Vivekananda institute of professional studies
Intellectual property Laws in India are getting more popular these days. It bestows a relief to the novel creators that their idea will remains theirs. And among all, the patent law is one of the most significant one. However, when it comes to pharmaceutical drugs, which is a vital item for every individual, the same laws act as obstruction to the access of these necessitous medicines. This paper basically deals with the pharmaceutical drugs, and it’s patenting in India, along with challenges that are faced in the public access to health.
In country such as India, a considerable part of the people is living in poverty who are not in condition to meet daily healthcare expenses and it significantly shows that there is a health crisis with inadequacy of resources with respect to affordability, availability and accessibility of the medicines in India. The Indian government introduced a provision into the patent law under the obligations of world trade organisation’s agreement on trade-related aspects of intellectual property rights also known as TRIPS. Section 3(d) is an exclusive provision under the Indian patent law which tries to limit the grant of “secondary” pharmaceutical patents. It attains a balance between TRIPS directive and protects access to medicine and drugs for the low-income population. whereas this situation has subjected to a change after the TRIPS regime. The Indian market being an important supplier of low priced affordable pharmaceutical products makes the patenting issue more relevant. The recent judgement including that of the Supreme Court in the NOVARTIS A Cancer Drug “GLEEVEC” case point toward that India stays to place a premium on public health in relation to pharmaceutical patent law and it is seen that the pharmaceutical patents restrict the competition which led to rise in the prices, and are a significant hurdle to access of medicines in developing countries such as India itself.
PHARMACEUTICAL PATENTING IN INDIA
The Indian pharmaceutical industry has a strong generic base with almost 60,000 generic brands in 60 therapeutic categories in the market. On January 1, 1995, the TRIPS Agreement went into force, which meant that India was required to abandon some of its long-held position in the intellectual property field to comply with the provisions of the TRIPS Agreement. After this, several amendments were made in Indian Patent Laws including The Patents (Amendment) Act, 1999 which increased Exclusive Marketing Rights in the transition Period, The Patents (Amendment) Act, 2002- which bring up Widespread Changes to keep up the TRIPS Standards and The Patents (Amendment) Act, 2005 this act bring a Wide-ranging Improvement before the Expiration of the Transition Period.
The 2005 amendment is the most recent where it brought significant changes in the pharmaceutical patent law of India. This amended Section 5 of the Patents Act, 1970, which provided that no patent shall be granted in respect of claims for substances intended for use, or capable of being used, as food or as medicine or drug or relating to materials prepared or produced by chemical processes. The most controversial law till date is the inclusion of section 3(d) that tries to control the access of “secondary” patents which means patents on new forms of existing drugs. This section was brought into the public eye with the case of Novartis AG &Ors. v. Union of India & Ors. In this case, Novartis International AG filed an application in accord with the TRIPS agreement before the Chennai Indian Patent and Trademark Office Database for a licence of the patent of drug named ‘Glivec,’ which is expended to aid Chronic Myeloid Leukaemia and Gastrointestinal Stromal Tumours. In 2005 the Madras Patent and Trademark Office Database Rejected his application by stating that the drug is un-patentable under section 3(d) of Patent Act, 1970. the Novartis filed two writ petitions under Article 226 of the Indian Constitution to high court of madras, where the case was transferred to IPAB (Intellectual Property Appellant Tribunal) in 2007 dismissed the petition. Novartis filed an SLP (Special Leave Petition) before the Supreme Court, which was later rejected by the court.
In Doha Ministerial Declaration of November 14, 2001 WTO members stressed on implementation and interpretation of the TRIPS Agreement in approach that aids public health by disseminating both access to existing medicines and the creation of new medicines i.e. without hindering the research. It gives emphasis to the TRIPS agreement that it should not hamper the nations to make legislations according to the socio-economic status of the country. They have autonomy to act in continuance of their public health care. Whereas the TRIPS agreement impersonated a serious threat upon the developing nations as to the obstruction caused by it on implementation of measure to promote access to affordable medicines in the interest of public health. While acknowledging the role of intellectual property protection “for the development of new medicines”, the Declaration specifically recognises concerns about its effects on prices. The Declaration makes it clear that the Trips agreement’s provisions on exhaustion in effect, leave each member free to establish its own regime without challenge but subject to the general TRIPS provisions prohibiting discrimination on the basis of a person’s nationality. Despite having such mechanism the plight of developing countries is not solved. It is pertinent to note that many developing nations choose to issue the same, since it could be perceived as indifference towards intellectual property rights and thereby seriously weakening trade relations with other nations. The developing countries due to minimal incentives have a strict pharmaceutical patent regime much flexible in granting compulsory licensing and there is no incentive to issue compulsory licence for exports in developed countries, these hitches are rendering these flexibilities granted by trips unapproachable.
TRIPS AND PATENT EXCLUSIONS IN INDIAN LEGISLATION
The Supervisor of Patents can grant compulsory licence under Section 84, Section 91, Section 92 and Section 92-A. Provisions related to the grant of compulsory licence in India are prescribed under Sections 82-94 (Chapter XVI) of the Patents Act, 1970, and Rules 96-102 (Chapter XIII) of the Patents Rules, 2003.
In the case of Natco case has initiated a transformation in pharmaceutical commerce on functioning of patents and established a harmoniousness between TRIPS and domestic laws. It has India can use the TRIPS flexibility effectively to provide health care to people. also accomplish the constitutional responsibility of right to life as envisioned under Article 21. even the Bombay High Court settled with the discoveries of the Controller General of Patents and the Tribunal concerning obligatory licensing under Section 84 of the Act.
Other applications for compulsory licensing have also been filed, however, they were rejected by the Controller. One such application was filed by BDR Pharmaceuticals to manufacture the generic version of anti-cancer drug Dasatinib, patented by Bristol-Myers Squibb in India. Further, in 2015, Lee Pharma filed an application for seeking the grant of a compulsory licence for manufacturing and selling a drug named Saxagliptin. Both applications were rejected as they failed to convince the Controller of Patents to make a prima facie case for the grant of compulsory licensing.
According to the study the TRIPS compliant the compulsory licensing provisions in the country but these licences are primarily problematic. It is unfortunate that till date only one compulsory licence has been granted in vast nation such as India, the prime reason for this can be credited to the restricted usage of flexibilities is the bureaucratic complications. Theoretically this concept seems prodigious but the picture of patent office is different. To strengthen the licensing provisions there is a need of strong policy makings and a comprehensive procedure should be issued by Indian patent office.
It is essential as with the change of time the technology is at high pace, it becomes more important to protect the ideas, creation and innovation of people, this is done by the patent law that the of research and development of creator pays off. But condition in the medicines are different as it basic requirement for all. In country like India, the basic rights are violated as majority of population do have access to basic healthcare support and the future of health care sector depends on upon the pharmaceutical corporates responds to the TRIP agreements. Patent and innovation are two sides of the same coin. Innovations should be for assisting the humanity exceptionally in the domain of medicine and patents should not have only one objective to accumulate profit.
Grammar and Spelling errors- None
The article has conceptual clarity. Analysis could be more.