“We launched Safyr specifically to meet requirements of India's domestic pharmaceutical packaging market”

Arvind Pachhapur,
South Asia Head - Intellectual Property & Science and Legal Business, Thomson Reuters.
“Globally, innovation is recognized by governments and corporations alike as the fundamental driver of economic and business growth. In India, however, the links between innovation in industry, academia and government is still in a nascent stage,” says Arvind Pachhapur South Asia Head - Intellectual Property & Science and Legal Business, Thomson Reuters. In an interview with Mahesh Kallayil, he further discusses how the linkages between Industry-Academia-Government is a tool to achieve economic growth.

Please elucidate over the IPR environment in India? How do you compare this with other international markets?
India IPR environment has been evolving steadily. Acts and rules pertaining to IPR have been reviewed periodically. Eg, Patent Act 1970, Patent Amendment Act 2005, Copyright Amendment 2012 etc. The laws have aligned with the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Government follows an inclusive approach and had invited public to provide inputs on the patent draft rules 2015. In addition, there is a lot of emphasis by the government to raise the IP awareness sessions for public.

In 2014, there was in increase of 4.5 per cent in the number of patent applications filed worldwide. Similarly, an increase of 6 per cent for trademarks and 8.1 per cent in industrial designs. In contrast, India witnessed an overall increase of 2.16 per cent in IP filings during 2013-14. Patent filings witnessed an increase of 1.65 per cent, trademarks 2.98 per cent and industrial designs 2.35 percent.

India had the fastest growth in number of patent applications that were filed compared to other countries. China leads the race in terms of patent filings with almost 1 million (928,177) patent applications were filed in 2014. US and Japan followed with half million and quarter million patent applications filed respectively.

Major points to be noted in context of Indian Pharmaceutical industry IPR are:Section 3D, compulsory licensing, Patent link age and data exclusivity.

IPR environment in India is consistent with other developed international markets such as US and EU as well as developing markets such as Brazil, Indonesia, China, etc.

Section 3(d) of the Indian Patents act does not set up context for an altogether additional/different requirements rather it mandates 'enhanced efficacy' as a criterion for granting the patent which itself indicates an advancement in 'the inventive step'. The case of Pfizer vs. Apotex (Fed. Cir. 2007) and the decision on this case showcases that the US patentability requirements are in-line with the section 3(d) on the enhanced efficacy condition

TRIPS signatories eg, the Philippines and Argentina look upon at India for framing amendments in their patent laws and have modeled their law on section 3(d).

Compulsory Licensing allows all participant countries to hold the rights of drug licensing keeping in view the affordability and reach of the drug to mass. Hence Indian IPR rule is globally compliant and in national interest. The case in point is the Bayer vs. NATCO case where the decision targeted at making the drug accessible and affordable in Indian market.

Patent linkage is not approved by EU Considering the fact that it delays generic entry and reduces the access to drug. To compensate this, originator firms enjoy one of the longest data exclusivity period in EU. Indian rules, though at a formative stage, are consistent with the rules followed in China, Indonesia, Brazil, South Africa, Vietnam, Philippines, etc.

How could we make the most of academic drug target discoveries?
By collaborating academia with pharmaceutical companies to assists in promoting innovation. The key is to play on the strengths of academic institutes which is research and strengths of the pharmaceutical companies to manage/ fund the clinical studies, IPR protection and marketing for the drug. A case in point is Ohio University that conducted research on Somavert, a drug marketed by Pfizer. Since then, this has been generating more than 90 per cent of university's royalty revenues. The university has received more than USD 30 million in royalty income.

For example, University of Cambridge has partnered with GlaxoSmithKline to develop a program specifically focused on advance drug discovery and development of new medicines. Scientists at University of Cambridge will be working alongside GSK drug development experts and collaborate on drug discovery.

Based on a study done by Thomson Reuters, we found maximum number of patents have been filed in medicinal preparation category both in the corporate and academic and government segments alike. This indicates a good potential for the seentities to collaborate on pharmaceutical inventions and discoveries.

Could you please elaborate on the emerging role of academia in commercializing innovation?
Commercializing innovations by academia though still at a nascent stage is growing globally. Increasing number of universities are setting up IP cells or technology transfer offices to focus on protecting and commercializing their innovations. According to a Forbes report, lots of universities are enjoying royalty revenues from patents. Stanford, Stevens University, New York University are few such universities who have had a significant return vis-à-vis the investment on research.

Could we have your views on government initiatives in linking between academia, industry and government to achieve economic growth and build innovation ecosystem in India?
Overall collaboration between academia, industry and government in India is still at nascent stages. Major government research organization, Council of Scientific & Industrial Research (CSIR) has collaborated actively with corporations to focus on different research areas. Indian Govt. can build Technology Transfer Offices in universities to assist academia to patent its research and generate revenue through license fees and royalties.

Corporations can sponsor research grants in Indian Institutes to promote innovation. Government in turn may provide tax incentives to such collaboration between institutes and corporations.

Additionally, Govt. may develop science parks near universities to foster links between industry and academia. Govt. is already funding such science parks and we need more of these. Example IIT Bombay and IISC have CEN centre of excellence in Nanoelectronics funded by Dept. of IT etc.

The Ministry of Human Resource Development (MHRD) has constituted Council for Industry & Higher Education Collaboration(CIHEC) to identify issues and opportunities and facilitate development of strategies and innovative instruments of collaboration between Industry and Academia and endeavor to mobilize additional resources to support these initiatives.

The Prime Minister has promised several initiatives that promotes innovation in the country especially from startup companies eg, Startup Intellectual Property Protection (SIPP).

How you think, collaboration between biomedical scientists in academia and in the pharmaceutical industry could address the pharmaceutical innovation crisis?
Globally, industry and academia collaboration is most prominently visible in the pharmaceutical sector. Based on a study done by Thomson Reuters, we have found that top 20 corporations who are funding academic research are from pharmaceutical sector. This indicates that the top pharmaceutical corporations value the R&D efforts of the Academia. Successful collaborations include collaboration of Max Planck Institutes with Pfizer for development of blockbuster cancer drug sunitinib.

What do you see as the big drivers of innovation occurring right now?
R&D spend - by the government or the corporations-is one of the biggest innovation drivers. It is worth noting that as per the Thomson Reuters top 100 Global innovators, two countries - Japan and USA - account for 75 per cent of the top 100 global innovators list and both these countries have comparatively higher R&D funding as a percentage of GDP.

Industry-Academia collaboration in innovation has helped in leveraging the strengths of the Academia and Industry segments. IITs in India have been quite successful in driving the innovations through various such industry linkages including the research parks.

Various incentives chemes from the government have helped in driving innovation in a country. Special programs such as Make in India, Startup India that have been spearheaded by Prime Minister Modi will help in providing optimum traction to drive innovation in India.

A conducive IPR Regime that reassures the innovators on the protection of their IP rights is critical for driving innovation further.

Please brief us about the role of IPR in forming legal strategies for Pharma industry?
Formation of legal strategies in the current scenario of IPR in India involves multidimensional approach. Various national and international laws, rules to the laws, treaties and pacts, and local practices needs to be considered before framing legal strategies. Multiple commercial factors such as market needs, market response and the cost involved in converting IP into financially viable venture will impact legal strategy designing. In addition, legal practices and laws such as section 3(d) of Indian patents law, compulsory licensing and Bolar exemption/provision will also have an impact on the same.

Could you please compare the arena of Indian Biopharmaceutical Industry before and after Patent Amendment Act, 2005?
Before Patent Amendment Act, 2005, Indian Biopharmaceutical industry was governed by Section 5 of the Indian Patents Act, 1970 which expressly permitted only process patent and prohibited product patents. This led to immense reverse engineering as the pharmaceutical companies were free to produce the patented drug with a different process. A huge generic industry prospered in India as a result and exile of MNCs which were afraid of launching their patented products in India. As India signed TRIPS agreement and WTO, the Patents amendment Act, 2005 repealed process patent and therefore gave way to product patents. This new amendment act opened the doors for MNCs and Indian domestic players also started focusing on research and development. MNCs started investing in India by outsourcing manufacturing and also by bringing new skills and investments. Government of India is also providing incentives to encourage R&D and permitted 100 per cent foreign direct investment (FDI) under the automatic route in the drugs and pharmaceuticals sector including the companies using recombinant technology.

Central Government has identified Biopharma as one among the 25 key industries to be covered under Make in India initiative. But foreign companies are reluctant to invest in India as they fear compulsory licensing. As a market observer how you think government should deal with this and how Indian biopharmaceutical companies going to reap the benefit in near future?
Government should emphasize on and publicize the fact that compulsory licensing is not a law/rule designed by India nor is a new phenomenon in global IPR context. The Paris Convention of 1883, under Article 5A.(2) reads: "Each country of the Union shall have the right to take legislative measures providing for the grant of compulsory licenses to prevent the abuses which might result from the exercise of the exclusive rights conferred by the patent, for example, failure to work." Post Paris convention, TRIPS agreement also emphasized on the fact that member nations should have the rights of compulsory licensing for public health reasons, and may suspend patent protection over drugs. Another point to understand here is the fact that it's not only compulsory licensing due to which foreign companies are reluctant to enter in Indian market. Various other factors such as differential pricing, drug profile, diseases profile, and companies' priorities also play an important role. US FDA approved 268 drugs since the product patent regime came into effect in India and only 48 have been introduced in the country so far.

To conclude it is highly unlikely that foreign Pharma companies will not focus on Indian market as its one of the fastest growing and most lucrative markets. MNCs like Novartis, GSK, and Roche etc. have launched their patented drugs in Indian market and other Pharma companies are expected to tap the Indian market.

Indian biopharmaceutical companies can reap the benefit by forming strategic alliances with foreign companies to produce and market the patented drugs at lower costs in India as recently done by Gilead for it HCV and HIV drugs.