Monsanto ruling and Patent regime in India

Context:

• Recently, the Supreme Court set aside an order of the division bench of the Delhi High Court invalidating US-based Monsanto Technology’s patent rights over technology used in BT Cotton seeds. 
• As a result, the patent held by Monsanto over its Bollgard-II Bt cotton seed technology, a GM variant that resists the bollworm pest, will be enforceable in India for now.
• The court’s order came in a case filed in 2015 by Monsanto, through MMBL, against Nuziveedu Seeds and its subsidiaries for selling Bt cotton seeds using its patented technology despite termination of a licence agreement in November 2015.

About

Patent and Patent laws in India:

• Patent is a form of intellectual property. Patent grants exclusive legal rights to the inventors in exchange for making their invention public.
• In India, an invention pertaining to a new product/process, involving an inventive step and capable of industrial application can be patented.
• The Indian Patents and Designs Act was enacted in 1911, providing basic protection to patents.
• The Patents Act, 1970 is the legislation that till date governs patents in India. It first came into force in 1972 which is in synch with WTO’s TRIPs.
• The major amendment was done in 2005, when product patent was extended to all fields of technology like food, drugs, chemicals and microorganisms.
• TRIPS became effective on January 1, 1995 by agreement of WTO member states, who then became obligated to implement domestic laws to comply with the TRIPS minimum requirements.
• Monsanto's GM cotton seed trait, the only lab-altered crop allowed in India in 2003.

• As more than 50% of Indian population are engaged in agricultural activities, genetically modified crops have significant impact on the Indian farmers.
• Monsanto's GM cotton seed technology dominates 90 percent of India's cotton acreage.
• Monsanto is a global provider of agricultural products for farmers, viz. seeds, biotechnology traits and herbicides.
• Genetic engineering has not been able to deliver on its promises – it is just a tool of ownership. Bt Cotton is not resistant to Bollworm; Roundup Resistant varieties have only given rise to super weeds.
• Monsanto, on its own website, admits that pink bollworm is resistant to Bt. the resistance to Bt poses a significant threat to the nearly 5 million farmers who are planting the product in India.
• Monsanto undemocratically imposed the false idea of “manufacturing” and “inventing” a seed, undermining robust Indian laws—that do not allow patents on life—and by taking patents on life through international trade law.
• Since 1999, Monsanto has had the US government do its dirty work, blocking the mandatory review of the Monsanto Law in TRIPS (the Trade Related Intellectual Property Rights Agreement implemented through the WTO).
• Monsanto’s collection of royalties as “trait value” or as a “fee for technology traits” is illegal. These illegal royalty collections have been collected from the most marginal farmers, pushing them to take their own lives.
• The smuggling of a controlled substance without approvals is a violation and subversion of India’s Biosafety Regulations. Illegal introduction of GMOs into the food system in India poses grave risks to the health of ordinary Indian citizens.

Facts related to Environment Protection Act, Monsanto, and GEAC

• India’s biosafety framework is one of the strongest in the world. It is governed by The Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro Organisms, Genetically Engineered Organisms or Cells (notified under the Environment Protection Act, 1986).
• Article (7) of The Rules stipulates: Approval and Prohibitions etc.
• No person shall import, export, transport, manufacture, process, use or sell any hazardous microorganisms of genetically engineered organisms/substances or cells except with the approval of the Genetic Engineering Approval Committee.
• Article (4) of The Rules stipulates: Genetic Engineering Approval Committee (GEAC)
• This committee shall function as a body under the Department of Environment Forests and Wildlife for approval of activities involving large scale use of hazardous microorganisms and recombinants in research and industrial production from the environmental angle. The Committee shall also be responsible for approval of proposals relating to release of genetically engineered organisms and products into the environment.
  
  

  Technical and legal aspects of the Judgement While looking at Monsanto’s claim that its Patent is essentially about a “nucleic acid sequence” which is a chemical created in a laboratory, the Court has to remember that if that is the case, this chemical compound would be regulated within the pesticides regulatory regime in India, not the GMOs regime. It is after all this genetic sequence which makes ordinary cotton varieties into Bt cotton, which consequently get regulated as living organisms, under the EPA 1986 and not as a pesticide. The nucleic acid sequence is heritable when embedded into a plant cell. And heritability is a trait connected with a living organism. However, it is not capable of reproducing itself and therefore, is not a micro-organism which is specified as a patentable matter in the Indian law. But for any invention to be patented, an essential criterion to be fulfilled is that of industrial application. Monsanto’s nucleic acid sequence described by it as a chemical product is not capable of industrial application until it is first integrated into a plant cell. Stabilization into the plant requires repeated back-crossing processes which happen through essentially biological processes. This “essentially biological processes” makes nucleic acid sequence un-patentable under Indian law.

Do the farmers not have the right to save the seeds from their own crops? They do have this right but in traditional and conventional context. The Supreme Court has decided to send back the matter to the High Court for a fair hearing, because the case regarding patent infringement, patentability, seed patents, etc. are complex and cannot be decided in summary proceedings.

Practice Question:

It is a universal fact that life cannot be patented. Given the recent ruling on Monsanto and the objections that it raised, critically evaluate the effectiveness of Patent law in India and how far this ruling will impact Indian cotton farmers?