Patenting of natural products

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 20^th 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

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

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)

26 (Power of Attorney)

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