We bring you a guest post from Mr. R.K. Trivedi, Director (Technical) of National Seed Association of India (NSAI). This post is in response to Prashant’s post on whether Monsanto’s invention can be protected as a plant variety and seek benefit-sharing from Nuziveedu, which was published on the blog last week.
As readers may be aware, Monsanto is locked in what is possibly the biggest patent/technology battle against various seed companies for some years now. The main seed companies at the forefront of this dispute include Nuziveedu, Prabhat Agri Biotech and Pravardhan Seeds etc. All of these seed companies are part of NSAI.
The disputes between Monsanto and NSAI companies also involve issues of plant variety protection, Essential Commodities act, Contract Act, Specific Relief Act, Arbitration Act etc. For our previous posts on various aspects of this controversy and litigation etc., please click here.
National Seed Association of India (NSAI) on Delhi High Court’s Judgment in the Monsanto-Nuziveedu Dispute
R.K. Trivedi
Mr. Prashant Reddy’s post does not give a correct interpretation of the Delhi High Court’s recent decision in the Monsanto-Nuziveedu dispute. If we want to correctly interpret the Delhi High Court’s decision, we have to first understand the provisions of Indian Patents Act, PPV& FR Act and TRIPS Agreement of WTO.
Indian Patents Act, Section 3(j) excludes from patentability “plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals”, in pursuance of Article 27(3)(b) of the TRIPS Agreement.
PPV&FR Act covers transgenic variety as a “new variety”, which is, therefore, eligible for registration under Section 15(1) provided it satisfies the conditions of ―novelty, distinctiveness, uniformity and stability. A breeder under Section 16(1) includes the breeder of such transgenic variety. Under Section 24, varieties, other than essentially derived varieties can be given registration. The facility of benefit sharing then is conferred upon all interested to seek the advantages, upon fee determined in this regard. What is crucial in this enactment is benefit sharing under Section 26. If someone’s variety with a unique trait (like the Bt. Trait) is used to create a new variety, benefit sharing can be claimed from the creator of the new variety under Section 26 of the PPV&FR Act read with Rules 41 to 44 of the PPV&FR Rules. The registration of a plant variety or a transgenic variety under Section 28 of the PPVFR Act confers certain exclusive rights enshrined therein on the breeder. Section 30 of the PPVFR Act provides for “Researcher’s rights” allowing use of any registered variety for developing new varieties. Under section 39, the farmers have the right to save, sow, re-sow, exchange, share and sell the farm saved seeds of any protected variety including a transgenic variety.
The Delhi High Court has critically gone through the above provisions of Indian Patents Act and PPV&FR Act and observed that India has a well-balanced legal framework that protects the rights of plant breeders, farmers and biotech companies.The Court held that Monsanto cannot have patent on transgenic seeds per se. They can have a patent on gene or gene sequences that have been synthesized in the laboratory and under Patents Act they have the right to prevent anyone else from producing such transgenic seeds in a laboratory and selling the same. However, once they sell transgenic seeds to Indian seed companies for use as initial varieties for creating new varieties, they cannot claim patent rights on subsequent seeds produced by farmers and breeders using essentially biological processes. For that, it must rely on the provisions of benefit sharing under the PPV&FR Act.
Further, I would like to correct this notion that our PVP legislation is a copy of UPOV model. The Indian PPV&FR Act is a unique enactment and is not modeled on UPOV as claimed in Mr. Prashant Reddy’s post. Indian Government categorically states to TRIPS that we shall not copy the UPOV model but will adopt a sui generis system having a separate law to fulfill our national requirement by providing farmer’s rights and rewarding farmers for their efforts to conserve crop biodiversity. Some of the differences between the UPOV Convention and the PPVFR Act are as follows-
(i) In PPV&FR Act, the definition of ‘variety’ includes transgenic variety also, whereas, ‘variety’ definition of UPOV does not cover transgenic variety.
(ii) In PPV&FR Act researcher’s right is very comprehensive whereas in UPOV, the researcher’s right is restrictive.
(iii) In PPV&FR Act, there is a provision for Farmer’s Right, Right of Communities, Benefit Sharing, Gene funds etc. However, such provisions do not exist in UPOV.
As can be seen from the above in UPOV, the transgenic plant varieties are not even covered in the definition of the variety. Similarly, the benefit sharing provision is not there in UPOV as per the requirements set out by advanced countries which may not be favorable for recognition and reward of the conservation or breeding activities carried out by the farmers or breeders of the third world. UPOV does not provide farmers’ rights and also does not provide for compensation to farmers on failure of the registered variety to give expected performance under given conditions. Therefore, the Indian PPV&FR Act is a balanced Act and a complete code, protecting the interest of all the stakeholders. One of the unique features of the PPVFR Act is that, it prevents creation of monopoly in agriculture sector. This clarifies that the Govt. of India had consciously chosen not to join UPOV and develop a sui generis legislation in the form of PPV&FR Act to suit Indian national interest.
In view of the above, it is pertinent to note that the Delhi High Court order only captures the legislative intent of the Govt. and the provisions of the Indian Law. The Indian law is balanced and provides incentives for the innovation in the form of trait development to companies like Monsanto and also encourages the breeders to incorporate the new innovations and develop new plant varieties by giving access under the researchers’ rights. The farmers are given protection to save, use all plant varieties including transgenic plant varieties.
In my opinion, Monsanto should be happy as the trait value fixation would now be carried out by a statutory body, PPV&FR Authority whose actions need to be transparent and accountable through judicial review. It is impossible to get a judicial review for actions under the Essential Commodities Act since they have a protection under the public interest.
In view of the above, I am surprised why Monsanto is not welcoming the fair decision of the Hon’ble High Court of Delhi, which will help all other biotech trait developers as well. It is heartening that the breeders of small and medium seed companies along with the breeders of public sector and large seed companies are brought on the same footing by the Court order. This will encourage not only innovation but also competition by bringing more players which will ultimately benefit the farmers. Thus, the judgment takes care of the interest of all stakeholders and thereby benefits the farmers.
Image from here
I have read the SIP articles posted on this website about the Monsanto/NSL battle, and have taken up an effort to read the patent, the Single Judge Decision that was levied in 2017, and the April 2018 Delhi High Court appeal decision (the DB decision) which was the result of both MON and NSL appealing the Single Judge decision but for very different reasoning. The Single Judge, in my opinion, nailed the decision, on all points except perhaps on the issue related to price control orders and reinstatement of the agreement between the parties. Heres where I see the issues:
First, the issue in the case has been confused by NSL arguments suggesting that the instant that a patented artificial nucleic acid sequence is inserted into the plant genome to create a transgenic plant, the transgenic plant is then not patentable, and NSL further argues that because the DNA molecule is inserted into the plant genome, it has become a “part of a plant” and thus the claim to the nucleic acid sequence in Monsanto patent is now invalid because it is a patent on the plant. Thats the most absurd reasoning I have ever encountered, and it flies in the face of what the two statutory regimes in India, the Patents Act and the PPVFRA are intended to allow “inventors” to cover. First the patent statute is to allow protection of inventions, inventions are allowed to be claimed and a patent granted on such inventions if the invention is determined by the india patent office examiner to be novel, to exhibit inventive step, and to exhibit AN industrial applicability. In this case, the examiner in India found the nucleic acid sequence claimed by Monsanto to be “inventive”, i.e., meet all of these criteria, and the patent was granted. The entirety of Monsantos patent specifies that the nucleic acid sequence is “intended for use in plants”. Thats not disallowed under the india statutes, and in this case, the nucleic acid sequence is inserted into a plant to cause the plant to exhibit resistance to insect attack, and it works, and the plants in which this works are in the cotton industry, and agricultural industry, and so this is AN industrial applicability. In fact, the various agencies of India govt have determined its useful and CRITICAL to India’s economy, i.e. GEAC/RCGM have determined its safe and effective to use in commerce; and cotton was recently added back onto the list of ESSENTIAL COMMODITIES so that the govt could prevent foreign national companies from being able to price cotton traits at fair market prices, and instead choke from the India farmers’ future, the next generation of inventions of this type. Eventually, the current insect resistant cotton will become worthless because of the pests that develop resistance to the traits, so the farmers will want that next generation of protection from the foreign nationals, and guess who is no longer even seeking to have their new traits authorized to be cultivated and sold in our country? NONE of the foreign nationals. Thank you India Govt for choking us like #DelhiChokes!!!
I digress. So, we have this invention that is patented by MON, and NSL has detested having to pay MON any money at all for the USE of the Nucleic Acid Sequence, lets call it a NUC for short. Well, NSL has successfully lobbied the various state and national India govts to choke off any income MON can make from this endeavor and appears to be winning in court too. But wait, because the NUC is patented, it then shifts to Sec 48 of the patents act to what MON is allowed to do with its invention. Sec 48 says that the owner of a patented invention can EXCLUDE any third party that does not have permission from USING the Invention. Monsanto licensed the USE of the invention to NSL, and NSL has introduced the invented NUC into its own germplasm and then propagates the germplasm and makes lots of seed containing the NUC and sells that and keeps all the money because it now doesnt have to pay MON anything if NSL’s position stands, and you better hope it doesnt. NSL has represented that a NUC, if patented, becomes unpatentable if its used in a plant or animal cell and then twists the meaning of the PPVFRA by saying that MON should register the DNA, the NUC. This is absurd!! MON cannot register the NUC or its DNA because its not a variety. The PPVFRA provides for the registration of new varieties. The subject matter claimed by MON can never rise to that occasion, its a chemical molecule, not a variety!! a variety is a plant, plant part, seed or part thereof including ….things that can be propagated or regenerated, essentially if you look at where this language came from to be in our own india PPVFRA, it came from UPOV statutes, but India legislature left out critical elements. The smallest part of a variety would be a plant cell!!! Thats what contains the DNA and the DNA cannot regenerate itself, nor be propagated unless its within the cell. What the DB failed to realize, but the Single Judge decision in fact did, is that the two statutes are intended to be co-existent. Obviously someone never heard of dominant patent rights, right? Monsanto’s patent rights to exclude use of its patented sequence extend to excluding use in someone’s variety, whether its corn, cotton, soybean, and the like. The PPVFRA is intended to allow breeders of plants that identify new varieties through their breeding efforts (like, for example, breeding a cotton plant from Andra Pradesh that grows well in sandy loamy soil with a cotton plant from Telangana that grows well in a more dense, clay laden soil, to produce a new variety that has the benefits of both), the new varieties described by the breeder are then capable of being protected by being registered under the PPVFRA, EVEN IF THE NEW VARIETY CONTAINS THE NUC!!! In that case, the new variety containing the NUC can be protected by registration under the PPVFRA, but as long as MON patent is not expired or determined to be invalid for one of the reasons for patentability (novelty, inventive step, industrial applicability), then the MON patent rights for excluding the USE of its NUC prevail over the variety registered by the breeder. in this case, the breeder needs to seek a license from MON in order to commercialize its variety containing the NUC. If the breeder would rather not license mon technology then it can simply breed the NUC out of its germplasm and sell the germplasm (still a new variety) but without the protection afforded from insect attack that is yielded by having the NUC in its genome. Very simple, the DB screwed ALL of this up, principally because NSL and its attorneys confused the entire issue relative to the exclusion of plants from being patented under the patents act exclusionary rules set forth in Section 3 of the act. If the Supremes would hurry up and get this onto their docket at the Supreme Court of India, we could hopefully get some resolution on this matter. If the Supremes allow the current DB to stand, no one will ever bring any useful patented DNA to this country again, including DNA’s useful in agriculture, horticulture, veterinary animal sciences, human health care and beyond. Its been rather comical watching all of this play out. no one seems to be able to comprehend both the science and the law on this matter. I am hopeful our Supreme Court can, certainly the Single Judge got it right, and all that is really needed is for the Supremes to simply republish the Single Judge decision, because the DB frankly didnt understand the law or the science, and thats what its going to take to get this right; or just read this post
The above comment is erroneous in understanding of the basic process of plant breeding and agribiotechnology. What NSL got from Monsanto are 50 donor seeds of a plant variety DP50B containing MON 15985 event. The MON 15985 event is protected by another patent 232681 for the detection methods. The impugned patent 214436 which is in the Apex court presently is a different patent which describes gene constructs /expression vectors which can provide enhanced expression of delta endotoxin localized to sub-cellular level (plastids). The gene constructs or Nucleic acids described in this patent can be used to generate events or transgenic plants in multiple crops and theoretically in all angiosperms or seed producing plants (Monocots and Dicots). The seeds of the selected events are used to develop transgenic plants which are further backcrossed into elite transgenic plant varieties. What NSL has done legally is it transferred the insect tolerance trait into its elite plant varieties and developed many more transgenic plant varieties as per approval of GEAC. This perfectly aligns with provisions of section 30 of PPVFR. Also Nucleic acid or a plant cell are not eligible to be classified as a definition of a plant variety, which is a mischievous and misleading argument like comparing car and carbuerettor. The paradigm is about plant varieties out of which a subset is transgenic plant varieties and the contributors of the traits (both natural and GM traits) can get a benefit share under section-26.