India's transition towards a product patent regime as required under World Trade Organization (WTO) agreements became complete with the third amendment of the Patent Act last year. Since then, the Office of Controller General of Patents & Designs has issued nearly 100 pharmaceutical related patents alone. Among the latest to receive the patents are Pfizer Inc and AstraZeneca AB, whose patent applications for 3-Azabicyclo [3, 1, 0] Hexane derivatives and Midazo Pyridine derivatives respectively were cleared by the Patent Office. While Pfizer had applied for an Indian patent, it was a PCT application for AstraZeneca.
Domestic pharma major Ranbaxy Laboratories received at least seven process patents during the current year. The other patents have mostly gone to government research institutions affiliated to Council of Scientific and Industrial Research (CSIR). As per the current rules, post-grant oppositions can be filed against any patents within a year of granting the patent. However, pre-grant opposition is the commonly used tool to oppose the patent claims in the country. According to official sources, there are 56 pre-grant oppositions (mostly pharmaceutical) filed in Delhi Patent office alone. With over 40% of the total patent filings happening in Delhi, this opposition should cover most of the drugs of major commercial / social significance.
Delhi office had received 9700 patent applications in 2005, sources informed. As pointed out, the new patent era began with the third amendment to the Patent Law, which saw an extension of product patent protection to all fields of technology ( i.e., drugs, food and chemicals), deletion of the provisions relating to Exclusive Marketing Rights (EMRs) (which would now become redundant), and introduction of a transitional provision for safeguarding EMRs already granted.
It also granted provision for enabling grant of compulsory licence for export of medicines to countries that have insufficient or no manufacturing capacity, to meet emergent public health situations. Modification in the provisions relating to opposition procedures with a view to streamlining the system by having both pre-grant and post grant opposition in the Patent Office is another salient feature of the amendment.
Similarly, new proviso to circumscribe rights in respect of mailbox applications so that patent rights shall be available only from the date of grant of patent, and not retrospectively from the date of publication have been incorporated.
Strengthening the provisions relating to national security to guard against patenting abroad of dual use technologies, clarification of the provisions relating to patenting of software related inventions when they have technical application to industry or are in combination with hardware and rationalisation of provisions relating to time-lines with a view to introducing flexibility and reducing the processing time for patent applications, and simplifying and rationalising procedures are the other major highlights of the currently prevalent patent law in India.
Alongside the changes that have happened in the Patent Law of the country, a major capacity building exercise has been initiated at the patent enforcement agency level. The Patent offices across the country have already been modernized. The government has also fixed time line for processing of patent applications thereby turning India a patent friendly place to deal with. Patent officials have been trained to deal with the new requirements. An exhaustive Patent Manual, describing the procedures that need to be followed during patent examination have also been published.
In the words of Patent Controller, the manual is intended to give guidelines relating to the practice and procedure to be followed in examination of patent applications in India with a view to establish a uniformity and homogeneity in the processing of the applications in patent offices. It also aims to make industries, R&D organizations, individual researchers and inventors familiar with the patent system in India and to provide a userfriendly system for obtaining as well as maintaining patents under the existing patent law. It is expected that this manual will be of considerable use to the target user who are engaged in innovative and inventive activities in developing and marketing new products and technologies.
Tracing the history of patent laws in the country, one would find that Indian decision to move towards product patent regime started as part of the Uruguay round of GATT negotiations which paved the way for WTO. India was put under the contractual obligation to amend its patents act in compliance with the provisions of TRIPS. India had to meet the first set of requirements on 1- 1-1995. This was to give a pipeline protection till the country starts giving product patent. It came to force on 26 th March 1999 retrospective from 1-1-1995. It lays down the provisions for filing of application for product patent in the field of drugs or medicines with effect from 01.01.1995 and grant of Exclusive Marketing Rights on those products.
India amended its Patents Act again in 2002 to meet with the second set of obligations (Term of Patent etc.), which had to be effected from 1-1-2000. This amendment, which provides for 20 years term for the patent, Reversal of burden of proof etc. came into force on 20 th May, 2003. The Third Amendment of the Patents Act 1970, by way of the Patents (Amendment) Ordinance 2004 came into force on 1st January, 2005 incorporating the provisions for granting product patent in all fields of Technology including chemicals, food, drugs & agrochemicals and this Ordinance is replaced by the Patents (Amendment) Act 2005 which is in force now having effect from 1-1-2005 .
Patent system in India is administered under the superintendence of the Controller General of Patents, Designs, Trademarks and Geographical Indications.