The São Paulo State Court of Appeals established on August 27, 2018 that suppliers of active pharmaceutical ingredients (APIs) for compounding pharmacies are liable for patent. The case was filed by Lundbeck against a local supplier (Idealfarma) claiming infringement of a patent covering vortioxetine. Idealfarma had been supplying several compounding pharmacies around Brazil. The case […]
In 2015, Brazil enacted Federal Law #13,123 to enlarge the definitions provided by 1992 Convention on Biological Diversity (CBD), notably those related to genetic heritage and associated traditional knowledge.As per the Article 47 of Federal Law #13,123, the grant of a patent by the BRPTO on a finished product or on reproductive material obtained from […]
(BRPTO’s gazette of August 21st, 2018) The BRPTO published on August 21st, 2018, Rule #223/2018 implementing the PPH Pilot program with the DKPTO, which might speed up the examination of pending Brazilian applications with an application from the same family for which a “Grant” decision has been issued by the DKPTO. The Program will accept […]
(BRPTO’s gazette of July 24th, 2018) The BRPTO published on July 24th, 2018, Rule #222/2018 implementing the PPH Pilot program with the UKIPO, which might speed up the examination of pending Brazilian applications with an application from the same family for which a “Notification to Grant” or “Intention to Grant” letter has been issued by […]
On July 10, Brazilian Senate passed the General Data Protection Bill, which will now be forwarded to the President for sanction or veto. It is a step establishing a legal framework for data privacy in Brazil. After the bill matures into legislation, companies will have an 18-month window to comply. MAIN PROVISIONS Influenced by European […]
China merges its three antitrust agencies into a single authorityThe Chinese government has approved a major institutional reform that consolidated its three competition agencies into a new super governmental agency.The three former agencies integrated are:• The Price Supervision and Anti-Monopoly Bureau of the National Development and Reform Commission (NDRC), which analyzed price related conduct.• The […]
(BRPTO’s gazette of May 08 th , 2018) The Brazilian PTO issued today, on its gazette #2470, Rule #217/2018, which modifies Rule #80/2013, on fast-track examination of patent applications and patents related to pharmaceutical products and processes.In addition to patent applications related to cancer, HIV and neglected diseases, patent applications related to rare diseases are […]
The BRPTO published on May 8, 2018, Rule #218/2018 implementing Phase II of the PPH Pilot program with the USPTO. Most relevant is the expansion of technologies eligible for PPH, now embracing applications claiming IT arts, which has the longest examination pendency at the BRPTO. Rule #218/2018 also indicates more International Patent Classifications (IPCs) related […]
The trade dispute between the world’s two biggest economies is escalating since the announcement of President Trump’s decisions on the actions the U.S. will take in response to alleged China’s unfair trade practices. The subject was covered in a USTR Section 301 investigation of Chinese acts, policies, and practices related to technology transfer, intellectual property, […]
João Pedro Accioly The Brazilian natural response to controversial issues is the prohibition and denial of its existence. This immature approach ultimately encourages unavoidable and even positive activities to be carried out in the shades, without the knowledge of society, the supervision of control authorities and the necessary legal safety. The created darkness also tends […]
(BRPTO’s website communication of March 28 th , 2018) The BRPTO and the UKIPO signed, on March 28 th , 2018, an agreement to speed up the examination of pending Brazilian applications. The agreement regards the implementation of a PPH Pilot program between both Offices. The PPH program shall come into force in the third […]
Like in the US and Europe, the regulation of pharmaceuticals in Brazil is conducted by a regulatory entity, who is statutorily responsible for reviewing marketing applications and conduction GMP inspections. These are the cornerstones under which ANVISA1 (Brazilian Food and Drug Agency)ensures the safety and efficacy of drugs and biological products 2.There are, however, two […]
