It has taken a long time for India to develop a productive environment for biotechnology. But recent developments look to have put it on the right track. Archana Shanker explains.
In May 2011, Glenmark Pharmaceuticals entered into a licence agreement with Sanofi Aventis in one of the first-ever deals for a novel biologic molecule in India for the treatment of autoimmune diseases. Bharat Biotech, an Indian Biotech company, developed a diarrhoea vaccine to be supplied to the UN and other markets at $1 each, making it the cheapest vaccine available in the market.
In 2006, India, despite having excellent technical manpower, did not have any novel biotechnology product to its credit. In 2009, Biocon developed the first and only novel humanised monoclonal antibody for the treatment of rheumatoid arthritis and psoriasis in Class 1, and in 2011, Glenmark developed a novel biopharmaceutical for the treatment of auto-immune diseases.
A recent survey shows that there are around 400 biotechnology companies in India that contribute approximately 30 percent of the total revenue of the sector. There are around 50 research and development labs in the public sector providing high-quality R&D services at a low cost.
Some of the primary reasons for the impetus in India’s biotech sector include excellent technical manpower, low cost and genetic diversity. Besides the above, several worldrenowned institutes such as the Indian Institute of Science (IISc), the National Centre for Biological Sciences (NCBS), the Jawaharlal Nehru Centre for Advance Scientific Research and the BARC Central Direct Research Institute provide high-quality R&D services to India and other countries.
Having said this, the two critical factors conducive to both investment and growth in the biotech sector are government policy on biotechnology and a robust intellectual property protection and enforcement mechanism.
The Department of Biotechnology issued a vision statement to provide a broad framework and outline the progress in this sector, including agriculture and food biotechnology industries, industrial biotechnology therapeutic and medicinal biotechnology, regenerative and genomic medicine.
"WHETHER OR NOT A MICRO-BIOLOGICAL PROCESS IS CONSIDERED AS BEING ESSENTIALLY BIOLOGICAL IS JUDGED BY THE PATENT OFFICE ON THE BASIS OF ESSENCE OF THE INVENTION, TAKING INTO ACCOUNT THE EXTENT OF HUMAN INTERVENTION AND ITS IMPACT ON THE RESULT."
Intellectual property, and particularly patents, become the central focus of research and development in this area of technology. As biotech business requires huge front-end investment at a very high risk, an obvious expectation of such investments is to provide market exclusivity with robust judicial enforcement, so as to provide a platform for the high-risk investment to flourish and prosper. Against this backdrop, the number of patent applications filed under the biotechnology category seems to have dropped from 1,950 in 2007-2008 to 1,303 in 2009-2010. Let us now examine why there has been a drop in patent filings despite the boom in the biotech sector.
The patent office recently finalised the Patent Office Manual, which is intended to provide directions to the examiner on examining patent applications and bring uniformity in practice between the four patent offices. However, in the absence of significant case law, several of these provisions are open to different interpretations.
Under the Indian Patents Act, once the subject matter has been scrutinised for novelty and innovativeness, a second level of scrutiny is undertaken by the Indian Patent Office under Section 3. Some of the important provisions of Section 3 that have an impact on the grant of patents to biotechnology inventions include:
- Section 3(c) prohibits the grant of a patent to a mere discovery of any living thing or nonliving substance occurring in nature. Therefore, from the biotech perspective, in order for Section 3(c) not to be invoked, the applicant needs to establish that the subject matter is an invention and that human intervention was involved. This would particularly apply in cases where the subject matter relates to ‘isolation’ of biological materials.
- The second provision is Section 3(d) of the act. According to this provision, the following are not inventions and hence are not patentable:
mere discovery of a new form of a known substance that does not result in the enhancement of theknown efficacy of that substance
mere discovery of any new property of a known substance
mere discovery of new use for a known substance
mere use of a known process unless it results in a new product or employs at least one new reactant
mere use of a known machine or apparatus.
The interpretation of this provision of law has been dealt with by the Intellectual Property Appellate Board in the Novartis case, in which it held that for a new form of a known substance to be patentable under Section 3(d), the applicant has to establish that the new form results in enhanced efficacy. The definition of ‘efficacy’ adopted by the IPAB, particularly in the field of pharmacology, was limited to ‘therapeutic efficacy’.
At the outset, this provision clearly makes a distinction between an invention and discovery. Secondly, the interpretation of the expressions ‘known substance with a known efficacy’ and whether efficacy is understood to mean ‘therapeutic efficacy’ will be decided by the Supreme Court in the Novartis case.
- Section 3(h) excludes ‘a method of agriculture or horticulture’ from patentability. Inventions that fall in this category will particularly include inventions in the agri-biotech industry, such as methods for producing mushrooms or cultivating algae.
- Section 3(i) excludes inventions directed to methods of treatment of human beings or animals, and encompasses surgical, diagnostic, therapeutic or curative treatment. The 2002 Amendment modified this provision so as to permit grants of patent to inventions that relate to the treatment of plants so as to render them free of diseases or to increase their economic value. What this could mean is that inventions such as gene therapy or in-vitro methods of diagnosis are not considered as inventions within the meaning of the act.
- Section 3(j) excludes the following subject matter:
- plants in whole or in part
- animals in whole or in part
- varieties and species of plants and animals
- essentially biological process(es) for production or propagation of plants and animals.
Micro-organisms, other than the ones discovered from nature, are considered as being patentable. One of the reasons for excluding plants from protection under the Indian Patents Act is on account of the sui generis legislation provided for the protection of plants under the Protection of Plant Varieties and Farmers’ Rights Act.
The Indian Patent Office, during prosecution, has consistently maintained a definition of what constitutes an ‘essentially biological process’ for the production or propagation of plant and animals. Section 3(j) prohibits the grant of a patent to an ‘essentially biological process’ and not a process in which essentially biological steps have been carried out.
The process for production of a plant or animal is essentially a biological process if it consists entirely of biological phenomena such as crossing or selection. Whether or not a micro-biological process is considered as being essentially biological is judged by the patent office on the basis of essence of the invention, taking into account the extent of human intervention and its impact on the result.
Micro-organisms were not considered patentable. However, pursuant to the amendment of the Indian Patents Act in 2005, genetically modified micro-organisms are allowable.
Having had a look at the protection and prosecution of patent applications, the role of judiciary becomes equally important in ensuring effective enforcement of patents in India.
The main events that led to the speeding up of litigation are the amendments to the Code of Civil Procedure in 2002; the case management culture built up in the courts in India; and the remarks made by the Supreme Court in TVS v Bajaj.
The Supreme Court remarked that “all intellectual property matters should be disposed off within four months from the date of institution of the suit”. Since then, there have been several instances where the High Court has been passing such four-month orders. The Delhi High Court also became an e-court in December 2009, adding to the speed of disposal of cases.
With the above background, the prosecution and enforcement of IP in India has been evolving in recent times. This is because companies and organisations are keen to assert their rights and ensure that the high investments made by them in research and development of products are protected.
This has been well supported by the Indian government through appropriate legislation, and by the Indian courts in enforcement of laws. We believe that India is currently in the middle of a revolution in this area.
Archana Shanker is a senior partner at Anand and Anand. She can be contacted at: email@example.com
biotechnology, biological processes, Glenmark, Sanofi Aventis, Novartis