News & Analysis as of

China Generic Drugs

Axinn, Veltrop & Harkrider LLP

Will India Replace China in the U.S. Drug Supply Chain?

In a recent opinion piece in Newsweek, Dr. Rahul Tiwari asserts that pharmaceutical companies in India have an opportunity to supplant China's dominant position in producing active pharmaceutical ingredients ("API's") and...more

Morgan Lewis

New Chinese Administrative Forum, CNIPA, Issues First Patent Infringement Decisions Against Generic Drug Makers

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The China National Intellectual Property Administration, a newly established administrative authority on patent infringement disputes, recently issued its first decisions, addressing questions many companies had on the...more

Kilpatrick

The Fast and the Furious: Article 76 Proceedings in China Proceed with Speed

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Article 76 of the Fourth Amendment1 to the Chinese Patent Law links regulatory approval of a generic drug and patent protection of the brand-name drug. It establishes a legal framework for resolving drug patent disputes...more

Linda Liu & Partners

A brief introduction to the relationship between a drug’s generic name, trade name, and trademark

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As a special product, the quality of drugs is a matter of health and safety for millions of consumers. Therefore, China has implemented strict regulations on drugs, including their names. There are three different names for...more

Jones Day

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

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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

Hogan Lovells

China's IP Administration publishes Draft Administrative Adjudication Measures for Patent Linkage

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On 9 February 2021, China's National Intellectual Property Administration ("CNIPA") published its Administrative Adjudication Measures For The Early Resolution Mechanism For Drug Patent Disputes. These Measures are aimed at...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

Jones Day

China Promulgates Fourth Amendment to Patent Law

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On October 17, 2020, the Standing Committee of the National People’s Congress in China promulgated the fourth amended Patent Law of the People’s Republic of China, which came into force in its original form in 1985, with...more

A&O Shearman

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

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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

MoFo Life Sciences

China Patent Linkage Update: Codification And Rulemaking

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On July 3, 2020, China’s National People’s Congress published the second draft of the latest amendment to China’s Patent Law (the “Draft Amendment”) for public comments, which were allowed to be submitted by August 16, 2020....more

Hogan Lovells

China’s NMPA releases proposal for modified “Hatch Waxman” following patent law reform

Hogan Lovells on

On 11 September 2020, China’s National Medical Products Administration (NMPA, formerly “China Food and Drug Administration”) published its proposed regulation on patent linkage, “Measures for the Implementation of the Early...more

Robins Kaplan LLP

Financial Daily Dose 8.10.2020 | Top Story: Twitter Enters Fray in Pursuit of TikTok

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With “Twit-tok” trending this weekend, you should be unsurprised to learn that Twitter has joined the group of suitors for TikTok, revealing that it’s held preliminary talks with the video-sharing app about a possible combo. ...more

Robins Kaplan LLP

Financial Daily Dose 3.3.2020 | Top Story: Promised Central Bank Action Halts Market Slide (for now)

Robins Kaplan LLP on

Despite news of additional COVID-19-related deaths and infections in America, central bankers appear to have bought at least one day of peace for US markets, which posted strong gains on a late surge on Monday, breaking a...more

Eversheds Sutherland (US) LLP

US-China Trade Agreement - Pharma impacts

President Trump has signed Phase I of a much anticipated multi-part trade agreement between the United States and China with provisions that will aid the branded pharmaceutical industry. One of the main goals of the agreement...more

Verrill

Is the New U.S.-China Agreement What Was Prescribed?

Verrill on

The trade relationship between China and the United States has been top of mind for businesses over the past year. In spring 2018, Chinese President Xi Jinping denied the U.S. Government's request to end subsidies for key...more

Robins Kaplan LLP

Financial Daily Dose 7.29.2019 | Top Story: Pfizer and Mylan Join Forces to Create Generics Powerhouse

Robins Kaplan LLP on

Drug giants Pfizer and Mylan have inked a deal that will merge the former’s off-patent drugs with the latter’s generics business, a tie-up that creates a mammoth global seller of lower-priced medicines....more

Hogan Lovells

China: Survival of the Fittest or Cheapest?

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The past year is set to be a milestone year for China’s pharmaceutical regulatory reform as the newly formed National Medical Products Administration (NMPA) continues to aggressively cut back on red tape for new drug...more

Hogan Lovells

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

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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. ...more

A&O Shearman

China Announces Pilot Scheme for Tendering with Minimum Procurement Quantities

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On 15 November 2018 the Joint Procurement Office (the JPO) published its Paper on Centralized Drug Procurement in “4+7” Cities (the Paper), which launched the national pilot scheme for tendering with minimum procurement...more

Hogan Lovells

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

Hogan Lovells on

With the opportunity for global pharmaceutical companies to gain new access to the Chinese market presenting itself like never before, significant news broke on December 7, 2018, regarding a newly implemented pilot...more

Hogan Lovells

China drug regulator calling on international pharmaceutical companies to bring “urgently-needed” new drugs to China

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On 8 August 2018, in an unprecedented regulatory action, the China National Drug Administration (CNDA) called on international pharmaceutical companies to bring 48 new drugs to China. These new drugs are viewed to be urgently...more

Akin Gump Strauss Hauer & Feld LLP

Trump Administration: 2017 Recap and 2018 Outlook

On January 20, 2017, businessman Donald J. Trump was sworn in as the 45th President of the United States following a contentious and unconventional 2016 presidential election. Republicans also successfully maintained control...more

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