Patent Potential in Molecular Biology Research

Dr Karan Veer Singh,

Scientist

NBAGR, Karnal

Patent

NoveltyPrior art

InventivenessNon-obviousnessSkilled Person

Usefulness

Historical PerspectivePatent Act 1970 Amended in 1999, 2002 and recently in 2005

The Act of 1970 has provision for process patent. Now amended Act also covers product patents.

British Era Patents and designs Act, 1911

Cont…(Historical Perspective)

India is socialist country. Constitution of India guarantee social justice to all.

Reverse Engineering

Involves manipulating an existing process or method to produce a new process or method. India was alleged to encourage reverse engineering by not providing product patents.

Cont…(Historical Perspective)

Product patent does not allow manipulation of existing processes or methods.

General Agreement on Tariffs and Trade (GAAT)

Negotiations started in 1947 and ended in 1993

GATT negotiations signed by WTO Member-States - 1994

Agreement (WTO) including TRIPS came into being on 1-1-1995.

Article 27 of TRIPS Agreement provides blanket permission for patents on all types of inventions including product and process patents.

Patent Act of India 1970 does not provide granting of product patents. Further food and pharmaceutical forms were an exception to patenting.

Cont……(Historical Perspective)

India was given 10 years transformation period to implement provisions of TRIPS, which ended on 1-1-2005.

The objective of amendment was to grant Exclusive Marketing Rights to the patent applications claiming food products (agricultural products) and pharmaceuticals.

The latest amendment to the Patent Act was in 27-3-2005 which brings Patent Act in conformity with TRIPS Agreement.

Cont…(Historical Perspective)

Patentable Subject Matter

Patent system varies from country to country.

US Patent LawWhat is patentable “whoever invents or discovers any new and useful process, machine, manufacture or composition of matter, or any new and useful improvement thereof, may obtain a patent”.

England Patent Law stateswhat is not patentable“Inventions against public interest, public policy and morality are not patentable”.

As a matter of practice, inventions relating to life were kept outside the purview of patentable subject matter.

Cont…(Patentable Subject Matter)

Living beings eg. Microorganisms, plants and animals produced through natural or biological processes are not patentable.

Non-natural living beings produced through non-biological processes like biotechnological processes are patentable.

Now genetically modified organisms, which are non-natural can be patented.

Cont…(Patentable Subject Matter)

LIFE AS A PATENTABLE SUBJECT MATTER in 1980’s in US

Patent was filed on a method of breeding of doves.

The patent was rejected on the ground that the breeding method was not repeatable.

The patent office did not answer question whether living being is patentable or not.

LIFE FORMS

Lower Life FormsSingle cell organisms eg. bacteria, fungi, algaeCertain multicellular organisms eg. Plants

High Life FormsMulticellulaur organisms eg. animals and human beingsAnimals and human beings think and express in contrast to plants

Patenting Lower Life-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 CourtInventor Dr. Charabarty sought patent on “Genetically

modified bacteria” being capable of eating oil spills”. It was permitted.

Microorganism in its Claimed Form does not exist in nature.

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

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

Cont…(Patenting Lower Life-Microorganism)

Plant as Patentable Subject Matter

US patent office did not allow patent for mutant of maize plant

Board of Patent Appealsallowed patent of mutant maize

Patent on Higher Life: Animal

US patent office allowed Patenting of Oncomouse. The claim was

for genetically modified mouse susceptible to cancer disease that is useful for cancer research and drug development.

16 patents are granted on transgenic mice. Patents for transgenic pig, rabbit, sheep are also granted.

Patent on Human Genetic Material

1984, human cell line producing cancer-fighter proteins was isolated from the body of patient name ‘Moore’.

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

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

Patent has been granted on DNA sequence coding human protein erythropoietin (EPO) on the protein itself. (Erythropoietin is a protein that boosts red blood cell production)

Patent on chimeric gene (combination of human gene and animal gene) has been granted.

Patent on DNA and RNA for human insulin like growth factors (mediation of somatic cell growth on the administration of growth hormone).

Cont…(Patent on Human Genetic Material)

Patent on DNA and cDNA encoding Heparin-Binding growth factors and & HBGF stimulate cell division and facilitate the repair or replacement of damaged or diseased tissue

Human cloning methods of the therapeutic purpose can be patented

Human cloning is prohibited

Cont…(Patent on Human Genetic Material)

What is Next.Will the non-natural human beings be

patented?

European Union’s Directive prohibits

patenting of invention of human cloning and non-natural human being on ethical grounds

Processes of cloning human being

Processes for modifying the germ line genetic identity of human being

Use of human embryos for industrial or commercial purposes

TRIPS agreement gives flexibility to member-states to prohibit patents on the basis of public order and morality.

Cont…(What is next)

Case StudyRecombinant DNAA patented Research tool, non-exclusively licensed

with low fees.

Cohen-Boyer Technology for recombinant DNA, most successful patent in University licensing.It has three patents

Process for making molecular chimeras

Product patent :proteins produced using recombinant prokaryote DNA.

Product patent : Proteins produced using recombinant eukaryotic DNA.

Application was filed by Stanford University in Nov. 1974.

Stanley Cohen and Herbert Boyer at together developed technique at Stanford and the University of California, San Francisco respectively.

Dec.1980, process patent for making molecular chimeras was issued.

Cont… (Case Study)

In 1984, product patent for prokaryotic DNA was issued.

Licensing agreement generated $139 million (700 crore Rupee) royalties as on 13-02-1995.

The technology was inexpensive and easy to use. There was no alternative. The technology was critical to research in molecular biology.

Technology developed in Universities through publicly funded research. Licenses inexpensive and minimum rider. Tremendous volume of sale

Cont… (Case Study)

Bayh-Dole Act- Exclusive License is recommended

Nelson, Director of Technology Licensing office at MIT was of view that Industry- sponsored research- university will retain ownership but will give first option to sponsor for an exclusive license.

Cont… (Case Study)

PCR and Taq Polymerase PCR allows specific and rapid amplification of target

DNA

Taq polymerase, the heat stable DNA polymerase used in the amplification

Kary Mullis was primary inventor of PCR working at Cetus corporation. He won Noble prize in 1985. PCR is developed in corporate environment.

Cetus corporation sold PCR patent to Hoffman-La Roche for $300 million in 1991.

The products are to be purchased to provide rights to use technology.

The product license policy was instituted by cetus.

Roche established three categories of licences(i) Research application eg. human genome

project(ii) Disease diagnosis(iii) PCR licensing programs

Cont…(PCR and Taq Polymerase)

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 1970-1986. this laboratory sequenced lymphokines, platelet-derived growth factor and interferons. Since middle of 1990’s the technology became widely available.

Funds for instrumentation by NIH was denied. Dr. Hood approached 19 companies; all declined support. Publication by Nature derived and treated it as a speculation.

Finally Applied Bio System agreed to fund but for exclusive license. ABI has sold more 3000 DNA sequencers and more than 1,000 protein sequencers.

LI-COR developed infrared fluorescence DNA sequencer. The company negotiated cross-licenses to develop its product

Cont…(Protein and DNA sequencing Instruments)

Patents for genetic inventions

Three categoriesCloningProduction of therapeutic proteinsAdvances in plant biotechnology: improving agricultural productivityGenes as diagnostic tools: Diagnosis of genes implicated in disease of DNA coding sequence enables

Molecular Biology Related Patents

Jawaharlal Nehru Centre for Advanced Scientific Research

Process for extraction of superior quality of DNA

A high sensitivity assay for molecular tying of biological samples, Probes and a kit thereof

Tat DNA sequences, Gene constructs, Vaccine and processes thereof

Patenting of Biotechnological Inventions

DNA sequence patents:

• EPO: European Patent Office• USPTO: United States Patent and Trademark Office • JPO: Japan Patent Office.

Common position on DNA sequence patents -Mere 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 diagnosis or therapy – this can be patented.

THANKS