The new patents bill must cover all Indian traditional plant-based medical formulations.
THE SUGGESTIONS that follow for inclusion in the new patents bill before Parliament are based on (a) recognition of the fact that many provisions of TRIPS are weighted heavily in favour of the developed countries; (b) that there are provisions in TRIPS that can be used to maximise and protect our national interests; and (c) that the recent decisions taken at the WTO's Doha meeting provide for even greater flexibility in the use of certain provisions of TRIPS; that would be in our interest provided we have the wits and the courage to use these provisions. An example of maximising the protection of our interests is the recent Plant Varieties Protection Act passed by Parliament. Although some provisions of this Act could be improved upon, by and large it would help our farmers and thus also help protect our agriculture.
The following are some of the problems with TRIPS. Article 23 (Additional Protection for Geographical Indicators for Wines and Spirits) when we have Article 22 (Protection of Geographical Indicators). Article 27.2 which permits patenting of products, not recognising that the development of an alternative process for the production of, say, a drug is as much of an intellectual challenge as developing a new product to begin with. Article 27.3 (b) which permits patenting of micro organisms (naturally occurring or genetically engineered). Article 31 about compulsory licensing in which terms such as "reasonable" and "adequate" have been used without definition. Article 34 which puts the burden of proof on the defendant.
Some suggestions for inclusion in the new patents bill are given below. The bill must provide for protection of our geographical indicators such as various kinds of Indian tea, basmati and other rice indigenous to India, the many varieties of Indian mangoes, the orchids found only in the Himalayas (which would include several hundred varieties found only in Arunachal Pradesh), and so on. It must state that any derivatives of Indian geographical indicators based on the germplasm of these indicators, would not be patentable. This may not mean very much for us but it will prevent the use of our market by people who may, for example, use basmati rice as a starting material for developing a new variety with minor genetic modifications. We should recognise that India would eventually be one of the world's largest markets.
We could use the provisions of Article 27.2 and Articles 8.1 and 8.2 to take care of some of the problems that would arise, following implementation of Article 27.1. One suggestion would be to include a clause in the patents bill that the Government will set up a high-power committee which would, say, every six months, prepare a list of products (including drugs) for which cheaper alternatives than the patented one are available in India through the efforts of our scientists such as organic chemists, and the production of which through the new process would make it cheap enough to be within the reach of the masses, and thus necessary "to protect order public or morality, or human, animal or plant life or health, or to avoid serious prejudice to the environment". The committee will then permit, using the above quoted provision under Article 27.2 and similar provisions under Articles 8.1 and 8.2, the production of these products by the new process in the country even though the product (made by another process) may have been patented by a party outside the country. To make optimal use of the provisions under Article 27.3(a), we must clearly spell out that no chemical entity (such as a monoclonal antibody) that is used for diagnosis or for preparing diagnostic kits, or any diagnostic kit or product, would be patentable.
As regards Article 27.3(b) of TRIPS, our patent law must exclude patenting of naturally occurring or genetically engineered plants, animals and micro-organisms (including those of marine origin) or any product(s) derived from them. In the case of such products, their patenting may be permissible only if a new use has been found for them which has not so far been known to mankind, either through published literature or through tradition The amendment must also clearly state that naturally occurring genes, single nucleotide polymorphisms (SNPs), and naturally occurring macromolecules such as DNA will not be permitted to be patented.
We may permit the patenting of specified processes for producing a genetically engineered plant, animal or micro-organism using a specified starting organism. Thus, we may permit the patenting of a process for producing a transgenic sheep of a certain breed, designed to produce a specific protein in a specified organ or secretion (such as milk, made by a specified procedure in which every element that is used (such as the vector) is definedfor genetic engineering, do not give the same results.
The new patents bill must cover all Indian traditional plant-based medical formulations (estimated to be about 40,000) that are part of either the documented Ayurveda, Unani, Siddha or Tibetan systems of medicine or the undocumented tribal systems of medicine, or which can be demonstrated to be part of our culture and for which social, if not, written validation exists. Thus the use of any of these formulations, or any modified versions of them, for any disease which can be identified with symptoms for which the formulations have been traditionally used, would not be patentable. A use patent could be granted for even a known formulation or a modification of it, if it has been shown to be useful for purposes for which it has never been used early. An example would be the two patents of Baruch Blumberg (a Nobel-prize-winning scientist who discovered the Hepatitis B virus) on a preparation of Phyllanthus amarus which has been widely used all over India (and elsewhere) for curing symptoms that correspond to Hepatitis B; these patents cannot be challenged as he has shown that the drug inhibits two key enzymes of the virus and actually clears the Hepatitis B virus from carriers. Similarly, patents should be grantable for developing processes for stabilisation of a traditional formulation so that it becomes commercially marketable. However, changes in the methods of extraction for a traditional medical formulation must not be permitted to be patented.
As regards Article 31, we should clearly state that compulsory licensing would be automatic, if three years have lapsed after the grant of the patent or five years after the filing of the patent, whichever is less, and the person or party desirous of producing the product in India has written to the patentee and received no reply within 90 days of proof of delivery of the communication to the patentee. As regards Article 34, we must insist that in case of an alleged violation of a patent, the burden of proof would life on the owner of the patent and not the defendant. We must also not permit patenting of formulations, drug metabolites, particle size variants and polymorphs.