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I.  Introduction

In India, the national legal regime pertaining to patents is contained in the Patents Act, 1970. The object of patent law is to encourage scientific research, new technology and industrial progress. Grant of exclusive privilege to own, use or sell the method or the product patented for a limited period, stimulates new inventions of commercial utility. The price of the grant of the monopoly is the disclosure of the invention at the patent office, which, after the expiry of the fixed period of the monopoly, passes into the public domain.

The fundamental principle of patent law is that a patent is granted only for an invention which must be new and useful. That is to say, it must have novelty and utility.

The Patents Act, 1970 recognised two kinds of patent i.e., product and process patents. A product patent is one where the patent holder has the absolute right to produce and market the product. A process patent is where the exact process of the product is patented. Similarly, a product patentee has the right to make, use, exercise, seller distribute such article or substance in India, while a process patentee has the right to use or exercise the method or process in India.

Under the Act, only process patents were granted to inventions relating to food, medicine or drug and substances produced by chemical process. However, in the context ofIndia being the member of WTO accepting TRIPS agreement. This scheme requires modification before 01-01-2005.

The law should not come in way to stop the economic progress of the country and to vitiate the constitutional right to health and life. Hence, forth proper measures should be taken to protect the interest of the public which is the eventual objective of the patent legislation.

II.  Trips and its effect

The agreement of trade-related aspects of Intellectual Property Rights (TRIPS Agreement), is the most controversial component of the WTO’s “package deal” struck in 1994. It was evolved to set minimum standards in the field of intellectual property (IP) protection that all WTO member countries have to respect. Very strict in regard to its compliance, it differs from many previous agreements similar to its type. It held its own multilateral dispute settlement body and also stipulated obligation related to administrative and judicial procedure. Its aim as specified in its preamble[1]:


“desiring to reduce distortions and impediments to international trade, and taking into account the need to promote effective and adequate protection of intellectual property rights, and to ensure that measures and procedures to enforce intellectual property rights do not themselves become barriers to legitimate trade”.

However, the intention to set up global standards for patent protection was also to generate funds for innovation, R&D investment, and product availability, especially for developing economies. Its impact can be well read through the price policies of pharmaceutical companies. It enables pharmaceutical drug manufacturers to make up unaffordable prices for their products. New, better drugs are made available in developed countries only who maintain huge capital for the same. Despite allof this, TRIPS itself allows WTO members certain measures to protect public health, such as parallel importation and compulsory licensing. However, developed countries, exert extremem pressures on developing countries to prevent them from implementing these flexibilities[2].

III. Patenting of method of medical treatment in the west

Patent law, particularly in the west, offers a monopoly to the developer of a useful product or process with a requirement that he discloses the invention to the public. To be patentable, an invention must meet stringent statutory requirements such as novelty, inventive step and industrial application and also that it must not fall ‘as such’ within any of the categories of subject matters specifically excluded. Patent law has to define the subject matter to which it accords protection. The range and types of subject matter over which patents are granted varied from time to time. In Britain, before the 1977 Act, the judges dealt with the matter, guided only by the phrase “manner of new manufacture”[3]. The 1977 Act provides a list of things, which are not be granted patents. Normally, intellectual conceptions and living organisms, animals or vegetable, need not be granted patents. However, in the recent years boundaries of patent system are widening as industries, which are used to working with patents extend their ambits of operation.

Now the trend in the west is to accord patent protection to all technical processes and products. Advances in microbiology and biotechnology virtually extended patent protection to micro-organisms and living beings including plants and animals[4]. It is claimed that the decision of the U.S. Supreme Court in Diamond Vs. Chakraborthy[5], made the sweeping generalization that “anything under the sun”, apart form a human being should be regarded as patentable. Unlimited extension of patent protection raises issues of public interest and policy and such issues are prominent in respect of patenting of method of medical treatment, drugs and pharmaceuticals.

The patentability of methods of medical treatment is inventions is an issue that has been proposed, argued and rejected and also accepted at different times. Normally, almost all patent system regard “method of treating the human or animal body by surgery or therapy or of diagnosis practiced on the human or animal body” as unpatenable[6]. The British 1977 Act deems these activities to be incapable of industrial application. The reason appear to be that the public policy requires the dissemination of new medical techniques unimpeded by claims to exclusive rights[7]. It was also observed that the patent system should not intrude into the realm of a leading liberal profession where expectations of renown and reward have traditionally taken to be different forms from those which flow form exclusive rights over commercialization. Accordingly, Cornish asserts that such patenting would equate a doctor with a successful pop star.

Nevertheless, pharmaceutical producers insisted upon patent protection in respect of drug therapies, and, at times, secured patents for substances used in medical treatment. Now the trend is towards according patents to methods of medical treatment that does not involve surgery or therapy or diagnosis. The British Court of Appeal in one case held that a method of contraception comprising dosages of hormones to women to prevent conception was patentable[8]. In this connection Whitford J. Observed

“It is not doubt sensible that a person who is able to produce a substance, which, for example, would cure or prevent cancer should, subject to safeguards, be offered a limited monopoly as a reward, and the possibility of such monopoly protection has undoubtedly resulted in an enormous investment in research in medical field. If this position is accepted, it is little difficult to see why someone who by research effort devises a new method of using a known substance to achieve equally beneficial results should be denied patent protection”[9].

However, another court in the Uniliver’s Application[10], observed that the word “therapy” has be construed in its wide meaning as including preventive, that is to say prophylactic treatment as well as curative treatment of disease of the human or animal body. Accordingly the Court held that a method of immunizing poultry against certain disease was not patentable. Nevertheless, the Courts in Australia, tried to interpret the medical treatment exception by making a distinction between non-economic methods of medical treatment in curing and preventing disease and economic methods such as cosmetic treatment[11].

An Australian Federal Court in Anaesthetic Suppliers Pty Ltd. Vs. Rescare Ltd., held that an invention of a method to control sleep apnoea is patentable because under the Australian Patent Act, 1990 there was no provision expressly providing such methods unpatentable[12].

In the U.S.A. claims to medical treatment of humans have been allowed for a long time since the Constitution empowers the Congress “to promote the progress of sciences and useful arts by securing for limited times to Authors and inventors the exclusive right to their respective writing and discoveries. Earlier, the Courts have held that methods of treatment are not patentable since they dealt with human beings produced unpredictable results and therefore cannot be equated with mechanical inventions. Now this view is rejected totally and methods of medical treatment have been considered patentable. Claims to surgical procedures caused controversy when a U.S. surgeon patented new type of incision for eye operation, demanded royalty payment from hospitals carrying out this technique, and in 1993 sued a clinic for patent infringement[13]. An attempt was made to statutorily exclude medical treatment but pharmaceutical and biotechnology industry successfully prevented enactment[14].

TRIPs agreement also provides for exclusion from patenting certain inventions on the ground of public order and morality and also excludes those relating to medical treatment of humans, animals and plants other than microorganisms[15]. It is interesting to note that Article27.3 of TRIPs uses the word ‘may’ and therefore it is claimed that it need not be read as introducing an exception for medical treatment. Accordingly, a British Court has held that a method of administering taxol in cancer treatment can be patented on the ground that the medical treatment exception must be narrowly construed to only prevent patent law interfering directly, with what doctor actually does to a patent.

It is observed that patenting of medical treatment has to take in to consideration issues such as access to patented treatments, affordability of treatment, interferences with free flow of ideas and interfering with privacy concerns in record maintenance.

IV. Patenting of methods of medical treatment in India

Unlike U.K. where the concept of a patent originated from the exercise of royal prerogative to grant monopolies, in India patent for an invention has always been statutory. The first Act relating to patent was passed in the year 1856 where “exclusive privileges” to inventors were granted for 14 years[16]. The Indian Patents and Designs Act, 1911 introduced a system of patent administration. In 1957 a committee headed by Justice Rajgopala Ayyangar was appointed to review the law relating to patents. Its recommendation paved way for the enactment of the Patents Act 1970. The Act follows U.K. Patent Act 1949 in many respects, but also differs from it in some important aspects.

1. Basic Features of 1970 Act prior to 2002 Amendment

It is fundamental principle of law that a patent monopoly can be granted only for inventions which are new and useful and which have industrial application. In respect of operating of medical treatment and drugs the following principle contained in the Act are considered to be useful. First, an invention in order to be patentable must relate to a new and useful manner of manufacture. “Manner of manufacturer has been interpreted to include not only a process of manufacture, but also a manufactured product[17].

Second, under the Indian law, grant of patent monopolies in respect of discovery of a scientific principle, or an invention injurious to public health, or a method of agriculture or horticulture, or a process of treatment of human beings, animals or plants, is prohibited in public interest[18].

Third, patent monopoly being purely a creation of the statute, the state can impose any condition for its grant[19].

Last, the object of a patent grant is not only to encourage innovation, but also to see that inventions are worked to the advantage of the society[20].

On the above bases patent law makes some departure from U.K. law or the western law, at least in the following aspects. Firstly, in respect of food, medicine and drug patent can be granted only for the process of manufacture of the substance and not of the substance itself[21]. Similarly, in respect of chemical substances except alloys.

Secondly, a method of medical treatment of human beings, animals and plants, is not an invention under the Act. In U.K. and EPC medical treatment exception is confined to human beings where as under Indian law it extends to animals and plants[22].

Thirdly, under 1970 Act the term of a patent for an invention relating to food, medicine and drugs has been reduced[23] substantially with a view to mitigate the evil effects of monopoly.

Lastly, under the Indian law there is no provision for extension of patents as in U.K.law[24].

Often, it has been argued that Indian patent law unduly restrict the rights of patentees and therefore, it cannot attract foreign technology. It is perhaps believed that the process of globalization influenced the policy makers to introduce certain changes with the sole purpose of attracting foreign technology to persue economic development. Accordingly, during 1995 a system of product patenting was introduced through incorporation of “exclusive marketing rights”.

2. The Patent Amendment Act 2002

The patent law has undergone drastic changes in 2002, especially, to incorporate TRIPs provisions. There was some resistance to the amendment both inside and outside the parliament on the ground that TRIPs agreement is an attempt by the industrialized countries to strengthen their monopoly over technology regardless of the fact that such an approach is protectionist, anti-competitive and anti-liberalization. The provisions of the Act may be summarized as follows :

Firstly, the amendment introduced product patenting by defining invention as a product or process involving inventive step and capable of industrial application.

Secondly, provision of process patenting is retained in respect of substances intended for use as food or as medicine or as drug but such substances can be patented indirectly through the grant of “exclusive marketing rights”.

Thirdly, now the Act excludes from patenting inventions the primary and intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to the human, animal or plant life or health or to the environment.

Fourthly, any process for medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process of treatment to animals to render them free of disease or to increase its economic value or that of their products, cannot be patented.

Fifthly, the Act further excludes form patenting living organisms, plants and animals including seeds, plant varieties and animals except microorganisms.

Sixthly, an important provisions in the Act is that an invention which, in effect, is a traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components is not patentable. This provision is intended to conserve biological diversity against bioprospecting and bio piracy.

Seventhly, a uniform term of 20 years from the date of patent has been incorporated repealing earlier provision providing for a shorter term for inventions relating to food, medicine and drugs.

Lastly, for the purpose of regulating excessive monopoly associated with patenting and in consonance with TRIPs provision relating to anti-competitive measures. Section 83 incorporates certain general principles. They are, (i) the patents are granted to encourage inventions and should be worked in India on a commercial scale; (ii) patents are not be granted merely to enable patentees to enjoy a monopoly for the importation of the patented articles; (iii) the patents granted do not impede protection of public health and nutrition; (iv) patents granted do not in any way prohibit central government in taking measures to protect public health; (v) patent rights are normally not abused by patentees; and (vi) patents are granted to make the benefit of patented invention available to the public.

3. The Patents (Amendment) Act, 2005

India being a developing country is required to introduce product patent of medicines and drugs from 1-1-2005. To implement the TRIPs obligation, the Parliament has amended the Patents Act 1970 by the Patents Amendment Act, 2005 w.e.f. 1-1-2005. Apart from reintroducing the product patent of medicines and drugs which was permitted before 1970 by the Patents Amendment Act, 2005 w.e.f. 1-1-2005. Apart from reintroducing the product patent of medicines and drugs which was permitted before 1970, the 2005 amendment has effected number of changes in Patents Act 1970. Amendment has effected number of changes in Patents Act 1970. The notable changes are (1) Change in the definitions of ‘inventive steps”, “New invention”, and “pharmaceuticals” (2) introduction of requirement to communicate the adverse report of examiner, and the gist of objections etc. to the applicant by the controller” (3) Substitution of new sections 25 and 26 relating to opposition to the patent (4) substitution of “granted in place of “granted and sealed” in case of patents and (5) introduction of provision to grant compulsory licence for export of patented pharmaceutical products in certain exceptional circumstances.

The patents (amendment) act, 2005 not directly allowed to patenting of medical treatment. But indirectly it allows.

V. Conclusion

International trading system and its IPR regime built on principles of market economy ignores certain social costs associated with economic development. It has been claimed that modern states have a duty to protect more basic individual’s interests, at least, of those who are or may be victims of injustices associated with modern socio-economic, political and cultural life. An economic system base on market principle may be partly responsible for violation of fundamental human rights. Therefore, it is asserted that a treaty like IPR should not have been the part of global trading system. To mitigate the evil effects of economic forces it is asserted that Indian patent law rightly claims that it should emphasis only on process patenting of foods, medicines and drugs and that living organisms plants and animals including micro-organisms should be kept out of paten


Varun Desai


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Category Intellectual Property Rights, Other Articles by - Varun Desai