PATENTABILITY OF MICRO-ORGANISMS

CHAKRAVARTY TO TRIPS AND BEYOND

By – Manpreet Kaur

LLM (Business Laws)

National Law School of India University, Bangalore

THE RATIONALE

INNOVATION AND ENTERPRISE

INDUSTRIAL AND TECHNICAL PROGRESS

SOCIO ECONOMIC PROGRESS

Where to draw the line?

Patentability of micro-organisms has ignited a debate

1. Unethical – life forms

2. Discovery – invention dichotomy

3. Definitional ambiguities

4. Part of Bio-diversity CBD

THE BASIC PATENTABILITY CRITERIA

NEW / NOVEL

INVENTIVE STEP / NON-OBVIOUS

CAPABLE OF INDUSTRIAL APPLICATION OR USEFULNESS

THE TRIPS AGREEMENT

ARTICLE 27.1- PATENTABLE SUBJECT MATTER

patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application…….patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.

PATENTABILITY – US POSITION

35 U.S.C Section 101 – “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 therefore, subject to the conditions and requirements of this title”

Patentability of Micro-organisms – US position

Diamond v. Chakravarty 447 U.S. 303 (1980)

Facts –

“A bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway” was a human-made, genetically engineered bacterium capable of breaking down multiple components of crude oil. It was asserted that because of this property, which is possessed by no naturally occurring bacteria, the invention could treat oil spills.

Diamond v Chakravarty – the Claims

first, process claims for the method of producing the bacteria;

second, claims for an inoculum comprised of a carrier material floating on water, such as straw, and the new bacteria; and

third, claims to the bacteria themselves.

Diamond v Chakravarty

“Invention – Discovery” dichotomy

“Composition of Matter” or “Manufacture”

“Anything under the sun that is made by man”

PATENTING OF MICRO-ORGANISMS

ARTICLE 27.3(b)

Members may also exclude from patentability: plants and animals other than microorganisms, and essentially biological processes for the production of plants and animals other than non-biological and microbiological processes.

DIMMINACO AG v. CONTROLLER OF PATENTS & DESIGNS

Dimminaco A.G., a Swiss Company applied for patenting “the process for preparation of a live vaccine for Bursitis”.

Indian position

2002 Amendment Section 3(j) of the Indian Patents Act 2005 amendment Compliance with TRIPS

Conclusion & Suggestions Defining the term “micro-organism” in a precise and scientific

manner

Mitigating the rigours of patent “overspill” by devoted application of general patentability criteria (novelty, non-obviousness and utility), to the inventions involving living subject matter such as micro-organisms.

Striking an efficacious balance in the realm of “discovery-invention” dichotomy, by granting patents to only those inventions which involve substantial human intervention (for example- genetic engineering). It entails that mere isolation or purification of micro-organisms through known procedure should not be patented.

THANK YOU