TITLE: New amendments to Patents Act, 1970 to affect farm sector AUTHOR: Ashok B Sharma PUBLICATION: Financial Express (New Delhi) DATE: 3 January 2005 URL: http://www.financialexpress.com/fe_archive_full_story.php?c ontent_id=78652 FARM FRONT NEW AMENDMENTS TO PATENTS ACT, 1970 TO AFFECT FARM SECTOR by Ashok B Sharma NEW DELHI, JAN 2: The new Ordinance, issued by the government for amending the Patents Act, 1970, is likely to affect the farm sector as it extends the product patent regime to agro-chemicals, food and biotechnology products, apart from drugs and pharmaceuticals. This is the third amendment to the patent law, in succession. This was done to fulfill the country's commitment to TRIPs and WTO. The amended patent law came into effect from January 1, this year. The new amendment has not categorically excluded seeds developed by novel means. Though India had earlier opted for the sui generis system for protection of plant varieties and had subsequently put in place, the Plant Varieties Protection & Farmers' Right Act, lack of clarity in the amended patent law will lead to a situation of patenting of seeds developed by novel means, particularly the transgenic seeds. The seed industry, engaged in developing transgenic seeds, is eager to seek such a protection, citing Article 27 of the TRIPS agreement. The TRIPS agreement has stipulated three criteria for patent rights, namely novelty, inventive step and utility. Though the second amendment to the Patent Act had excluded plants from the patent regime, it said that the bio-technological processes, to develop unique plants, can be covered under patents. The third amendment, which has extended the product patent regime, has not categorically excluded such seeds from being patented. It has done little to restrict the scope of patentability. Several experts like Dr KV Swaminathan, chairman of Waterfalls Institute of Technology Transfer and BK Keayla, convener, National Working Group on Patent Laws had earlier criticised the liberal ways in which patent rights are granted, citing minor changes as 'innovation'. They had suggested granting of patent rights over basic invention. The third amendment has limited the scope of pre-grant opposition to patent rights to mere filing of representation before the controller of patents, while at the post-grant stage, objections can be filed before the board constituted for the purpose. This amendment failed to define the emergency clause, where the government can step in and intervene in public interest. It mentions only the national emergency and circumstances of extreme urgency, without stating specific emergencies, relating to health and environment. The third amendment, though, has a clause for dealing with abuse of patent rights, it fell short in defining the terms for commercial use. Such terms for commercial use are in vogue in Argentina, China, UK and France. Defining terms for commercial use is necessary to check monopolies and encourage competition and this finds mention in Article 31 (b) of the TRIPS agreement. The TRIPS agreement has not defined micro-organisms and microbiological processes. Here, the question is whether the micro-organisms, existing freely, are patentable or their mere isolation in pure form are patentable or human intervention, in establishing a level of novelty in the discovered micro-organism, is needed for patenting. The USPTO verdict of the case Diamond vs Chakrabarty in 1980 establishes that human intervention, leading to a novelty in expression, can be patented. It says: "the respondent's micro-organism plainly qualifies as patentable subject matter. His claims is not to a hitherto unknown natural phenomenon, but to a non-naturally occurring manufacture or composition of matter - a product of human ingenuity having a distinctive name, character and use...... His discovery is not nature's handiwork, but his own..." The next question is whether a product produced by a micro-organism, which is known, can be patentable or the process is patentable. In absence of clear definition of micro-organism and micro-biological process in the TRIPS agreement, the country's policymakers need to draw a distinctive line between the the product of human intervention, leading to novelty and those freely occurring in nature. In the absence of clarity in the third amendment, claims in gene patent applications may pertain to genes or partial DNA sequences, proteins encoded by these genes, vectors used for transfer of genes, genetically modified micro-organisms, cells, plants and animals and the process of developing a transgenic product. These may lead to multiple rights owned by multiple actors, called patent thickets over a final product. Hence, there are problems of not only patent thickets, but also of royalty stacking and reach-through claims. The food sector in India will also have to face new challenges in the new patent regime. Different processes and products will become patentable. There is, therefore, a need to document all the traditional processes as well as products, with a view to reduce the number of controversies over claims for patent rights. TITLE: All about rights and patents PUBLICATION: Financial Express (New Delhi), Op-Ed DATE: 3 January 2005 URL: http://www.financialexpress.com/fe_archive_full_story.php?c ontent_id=78614 OP-ED ALL ABOUT RIGHTS AND PATENTS Patent is a kind of intellectual property right (IPR). It allows rights (including exclusive manufacturing and marketing rights) pertaining to an object (product) and/or a means (process), with a view to rewarding the invention. A patent right is mandated by the government for the inventor of the product or process. Since a patent right is trade-related, the relevant norms under the Trade-related Intellectual Property Rights (Trips) agreement of the World Trade Organisation should apply to patent systems of WTO member countries. Being a member of WTO, India is mandated to make its patent-related laws (the Patent Act 1970) and other trade-related IPR laws (like those related to copyright, geographical indications etc.) in conformity with the Trips norms. Let's look at some related aspects. Are patents universal or national? Patents are technically national, given that the designated authority in each country grants patents in that country. But with many multilateral agreements, like Trips, Patent Cooperation Treaty (PCT), Substantive Patent Law Treaty etc., patenting systems are increasingly being globalised. An international patent search/examination system mooted by the World Intellectual Property Organisation may even bring a confluence of the decision-making processes in many countries. In future, a particular patent application filed under the PCT in many countries simultaneously might get examined and decided upon with a greater degree of cohesiveness among the national patent authorities. For how many years does a patent remain valid? Trips mandates a 20-year patent protection. India, too, allows the same duration. What distinguishes a product patent from a process patent? The difference is reflected in the names. However, a more relevant question would have been: why is a product patent considered more attractive? This is because process patents, in general, accord the owners comparatively fewer commercial benefits compared with product patents. Can a patent be sold? The holder of a patent can transfer it, by whatever means, including a commercial transfer (sale). He can also hand over the rights in part, say, to exclusively or otherwise market the patented product for a specified period within the duration of the patent. This can be done under a voluntary licence. If a patent-holder does so, he is likely to do that for a compensation called royalty, which is usually monetary. What about the recent amendment to the Patents Act? The basic objective of the recent amendment to the Patent Act was to introduce product patenting in three sectors -- pharmaceuticals, agrochemicals and food. This was under the Trips obligation to introduce product patenting in these sectors, latest by January 1, 2005. So far, only process patents were allowed in these sectors in India. Has the Patent Act been amended earlier? Yes, the Act has been amended twice -- in 1999 and 2002. In 2001, the provision of exclusive marketing rights (EMRs) was introduced. This was a transitional arrangement till the introduction of the Trips-mandated product patents in pharma, agrochem and food sectors. Under Trips, product patenting was required to be introduced by WTO members effective from 1995. Many developing countries, including India, however, were given a 10-year grace period for introduction of product patenting in these sectors, that is, till 2005. The first amendment, therefore, also brought in a Mailbox with the patent controller's office to facilitate making of applications for products invented during 1995-2005. This Mailbox -- with over 12,000 applications -- is now open (effective from January 1). The applications will be examined and decided upon as per the set procedures. The 2002 amendment introduced a 20-year duration for patents in compliance with Trips and substantially modified compulsory licensing provisions. What is a compulsory licence? It is a Trips-compliant provision empowering the governments to check abuse of patents. Notwithstanding the existence of a patent, the government can, given a national emergency, circumstances of extreme urgency, and/or for public non-commercial use, invoke the compulsory licence to make available the patented product to the people. Compulsory licence can also be invoked if the government feels reasonable requirements of the public with respect to the patented inventions have not been satisfied and the invention is not available for the public at an affordable price. What other options are there to prevent patent misuse? The government can revoke a patent where it is found to be mischievous to the state or prejudicial to the public. It can also acquire a patent to meet national requirements. In order to facilitate production and marketing of patented products after the expiry of the term of patent protection, preparatory action by persons other than the patent-holder can be allowed. Will drug prices rise because of product patents? The price of a patented drug would normally be much higher than other (generic) drugs. Currently, not a single drug in the Indian pharma market is patented in India (barring three under EMRs). A dozen or so drugs marketed in India are under patent in other countries. These may get patented in India too in the coming months. With new drugs slated to be introduced in the Indian market, the share of patented drugs is expected to rise. But then patent expiries, too, would happen, contributing to the generics market. According to an estimate, given the current frequency of new drug discoveries in the world, 25% of the Indian retail pharma market would be of patented drugs by 2015.