The recent US Supreme Court ruling over patent protection should spark a fresh debate on granting patents to pharmaceutical products in India. Overturning a decision of Appeals Court for the Federal Circuit in a patent dispute case involving Teleflex and KSR International, the Supreme Court of the US ruled that granting patent protection to advances that would occur in the ordinary course without real innovation retards progress and may deprive prior inventions of their value. The US apex court further said that if the courts and the patent office start actually looking at obviousness of patents, the country could get rid of plenty of bad patents. The US verdict is of immense value for India which is flooded with hundreds of frivolous patent applications for various pharmaceutical products and is also struggling to arrive at an appropriate patentability criteria after the notification of the new patent law in 2005. In the absence of a right patentability guideline, industry is challenging the patent controller's decision in courts seeking patents for products with virtually no innovation. The classic case is that of Glivec of Novartis. It is important to note, in this context, that any laxity in framing the guidelines or rules on patentability can only help to enrich the undeserving. There is a strong MNC lobby trying hard to manipulate the Indian government into believing that any modification to the existing molecule is an innovation.
Global pharmaceutical industry is in the midst of a serious crisis with very few new molecules coming out of their laboratories. This unprecedented dilemma is forcing many of them to work on the known molecules just to get patent rights and monopoly pricing. It is interesting to note in this context that only a small fraction of drugs coming to market are innovative. Between 1998 and 2003, the US FDA classified 78 per cent of the 487 drugs that entered the market as likely to be no better than existing drugs. And 68 per cent of these drugs were not new at all but old drugs in new forms or combinations. In other words, the major output of the pharmaceutical industry is not new drugs, but minor variations of drugs already in the market. Take for instance, world's top-selling drug, Pfizer's Lipitor. It is one of the six cholesterol-lowering drugs in the market. There are whole families of me-too drugs in the pharmaceutical market and there is little reason to think that one is better than the other at comparable doses. The few innovative drugs that emerge usually stem from publicly funded research done at government institutions or university labs. Even in me-too drug families, the original is usually based on government sponsored work. The first of the Lipitor-type drugs, Mevacor, came to the market in 1987 and was based largely on university research. The truth is that despite their tall claims, the drug companies are growing less and less innovative. They re-jigger the same old drugs just enough to get new patents and rely on marketing strategies to convince doctors that they are producing medical miracles.