Webinar: Orange Book listing sheets under the microscope
Key Considerations for Reshoring U.S. Drug Manufacturing
Drug Pricing Initiatives During the Trump Presidency
Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
Patent law in Europe: What pharmaceutical companies need to know
EU excessive pricing laws
Polsinelli Podcast - Generic Drugs to Market - What's the Climate in 2014?
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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