Patenting of natural products
Content
Patenting of natural products
• Indian Patent act 1970
• Patentable and non-patentable
natural products
• Different steps involved in
obtaining patent
Ø Application for patent,
Ø Formality check
Ø Publication
Ø Request for examination
Ø Examination
Ø Issue of FER
Ø Response from the applicant
Ø Patent
Ø Pre grant opposition
Ø Grant of patent, renewal fees
Objective
At the
end of this lecture, student will be able to
• Discuss Indian Patent act 1970
• Explain patentable and non-patentable
natural products
• Explain the different steps involved
in obtaining patent
Indian Patent Act
Ø In
India the grant of patents is governed by the patent Act 1970 and Rules 1972
Ø The
patents granted under the act are operative in the whole of India
Ø With
reference to IPR, we will have 3
distinct phases
The patent
act 1970
Transition
period
Post GATT
period
1. Patent act 1970
Ø Most significant act in the legislature of
protection of IPR
Ø Act
came into force on 20th 1972
Ø As
per this act the major prerequisites for
patenting in India are
– A new
invention
– Should be new
and non-obvious with respect to the prior art
– It must be
useful
-Not previously
in use in India
Invention, as per the act may be defined as any new and
useful
Ø Art, process, method of manufacture
Ø Machine, apparatus or other article
Ø Substances
produced by manufacture, including any new and useful improvements of any of
them
Some examples in Pharmacy, which are patentable are
Ø New process of manufacture
Ø New
Chemical Entities (NCE)
Ø New
formulation process
Ø New composition of matter
Following are non-patentable in India
Ø Discoveries
Ø Method
of detection, diagnosis or treatment of diseases
Ø Analytical
methods
Ø Methods
of agriculture/cultivation
Ø Animals,
plants and biological methods for rearing and growing them
Ø Products
made by chemical synthesis
2. Transition period
Ø By becoming a member of WTO and accepting
GATT (General Agreement on Trade and Tariffs), it has become obligatory for our country to implement TRIPS
Ø TRIPS
– Trade Related Intellectual Property Agreement
Ø TRIPS
were signed in 1995 in Uruguay, which try to enforce a common patent law to all
its 117 signatory countries
Ø Trips
specifies product patent with a validity of 20 years
3. Post GATT period
Ø Govt
of India timely introduced a bill for the introduction of product patent regime
in place of process patent as per trips
|
Indian |
Post |
|
Process |
Product |
|
Indian |
Common |
|
Period of |
A period |
Patenting of natural products
Ø In
general naturally occurring plant materials as such are not patentable
Ø Therefore
medicinal plants are to be redefined as per the concepts of patent
Ø European
commission on patents suggests that a patent cannot simply be denied because it
involves living matter
Ø European
patent office stipulates certain regulations for patenting of natural products
Ø It
clearly distinguished an invention from discovery
Discovery: Finding out a substance occurring free in
nature
Invention: Novel isolation process of a natural
constituent from its surroundings
Non patentable natural products:
Ø Plants
growing wild
Ø Plants
adopted for cultivation
Ø Hybrids
of other cultural varieties, which have been tried for a particular use
Patentable natural products:
Ø A
novel isolation process
Ø Characterization
of the new product
Ø A
new application
Ø Biotechnology
related products
1. A novel isolation process of natural products from its
surroundings
Ø An
Indian patent, NCL, Poona – For the process of isolation of azadirachtin from the seeds of neem and also its storage
Ø An
Indian patent – For the processing technology of taxol isolation from taxus
species, CIAMP
Ø A
Chinese patent – Extraction of curcumin from turmeric
Ø A
poland patent – Isolation of artemisin from
Artemesia annua
Ø An
US patent, processing technology for the isolation of curcuminoids from
turmeric
2. Characterization for new product- By its structure
or by other physical parameters
3. A new application of an isolated compound
Ø A Japanese patent – For the use of
turmeric as a stabilizing agent for menadione, an anti fungal agent
Ø A
Belgian patent – Turmeric as an ingredient for imparting flash of golden yellow
colour to hair/hair dye preparation
Ø A
number of Indian traditional plants have been patented for various uses in US
|
Name |
Traditional |
In US |
|
Pomegranate |
Anti-bacterial |
Anti-viral |
|
Bitter |
Leaves – |
Anti-tumour |
|
Neem |
Anti-bacterial |
40 |
|
Pepper |
Digestant |
Decrease |
4. Patenting in relation with Bio technology
a. Patenting of biological matter:
Ø Before 1980 life forms were not patented in US
Ø First time the invention of oil eating
bacterium (Pseudomonas) was patented
Ø Patentable microbial inventions are methods for
producing new organisms like reducing pathogenesity, increasing biological
activity
Ø Antibiotics
and other products, invention of media or culture conditions
Ø Gene
recombination or cell fusion
b. Non naturally occurring, non-human multicellular
organisms:
Ø Transgenic
plants and transgenic animals
Ø Transgenic
plants – Herbicidal resistant cotton, insecticidal resistant tobacco
Ø Transgenic
animal – Oncomouse is patented
c. Patenting
of the secondary metabolites by cell culture
Ø Production
of taxol from taxus species
Ø Cantharanthine
and ajamalicine from Cantharanthus roseus
Ø Production
of shikonin – Lithospermum erythrorhizon
Stages from filing to grant of a patent
Ø File
an application for patent – With one of the patent offices based on territorial
jurisdiction of the place of office or residence of the applicant /agent – Pay
the required fee
Ø Information concerning application form and
details of fee available at www.ipindia.nic.in
Ø Guidelines for applicants also available on
this website
Ø Receiving
Office – Delhi, Kolkata, Chennai, and Mumbai.
Ø Language
of Filing – English or Hindi
Ø Forms
(2nd Schedule)
1 (Application
for Grant of Patent),
2 (Complete or Provisional Appln),
3 (Statement & Undertaking u/s 8
),
5 (Declaration As to Inventorship)
Formality Check
Ø An
Examiner checks the formal requirements before accepting the application and
the fee – this is done immediately
Ø Issue of application number and the cash
receipt – this is done the same day
Ø In
case of receipt of application by post, cash receipt, application number is
sent by post within 2- 3 days
Publication
Ø Application
is kept secret for a period of 18 months from the date of filing, In 19th
month, the application is published in the official journal – this journal is
made available on the website weekly
Ø Applicant has an option to get his application
published before 18 months also
Ø In that case, application is published within
one month of the request
Request for Examination
Ø Application
is examined on request
Ø Request for examination can be made either by
the applicant or by a third party
Ø A period of 48 months, from the date of
filing, is available for making request for examination
Examination
Ø Application
is sent to an Examiner within 1 month from the date of request for examination
Ø Examiner undertakes examination w.r.t. –
whether the claimed invention is not prohibited for grant of patent – whether
the invention meets the criteria of patentability
Issue of FER
Ø A
period of 1 to 3 months is available to Examiner to submit the report to the
Controller
Ø 1 months’ time available to Controller to vet
the Examiner’s report
Ø First Examination Report (FER) containing list
of the objections is issued within 6 months from the date of filing of request
Response from the applicant
Ø 12
months’ time, from the date of issue of FER, is available to the applicant to
meet the objections
Ø If
objections are met, grant of patent is approved by the Controller – within a
period of 1 month
Patent Pre-grant Opposition
Ø After publication, an opposition can be filed
within a period of 6 months. Opportunity of hearing the opponent is also
available
Examination of Pre-grant Opposition
Ø Opposition
(documents) is sent to the applicant
Ø A period of 3 months is allowed for receipt of
response
Consideration of pre grant opposition
• After
examining the opposition and the submissions made during the hearing,
Controller may – Either reject the opposition and grant the patent – Or accept
the opposition and modify/reject the patent application
• This is to be done within a period of 1 month
from the date of completion of opposition proceedings
Grant of Patent
Ø A
certificate of patent is issued within 7 days. Grant of patent is published in
the official journal
Renewal Fee
Ø To
be paid within 3+6 months from date of recording in the register [sec 142 (4) ]
Ø No fee for 1st and 2nd year. Renewal fee, on
yearly basis, is required to be paid for 3rd to 20th for keeping the patent in
force
Ø Delay up to six months from due date
permissible on payment of fee for extension of time
Ø Patent
lapses if renewal fee is not paid within the prescribed period
Rights of a Patentee
Right to exploit the patent
Ø The
patentee has a right to prevent 3rd parties, from exploiting the patented
invention
Right to grant license
Ø The
patentee has a power to assign rights or grant license
Right to surrender
Ø The
patentee is given the right to surrender the patent by giving notice in
prescribed manner to the controller
Right to sue for infringement
Ø A
patentee is given the right to institute proceeding for infringement of the
patent in a district court
Summary
Ø Indian
patent act -1970
Ø Transition
period and post GATT period
Ø Discovery
and inventions
Ø Non
patentable natural products – Plants growing wild, adopted for cultivation, hybrids
Ø Patentable
– Novel isolation, characterization, production of secondary metabolites by
cell cultures and biotechnology related products