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Issues related to patenting of

biological invention

S.Pavithra (14MBT0040)
P.Vengatapriya(14MBT0045)

Patents
Patent can be defined as an exclusive right to
stop others, other than the inventor, from
making using or selling the invention.
Requirements:
Novel
Useful
Not- obvious

Patentable
Biological materials such as DNA, plasmids and
processes of manufacturing
Micro-organisms, vaccines and processes
Biotechnological entities such as nucleotides and
amino acid sequences,;
Expressed sequence tags (ESTs), gene sequences
and DNA sequences.

Non Patentable
Naturally produced antibodies and cells (including stem
cells)
Processes for cloning human beings or animals,
modifying germ lines or genetic identity of human beings
or animals and any use of human embryos for any
purpose
Living entities of natural origin
Essential biological processes for the production of plants
and animals such as methods of crossing or breeding
Biological materials such as organs, tissues, cells, viruses
and processes relating thereto
Any biological material and method that poses serious
threat.

First Biotechnological Patent

Pseudomonas that degrades crude oil.


USPTO rejected the claim
Bacterium manipulated with four plasmids
Product of nature objection failed.
Over 7000 patent applications were received by
the USPTO after this.

Difficulties in patenting
Biotech field is diverse, so standard rules cannot
be designed.
In India, plant varieties are not patentable
Instead we have a Sui generis system called
Protection of Plant varieties and Farmers right.
We cant patent anything related to human body.

The Novartis Case Incremental


innovation
In 1993 - imatinib mesylate a viral-leukaemia
drug
In 2003, Glivec (beta crystalline) was granted
EMR.
Obtained order preventing generic equivalent
Other companies filed opposition.
Novartis application rejected.

Case of compulsory licensing: Bayer vs.


Natco
Bayer patent drug Naxaver (2,80,000 rupees for
a pack of 120 tablets)
Nacto asks for a voluntary licence.
Bayer turned down
Natco applied for compulsory licence.
Indian patent office granted the licence

Bio piracy

Neem
From 1985, over a dozen of neem extracts have
been patented in US.
Patent for fungicide neem extract was granted to
W R Grace and Co in 1995 by European Patent
Office.
India appealed with evidence of farmers using
this knowledge for a long time.
W R Graces patent was revoked in 2000.

Turmeric
University of Mississippi Medical Centre in 1995,
obtained patent for the "use of turmeric in
wound healing.
a complaint was filed by India's Council of
Scientific and Industrial Research, challenging
the novelty of the University's "discovery.
Proven by ancient Sanskrit writings that
documented turmerics extensive and varied use
throughout Indias history
In 1997, the patent was revoked.

Basmati
In 1997, RiceTec was granted patent for Basmati
by the US government.
It claimed a Equal to or Superior quality
Basmati
Claimed right to sell rice as Basmati
The Indian government opposed it by
mentioning that the patent will affect the
livelihood of many north Indian farmers.
US withdrew just 4 out of 20 claims and also the
right to call their rice lines "basmati.

Monsato - Wheat
MONSANTO, was assigned a patent on the
Indian variety of wheat Nap Hal under the
simple title plants.
On January 27th 2004 Research Foundation for
Science Technology and Ecology (RFSTE) along
with Greenpeace and Bharat Krishak Samaj filed
a petition challenging the patent rights.
The patent was resultantly revoked in October
2004.

Colgate case:
Colgate obtained a US patent in 2010 for the
tooth powder composition comprising rust-like
red iron oxide, clove oil, camphor, black pepper
and spearmint.
Indian activists are accusing Colgate of
'biopiracy' for allegedly stealing and patenting a
1,000-year-old folk recipe for toothpaste.
All the ingredients have been used by the
common Indian man for thousands of years.

Traditional Knowledge Digital Library


Set up in 2001, in collaboration between the
CSIR and the Department of AYUSH, Ministry
of Health & Family Welfare.
The objective is to protect the ancient and
traditional knowledge of the country from
exploitation through biopiracy and unethical
patents
TKDL contains more than 2.60 lakh
formulations covering Indian Systems of
Medicine, viz., Ayurveda, Unani, Siddha and
Yoga available in public domain.

Cont..
Library collects the information on traditional
knowledge from the literature existing in local
languages such as Sanskrit, Urdu, Arabic,
Persian and Tamil in digitized format.
Information will be available in five
international languages: English, German,
Spanish, French and Japanese
Signed agreements EPO, UKPTO and the
USPTO by giving patent examiners access to the
TKDL database for patent search and
examination.

Ethical aspects
Treating life as a commodity.
Should multicellular organisms be excluded
from patenting?
Does naturally created animals apply in whole
or in part to invented animals as well?
Do ethical issues arise when the current
patenting system is extended to a new type of
invention such as germ line engineering
produced by a new technology?
Should patents on germ line engineering be
permitted on the descendants in perpetuity?

Cont...
Risk of unexpected behaviour of new inventions.
To say that we own an animal is different from
saying that we invented it.
Should protections and guarantees, including
sharing in any profits, be extended to the human
subjects or communities that DNA material is
collected from?
Patent holders exploitation over their patent.

Thank you