Biotechnology is a multidisciplinary science that integrates concepts of Biology, Chemistry, Engineering and Informatics, based on the use of living organisms and biological systems for the production of improved products and processes with applications in agriculture, food and human health. The development of new vaccines, drugs and hormones is also related to Biotechnology.
The market was dominated for many years by purely synthetic chemical drugs which consist of small molecules endowed with a simple structure. With the rise and understanding of complex mechanisms linked to the modification of genes and the use of cells and microorganisms, provided by Biotechnology, the production of biological drugs represented by larger molecules and complex structures became possible. As a result, inventions directed at biological products and processes have shown promise in the treatment and prevention of a wide range of diseases such as cancer, multiple sclerosis, rheumatoid arthritis and asthma, among others.
Processes and products derived from Biotechnology could be measured in the last decade by a considerable increase in patent application filings in this area. Among the most prominent biologics in the context of patents are monoclonal antibodies, which act mainly as molecules capable of locating substances of interest precisely and fighting them in a better and successful way. It is worth noting that, given the complexity of the biologics, cells and various genetic materials are usually involved in the processes of their generation. Such a situation often gives rise to different patent applications related to the same biological drug involving many technologies worthy of patent protection, such as DNA, RNA, protein, vector, expression cassette, antibody and hybridoma, among others, and microorganisms modified by human intervention, such as bacteria and yeast. To obtain a patent in Brazil, these technologies need to be genetically modified and different from their natural counterparts.
In order to keep up with innovations in Biotechnology, the National Institute of Industrial Property (“the Brazilian Patent Office”) published Resolution 144 in 2015, establishing Guidelines for the Examination of Patent Applications in the Biotechnology area. It is a well-known fact that the main problem currently facing the Brazilian PTO is the backlog (or delay in the examination of patent applications), where the time scale for the issuance of a technical opinion is excessively long and ends up delaying a final decision on the application.
The Brazilian PTO has announced measures in recent years to reduce the backlog. The promise of creating the e-Patent electronic filing system has been kept and it is already in operation and the review of internal procedures has been strengthened. A program called “Task Force” is set to get underway in 2016 and will bring together groups of public employees, divided by strategic areas, to speed up the examination of the admissibility of patent applications via the Patent Cooperation Treaty (PCT), examination of industrial designs, trademarks and patents, including appeals and request for administrative nullity. An Executive Order for the creation of the Working Groups involved was signed by the President of the Brazilian PTO, Luiz Otávio Pimentel, recently. As a result , a greater number of pending decisions under the Brazilian PTO is expected, with a subsequent reduction in the backlog of patents applications under examination.
Backlog in the Biotechnology area: according to data and charts published by the Brazilian PTO, 67% of patents granted in 2014 were filed over 10 years ago. Furthermore the Brazilian PTO reports that the average time for granting patents in the Biotechnology area is around 12 years.
How does the term of the patent work in view of the backlog?
The backlog issue is a reality, particularly for patent applications that cover biological products. In this sense, the granting of patents in this specific area has benefited from the sole paragraph of Article 40 of the Industrial Property Law (or IPL) 9,279 of May 14, 1996 , which determines that the length of the protection of a patent shall be a minimum period of 10 years from the date of granting it, except in the case of the Brazilian PTO being prevented from proceeding to examine the merits of the application due to a proven pending litigation or force majeure.
What is the current situation of patent applications directed at drugs in Brazil?
There are currently over 14 drugs protected by patents that benefit from the provisions of the sole paragraph of Article 40 of the IPL, especially a biologic drug consisting of monoclonal antibody for treatment of autoimmune diseases. It is estimated that more than 40 drugs in Brazil whose patent applications are pending in the Brazilian PTO are likely to fall within Article 40 of the IPL.
From the perspective of domestic and foreign companies, Biotechnology is currently the source of greatest innovation of their products. However, there is a need for a large investment in research and development (R&D) in biologics, which is influenced primarily by the need for long and complex laboratory studies, and material and reagents, which ensure the maintenance of adequate means to obtain the final biological product. Therefore, considering the time needed in research to obtain a tested safe and effective biological drug, it is natural to expect that the Brazilian patent system should be dynamic and efficient in the granting of patents in the Biotechnology area.
With the recent news and plans of action and goals published by the Brazilian PTO, there is a strong tendency to align the patent system to innovations brought by domestic and foreign companies through a more responsive policy of granting patents. Simplification and flexibility in the processes are essential to meet the demands in the patent area.