Patenting in biotechnology can be safely arrived at when law and morality are juxtaposed together.
Patent laws involve no simple application and implementation process as maybe the case with other laws. The patenting system has umpteen restrictions set upon it and a myriad of limitations that it is bound by, due to its conflicting and complicated nature. So, patenting in biotechnology seems like a quagmire through which it seems impenetrable to get through. However, Biotechnology Patents Laws do exist in different spheres of the world, including India itself, the U.S., European Union, Australia, etc. Issuing property rights over intangible property has its own set of difficulties which are dealt with in the various patent laws governing biotechnology. Since the association of biotechnology and patents has been fairly new due to the commercialization potential of biotechnology in recent years, the age-old patenting system has accommodated new subject matter such as DNA sequences, microorganisms, plants and animals which were not intended to be included during the time when the patenting laws were formulated.
Biotechnological inventions cover the ambit of techniques that use living organisms or their parts to produce or modify certain traits/attributes of plant species, animal species and living or non-living microorganisms. All those products that are related to biotechnology are known as “bio-matter” and this bio-matter can be living, non-living and in some cases, a situation between living and non-living like viruses.
Biotechnological innovations can also be referred to as “genetic engineering” and this genetic engineering has helped create a variety of miraculous new drugs like human insulin, various vaccines, interferons, etc., that are used to treat numerous human ailments such as anaemia, cancer, AIDS, hepatitis, etc.
These products can be protected by the grants of patents. However, there are certain rules and exceptions to patent protection in various countries for these inventions that will be dealt with hereafter.
RULES REGARDING PATENTS IN BIOTECHNOLOGY:
The present legal situation in India is that all inventions pertaining to living matter are patentable. The only exceptions are:
a) the mere discovery of a scientific principle or coming up with an abstract theory or even a discovery relating to living and non-living compounds occurring in nature;
b) the biological processes that are involved in the scientific production/propagation of plants and animals, including microorganisms.
UNITED STATES OF AMERICA:
The authority to grant patents in the U.S. is provided under their Constitution only. They follow a very liberal approach to what can be included in patentable subject matter. It includes any useful and novel machinery, manufacture, process, composition of matter or any such kind of improvement. It basically aims to include almost everything as was settled in the judgment of the famous case, Diamond v. Chakrabarty.
A very common issue that arises during the patentability of biotechnology is the distinction between discoveries and inventions. Naturally occurring substances or discoveries are not patentable. However, patentability can be granted to those naturally occurring substances which could not have been made available to the general public if not for technical intervention.
The countries of European Union follow the principle that any invention which is novel, has an inventive step and has an industrial application is a subject to patentability. Discoveries are expressly excluded, however, discoveries that involve a technical intervention cease to make it a discovery and thus, can be patented.
Another principle that E.U. adheres to is that if any invention is at loggerheads with the public order or morality of the society, it is not patentable. Examples include cloning of human beings or using the human embryos for industrial and commercial testing.
It becomes very difficult for law to join hands with protecting the intangible property rights of biotechnology patents. The only way to get about this problem is through striking a balance between property rights of biotechnological inventions and the greater good that is served to the human community at large.