Patentable Inventions in Biotechnology :

The exciting developments in the domain of biotechnology have resulted in intensive R&D activities all over the world including India. After information technology, biotechnology is increasingly recognised as the next wave in the knowledge-based economy. Biotechnology has been at the core of a number of important developments in the pharmaceutical, agrochemical, energy and environmental sectors. In particular, progress in the field of molecular biology, biotechnology and molecular medicine has highlighted the potential of biotechnology for the pharmaceutical industry.

Conventionally, a micro-organism is considered as an organism that is microscopic, i.e., too small to be seen by the naked human eye and can be viewed only under a microscope, usually, an ordinary light microscope. Micro-organisms include bacteria, fungi, virus, protists and other prokaryotes as well as some microscopic plants (phytoplankton) and animals (zooplankton).

Prior to 1980, micro-organisms were clearly “products of nature” and as such were not considered patentable. In 1980 the US Supreme Court in Anand Chakrabarty’s case allowed patenting of crude oil spilling bacterium) and this subject has been drawing a great deal of attention all over the world. As microorganisms are important constituents of biodiversity, issues like the origin of a microorganism and its patentability and ownership have gained importance.

The US Supreme Court ruled that genetically altered micro-organisms were indeed patentable based on the following criteria:

• They were man-made;

• They were products of human manipulation and therefore considered similar to any other invention;

• They had a specified industrial application (one criterion for patenting is that the invention has utility).

Further, Supreme Court cited the fact that there was precedence for patenting living matter. Since 1930 certain asexually reproduced plants have been protected by patenting. Furthermore, in 1970 the Plant Variety Protection Act allowed for protection of some sexually reproduced plants.

As a result of the Supreme Court’s decision, the US biotechnology industry flourished and many US patents have been granted on human-made higher life forms such as transgenic mice, fish etc. Thus, microorganisms, plants and animals have now all received U.S. patenting status. Europe views patenting of “man-made” life in much the same manner as the U.S. patent office.

TRIPS Agreement obliges member states to patent micro-organisms. Article 27.3 permits WTO member countries to exclude two specific classes of subject matter from patentability:

(1) diagnostic, therapeutic, and surgical methods for the treatment of humans or animals; and

(2) plants and animals other than microorganisms, and essentially biological processes for the production of plants or animals other than non biological and microbiological processes.

Though the TRIPS agreement mandates patent protection for micro-organisms, it does not define microorganisms; thus there is no standard definition for member nations to follow.

To comply with the World Trade Organization (WTO), Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, India amended the Patents Act, 1970 with effect from January 2005. The Indian Patent Act has now a specific provision in regard to patenting of micro-organisms and microbiological processes. It is now possible to get a patent for a microbiological process and also products emanating from such processes.

The most vital distinction between the legal practices of India and developed countries is that India does not allow patenting of micro-organisms which already exist in nature, as the same is considered to be a discovery as per the provisions of the Section 3(d) of the Patents Act, 1970 and therefore not patentable. But genetically modified versions of the same microorganisms that result in enhancement of its known efficacies are patentable.

Another requirement is sufficiency of disclosure which is very important. The Patents Act, 1970 stipulatesthat sufficient and clear description of the invention should be given. The Act or the Rule, however, does not stipulate any condition or procedure to meet the requirement of sufficiency of disclosure in the case of inventions involving use of biological material, which are very difficult to describe in words.

It has been the practice of the Patent Office from time immemorial to follow the practice adopted by the foreign patent offices by allowing the accession No., accorded by a depository institution either foreign or Indian in the patent specification to satisfy the requirement of sufficiency of disclosure of the invention desired to be patented.

It may be mentioned here that a system of depositing strain of microorganisms in some recognized depositories was evolved way back in 1949 in USA. An international treaty called “Budapest Treaty” was signed in Budapest in 1973 and later on amended in 1980. India became a member of this Treaty with effect from December 17, 2001. This is an international convention governing the recognition of deposits in officially approved culture collections for the purpose of patent applications in any country that is a party to this treaty. Because of the difficulties and virtual impossibility of reproducing a microorganism from a description of it in a patent specification, it is essential to deposit a strain in a culture collection centre for testing and examination by others.

Under the Patents Act, 1970 if the invention uses a biological material which is new, it is essential to deposit  the same in the International Depository Authority (IDA) prior to the filing of the application in India in order to supplement the description. The description in the specification should contain the name and address of the International Depository Authority and date and number of deposition of Biological material. [Section 10(4) (d)(ii)]. If such biological material is already known, in such case it is not essential to deposit the same. There are many international depositories in different countries such as MTCC, DSM etc. which are recognized under the Budapest Treaty.

The Institute of Microbial Technology (IMTECH), Chandigarh is the first Indian depository set up under theBudapest Treaty. Very recently Microbial Culture Collection Centre (MCC), Pune (which is located in the NCCS, Pune) has been recognized International Depository Authority (IDA) under the Budapest Treaty on the International Recognition of the Deposit of Micro-organisms for the Purpose of Patent Procedure.