India's entry into the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) compliant product patent regime has stirred hornet's nest in the global IP scenario. The lawmakers, jurists and patent challengers have all woken up to review the imbalances and shortcomings in the system. Eminent European jurists and patent attorneys have expressed strong views supporting the need for enhancing the efficacy in a new form of known substance to meet patentability criteria. It is common practice in Patent Cooperation Treaty (PCT) search and preliminary examinations to report absence of improved performance to negate patentability. The need for beneficial improvement over prior art, for claiming patentability, has recently been highlighted in US Supreme Court opinion.
The Japanese who came to India were eloquent on 'elephant patents' and 'mouse patents' to distinguish between robust new chemical entity (NCE) or breakthrough patents and incremental inventions bordering on frivolous limits, which are prone to be invalidated overseas in post grant oppositions or prophylatically rejected in India through pre-grant oppositions. It is pertinent to note that India does not have 'petty patents' unlike many other countries like Japan, Australia and Thailand.
Patent perspectives in India need to be reviewed in the context of the inventors/patentees, lawmakers, patent office practices, patent practitioners and finally the common man and civil societies.
Post 1995, more predominantly, post-2005, researchers in academic environs and corporate corridors have woken up to the benefits and need for protecting the inventions, incremental or more practically beneficial. There are enthusiastic efforts from academic campuses for licensing and technology transfer. There is also slightly premature over-enthusiasm and excitement from inventors for claiming royalties and milestone payments. From the visible trends in the research camps, one thing is abundantly clear. India will climb on to the drug discovery bandwagon faster than USA or Japan did in the past. What is disturbingly lacking is the (inadequate) infrastructure apart from negative mindset, myth-based anti-propaganda against drug discovery research and much needed impetus to clinical research logistics. It is also disturbing that key government departments, which ought to provide all support for drug discovery research, are dragging their feet over 'mindset' issues. Another factor affecting effective utilization of innovative potential is the unwillingness of government controlled or managed research laboratories to open up to private initiatives. There should be appreciation from where it matters, irrespective of who benefits. The national facilities must be allowed to be fully utilized for value-creation, which would in turn speed up the innovation juggernaut. It will also help face the discovery challenges better. The Indian CSIR laboratories and other nationally subsidized research institutions must give priority and fillip to domestic research initiatives, rather than chase global giants to serve.
Contrary to the early slip-up during Uruguay Round, TRIPS negotiations and post 95 setbacks, the lawmakers, bureaucrats and ministry officials are lately demonstrating 'surprisingly' strong national spirit and 'public good' postures. The old mindset was to accept anything coming from overseas as golden and implement the friendly orders as such, without scrutiny or review. Of late, especially from the mid 2000s there appears to be better awareness and appreciation of the key elements in the delicate balance of rights and obligations in the corridors of the North/South blocks and elsewhere.
While the widely discussed and reported cases of neem, turmeric and basmati generated public interest and participation in IP deliberations, the 'gleevec' patent case did immense good to Indian patent awareness among the public as well as legal circles. It is hoped that the Indian patent law drafters will study the latest judgements and opinions of the Court of Appeal of the Federal Circuit as well as the Supreme Court of USA, which in their pronouncements, have used more widely acceptable terminologies to qualify patentability criteria in incremental innovations. Those who criticize the Sec.3 (d) of the Patents Act, 1970 and those who find it difficult to understand and appreciate the 'thin line' between frivolous patent and incremental innovation patent would do well to study the latest US Supreme Court and Appeal Court judgement, reversing earlier narrow interpretations of lower Courts.
Between 1995 and 2007, the Indian patent offices have undergone major facelift as well as overhauling of mindsets. While modern buildings and reasonably well-equipped patent offices (not comparable to Japan, China or even smaller countries like Thailand) have sprung up, the people resources (well trained and motivated patent examiners and patent controllers) are still lagging behind.
It is heartening, however, to note that the government is doing all it can to improve the status quo. Nagpur patent office is being revamped as a major training centre, well-planned recruitment program for patent examiners is on the anvil and there is widespread appreciation in the Ministry and government that better working conditions and emotional support need to be provided to the personnel in the patent offices. However, till the shortfall in patent professionals in the market place are met reasonably, the attrition rate from patent offices will remain high. This would, however, not matter (it may infact be good for Indian patent perspective), if there is continuous replenishment through recruitment and scientific training, indirectly meeting the market demand for patent professionals.
The patent practitioners are, however, in dilemma most often. The definition of inventive step as amended (compared to earlier crisp definition - "inventive step means a feature that makes the invention not obvious to a person skilled in the art") is vague and confusing. The new definition 2(i)(j)(a) reads:
"Inventive step means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art"
Anyone, who can read and understand English, would naturally get confused with the multiple 'or' and 'or'. A simple economic significance, such as cost reduction should be inventive as per the definition. However, the patent office, by and large, follows the TRIPS compliant pre-95 definition (which is tighter) in patent examination practice. Another glitch, which is outstanding, is the definition of 'new invention', while there is no reference or mention of 'new invention' (which of course is a misnomer anywhere else in the Patents Act, 1970 except in the definition. A recently retired Patent office expert called it a 'harmless appendix' to the Patents Act, 1970).
Indian Patent Act provisions in the Sec. 3, including that of Sec. 3(d) has found wider appreciation worldwide, than originally expected. Even though, Patents Act 1970, spells out what are not inventions in Sec.3, patent examination practices in most advanced countries follow these very same guidelines in patent examination, as their patent laws evolve more through judicial pronouncement and opinion, as is evident from MPEPs.
Patents and biodiversity
The most disheartening and discriminating provisions for Indian inventors and patentees are coming from the most impractical, badly conceived and even more badly implemented provisions of the Biodiversity Act, 2004. These provisions are extremely discriminatory to Indian herbal industry. The successful implementation of any act is in its practical exemption provisions. Unfortunately, the Biodiversity Act is under governance of the Forest/Agriculture Ministry and the committee who scrutinize the applications is exclusively comprised of chiefs of public sector laboratories, who appear to be insensitive to the innovation potential of the private sector.
Even when a private research-based corporate patentee applicant undertakes whole process from seed to plantlets, cultivation, extraction and commercialization, the Biodiversity Authority insists on sharing 5 per cent of the royalty with them. This is a prerequisite for the permission from the biodiversity authority, which need to be statutorily (without exemption) produced to the patent office, before a patent is granted to an otherwise patentable herbal plant-based invention. What is surprisingly discriminatory is that, there is no restriction whatsoever for exploiting the Indian plants and herbs and patenting an Indian herbal based product overseas. It is fervently hoped that this anti-Indian, anti-herbal research provisions (without exemption) gets reviewed and revamped for the herbal patent perspective in India.
Civil society initiatives in India, in patent perspective, appear to have outpaced other players in the field. There is better co-ordination and participation among NGOs in India than among patent practitioners and professionals. The vigilance and pro-active approach of the NGOs are amazing, considering that Indian patent perspective is so nascent and in its infancy.
Unlike the 'patent-astrologers' of the 80s and 90s, the common man appears to have (yet) been least impacted by the WTO/TRIPS and product patent regime, at least in pharmaceuticals, biologicals and agrochemicals. It, however, need to be appreciated that this scenario has emerged only because the government has risen to meet the challenges of globalization and harmonization and have alertly and pro-actively taken effective steps to take reasonably permissible liberties to avail of the flexibilities under international agreements such as TRIPS, to continue to protect sovereign national interests, to the extent possible. Indian patent perspective has so far hopefully led the way for rest of the world and is expected to do so if this novel, original and creative approach of lawmakers continue. Once again, a 'reverse engineering' era in patent practice is emerging from India, to haunt the 'litigation sharks'.
(The author is CEO of GA Patent Gurukul & Gopakumar Nair Associates, Mumbai)