The biotech industry, probably more than any other industry sector is facing a concern to deal with the challenges of the emerging TRIPS compliant patent system in India from January 1, 2005. Possibly the country is going to experience at least one more amendment to the Act very soon as an obligation to the TRIPS agreement to have the countries patent laws fully compliant with the TRIPS guidelines.
A strong intellectual property protection strategy is crucial in the biotechnology and bioinformatics space as monetary and temporal resources are tremendous in finding a blockbuster drug or gene therapy. Current problems and IP practice in the genomic space are not few. Various strategy and solutions have been proposed to guide companies in forming an aggressive strategy to protect one's intellectual property and competitive positioning.
The IPR protection of new life forms raises a number of difficult technical and ethical issues that do not apply to other inventions. For that reason, the patentability of new biological forms and processes is still not accepted in many countries.
A few explanations are needed on why the IPR protection of biotech innovations is so controversial. First, there are ethical issues concerning the creation of new life forms. While this is a legitimate concern, one should not lose sight of the fact that human societies have been creating new life forms through selective breeding and hybridisation of plants and animals for thousands of years. The social acceptability of new life forms is a moral issue well beyond the realm of IPR protection.
On the technical side, a frequently raised question in relation to biotechnological research is whether the new life form, or an organic substance derived from the new life form, is a scientific discovery or a technological invention. Patents are not supposed to cover scientific discoveries, only inventions. Moreover, many products of recombinant DNA are more a result of luck and patience than of original thinking. Much work in genetic engineering involves inserting and recombining genes using established techniques. It is not clear whether such recombinations should be eligible to pass the non-obviousness test, even if the result is quite novel. But there are different opinions about what is obvious and what is not to technical experts in this new field of study.
Another technical question is whether the patent should be regarded as extending to the progeny of the protected life form. According to law, sellers generally exhaust their rights in the item sold, so that buyers are entitled to use it as they see fit. Thus, according to this principle, the progeny belong to the buyer. On other hand, the unauthorized reproduction of an article containing some patented element(s) is an infringement of the patent. This clearly represents a conflict between two legal doctrines that has to be resolved.
The Biotechnology sector is dealt quite closely by Article 27 of TRIPS. Article 27 makes a distinction between biological material produced by biological processes and those by essentially a non-biological routes - the later only being a subject matter of patents. Natural material of any kind is not patentable. Again, new plant varieties can be protected by patents or a sui generis system. India has chosen to have a special legislation and has legislated the Plant Varieties Protection and Farmers Right Act. TRIPS directs that microorganisms should be patentable; but microorganism is yet not defined to the fullest extent. TRIPS does not provide a definite code regarding new life forms. The present version of TRIPS allows members to exclude from patent protection:
- Plants and animals other than micro-organisms;
- Biological processes for the production of plants or animals other than microbiological processes.
However, TRIPS stipulates that protection must be available for new plant varieties (including seeds), though this does not have to be necessarily by patents. Most countries, including Australia, offer specially designed (sui generis) protection to new plant varieties.
Patenting or nonpatenting of genes is another area, which still requires some more clarity. Two school of thoughts at present include:-
1. Isolation and characterization of genes lacks inventive step and hence not patentable;
2. Isolation and characterization of genes is not straight forward and does constitute an inventive step and hence patentable
Additional clarity is requi-red in these aspects of patenting of genes and patenting of living things - an area that needs serious attention during the third amendment.
Article 30 and 31 of TRIPS allows the grant of Compulsory Licenses during conditions of national emergencies. The terms and condition of granting Compulsory License has been laid down clearly in Para 6 after the DOHA Declaration. In simple words this means that general public health concerns will rise above the private monopoly governed by patents.
By virtue of requiring the protection of new microorganism by means of patents, TRIPS already cover most of the field of genetic engineering related top pharmaceuticals.
The development of new proteins for pharmacological use (such as new vaccines, blood clotting agents, hormones and other therapeutic substances) depends on new strains of microorganism incorporating imported genes, rather than higher forms of life. New microorganism has been patentable in most industrialized countries for many years. However, there is no international consensus about what precisely should be covered by patents microorganisms.
- (The author is Head - IPR, Biocon Group of Companies)