Biotechnology patents: problems and expectations

Biotechnology is a multidisciplinary science that integrates biology, chemistry, engineering and informatics, and focuses on the use of living organisms and biological systems for the production of improved products and processes with applications in agriculture, food and health. The development of new vaccines, drugs and hormones is also related to biotechnology.

For many years the market was dominated by purely synthetic chemical drugs which consisted of small molecules endowed with a simple structure. With the rise in understanding of complex mechanisms linked to the modification of genes and the use of cells and microorganisms, 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 begun to treat and prevent a wide range of diseases such as cancer, multiple sclerosis, rheumatoid arthritis and asthma.

Over the past decade the processes and products derived from biotechnology can be measured through the considerable increase in patent application filings in this area. Among the most prominent biologics in the context of patents are monoclonal antibodies, which act as molecules capable of locating precisely substances of interest and fighting them in a better way. Given the complexity of the biologics, cells and various genetic materials are involved in the generation process. This situation often gives rise to different patent applications related to the same biological drug involving many technologies worthy of patent protection (eg, DNA, RNA, protein, vector, expression cassette, antibody and hybridoma) and microorganisms modified by human intervention (eg, bacteria and yeast). In order to obtain a patent in Brazil, these technologies must be genetically modified and different from their natural counterparts. In order to keep up with innovations in biotechnology, in 2015 the Brazilian Patent and Trademark Office (PTO) published Resolution 144 which established the Guidelines for the Examination of Patent Applications in the Biotechnology Area.

Biotechnology patent backlog
Currently, the main issue facing the Brazilian PTO is the backlog in the examination of patent applications. However, the new e-patent electronic filing system is now in operation and the review of internal procedures has been strengthened. Throughout 2016 the Task Force Programme will bring together groups of public employees to speed up the examination of patent applications under the Patent Cooperation Treaty and the examination of industrial designs, trademarks and patents, including appeals and request for administrative nullity. Further, Brazilian PTO President Luiz Otávio Pimentel signed an executive order for the creation of the relevant working groups. As a result, the Brazilian PTO is expected to reduce the backlog of patents awaiting examination.

According to data and charts published by the Brazilian PTO, 67% of patents granted in 2014 were filed more than 10 years ago. Further, the Brazilian PTO reports that the average time for granting patents in the biotechnology area is around 12 years.

The backlog is a major issue for patent applications covering biological products. The granting of patents in this area has benefited from Article 40 of the Industrial Property Law (9,279/1996), which states that the duration of patent protection must be at least 10 years from the date of grant, except where the Brazilian PTO is prevented from examining the merits of the application due to pending litigation or force majeure.

Present situation
At least 14 drugs are protected by patents that benefit from Article 40 of the Industrial Property Law, including a biologic drug consisting of a monoclonal antibody for the treatment of autoimmune diseases. It is estimated that more than 40 drugs for which patent applications are pending before the Brazilian PTO are likely to fall under Article 40.

For both domestic and foreign companies biotechnology is the greatest source of innovation for their products. However, major investment is needed in biologics research and development, which is primarily influenced by the need for long and complex laboratory studies, plus material and reagents, thus ensuring the maintenance of adequate means to obtain the final biological product. Therefore, considering the research time needed to obtain a safe and effective biological drug, it is natural to expect the Brazilian patent system to be dynamic and efficient in granting biotechnology patents.

The Brazilian PTO's plans and goals demonstrate a strong tendency towards aligning the patent system to innovations created by domestic and foreign companies, as well as a more responsive patent-granting policy. Simplification and flexibility in the processes are essential to meet current demands in the patent area.