The global bio pharma industry has been forced to reinvent itself.
The looming ‘patent cliff’ is the biggest challenge to Big Pharma. In the past, this would have been a mouth-watering arena for Indian generic players. But the windfall profits of the past have all but disappeared. Generic competition is sustained and new generic drugs face severe competition from the very day they are launched.
The Life Science innovation has shifted focus to areas that are niche, with more directed indications, such as cancer. Diseases of high unmet needs, such as auto-immune disease, are also gaining the attention of policymakers, as millions of people suffer, and healthcare costs rise. In a recent shift, policy makers urged regulators to lower the bar for diseases such as Alzheimer’s. Metabolic disease and chronic diseases are affecting more people worldwide.
VALUE OF IPR
The “pharmemerging” markets are capturing attention, with the BRICS countries increasing spending on healthcare (see table). It is clear that Big Pharma is not going to invest in diseases of developing countries such as resistant tuberculosis, or mutations of HIV prevalent in India. Indian innovators must develop their own unique method and bet on innovation and intellectual property.
Intellectual property rights (IPRs) assets are often described as intangible assets. They include a company's brands, patent portfolio, R&D strategies and licensing agreements.
Other significant intangible assets are invested in a company’s human capital, its knowhow, and include such things as its databases, manuals, product specifications and manufacturing guidelines.
All of these intangibles have a value. As an asset, IPRs play a substantial part in a company’s commercial outlook and may impinge on just about every aspect of its business — from its sales, marketing and product development to the overall financial health of the company.
Patents are not intrinsically valuable, in the sense that a patent is not economically an “end in itself”. Rather, a patent claiming an invention with market demand is likely to have economic value, because the patent-holder can exclude others from making, importing, using, and offering the same for sale.
Top business journals such as Forbes , Fortune or the Harvard Business Review as well as the pundits are calling it the next corporate strategy challenge — how to use patents and other intellectual property not just as legal tools, but as weapons of business competition. According to authors Rivette and Kline: “Firms can no longer ignore the growing power of patents in business competition. The competitive battles once fought for control of markets and raw materials are today increasingly being waged over the exclusive rights to new ideas and innovations.”
High-quality patents can capture and defend markets, outflank rivals, boost bottom-line revenues and shareholder return, and enhance the commercial success of their enterprises. R&D managers can employ intellectual property strategy to help build category-leading products, amplify the branding and marketing efforts devoted to them, and help sustain their product or service advantage.
TRENDS IN INNOVATION
However India’s patent laws are some 400 years behind Western nations. England had the Statute of Monopolies in 1624, under King James I, which declared that patents could only be granted for “...projects of new invention.” During the reign of Queen Anne (1702–14), lawyers of the English Court developed the requirement that a written description of the invention must be submitted. In 1778, in the US, several states adopted their own patent systems. The US Constitution authorises the American patent system in Article One, ‘the Congress shall have power. To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries...’
Today, the US is known as one of the most innovative countries in the world. Twelve European countries figure in the top 20 list. India does not figure in the top 20 list of patent filers in the world and her patent law was enacted in 1995. Yet, Indians are recognised for their innovative culture, especially in science and mathematics, for centuries.
In society, innovation aids in comfort, convenience, and efficiency in everyday life.
Innovation is the development of new values through solutions that meet new requirements, inarticulate needs, or old customer and market needs in value adding new ways. This is accomplished through more effective products, processes, services, technologies, or ideas that are readily available to markets, governments, and society.
INDIA’S POTENTIAL
Indian innovation must be invested in unmet needs of both Indian as well as global industry. It must be able to find new niche products that can be used to improve health. With a large population in the home country, India has a distinct advantage.
Biomaterials and Med Tech are arenas (where engineering and medicine cross over), where Indian scientists have strong skills. Cutting-edge technologies such as molecular diagnostics and analytics, which need a new kind of infrastructure, are critical.
However recently, the Indian advantage is dissipating. Regulatory bottlenecks, poor systems and processes, processes that are not transparent, timelines that are opaque, are reasons cited by innovators as seriously hampering progress. Clinical trials are easier to carry out in other developing markets such as Singapore, Thailand and Malaysia as guidelines are transparent and approvals are timely.
Indian innovators are reviewing whether it is worthwhile to invest in new inventions; with a weak legal system, others can unjustly profit from the innovator’s long years of hard work. It is one thing to file a patent, but quite another to defend it.
It is clear that Indian scientists are among the best in the world. A recent drug molecule for a blood thinning medicine was brought to the market by a big pharma company in the US, but the key members of the team, from invention to development, were from India. As much as 30 per cent of Big Pharma scientists are of Indian origin.
To attract this talented diaspora, and start a reverse brain-drain, Indian policymakers must re-energise the system — which is full of self-inflicted damage — with radical measures for improvement. Till then, India will not be able to take her rightful place at the head of the table of innovative nations and be medicine-maker to the world.
(The author is Vice-Chairperson of Piramal Enterprises. The company has launched patented technologies in regeneration medicine in Europe and critical care products in US and Europe.)