts revised patent law with Hatch-Waxman-like incentives for innovative drugs

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On October 17, the National People’s Congress (NPC) formally adopted a revised patent law, which will take effect on June 1, 2021. The new law includes significant changes in the intellectual property legal framework with...more

Hogan Lovells

China’s drug regulator seeks comments on updated drug recalls regulation

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On October 10, thirteen years after China’s Measures for the Administration of Drug Recalls first took effect, China’s National Medical Products Administration (NMPA, formerly “China Food and Drug Administration”) proposed an...more

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