Genetic Modification Technology Deployment...Genetic Modification Technology Deployment: Lessons...

Genetic Modification

Technology Deployment:

Lessons from India

Sachin Sathyarajan

Balakrishna Pisupati

FORUM FOR LAW, ENVIRONMENT, DEVELOPMENT AND GOVERNANCE

Genetic Modification Technology Deployment: Lessons from India

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Citation: Sachin Sathyarajan and Balakrishna Pisupati 2017 Genetic Modification

Technology Deployment: Lessons from India. FLEDGE, India.

© FLEDGE, 2017

Disclaimer: Views and opinions expressed in this publication are those of the

authors and not necessarily that of FLEDGE.

Acknowledgements: Thanks are due to two anonymous reviewers, Dr. Seetharama

Annadana of Syngenta India for their comments on the paper.

Published by;

Forum for Law, Environment, Development and Governance (FLEDGE) Chennai, India


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Table of Contents

1. Introduction ..................................................................................................................................... 4

2. What is Bt technology? ............................................................................................................... 4

3. Evolution of the conflict ............................................................................................................. 5

4. Developments until 2016 .......................................................................................................... 6

4.1 Essential Commodities Act .............................................................................................. 6

4.2 Competition Law .................................................................................................................. 7

4.3 Patent law - Compulsory Licensing and Revocation ........................................... 8

4.4 Trait value as an Intellectual Property Right .......................................................... 9

5. Regulation of MSP and Trait value by Central Government .................................. 10

5.1 Order of Ministry of Agriculture, Government of India .................................. 10

5.2 Ministry of Agriculture Guidelines 2016 ............................................................... 11

5.3 FRAND terms of licensing ............................................................................................. 11

5.4 Issues of Patentability of the Monsanto gene ...................................................... 12

5.5 National Intellectual Property Rights policy........................................................ 14

5.6 Trade Related Intellectual Property Rights (TRIPS) ........................................ 14

6. Provisions from the Protection of Plant Varieties and Farmers Rights (PPVFR) Act, India .............................................................................................................................. 15

6.1 Compulsory licensing and compensation ............................................................. 15

6.2 Regulatory control – No Objection Certificate (NOC) & Benefit Sharing 16

7. Judicial decision - The Delhi High Court order 2017 ................................................ 17

8. Impacts of the decisions and rulings ................................................................................ 18

8.1 Technology transfer and investment ...................................................................... 18

8.2 Intellectual Property strategy ..................................................................................... 19

9. Conclusions ................................................................................................................................... 20

10. Endnotes and References ....................................................................................................... 21


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1. Introduction

India approved the genetically modified Bt Cotton technology for commercial

cultivation in 20021. The selling point of the technology was its resistance to the

bollworm complex that significantly reduced the use of pesticides and increased the

yield per square meter significantly. The technology helped India become the world’s

largest producer and exporter from a net importer of cotton2. India recently replaced

China as the World’s largest cotton producer and in 2016 accounted for more than a

quarter of global output, with a value of over $8.5 billion3. Cotton production shot up

from 14 million bales in 2000-01 to 39 million bales in 2014-15, a 178 per cent

increase according to the Cotton Advisory Board estimates4. Cotton yields rose by 84

per cent, from 278 kg/hectare to 511 kg/hectare during the same period5. Ashok

Gulati, the eminent agricultural economist estimates that the introduction of Bt

cotton has so far helped India to the tune of about 55 billion USD6.

The Bt technology was introduced in India by Mahyco Monsanto Biotechnology

(MMB). MMB is a 50:50 venture between the Maharashtra Hybrid Seed Company

(Mahyco) and Monsanto Holdings Private Limited, where Monsanto Holdings

Private Limited is a wholly owned subsidiary of Monsanto Company. Monsanto is an

American multinational agrochemical and agro-biotechnology corporation.

Monsanto has been swamped in controversy across the world on issues like

misappropriation of genetic resources (also termed ‘biopiracy’ by some jurisdictions),

seed rights, pollution and others. This has often resulted in Monsanto being at the

receiving end of contentious litigations in India7, the US8, Canada9, Brazil and

Argentina10. This article attempts to shed light over the issues engulfing Monsanto

within India related to use of their licensed technology of GM Cotton, the IP

protection thereof, public policy and impacts on technology transfer and cooperation.

2. What is Bt technology?

Monsanto’s Bt gene technology, which is at the heart of this dispute, is basically a

gene modification technology. It ensures the resistance of the cotton seeds against the

bollworm complex, three different pests that has often been noxious to the cotton

crop globally. “Bt” stands for Bacillus thuringiensis, a bacterium commonly found in

the soil, which is responsible for producing the crystalline insecticidal endotoxin.

When the relevant genes of this bacteria, are “introgressed” into a species like cotton,

the resultant crop develops immunity to certain kinds of pests. “Introgression” refers

to the movement of a gene from one species to another. In the Indian scenario, the

relevant Bt gene is inserted into the different hybrids of cottonseed bred by domestic

seed companies.

Monsanto creates the Bt cottonseeds and distribute them to seed companies under

specific agreements mandating the payment of royalties (trait fees). Seed companies

in turn used these donor seeds to introgress the desirable genetic trait (bollworm

resistance) into their own specific hybrid by repeated 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)11. However, any seed company that


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uses this donor seed and creates a new plant variety is entitled to register such variety

for plant variety protection in India.

The seed that finally reaches the farmer will therefore consist of Intellectual Property

(IP) belonging to both Monsanto and the Indian seed company. In India, Monsanto

Mahyco Biotech India Ltd (MMBL), a joint venture of Mahyco Seeds Ltd and

Monsanto, licenses its patented Bollgard II cottonseed technology to 49 seed

companies. These 49 seed companies licensing Monsanto’s technology cumulatively

have introduced several different varieties of cottonseeds in the Indian soil

incorporating this Bt technology 12 . As of today, there is no patent on the first

generation of Bt technology, called Bollgard, developed by Monsanto. However, since

the pests have reportedly developed resistance to this technology, Monsanto released

a second generation Bollgard and Bollgard II technology, which is protected under an

Indian patent13.

However, in recent years, resistance of Bollgard II technology to pest attacks

(especially the pink boll worm) has diminished and the technology is in the threshold

of a revamp. A research by the Central Institute of Cotton Research (CICR), indicates

that the pink bollworm has developed resistance to Bollgard II Bt cotton in all major

cotton-growing states in India14. Monsanto’s interest to commercial introduction of

Bollgard III is imminent15. Bollgard-III is claimed to have resistance to the bollworm,

army worm and pink bollworm in addition to herbicide tolerance16. It is widely

speculated that the technology will not be released in India considering the uncertain

legal and regulatory terrain. The impact of this is yet to be fully understood.

3. Evolution of the conflict

Why does Monsanto find the Indian legal and regulatory framework uncertain to

release its new BG III technology?

For several years now, Monsanto and the Indian seed companies who licenses

technology from Monsanto have had to wrestle price control legislations from both

the Central Government and the State Governments. In 2015 with the State

Governments attempting to regulate IP licensing fees, the Indian seed companies

have refused to pay royalties as per the existing royalty agreements with Monsanto on

the grounds that the further lowering of prices have squeezed their profits. In their

attack on Monsanto, the domestic seed companies have been pressing for compulsory

licensing provisions, while the State Governments continue to push for price control.

The events were further escalated by the Central Government order passed in 2016

and later the Ministry of Agriculture Guidelines 2016, both attempting to regulate

trait fees and licensing. These legislative and executive developments are intertwined

with several litigations across various jurisdictions in India, opening a floodgate of

claims and counterclaims. The showdown in the Indian landscape is going to have a

tremendous impact on other jurisdictions especially agriculture intensive developing

economies who are heavily dependent on technology transfer like Mexico, Brazil, Sri

Lanka, Uzbekistan, Pakistan and others.


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Various legislations have been employed to counter Monsanto’s Bt cotton dominance

such as the Essential Commodities Act, Competition Act, Patents Act, Protection of

Plant Varieties and Farmers Rights (PPVFR) Act and the Seed Act.

This paper provides the background, chronology of events that led to the conflict and

key lessons to be learnt from the conflict.

Section 4 of this article discusses the developments prior to the Central government

orders in 2016.

Sub-section 4.1 discusses the Essential Commodities Act invoked by State

Governments to regulate the maximum selling price (MSP) of the cottonseeds.

Sub-section 4.2 examines the intervention of the Competition Commission in the

dispute.

Sub-sections 4.3 and 4.4 look at the Patent Act specifically from the angle of

compulsory licensing, revocation for public interest and fixing of trait value.

Section 5 of the article examines the Central Government orders and guidelines

(Ministry of Agriculture - MoA) passed in 2016

Sub-sections 5.1 and 5.2 discusses the specific provisions of the MoA order and

the Guidelines passed which regulates trait fess in addition to the MSP

Sub-sections 5.3 and 5.4 examines the implications of the FRAND licensing and

patentability as discussed in the order and guidelines

Sub-sections 5.5 and 5.6 tests the MoA measures against the National IPR policy

2015 and the TRIPS provisions

Section 6 of the article discusses the provisions of the Protection of Plant Varieties

and Farmers Rights (PPVFR) Act applicable to the Bt cotton issue

Sub-section 6.1 concerns primarily with the compulsory licensing provisions,

research exemption and the benefit-sharing element.

Sub-section 6.2 looks at the regulatory control provisions within the Act

specifically looking at the No objection certificate and benefit sharing aspects

Section 7 scrutinizes the Delhi high court order of 2017 to ascertain the judicial

standpoint over the issue.

Section 8 is a study of the impact of the decisions and rulings on the domestic

technology transfer and investment scenario (sub-section 8.1) and the Intellectual

property strategy (subsection 8.2)

Section 9 concludes the paper summarizing the lessons learnt and looking at the

future of biotechnology.

4. Developments until 2016

4.1 Essential Commodities Act

Since the price of cottonseeds has a direct impact on farmers, the issue of pricing has

attracted immense political clout for more than a decade. In the wake of farmer

suicides in the 2011-12 period, an internal advisory document from the Ministry of

Agriculture17 had linked the crisis to Bt cotton. With the rising cost of Bt cotton seeds

for farmers, the main cotton growing states like Gujarat, Maharashtra and Andhra

Pradesh have enacted state-wise legislations to regulate prices.


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Typically, State Governments have controlled prices of essential commodities under

the powers delegated to them by the Central Government under the Essential

Commodities Act, 1955. These legislations gave the power to the State Governments

to regulate the Maximum Selling Price (MSP) of Bt cottonseeds sold by domestic seed

companies. The National Seed Association of India (NSAI) which primarily

represents Indian seed companies, had challenged these state legislations in all three

states. In 2011, the Gujarat High Court struck down the state legislation on the

grounds of repugnancy since it conflicts with the Central legislation18. The Bombay

High Court however upheld a similar state legislation enacted in Maharashtra.

Appeals against both orders are pending before the Supreme Court. The seed

industry has also challenged the act passed by the Andhra Pradesh government,

which regulates Bt seed prices, and the case is pending in the High Court. Before the

price regulations by the Andhra state government, the official price of Bt cotton seed

in India was Rupees 1,600/packet of 450 grams, which was reduced to Rupees

750/packet by the Andhra Pradesh government19.

Essential Commodities Act gives wide powers to the State Government. It is an “Act

to provide, in the interest of the general public, for the control of the production,

supply and distribution of, and trade and commerce, in certain commodities.”

Further, the Act gives powers to regulate or prohibit “any class of commercial or

financial transactions relating to foodstuffs or cotton textiles which, in the opinion

of the authority making the order, are, or, if unregulated, are likely to be,

detrimental to the public interest20”.

The Patents Act, 1970 does not eclipse the provisions of Essential Commodities Act,

1955 in relation to patented products. Both enactments should be read together

unless there is an express provision to the contrary. The enabling provisions of

Essential Commodities Act, 1955 can be made use by the State Governments if there

is evidence that higher license fees are contributing directly to higher seed prices.

Since patent law doesn’t function in silos, a holistic judicial approach is warranted for

appreciating the relationship between the Patents Act, 1970 and the Essential

Commodities Act 1955.

4.2 Competition Law

The Indian seed companies (NSAI) consulted Retired Justice Srikrishna for expert

judicial opinion on the matter and the recommendations were submitted to the

Ministry of Agriculture for further action 21 . The recommendation by Justice

Srikrishna was to have the matter referred to the Competition Commission for

“suitable corrective action”. The CCI got involved in the issue for taking suitable

corrective action given the (a) dominant share enjoyed by Monsanto, (b) lack of

competitors and (c) existence of high entry barriers. The CCI’s order dated February

10, 2016 cited prima facie violation of Sections 3(4) and 4 of the Competition Act,

calling it “a fit case for investigation by the director general22”. Section 3 of the Act

refers to anti-competitive agreements and Section 4 deals with abuse of dominant

position. The various allegations made by the seed companies against Monsanto and

MMBL includes:

a) Unfairness of Clause 3.1(a) which requires the sub licensees to pay one-time non-

refundable technology fee of INR 50 lakh


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b) adopting differential discounting/ pricing policy to its affiliates in downstream

market (MMBL)

c) requirement that the advertisement and selling expenses have to be borne by the

d) seed manufacturers/sub-licensees

e) restriction on the sub-licensees to use the donor seeds, such as modification of

the genes therein or backcrossing with public germplasm

f) entering into different sub-license agreement with its affiliates in the downstream

market where the onerous requirements as imposed on the Informants were

absent.

g) influencing Genetic Engineering Appraisal Committee (GEAC) to insist on no-

objection-certificate from Monsanto, for approving any hybrid based on single

gene technology, even though Monsanto did not possess any patent over

Bollgard–I in India23.

Similar cases of the abuse of dominant position have been investigated by the CCI

including the Ericsson case involving Standard Essential Patents (SEP) on mobile

technologies. In this case, the downstream users of the Intellectual Property (mobile

phone manufacturers) had little choice in terms of alternative technology. Domestic

mobile phone manufacturers like Micromax and Gionee are dependent on Ericsson

because these patents govern the essential standards followed by manufacturers

worldwide. The pertinent question is whether the Monsanto’s dominant position in

the market has been the result of a throttlehold over pest resistant technology and

that it is impossible for any competitors to enter the market to compete with it. While

there is no denying that MMBL has virtually 99% of the market share, the issue of

dominance should be judged by the ability of MMBL to operate independently of

competitive forces prevailing in the market. Prima facie it is possible for other GM

and non-GM cottonseeds to be invented and commercialized in India. The major

deterrent in respect of GM technology is the high regulatory risks and the huge

investments in Research and Development (R&D) associated.

It has been argued by the seed companies that the Indian society must obtain a net

advantage by awarding the monopoly to Monsanto. If that is not possible, the very

essence of the patent rights is lost. India cannot go back to traditional varieties of rice

and wheat in the pre-Green Revolution era since a new ‘standard’ has been set by the

High Yielding Varieties (HYVs). Similarly, Monsanto has set a new standard in the

market which has changed the way the cottonseed industry functions and it is

impossible to go back to pesticide intensive cultivation. In the nascent stage of

Competition law jurisprudence in India, the Bt Cotton issue has immense significance

in the realm of technology licensing.

4.3 Patent law - Compulsory Licensing and Revocation

Justice Srikrishna in his judicial opinion had further recommended that the

government could issue compulsory license in circumstances like national emergency

when it finds that the patentee was “abusing its patent rights” and was “unreasonably

restraining trade24”. While section 87 of the Patents Act does allow the Central

Government to issue compulsory licenses in the case of a national emergency, it is

unlikely that the profits of the domestic seed companies are likely to qualify as a

national emergency. It requires an understanding of the actual impact on the cotton

farmers whether there is any national emergency in terms of the price of the


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cottonseeds. Even in previous cases where such issues had cropped up, Department

of Industrial Property and Promotion (DIPP) under the Ministry of Commerce and

Industry had taken the view against it. Earlier in 2012 and 2013, a campaign for

affordable “trastuzumab” by an association for patients and NGOs had urged the

Ministry of Health to take appropriate measures to ensure affordability of the cancer

drug 25 . Subsequently, the DIPP categorically rejected the recommendation for

compulsory licensing forwarded by the Central Ministry of Health. There has been

increased international pressure pertaining to the invoking of S 87 previously for

pharmaceutical patents and the Indian Government is already facing condemnation

for allegedly nonchalant patent laws.

Another aspect of the Justice Srikrishna recommendation was with respect to the

application for revocation of the patent altogether. Under the section 66 of the Indian

Patents Act, it is possible to revoke the patent in public interest:

“Revocation of patent in public interest: Where the Central Government is of

opinion that a patent or the mode in which it is exercised is mischievous to the State

or generally prejudicial to the public, it may, after giving the patentee an

opportunity to be heard, make a declaration to that effect in the Official Gazette and

thereupon the patent shall be deemed to be revoked”

Drawing on a similar example, history of Section 66 shows that it has been invoked a

few times to revoke patents. The first instance was when a process patent was granted

to Agracetus, a U.S. company, for genetically engineered cotton cell lines. Around the

year 1997, this patent was revoked in public interest because it was viewed as being

prejudicial to farmers’ rights26. The Indian Council of Agricultural Research (ICAR)

claimed the Agracetus patent could have restricted India's access to a crop line

produced by this method for research purposes and would have harmed the interests

of India's cotton economy 27. Interestingly, the Government had held the standpoint

that cotton is an important crop essential to the national economy and should not be

the subject matter of patents alone28.

4.4 Trait value as an Intellectual Property Right

The “trait value” paid by seed companies, is basically the licensing fees paid by seed

companies to Monsanto for using its patented BG-II technology along with the

associated ‘know-how’ and ‘trade secrets29’. Justice Srikrishna recommendation has

suggested that the government can fix the trait value payable to Monsanto. “Citing

the provisions of the Patents Act 1970 pertaining to price fixation methods, he said

the government was entitled to “fix trait value that may be payable to MMBL while

fixing the prices of cotton seeds30”. There is Section 84 which deals with fixation of

royalty rates in case of compulsory licensing but to trigger Section 84 it is first

necessary for the domestic seed companies to file a compulsory licensing application

and establish that the reasonable requirements of the public are not being satisfied or

that the price of the patented article is too high. Given Monsanto’s business model of

being a technology provider and not directly selling seeds and the fact that they are

licensing its Bt technology to approximately 49 different companies, it is difficult to

establish that the reasonable requirements of the public are not being satisfied.

In May 2015, the newly formed State of Telangana issued an order, for the first time

attempting to regulate the “trait value” paid by seed companies to Monsanto for the


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Bt technology31. This is perhaps the first time that a state government endeavored to

regulate prices of a commodity that involved a patent. This move by Telangana

obviously triggered litigation, with Monsanto challenging the move to fix trait value

and was subsequently stayed by the Court32. Monsanto India's joint venture MBBL

has filed an arbitration petition against 8 domestic seed companies33 which account

for 65 per cent of cotton seed produced in India, for the alleged breach of contracts

resulting in around Rupees 400 crore (roughly 60 million USD) payment dues. In

response, the seed companies have filed a counter affidavit, arguing among other

things, that they have paid more than Rupees 1,300 crore (roughly 200 million USD)

to MMBL over and above the government stipulated trait value since the year 2010

and demand that money back34. It is to be asserted that the trait fee collected for the

Bt technology is the lowest in India in comparison to other cotton growing

countries35.

5. Regulation of MSP and Trait value by Central Government

5.1 Order of Ministry of Agriculture, Government of India

In 2016, the Central Ministry of Agriculture issued an order regulating the prices of

Bt cottonseeds and slashed trait fees 36 . The details of this notification dated 7

December 2015 were:

1. The maximum sale price (MSP) 37of genetically modified Bollgard II cotton seeds

were reduced to Rs.800 per 450gm packet (12.4 USD) from Rs.830-1,000 earlier.

2. “Royalty (Trait Value)” was defined as the amount, which the Licensor collects

from the Licensee under the License Agreement for granting license to GM

Technology 38 . The trait fee was reduced by 74%, from Rs.163 (2,5 USD

approximately) per packet to Rs.43 (0.67 USD approximately) excluding taxes39.

The changed prices were to have effect from the next winter crop season. A nine-

member committee constituted by the Central Government on cotton seed prices

recommended reduction in trait fees payable to seed technology companies to benefit

nearly 8 million cotton farmers in India40. The order states that it has been passed

with the objective of “provid(ing) for an effective system for fixation of sale price for

cotton seeds to ensure their availability to the farmers at fair, reasonable and

affordable prices41”. If the objective was merely to lower the price of Bt cotton for the

farmers, the scope of this order would have been confined to regulating the MSP, but

the order is crafted in a manner that is likely to further the interests of seed

manufacturers as against Monsanto. This is evident from the various provisions

including:

a) clause 5.5 of the order states that the government can regulate the license fee

including the “trait value” and royalty that seed companies pay to biotechnology

companies.

b) clause 5.8 states that all license agreements must be in the format prescribed by

the government.

c) clause 5.3, which sets out the composition of the committee that is responsible for

advising the government on the imposition of the MSP, does not include any

representatives from biotechnology companies but has a representative from the

seed industry.


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d) clause 5.6 which states that the Maximum Sale Price fixation along with fixation

of its components shall be binding on all stakeholders including the Licensor and

the Licensee, notwithstanding anything contained in any previous contract or

instrument to the contrary42.

5.2 Ministry of Agriculture Guidelines 2016

The reduction of trait fee payable to Monsanto was rendered futile by the fact that

Monsanto had already terminated its licensing agreements with nine Indian seed

companies after they refused to pay Monsanto around R. 400 crores (60 billion USD

approx.) in outstanding royalties43. The other companies like Nuziveedu continued to

sell seeds with Monsanto’s Bt technology and Monsanto instituted patent and

trademark infringement lawsuit before the Delhi High Court in February 201644.

Before the High Court, Nuziveedu agreed to be restrained from manufacturing any

new seeds after disposing its existing stock and also consented to paying Monsanto

outstanding royalties45.

Since the technology licensing agreements were terminated and the courts intervened

to restrain IP infringement, the government’s orders had no real practical impact for

the Indian seed companies. And thus, the Ministry of Agriculture notified the

“Licensing and Formats for GM Technology Agreements Guidelines, 2016” in the

Gazette of India on May 18, 2016 to essentially force Monsanto to license out its

technology. The clause (5) of the Guidelines states that:

“(5) The Licensor shall not refuse grant of a license to any eligible seed company

fulfilling the aforesaid criteria. The Licensor shall award the license for the Genetic

Engineering Appraisal Committee (GEAC) approved GM Trait within 30 days of

receipt of a request from Licensee along with proof of fulfilling the qualification

criteria. An Agreement shall be signed by the Licensor and the Licensee in

accordance with the approved License Format as specified in the ANNEXURE. If the

Licensor fails to meet the above obligation, the Licensee is deemed to have obtained

the license for the GEAC approved GM Trait as per FRAND mechanism and the

deemed license holder shall abide the terms of such licensing guidelines and

agreement issued under the Order46”.

These Guidelines require all patentees of GM technology to offer their technology on

a Fair, Reasonable and Non-Discriminatory (FRAND) basis to any seed company

willing to pay Monsanto, a government mandated royalty for the patent. Monsanto

cannot deny any of the seed companies a license. In case Monsanto doesn’t respond

within 30 days, the guidelines create a presumption that the license has been granted

by Monsanto47.

5.3 FRAND terms of licensing

The requirement of the MoA Guidelines has extended the FRAND licensing terms

which have been previously used in the context of SEPs to Bt cotton. The

development of certain technologies depends on the entire industry adopting certain

standards. In the context of mobile phones, if a phone manufactured by one company

has to communicate to a phone manufactured by another company, they will have to

agree to use certain technologies as standards. Deciding which technologies may be


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recognized as “standards” necessitated the creation of “Standard Setting

Organizations (SSOs)”. SSOs are implied to deliver in a transparent manner while

declaring the SEPs and once declared, the patentee is required to license it on a

FRAND basis. The FRAND requirement is necessitated by the fact that the SEP

owner wields exceptional powers because without access to a technology declared as

a “standard”, no new player can enter the market. In the Indian context, the

complexity of the provision was evident in the Ericsson patent litigation against

Indian telecom companies with the debate surrounding the “reasonableness” and

“non-discrimination” of the individual licenses.

However, in case of Bt cotton, the FRAND licensing is not operating within the same

context. If a seed company wants to sell cottonseeds without Monsanto’s Bt

technology, it can do so. The issue of bollworms can be tackled through increased

pesticide use. Thus, Monsanto’s Bt technology is substitutable. This is different from

cellular phone technology where new players cannot enter the market if denied access

to SEPs. Thus, GM technologies like Monsanto’s Bt technology does not meet the

requirements to become an industry standard. Moreover, FRAND as a concept is

constructed to be a voluntary act, wherein both parties enter into a contract on

mutually agreed terms. Monsanto hasn't agreed to license on FRAND terms

voluntarily while the Government has imposed the concept into the licensing

framework.

5.4 Issues of Patentability of the Monsanto gene

The patentability determination has been addressed in the preamble of the

“Licensing and Formats for GM Technology Agreements Guidelines, 2016” as:

“And whereas, even though biotechnology inventions are patentable, once the GM

Traits developed through biotechnology are transferred into a variety (“transgenic

variety”), the transgenic variety per se cannot be patented; the seeds carrying such

trait also cannot be patented and hence, the plant varieties including transgenic

varieties carrying the GM Traits can be protected only under the Protection of Plant

varieties and Farmer’s Rights Act, 2001.

“And whereas, the transgenic varieties become the intellectual property of the

breeder or company who has developed it48’;

Unless Monsanto cannot have a claim on the modified genome, the new variety will

contain IP rights belonging to both the seed company and Monsanto. While the new

variety is protected under the Protection of Plant Varieties & Farmer’s Rights

Authorities Act, 2001, the modified genome is protected under the Patents Act, 1970.

The initial set of claims filed by Monsanto in their patent application was modeled

heavily on the American patent application.

a. Claim No.1: “An insect resistant cotton plant, or parts thereof, seed of said cotton

plant having been deposited with the American Type Culture Collection under

accession number PTA-2516.”

b. Claim 2: “An insect resistant cotton plant, or parts thereof, wherein DNA having

at least one nucleotide sequence selected from the group of SEQ ID NO: 14, SEQ


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ID NO: 15, SEQ ID NO: 16, SEQ ID NO. 17 and SEQ ID. NO. 18 forms part of the

plant’s genome49”.

The remaining claims were dependent on Claims 1 and Claim 2. Objection No. 1 was

“Claim 1 to 7 attracts 3(j) of the Patents Act, 197050”. This provision of the Patents Act

prohibits the patenting of plants, animals, seeds etc. A total of 59 claims were applied

for by Monsanto in Indian patent no. 214436. Almost all of these claims were rejected

outright by the IPO, and subsequently deleted by Monsanto. These included the

following:

a. claims 1 to 7 and 10 to 40, which were directed to a plant comprising the said

nucleic acid sequence;

b. claims 8, 9 and 53, which were directed towards a plant tissue, such as a seed

containing the nucleic acid sequence;

c. claims 48 to 52 and 54 to 56, which were directed to a plant cell containing the

nucleic acid sequence; and

d. claims 41 to 43, which were directed to a conventional breeding method of

producing a transgenic plant involving a step of crossing two plants51

Monsanto then re-submitted a fresh set of claims. Claim 1 of which reads as follows:

“1. A synthetic DNA molecule, comprising at least fifteen nucleotides of SEQ ID No.

11 or SEQ ID No. 12, and overlapping the junctions of the Cry2Ab insertions in

cotton event MON15985 or the junction of the Cry2Ab insertions and the genomic

sequence in cotton event MON 15985, or the complement thereof, wherein said

cotton event MON15985 occurs in the cotton seed having been deposited with the

American Type Culture Collection under accession number PTA-251652”.

Is the claim for a gene sequence or for the entire cotton seed which contains the

modified gene sequence? Would this fall foul of Section 3(j) of the Patents Act and if

so, what would be the correct format to claim gene sequences? Since these issues

have never been litigated in India, the outcome of such litigation will decide the

future of biotechnology and genetic engineering in the Indian turf. If Monsanto seeks

to patent a gene sequence of Bt. Bacteria it should be permissible under the law

because Section 3(j) of the Patent Act specifically excludes micro-organisms from the

list of non-patentable subject matter in Section 3 of the Patents Act 53 . Foreign

jurisdictions like the US have looked at these issues in detail and it is to be seen how

the Indian judiciary will decide over it.

“Claim 25: A nucleic acid sequence comprising a promoter operably linked to a first

polynucleotide sequence encoding a plastid transit peptide, which is linked in frame

to a second polynucleotide sequence encoding a Cry2Ab Bacillus thuringiensis δ-

endotoxin protein, wherein expression of said nucleic acid sequence by a plant cell

produces a fusion protein comprising an amino-terminal plastid transit peptide

covalently linked to said δ-endotoxin protein, and wherein said fusion protein

functions to localize said δ-endotoxin protein to a subcellular organelle or

compartment54”.

The most pertinent issue here is the right construction of the patent specification and

the claims in particular. Claim 25 of the Indian patent no 214436 deals with not

merely a nucleic acid sequence but rather a nucleic acid sequence having a certain

effect in the plant cell. The interpretation of the ‘wherein’ clause to limit the invention

in a patent claim55. In the present claim, if “wherein” limits the claim to ‘a plant cell’


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in which the “nucleic acid sequence is to deliver its intended purpose” the claim

would necessarily fail under Section 3(j).

Monsanto, however, has argued, in court as well as in various public forums, that the

true scope of claim 25 is not a plant cell but the nucleic acid sequence56. By accepting

that claim 25 applies only to the nucleic acid sequence, it leads to ignoring the

reference to plant cell completely. It also needs to be understood whether the scope of

claim 25 can be enforced against plants and seeds that may have naturally inherited

such a nucleic acid sequence through naturally biological processes. This is the first

set of cases before the courts on the patentability of genetically modification, ‘traits’

and the scope of section 3(j) of the Patents Act. The interpretation that the courts

finally arrive at on the patent matter will undoubtedly have a huge impact on the seed

industry, and will likely affect the licensing strategies and models that biotech

companies employ to commercialize their innovations in India.

5.5 National Intellectual Property Rights policy

India needs to create an environment that encourages research in developing new

seeds and sustainable innovation. The National Intellectual Property Rights (IPR)

Policy 2015, outlines various policies to encourage innovation. It is useful to consider

whether the MoA Guidelines are consistent with the National IPR Policy. The policy

emphasizes the need for “a stable system of laws” which provides assurance to

innovators that their rights will be protected. Furthermore, the Objective 3 of the

National IPR Policy, 2016 is “to have strong and effective IPR laws, which balance the

interests of rights owners with larger public interest”. Under this objective, the Policy

inter alia envisages “identifying important areas of study and research for future

policy development, such as:

i. Interplay amongst IP laws, and between IP laws and other laws to remove

ambiguities and inconsistencies (3.8.1)

ii. IP interface with competition law and policy (3.8.2)

iii. Guidelines for authorities whose jurisdictions impact administration or

enforcement of IPRs such as patents and biodiversity (3.8.3)

5.6 Trade Related Intellectual Property Rights (TRIPS)

One of the major points of contention during the negotiation of TRIPS was the

concept of ‘license of rights’. The concept of ‘licenses of right’ which was enshrined in

Section 87 and 88 of the Patents Act in India allowed any person to seek a license for

a certain class of patents (mainly process patents for technologies like drugs and

chemical) at a royalty rate determined by the Controller and subject to an upper

ceiling of 4% of the net ex-factory sales price57. The developed countries were against

such blanket licensing provisions and India couldn't retain the “license to rights”

system. However, the MoA Guidelines under discussion, basically attempt to recreate

a “license of rights” framework by allowing all seed companies the right to a license

from patentees of GM technologies related to increased insect resistance in cotton

seeds, provided that they agree to pay government mandated royalties. The potential

TRIPS challenge on this issue will be strong because the government is targeting an

entire class of technologies rather than a particular patent.


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However it is interesting to note that the Uruguay Round Agreement on Technical

Barriers to Trade also provides flexibility to the member states in framing technical

regulation and standards, and their testing and certification process58. Article 12.2 of

Agreement on Technical Barriers provides that “Members shall give particular

attention to the provisions of this Agreement concerning developing country

Members’ rights and obligations and shall take into account the special

development, financial and trade needs of developing country members in the

implementation of this Agreement, both nationally and in the operation of this

Agreement’s institutional arrangements.”

6. Provisions from the Protection of Plant Varieties and Farmers Rights (PPVFR) Act, India

The relevant Act, which protects IP for seeds and plants, is the Protection of Plant

Varieties and Farmers Rights (PPVFR) Act. This Act is also explicitly mentioned in

the National IPR policy as the relevant Act in this area, in accordance with TRIPS.

The alternative way of addressing the seed pricing issue have been through the

PPVFR Act, which contains provisions for compulsory licensing similar to those

under the Patents Act.

6.1 Compulsory licensing and compensation

The PPVFR Act provides that if any person believes that the “reasonable

requirements of the public” for seed or other propagating material of a variety

registered with the Protection of Plant Varieties and Farmers’ Rights Authority, have

not been satisfied, or that the seed or propagating material is not available “at a

reasonable price”, that person can approach the authority for the grant of a

compulsory license to undertake production, distribution and sale of the seed or the

propagating material. If, after hearing the technology holder, the authority is satisfied

that the claims are valid, it can grant to the applicant a compulsory license and

prescribe a compensation that has to be paid to the technology holder. The Act

provides that the compensation must take into account the cost of developing the

technology.

The NSAI’s argues that any variety containing the Bt Trait will then be subject to the

limitations and exceptions listed under the PPVFR Act. If the variety is not registered

under the Act then any person is free to use such varieties. What if the variety

containing the Bt. Trait is registered? In such a case NSAI argues that a combined

reading of Section 30, followed by Section 26 of the PVP Act, gives any Indian seed

company the right to conduct research on any registered variety to develop a new

variety and subsequently it is subject to the benefit-sharing requirements59. Section

30 of the PVP Act contains a rather wide research exception – that any person may

use any variety registered under the PVP Act for conducting experiment or research

or use such variety as an initial source of variety for the purpose of creating other

varieties.

The section also has a proviso which states that the authorization of the breeder of a

registered variety is required where the repeated use of such variety as a parental line

is necessary for commercial production of such other newly developed variety. In

other words, NSAI appears to be setting the ground for the argument that it can use


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existing varieties containing the Bt trait to conduct research and develop new

varieties. And if the varieties are registered and not within the scope of the proviso to

Section 30, but within the scope of Section 23(8) i.e. an essentially derived variety,

the owner of the initial variety may seek benefit sharing under the terms of Section 26

of the PVP Act60. NSAI’s argument appears to be that any variety that its members

develop, which contains the Bt. gene, may be subject to the benefit sharing provision

of Section 26. In such a scenario, Monsanto can only seek compensation under the

PVP Act and not an injunction under the Patents Act. And most importantly, the

Registrar of PVP determines the compensation under S. 26.

6.2 Regulatory control – No Objection Certificate (NOC) & Benefit Sharing

Ordinarily, a transgenic plant variety ought to be registrable under the PPVFR Act so

long as it satisfies the NDUS criteria (Novelty, Distinctiveness, Uniformity and

Stability)61. In August 2016, the Genetic Engineering Appraisal Committee (GEAC)

under the Ministry of Environment and Forests (Moe) transferred the authority to

release new cotton varieties and hybrids with approved GM plant traits to the Indian

Council of Agricultural Research (ICAR)62. The regulatory framework as enforced by

GEAC under the Environmental Protection Act required Indian seed companies to

seek a ‘No Objection Certificate’ from the trait owner (Monsanto), before they release

a new variety containing the Bt. Trait. The GEAC would require an applicant seed

company to present a NOC from the patent-holder. According to NSAI, Monsanto

“misused” this power to issue a NOC, by forcing seed companies to sign one-sided

agreements and extract unfair royalties from the seed companies 63 . NSAI has

therefore reportedly requested GEAC and Review Committee on Genetic

Manipulation RCGM (both are setup under environmental laws to regulate GMOs) to

do away with this requirement to seek an NOC from Monsanto and instead allow the

prevailing system under the Seeds Act, 1966 to approve new varieties64.

In response to an RTI query65 the Authority claimed that the NOC requirement was

stipulated under Section 18 of the PPVFR Act, and in particular, the requirement of

declaration under Section 18, read with Section 20 and Section 2366. The substantive

requirement is contained in the Section 18, which deals with the form of application:

“Section 18(1)(h): Every application for registration shall contain a declaration that

the genetic material or parental material acquired for breeding, evolving or

developing the variety has been lawfully acquired;

Section 18(1)(i): Every application for registration shall be accompanied by such

other particulars as may be prescribed.

Section 2(q): “prescribed” means prescribed by rules made under this Act67 “

It is relevant to note that Section 18(1)(h) refers to a declaration to be made by the

applicant, and does not require the applicant to obtain any form of “authorization”

from a third party. Section 18(1)(i) requires that additional information as may be

‘prescribed’ may also be required to be submitted in the application for registration.

But whatever is “prescribed” must necessarily be prescribed under the rules made

under the PPVFR Act (Section 2q). Hence it is to be understood that the Authority

cannot impose additional conditions for registration, such as the requirement of an

NOC, under the PPVFR Act. Such additional conditions can only be imposed by the


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Central Government through an amendment to the PPVFR Act. 68 The NOC

requirement raised a few legal questions. Firstly, Section 8 of the PPVFR Act casts a

duty on the Authority to promote development of new varieties and to protect the

rights of the farmers and the breeders69. An NOC requirement arguably discourages

breeders from creating new transgenic varieties and suppresses farmers’ and

breeders’ rights, instead of protecting them.

Secondly, the NOC requirement has serious consequences for the benefit sharing

provisions under the PPVFR Act. Under Section 26 read with Rule 43 of the PPVFR

Act, a claim70for benefit sharing can be submitted on the commercialization of a

hybrid or variety developed using a plant variety containing the originally developed

Bt trait. The benefit sharing amount must be determined by the Authority, and must

be fair and reasonable. It must also address the interests of all the parties i.e.,

breeders, the Bt trait provider and farmers. The requirement of an NOC had shifted

the power to determine the benefit sharing from the Authority to a private player.

On June 21 2017, Vivian Fernandez had reported that the authority for protection of

plant varieties is set to dispense with the requirement of the NOC from patent-

holders for use of their GM traits71. In such a scenario, seed companies can effectively

claim that creation of Bt varieties necessitates the use of the transgenic parent of a

Monsanto only once. One-time use of patented material without permission of the

patent-holder is allowed under researchers’ rights conferred by the Act. Only

unauthorized repeated use of the material for commercial purposes constitutes an

infringement. Even if a patented trait is used by seed companies without explicit

authorization, the patent developer can only make a claim for “benefit sharing” under

the PPVFR Act. Now, any seed company can seek approval from ICAR for their cotton

varieties and hybrids with approved patented GM plant traits without NOC after

getting them certified for potency and stability of the Bt trait72.

7. Judicial decision - The Delhi High Court order 2017

The Delhi High Court order in Monsanto Technology LLC and others v Nuziveedu

Seeds Private ltd and others pronounced by Justice Gauba on 28th March 2017 73 has

held Monsanto’s termination of the contract to be prima facie illegal and has allowed

Nuziveedu and others to continue using the technology provided that the trait fee is

paid in accordance with the prevalent laws till the suit is finally disposed. The parties

will have to adhere to the Central Government’s price control order which not only

fixes the retail price of the seeds but also the “trait fee” payable to Monsanto by

Nuziveedu.

It appears that the defendant raised arguments based on Section 8, Section 10(4) and

other grounds in the Patents Act, 1970. Justice Gauba refuses to get into the issue of

validity of the patent at the interim stage on the grounds that the matter requires

evidence to be led through trial. The Court rejected the argument pointing out that

‘research’ is different from ‘using’ a patented invention:

“113. It is the defendants’ argument that sub-license granted by the plaintiffs

permitted the nucleic acid sequences made available in the form of donor seeds to be

introduced into a cotton plant cell and once such implanting was done, the claim of

the plaintiffs concerning a suit patent in so far as the defendants is concerned, stood

exhausted and the rights under the suit patent do not extend to inhibiting the

development of new varieties or cells or tissues or plants or seeds through biological


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processes as the same are excluded by the provisions contained not only in Section

3(j), as noted above, but also Section 3(h) which excludes “a method of agriculture

or horticulture” from the definition of “invention74”.

Monsanto argued that Article 9.02 of the contract allowed for the termination of the

contract if royalty payments due to it were not made to within a fixed period.

Nuziveedu appears to have argued that because the state governments were revising

the rates of the seeds and fixing the trait value, Monsanto was required to renegotiate

the rates since Article 11.03 of the contract required the contract to be in adherence to

the local laws. Justice Gauba appears to disagree with Monsanto’s refusal to

renegotiate its contractual rates stating the following:

“The plaintiffs, it appears, refused to even acknowledge the effect of the State

government legislations or notifications on the cotton seed prices and only asserted

the right to receive the trait fee as settled “through mutual consent” under the

contract. This, positioning, prima facie, was not correct75”.

Monsanto had originally filed this case for patent and trademark infringement. The

applications being heard by Justice Gauba related to the simple issue of an interim

injunction. Instead of denying an interim injunction, an elaborate mechanism was to

ensure payment of trait fees to Monsanto. However, a Division Bench of the Delhi

High Court comprising Justice Ravindra Bhat and Justice Yogesh Khanna has

granted a stay on the restoration of the license contracts between Monsanto and seed

companies (as ordered by Justice R.K. Gauba) on March 28, 201776.

8. Impacts of the decisions and rulings

8.1 Technology transfer and investment

Ashok Gulati, a revered agricultural economist, has criticized the Ministry’s actions

that had lowered the price of Bt cotton seeds by about 4%, but has lowered the trait

value payment significantly by 74%77. He warns that the new regime could discourage

the technology holder from introducing the new Bollgard III variety in India. Seed

producers may welcome the proposed change today because it reduces the fee they

pay but if it risks losing introduction of the new strain it is the same seed companies

and the farmers that will lose out on the new wave of technology. It is important to

understand that a major chunk of the revenue comes from cotton export and India

has to compete with major international competitors like China, Brazil and Australia.

Disparity in technology is a major factor that affects production and countries like

Australia have already been introduced to the Bollgard IIII technology. The

development of new seeds is expensive, and especially so with GM technology, where

prolonged safety testing is involved. Profitability may not be the key consideration for

public sector seed producers but we cannot rely exclusively on the public sector to

provide seeds.

Arguments are provided that the private sector provided more effective solutions for

the challenges faced by the industry. Monsanto alone has a research and development

budget which is twice that of the total budget of the Indian Council of Agricultural

Research78. Proponents of this argument support the premise that the private sector

companies, including multinationals, should be encouraged to get actively involved

and even partner with public sector institutions such as the agricultural universities.


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However, this will only happen if private players are assured that the India will

provide stable legal terrain for innovation. Due to the sheer size of the Indian market

it is however not easy for global technology players to completely ignore and walk

away. India is a fertile destination for companies to invest in the biotechnology

sector. The very scale and steady growth of the Indian economy is what probably

fuels the stand the Indian Government is taking on its aggressive domestic policies.

8.2 Intellectual Property strategy

Whatever be the subjective predilections against GMOs, it is a matter of concern that

the Indian governmental agencies have taken unprecedented and drastic steps

towards regulation of profits accrued by Monsanto. By slashing trait fees and

imposing licensing terms, the Government has clearly shown that it is favoring short-

term populist measures rather than sustaining the cotton revolution for the long

term. This appears to be a violation of the rule of law and the danger is when the

national interest rationale can be employed to justify similar or parallel instances in

the future. India has capitalized on the TRIPS plus provisions in building a robust

indigenous generic pharmaceutical industry from scratch to transform it to becoming

the third largest in the world in a course of two decades. The industry thrived on the

business model of reverse engineering pharmaceutical drugs patented by

multinational pharmaceutical companies who had invested the lion’s share into the

R&D. However, the Indian pharmaceutical industry was able to create cheaper

generic versions of the original combinations and was successful in reaching out to

millions of poor patients across the globe. The pharmacy of the developing world was

created through the backdoor of IP exclusions, however changing the landscape of

access to healthcare within the country and globally. In the case of Bt cotton, it

appears that India is attempting to replicate the pharma model. We are striving to

create an indigenous seed industry exploiting the Bt cotton technology to maximize

profits for the domestic seed industry. The plight of the farmers and the deprived

state of Indian agriculture has set the moral anchor for advancing the cause of the

seed companies. While there is merit in bringing regulations on the monopoly of a

dominant player in the market, this must be done after following due processes under

the law and through the relevant competent authority.

This is where the pharmaceutical model differs from the seed industry model. The

first compulsory license issued to Natco was in response to the cancer drug that was

largely unaffordable for the vast majority of Indian population. However, in the seed

rights issue, capricious orders have been issued to ostensibly favour one set of

stakeholders in what is essentially a private commercial dispute. An actual financial

emergency in the cotton sector that is threatening the livelihoods of the cotton

farmers could have been a fertile ground for such fervent reactions from the Indian

government. Bt cotton had spread to cover 95% of the cotton area. There was clearly

no evidence showing constraint on seed availability or even affordability and also the

farmers had the choice to continue using traditional varieties. The rapid spread of the

Bt cotton is clear evidence that the farmers preferred the new variety and found it

profitable. This recent turn of events is strategic not just for Monsanto, but for all

possible technology suppliers, including potential Indian suppliers of genetically

modification technology. Major developing economies like Brazil, Sri Lanka, Mexico

and Uzbekistan are heavily dependent on the Bt technology and have several lessons


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to learn from the Indian episode. The rundown of events and the various questions it

poses especially in the context of the Intellectual Property provisions are directly

applicable to their domestic contexts.

9. Conclusions

Details presented thus far in this paper clearly demonstrate the complexity of not just

commercialization of genetically modified crop such as cotton in a country like that

has been besieged with problems of crop failure and related suicides by the farmers

but also the absolute need for a coordinated approach by decision makers (the

executive), the judiciary (adjudicating the case), the industry (focusing on technology

development and deployment), stakeholder groups (looking for better seeds and

technology associated) and the international decision making processes that impact

such actions.

The decision by Monsanto to sell its cotton seed business in India, the withdrawal of

next generation technology of Bollgard, the implications of patent suits in the courts,

all indicate the delicate balance between technology development, protection of

intellectual property and government policies to deal with social and market issues

driven by immediate considerations of farmers.

Lessons from this experience in India are the following:

1. There is a need for absolute clarity and consistency with regard to government

policies at sub-national and national levels on issues of technology transfer,

incubation, use, value-addition and protection of related intellectual property.

2. While small scale players and national seed companies are to be viewed with

considerable space to maneuver the market, concessions to such stakeholders

should not be at the cost of established legal and related provisions.

3. The need to have inter and transdisciplinary understanding of various issues

related to such technology use and adoption has to be properly understood. Both

public and private sector need to build the capacities of stakeholders to make

rational choices and decisions using a perspective that is wholesome.

4. While international agreements and decisions on issues such as intellectual

property rights are to guide national actions and policy making, often local

compulsions will influence the way the agreements and decisions are made. This

will, in all probability, reduce the confidence of research and development

practitioners in providing the technology and related services.

5. Lastly, lack of appropriate linkages between the science-policy-practice as well as

understanding between the executive-experts-executive will have a long-term

impact in investments into research and development that will reduce and, many

a time, nullify the options for new advancements in science.

In conclusion, the experience from India, through this case, provides a set of options and answers to questions raised in other countries on issues related to genetic modification, agricultural production systems, technology transfer, markets and pricing and role of public sector institutions and the judiciary in dealing with future of biotechnology research and development. We hope that stakeholders will critically assess the implications of each of the above intervention before decisions are made in dealing with future of biotechnology.


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10. Endnotes and References

1 Ministry of Environment and Forests available at www.moef.gov.in/sites/default/files/geac/bgnote.doc 2 Ashik Gulati, Shreya Sarkar “Heading backwards: The cotton revolution is in danger of being reversed by government control over GM seed pricing.” Available at http://indianexpress.com/article/opinion/columns/gm-crops-cotton-heading-backwards/ 3 Mayank Bhardwaj, Rupam Jain and Tom Lasseter “Seed giant Monsanto meets its match as Hindu nationalists assert power in Modi's India” available at http://www.reuters.com/investigates/special-report/monsanto-india/ 4 Ashik Gulati, Shreya Sarkar “Heading backwards: The cotton revolution is in danger of being reversed by government control over GM seed pricing.” Available at http://indianexpress.com/article/opinion/columns/gm-crops-cotton-heading-backwards/ 5 Ashik Gulati, Shreya Sarkar “Heading backwards: The cotton revolution is in danger of being reversed by government control over GM seed pricing.” Available at http://indianexpress.com/article/opinion/columns/gm-crops-cotton-heading-backwards/ 6 Ashik Gulati, Shreya Sarkar “Heading backwards: The cotton revolution is in danger of being reversed by government control over GM seed pricing.” Available at http://indianexpress.com/article/opinion/columns/gm-crops-cotton-heading-backwards/ 7 Sreeja V N at http://www.ibtimes.com/indian-high-court-reinstates-criminal-proceedings-against-monsanto-its-partners-1431534 8 Monsanto v Bowman 9 Monsanto v Percy Schmeiser 10 Olivier Bach “ Seeds of Dispute” at https://www.theguardian.com/science/2006/feb/22/gm.argentina 11 Shamnad Basheer “The Battle over Cotton” available at http://www.thehindu.com/opinion/op-ed/The-battle-over-Bt-cotton/article15424211.ece 12 Shruthi Chandrasekharan available at https://spicyip.com/2015/10/guest-post-the-rs-400-crore-war-between-monsanto-and-indian-seed-companies-with-threats-of-price-control-and-compulsory-licencing-of-patents.html 13 Shruthi Chandrasekharan available at https://spicyip.com/2015/10/guest-post-the-rs-400-crore-war-between-monsanto-and-indian-seed-companies-with-threats-of-price-control-and-compulsory-licencing-of-patents.html 14 Bhavika Jain “Bt cotton falling to pest, Maharashtra tensed” available at http://timesofindia.indiatimes.com/city/mumbai/bt-cotton-falling-to-pest-maharashtra-tensed/articleshow/59449010.cms?utm_source=toimobile&utm_medium=Whatsapp&utm_campaign=referral 15 M. R. Subramani “Bollgard III may come to India only around 2020” available at http://www.thehindubusinessline.com/economy/agri-business/bollgard-iii-may-come-to-india-only-around-2020/article2633343.ece 16 M. R. Subramani “Bollgard III may come to India only around 2020” available at http://www.thehindubusinessline.com/economy/agri-business/bollgard-iii-may-come-to-india-only-around-2020/article2633343.ece 17 Anne Sewell “Ministry blames GMO cotton for farmer suicides” available at http://www.digitaljournal.com/article/323656 Also refer to Vandana Shiva “Seeds of suicide and slavery versus seeds of life and freedom” available at http://www.aljazeera.com/indepth/opinion/2013/03/201332813553729250.html 18 http://www.outlookindia.com/newswire/story/guj-hc-declares-gujarat-cotton-seeds-act-invalid/720280 19 Bombay HC upholds Maharashtra Seed Act, delivers blow to industry http://economictimes.indiatimes.com/news/politics-and-nation/bombay-hc-upholds-maharashtra-seed-act-delivers-blow-to-industry/articleshow/23344303.cms?intenttarget=no 20 Essential Commodities Act 1955 http://consumeraffairs.nic.in/consumer/sites/default/files/userfiles/ecact1955.pdf 21 http://economictimes.indiatimes.com/news/economy/agriculture/royalty-payments-indian-seed-makers-to-take-on-monsanto/articleshow/49347160.cms 22 http://www.cci.gov.in/sites/default/files/Common%20order%20for%2037-2016%2C38-2016%2C39-2016.pdf and further CCI order dated 18th February 2016 available at http://www.cci.gov.in/sites/default/files/03-2016%2C%2010-2016%2C%20ref%2001-2016_18.02.2016.pdf 23 http://www.cci.gov.in/sites/default/files/Common%20order%20for%2037-2016%2C38-2016%2C39-2016.pdf 24 http://economictimes.indiatimes.com/news/economy/agriculture/royalty-payments-indian-seed-makers-to-take-on-monsanto/articleshow/49347160.cms 25 Madhulika Vishwanathan at https://spicyip.com/2013/07/dipp-refuses-cl-plea-for-herceptin.html


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26 Central Government’s power of Revocation of Patent in Public Interest https://iiprd.wordpress.com/2014/01/02/central-governments-power-of-revocation-of-patent-in-public-interest/ 27 Anumita Roychaudhary at http://www.downtoearth.org.in/news/revoked-29643 28 Anumita Roychaudhary at http://www.downtoearth.org.in/news/revoked-29643 29 Shruthi Chandrashekharan at https://spicyip.com/2015/10/guest-post-the-rs-400-crore-war-between-monsanto-and-indian-seed-companies-with-threats-of-price-control-and-compulsory-licencing-of-patents.html 30 http://indiatoday.intoday.in/story/monsanto-feels-only-bt-cotton-seed-price-fixed-not-trait-value/1/618051.html 31 “A Rs 400 cr Case That Tests Intellectual Property Law in the Agricultural Sector” at http://www.smartindianagriculture.in/1807-2/ 32 “A Rs 400 cr Case That Tests Intellectual Property Law in the Agricultural Sector” at http://www.smartindianagriculture.in/1807-2/ 33 Prabhat Agri Biotech, Ajeet Seeds Limited, Kaveri Seeds, Ankur Seeds, Nuziveedu Seeds, Green Gold Seeds, Ram Agrigenetics and Amar Bio tech 34 “Monsanto, cotton seeds firms at war” at http://www.business-standard.com/article/companies/monsanto-cotton-seeds-firms-at-war-115101901068_1.html 35 http://www.thehindubusinessline.com/economy/agri-business/monsanto-gets-stay-on-bt-cotton-royalty-cut/article7231925.ece 36 http://seednet.gov.in/PDFFILES/Cotton_Seeds_Price.pdf 37 Maximum Sale Price” means the maximum price inclusive of Seed Value, License Fee, Trade margin and local taxes or duties, at which the Cotton Seeds or transgenic varieties of Cotton Seeds are sold to the farmers; http://seednet.gov.in/PDFFILES/Cotton_Seeds_Price.pdf 38 http://seednet.gov.in/PDFFILES/Cotton_Seeds_Price.pdf 39 http://seednet.gov.in/PDFFILES/Cotton_Seeds_Price.pdf 40 https://spicyip.com/2016/03/spicy-ip-fellowship-2016-17-the-governments-price-control-order-on-gm-cotton-may-be-bad-in-law.html 41 http://seednet.gov.in/PDFFILES/Cotton_Seeds_Price.pdf 42 http://seednet.gov.in/PDFFILES/Cotton_Seeds_Price.pdf 43 https://spicyip.com/2016/05/guest-post-india-creates-a-licence-of-rights-system-for-gm-patents-is-it-legal.html 44 http://egazette.nic.in/WriteReadData/2016/169713.pdf 45 Aparajitha Lath at https://spicyip.com/2016/05/guest-post-india-creates-a-licence-of-rights-system-for-gm-patents-is-it-legal.html 46 http://egazette.nic.in/WriteReadData/2016/169713.pdf 47 http://egazette.nic.in/WriteReadData/2016/169713.pdf 48 http://egazette.nic.in/WriteReadData/2016/169713.pdf 49 Prashanth Reddy at https://spicyip.com/2016/09/gene-patents-and-plant-varieties-nsai-v-monsanto.html 50 Prashanth Reddy at https://spicyip.com/2016/09/gene-patents-and-plant-varieties-nsai-v-monsanto.html 51 “Monsanto vs. Indian Seed Companies: Enforcement of rejected patent claims?” At http://www.obhanandassociates.com/wp-content/uploads/2017/04/Monsanto-vs-Seed-Companies.pdf 52 “Monsanto vs. Indian Seed Companies: Enforcement of rejected patent claims?” At http://www.obhanandassociates.com/wp-content/uploads/2017/04/Monsanto-vs-Seed-Companies.pdf 53 [(j) plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals; 54 Patent no 214436 at http://ipindiaservices.gov.in/PublicSearch/PublicationSearch/Searchs 55 Monsanto vs. Indian Seed Companies: Enforcement of rejected patent claims? At http://www.obhanandassociates.com/wp-content/uploads/2017/04/Monsanto-vs-Seed-Companies.pdf 56 Monsanto vs. Indian Seed Companies: Enforcement of rejected patent claims? At http://www.obhanandassociates.com/wp-content/uploads/2017/04/Monsanto-vs-Seed-Companies.pdf 57 Aparajitha Lath “India creates a ‘license of rights’ system for GM patents: Is it legal?” available At https://spicyip.com/2016/05/guest-post-india-creates-a-licence-of-rights-system-for-gm-patents-is-it-legal.html 58 https://www.wto.org/english/tratop_e/tbt_e/tbt_info_e.htm 59 Shanti Chandrashekharan and Sujata Vasudev available at http://nopr.niscair.res.in/bitstream/123456789/4936/1/JIPR%207%286%29%20506-515.pdf

https://spicyip.com/2015/10/guest-post-the-rs-400-crore-war-between-monsanto-and-indian-seed-companies-with-threats-of-price-control-and-compulsory-licencing-of-patents.html



http://www.business-standard.com/article/companies/monsanto-cotton-seeds-firms-at-war-115101901068_1.html

http://www.business-standard.com/article/companies/monsanto-cotton-seeds-firms-at-war-115101901068_1.html

http://www.thehindubusinessline.com/economy/agri-business/monsanto-gets-stay-on-bt-cotton-royalty-cut/article7231925.ece

http://www.thehindubusinessline.com/economy/agri-business/monsanto-gets-stay-on-bt-cotton-royalty-cut/article7231925.ece

http://seednet.gov.in/PDFFILES/Cotton_Seeds_Price.pdf






https://spicyip.com/2016/05/guest-post-india-creates-a-licence-of-rights-system-for-gm-patents-is-it-legal.html

https://spicyip.com/2016/05/guest-post-india-creates-a-licence-of-rights-system-for-gm-patents-is-it-legal.html

https://indiankanoon.org/doc/124832407/


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60 Prashanth Reddy at https://spicyip.com/2016/08/the-nsais-new-ip-strategy-in-its-dispute-with-monsanto.html 61 http://www.upov.int/about/en/upov_system.html 62 http://www.moef.gov.in/divisions/csurv/geac/OM-Bt%20Cotton%20Hybrids.PDF 63 Prashanth Reddy at https://spicyip.com/2016/08/the-nsais-new-ip-strategy-in-its-dispute-with-monsanto.html 64 Prashanth Reddy at https://spicyip.com/2016/08/the-nsais-new-ip-strategy-in-its-dispute-with-monsanto.html 65 Pankhuri Agarwal “The Plant Variety Authority and Bt Cotton: A Case of Regulatory Capture? at https://spicyip.com/2017/01/the-plant-variety-authority-and-bt-cotton-a-case-of-regulatory-capture.html 66 Pankhuri Agarwal “The Plant Variety Authority and Bt Cotton: A Case of Regulatory Capture? “at https://spicyip.com/2017/01/the-plant-variety-authority-and-bt-cotton-a-case-of-regulatory-capture.html 67http://lawmin.nic.in/ld/PACT/2001/The%20Protection%20of%20Plant%20Varieties%20and%20Farmers%E2%80%99%20Rights%20Act,%202001.pdf 68 Pankhuri Agarwal “The Plant Variety Authority and Bt Cotton: A Case of Regulatory Capture? “at https://spicyip.com/2017/01/the-plant-variety-authority-and-bt-cotton-a-case-of-regulatory-capture.html 69 AND WHEREAS for accelerated agricultural development in the country, it is necessary to protect plant breeders' rights to stimulate investment for research and development, both in the public and private sector, for the development of new plant varieties available at http://lawmin.nic.in/ld/PACT/2001/The%20Protection%20of%20Plant%20Varieties%20and%20Farmers%E2%80%99%20Rights%20Act,%202001.pdf 70 any person or group of persons or firm or governmental or non-governmental organization can submit its claim 71 Vivian Fernandez at http://www.financialexpress.com/economy/ppvfr-act-dispensing-with-nocs-agriculture-ministry-rendered-hollow-the-plant-trait-patents-of-companies-like-monsanto/728559/ 72 Vivian Fernandez at http://www.financialexpress.com/economy/ppvfr-act-dispensing-with-nocs-agriculture-ministry-rendered-hollow-the-plant-trait-patents-of-companies-like-monsanto/728559/ 73 Monsanto Technology Llc And Ors. vs Nuziveedu Seeds Limited & Ors on 28 March, 2017 at http://lobis.nic.in/ddir/dhc/RKG/judgement/28-03-2017/RKG28032017IA24062016.pdf 74 Monsanto Technology LLC and others v Nuziveedu Seeds Private ltd and others https://indiankanoon.org/doc/143517948/ 75 Monsanto Technology Llc And Ors. vs Nuziveedu Seeds Limited & Ors. on 28 March, 2017 at http://lobis.nic.in/ddir/dhc/RKG/judgement/28-03-2017/RKG28032017IA24062016.pdf 76 Monsanto Technology LLC and others v Nuziveedu Seeds Private ltd and others https://indiankanoon.org/doc/143517948/ 77 Ashik Gulati, Shreya Sarkar “Heading backwards: The cotton revolution is in danger of being reversed by government control over GM seed pricing.” Available at http://indianexpress.com/article/opinion/columns/gm-crops-cotton-heading-backwards/ 78 http://www.livemint.com/Opinion/lAB4aJlNNVPYmIsdmfEk7N/A-new-policy-needed-for-GM-seeds.html

https://indiankanoon.org/doc/143517948/

http://www.livemint.com/Opinion/lAB4aJlNNVPYmIsdmfEk7N/A-new-policy-needed-for-GM-seeds.html

http://www.livemint.com/Opinion/lAB4aJlNNVPYmIsdmfEk7N/A-new-policy-needed-for-GM-seeds.html


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