Indian pharma is thinking beyond generics and is investing considerably in developing new drugs and filing patents. This change is attributed to the post 2014 drug patent guidelines and facilitation by the Indian government for promotion of innovation, manufacturing and developing India as drug hub, according to Ruhan Rajput, Director, Einfolge. In an email interaction with Nandita Vijay, he elaborates the current patent scene in the country and challenges the companies face. Excerpts.
In the wake of the government’s efforts to drive innovation and R&D, how would you describe the current scene for patents in India?
Controller General of Patents, Designs and Trademarks (CGPDTM) under the Department of Industrial Policy and Promotion, Ministry of Commerce and Industry has shown consistent growth over the years. This year, India witnessed an enormous surge of about 30 per cent in filling of intellectual property applications compared to the previous year. But in comparison with countries like China, India is still lagging. The Global Innovation Index, 2017, ranks India 60th out of 127 economies where China is at 22. Clearly, India’s innovation performance is abysmal. Proposals for strengthening India’s inventiveness have been made by public policy experts, notably, the World Bank and (World Intellectual Property Organisation (WIPO). Suggestions fall into three broad categories: one is to create and support world-class universities. The second is to cut bureaucratic red-tape, and the third is to foster an entrepreneurial culture.
Recently the Indian Pharmaceutical Alliance had appealed to USTR to remove India from Priority Watch List. Your comments?
In the last few months there have been many developments which are a pointer to the fact that Indian pharma is thinking beyond generics with a big change in approach. They are investing a lot in developing new drugs and are also aggressively filing patents. This change is attributed to many factors. One such is the post 2014 drug patent guidelines and facilitation by the Indian government for promotion of innovation, manufacturing and developing India as a drug hub. India being one of the biggest consumer markets of drugs due to its high population brings in a lot of competition among the players. Besides domestic pharma, there are also global majors who have made huge investments in R&D and filing patents globally.
What do you have to say about the objections to grant of patents and patent-related litigations in various courts in the country?
A patent is an exclusive right granted to the original inventor for a novel product or a novel process that provides, a unique way of doing something, or which discloses a new technical solution to a problem. It provides monopoly rights to the inventor to make, sell his invention or product. Hence it is essential that patent is only awarded to those innovations which justify the exclusive right and comply with the patentability criteria. Opposition proceedings are structured to restrain wrongful obtaining of patents and claiming of the frivolous or petty inventions. Laws provided under Indian Patent Act for pre-grant and post grant of patent are essential to obstruct the unlawful grant of patent. Under Indian Patent Act, there are two provisions when opposition may be filed either via pre-grant opposition or post-grant opposition provision depending upon the stage of the patent.
Do you feel that Evergreening of patents is a bane to the pharma industry?
In recent times, it has become a practice by innovator companies to extend the patent term of their innovative molecules to maintain market dominance. The extension of the monopoly term ‘Evergreening’ is a predominant aspect of pharmaceutical patenting. Evergreening refers to different ways wherein patent owners take undue advantage of the law and associated regulatory process to extend their IP monopoly particularly over highly lucrative ‘blockbuster’ drugs by filing disguised/artful patents on an already patent protected invention shortly before expiry of the ‘parent’ patent.
In India, under the Patent Act 1970, the term for a patent is given for 20 years. The Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement also provides for a minimum length of 20 years for any patent. At the same time, Article 1.1 of the TRIPS agreement recognizes every party’s right to implement more extensive protections in their laws. Free Trade Agreements (FTAs) allow for an extended patent term in cases where an unreasonable delay occurs in granting the patent which is Article 15.9 of the Central America Free Trade Agreement (CAFTA) that is also compliant with the TRIPS agreement.
From a global perspective how does Indian pharma appear in patent filing?
India is a leading producer of generic medicines and caters to the most developing nations by providing lower priced drug formulations. The industry is also one of the leading filers of abbreviated new drug applications (ANDA) in the US and supplier of finished formulations to the European region. However it is generally observed that the Indian patent scenario is not robust and is witnessing lower number of patent applications despite the tremendous growth in terms of market presence.
What are the challenges that you see in patent filing by India?
The new patent regime in India has raised several contentious issues relating to the right for health, which is in conflict with the economic right of patent holders. It is also likely to restrict access of allopathic medicines to only the affluent, affordable and more privileged class in India and other countries in the immediate future. The institutions associated with enforcement and protection of right to health of human beings whilst upholding the rights of patent holders are faced with the daunting task and challenge of devising ways to fulfil their defined, roles so that the conflict in rights of intellectual property owners and health of human beings is minimized whilst balancing the prevailing hierarchy of human rights to achieve the social and economic objectives.
Could you dwell on Einfolge expertise in pharma patents?
Einfolge has a dedicated team related to pharma patents. We have also collaboration with another US pharma contract research organisation: Pharmasci. This brings on table the expertise of their talents who have had many years of industrial R&D, especially in process development for active pharmaceutical ingredients (APIs).
We have plans to expand to the US, Europe, China and Japan. These are the biggest markets for pharma patents. We plan to double our employee strength in next two years and a chunk will be pharma experts.
We see a big potential in near and long-term on advanced medical care related technologies and innovation will be a key to all such developments. We are gearing up to excel in pharma and healthcare to handle critical analysis and projections
How important is pharma in the company’s growth plans and what are your future efforts to increase presence in this space?
Pharma is one of the key sectors of the economy. We are targeting 25 per cent of our work from the pharma sector. We regularly participate in the annual Indian pharma -medical devices expo organised by Government of India. Besides this, we aim at collaborations with pharma focused institutes and research centres. A number of research institutes are contacting us for collaborating on various fronts including educating their staff and students on IPR matters, supporting them in protecting and monetizing the crude research and help them to take it to industry level. In future, we are also planning collaborations with medical research centres, medical device pioneers to shape further strategies in IP protection for the pharma sector. We are also planning to organise pharma patent camps in collaboration with other strategic partners for highlighting our expertise and excellence.