NAME: SANJANA

KOTHARI
ROLL NO: D-51 INDUSTRIAL PATENT RIGHTS
PRN: 19020441229

CASE STUDY OF BT BRINJAL

FSB-resistant brinjal or Bt brinjal was developed using a transformation process similar to

the one used in the development of Bt cotton, a biotech crop that was planted on 7.6 million
hectares in India in 2008.

Bt brinjal incorporates the cry1Ac gene expressing insecticidal protein to confer resistance
against FSB. The cry1Ac gene is sourced from the soil bacterium Bacillus thuringiensis (Bt).
When ingested by the FSB larvae, the Bt protein is activated in the insect’s alkaline gut and
binds to the gut wall, which breaks down, allowing the Bt spores to invade the insect’s body
cavity. The FSB larvae die a few days later.

Bt Brinjal was developed by the Maharashtra Hybrid Seeds Company (Mahyco). The
company used a DNA construct containing the cry1Ac gene, a CaMV 35S promoter and the
selectable marker genes nptII and aad, to transform young cotyledons of brinjal plants.

A single copy elite event, named EE-1, was selected and introduced into hybrid brinjal in
Mahyco’s breeding program. Mahyco also generously donated the Bt brinjal technology to
the Tamil Nadu Agricultural University (TNAU), Coimbatore and University of Agricultural
Sciences (UAS), Dharwad. The event EE-1 was backcrossed into open-pollinated brinjal
varieties. Mahyco also donated the technology to public research institutions in the
Philippines and Bangladesh.

Bt brinjal is the first food crop under evaluation for commercial release in India. Since its
development in 2000, the crop has undergone rigorous scientific evaluation to assess its food
safety, environmental safety, human and animal health safety and biodiversity.

BIOSAFETY AND FOOD SAFETY ASSESSMENTS

Rigorous scientific tests, including toxicity and allergenicity evaluation as well as nutritional
studies on rabbits, rats, carps, goats, broiler chickens and dairy cows, have confirmed that
Bt brinjal is as safe as its non-Bt counterparts. The safety of Bt brinjal was further validated
by the results of the studies on pollen escape, effects on soil microflora and non-target
organisms, agronomy, invasiveness and Bt protein degradation. Results of the studies
demonstrated that Bt brinjal does not affect beneficial insects such as aphids, leafhoppers,
spiders and lady beetles.

IPR CASE

What the Novartis case is to the Right to Health, the Monsanto case is to the Right to Food
and Farmers Rights to Seed and Livelihoods.

From the past, it is clear that Monsanto sued over 100 farmers for infringement of its patent
and have won all the suits. In the recent decision by US court of Appeals for the Federal
Circuit, it was again established by the court that group of organic and non-GMO farmers and
other plaintiffs do not have any locus standi to restrict Monsanto from suing them. Monsanto
claims that if farmers are using the patented product of Monsanto without giving royalty, this
will provide ground for Monsanto to sue farmers or whoever infringes its patent.

In India, Mahyco, the Indian subsidiary of Monsanto, a Bt Brinjal promoter, is facing one more
trouble in addition to the existing moratorium on GM-Crops. Recently a case for criminal
prosecution of the company officials for biopiracy has been revived. Karnataka High Court
dismissed a petition to stay the prosecution. National Biodiversity Board (NBA) and the
Karnataka Biodiversity Board (KBB) that had complained that the company, along with
others, had genetically modified local varieties of eggplant without mandatory approval and
laid illegal proprietary claim to the genetically modified seeds.2 In addition to this, it was also
pointed out that Mahyco entered into an agreement with Agricultural Sciences, Dharwad
(UAS) for sub-licensing the Bt gene for use in local varieties of eggplants and further breeding
without NBA approval. Under section 3 of the Biodiversity Act, 2002 it is required that approval
from NBA should be taken for using India's biological resources.

Moreover, the complaint said, the UAS, in collusion with Mahyco and Sathguru Management
Consultants Private Limited, had carried out breeding to achieve genetic modification of
India's biological resources without permission.3 NBA and KBB explained that "Mahyco
technology (the eggplant containing the Bt gene that will be backcrossed with local varieties
provided by the UAS) and Monsanto's technology (the Bt Gene itself) are incorporated into
local varieties, [and] these varieties become 'licensed domestic eggplant products' and
therefore providing Monsanto and Mahyco intellectual property resources that can restrict
any making, using or selling of these licensed domestic eggplant products.
Name: Sanjana
Kothari BIOTECHNOLOGY, AGRICULTURE AND
Roll No: D-51
A SEED STORY
PRN:19020441229

Hence, the obvious implication of the US current position is that the petition filed by the
farmers will further strengthen the Anti-Monsanto case in India.

II. MOSANTOS BIOPIRACY OF INDIAN MELONS

The European Patent Office (EPO) has revoked a patent held by Monsanto on melons
(EP1962578) for technical reasons. Monsanto was claiming melons with a natural resistance
to plant viruses as its own invention, derived from breeding without genetic engineering. The
resistance was detected in

Indian melons. The patent was granted by the European Patent Office (EPO) even though
European patent law does not allow patents on plant varieties and processes for conventional
breeding. The Indian government supported the opposition from No Patents on Seeds! by a
sending letter requesting the patent to be revoked. The letter was sent to the EPO just one
day before the hearing. Essentially the application of the patent constituted an act of biopiracy
– violating Indian law and international treaties.

In May 2011, the US company Monsanto was awarded a European patent on conventionally
bred melons (EP 1 962 578). These melons which originally stem from India have a natural
resistance to certain plant viruses. Using conventional breeding methods, this type of
resistance was introduced to other melons and is now patented as a Monsanto “invention”.
The actual plant disease, Cucurbit yellow stunting disorder virus (CYSDV), has been
spreading through North America, Europe and North Africa for several years. The Indian
melon, which confers resistance to this virus, is registered in international seed banks as PI
313970.

With the new patent, Monsanto can now block access to all breeding material inheriting the
resistance derived from the Indian melon. The patent might discourage future breeding efforts
and the development of new melon varieties. Melon breeders and farmers could be severely
restricted by the patent. At the same time, it is already known that further breeding will be
necessary to produce melons that are actually protected against the plant virus.

According to a press release from the organization, Monsanto claimed that melons with a
natural resistance to plant viruses was its own invention even though the resistance was
already detected in indigenous melon varieties in India. certain melons are known to be
naturally resistant to the virus. Using conventional breeding methods, this type of resistance
was introduced from an Indian melon to other melons and has now been patented as a
Monsanto “invention.”

Opponents feared that by arming itself with this patent—"closterovirus-resistant melon

plants," or EP1962578, issued May 2011—the St. Louis-based agribusiness "could block
access to all breeding material inheriting the virus resistance derived from the Indian
melon," The Hindu reported.

According to the European Patent Office, the "melon patent" case kickstarted in February
2012 after the agency received two notices of opposition from two different groups:

One of them was from Nunhems, the vegetable seed-producing subsidiary of Bayer Crop
Science, who objected to the patent on technical grounds, including lack of novelty and
inventiveness of the patented plants. The other was from a coalition of NGOs and private
persons, who, in addition to technical arguments, voiced their concerns over the use of
conventional breeding methods.

The reason why the Melon case took so long in coming before the EPO court was because
of another, rather important case, The Broccoli and Tomato II Case, involving the patentability
of plants.

The question before the EPO's Enlarged Board of Appeal was whether a "process for the
production of plants comprising the steps of crossing and selection is excluded from
patentability even if it contains an additional step of a technical nature, such as the use of
molecular genetic markers."

The board ruled that the products of such processes (i.e. plants or fruits) could still be
patented – if the conditions of patentability are fulfilled – even if they are obtained from such
a non-patentable method. And there-in lies Monsanto's opening for appealing the patent
revocation.
REFERENCES

https://lawdigitalcommons.bc.edu/cgi/viewcontent.cgi?article=1209&context=iclr

https://ris.org.in/sites/default/files/article1_v8n1.pdf

https://spicyip.com/2019/07/the-sustainable-seed-innovations-project-the-story-of-
sona-moti.html

https://www.google.com/url?sa=t&source=web&rct=j&url=https://croplife.org/a-seed-
story/&ved=2ahUKEwikm-
6Kj7_mAhXRb30KHa7CDHQQFjAZegQIARAB&usg=AOvVaw1w00LyHnU7yLQdM
RneJIzU

https://web.williams.edu/AnthSoc/native/rosyperiwinkle.htm

https://seedfreedom.info/european-patent-office-revokes-monsanto-patent-on-melons/