by Moeller IP Advisors
Brazil is one of the biggest pharmaceutical markets in the world. IMS Health -a pharmaceutical consulting and information company- estimated that the Brazilian market will achieve around 40 billions of US dollars in 2017, in pharmaceutical sales. From 2007 to 2011, the market grew an astounding 82%, according to a report by Interfarma, based on IMS Health data.
It’s not surprising that the news about the long expected reform in the pharmaceutical patent procedure was favourably welcomed by the experts.
The ordinance 1/2017 was signed by the Brazilian PTO and ANVISA (the Brazilian Health Surveillance Agency) and came into force on June 12th. The purpose is streamlining the process for obtaining pharmaceutical patents, getting rid of the double approval system that caused the backlog.
Patenting Drugs in Brazil
What did the previous rules for patenting pharmaceutical products say?
The story goes like that: in 2001 the Brazilian IP Law was amended to establish that all the applications for pharmaceutical patents had to be approved by ANVISA after undergoing the usual examination in front of the Brazilian Patent Office. ANVISA evaluation should have been limited to assessing the medicines’ potential risk to public health. In 2013, however, ANVISA single-handedly approved resolution 21/2013, establishing that the process should begin at ANVISA which would approve the application to subsequently forward them to the Brazilian PTO.
As a result, the review process ended up being longer because of poor communication between the two bodies. The same applications were examined twice as ANVISA performed also a technical examination to establish the novelty, inventive step and industrial applicability of the invention. However, the very same requirements were also evaluated by the Brazilian PTO. Delays and backlogs were the obvious consequences, especially if the two bodies did not agree on the patentability criteria.
In 2016, the big pharma company Novartis sought and obtained a preliminary injunction against ANVISA, claiming that the agency was taking an unreasonable amount of time to examine its application, and claiming that the task of examining the compliance with patentability requirements belongs solely to the Brazilian PTO.
According to the new ordinance, ANVISA shall only stick to reviewing the public impact of the pharmaceutical application, while the Brazilian PTO will examine the patentability requirements.
Going even quicker
In 2015, ANVISA had already approved a new resolution to speed up the process for approving clinical trials of drugs in Brazil. Under this resolution, ANVISA has two deadlines to evaluate the clinical trial applications in Brazil: 180 days for reviewing local Phase I and II clinical trials; 90 days for reviewing international Phase III clinical trials of synthetic medicines. In the latter case, should ANVISA fail to reply within the deadline, the sponsor can start the clinical trial if it obtains approval from the responsible ethics review boards.
The aim of this resolution – especially in the more favourable treatment granted to international clinical trials – is to boost the applications from foreign pharma companies. This goes together with another resolution by ANVISA, approved in 2014, that accelerated the process for importing drugs. It is true, indeed, that the national pharmaceutical companies account for around 50% of the market – but their effort is usually focused on “copy” products like generics. Improved and quicker procedures should foster investments and innovation in the creation of new pharmaceuticals in Brazil.Read More
By Moeller IP Advisors
Stem cells have the potential to treat a wide range of diseases and constitute a key research tool in the development of novel therapies and personalised medicine. There are two major types of stem cells: adult and embryonic. Embryonic stem (ES) cells seem to possess a much higher therapeutic potential, due to their unique properties, and they are derived from a four or five-day-old human embryo. ES are able to produce all of the body’s cells, propagate quickly and serve as a source of replacement cells and tissue for damaged organs.
Properties of human stem cells have led to extensive R&D investments- and raised the necessity of protecting these assets through adequate IP legal instruments.
Ethical Issues Related to Human ES Cells
The attention toward stem cells has been growing in Mexico in the last few years. The Mexican Society for Stem Cell Research was founded in 2014 and the National Council of Science and Technology has several grant programs for research within the field of adult stem cells.In Mexico, claims related to adult stem cells have been rejected by the Mexican Institute of Industrial Property (IMPI) until not so long ago. However, such institute, in a truly surprising and radical change on the subject, has recently indicated that adult stem cells can be considered perfectly patentable.For embryonic stem cells, however, it’s another matter.
Article 4 of the Mexican Industrial Property Law, states that
“No patent, registration or authorisation shall be granted, nor shall any publicity be given in the Gazette in respect of any of the legal devices or institutions regulated by this law, where their contents or form are contrary to public policy doctrine, morals or good practices, or if they violate any legal provision.”
The Mexican Institute of Industrial Property (IMPI) referred to this article to deny the patentability of ES cells. Indeed, the procedure for extracting ES cells require the destruction of the human embryo: an act that IMPI considered as contrary to public morality – as a consequence, the IMPI has rejected patent applications concerning ES cells.
Mexico is not unique in rejecting inventions relating to human ES cells.
In 2009, the European Patent Office Opposition Division ruled against the “Edinburgh Patent” (T1079/03), arguing that wherein human embryos would be destroyed in the process to obtain ES stem cells, the invention was to be considered against Article 53(a) and Rule 23d(c) of the European Patent Convention (EPC) and therefore not patentable.In 2010, the European Patent Office’s enlarged Board of Appeal similarly denied the patentability of biotechnological inventions which require the destruction of the human embryos for industrial or commercial purposes.
On the other hand, the EPO in practice admits these type of patents if the applicant demonstrates that the Stem cells could have been obtained without destroying the human embryo.
New Requirements to Stem Cells Patentability
This is exactly the route that Mexico may be following in the future. Since 2008, evolvements in biotechnological techniques have made possible to obtain human ES cells without the destruction of a human embryo.
These new methods of obtaining human ES cells could effectively circumvent the morality provisions. While filing a patent application, then, the applicant must clearly specify that the ES cells can be obtained without destruction of the human embryo and that this alternative method was already known and available to the public at the time of filing. In other words, the applicant has to prove that the invention could be performed without necessitating the destruction of an embryo at the filing date of the patent application.
By Moeller IP Advisors
According to data from the Chemical Abstract Service (CAS), a division of the American Chemical Society, the number of patents related to chemical products has grown tremendously in the last 20 years: the CAS Registry collects data on more than 132 million organic and inorganic substances. Brazil makes no exception to this trend.
It’s therefore particularly relevant that the Brazilian Institute for the protection of Industrial Property (INPI) had published, last January, a new set of guidelines for the examination of patent applications related to the chemical field.
The guidelines have been issued on January 2 with the Rule 208/2017 and following a request for public consultation on a draft version of the same guidelines, submitted in March 2017.
Rule 208/2017 complements the previously issued Rules 124/2013 and 169/2016 – respectively guidelines for the Examination of Patent Applications – Parts I and II. The new guidelines replace the previous guidelines published in 2002 by the INPI Brazil for the examination of patent applications in the biotechnological and pharmaceutical field.
Content of the new guidelines
The recently published guidelines contain additional content when compared to the draft published in March 2017. What are the main aspects of the newly issued guidelines?
- Definition of a chemical compound: according to the new INPI guidelines, a chemical compound must be defined by its chemical structure or chemical name. This implies that compounds defined solely by their physical, physicochemical or biological properties or by their use or application (so-called functional claiming), cannot be accepted.
- Esters, ethers, pro-drugs, solvates, hydrates, clathrates, and co-crystals: these terms alone, lacking any specific definition, will be interpreted as generic expressions with the consequence that the application risk to be rejected.
- Selection patents: applicants should provide comparative data between selected compounds claimed in an application and those of close structural similarity known in prior art. Clearly, this is necessary to demonstrate how the selected compounds contain an inventive step.
- Polymorph claims: the application should contain a precise characterization of the crystalline solids. Single-crystal X-Ray Diffraction is an analytical technique that, for the INPI, is sufficient to characterize the crystalline structure of the solid. Alternatively, INPI admits that the Powder X-Ray Diffraction – considered a “bulk characterization technique”- can be used in association with at least another identification method. Lack of data for characterizing a crystalline solid will likely result in a rejection of the claim.
- New medical use claims: this is particularly relevant for the pharma industry. According to the guidelines, the application should contain evidence supporting the new medical use of the compound, otherwise the examiners may reject it. In this regard, the guidelines adopt a more flexible approach compared to the draft published in March last year. Indeed, in the new version, the INPI admits that in vitro studies can be used to support an in vivo effect if the applicant submits complementary information – for instance, a scientific publication – proving the equivalence between the two methods.
By Moeller IP Advisors
The market of counterfeit pharmaceuticals is probably the largest among all counterfeit goods, ranging from US$163 billion to $217 billion per year. Counterfeit medicines can include products with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.
Peru is one of the main markets for counterfeit pharmaceuticals and has been listed on the Watch List several times, under USTR Special 301 Report.
The reason is that the Peruvian pharmaceutical market has been deregulated in the 90s: as a consequence, pharmaceutical establishments have grown exponentially, making it impossible for the national authorities to perform the necessary controls over the production.
Since 2005, counterfeit medicines have increased by approximately 45% annually in Peru, and according to Peru’s Association of Pharmaceutical Laboratories (ALAFARPE) the sale of counterfeit drugs increased from US$ 40 million in 2002 to US$ 66 million in 2006. Only in 2005, the DIGEMID, Dirección General de Medicamentes, Insumos y Drogas, which operates under the Ministry of Health, seized around 460 000 adulterated and expired medicines.
Clearly, the market of counterfeit pharmaceuticals is not only relevant from an IP profile. The risks for public health are also extremely high: almost 25% of the counterfeit medicines checked by Peru’s National Quality Control Center did not contain any active ingredient.
According to DIGEMID the most counterfeit drugs circulating in Peru are analgesics and anti-influenza drugs, which account for around 70% of the market.
The legal framework against counterfeit pharmaceuticals in Peru
Peru has tried to fight the phenomenon by enacting a series of laws.
In 2009, the Law of Pharmaceutical Products, Medical devices and Sanitary products n.29459 modified the Chapter III of the General Law of Health n.26842 and established a series of sanitary authorisations for operating pharmaceutical establishments. The law also establishes a mandatory pre-inspection prior to starting production and asks companies to provide certificates that prove their compliance with Good Manufacturing Practices.
In 2014, the Temporary Supplementary Provisions of the Supreme Decree No. 033-2014-SA modified the Regulation of Pharmaceutical Establishments and introduced additional requirements for the registration of the establishments.
The DIGEMID also periodically releases an alert in which any regulatory actions regarding pharmaceutical products, including counterfeit medicines, are published. The sale of counterfeit medicines is also considered a crime against public health, punishable by a term of imprisonment of 4 to 15 years.
Notwithstanding the progress made, a lot remains to be done: large volumes of counterfeit medicines continue to plague the market and the Special 301 Report, published in 2018, points out that while laws are in place to fight the production and sale of counterfeit pharmaceuticals, the enforcement remains very weak.
According to a report by the Pharmaceuticals Export Promotion Council (Pharmexcil), the entry of foreign retail chains into the Peruvian market, which is expected in the next years, should also have the effect of improving the quality of the supply chain and reducing the presence of unregistered and counterfeit medicines.Read More
By Moeller IP Advisors
On February 1, 2018, the latest Patent Prosecution Highway Agreement signed by the Brazilian Institute for Intellectual Property (INPI Brazil) and the State Intellectual Property Office (SIPO) of China, came into force. The pilot program provides for an accelerated procedure for all patents filed in the field of Information Technology, packaging, measuring technology or chemistry (except pharmaceuticals).
The program is -probably not the last- of a long series of agreements that INPI Brazil has signed with other major commercial partners throughout the years to ensure a smooth and fast registration of patents.
It is well known, indeed, that notwithstanding the economic growth that Brazil has witnessed in the last years, the backlog is still one of the major issues for companies wanting to register their intellectual property in the South American country. The average registration process for a patent in Brazil lasts around 12 years – making it burdensome and costly to protect inventions.
For this reason, Brazil has been launching a range of pilot programs setting more expedite patent registration procedures in those areas which are deemed particularly relevant for the country’s economy.
USTPO-INPI PPH Agreement
In 2016, Brazil launched the first PPH Agreement with the United States Patent and Trademark Office. The pilot program concerned all the applications in the oil and gas field. According to the PPH, an applicant who successfully applies for a patent at either the INPI-Brazil or the USPTO may request an accelerated procedure in the other office. The time for the examination is reduced because the examiners do not need to re-analyze the application substantially but may rely on the work done by the other office.
On February 2018, the first provisional results on the USPTO-INPI PPH Agreement were published. In two years, the offices received 68 patent applications – and a final decision has already been granted on nearly half of them. The program, which was supposed to end in January 2018, is in the process of being extended.
JPO-INPI PPH Agreement
Another relevant PPH Agreement was signed between INPI Brazil and the Japan Patent Office (JPO) and started in 2017.
Japan is one of the biggest commercial partners of Brazil. The Asian country has the sixth largest foreign direct investment stock in Brazil, for a value that reached US$ 26.8 billion in 2014.
Moreover, in the past 17 years, the number of Brazilian patent applications filed by Japanese companies has greatly increased. In 2016, the filings by Japanese companies were 1829.
The pilot program is set to last for 2 years and concerns all patents applications related to the technological field. This is relevant, as today imports from Japan consist mainly in automobiles, motorbikes and car parts – the PPH aims at increasing registration of patents in different sectors. In particular, the patent applications should relate to machinery and electrical appliances, energy, telecommunications, audiovisual technology, digital communication, basic communication processes, computer technology, methods of information technology for management, and semiconductors.
In February 2018, there were 47 requests, of which 11 have already been decided.
Other relevant PPH programs have been signed with the members of PROSUR, namely Argentina, Chile, Colombia, Costa Rica, Paraguay, Peru and Uruguay, and with the EPO, the European Patent Office. Both PPH started in 2017.Read More
by Moeller IP Advisors
Nanotechnology is the manipulation and production of materials and devices on the scale of atoms; through molecular manufacturing. In theory, any physical object could be reproduced in the laboratory. It is easy to note how the potential of nanotechnology could be immense, especially in the medical field, where nanotech developments can be exploited for a wide range of uses like tissue engineering, diagnostics, surface texturing, biointerfaces and drug delivery. However, biotechnological innovations could have a much greater variety of applications in areas like electronics, food production, cosmetics, textiles and even environmental protection.
Within Latin American countries, Brazil is being recognized at the forefront of nanotechnology research. Technological research is well funded at the public level and carried out by universities and research bodies.
The Nanotechnology sector in Brazil
A growing number of research institutes focus on nanotechnology research in Brazil: the Laboratorio Nacional de Luz Sincroton (LNLS) operates the only synchrotron light source in Latin America; the Centro Brasileiro-Argentino de Nanotecnologia (CBAN) focuses on nanobiotechnology, nanophotonics, nanotech molecular nanobiomagnetism, nanosciences, nanocoatings and nanocosmetics; the Rede de Nanotecnologia Molecular e de Interfaces (RENAMI) – is a network of 17 institutions that focus on the development of nanostructured materials, interfaces and devices for molecular nanotechnology.
Many private companies have been allocating growing budgets in R&D for nanotechnologies. In 2004, the Brazilian Ministry of Science and Technology launched the Nanoscience and Nanotechnology Development Program and one year later the National Nanotechnology Program, encouraging research and initiatives in the area. The Funding Authority for Studies and Projects (FINEP), and the National Council for Scientific and Technological Development (CNPq) also have been funding nanotechnology research since 2003.
Biotechnologies and intellectual property protection in Brazil
How is the effort in biotechnological research and investments mirrored by the growth of registered patents in Brazil?
Since 2004, the Brazilian Intellectual Property Institute (INPI) recorded a growing number of patents obtained in the field of nanotechnologies – in correspondence with the creation of the Nanoscience and Nanotechnology development program.
According to a research carried out by the University of Sergipe, out of a sample of 69 nanotechnology patents obtained from 1993 to 2015, 57% were filed by private companies, 23% by universities and public research centres and 20% by individual inventors.
Most of the inventions patented belonged to the category “Manufacture or treatment of nano structures formed by individual manipulation of atoms, molecules, or limited groups of atoms or molecules as discrete units”, followed by “nanocapsules”.
Another, more comprehensive research carried out by scholars at the University of Rio de Janeiro and the ICICT, shows that the INPI Brazil received 1343 patent applications in the nanotechnology field from 1991 to 2011. Again, the peak in the number of patent applications occurred from 2004 to 2010, as a result of various funding initiatives directed at nanotechnology research. Most of the applications have been filed in the areas of nanomaterial, medicine and biotechnology.
It is worth noting that government funding initiatives could positively boost the number of patent applications in the biotechnology field, as nanotechnologies require a strong R&D investment, for which an initial support from the state can be incredibly useful.
It is also important to note that the Brazilian IP law does not provide a special treatment to nanotechnologies. However, the recent changes in the procedure for pharmaceutical patents – that does not require the assessment of the ANVISA anymore – other than for the analysis of potential public health issues- could positively affect pharmaceutical nanotechnologies.
By Moeller IP Advisors
Nanotechnology is a growing field with an incredible potential for several sectors. In healthcare, the development of nano-enhanced pharmaceuticals could prove incredibly powerful for treatment of widespread diseases like cancer. Electronics have also embraced nanotechnologies, for developing more powerful computer processors and increased storage limits.
Together with Brazil, Mexico has been the first Latin American country to develop a strategy in this nascent field. Since the early 2000s, Mexico has recognized the enormous potential of nanotechnologies by enacting the Special Program of Science and Technology (PECYTI) 2001-2006, part of the National Development Plan. The Program focused on the need to develop a national policy for promoting nanotechnology and on the creation of a research network in Mexico.
In 2002, the Mexican Program for Nanoscience and Nanotechnology was drafted by seven prominent public institutions and four foreign expert advisors.
In 2009, the National Nanotechnology and Nanoscience Network was created and funded with $700,000 USD, gathering together more than 100 researchers in the field. Two national nanotechnologies laboratories have been built, one in Chihuahua, at the Advanced Materials Research Center and one in San Luis Potosí, at the Potosí Institute of Scientific and Technological Research.
The effect on the research development has been notable: in the Latin American region, Mexico is second only to Brazil for the number of publications in nanotechnology.
Moreover, several companies have started to operate. It has been estimated that in Mexico more than 150 products have been developed using nanotechnology. Gresmex designed and patented a sanitizer able to destroy H1N1 virus; Sanki developed a food supplement made with nano-biotechnology. The Monterrey-based Sigma Alimientos commercializes a nano-packaging for storing food that otherwise deteriorates quickly in the presence of oxygen, while Nanosoluciones sells nano-enhanced water-repellent coatings.
Proximity with the United States also enabled cooperation in the field, like the Silicon Border Development Science Park, started in 2006.
Nanotechnology regulation Mexico
Regulation of the nanotechnology sector in Mexico has close ties to the United States’ one. In 2010, the U.S.-Mexico High-Level Regulatory Cooperation Council was created and a year later the Council released a memo from the U.S. Executive Office of the President called “Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials”.
Although this Memo was addressed to the agencies in the United States, Mexico also started to develop a set of Guidelines that substantially mirrored the content of the Memo. At the end of 2012, the Guidelines for nanotechnology regulations to encourage competitiveness and protect the environment, health and consumer safety were enacted.
Although the MEMO and the Guidelines have some differences, they both focus on the necessity of enacting a specific regulation that would enable the nanotechnology sector to thrive while evaluating the health and environmental risks that nanotechnologies entail. In this regard, however, it must be noted that neither the Memo nor the Guidelines make reference to the precautionary principle, which is included in the 2005 Ley de Bioseguridad de Organismos Genéticamente Modificados (LBOGM).Read More
By Moeller IP Advisors
Protection for Biologic Drugs
Until 2016, 35,480 applications for patenting biological drugs were filed in Mexico, according to data provided by Innography, an IP consulting company. It seems clear that Mexico constitutes a highly valued market for biologics. However, at this date, Mexico doesn’t have a law or another regulatory instrument that guarantees personal data exclusivity to pharmaceutical companies that produce and market biologic drugs, although this protection has been granted, in some cases, via case law. This is particularly critical, especially when compared to other jurisdictions: the US legal system provides for 12 years of DPE, while Canada grants a protection that lasts 8 years.
If you need help registering a patent our patent attorney can help you.
Why is DPE important for Biologics Drugs
Biologics are drugs that, because of their complexity, are particularly expensive to manufacture compared to the traditional pharmaceuticals. On the other hand, it is possible to synthesize a generic biologic agent that is structurally different enough from the original without infringing a patent on the original biologic. In other words, it’s relatively easy to manufacture a “copycat” biologic without breaching a patent. This copycat biologics are called biosimilars, they have the same therapeutic effect of the original biologic and, in fact, they can reduce the effectiveness of patent exclusivity.
Hence the necessity to protect the original producer through another tool: granting the exclusivity of the personal data used in the clinical trial. This way, other companies would not be allowed to leverage the clinical data that supports the effectiveness and safety of the biosimilar – but would need to produce their own data, which is clearly more costly and time-consuming.
DPE Protection in Mexico
On June 19, 2012, Cofepris, the Mexican Commission for Health Risks (Comisión Federal para la Protección contra Riesgos Sanitarios) published an internal decree providing guidelines to grant protection to DPE in Mexico, but only with regard to traditional pharmaceuticals.
The protection has a duration of 5 years: during this period, competitors are not allowed to use clinical trials and other information provided by the producing company to prove the drug’s safety and efficacy.
The DPE established by the Cofepris, however, didn’t include biological pharmaceuticals.
On the other hand, in the last few years pharmaceutical companies asked and obtained, through legal actions, a sort of de facto DPE protection for biological pharmaceuticals, on the basis of the interpretation of international treaties (namely, NAFTA and TRIPS). The protection granted by the Courts has been established in 5 years – which is the term NAFTA refers to- although in 2015, after a trial initiated by the company Janssen Cilag, a Federal Circuit Court determined that the duration could be longer than 5 years if gathering the clinical data involved considerable efforts and time.
The Trans Pacific Partnership and the future of DPE
The Trans Pacific Partnership (TPP), a free trade agreement between twelve Pacific rim countries, was initiated to encourage commerce among 40% of the world’s economy, including Mexico, Australia, Canada and, until January 2017, the US. Some parts of the TPP deal with Intellectual Property Rights: one of them aims at uniforming the term for data exclusivity between all the member countries. Mexico signed the TPP in 2012, but so far, hasn’t issued any normative act referring to DPE.
Implementing the TPP would mean a safer, normative scene for warranting DPE to producers of biologics in Mexico.
By Moeller IP Advisors
Last month, the Federal Economic Competition Commission (Cofece) of Mexico released a report stating that major pharmaceutical industries did not face substantial competition from generic drugs in the Mexican market because of regulatory delays and issues.
How does the Mexican law regulate generics? What sorts of issues does a company face when trying to introduce a generic drug to Mexico?
The issue with Generics
According to the Cofece report, generic pharmaceuticals seem to make their way particularly slowly in the Mexican market. On average it may take more than two years between the expiration of a patent and the launch into the market of the first generic drug: in the United States, the launch is almost immediate, while in the European Union it is around seven months. Moreover, two years after the entry of the first generic, the penetration of generic drugs reaches only 21.4% of the market, against the 89% of the United States or 74% of Canada.
The Health Registration Procedure for Generic Drugs in Mexico
In order to market a drug in Mexico, a company should apply for a health registration that certifies the efficacy, safety and quality of the drug. It is issued by the Mexican Commission for Health Risks (Cofepris).
Cofepris grants the health registration to generics if they contain the same amount of the active ingredient and have the pharmaceutical form of the “original”. Cofepris also checks that the pharmacopeial specifications, dissolution profiles or bioavailability are equivalent to the original.
Cofepris has a maximum term of 180 days to conclude the procedure; the term is cut in half if the application is accompanied by a favorable technical report issued by a third party authorized by the Ministry of Health.
However, the reality is different: the average time for concluding the procedure is usually 347 days, and 214 days in case of a pre-assessment by an authorized third party.
It has to be noted that unlike in most countries, the Cofepris certification lasts only five years.
The Linkage System
The Mexican law also introduced a linkage system. The system should make sure that no generic pharmaceuticals are marketed until the patent is pending on the drug of reference, in order to protect the rights of the patent holder.
In particular, Article167-bis of the Rules of Health Suppliers states that, once having received the application for registering a new drug, the Cofepris should “ask the technical cooperation of the Mexican Industrial Property Institute so that the latter determines at the latest of ten working days after receipt of the request, if current patent rights are breached.”
At the same time, Article 47 bis of the Mexican Industrial Property Act establishes that the Mexican Industrial Property Institute (IMPI) “shall publish in the Gazette, and will make available to the public a listing of products which shall be subject matter of industrial protection according to the substance or active ingredient” and specify the validity of the corresponding patent. Thus, the list includes the trade name, the pharmaceutical identity, the patent number and the expiring date.
Because of the publications of the list, the company that aims at introducing the generic on the market can check if all the patents on the original drug have expired in relation to the ingredients, the formulation and the use of that drug for a specific disease.
This June, the Brazilian INPI granted the registration of Geographical Indication to the product “Uvas Finas de Mesa” of Marialva. Marialva is a municipality located in Northern Brazil and is considered the largest producer of grapes in the state of Paraná. Recently, the Geographical Indication was also granted to the “Erva-mate” of São Matheus, a region that accounts for 14% of the national production of erva-mate. Brazil is the largest state in South America and, due to its geographical and natural variety, possesses a strong potential for obtaining GIs. Indeed, the country is the largest producer of coffee and sugar cane, and one of the largest for soybeans, cotton, beef and tobacco. However, as of 31 July 2012, only twenty-seven GIs were registered for products in Brazil, well below the average of most European countries.
The concept of Geographical Indication in the Law
The Geographical Indication is a mark used to identify products and services that come from a particular geographical area and that, because of their origin, own particular qualities.
The Industrial Property Law no. 9279/96, establishes the system for protecting Geographical Indications in Brazil. The law distinguishes between 2 types of GIs: Indication of Source (“Indicação de Procedência – IP) and Appellation of Origin (“Denominação de Origem – DO). Both indicators certify that a product or a service comes from a particular area – but the link with the origin must be stronger in the case of Appellation of Origin. In other words, for obtaining DO it is necessary to prove that the raw materials were sourced in the place of origin and that the processing of the product also took place there. Through DO, consumers are not only able to recognise the product as originating from a specific area but they can also identify the features that make it unique, differentiating it from others.
It must be noted that when a geographical name has become the common name for designating a given product or service, it cannot become a GI.
How to obtain Geographical Indications in Brazil
The Normative Instruction 12/2013 and the Resolution 55/2013 of the Brazilian INPI integrate the norms of the Brazilian IP Law concerning the registration of Geographical Indications.
Generally it is not possible for a single producer to apply for “Indicação de Procedência” or “Denominação de Origem”: producers must be organized in associations, institutions or entities representing the community, which are established in the relevant area and are effectively producing the goods they want to be certified. The GIs can have a nominative or graphic representation.
It is also necessary that the relevant geographical area is precisely defined in the application.
The most important part of the application concerns the proof of the existence of a control structure on producers or service providers: the applicants must provide the description of the product and its main physical, chemical and organoleptic characteristics; evidence concerning its geographic origin; a description of the method for obtaining it and of the method of control.
Foreign geographical names can also be registered in Brazil if already recognised in the country of origin or by an international organization. This has been the case of “Cognac”, “Franciacorta”, and “San Daniele” that indicate, respectively, French and Italian Denominations of Origin. In order to register the GIs, many of the elements required by the Resolution for local products can be omitted, provided that they arise from the official document that recognizes a GI in its country of origin.