Pharmacy

...says Atulya Nath, CEO, Global Institute of Intellectual Property (GSIP). He discusses importance of patents and policy framework in the life sciences vertical, which is favoured towards domestic companies.

Arshia Khan

What is the importance of Intellectual Property (IP) in pharma and healthcare?

IP protection boosts innovation. It goes without saying that a strong enforceable IP regime fosters research and encourages inventors to produce technology, which is both beneficial to the society at large and has commercial value for the innovator. With the coming-in of the TRIPS compliant product patent regime in India, effective 2005, India has come a long way in the field of establishing a patent system, which can boast to be at par with the rest of the world. IP protection for the pharma and healthcare sector in India assumes a great significance, since apart from the considerable size of our generic industry, innovator companies are also gaining a solid footing and recent market analysis indicates that many such companies are investing more and more into their R&D divisions.

What kinds of training services do you provide? Which are the other institutes that provide such trainings?

GIIP provides basic and advanced training   services   in   the   field of    IP    generation,    protection, commercialization and management. GIIP, a pioneer in IP education, has been involved in capacity building for IP & patent professionals since the past four years and has trained more than 200 professionals in the PG Diploma and certificate courses and over 2000 corporate employees.

GIIP offers diploma (full-time), certificate (full-time & part-time). executive and corporate (customized' programmes to hone skills of pharma. biotech, science,  engineering,  law graduates,    post-graduates,    PhDs in the field of Intellectual Property Rights (IPR) with focus on patents and patent process of US, European and Indian jurisdictions.

Some of the other institutes that provide training in field of IPR are National Law School University Bengaluru, National Academy of Legal Studies and Research (NALSAR) University   of Law,   Hyderabad, Indira   Gandhi   National   Open University (IGNOU) Delhi, Institute of Intellectual Property Research & Development   (IIPRD) NCR, The Academy of Intellectual Property Studies (AIPS) Mumbai, Institute Of Intellectual Property Studies (UPS) Mumbai, etc.

What is the need of the hour in the Indian IP scenario with regard to the life sciences vertical?

The life sciences vertical is predominantly revolving around the pharma and the, biotech sectors, which are seeing a flurry of IP activity, especially with patent oppositions and litigations on the rise. An increase in patent- related issues has thus created a great demand   for   skilled   professionals having sound technical knowledge clubbed with patent skills. Trained  Personnel having key patent skills such as searching, drafting of patent specifications, filing, prosecution and other pre and post grant issues, are the need of the hour.

The Indian Patent law being very complex, especially with respect to pharma and biotech, the industry is always on the lookout for professionally qualified   and   skilled people   in this sector.

How are we placed in terms of IP services over other highly regulated Western countries?

India became WTO/TRIPS compliant with the passing of the 2005 amendments in the Indian Patents Act. We are a global player in terms of providing IP services as is evident from more and more inbound off- shore work to KPOs and LPOs. Broadly speaking, the Indian IP service segment is now fine-tuned with the requirements of the overseas clients and at least the key players do

 pay a lot of attention to the quality of work being generated for in-bound work thereby ensuring customer satisfaction.

What are the issues faced by the Indian pharma industry with regard to patent protection?

According to Dr Deepa K Tiku, Program Director, GIIP, the Indian pharma industry is presently embroiled in a lot of patent litigation issues that have arisen due to patents being granted (post 2005) on the innovator drugs for which they have traditionally been producing generic versions. The prohibition on drug patents in the country till 2005 enabled India, a country with a relatively large domestic market, to develop a strong generic drug industry. From 2003 to 2008, in programs supported by donor organizations like the Global Fund, Indian generic drugs accounted for more than 80 per cent of the drugs used to treat AIDS, including 91 per cent of paediatric antiretroviral products, and 89 per cent of the adult nucleoside and non-nucleoside reverse transcriptase inhibitor markets AIDS Soc., 2010; 13:35)] India is also the most important source of generic drugs for cancer, heart disease and other diseases.

While India introduced drug patents in 2005, provisions such as Section 3(d) in the Law have meant that Novartis could not obtain patent protection of a new formulation of the cancer drug, Imatinib, and Abbott could not stop the manufacture of generic heat stabilized versions of the AIDS drugs, Ritonavir and Lopinavir, Taken together, the policies in place in India even today are favoured towards the domestic pharma companies.

However, since even Indian companies are turning innovative, it would be interesting to see the repercussions of these new provisions on such Indian companies.

Kindly provide us with an analysis on the demand for trained patent professionals, agents and IP litigation attorneys in India. How has the same increased over the last decade and the reasons for the same?

Today, we have approximately 5000 practicing patent professionals (patent agents,   patent   attorneys,   patent engineers, patent analyst) in the country, which is expected to grow nearly four times to reach 20,000 by 2015. About 60 per cent of these  professionals are working in the Knowledge Process Outsourcing (KPO) 6- Legal Process Outsourcing (LPO) segments and the rest are employed with MNCs, domestic companies and law firms. This number was less than 1200 patent professionals in 2005 out of which only 800-900 were in actual practice.

India being a WTO/TRIPS signatory was under International obligation to comply with the standards set by the Treaty and in this direction, made substantive amendments to its Patent Law. Effective January 1, 2005, a transition from a process patent regime to a full-fledged product patent regime took place, which has significantly boosted innovation.

With the opening up of trade in goods and services, IPR has become more  susceptible  to  infringement without adequate return to the creator of knowledge. A quantum jump in R&D costs with an associated jump in investment is required for putting a new technology in the market place. Hence, the need to protect the knowledge from unlawful use has become expedient.

Increase in patent-related off-shoring services to India. At present, India generates $100 million in revenue from patent services off-shoring industry, which is expected to reach $ 495 million by the end of2015.

What is the demand for LPO and KPO services in India?

The number of patent filings in India is increasing every year and so is the number of patents being granted by the Indian Patent Office. This inevitably has led to a demand for skilled patent professionals having sound technical knowledge. It is envisaged that KPO holds strong potential as it is not restricted only to Information Technology   (IT)   or   Information Technology Enabled Services (ITES) sectors but also includes other sectors like LLPO, Legal research, IP-related services, business research and analytics, engineering R&D, finance and accountants management and consultancy, education, clinical research, market research (market research KPO), etc.

The KPO boom is expected to overtake the BPO business, and as the KPO sector grows, over 300,000 new jobs will be created. Further, a report by Forrester Inc. estimates that an additional 35,000 new jobs will move to offshore locations by 2010, while a massive 79,000 more will shift to offshore locations by 2015. Again, nearly 70 per cent of those jobs will be shifted to India.

Tell us about the accreditations at GIIP.

GIIP is a professional education institution established with the objective of developing employable global skills in the area of patents and IPR. GIIP trains both technical and legal professionals looking for a full-fledged career in this emerging area. GIIP programs have strong credibility in the industry and ex-GIIPians are working with MNCs, large organizations, KPOs and law firms

across India.

GIIP is an academic partner with IIT Delhi, National Law University Delhi, Ministry of Micro Small and Medium Enterprises (MSME), Council of Scientific and Industrial Research (CSIR), Centre for Development of Advance Computing (C-DAC), University of Washington USA, Dutch User Group (WON), The Netherlands, and has earned the reputation of being the leaders in field of IP education & training.

Tell us about the campus placements at GIIP.

GIIP provides campus placements to participants of its full-time programs we have placed more than 200 program participants at organizations, such Honeywell, Infosys, GE, Symantec, HCL, TCS, Siemens, Evalueserve, Altacit Glot Lexadigm, CPA Global, Ripple IP Service Inventurus, lus-Juris, IPpro Inc., Panac Biotech, Sanofi Aventis, Biocon, Ranba Laboratories, Dabur, Jubilant, Amarchad & Mangaldas, Anand & Anand, K&S Partners, Remfry & Sagar.

Till date, GIIP has trained more than 2500 professionals working in the ICT, automobile, pharmaceutical, biotechnology, heavy engineering, KPO sectors. Can you give us a break up of professionals working in pharma, biotech and KPO segment?

GIIP has trained graduate, pa graduate, PhD students with pharma biotech, engineering background an placed them in different industries is India and has also conducted corporal programs for professionals working u the ICT, automobile, pharmaceutical biotechnology, heavy engineering, KPC sectors. Out of the total of 2500 trainee so far, GIIP has trained more than 1200 people who at present are working the phrama (175+), biotech (300+) and KPO (725+) sectors.

What are your plans with regard to expansions?

Going forward, GIIP's training division has the following expansion plans (12-15 months) -

a) Set up new learning centres at Pune, Hyderabad, Baroda, etc.

b) Launch   distance  learning  and| e-learning courses in area of patents; &IPR

c) Seek affiliations, tie-ups with US, UK universities and international training organizations

d) Launch new IP programs for experienced & management level professionals