Monday, November 24, 2008
Many of India’s pharma companies, including even the big and transnational ones who themselves have some stake in innovation and R&D, are alleging that patent authorities in India have become very liberal when it comes to grant of patents. Many frivolous patents have been granted and even bogus applications are being entertained, they say. The Indian Pharmaceutical Alliance, a group of big India-born drug companies, is mulling a thorough study of the patents granted since 2005 to find out how many of these are in fact ‘bad patents.’ At the other end of the scale, the foreign pharma companies not only brush aside the allegation of granting patents for ‘trivial inventions’ but also aver that “a lot of important applications” have in fact been turned down by India’s patent authorities. The question that underlies this row is what’s a ‘patentable invention’. At a very general and non-codified level, the newness or rather the surprise element of an invention should be the deciding factor.
The World Trade Organisation’s Trade-Related Intellectual Property Rights (TRIPS) agreement defines the term ‘patentable subject matter’ with due considerations to present-day commercial realities—it says an invention should be “new, involve an inventive step and capable of industrial application” to be deserving of a patent. National governments have drawn a lot of freedom from the TRIPS agreement itself and even autonomously to elaborate on the TRIPS definition. However, national laws of many countries, including the US, are framed in such a way that even “incremental, adaptive or cumulative” inventions could qualify for patents if such invention has a definitive industrial use and thereby considerable commercial value. Indian government has been chary about unfair patenting—thanks to lobbying by domestic industry and the unrelenting stand of leftist outfits. It introduced an additional provision—Section 3(d)—in Patents Act to make patenting criteria more stringent in the pharmaceutical space. This provision was introduced through the third amendment to the Act, which also introduced product patenting for pharma and agrochem inventions.
While the Big Pharma—the large pharmaceutical companies based in the US and EU who hold most of the patents—have been a strident critic of Section 3(d), international organisations like the World Intellectual Property Organisation endorsed it and termed it TRIPS-compliant. According to this provision, incremental inventions (like salts, isomers etc of known molecules) can be patented only if they have contributed to improve the efficacy of the (known) substance. And the patent authorities—read the examiners—would decide if efficacy has really been improved. The current strife over the allegation of the patent authorities practically becoming very liberal in grant of patents would need to be viewed in this context. The fact is India’s Patent Act, even with the fairly elaborate rules notified under it including those to support the Section 3(d), bestows substantial discretionary authority with the patent authorities. Patent examiners in India are still grappling with the complexity of the world of pharmaceutical inventions—the area is abstruse and dynamic enough to baffle even the seasoned examiners. Leaving a lot of things to the discretion of a group of patent examiners is therefore bound to generate conflicts. Here, what the government can do is to create many layers of examiners so that the probability of genuine error can be minimised. But the patent examination, search and grant system in India is currently highly unorganised. The four patent offices—Delhi, Mumbai, Kolkata and Chennai—are yet to achieve a fair degree of cohesiveness among them. These offices, manned by patent controllers and scores of patent examiners who assist them, are allegedly employing separate yardsticks and this is what caused the current allegations and counter-allegations. Clearly, there is a case for a very high degree of coordination between the four patent offices. Patents are anyway prone to contestation. Some disputes would inevitably reach the courts. Such disputes can however be minimised by bringing as much uniformity as possible in standards of patent grant. The Patent Act already provides for pre and post grant opposition and making a review plea before the controller who granted/denied the patent. And there’s the intellectual property appellate board, which is the body for the aggrieved to appeal to. What is lacking is proper coordination among the patent controllers and examiners. The government would do well to address the issue immediately.