Brazil is the eighth largest pharmaceutical market in terms of revenue and Latin America's largest markets. The consumption of drugs in the retail market represents about 70% of the pharmaceutical industry. Over the past 4 years, there has been a growth of 45% of drugs sold by pharmacies. According to statistics reported by pharmaceutical market reports, sales in the pharmaceutical market at the retail level in Brazil have jumped from BRL28.7 billion (US$11.2 billion) in 2010 to BRL41.8 billion in 2014 (US$13.5 billion). This represents an increase of 45.6% during this period. In 2014, sales in the retail Brazilian market grew by 11.4% over the BRL37.5 billion sold in 2013.
However, recently, the market has undergone some changes. Originator drugs, which accounted for 44% of sales in value terms in 2010, declined to 39% in 2014. In the interim, generics and 'similares' (branded copies of off-patent drugs) have gained market share, climbing from 55% in 2010 to 61% in 2014.
Despite positive performance in the Brazilian pharma market at the retail level, poor economic indicators and economic instability have hampered positive performance in 2015.
The main concern is the high level of inflation in Brazil, which is heading toward double digits according to Brazil's Central Bank forecast.
Additionally, the US dollar attained its highest level in 9 years, reaching BRL4.00 in the last quarter of 2015, which will have implications for the cost of pharmaceutical imports.
The generics sector is one that grows fastest in Brazil. Brazilian government policy is to provide domestic generic production of essential medicines, particularly, vaccines and insulin.
To this end, the government has invested large sums to spur local production, technology and capacity drugs for the treatment of various health problems such as cardiovascular system diseases, anti-infectives, digestive and CNS diseases. As a result, generic drugs have become at least 35% cheaper than the brand named drugs. In 2015, Brazil's generic drug market was valued at approximately BRL17 billion in 2015 [1,2].
Intellectual property issues
There is no doubt that Brazil offers excellent opportunities for foreign drugmakers as market growth for patented drugs is increasing in view of the high number of chronic diseases in Brazil that will generate an ongoing high demand for patented drugs. This scenario will generate opportunities for multinational companies to sell in the Brazilian market. In spite of Brazil's market appeal and the strong presence of the largest innovative drugmakers doing business in Brazil, the United States Trade Representative and the Pharmaceutical Research and Manufacturers of America have each placed Brazil on the 'Priority Watchlist' to date [3,4]. Some key issues of concern and disagreement are patentability standards, data protection, Government price controls and the inappropriate review of pharma patent applications by the National Sanitary Surveillance Agency (ANVISA). In addition, although there is no express bar, in terms of patentability with respect to secondary and polymorph inventions in the Brazilian Intellectual Property (IP) Statute, these inventions have been challenged by ANVISA. To be specific, there is a strong resistance against patenting these inventions from the local pharma industries.
An update on ANVISA's examination
The two-tier substantive examination has completed 15 years ever since Brazil's current Patent Law No. 9279/96 was amended in 2001 to allow ANVISA to conduct a mandatory review/examination on pharmaceutical patent applications before the Brazilian Patent and Trademark Office (PTO)'s substantive examination.
ANVISA Resolution RDC 21/2013 introduced a significant change in the pharma patent examination. Brazilian Resolution RDC 21/2013 [5,6] introduced a new workflow for pharmaceutical patent applications.
With the advent of the new workflow, pharma cases are forwarded directly to the ANVISA for examination supposedly to take into consideration public health issues. ANVISA examiners determine whether or not an application poses risks to public health, and this analysis results in either a grant or denial of 'prior consent' in respect of the pharma applications. Patent cases receiving 'prior consent' will be returned to the PTO for continued prosecution. In practical terms, the applicant receives an unfavorable opinion denying 'prior consent' and has 90 days from receipt of the said opinion to submit a reply. Should the applicant fail or choose not to submit a reply, ANVISA will deny 'prior consent'. All written opinions reporting the conclusion of ANVISA's analysis regarding 'prior consent' (both granting and denial) are published in the Brazilian
Official Gazette. If 'prior consent' of an application is denied by ANVISA, the applicant can file an administrative appeal to the Appeal Board of ANVISA within 60 days of receipt of the opinion. In the event, the appeal is held to be unfounded; the denial of 'prior consent' will be ratified by ANVISA. After ratification of the denial, the application is back to the PTO. At this point, the PTO will essentially 'shelve' the application for an unknown period of time. Presently, no patent application for which 'prior consent' has been denied, under the current workflow, has been shelved by the PTO. It can be asserted that the majority of Brazilian attorneys view the 'shelving' of a patent application without substantive examination by the PTO as a violation of the law and unconstitutional. The rationale is that payment of the examination fee to the Agency (PTO) guarantees an applicant to have its application examined by the Brazilian PTO (which is specifically authorized under the Brazilian Constitution to review patent applications). In the event, an application is 'shelved' by the PTO; the applicant can file an administrative appeal against the shelving. Administrative appeals filed at the Brazilian PTO are analyzed by a board of examiners. If the appeal is rejected, the only available recourse available for the applicant is to file a lawsuit in a Brazilian federal court against ANVISA's intervention in the substantive examination of the pharmaceutical patent application and against the PTO's refusal to examine the application.
Recent statistics show that approximately 20 lawsuits have been brought against ANVISA in connection with its denial of 'prior consent' under the previous workflow (where applications were first examined by the PTO and then sent to ANVISA for examination based on public health issues). In the majority of these lawsuits, the court has reversed ANVISA's denial of 'prior consent'. In these cases, the court has held that ANVISA must limit its review of an applicant's patent application solely to health issues, meaning that if the PTO approved a patent application directed to a pharmaceutical product of process, then a patent should be granted. Court decisions in favor of patentees have been issued in district courts of Brasilia.
Some courts have issued preliminary injunctions ordering ANVISA to grant 'prior approval' of patent applications on the ground that ANVISA did not have the competence to conduct 'patentability' examination.
A recent unexpected decision from the Federal District Court in Rio de Janeiro denied a preliminary injunction and ruled that ANVISA was competent to examine a pharma patent application in terms of patentability requirements. In all likelihood, this decision will be used by ANVISA to assert its legitimacy to examine pharma patent applications and patentees and
Brazilian attorneys will have to be innovative to overrule this decision. Several grounds for court actions against ANVISA exist but the main ones include:
ANVISA examiners have no competence and expertise to examine pharmaceutical patent applications;
ANVISA's mandatory review of pharma cases which results in rejection of certain claims is a discrimination against pharmaceutical inventions and is a clear violation of Article 27.1 of Trade Related Aspects of Intellectual Property (TRIPS) agreement; and the shelving of a pharmaceutical patent application by ANVISA without prior substantive examination by the Brazilian PTO is unconstitutional.
Mailbox patent litigation
Given the huge backlog of patent applications pending examination, patent prosecution in Brazil has been taking much longer than 10 years. This delay can be evidenced by productivity at the Brazilian PTO in 2014. Statistics show that the government agency granted a little over 2000 patents and that approximately 1300 of these granted patents issued with a term of 10 years from the date of grant. This is a clear indication that the prosecution time span exceeded 10 years and consequently the patentee is guaranteed the term established in the sole paragraph of Article 40 of Brazilian Patent Law 9.279/96. Said Article 40 reads as follows: "the term of a patent of invention shall be 20 years and that of a utility model patent shall be 15 years counted from the filing date of the application" . "Sole paragraph – The term shall be no less than 10 years for a patent of invention and 7 years for a utility model patent counted from the date of the grant, except where the BPTO is prevented from carrying out the substantive examination of the application owing to a duly evidenced judicial dispute or for reasons of force majeure." This 10-year term guarantee has, suddenly, spurred controversy, in particular from the local generic industry and non-governmental organizations. The applicability of the sole paragraph of Article 40 to mailbox patents is currently being challenged by the Brazilian PTO and by the Gx industry associations such as ABIFINA at the lower federal trial courts.
The Brazilian PTO has recently filed a large number of court actions aiming revoking several pharmaceutical and agrochemical patents before the Federal Court of Rio de Janeiro.
Actually, all of the patents involved in such court actions are related to pharmaceutical and agrochemical products/processes that belong to the so-called 'mailbox' types (also called black box), in other words, they were filed between 1 January 1995, when the TRIPS agreement came into force, and 14 May 1997, when the new Brazilian IP Law came into force. Note that inventions covering pharmaceutical and agrochemical products/processes were not statutory subject matter prior to the TRIPS and the new law. It is important to highlight that the Brazilian PTO published on 10 September (one day before filing the court actions) a legal opinion from the Attorney General's office asserting that such patents (known as mailbox types – filed between 1 January 1995 and 14 May 1997) must be granted with a 20-year term counted from the filing date (as provided by Article 40 of the Brazilian IP Law), and not with a 10-year term counted from its granting (sole paragraph of Article 40 of the Brazilian IP Law).
In view of the above, considering that all patents involved in these court actions were granted with a 10-year term from the (granting) date of issue, instead of the 20-year term from the filing date, the PTO alleges that such patents were granted in dissonance with the provisions of the Brazilian IP Law. As a result, these patents should be canceled by the Federal Court of Rio de Janeiro. Moreover, based on Article 229, sole paragraph of Law 9279, the PTO has requested the Federal Court to recognize that the patents should not have been granted with the 10-year term and so apply the 20-year term of protection counted from the filing date.
Based on this allegation, ABIFINA and the Brazilian generic industry have fiercely contested the 10-year patent term guarantee in the sole paragraph of Article 40 through a number of different mechanisms. For example, the local chemical industry has lobbied against Article 40 via the 'Patent Reform' Bill (#5402/2013), which is presently being discussed by the Brazilian Congress. The Patent Reform Bill contains a number of antipatent provisions, including one that would eliminate the 10-year minimum patent term. Six court actions were already decided by trial judges against the Brazilian PTO's claim, that is, maintaining the patents in force and reinforcing that their term of protection should be 10 years counted from the grant. In response, the Brazilian PTO has filed appeals on the merits against these decisions at the Federal Court of Appeal arguing that:
- The delay in granting the 'mailbox' patents was brought about by the aforementioned Provisional Measure of 1999, which has been beneficial for patentees inasmuch as their patents would never have been granted without these specific provisions for 'mailbox' patents;
- The principle of legitimate expectations is not applicable in the present case since patentees would not be assured that the decision that granted their 'mailbox' patents would not be challenged in the future, since a patent can be declared null at any moment, as provided in the Brazilian IP Law; The purpose of these lawsuits is to modify the patent term of the 'mailbox' patents, and, therefore, the consequences of this change would apply from now on;
- The principle of legality should prevail in view of the social interest since the grant of a patent with a longer term than the one defined in the law would be detrimental to the general public.
The decisions so far at the appellate level have been favorable for the plaintiff (Brazilian PTO). And the PTO scored successfully 2 × 1 in practically all the cases. Given these results, it can be interpreted that the patentees can still pursue this issue further at the Superior Court.
Brazil's new biodiversity law
Until recently, Provisional Act 2.186/16/01 of 23 August 2001 was the piece of legislation that governed the access to components of Brazilian genetic heritage, and the protection and access to any associated traditional knowledge.
On 20 May 2015, the Brazilian President Dilma Rousseff sanctioned the Biodiversity Law No. 13.123/15, which regulates the access to components of Brazilian genetic heritage, the protection and access to associated traditional knowledge and the sharing of benefits for the preservation and sustained use of Brazilian biodiversity. The main objective of the new law is to facilitate scientific research and economic exploitation involving access to samples of Brazilian genetic heritage .
As a result, there is a great expectation that national and international companies, especially those in the pharmaceutical, agricultural and cosmetic fields, will be encouraged to develop new products containing active ingredients from Brazilian biodiversity.
Some of the key changes brought by the new law are as follows:
- New rules for access to Brazilian genetic heritage made by foreign companies;
- Legal security for private companies investing resources in Research Development & Innovation – a 'benefit sharing program', which supports communities that provide their traditional knowledge to the industry, and the 'National Sharing Fund' to manage the financial resources received – adoption of the maximum share of 1% of the company's net revenue obtained by selling the final product resulting from the access to a component of Brazilian genetic heritage;
- A guarantee to free negotiation over the traditional knowledge and an additional 0.5% of the profit to the National Sharing Fund while the product is being sold – profit sharing of 1% with the National Sharing Fund if the traditional knowledge is not identified;
- Exemption of small companies and suppliers from sharing their profit, since they have less productive capacity. It is important to highlight that the companies and researchers will no longer need prior authorization to start a research project involving an active ingredient from Brazilian biodiversity, but rather simple electronic registration. Based on the provisions of the new Biodiversity Law, an authorization is only required if the company decides to commercialize a product developed from the results obtained in the research.
The Brazilian ANVISA published a final resolution in February 2015 on new rules to expedite the authorization of clinical trials of medical products in Brazil . This final version of the regulation modifies
Resolution 39-2008 following a public consultation held in 2014, with 641 contributions from the Brazilian clinical research sector. Under the new regulation, ANVISA will have two new deadlines to evaluate the Drug Clinical Development Briefings, which contain the clinical trials applications to be carried out in Brazil:
- A 90-day period for reviewing international Phase III clinical trials of synthetic medicines: if ANVISA does not reply within the 90-day period, the sponsor may start the clinical research, provided it obtains approval from the responsible ethics review boards.
- A 180-day period for reviewing local Phase I and II clinical trials: for this group of trials, the clinical research cannot begin until an official ANVISA decision. With the advent of this new regulation, ANVISA aims at expediting the authorization process for starting clinical trials without losing the quality and credibility of the process.
The new regulation seeks to harmonize national legislation with international industry guidelines. This new reform is particularly favorable for the international pharmaceutical industry as a regulation to speed up approval of clinical trials has been the subject of discussions between the agency and industry since 2012. The new regulation aligns with ANVISA's policy of improving the process for pharmaceutical companies to access the Brazilian market. In fact, recently ANVISA introduced new regulations that facilitate some of the internal processes such as marketing authorizations and the process for importing drugs. It is expected that a faster and efficient assessment of clinical trials' applications will attract more international pharmaceutical companies to develop clinical research in the South American country. An important aspect is that since private R&D activities consists mainly in clinical studies, a speedy approval of a clinical study will stimulate investments by foreign pharma companies.
Unfortunately, in spite of the fact that the Brazilian PTO have taken steps to increase the number of patent examiners, the situation has not improved for the simple reason that during the last decade, there has been a constant hike in patent filings at the Patent Office.
It is estimated that total patent filings in 2014 were approximately 36,000. As a result, the backlog of patent applications pending substantive examination has continued to increase. The Brazilian PTO's Director, at one point of time, considered launching a program called 'Promoted Withdrawal'. Basically, this program contemplated allowing an applicant to abandon an 'old' pending patent application and refile it as a new application (paper or electronic filing) which would be placed much ahead in the queue for examination. The rationale was to encourage applicants to maintain only those applications that were of real commercial interest. Apparently, this project has not materialized.
Also, the PTO's intention is to add 100 examiners to the existing workforce each year until 2018. This will entail sitting a compulsory examination to qualify as an examiner inasmuch as civil servants must undergo such a procedure to work in a government office. The Director holds that with advent of the new examiners the prosecution and examination of applications will be expedited, thus reducing the backlog. Given the current political and financial turmoils, it is hardly expected that the Brazilian Government will be able to implement and/or materialize any favorable changes to existing IP legislation and policies.
The adoption of Patent Prosecution Highway (PPH) has been discussed for several years but nothing concrete had come out from these prior discussions and/or negotiations. However, in June last year, during the Brazilian President's visit to the USA for a bilateral trade agenda, the USA and Brazil have agreed to sign a letter of intentions whereby the Brazilian PTO would adopt a PPH Pilot Program to streamline the examination of patent applications and ultimately reduce the huge backlog of patent cases. At the outset, the Pilot Program would apply solely to the oil and gas technology area. Since then, a memorandum of understanding has materialized and executed by both parties.
On 5 January 2016, the Brazilian PTO published Resolution 154/2015 establishing the long-awaited guidelines of the PPH Pilot Program between the USPTO, and the Brazilian PTO which could speed up examination of Brazilian applications duly filed and regularly pending in Brazil after a corresponding application from the same family receives notice of allowance from the USPTO.
The Pilot Program will be limited to the first 150 applications. The program was launched on 11 January 2016 and relevant guidelines were made available on the PTO's website. Applicants requesting PPH examination at the Brazilian PTO must file a comparative table of the claims granted by the USPTO and the corresponding pending claims in the Brazilian PTO official files. The duration of the program is up to 2 years, or until 150 applications have been received and processed. It is too early to speculate how much the Pilot Program will benefit applicants who face a 13-year average backlog at the Brazilian PTO.
Similar fast-track initiatives have been adopted for expediting examination of applications relating to green technologies, cancer and HIV, as well as pending applications with at least one infringed claim. Statistics show that a final decision is rendered between 12 and 18 months.
The importance of the Brazilian market is unquestionable and the history of Brazil's initiatives to achieve a decent IP legislation is positive. Brazil was one of the first countries to join the Paris Union Convention and is signatory to most of the major World
IP Treaties. Although Law No. 9.279/96 is fairly a good piece of work, the Brazilian PTO has been labeled inefficient for its bureaucracy and backlog.
The current Patent Law is basically TRIPS compliant with the exception of some provisions which are not harmonized with those of leading legislations or even with TRIPS. The absence of provisions for data exclusivity periods for human pharmaceuticals and Patent Linkage bears weight when pharma companies seek patent protection in Brazil. The additional hurdle imposed by the Brazilian Government to empower ANVISA to conduct a second examination on pharmaceutical applications spurs dissatisfaction for pharma companies doing business in Brazil.
The serious adverse factor, however, is the backlog which has extended for years and years. The situation is chaotic as the backlog stands at approximately 200,000 patent applications pending substantive examination. The effective solution is to hire more patent examiners, which is easier said than done.
The total number is approximately 300 examiners and the goal is to raise this number to a realistic 700.
The PTO has adopted several measures to accelerate the examination of patent applications, namely, on the basis of evidenced infringement, a green patent Pilot Program. In the pharmaceutical arena, there are several situations where an applicant can expedite examination and, recently PPH, between the USA and Brazil, was adopted for patent applications in the oil and gas technology area. The country's logistics and infrastructure problems in the major cities were partially resolved after hosting two mega events, World Cup and Olympics, and as a result investments are expected to increase principally in the pharma, biotech and agrobusinesses.
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