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Episode 276 -- Review of Phillips and Franks Int'l SEC FCPA Settlements
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China’s state council issued State Council Degree No. 769 on December 21, 2023 to enact the Implementing Regulations of the Patent Law (Amended in 2023) (hereinafter referred to as “the Implementing Regulations (Amended in...more
On April 25, 2024, the Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion, recommending the granting of marketing authorization for Biogen Netherlands B.V.’s biosimilar TOFIDENCE (tocilizumab),...more
Recently, the new Rules for the Implementation of Patent Law (hereinafter referred to as "the Rules") has been approved and promulgated by the State Council, and will come into force on January 20, 2024. There are many...more
As a large pharmaceutical consumer market, China's position in the layout of pharmaceutical patents has been valued. Inventions such as medical use, drug crystalline form and the like, have been paid more attention in the...more
On May 26, 2023, the European Commission granted the marketing authorization to Samsung Bioepis for EPYSQLI, a biosimilar referencing SOLIRIS (eculizumab) developed by Alexion for the treatment of the paroxysmal...more
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
As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year...more
In patent examination, the examiner will cite a prior art document in order to determine whether or not an invention or utility model is novel and inventive. The applicants challenge the implementability of the cited prior...more
China's stance on pharmaceutical patents catches the eye of the entire globe due to its market position. Effective on January 15, 2021, the newly revised China’s Patent Examination Guideline provides new examination rules of...more
Polymorphism of a pharmaceutical compound refers to its state of existing in different solid forms that is caused by the fact that the molecules of the compound, though being of the same chemical structure, are arranged in...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 large pharmaceutical consumer market, China's position in the pharmaceutical patents has been valued. Patents such as medical use, drug crystalline form and the like have been paid more attention as they play a great...more
On November 8, 2021, Bio-Thera Solutions, Ltd. announced that China’s National Medical Products Administration has accepted the marketing authorization application for BAT1806, a biosimilar of Roche’s Actemra® (tocilizumab),...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
Starting in July of this year, China initiated a patent registration platform that bears some similarity to the generic drug framework under the Hatch-Waxman Act in the U.S. The purpose of this alert is to describe this new...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
Patent term adjustment (PTA), patent term extension (PTE), and patent linkage were made available in China as of June 1, 2021. While there are certain rules to be finalized and settled, it is advisable that patentees and drug...more
The China National Intellectual Property Administration (CNIPA) and the National Medical Products Administration (NMPA) in the People’s Republic of China (PRC) issued measures to facilitate the implementation of the newly...more
This update addresses three important changes to pharmaceutical patents in the People’s Republic of China (PRC) in view of the newly amended PRC Patent Law (the Law), which will take effect on June 1, 2021, and the recent...more
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
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 17 October 2020, China's NPC adopted amendments to the Patent Law, which will take effect on 1 June 2021. The highlights are the adoption of a patent linkage system, a patent term extension for pharmaceutical patents,...more