Current Status of Patenting Genes and Microorganisms in India

Asha K.

Intellectual Property

It is a product of mind, created by the exercise of intellectual faculty.

Similar to movable or immovable properties

Protected by the appropriate national legislations

Different Intellectual Property Rights

Patents

Copyright

Trade marks

Industrial design

Geographical indication

Trade secrets

What is a Patent?

A patent is an exclusive right granted by the

government for the commercial exploitation of invention

for a specific period of time

Right to prevent the use by a third party

Why do we need a patent system….

Induce inventor to disclose his invention

Encourage research activities

Reasonable assurance for commercialization

History……..

1856 - First provision in nature of Patent Right.

1872 - The patents and Design Protection Act

1911 - The Indian patents and Design Act

1970 - Patent Act

1999 - First Amendment of Patent Act

2002 - Second Amendment of Patent Act.

2005 - Third Amendment of Patent Act.

Novelty

Inventiveness

Industrial applicability

Criteria for patentability

Who can be an applicant?

True and first inventor

His \her assignee

Legal representative

Where to apply?

Patent Administration in India

Ministry of commerce and industry

Controller general of Patents, Designs, Trademark & GI

Senior joint controller of Patents and Designs

Deputy controller of Patents and Designs

Assistant controller of Patents and Designs

Examiners of Patents and Designs

Patent office Territorial Jurisdiction

MumbaiGujarat, Maharastra, M.P, Goa, Chattisgarh,

Daman and Diu, Dadra and Nager Haveli

DelhiHaryana, Himachal Pradesh, J.K., U.P.,

Punjab, Rajasthan, Uttaranchal, Chandigarh

Chennai A.P., Karnataka, Kerala, Tamil Nadu,

Pondicherry and Lakshadweep

Kolkata(H. O.)

Rest of India

Ordinary application

Convention application

Application for patent of Addition

Divisional application

PCT application

Different types of patent application

PCT Application

PCT- Patent Cooperation Treaty

India became a member of PCT in 1998

Agreement for international cooperation in the field of Patents.

Single application in a single language in a single patent office is sufficient

Processing of PCT Application

Formal examination.

International search

International publication

Provisional or complete specification

Declaration as to inventorship

Priority document

Proof of right

Patent application should contain...

Provisional Specification

Priority

Title of the invention

Description of invention

• Principle of invention

• General statement of actual invention

Complete specification

Techno - legal document

Contents A Title

Field of invention

State of the art in field

Objects of the invention

Detailed description of invention

Claims

Abstract

Claims makes the picture clear....

Single sentences

Possible equivalent variations

Not be too wide

Must be specific

The attractiveness and importance

PUBLICATION OF INVENTION

After 18 months from priority date

Early publication possible on request

Form 9 Fee: Rs.2500 /- or 10,000/-

What is published?

Date of application

Number of application

Name and address of applicant

Abstract of invention

Request for Examination

Form 18

Fee: Rs.2000/- or 10,000/-

Request within 48 months from the Priority date

No request : Application is treated as withdrawn

STAGES OF EXAMINATION

First Examination report (FER)

Formal Examination Technical examination

Opposition to the grant of Patent 

Form 15, fees Rs.300/-

Within 4 months from acceptance of the

complete specification

The Controller, notifies the applicant.

The opponent and the applicant are required to

file their statements

Granted by the controller

6 months from the period of FER

No need to make a separate request

Term of Patent

20 years as per patent amendment act 2002

Grant of patent

(Chandrasekaran, 2005)

Patent Grant ProcedurePatent Grant Procedure

Filing of patent application

Request for examination

Examination: Grant or Refusal

Publication of Grant of patent

Opposition to the patent

Decision by Controller

Early Publication Publication after 18 months

Patenting of Life Forms as per TRIPs

Article 27.3(b) explains……….

Members may exclude from patentability

Plants and animals other than microorganisms and

essentially biological process for the production of plants

and animals other than nonbiological and

microbiological process

On dissecting article 27.3(b)

Can exclude plants, animals and essentially

biological process

Must allow patents for microorganisms and

microbiological process.

Must provide protection for plant varieties

First patent based on microorganisms Louis US Patent No 141072 in 1873 for a process of

fermenting Beer Pasture was awarded using a yeast

www.uspto.gov/

Diamond v/s Chakrabarty Case

Developed a bacterium capable of breaking down

crude oil.

US patent office refused to give the patent

“Living organism is patentable since it involved a

human intervention”

(Eisenberg, 2006)

Dimminaco A.G filed a process patent of preparing

infectious Bursitis vaccine

The application was turned down by the Patent

Office

In 2002 Kolkata High Court granted patent for the

invention involving microorganism

A Landmark Decision for India

Budapest Treaty

Union for the international recognition of the deposit of microorganisms.

Signed in Budapest, Hungary in1977

Administrated by WIPO.

India become a signatory from 2001.

Purpose

• Sufficiency of disclosure of biological material

International Depository Authority for India

MTCC centre at Chandigarh.

Recognized as IDA in 2002

Requirements for deposit

Kind of organism

Technical requirements

Administrative requirements

(Arora et al, 2005)

Living entities of Natural origin

Any process of manufacture or production of living entities

Any method of treatment to human beings or animals

Transgenic plants and animals

Biological materials such as organs , tissues ,cells, viruses and process of preparing them.

Non Patentables in Biotechnology Indian status

Gene Sequences, DNA Sequences without disclosed function

Essentially biological process for production of plants and animals

Any biological material or a method causing serious prejudice to human, plant life, health or environment

Process of cloning human beings or animals .

Contd…

Then, What we can patent………

Recombinant DNA, Plasmids.

Process of manufacturing.

Recombinant microorganism

DNA sequence whose function is disclosed

(Saha, 2004)

Biotechnology patents in India by area of filing 1999-2003

Major applicants

(Saha, 2004)

A PROCESS FOR THE ISOLATION AND ACCLIMATION OF BACTERIA FOR LIGNIN DEGRADATION

LACTIC ACID BACTERIA CAPABLE OF REDUCING AN I INDIVIDUAL'S TENDENCY TO DEVELOP ALLERGIC REACTIONS

BIO POWE MICRONISED COMPOUND MICROPOUND FROM THE ACTIVE PRINCIPLES OF INACTIVATED SOIL BENEFICIAL BACTERIA FORTIFIED WITH BLUE GREEN ALGAE FOR IMPROVING SOIL CONDITION TO MOBILIZE NUTREINTS FOR ABSORPTION OF PLANT

MODIFICATION OF BACTERIA

EXPRESSION OF AN ANTIMICROBIAL PEPTIDE VIA THE PLASTID GENOME TO CONTROL PHYTOPATHOGENIC BACTERIA

BEVERAGES CONTAINING LIVE LACTIC BACTERIA

374/DEL/03

00404/CHENP/2003

1096/MUM/2002

IN/PCT/2002/01972/CHE

IN/PCT/2002/01370

IN/PCT/2002/01087

MICROORGANISM RELATED PATENTS IN INDIA Total no : 600

(Saha, 2004)

A METHOD FOR PRODUCING A VECTOR FOR INTRODUCING A DESIRED GENE INTO A PLANT

A METHOD FOR PRODUCING A VECTOR FOR INTRODUCING A DESIRED GENE INTO A PLANT

METHOD FOR ACCUMULATING FOREIGN GENE PRODUCT AT A HIGH LEVEL IN PLANT SEEDS

A METHOD OF DETECTION OF SP A2 GENE VARIANTS USEFUL FOR PREDICTION OF PREDISPOSTION OTO ASPERGILLUSIS

GENE ENCODING PROTEIN EXHIBITING AGARASE ACTIVITY OBTAINED FROM AN INDIAN SOIL ISOLATE

A NOVEL GENE OSISAP I OR RICE AND A METHOD OF INTRODUCING STRESS TOLERANCES IN PLANT SYSTEMS USIN G THE GENE OSISAP I

THE CHARACTERIZATION OF HUP B GENE ENCODING HISTONE LIKE PROTEIN OF MYCOBACTERIAL TUBERCULOSIS

NOVEL ENZYME AND THE GENE ENCODING THE ENZYME

358/MAS/2003

00594/DELNP/2003

00300/CHENP/2003

44/MAS/2003

00160/CHENP/2003

1317/DEL/2002 a

1274/DEL/2002

IN/PCT/2002/01387

Gene related patents in India Total no 146

(Saha, 2004)

Websites for patent search

http://www.uspto.gov/

http://www.ipindia.nic.in

http://www.indianpatents.org.in/

http://www.pctgazette.wipo.int

http://www.pk2id.delhi.nic.in

Present Needs

Patent awareness programmes

Patent cell for biological material

Increase the number of depositories