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1. What are the legal pre-conditions for a drug to be distributed within the jurisdiction?

Authorisation

The distribution of medicinal products is regulated by the National Sanitary Surveillance Agency (ANVISA)

Pharmaceutical can be marketed and distributed if the following requirements are met:

In the trial of Special Appeal # 1.512.647 (decided on the 13th of May and published on the 5th of August), the Superior Court of Justice (in charge of standardizing the jurisprudence in Brazilian Courts) provided some guidance on liability of ISP in case of copyright infringement – an issue that was not codified by the Civil Basis for the Internet (“Marco Civil”). In the case at stake, a video producer filed a lawsuit against Google demanding the removal of several Orkut communities that were offering for sale a range of unauthorized copies of educational videos. The producer also requested the payment of damages. According to the producer, Google failed to remove the Orkut[1] communities after receiving a cease and desist letter, whereas Google alleged that such C&D letter did not inform the URLs of the infringing pages.

The Special Appeal was lodged by Google against a decision rendered by the State Court of Appeals of Minas Gerais[2]. This decision ordered the company (i) to pay damages to the producer in an amount to be fixed by an Expert or, in case that was not feasible, in accordance with article 103 of Brazilian Copyright Act[3]; and (ii) to remove the infringing pages. In brief, Google alleged that the company company could not comply with the Court order, as the producer did not inform the URLs of the infringing pages. Moreover, the company argued that it was a case of subjective liability and Goggle did not perform any activity that was deemed as copyright infringement.

Although this case happened before the Civil Basis for the Internet entered in force, the Reporting Justice Luís Felipe Salomão understood that it was desirable to render a decision that was in line with the principles enshrined by that Act. Therefore, he confirmed that it was a case of subjective liability, and underlined that, since the matter was not codified by the Civil Basis for the Internet, the Brazilian Copyright Act applies.

[1] A social network that was owned by Google.

[2] A State in Southeast Brazil.

[3] That establishes a presumption of selling of 3,000 (three thousand) infringing copies.

The Superintendency of the Brazilian antitrust authority (Conselho Administrativo de Defesa Econômica – CADE) has dismissed a case brought against the holder of essential patents related to an international standard in cell phone technology. According to the

bureau, there was no infringement of the economic order concerning the abuse of intellectual property rights.

CADE's Superintendency is the first federal instance to analyze acts of economic concentration, such as mergers and acquisitions, and the occurrence of infringements of the constitutional economic order. CADE, the national antitrust watchdog, is encharged with enforcing the constitutional economic principles, such as free enterprise, freedom of competition, social role of property, consumer protection and the restraining of abusive behavior.

In the present case, the patentee of the international standard cell phone technology was accused of sham litigation and patent misuse, since it had sued the denouncing company, which tried to obtain the due licenses, for patent infringement.

The Brazilian Patent Office has finally regulated the procedures concerning the possibility of entering the national phase of international applications after the expiry of the 30-month term foreseen in the PCT.

As you may know, the PCT has suffered many recent changes. One of them was the introduction of Rule 49.6 which allows a designated office to accept an application after the end of the 30-month term. The applicant must show that the failure to meet the deadline was unintentional or occurred in spite of due care required by the circumstances. This rule has been in force since 01 January 2003, and each office may apply either criterion or both.

In Resolution 212/09, dated 14 May 2009, the Brazilian Patent Office did not specifically mention these two criteria, but rather defined fortuitous case and force majeure as the two reasons that may justify the delay by the applicant. The definition given to these two criteria is one and the same: “the forthcoming unpredictable and unavoidable event, natural or deriving from human action, superior and extraneous to the applicant's will that, by the influence thereof, prevented him from carrying out the act that he was supposed to.”

In either situation, a request must be presented describing the facts that caused the delay, and evidence of such facts must be submitted. A tax must also be paid. The request will be examined by the Patent Office and a decision will be made as to either accept the application or not. If the request is denied, the application will be considered as withdrawn in respect of Brazil. An appeal may be lodged against such a rejecting decision.

The Convention on Biological Diversity, signed in Rio de Janeiro, Brazil, back in 1992, set out that the genetic resources should no longer be considered as a heritage of the Humanity, but rather that each country should have sovereign to its own resources.

Brazil has signed the Convention in 1992, such International Treaty having been ratified in Brazil by means of Decree No. 2,519 of March 16, 1998. Nevertheless, it was only in 2000 that a legislation regulating the access to Brazilian genetic resources and associated traditional knowledge was enacted.

In compliance with the Convention on Biological Diversity (CBD), more specifically, in its articles 1, 8, letter “j”, 10 letter “c”, 15 and 16 items 3 and 4, previous Provisional Ruling 2,186-16/01 was enacted to regulate the access to and use of genetic heritage and associated traditional knowledge (TK) in the Brazilian territory, fair and equitable benefit sharing and access and transfer of technology for the conservation and use of biological diversity. 

Practical Law – Life Sciences / 2015

Practical Law – Life Sciences / 2015

The administrative court of the Brazilian antitrust authority (Conselho Administrativo de Defesa Econômica – CADE) has very recently fined a major pharmaceutical industry in over 36 million Brazilian reais (approx. 11 million American dollars) for sham litigation involving the patent application in Brazil of a blockbuster drug used in the treatment of cancer. Although this is not the first millionaire fine imposed by CADE on a pharmaceutical company, cases like this are still rare and the case law of the bureau’s administrative court, which is a federal nonjudicial instance encharged with enforcing the constitutional economic principles, such as free enterprise and free competition, is still being built.

In the present case, the accused company has filed a patent application for a procedure to produce the abovementioned drug before the TRIPS Agreement had come into force in Brazil (later it has broadened the application’s claims to include the drug itself). As it is of common knowledge, Brazilian Law did not admit the patentability of chemical and pharmaceutical compounds until the issuance of the new Industrial Property Act in 1996, which was passed by Congress in order to comply with TRIPS. Notwithstanding the foregoing, by the time the applicant has requested the examination of the invention before the Brazilian Patent Office (BPO), the TRIPS agreement had indeed come into force.

As we informed in our previous newsletters # 2, of January, 2014, and # 6, of August, 2014, the Brazilian Patent Office (“INPI”) enacted Resolution No. 113 in October 2013 ordering that all patents with 2 (two) or more annuities in arrears should automatically be definitely shelved and extinct, without the possibility of restoration. Such resolution aimed primarily at reducing the backlog of pending patent applications and also served to the general goal of increasing the realm of the public domain in Brazil, but many understood that INPI's resolution was in direct violation of Section 87 of Brazil’s Patent Act, according to which the shelving or extinction of a patent can only be decreed by INPI after the patentee has failed to apply for the restoration of the patent (paying the annuities in arrears with a penalty) within the deadline of 3 months after being summoned to do so through a publication in the Official Gazette.

INPI’s Resolution 113 had the potential to swiftly shelve or make extinct over 10,000 patent applications and issued patents, and on July 2014 the Brazilian Association of Patent & Trademark Agents (ABAPI) filed a class action against INPI seeking its revocation. On January, 2015 the 25th Federal Trial Court of Rio de Janeiro ruled in favor of ABAPI and ordered INPI to immediately halt the mass shelving or extinction of patents and to overturn all shelving and extinction decisions that by then had already been published by INPI.

The Trademark Reporter© Vol. 104 – The Law Journal of the International Trademark Association (site da INTA)

Trade secrets are protected as a category of intellectual property rights. In Brazil, their protection resides in the legislation set forth against unfair competition (considered a crime under Brazil’s Industrial Property Law of 1996), in the TRIPS Agreement (the Agreement on Trade-Related Aspects of Intellectual Property Rights) and in other legal provisions such as the ‘inviolability of privacy’ clause of the Federal Constitution.

Trade secrets are thus protected by the statutory rules on fair competition, established in Articles 195(XI) and 195(XII) of the Industrial Property Law with civil and criminal effects, and by Article 842(g) of the Labour Law, according to which the breach of a trade secret by an employee is considered a valid reason for dismissal.

In Official Gazette of February 11, 2015, ANVISA published RDC #7/2015, an update of the technical requirements for the regulation of personal hygiene products, cosmetics and perfumes, in order to simplify and expedite the treatment of this category of products in the country. The resolution came into force on February 25, 2015.

In Brazil, cosmetics are classified by ANVISA as products grade 1 or 2. Grade 1 products are characterized by having basic properties, which do not require further characterization or detailed information regarding their use and restrictions. On the other hand, grade 2 products have specific indications, which characteristics demand attesting safety and/or efficacy, as well as information regarding care, use and restrictions.

As of publication of RDC #4/2014, the procedures regarding the regulation of cosmetics had already been defined in order to stablish the Electronic Automation System of ANVISA as the basis for all activities comprehending notification, registration and corresponding alterations regarding this product’s category.

The Brazilian Patent Office has now started public hearing proceedings regarding the second block of consultations on the new “Guidelines for the Examination of Patent Applications”.

Companies commonly consider their databases as an intellectual asset. Brazilian Copyright Law recognizes that companies own the architecture of databases that can be considered works of authorship, either by the selection, organization or disposition of its contents (article 7, XIII of Federal Law n. 9.610/1998). However, some aspects must be considered when databases contain private information (usually consumer’s data). Given that such data relate to natural persons’ privacy, strong objections are raised in society against the unauthorized treatment and transfer of such information. Unlike other countries, only now this became an issue in Brazil and under an scrutiny of experts and the allegedly mistreatment of client’s personal data by some companies that the debate about the new draft bill of law was recently introduced.

For the last thirty years, Brazilian legal framework has superficially touched the protection of personal data.  Dispositions were spread in the Federal Constitution, the Consumer Protection Code, the federal laws on access to public information and on industrial property, as well as on the Civil Rights Framework for the internet. Still, the lack of a single law fully regulating the issue has led to undesired levels of legal uncertainty.

An old promise of the Ministry of Justice, the Draft Bill of Law on the Protection of Personal Data was finally disclosed last January. Long-awaited by companies, lawyers and consumer defense entities, the draft is under public consultation until April 30, 2015 and might be refined bt the Ministry before its submission to the Congress. It is already possible, though, from the analysis of the document, to derive some conclusions that may guide companies with regard to the best practices to be adopted until the effective enactment of the law.