It is time we initiate a new road map for “globalization” with specific strategies to encourage innovation. India in particular and the BRICS countries collectively can play a vital role in this initiative.
India has adopted the TRIPs regime and has adapted well to the balance of rights and obligations inherent in encouragement for IP owners with corresponding benefits accruing to the users and beneficiaries, at the same time operating within the flexibilities available in TRIPs.
The Patent Law, 1970 of India, as amended to meet the TRIPs compliance, has succeeded in providing for protection for genuine inventions, weeding out frivolous and ‘ever-greening’ inventions, without compromising on the fundamental rights of public health related affordable access of essential and lifesaving medicines to her citizens.
The Indian model of Patent Law has found acceptance globally as is seen from recent developments overseas. Even in developed countries, ‘ever-greening’ is being discouraged both by patent offices as well as by the judiciary. There is wide felt appreciation among developing and least-developed countries for the Indian Patent Law and the built-in balance of rights and obligations.
Even though, there is continuous and vigorous efforts from ‘vested interests’ to create “novel” and “inventive” legal and Technical (and non-tariff) Barriers to fair trade within and among member countries, the “ball” that has already been set in motion is hard to be retrieved or reversed.
In this context, it is in the best interests of the nation, that we start encouraging “Innovation” from grass roots. Innovation has to become a national priority, not only to face the global challenges, but also to move into the forefront of global pharma industry.
‘Innovation’ as a subject must be introduced from early curriculum, more importantly for Pharma education. Innovation has to become a ‘culture’ and a way of life for the Indian pharmacists and scientists as well as for all professionals (Home-makers and Dabbawalas are already experts of innovation). The emphasis has to shift from “Patents” to “Innovations” and encouragement and support to “innovations” outside the realms of Patents must come from one and all including Government and Governmental institutions. The reasons are as follows :
“I” ! Who is (am) “I” ? Inventor ? I denotes a person and “I” is (am) a “person”. There are “Rights in Personam” vs “Rights in Rem”, which means there are Private Rights and Public Rights. Private rights include rights of the IPR owner, inventor or Patentee. Public rights include public health rights, consumer rights and patient rights.
Having said so, the relationship between ‘Patents’ and ‘Patients’ is through the “I” in the middle. This “I” is the Inventor, who provides the invented medicines for which Patents have been granted. For a harmonious relationships in the rights (Personam vs. Rem) a fairness and mutual appreciation is essential.
This can only be possible if there is a mutually equitable balance of rights and obligations, between patients and patentees. This is vital, not only for keeping the pipeline of new drugs, new devices, new diagnostic techniques and lifesaving as well as “quality of life-improving” medicines, but also for providing timely affordable access to life-saving medicines to needy patients. This continued mutual recognition is paramount to keeping the institution of Patents alive and for public benefit along with private gains.
This relationship has been going on smoothly for years. However, in recent times, the inventor communities led by large MNCs have become greedy and are trying to exploit the ‘patients’ beyond reasonable limits. This is also because the costs of new drug discoveries and developments thereof, have been substantially hiked for “larger than life” personal benefits, sought to be derived from human sufferings.
The “TRIPs Plus” Patent Regime which the developed countries and their corporate interests are trying to force upon the third world countries, is tilting the delicate balance away from the target beneficiaries of these inventions, leading to abuse of patent rights and the inherent monopoly which is being wrongly interpreted as “absolute”.
Another reason for the need for an “innovation policy” and encouragement to innovations is the direct conflict of Patent Law with the provisions of Biodiversity Act and the provisions of Traditional Knowledge. The grant of a patent for herbal innovation is almost impossible in India, in view of the rigid attitude of the Biodiversity Authority and the lopsided definition and interpretation of a “value added product” therein.
Even if a herbal patent is granted by obtaining a prior permission (NOC) from Biodiversity Authority (which is possible only after signing an agreement to pay five per cent royalty on sales on the patented product by the patentee or his licensee), the patentee or licensee will find it difficult to commercialize and earn or license and save the balance (after paying five per cent on sales to Biodiversity Authority). To add insult to injury, the TKDL is now being enforced stringently by Indian Patent Office to bar all herbal patents based on herbs mentioned in TKDL. A “value -added product” is defined as follows in Biodiversity Act (OMG) :
“Value- added product implies products containing portions/extracts of plants and animals in unrecognisable and physically inseparable form. For example: Chyawanprash, Isabghol, Pudin Hara, turmeric creams etc”.
Further, every action leads to equal (or more) and opposite reaction. The “extreme” pressures from overseas corporations through their governments and through protracted expensive “enforcement” (often premature) litigations in India have generated equally “extreme” NGO & public reactions against the patent regime. Consequently, over a period of time, even a genuinely deserving (protection) patent also may find it difficult to be enforced.
For all these reasons, India should concentrate on evolving and propounding an innovation policy for & from India with a roadmap for encouraging and supporting innovations. This can best be done by all teaching academic institutions, institutes and universities putting in place an “Innovation Policy” supported by compulsory introducing the subject of “Innovation and IP generation” in the respective curriculae.
The “Innovation Policy” could also be adopted and put in place by corporations, both private and public, departments and ministries both at state and central levels. An effective innovation policy will incorporate knowledge-based approach in solving or resolving existing or identified problems, gaps or needs.
Such a policy will encourage scientific and technological progress with open access to the community. It goes without saying that the substantial encouragement for such innovations will need to come from Government and the rest from the beneficiary community.
(The author is CEO, Gopakumar Nair Associates)