EXCEPTIONS AND LIMITATIONS TO PATENT RIGHTS IN INDIA


Introduction
The TRIPS Agreement is the most exhaustive multilateral treatment on Intellectual Property Rights until now focuses on the global standards to protect and enforce such Intellectual Property Rights. Many changes have occurred after TRIPS. In the Pre-TRIPS era, over 35 countries did not grant patent protection for pharmaceutical products. But now, after becoming a member of this agreement, they have to comply with its rules and make changes in its legislations.
The basic purpose of TRIPS is to introduce the protection of intellectual property in trade and granting exclusive patent rights [1] as an incentive for investment in the production of knowledge.[2] Although, allowing enforcement of exclusive rights fully has never been the ultimate goal of patent legislation. To maintain a balance between the general public and the patent holders, there have to be certain exceptions or restrictions or limitations that need to be imposed on patent rights. Article 30 of TRIPS allows for imposing limited exceptions to the exclusive rights conferred by a patent. Such exceptions shall not unfairly prejudice the legitimate interests of the patent holder.
Since the socio-economic conditions and priorities of a country differ from one country to another, hence provisions in patent laws on exceptions and limitations vary as well. As India is a signatory to TRIPS, the Patent Act, 1970 has been amended from time to time to include the limitations and exceptions as per the norms of the agreement. Some of the following exceptions and limitations to the patent rights provided in the Act are:
(i) experimental or research use;
(ii) use of the patented invention on foreign vessels etc.;
(iii) for obtaining regulatory approval from authorities;
(iv) exhaustion of patent rights & parallel imports;
(v) compulsory licensing and
(vi) use or acquisition of inventions by the government. [3]  

1. Experimental or Scientific Use Exception
The exemption of Experimental use is granted under section 47(3) of the Indian Patent Act which states that the grant of a patent shall be based on any condition that any product or any process, in respect to which the patent is granted, may be made or used by a person for a purpose of intending to use the patent matter only for research work, including giving instructions to the pupils.
This clause grants third parties to carry out their scientific research work and experiments for teaching purposes without infringing the patent rights of the patent holder. Such an exception grew up out of the concern that any patent right should not disturb the bona fide experiments or scientific research work.

2. Private and Non-Commercial Use Exceptions
Private use or monopoly over a commercial activity is not allowed with respect to exclusive rights conferred by a patent. The Government has the power to grant a license, known as Compulsory License to a 3rd party to use the invention that is patented to restrict the patentee from misusing or abusing the rights of the property holder. Whenever the patented invention is not commercialized in India or is not open to the public at a reasonable price or the invention is not manufactured in the amount required, the Government then grants a Compulsory License. It is governed under Section 82 to Section 94 under the Indian Patent Act.
This kind of licensing allows the countries to produce patented innovations without taking consent from the patent holder.

3. Exception on Regulatory use or Private use
Patent Rights give economic incentives to innovate but such exclusive rights may result in monopoly and unaffordability of pharmaceutical products. As a result of which Indian Patents (Amendment) Act, 2005 incorporated Section 107 as a regulatory use or prior use exemption.to offer a trade-off between incentives to innovators, consumer cost, and limited access.
This exemption to patent rights is also known as Bolar Provision and allows the manufacturers to generic drugs to take reasonable steps related to the development and submission of the required information to achieve approval in the market of such a product when the patent still exists. This provision also allows manufacturers to start producing the product as soon as the patent expires.
In the case of Bayer Corporation v Union of India (2019), the Supreme Court realized that the Bolar Provision can be misused and therefore certain safeguards should be adopted to check the export activity. To sell patented products, irrespective of quantity, for research or experimental purpose within or outside the territorial boundary of India was held to be statutory and constitutional.

4. Exception on Foreign Vessel, Aircraft or Land Vehicles
The Patent Act says that patent rights will not be infringed when used on foreign vessels, etc. temporarily or outside India. [4] This section (i.e. Section 46) is required to enable the foreign vessels, aircraft, and land vessels to enter the territory of India so that the patent rights do not inhibit the movement of these transports.  The term ‘temporary’ include accidental and unintentional entry of transport as well as intentional and regular going into a port. However, it is important that the vessels, aircraft or land vehicles do not permanently remain in the territorial waters or land territory of India. This exception is beneficial in facilitating uninterrupted international travel and reducing tensions between countries over the treatment of vessels flying their flag.

5. Anticipation Due to Prior Use
Prior use or secret trial by third parties shall not be considered for the purpose of anticipation or obviousness under Sections 25 (5) and Sections 64 in proceedings involving revocations. Chapter VI deals with such exceptions which are:
(a) Anticipation by previous publication:[5]  which states that when a publication is published before the priority date, also without the consent of the rightful owner, then an invention will not fall under this provision.
(b) Anticipation by Public Display: [6]   states that an invention would not attract the provision if the invention has been displayed in an exhibition to which the provisions of the instant Section has been extended by the Central Government or the invention is described in a publication in consequence of display of the invention in such an exhibition, or the invention has been used by any person without the consent of the true and first inventor or a person deriving title from him after it has been displayed in such an exhibition, or disclosing the invention before a learned society or publishing the invention in the transaction of such society; provided the application is filed within 12 months from afore-mentioned public display.[7]

6. Doctrine of Exhaustion 
A patent holder is granted exclusive rights over his invention to prevent other people from using, manufacturing or selling his invention in the territory of patent grant or importing an invention into the territory of patent grant. This Doctrine states that once an unrestricted sale of a patented invention is made and the patent owner receives the economic advantage of the invention from the sale, the rights of the patent holder is exhausted with respect to such invention and the transferee of the product is entitled to use or dispose of it without any further restriction. Thus, the exhaustion of rights is linked directly to the distribution right. This way, the patent owner has already used the exclusive right of his product to prevent others from manufacturing, using or selling his product or invention in the territory of patent grant or importing an invention into the territory of patent grant and has thus reaped all the benefits conferred by a patent.

Conclusion
A patent on an innovation guarantees the patent owner with some exclusive rights which include excluding others from manufacturing, using, selling, or offer to sell in the territory of patent grant or importing an invention into the territory of patent grant. The TRIPS agreement introduced Article 30 so that monopoly and uncompetitive practices are prevented in the market. Its purpose is to promote sustainable growth and development of developing countries.
These provisions are not aged and have recently been added, however, a check over its usage is needed to ensure its proper working and implementation. Developing countries have adopted a liberal approach towards these exceptions to promote technology and research in their countries, unlike the developed countries which have a very narrow mind towards the interpretation of such exceptions.

References
[1] Article 28 of the TRIPS Agreement establishes basic rights of the patent holder, which is to preclude others without consent from the acts of making, using, selling, offering for sale or importing the patented product, or using the patented process (including importing products made with the process). Available here
[2] Report on the International Patent System, WIPO, Geneva, Standing Committee on the Law of Patents, Twelfth Session, June 2008.
[3] Biplap Kumar Lenin and Harsha Rohtagi, Exceptions and Limitation of Patent Rights and its Enforcement in India, Journal of Intellectual Property Rights, Vol 20, September 2015, pg. 297-304, Available here
[4] Patents Act, 1970, Sec. 49: Patent rights not infringed when used on foreign vessels, etc., temporarily or accidentally in India.
[5] Patents Act 1970, Sec. 29
[6] Patents Act 1970, Sec. 31
[7] Biplap Kumar Lenin and Harsha Rohtagi, Exceptions and Limitation of Patent Rights and its Enforcement in India, Journal of Intellectual Property Rights Vol 20, September 2015, pp 297-304, Available here

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