Knowing one’s “Intellectual Property” rights – IPR – Express Pharma Pulse

Knowing one’s “Intellectual Property” rights

Indian scientists are yet to realize the potential and the real value of their renovation and knowledge/ technology created, says Jayashree Padmini

Professor X of Amritsar University and Professor Y of a US-based multinational are good friends. Professor X, using Indian traditional wisdom identified a botanical based drug lead that exhibited anti-cancer activity and transferred the molecule to the ‘friend in US’ for further studies, and obviously commercialization. When asked what is the IPR sharing agreement, the professor said, he is my friend!

Three things have been transferred here without proper IPR sharing mechanism in place like the traditional wisdom, bio-resource of the country and the drug lead developed. Tomorrow, the foreign MNC would market the drug in the country at exorbitant cost.

Managing IPR

In an effort to familiarize the research community in Indian institutes and universities with the complexities of intellectual property rights and to upgrade their knowledge to effective IPR management, RRL Jammu, has taken up the initiative to organize the National Seminar on Intellectual Property Management of Herbs & Horticulture. The researcher community lags behind in assessing the potential of their own research and they fail to capture the nitty-gritty of patenting. The three-day workshop had been an intrepid effort to tell this aloud and to chart out future strategies and roadmap for post 2005, the WTO regime.

The term Intellectual Property is assigned to property created by intellect or intellectual efforts and national governments provide protection of IPR for a certain defined period by way of patents, copyright, trademark, and the like as an incentive to innovation. To ensure effective IPR protection countries need to put in place a legislative framework which is legally enforceable in respect of the granted right that excludes others from unauthorized use of a protected variety to make commercial gains. All patent owners are obliged, in return for patent protection, to publicly disclose information on their invention in order to enrich the total body of technical knowledge to the world.

Such an ever-increasing body of public knowledge promotes further creativity and innovation in others. Patents are coined to provide not only protection for the owner but valuable information and inspiration for future generations of researchers and inventors. Indian Patent Act neither has provision for product patent nor it allows patenting of life forms. Knowledge or ideas as such are not patentable, however, the recent Patent Amendment (2nd) Bill also brought plant variety under its ambit.

Patent information

Indian researchers are more or less living in closed shells without proper linkages to the outside world of knowledge and wisdom. A survey at the institutes under CSIR revealed that only around 50 per cent of the research work are actually patented. Dr G N Qazi, director, RRL Jammu, quipped, ‘‘This figure, to my mind is quite encouraging. CSIR witnessed this achievement and global wisdom started really percolating into CSIR institutes only after Dr Mashelkar took charge.’’

According to P M Bhargava, founder director of CCMB, Hyderabad, the concern is not really about patenting as such, but scientists in the country need to take the right direction and research should be result-oriented. However, patenting is crucial because, if the original innovator neglects patenting, there are high chances that others exploit the innovation and utilize it for unfair commercial advantage.

Dr V K Gupta of the National Institute of Science, Technology & Developmental Studies, New Delhi, stresses on the need for utilizing the patent information to enhance the scope of research conducted and to carve out strong patents. He says we need to integrate IPR into the R&D strategy of scientists from day one and build up capabilities to negotiate IPR. Even after being aware of the significance of patent information scientists fail to take up critical analysis of patent information and integrate it into R&D strategy. Patent information clearly helps in building up capability in R&D and technology development, R&D policy and management and information management which Indian innovators need to add to their agenda.

Patent information analysis helps in developing state-of-the-art in a specific field of research apart from keeping abreast of latest knowledge and having a general orientation on new scientific and technological developments. It takes a significant role in assessment of research trends and identification of opportunities for R&D defining a research project.

Another aspect is to avoid overlap with research results accessible in patent literature and clarify the novelty of a potential invention. With regard to R&D policy and management the patent analysis becomes crucial where researcher would get to identify the pattern of growth in patenting, evaluate performance of research groups, compare performance of research groups within and outside the country and monitor competitors’ R&D activities. This goes a long way especially when scouting for collaboration where researchers could easily identify active players in R&D in industry, academia or government.

Also patent information analysis takes researchers to wider arenas to identify assignees and owners of patents, evaluate productivity of individual inventors, examine nature of collaboration and identify core competency of R&D organizations. It plays an active role in information management like identify sources of patent and non-patent literature cited in patent documents, analyze references to patent and non-patent literature cited to obtain insights into organizing and managing science and technology information needs. Indian scientists are found to be in oblivion about the real value of their innovation and the knowledge/technology created.

Dr Rajendra P Jagdale, director, Science & Technology Park, University of Pune, citing a study at Pune University on the prospects of translating 22 technologies into business plan says, only two of these are found to be worth for commercialization. What ails India? He pours out statistics, while China has 180 and South Korea 200 business incubators the figure in India is at a dismal 12.

Dr Gupta of National Institute of Science asserts that utilization of patent information is an important competitive and strategic tool to take the right steps at the right time for technology development. The effective use of patent information in the research process is dependent on its timely retrieval, availability, and critical analysis, hence R&D organizations should take initiatives to develop necessary skills and support systems for this purpose.

H R Bhojwani, Emeritus Scientist of the CSIR, cautions against overlapping patents and stressed on the need to utilize effectively the ever increasing scope of patenting, pointing out the example of pipeline of which CSIR has patented four claims as a bioenhancer. But scientists abroad had, depending on the knowledge base built up by CSIR wrote 60 odd claims and constructed strong patents to cover all areas of applications, not only of pipeline but even of all essential oils. This CSIR could have done very well, but they failed to identify the wider aspect and did not know the art of patent writing.

Herbal drugs

The Indian exports of botanical based preparations is projected to touch Rs 3000 crore by the year 2005 from the present figure of Rs 446 crore as per the report of Task Force on Conservation & Sustainable use of Medicinal Plants. However, this figure is far below what India could achieve, say experts. Around 40 per cent global biodiversity is shared jointly by India and China, but while the herbal drug business in China is 10 per cent of the world business, the herbal drug business in India is less than one per cent.

Indian herbal technology scene being highly unorganized and unsystematic we do not have the authentic data on demand/supply. Innovators fail to take-off the research lead to final stages of commercialization due to lack of sufficient financial support for R&D from private houses. Most of the research work is limited to academic levels and preference is for publishing research papers rather than developing and taking products to market. Lack of comprehensive information on IPR is another hindering factor that impinges on the prospects of innovation in herbal arena and growth of herbal market.

India being a WTO member TRIPS is effective from January 1, 1995 and WTO members need to provide protection of plant varieties either by patents or sui generis system. S Bala Ravi, advisor (TRIPS & Biodiversity), M S Swaminathan Research Foundation, Chennai, in his presentation furnishes the herbal usage pattern in the country. Species largley used by pharmaceutical industry is only 400 of which 10,000 fall into the codified formulations. The known folk-lore formulations are about 25,000. Many countries have already plant variety protection laws and India recently passed the Plant Variety & Farmers Rights Act 2001 under which new, distinct, homogeneous, stable variety could avail protection.

Bala Ravi, stressing on the need to concentrate on traditional wisdom to evolve drugs scientifically and bring to market pointed out that about 7,500 species of medicinal plants identified but only less than 20 species brought under commercial cultivation. To protect indigenous drugs under IPR, Prof S S Handa, former director, RRL Jammu, suggests that the country should set up an inventory of medicinal plants indigenous to India and used in Indian Systems of Medicine, preserve germplasm of all plants used in ISM, adopt modern methods for preparation quality control with proven clinical efficacy and safety and enabling such products to become patentable entities. The country should also chart out innovative approaches for developing new processes of ISM drugs, use modern pharmacological models to enunciate new biological activities of standardized extracts which become patentable.

Dr R K Gupta, head, Intellectual Property Management Division, CSIR, is drawing up a multi-pronged strategy to address the complex issues in the herbal drugs segment in the country. He emphasizes on the significance of integration of traditional knowledge with modern concepts and need for standardization of products and documentation. To enhance the scope of patent apart from that on entirely new molecules, Dr Gupta puts forward a slew of suggestions: identify new activities for existing molecules, derive chemically known single molecule from herbal products with new applications, new method of administration and fractionate the extract, develop new combinations and isolate and establish new compound/activity.