Thursday, September 13, 2007 08:00 IST Varun Chhonkar
With India celebrating 60 years of independence, Indian pharma industry with its global competitiveness and robust growth has come a long way to be among the preferred destination for global drug research and manufacturing ably supported by its vast pool of technical manpower and traditional know-how. Over last few decades there had been number of success stories in Indian pharma industry with incredible rise of world-class generic companies pioneered by Cipla, Ranbaxy and Dr Reddy's Laboratories which continued to be source of high-quality, cost effective generics thanks to 1970 patent law reforms which abolished patent protection for drug and chemical products, not only allowing Indian pharma companies to copy and produce new drugs but also helped in becoming global hub for generic industry. Although the core expertise of all Indian pharma companies focused to stay around reverse engineering and copying of new drugs with only hand-full of companies managing to rise to the platform of global challenges and competitiveness. But importantly the success of Indian pharma industry was significantly designed around 1970 patent law reforms, which eventually made Indian pharma companies habitual of copying rather than research-based innovation. The overall impact of 1970 patent law reforms can be measured by the fact that as of today the Indian pharma industry has highest number of US FDA approved plants outside the US, with increasing share of Para IV filings. On macroscopic level every thing seems to be going in favor of Indian pharma industry with highest US FDA approved plants (outside the US), cost-competitiveness, increasing joint-ventures with foreign multinationals, flourishing contract manufacturing practices clearly indicates the strong building presence of Indian pharma in global healthcare industry.
Absence of patent protection for drug and chemical products significantly add to the success of Indian pharma industry, which finally started losing its shine with India becoming signatory member to WTO and adhering to comply with TRIPS agreement. India being a developing country managed to get away with 10-year transitional period giving Indian pharma companies sufficient time to make much-required transition from copying to research-based innovation. Even though it is different question whether 10 years was sufficient for such transition or not, but what was important that transition was undeniable. This transitional period was only critical for Indian pharma industry not also equally important for the Government of India to strengthen its infrastructure for building world-class intellectual property practice, in particularly mediocre Indian Patent Office. The new patent law reforms of 2005 not only reinstate patent protection for drug and chemical products but also posed serious challenges for Indian pharma industry in launching new drug products, both in domestic and global market. Thus, It was utmost vital for Indian Patent Office to build state-of-the-art patent administrative infrastructure to support Indian pharma industry in facing challenging and complex patent issues, even resolving issues concerning the patentability to fuel the growth of Indian pharma industry. However, as of now apart for modernizing its building structure, the Indian Patent Office miserably failed in modernizing its out-dated patent practice, most importantly digitalisation of Indian patent database and still lack sufficient man-power to meet and support the challenging and demanding requirements of Indian pharma industry, which in fact has raised uncertainties for Indian pharma companies in expanding their market growth.
In fact some of the Indian pharma companies have already made their move to tackle such uncertainties by establishing patent or IPR cells to support their R&D units in preparing and developing non-infringing products and platform technologies. Even such companies have also taken bold initiatives in protecting their innovative and incremental products/technologies by filing patent application in various countries, showing their building commitment in investing in research and innovation. However, in spite of such initiatives, many companies are still sceptical due to uncertainties surrounding the patentability of incremental inventions and enforceability of patent rights in India. Another important concern is with respect to Indian Patent Office, which already burdened with large backlogging of patent applications, even lacking a decent patent database to search Indian patents/patent applications. In past years, Government of India has time-to-time announced to introduce new measures to improve patent infrastructure and digitisation of Indian patent database but till date not able to deliver a fraction of what was committed. What is more surprising is that unlike US and European patent, one cannot obtain/ download a copy of an Indian patent from web source, instead one has to go through a cumbersome procedure to obtain a copy of an Indian patent by personally visiting Indian patent office, and that also by paying advance money. This is more shocking that Indian patent once issued should be published and made available for public view without any delay which is in fact an integral part of patent system worldwide but in India one has to personally visit and pay Indian Patent Office to obtain a copy of an Indian patent. This practice is not going to support the challenging demands of Indian pharma industry that need a more precise information regarding patents/patent applications before strategizing and launching new drug products in Indian market. Even it is not possible for each and every company to visit Indian Patent Office to locate relevant patent literatures due to various factors involved in deciding what need to be find out with the Patent Office. Indian Patent Office Gazette, which is now online available for last couple of years runs into hundreds of pages and often contains incomplete information and spelling errors, making searching more difficult, insufficient and time-consuming. Even earlier, when Gazette were made available for manual searching one need to invest large time in locating required information, which in fact seems to be never-ending task. Other critical concern is lack of patent examiners, which eventually affect working efficiency of Indian patent system, creating large backlogging of pending patent applications, examination reports and other administrative issues.
Building future! At a time when Indian pharma companies are faced with uncertainties on IPR front, a strong R&D base gives them hope that they will overcome. Most of these Indian pharma companies get a sizable portion of their sales from overseas markets, which they can responsibly utilize in establishing a reasonable innovation culture and building competitive R&D labs. But what is more critical is that Indian Patent Office must build a more transparent and high-end administrative infrastructure to support Indian pharma industry. Recently, Indian Patent Office has launched an online-facility for filing applications for patents and trademarks joining the likes of the USPTO and the EPO, which is one of the milestones achieved in Indian patent system, and may extend valuable support to Indian pharma industry enabling them filing patent applications from their respective locations without a need to visit Indian Patent Office. Despite there are number of concerned areas to improve on but what is commendable is the growth of patent awareness among the Indian pharma industry, which not only making Indian pharma companies globally competitive but also R&D driven. But there is an area that needs utmost attention to fuel overall potential of Indian pharma industry and that is patentability of incremental inventions/innovations. The Chennai High Court's recent decision rejecting the petition which challenged the constitutionality of the section 3(d) of the Patents Act, 1970 has left few concerns untouched which needed to be resolved for accelerating growth of Indian pharma industry in the global healthcare scenario and building future!
