Patenting Of Microorganisms

Preface

Preface

Patenting of Microorganism has become broader public debate as the old laws combines with new technology. TRIPS and the Budapest Treaty, signed on April 28, 1977 and amended on September 26, 1980 provide guidelines for patenting of microorganisms in particular. An Invention related to Microorganism whether is it a process for obtaining the microorganism or the microorganism itself are governed by special provision that is deposition of Microorganism into IDA. For the deposition of Microorganism in IDA, it must fulfill the requirements of Patent Legislation for an invention involving microorganism.

Indian Framework

Indian patent law initially did not provide adequate information for patentability of microorganisms. The Patent Amendment Act 2002 added section 3(j) to comply with the Article 27(3) (b) of TRIPS agreement. Section 3(j) excluded microorganisms from the inventions not patentable and allowed patenting of processes pertaining to microorganisms as well as non-biological and microbiological processes. Further, in Patent Amendment Act, 2005, Section 5 which allowed inventions where only methods or processes of manufacture were patentable was deleted thus paving way for product patents. The grant of patents relating to microorganisms depends upon the regulations as specified in Section 10 of Indian Patent Act, concerning with the requirements for the deposition of microorganisms in recognized International Depository Authorities (IDA) formed under Article-7 of the Budapest Treaty. Section 10 mandates the deposition of biological material disclosed in an application along with the name, address of the depository institution, date and number of the deposit, source and the geographical origin of the biological material.

US Framework

US allowed the patenting of microorganisms in 1980. The United States Patent and Trademark Office consider non-naturally occurring, nonhuman multicellular living organisms, including animals, to be patentable subject matter within the scope of 35U.S.C. 101.

European Framework

Europe views patenting of living beings in the same manner as the U.S Patent Office. The European Union defines 'biological material" instead of "micro-organism under Article 2.1(a). Law under the EPC has confirmed the patentability of microorganisms and higher life forms that is, plants and animals including genetically modified forms. Article 53(b) of the EPC describes microorganisms as patentable.

Conclusion

Though the patent system provides a comprehensive framework on the laws relating to the patenting of microorganism or the process for obtaining the microorganism, there are some unanswered questions which seem to be in a state of instability. The situation is further complicated by the rapid scientific and technological developments in biotechnology. The technical complexity implicated in the patenting of microorganisms needs to be understood.

by: EffectualServices

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