The more things change, the more they remain the same. In the context of the product patent regime, which became law in India in April 2005, what are the implications? On reading the title of this article, one may wonder, why the debate? Won't the new patent regime represent a change for the better? There are 2 differing schools of thought.
Pharmaceutical product patents represent a just reward for the innovation and intellectual effort that goes into drug discovery. The obvious benefit to society is that the invention is in public domain and is now available to other researchers to trigger other avenues of research, and make further refinements to come out with better products based on structure-activity relationship studies, either in terms of pharmacodynamics, pharmacokinetics, safety, tolerability, quality of life, cost-effectiveness, convenience, drug-delivery systems, and importantly patient outcomes.
As long as incremental innovations satisfy the NINSU (Novelty, INventive Step, Utility) criteria of patentability, they offer another incentive for the "indigenius". Given the strengths and competencies of Indian pharmaceutical companies, patenting incremental innovations would be in their interest (for example, the COD drug delivery system for ciprofloxacin licensed out to Bayer by Ranbaxy). The spectre of evergreening seems to be a reason for objecting to patenting of incremental innovations, but we must remember that one can never extend the original patent. At best one may get a patent for the incremental innovation.
In the absence of product patents would an innovator want to make his breakthrough public? Would there be an incentive to do research in the first place? Perhaps this is why there has been no indigenously discovered/ invented and developed
product that has made it big in the market place and why Indian scientists go abroad where they form 15% of the workforce in R & D labs of multinational companies (MNCs). With product patents being a reality in India, there is a reverse brain drain happening which should be encouraged. It will create a culture and infrastructure to attract, retain, and incentivize Indian research scientists to do cutting edge work here and hopefully leverage cost efficiencies to lower drug prices in this market. We are all aware of how the clinical trial market is booming in India for its various advantages (large pool of treatment-naïve patients, GCP trained English speaking and knowledgeable investigators, better quality of data capture, better IT infrastructure, amended regulations, increased awareness of informed consent process and ethics committee approvals, lower cost, etc). With our business process outsourcing attempting to flatten or 'Bangalore' the world, comes RPO or research process outsourcing and the birth of CRAMS (contract research and manufacturing services).
On the other side, the main worry seems to be whether product patents would lead to a rise in drug prices. It's now more than a year since promulgation of product patents in India but so far there has not been any rise in existing drug prices, which is what we have been maintaining all along. Only one product has managed to get a product patent so far. The Indian government is well aware of the availability of premium priced patent protected products in future but has already put certain checks and balances in place. Compulsory licensing, pre-grant opposition, and dithering over data exclusivity are all ways and means of catering to demands of the Indian generics manufacturer. Prices of medicines for life-threatening conditions will have to be managed through better access programmes, but the government should also do its bit to improve infrastructure; provide access to modern medicines to the 70% of its population that is not currently covered, and increase spending on healthcare of its citizens (from 0.9% to 2-3% of GDP spend on healthcare is what the government has promised). The industry is often a soft target for drug price reductions but drug cost (15%) is only a fraction of the overall cost of treating illness.
Indian generic manufacturers who have excelled in reverse engineering and working around process patents are worried since most of them have not invested in research and development and it will take a long time for them to be geared for this change. The Indian multinational is ambiguous. It appears to be a case of baking the cake, eating it, and having it too. The Indian MNC wants to be able to copy products that are the result of painstaking, costly, 'riskovery' and development research of ethical MNCs and launch them at prices at which it will still earn considerable profits, thus cutting into the market share and returns of the MNCs. A pertinent point is that the similar generic is prescribed by Indian doctors thinking bioequivalence is equal to therapeutic/clinical equivalence. Thus, clinical development of the generic is being done by Indian doctors on Indian patients at no cost to the generic manufacturer. Evidence presented by an ophthalmologist from Sankar Nethralaya, Chennai at the annual Glaucoma Society meeting this year showed that Pfizer's Xalatan (an 'original' invention) and Latoprost (the generic equivalent) are not clinically equivalent in terms of intra-ocular pressure reduction.
The Indian MNC is also doing early drug discovery work, the outcome of which is then handed over to foreign companies who have the wherewithal to take the molecule through the grueling and costly phases of drug development (70% of the Tufts estimate for the out of pocket costs for new drug discovery and development is attributed to clinical trials). And all this for a base payment and royalty which increases as the molecule crosses various clinical development hurdles. More often than not these molecules fail to clear the acid test of development (rubber meets the road), e.g., Parvosin (Ranbaxy and Schwarz Pharma), and ragaglitazaar/balaglitazone (Dr. Reddy's Laboratories). But the fallout of this failure is borne by the foreign company to whom the molecule is out-licensed. The icing on the cake is the fact that the Indian MNC also has a roaring generics export business, especially in the lucrative US (and to a lesser extent European) market. Outside of the US, India has the maximum number of US FDA approved manufacturing plants (70-75 at last count). The para IV filings are another case in point. So it's raining profits on all fronts, and little of that needs to be ploughed back into R&D. This leads one to wonder whether the products of indigenous R&D will be launched in patent protected markets abroad or whether Indian patients will get to experience the benefits of these products.
Moreover, if original drugs are not discovered, invented and developed by MNCs, would domestic companies have anything to copy? As with software or movie piracy, be original buy original. By killing the golden goose we are only pulling our own noose. Necessity is the mother of innovation. Let's innovate. Opportunity is knocking at our door and asking us are we in? Out initial response seems to be no. The winds of change are provoking us to reconsider but even so, we prefer to wait. Let it not be too late.
(The author is senior manager, Medical Affairs, Pfizer Limited)