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

Indian patent act 1970	Post GATT
Process patent	Product patent
Indian context	Common patent system in all 117 countries
Period of validity: 5 years from the date of patent grant/7 years from the date of filing the application for drugs and food substances	A period of 20 years

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 of the herb	Traditional use	In US patented for
Pomegranate	Anti-bacterial	Anti-viral
Bitter guard	Leaves – Anti diabetic	Anti-tumour
Neem	Anti-bacterial	40 patents for various uses
Pepper	Digestant	Decrease the dose of Rifamycin

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