The European Patent Office (EPO) is a first-to-file system. Often times, this means that applicants have to file their European patent applications with little or no experimental data to support the inventive property of the invention. This is particularly true
On August 11, 2021, the Brazilian Senate approved a Compulsory Licensing Bill (#12/2021). Bill #12/21 amends the Brazilian Patent Statute (Law #9,279/96) and authorizes the Federal Government to grant compulsory licenses for products or processes in the event of a
The European Patent Convention (EPC) does not contain any specific provisions regarding the possibility of the same applicant obtaining two European patents for the same invention. As a result, and in the past, the Boards of Appeal of the European
The Venezuelan Patent and Trademark Office (VPTO) has issued the first notice of allowances (NOA) in pending patent applications directed to pharmaceutical inventions since 2004. At least two patent applications have received NOAs pursuant to Article 27.1 of the World
Last night, several generic companies in Brazil filed lawsuits against patents held by pharmaceutical companies. Specifically, 46 identical lawsuits were filed 46 targeting 79 patents. The cases challenge the patent term awarded by the Brazilian Patent and Trademark Office (BRPTO)
This is an update to our posts on April 8, 2021, March 15, 2021 and March 10, 2021. As readers are aware, the Brazilian Supreme Court was scheduled to decide the constitutional challenge involving Article 40 of the Brazilian Intellectual Property
In a long awaited development, the Kuwaiti Patent Office (KPO) has finally initiated substantive examination of patent applications and is issuing search and examination reports on pending applications. Nonetheless, given that substantive examination is new in Kuwait, the process has
This is an update to our posts on March 15, 2021 and March 10, 2021. As readers are aware, the Brazilian Supreme Court was scheduled to decide the constitutional challenge involving Article 40 of the Brazilian Intellectual Property (IP) Statute (ADI
On January 4, 2021, the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) announced that they are seeking comments on proposed changes to the regulations entitled, “Rights to Federally Funded Inventions and Licensing of Government Owned Inventions”
In 2011, Impossible™ Foods (Impossible) was founded with the aim of providing meat products with the taste and nutritional benefits of meat but without the negative health and environmental impacts. In 2016, Impossible™ launched its first product, the Impossible™ burger, which
This is an update to our post on March 10, 2021. On Thursday, March 11th, Reporting Justice Dias Toffoli requested that the Brazilian Patent and Trademark Office (BRPTO) respond to 13 questions considered relevant by the Brazilian Supreme Court in
Welcome to Future Foods Friday! In this new Friday series, we will focus on patent, regulatory and other issues associated with “future food technologies” such as non-animal derived food products, cellular agriculture, and gene editing techniques. As many readers are
The constitutional challenge before the Brazilian Supreme Court (ADI 5529) that seeks to invalidate any remaining patent term of approximately 40% of Brazil’s patents and pending applications is scheduled to be decided on April 7, 2021 instead of May 2021.
This is the fifteenth 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 fourteen
This is the fourteenth 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 thirteen
In January 2021, the Ukrainian Government introduced managed entry agreements (MEA), a market access instrument widely known in the European Union, but brand new to Ukraine. Managed entry agreements are arrangements between pharmaceutical companies and healthcare payors for innovative medicines
This is the thirteenth 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 twelve
According to Articles 34 and 35 of Chinese Patent Law, an invention patent application (versus a utility model or a design patent application) will be published within 18 months from its filing date (or earliest claimed priority date) after passing
In 1981, the Gulf Cooperation Council (GCC) was established in Abu Dhabi by six founding members: Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates. According to Article 4 of the GCC Charter, the basic objectives of the
On December 1st, 2020, the Instituto Nacional da Propriedade Industrial (INPI; also known as the Brazilian Patent and Trademark Office (BRPTO)) published Normative Instruction #118 (November 12, 2020), revoking the previous guidelines (Rule #144/2015) and establishing new guidelines for the
On December 7, 2020, the United States Patent and Trademark Office (USPTO) and the Mexican Institute of Industrial Property (IMPI) announced the launch of the Parallel Patent Grant (PPG) initiative. The PPG initiative is in the form of a work
Background Since 2003, Article 1362 of the Russian Civil Code has provided patent holders the possibility of extending the term of a Russian patent for a drug, pesticide or agricultural chemical for a period of up to five years. A
This is the twelfth 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 eleven
On November 2, 2020, the Omnibus Law on Job Creation through Law No. 11 of 2020 (Job Creation Law) was passed and became effective immediately. Chapter VI on the Ease of doing Business, Article 107 of the Job Creation Law
This is the eleventh 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 ten
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,
Background In Europe, Regulation (EU) No. 1308/2018 (Regulation) establishes a common organization of markets for agricultural products. Article 78 of the Regulation states that the terminology and naming conventions (such as definitions, designations, and sales descriptions) for various sectors and
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
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
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
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,
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
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®. As published in
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
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
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
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
Back on April 2, 2015, the U.S. Patent and Trademark Office (USPTO) published final rules for implementing the Geneva Act of the Hague Agreement Concerning the International Registration of Industrial Designs July 2, 1999 (Final Rules). Implementation of the Hague
Patentability of Diagnostic Inventions in the United States, Europe and Canada – Part 3 This 3-part series will provide an overview of the patentability of diagnostic inventions in the United States (U.S.), Europe and Canada. Part 1 examined the patentability
This 3-part series will provide an overview of the patentability of diagnostic inventions in the United States (U.S.), Europe and Canada. Part 1 examined the patentability of diagnostic inventions in the U.S. and can be found here. Part 2 will
This 3-part series will provide a brief overview of the patentability of diagnostic inventions in the United States (U.S.), Europe and Canada. Part 1 will examine the patentability of diagnostic inventions in the U.S. United States As many readers are
On July 8, 2020, the Brazilian Chamber of the State Representatives unanimously voted on the Bill of Legislative Decree # 324/20 to approve the Nagoya Protocol. As a result, the text was sent for consideration to the Senate and, once
Background Israel has a unique patent term extension (PTE) system. Patent term extension orders are granted only for patents that claim an active pharmaceutical ingredient (API) once a marketing authorization is issued for the first time by the Israeli Ministry
On June 2, 2020, the Ukrainian Parliament passed a draft law introducing a legal exemption for patent infringement for actions relating to the development and submission of testing data to a Ukrainian regulator/authority for obtaining marketing authorization for medicinal products.
The Guidelines for Examination (Guidelines) of the Brazilian Patent & Trademark Office (BRPTO), also known as the National Institute of Industrial Property, establish a three-step test for examining the non-obviousness of a claimed invention. This three-step test involves: (i) determining
This is the eighth 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 seven
This is the seventh 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 six
This is the sixth 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 five
This is the fifth 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 four
In Singapore, Regulation 23(2) of the Health Products (Therapeutic Products) Regulations 106 (S 329/2016) (“TPR”) states that an applicant for the registration of a therapeutic product must, in its declaration, furnish to the Health Sciences Authority (“HSA”) certain information, including