Over the past three decades, the high-technology-based Indian pharmaceutical business has experienced sustained expansion. The current market participants include some privately held owned Indian businesses that have seized a significant portion of the domestic pharmaceutical market as a result of variables including an advantageous government policies and the absence of much foreign competition. However, because of Indian economy’s liberalisation, Indian companies are being transformed as they start to exit domestic markets and prepare for international rivalry. Eventually, factors including protection of intellectual property are escalating in significance due to the rising recognition of the need to safeguarding the valuable investments in research and development.
Therefore, endeavours are being putting on in the nation to curb the issue of weak enforceability of existing intellectual property legislations, and the legislators are moving towards setting a patent regime, that is beneficial to technological advances and is in keeping with its universal commitments.
Laws governing patent in India:
It was in 1856, when the patent rights were first time introduced in India, and thereafter, in 1970, the Patent Act, 1970 (Patents Act), was enacted. In addition to this, India has also signed the Paris Convention for the Protection of Industrial Property, 1883, and the Patent Cooperation Treaty, 1970. According to the Patents Act, any invention which meets the criteria of originality, non-obviousness and usefulness can be the subject matter of a patent. For pharmaceuticals, in the case of substances intended for use or capable of being used as food, drugs, or, medicines, or substances produced by chemical processes, patents are granted only for the processes of manufacturing of such substances and not for the substances themselves. Therefore, as of now pharmaceutical products are not granted patent protection under the Indian law.
At earlier instance, under the Patents and Designs Act, 1911, India had a product patent regime for all inventions. Howbeit, with the enactment of new Patents Act, pharmaceuticals and agrochemical products have been excluded from eligibility for patents. Resultantly, absence of patent protection for pharmaceutical products had a significant effect on the pharmaceutical industry in India and resulted in the growth of substantial expertise in reverse manufacturing of drugs that are patentable as products throughout the industrialised globe but unprotectable in India.
As a result, the Indian pharmaceutical sector expanded quickly by creating less expensive copies of certain medications that were trademarked for the home market, ultimately acting aggressively entering the global market with generic medications when the global patents expired. Aside from that a number of protections are offered by the Patents Act, halt the misuse of patent rights and improve drug availability
Striking features of the Patents Act:
It is marked here that the processes or methods of manufacture of a substance intended to be used as food, or as a medicine or drug, can be patented for a period of seven years from the date of filing or five years from the date of sealing the patent, whichever is less. Nonetheless, patents relating to other inventions are granted for a period of 14 years from the date of filing the patent, except shown to be invalid.
Additionally, the Patents Act contains provisions relating to compulsory licensing. On completion of three years from the date of sealing the patent, any person intends to working in the patented invention may apply for a compulsory license with regard to the invention. Moreover, the Patents Act provides for ‘licences of right’, according to which the Central Government, after lapse of three years from the date of sealing of the patent, can apply for an order that the word ‘licences of right’ be endorsed on the patent, by taking the ground that the patent invention is unavailable to the public at a reasonable price. Notably, the patent for certain substances that are no food items or drugs as such; however, capable of being used as food items or drugs are deemed to be endorsed with the words ‘licence of right’ immediately on completion of three years from the date of the sealing of the patent.
Impact of the World Trade Organization (WTO) on pharmaceutical patents:
Trade Related Aspects of Intellectual Property Right (TRIPS) is an agreement on international IP rights, which came into existence in 1995, as part of the agreement that provides establishment of WTO. India is a signatory to General Agreement on Tariffs and Trade (GATT), thereby making it mandatory to comply with the requirements of GATT, including the agreement on TRIPS. Hence, pharmaceutical companies in India are required to meet the minimum standards under the TRIPS Agreement.
In Patents (Amendment) Act, 1999, the provision of ‘pipeline protection’ was introduced. According to which, if the applicant has already filed an application for an invention in any convention country and a patent or Exclusive Marketing Right (EMR) has been granted in that country on or after 1st January, 1995, then such applicant can file for patent to pharmaceutical and agrochemical products in India. The pending patent application will be eligible for product patent. If the application is accepted and deemed appropriate, the applicant will be given EMRs in India until such patent is approved or refused, or for a term of five years (whichever is shorter).
India is a rising market of the drug industry and as a nation; it has made adequate efforts in the field of the pharmaceutical industry to come up with inventive research and development strategies of original drugs. Since our nation is gradually integrating into foreign markets and competing with costs and quality norms there. Although research and development is crucial to guarantee a competitive edge in the global market, the Indian pharmaceutical industry’s prospects depend on the existence of a patent.
Associate at Aggarwals & Associates, S.A.S Nagar, Mohali