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
This is the fourth 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 three
Background Under Israeli patent law, a divisional patent application can be filed any time after the filing of an application until payment of the allowance fees or abandonment of the application. Specifically, divisional applications can be filed under the following
Background Australia bats above its average in terms of the number of high-profile litigious patent disputes conducted before its courts. Despite its relatively small population, the large consumer appetite and rigorous court process make Australia a popular testing ground before
This is the third 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, Vietnam (in no particular order). Our first two posts
Filing Divisional Patent Applications in Mexico – Part 2 This is the second 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,
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 Part 1 of a 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). Filing Divisionals in Brazil
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 is generally not based on any statutory law
In Canmar Foods Ltd v TA Foods Ltd, 2019 FC 1233 (September 25, 2019), the Federal Court of Canada, for the first time, interpreted the new file wrapper estoppel provision, section 53.1 of the Canadian Patent Act. The Court held that a
In many jurisdictions, the scope of protection afforded by a patent is defined by the claims of the patent as read either literally or under doctrine of equivalents. Infringement based on the doctrine of equivalents is generally not based on
On December 29, 2017, the Legislative Yuan of the Republic of China (Taiwan) passed an Amendment to the Pharmaceutical Affairs Act (PAA) establishing a patent linkage system. On August 20, 2019, Taiwan’s long-awaited patent linkage system finally came into effect.
In many jurisdictions, the scope of protection afforded by a patent is defined by the claims of the patent as read either literally or under doctrine of equivalents. Infringement based on the doctrine of equivalents is generally not based on
In many jurisdictions, the scope of protection afforded by a patent is defined by the claims of the patent as read either literally or under doctrine of equivalents. Infringement based on the doctrine of equivalents is generally not based on
As many readers are aware, on December 1, 2018, the Canadian government published for public consultation an updated version of its proposed amendments to the Canadian Patent Rules (Rules). The consultation period ran from December 1, 2018 to December 31,
Background Sequenom, Inc. (Sequenom) sells a non-invasive test called “MaterniT® 21 PLUS” that is used to detect the presence of cell-free fetal DNA (cffDNA) in serum or plasma samples obtained from expectant mothers. The test avoids the risks of widely-used
On July 9, 2019, the Instituto Nacional da Propriedade Industrial (BRPTO) published its long-awaited rules implementing an action plan to reduce the patent backlog that has plagued the office for many years. As many readers are aware, on average, it
On June 4, 2019, the tenth senate of the Federal Court of Justice (FCJ) confirmed the German Federal Patent Court’s (FPC) rejection of an application for a preliminary compulsory license to Amgen’s European Patent No. 2 215 124 (the ‘124
A bill revising Japanese Patent Law (as well as other laws) was passed by the Diet (Japan’s bicameral legislature) on May 10, 2019 and promulgated on May 17, 2019. Purpose of the revisions As a result of the digital revolution,
On April 16, 2019, the Israeli Patent Office (IL PTO) held that an antibody targeting the same antigen as an antibody previously approved for patent term extension (PTE) was eligible for its own PTE provided that primary structural differences existed
On December 4, 2018, India’s Department of Industrial Policy and Promotion, Ministry of Commerce and Industry published Draft Patent (Amendment) Rules, 2018 (Draft Rules) for comment. These Draft Rules seek to amend the Patent Rules, 2003. Key highlights of the
On Friday, December 7, 2018, the Federal Circuit issued two important decisions involving obviousness-type double patenting. In the first decision, Novartis Pharmaceuticals Corporation v. Breckenridge Pharmaceutical Inc., the Court addressed the question of whether a patent filed after June 8,
In August 2016, a new amended patent law took effect in Indonesia which removed the obligation of patent owners to pay annuities on patents that lapsed through non-payment of earlier annuities. However, despite this change, patent owners in Indonesia remain
On September 27, 2018, the National Institute of Industrial Property in Argentina issued Resolution No. 250/2018 (Resolution) implementing certain changes to Argentine Patent Law that have been awaiting resolution as a result of Law No. 27.444 (Debureaucratization and Simplification Law
Post grant review (PGR) is a trial proceeding conducted at the Patent Trial and Appeal Board (PTAB or Board) to review the patentability of one or more claims in a patent on any ground that could be raised under 35
Article 20 of Indonesia’s Patent Law requires patent owners to either manufacture their patented products in Indonesia or use their patented processes in the country. Although controversial, the purpose of this working requirement is to drive foreign technology transfer, investment,
The Canadian Patent Office (CPO) is seeking comments on its proposed revisions to Chapter 17 of the Manual of Patent Office Practice (MOPOP) as it relates to pharmaceutical solid forms (namely, polymorphs, salts, hydrates, solvates, desolvates and co-crystals). In this
On July 24, 2018, the Instituto Nacional da Propriedade Industrial (INPI) published Rule #222/2018 implementing the Patent Prosecution Highway (PPH) Pilot program (PPH program) with the United Kingdom patent and trademark Office (UKIPO). Implementation of this PPH program may expedite