PATENTING AND REGULATORY REQUIREMENTS OF NATURAL PRODUCTS

1. PATENTING AND REGULATORY REQUIREMENTS OF
NATURAL PRODUCTS
PRESENTED BY-ANIKETH B.SURVE

2. PATENT
 DEFINATION
 Exclusive Right given to inventor for his/her invention for particular period
over limited territory.
 Term of every patent in India is 20 years from the date of filing of patent
application, irrespective of whether it is filed with provisional or complete
specification.
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3. TYPE OF IPR
IPR
PATENT
INDUSTRIAL
DESIGN
TRADE SECRET
C0PYRIGHT
TRADEMARK
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4. BREEDER RIGHT’S
 Plant breeder right (PBR) also known as plant variety rights (PVR) are rights
granted to breeder a new variety of plant that give the exculsive control over
the propagating material including (seed, cutting, tissue cultures) and
harvested material like (cut flowers, fruit) of a new variety for a number of
years. with these rights, the breeder can choose to become the exculsive
marketer of the variety, or to license the variety to others.
 in order to qualify for these exculsive rights ,a variety must be new, uniform
and stable.
 Stable if the plant characteristics are genetically fixed and therefore remain
the same from generation to generation or after a cycle of reproduction in
the case of hybrid variety.
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5.  Distinct if it differs from all other known varities by one or more important
botanical characteristics such as height and shape.
 The breeder must also give the variety an acceptable ‘denominator’ which
becomes it generic name and must be used by anyone who markets the
variety.
 Typically, plant variety rights are granted by national officers,after
examination seed is submitted to the plant variety office,who grow it for one
or more seasons,to check that is distinct, stable and uniform.if these tests are
passed, exculsive rights are granted for a specified period(typically 20/25
years for trees and vines. annual renewal fees are required to maintain the
rights.
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6. FARMER RIGHT’S
 Farmer’s rights are a precondition for the maintainence of crop genetic
diversity,the maintaince of crop genetic diversity,which is thebasis of all food
and agriculture.production in the world basically realizing farmer’s rights
means enabling farmers to maintain and develop crop genetic resources as
they have done,since the dawn of agriculture and recognizing them for its
indispensable contribution to the pool of genetic resources.
 Farmers rights consist of the customary rights of farmers to
save,use,exchange and sell farm-saved seed and propagating material ,their
rights to be recognized,rewarded and supported for their contribution to the
global pool of genetic resource as well as to the development of commercial
varities of plants,and to participate in decision making on issues related to
crop genetic resources.
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7. BIOPROSPECTING
 Bioprospecting is the process of discovery and commercialization of new
products based on biological resources. these resource or compounds can be
important for useful in many fields including pharmaceuticals, agriculture,
bioremediation and nanomedicine.
 Between 1981-2010,one third of all small molecule new chemical entities
approved by the U.S. food and drug administration (FDA) were either natural
products or compounds derived from natural products. despite indigenus
knowledge being helpful, bioprospecting has only recently begun to
incorporate knowledge in focusing screening effortys for bioactive
compounds.
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8. BIOPIRACY
 The term biopiracy was coined by pat mooney, to describe a practice in which
indigenous knowledge of nature, originating with indigenous peoples, is used
by other for profit, without authorization or compensation to the indigenous
people themselves.
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9. TURMERIC
 Turmeric (curcuma longa) is a perennial plant,which is native to the tropical
regions of southern asia.it is a plant that is frequently used in regional
cooking as well as having a central place in Ayurveda and Chinese medicine to
treat various ailments.its use within the medicinal field has been found to
help against among other things inflammations,digestive disorders,liver
diseases and cancer.
 Patent-
 In 1995 two indian scientist working in the U.S were granted a patent for a
method of”promoting healing of a wound by administering turmeric to a
patent with the wound.the patent was assigned to the university of Mississippi
medical centre.
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10. ANIKETH B.SURVE 10
 Opposition-
 The council of scientific and industrial research (CSIR) claimed that the
patent lacked novelty as the use of turmeric as a method for healing wounds
was age old in india and therefore a part of the prior art CSIR presented 32
references, some of them over a hundred year old,to support that the claims
of the patent were well known and part of the prior art.in 1997,the USPTO
rejected all six claims of the patent as anticipated by the administration of
CSIR. the patent was thus declared invalid,
 The university of missippi medical centre decided after this intial blow to
abandon the patent and the patent was reassigned to the inventors.the
inventors choose to pursue the case further on the grounds.

11.  The powder and paste had different physical properties. i.e bioavailability
and absorbability and therefore one of the ordinary skill in the art would not
expect, with any reasonable degree of certainity,that a powdered material
would be useful in the same application as a paste of the same material.the
inventors further mentioned that oral administration was available only with
honey and honey itself was considered to have woundhealing properties. the
USPTO however rejected this objection and stated that the references
submitted by CSIR.in 1997 the claims were rejected a second time, and in
1998 the re-examination certificate was issued which signified with end of the
case
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12.  Summary-
 The turmeric case is widely hailed as the first patent re-examination case
where the rejection was based on the presentation of TK.
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13. NEEM
 The neem tree (azadiracta indica) is a large tropical evergreen that can grow
upto 80 meter tall and 2.5 meter in width.the tree carries a yellow or
greenish yellow fruit,which hows a seed.the exact origin of the tree is
unknown.it is found in many different countries,but it is india that the tree is
most widely spread;the subcontinent is estimated to contain approximately
18 million neem trees.the tree has been shown to be useful in many different
areas including contraception ,dental hygiene and pesticides as well as being
part of many traditional indian medicines and cures,the widespread growth of
the neem tree and its many practical uses has made the neem tree very dear
to the indian people to whom it represent an integral part of their traditional
and even religious heritage.
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14.  Indian scientist have been researching the neem tree as a natural pesticide
since the at the1920’s but western awareness of its qualities was raised until
1959 when german entomologist heinrich schmutter witnessed a locust plague
in the sudan and to neem trees were the only ones that had withstood the
esonslaught.he immediately started studying the neem tree and his work in
turn generated a great deal of western scientific interest in pesticide
qualities.that the neem tree could withstand locust infestations had been
common knowledge among indian the farmers for centuries. both the seeds
and to a lesser extent the leaves contain the active substance azadirachtin
which is a powerful insecticide that is not harmful to human beings.
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15.  The patent-
 The first U.S patent on a storage stable composition for
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