Patentability Of Microorganisms

PATENTABILITY OF MICROORGANISMS -

Shradha Diwan

Are life forms patentable? Can microorganisms, for instance, be patented? Prior to 1980 the answer to this question was: NO. Microorganisms were clearly "products of nature" and as such were not considered patentable. However, the era of maneuvering DNA between organisms changed that.

In 1980, the Supreme Court of USA, in the case of Anand Chakrabarty, one of the scientists of General Electric Corporation, ruled that genetically altered microorganisms 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). Chakrabarty had filed a patent application for bacteria, a strain of Pseudomonas containing two plasmids after genetic manipulation, which had an enhanced propensity to digest oil hydrocarbons. Although getting bugs to eat oil seems like a neat trick, the Patent Office had initially rejected the application. Also, the Supreme Court cited the fact that there was precedence for patenting living matter. Since 1930 certain asexually reproduced plants have been protected by patenting. Further, in 1970 the Plant Variety Protection Act allowed for protection of some sexually reproduced plants. This ruling by the courts opened the door for biotechnology to become big business. Now companies could protect products based on genetically altered organisms. The next issue for the Patent Office regarding patenting of life forms became the patentability of genetically manipulated animals. In 1988 a patent was allowed f or the first genetically altered animal, a mouse that was very susceptible to cancer. This mouse showed promise in testing potential carcinogens. 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. Canada, however, still does not allow patenting of life.

THE SCENARIO IN INDIA

The Indian Patents Act, 1970 has been amended with effect from January 2005 to comply with the TRIPS agreement. The main provision of the Act is to allow the grant of product patents in the field of chemical, pharmaceutical, food and biotechnology. Patenta ble biotechnological inventions can be broadly categorized as: ‘Products in the form of chemicals, microorganisms, plant extracts, fermented material; processes/methods for using useful products and compositions/ formulations of product such as vaccines, proteins, hormones’ India has allowed patenting of microorganisms but the Patent Act does not provide a definition of the term "Microorganisms". This has led to many debates regarding patentability of microbes. The Mashelkar committee report has clearly stated that microorganisms are patentable subject matter in India. Further, the Patents Act does not allow patenting of plants and animals per se, essentially biological processes for the production of plants and animals and method of treatment of human and animals. Inventions pertaining to Microorganisms and other Biological material were subjected to product patent in India, unlike many developed countries. But with effect from 20.05.2003 India has started granting patents in respect of invention related to microorganisms, though India was not obliged to introduce laws for patenting microorganisms per se before 31.12.2004. Microorganisms patenting per se being considered to be a product patent, the period of protection was 5 years from the date of grant or, 7 years from the date of filing of application for patent. Now grant of patents for microbiological inventions is for a period of 20 years from the date of filing. The most vital and important distinction between the legal practices of the India and developed countries is that India (developing countries) does not allow patenting of microorganisms that already exist in nature as the same is considered to be a discovery as per the provisions of the section 3(d) and therefore not patentable. But genetically modified versions of the same microorganisms that result in enhancement of its known efficacies are patentable. The grants of Patent in respect of Microorganisms depend upon the regulations concerning the requirements for the deposition of Microorganisms under the Budapest Treaty of which India has become a member, and accessibility of that microorganism from the depositories. As per proviso (ii) to section 10(d) the Microorganism if not being described fully and particularly and is not available to public, the said Microorganism is to be deposited before the International Depositary Authority under the Budapest Treaty with 3 months of

making application in India. All details, available characteristics of the Microorganisms , and details of depositary institutions shall be mentioned in specification for correctly identifying the same. Further access to the same is required to be made available only after date of Application in India or date of priority. For the purpose of Microorganisms and other Biological materials Microbial Type Culture Collection and Gene Bank (MTCC) is an internationally recognized depository institution. It is therefore advisable before proceeding to file a patent application in respect of Microorganisms and other biological material to ensure that the same is not hit by the provisions of the section 3(d) of the Indian Patent Act and the invention is not a mere discovery of what already exist in nature and in case of genetically modified variant of the Microorganism or other biological material the invention results in enhancing the efficacy of the already exiting strain of the Microorganism or other biological material.

A CONSERVATIVE APPROACH – The Other Side of the Coin THE GENETICIZATION OF SOCIETY Some societies have more explicit public policy examination of the patentability of life forms and products. For example, the patent laws in Brazil, India, and Argentina forbid the patenting of pharmaceuticals on the grounds that drugs are of such great importance that no one should have the right to monopolize them. Columbian researcher Dr. Manuel Patarroyo recently gave the World Health Organization exclusive royalty-free rights on an anti-malaria vaccine he developed: "We wanted to do this for the benefit of humanity," he explained. The European viewpoint is greatly influenced by the Napoleanic concept that denies patentability to subject matter which is contrary to ordre public (fundamental moral precepts essentially acknowledged universally). In Europe, too, the more explicit acknowledgment of a colonialist past may play a role in shaping public consciousness; according to a Dutch member of the European Parliament from the Green Party "Ninety percent of the genetic resources which are used in our agricultural production come from the Third World. We have never asked if we ought to pay anything for them. And now for the biotechnology industry to demand monopoly property rights over them is utterly unjustifiable. Whether wild species or crop plants, genetic resources are the common heritage of humankind. All farmers must be guaranteed free access to them."

Although there has always been a recognized public policy exemption to patentability (for example, nuclear devices are not patentable, under the Atomic Energy Act of 1954), one has to ask what ideological currents are gaining strength in America to permit such an unusual notion as the ability to have exclusive ownership of life forms. Genetics is increasingly being presented to the American public as a mysterious realm of knowledge which is now coming under human control, presumably for our economic and social betterment. "We used to think our fate was in the stars. Now we know, in large measure, our fate is in our genes," is the way this ideology has been formulated by James Watson, the Nobel laureate who participated in the discovery of the DNA double helix. This world view -which magnifies the claims to power by scientists and is trumpeted in the media-ignores the complex interactions within an organism and between an organism and its environment, as well as the social and political and economic factors that contribute to shaping life patterns.