While Monsanto and Indian seed companies spar, more worrying is the confused lawmaking underpinning regulation of patents
Genetically Modified Organisms (GMOs) breed controversy like no other. Little wonder then that Monsanto’s much-maligned Bt cotton has spawned the mother of all intellectual property (IP) disputes in India, involving at least 15 different proceedings in various courts, government agencies and tribunals at last count.
Most proceedings appear to have come at the behest of certain seed companies led by Nuziveedu. Its founder, Prabhakar Rao, is leaving no stone unturned to ensure that these seed majors beget a better deal than what they bargained for when they first contracted with Monsanto to licence its proprietary GM technology.
A recent controversy centres around which of the two IP regimes governs the dispute: the Patents Act or the Protection of Plant Varieties and Farmers’ Rights Act (PPVFRA). To me, this appears to be a false dichotomy and a red herring of sorts. Both these legislations apply and one does not necessarily trump the other. But first a word about the technological underpinnings of this dispute, so this point about co-existence can be appreciated better.
Monsanto and patent protection
Monsanto patented a number of components related to Bt cotton, a biotech invention involving the infusion of the Bt gene into the cotton genome. Bt stands for Bacillus thuringiensis, a bacteria whose genome codes for a protein that kills the bollworm, a pest that has perennially plagued the cotton plant. The patent does not cover the plant itself, as plants and animals are ineligible for patent protection in India, as are ordinary biological processes for creating them. However, microbiological processes (such as methods of creating transgenic varieties) and microorganisms (such as new and inventive transgenes and their constructs) are patentable under the terms of the Indian Patents Act, and Monsanto’s patents cover most of these components. It bears noting in this regard that Bt cotton technology was never static, but evolved over time to cater to the pest resistance that soon developed. While the technology pertaining to Bollgard-I was never patented in India (since this technology was discovered prior to India’s undertaking of Trade-Related Aspects of Intellectual Property Rights or TRIPS commitments), Bollgard-II was, and it is this technology that is in dispute.
Using the patented technology, Monsanto created a host of donor Bt cotton seeds and distributed them to seed companies under specific agreements mandating the payment of royalties (trait fees), etc. Seed companies in turn used these donor seeds to introgress the desirable genetic trait (bollworm resistance) into their own specific hybrid varieties by backcrossing.
Monsanto’s patents cover various components of the technology embedded in the donor seeds handed out to seed companies (the new man-made transgene, the DNA construct and the method of creating the new cotton genome). Any seed company that uses this donor seed and creates a new plant variety is entitled to register such variety under the PPVFRA.
This new plant variety registration, however, does not extinguish Monsanto’s upsteam patent rights. Neither does the patent right override the plant variety protection. They co-exist. As such, seed companies cannot commercialise their hybrids without a patent licence from Monsanto, in much the same way that Monsanto cannot sell or distribute these hybrids without permission from the seed company. If Monsanto refuses to licence the seed companies, they can move for a compulsory licence (CL) under the Patents Act, provided they satisfy the terms of Section 84, which states that a CL could be granted if the patented invention is exorbitantly priced or not available in reasonable quantities to the public or is not being worked in the territory in India.
But this licence application has to be under the terms of the Patents Act, and not the PPVFRA. Given this clear-cut demarcation, one wonders what the legal fracas is all about!
Unless of course one were to invalidate Monsanto’s patent. If news reports are to be believed, there are pending invalidity proceedings before both the IPAB (Intellectual Property Appellate Board) as also the DIPP (Department of Industrial Policy and Promotion).
At cross-purposes
The DIPP proceeding is a particularly interesting one, given that Section 66 of the Patents Act has been invoked, an exceptional provision that provides for revocation on grounds that the patent is “mischievous to the state or generally prejudicial to the public”. The key contention appears to be that the patent is no longer effective, given the pest resistance that developed over time. A ground not likely to pass muster with a court of law, given the rather high bar for invoking Section 66. Quite apart from the fact that it appears a tad bit paradoxical that while one wing of the government (the Ministry of Agriculture) has recently issued a draft notification qualifying GM technology as an industry “standard” that must mandatorily be licensed on FRAND (Fair, Reasonable and Non-Discriminatory) terms to as many seed companies as possible, another one (DIPP) insists that the technology is useless!
More surprising is the fact that the Ministry of Agriculture, with no proven expertise or jurisdictional competence over patent issues, would go out on a limb and suggest (in an official draft notification no less) that Monsanto’s patents over upstream GM technology must necessarily yield to downstream plant variety rights.
Whatever be our personal predilections against GMOs, it is a matter of deep concern that government agencies appear to be flouting the rule of law with impunity. While there may be merit in regulating GMO patents, this must be done after following due processes under the law, through the relevant competent authority (such as the Patent Office), and not through abusive lawmaking designed to seemingly favour one set of stakeholders who are essentially engaged in a private commercial dispute.
More importantly, one wonders why the government chooses to concentrate all of its eggs in the Bt cotton basket. Particularly so when its own institutes contend that even Bollgard-II technology is soon succumbing to progressive pest resistance.
Shouldn’t our government be encouraging a diversity of approaches in Indian agriculture, entailing both GM technology and the more traditional processes that have stood the test of time? More so, when nature has taught us time and again that the best of technologies can never really match up to the wisdom of an innate evolutionary process.
In fact, if it wishes to be a bit radical, the government could even encourage what maverick scientists did in Assam recently, when they encouraged farmers to reimagine beetles (that destroyed crops) as protein-laden delicacies to be consumed with relish. And this leaves us with just one real question in the end: can the bollworm be barbecued?
Shamnad Basheer is Honorary Research Chair Professor of IP Law at Nirma University and founder of SpicyIP.
source: The Hindu, 5-10-2016