A creation is viewed as new on the off chance that it isn't distributed in any archive or not utilized in the nation or somewhere else in the world.*1
Intellectual Property Rights provides certain exclusive ownership rights to the innovators; enable them to reap commercial benefits and reputation for their innovations. Pharmaceutical industry as of now has an advancing IPR technique and demanding higher approach in the coming era.
With the quick advancement of science and innovations, the pharmaceutical industries have been thriving the market with life sparing drugs administered by patent law. India being a signatory of the GATT is represented by TRIPS, aside from having its own national IPR laws. Also, with the presentation of compulsory Licensing and ever-greening techniques patent laws are in demand.
In the era of globalization, pharmaceutical industries making lots of investment on research and development because of rise in competition, and hence, it is essential to protect the innovations through patent law. Innovations in field of Pharmaceutical industry lead to the introduction of original life-saving medicines and have to be protected through Intellectual property rights (IPRs). With the help of patent right Pharmaceutical industries gets and acquire good returns by its commercialization and impose a restriction on others to sell, and manufacture the same medicines for a period of 20 years. IPR is mandatory for pharmaceutical industries for identification, recognition, commercialization, planning, and protection of innovation.
The IPR protection works in numerous ways by providing effective and transparent incentives and strong tools for defending patents already infringed.
According to the Indian Patent Act, a patentable invention is defined as “a new product or process involving an inventive step and capable of industrial application”.*2 The fundamental requirements for any invention to be patentable depends upon it originality, innovative steps and its industrial suitability. It is characterized as the element of a creation that include specialized progression when contrasted with existing information or having economic significance or both, that makes the development not evident to an individual talented in the art.*3
In the case of Bayer v. Natco 2012 the first compulsory license in India was granted on 12 March 2012. Appeal filed by Bayer challenge the compulsory license granted by the Controller-General to Natco. It was held that the invention must be available at a reasonably affordable price to the public and if in case it is not available compulsory license can be issued and observed that the Sub-sections (a), (b) and (c) of Section 84(1) are separated by the disjunctive ‘or’ and therefore, even if anyone conditions are satisfied, the Controller will be well within his rights to grant compulsory licensing.
Manufacturing a new drug and then introducing it in the market is a very costly job. Therefore industries involved in manufacturing new drugs or medicine always seek the protection of their financial interest and Business model by patenting the final product which leads to its better growth. For investors, it is very vital to consider that he must feel secure in investing their time, efforts, and money into that particular sector. The Patent Act provides that sense of security to the pharmaceutical industries. It is also required to ensure that there are some points of safeguards also so that a few firms do not take over the market in the name of IPR. Safeguards are necessary for the purpose of the welfare of society. Organizations such as universities or academic institutions without sufficient marketing or manufacturing eligibility can make use of a patent as a tool for the technology transfer. Patented goods or processes can outsource by these organizations to third parties and in return, they can earn income.
Although lots of patent applications from the pharmaceutical sector, their clinical translation is very less. Logically speaking, right now the Indian Pharmaceutical Market is dominated by the generic market and invention has very little share in its expansion. The main reason behind this seems to be segregatory work in each field, lack of proper multidisciplinary work between the preclinical and clinical scientists, deficient funding, and heterogeneous interests of the involved sectors, lack of systematic training of workforce, and lack of visionary. Industry-academia collaboration and establishment of quality control bodies can be valuable in this regard.
This Article is written by Saumya & Pushpesh Srivastava. Currently, Saumya is pursuing B.Com (III year) at Deen Dayal Upadhyay and Pushpesh is pursuing B.B.A.LL.B (III year) at Amity University, Lucknow.
REFERENCES:
1.Section 2(1)(j) of the Patents (Amendment) Act, 2002, No. 38 of 2002 (June 25, 2002)
2. Mukherjee S. The new Indian patent Law: a challenge for India. Int J Prop Manage 2006; 1(1/2): 131-149
3. Section 2(1)(I) of the Patents (Amendment) Act, 2005, No. 15 of 2005 (April 4, 2005)
This Article is written by Saumya & Pushpesh Srivastava. Currently, Saumya is pursuing B.Com (III year) at Deen Dayal Upadhyay and Pushpesh is pursuing B.B.A.LL.B (III year) at Amity University, Lucknow.
REFERENCES:
1.Section 2(1)(j) of the Patents (Amendment) Act, 2002, No. 38 of 2002 (June 25, 2002)
2. Mukherjee S. The new Indian patent Law: a challenge for India. Int J Prop Manage 2006; 1(1/2): 131-149
3. Section 2(1)(I) of the Patents (Amendment) Act, 2005, No. 15 of 2005 (April 4, 2005)
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