Patenting of biological materials

CONTENTS

•INTRODUCTION

•HISTORY

•PATENT OF HUMAN GENETIC MATERIAL

•PROTEIN AND DNA SEQUENCE INSTRUMENTS

•PATENT OF BIOTECHNOLOGICAL INVENTIONS

•PATENTING OF MICROORGANISM

•PLANT PROCESSES

•GENE PATENTS

•APPLICATIONS

•ADVANTAGES OF PATENTING

INTRODUCTION

•Biological patent is the patent on an invention in the field of biology that by law allow the patent holder to exclude others from making , using , selling or importing the important invention for a limited period of time .

•It may include biological technology and products , GMO’s and even genetic material.

•Patent system varies from country to country.

HISTORY

•Patent Act 1970 which amended in 1999,2002 and recently in 2005. This makes biological processes as patentable , including biochemical , biotechnological and microbiological processes under section 5.

•The Act of 1970 has provision for the process Patent . Now also amended Act also covers product patents.

•Product patent doesn’t allow manipulation of existing processes or methods .

•General Agreement on Tariffs and Trade(GATT)

•Negotiation started in 1947 and ended in 1993

•GATT Negotiation signed by WTO (World Trade Organization) Member- states-1994

•Agreement (WTO) including TRIPS(The Agreement on Trade-Related Aspects of Intellectual Property Rights) came into 1995.

PATENT ON HUMAN GENETIC MATERIAL

In 1984,human cell line producing cancer-fighter proteins was isolated from the body of patient .

Now patents on methods to isolate human genetic material and also on proteins product by human genetic material are allowed.

Patent have been granted for producing foreign protein in transformed species of bacteria.

Patent has been granted on DNA sequence.

Patent on chimeric gene, that means combination of human and animal gene, has been granted

Human cloning methods of the therapeutic purpose can be patented.

Human cloning is prohibited.

PROTEIN AND DNA SEQUENCING INSTRUMENTS

Highly sensitive DNA and protein sequencers.

Were developed at California Institute of Technology. But it required help of substantial private investment.

Prototype was developed in Hood’s laboratory during 1970-86

This laboratory sequenced lymphocytes , platelet-derived growth factor and interferon’s.

PATENTING OF BIOTECHNOLOGICAL INVENTIONS

•DNA  sequence patent:-

•EPO:-European patent Office

•USPTO:-United States Patent and Trademark Office .

•JPO:- Japan Patent Office

•Common position on DNA sequence patents:-

•More determination of DNA sequence is not patentable

•Inventor to identify gene ,its useful function , to isolate and clone the gene and thereby make synthetic copies of gene that are unavailable for use in therapy –this can be patented.

PATENTING OF MICROORGANISM

•Till 1980’s life was not considered as patentable ,during that period, German Federal  Court upheld patent of new microorganisms.

•Australia –naturally occurring microorganisms –not patentable , but allowed use of naturally occurring microorganisms to produce new product.

•US Supreme Court – Inventor Dr. Charabarty sought patent on “Genetically modified Bacteria” being capable of eating oil spills.  It Was permitted.

•Microorganisms in its Claimed form doesn’t exist in nature.

•It was a product of human ingenuity that can be patented even if it encompass living being .

•This decision resulted in filling of large number of patents for genetically modified organisms.

PLANTS PROCESSES

•Patentable inventions

•             Processes involving plants to increase the yield

•              Genetic transformation

•               Tissue culture methods

•               Micro-propagation

•               Somatic embryogenesis

GENE PATENTS

Useful products

•          Claims

•           DNA of specific function /nucleotides sequence

•           Recombinant plasmid

•           GMO’s containing the plasmid

•           A process for the production of product

APPLICATION OF DNA SEQUENCES IN RELATION TO PATENT CLAIMS

•Diagnostic testing         -BRCA1

•Research tools               -CCR5 Receptor

•Production of protein   -Human insulin   

                                             -EPO

ADVANTAGES OF PATENTING

•Avoids duplication of research

•Keeps abreast with latest development in different fields of technology

•Helps industry to improve existing technology to produce cheaper and better product

•Helps to frame business strategy according to trend of technology.