On September 21, 2020, the United Arab Emirates (UAE) Ministry of Health & Prevention (MOHAP) issued Ministerial Decree 321 of 2020 (Decree 321) relating to the use of clinical and preclinical data and information regarding innovative pharmaceutical products registered in …
Are You Ready for China’s Patent Linkage System?
On September 11, 2020, the National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA) issued the “Implementing Measures for Drug Patent Dispute Early Resolution Mechanism (Trial for Implementation)” (Draft Measures). The Draft Measures establish a framework …
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Data and Marketing Exclusivity in Russia
Article 13 of the Law “On Circulation of Medicines” (the Law) in Russia provides a list of medicines that are subject to state registration (namely, the grant of marketing authorization (MA)) by the Ministry of Health (MoH)), namely: Medicines that …
The Doctrine of Equivalents: Examination of the Law in France
In many jurisdictions, the scope of protection afforded by a patent is defined by the claims as read either literally or under doctrine of equivalents. Infringement based on the doctrine of equivalents may be based in part on statutory law, …
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Filing a Divisional Application in Singapore – Part 10
This is the tenth post in our 16-part series examining divisional practice in Argentina, Brazil, Canada, China, Europe, India, Indonesia, Malaysia, Mexico, Pakistan, Russia, Thailand, Saudi Arabia, Singapore, the United States, and Vietnam (in no particular order). Our first nine …
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First Gene Therapy Products Approved in Brazil
Brazil has become the first among the Latin American countries to approve the marketing of gene therapy products. Specifically, the Brazilian Health Regulatory Agency (ANVISA) recently granted marketing authorization for Novartis’ gene therapy products Luxturna ® and Zolgensma ® . …
Brazil’s Path for Speeding Up Innovation: A New National Strategy for Intellectual Property
On August 10, 2020, a draft of the National Strategy of Intellectual Property (ENPI) was published in the Brazilian Official Gazette Public Consultation #46/2020. A copy of the ENPI can be found here: Eng_Annex-ii_enpi -public consultation. Publication of the draft …
Implementation of a new patent linkage system is imminent in Mexico – are you ready?
It is expected that on November 5, 2020, Mexico’s new Federal Law on Protection of Intellectual Property (LFPPI) will take effect. Pursuant to the LFPPI, the Mexican Institute of Industrial Property (IMPI) and the Federal Commission for the Protection against …
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Filing a Divisional Application in Malaysia – Part 9
This is the ninth post in our 16-part series examining divisional practice in Argentina, Brazil, Canada, China, Europe, India, Indonesia, Malaysia, Mexico, Pakistan, Russia, Thailand, Saudi Arabia, Singapore, the United States, and Vietnam (in no particular order). Our first eight …
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Changes in Ukrainian Patent Law Strongly Favor Generic Manufacturers
On July 21, 2020, the Parliament of Ukraine introduced several major amendments to Ukrainian patent law. Although the amendments still need to be approved by the President in order to become effective, this is considered a mere formality and is …
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