It is one of the great ironies of this country that regulations put together after careful thought and debate to prevent their misuse by smart companies (and individuals) are carelessly flouted by the implementing agency. So what the lawmakers feared and hoped to primp comes to pass because either the regulators or the executing agency do not have the skill, interest or wherewithal to ensure that the law is implemented in spirit and letter.
Nothing reveals this more than the functioning of the Controller General of Patents. Its examiners have been merrily granting patents to drugs that were patented globally some 40-50 years ago. In other words, India’s patent office, which began to hand out product patents to pharmaceuticals, food and chemicals from January 1, 2005, under an amended law, is extending the patent protection for some pharmaceuticals way, way beyond their normal 20-year span. In one case, a drug that was patented in 1952 was granted to a Dutch company last year, while several others that were first patented in the 1970s, 1980s and 1990s, have been given patented here. Worse, many of these drugs were commercialised in India long before the country introduced product patents. So, it’s not as if the examiners were caught unawares in these in stances.
How do drug companies go about getting new patents for ancient drugs? They do this by tweaking the product a little, by deriving salts, esters, ethers and so on, from the original molecule or by combining two or more drugs. Evergreening, as the practice is called, is a more sophisticated and complex version of what a toothpaste manufacturer does. He adds a whitener or a new flavouring agent to the old formula and calls it as the new, improved product. The key difference in pharma is that companies call the improved version a new drug and seek a fresh lease of patent protection. It was to prevent evergreening and to ensure access to affordable medicines (through inexpensive generic versions of off-patent medicines) that India inserted Section 3(d) and 3(e) in its Patent Act amendment of 2005.
Section 3(d) says patents cannot be granted for the mere discovery of a new form of a substance which does not result in improved efficacy or for the mere discovery of a new property or new use of a known process unless the process results in a new product or employs at least one new reactant.
Yet, in an appalling number of cases, patents have been granted on new formulations of old molecules. This has come to light in a detailed analysis by the Indian Pharmaceutical Alliance (IPA) of some of the 2,339 pharma patents granted in India since 2005. It shows that 67 of the 86 patents that were granted in the past four years were in violation of Section 3(d) and another 19 of Section 3(e).
The shocker of a report on the deplorable state of India’s patent regime has been presented to the ministry of commerce and industry which oversees the patent office.
IPA secretary general D G Shah, who was the moving force behind the study, has asked the government to tighten the rules and guidelines for the patent office so that patent examiners adhere strictly to the provisions against evergreening. While multinational companies are the main beneficiaries of the lax ways of the patent office, Shah readily concedes that domestic companies, too, have benefitted. Five of the 86 patents analysed so far have gone to Indian firms.
Shah is an old warhorse in the campaign against unfair global trade practices that hurt developing countries but he says that is no reason why Indian companies should get any undue advantage. Section 3, he says, should be applied uniformly and to ensure that it is implemented properly; he has suggested some changes in the rules and guidelines for the patent office. All applications must mention the INN (the generic or non-proprietary name) of the drug and also provide adequate information on all the claims made by the applicant. The incomplete disclosures by applications are not just anti-competitive but go against the very spirit of patenting and this something India needs to pay attention to.
His best suggestion, to my mind, is the one calling for all examiners to record the application of Section 3 on all applications to get this vetted by the patent controllers. No sensible government will reject such proposals which can only make for greater transparency in the process of granting patents. But will it order a re-examination of all the patents listed in the IPA study and revoke those that do not meet the required standards of patenting as Shah has demanded? If the ministry does agree, it will show that the government is made of sterner stuff than we thought. Hopefully, it will surprise us yet.
