Analyzing the Laws on the Patentability of Microorganisms
Exploring the intersection of microorganisms and patent laws
Microorganisms play a crucial role in leading several natural as well as industrial processes. Moreover, they form the backbone of numerous industries such as the pharmaceutical industry, baking goods industry, and brewing industry. In fact, the usage of microorganisms in the baking and brewing industry can be traced back to as early as the 1830s. Over the years, scientists and technologists have created microorganism-related inventions by altering their genetic structure for commercial as well as research purposes. Patent laws around the world have time and again restricted the patenting of ‘living organisms’ or ‘products of nature. However, certain living organisms that are novel in nature and are created with the help of human intervention can be patented. The provisions that were created to patent such organisms can be traced back to the case of Diamond v. Chakrabarty. Moreover, processes that involve the presence of microorganisms or products that are obtained from processes that are created using microorganisms are susceptible to patent protection. In 1873, for the first time, Louis Pasteur was granted a patent for a microorganism-related invention. The invention comprised a process for fermenting beer with the help of yeast. It is pertinent to note that a microorganism that is merely discovered in its natural form is not patentable. Typically, a patent can be granted to a microorganism that is novel, non-obvious, useful, and is capable of industrial application. Therefore, patents can be granted to microorganisms that are created with the help of human intervention using methods such as cell fusion or genetic modification.
Diamond v. Chakrabarty: Opening new doors in the realm microbiology patents
Until 1980, living organisms were not susceptible to patent protection. However, significant changes with respect to the patentability of genetically modified microorganisms were introduced upon adjudicating the case of Diamond v. Chakrabarty. In this case, Ananda Mohan Chakrabarty, a genetic engineer who worked for General Electric, developed a bacterium that is capable of breaking down crude oil. According to Chakrabarty, this bacterium can be used to treat oil spills. However, upon applying for a patent for the bacterium, the application was rejected by the patent examiner. Consequently, Sidney A Diamond, the commissioner of patents and trademarks, appealed to the Supreme Court. Upon appeal, the SCOTUS (Supreme Court of the United States) agreed to hear the case and subsequently held that alive, the human-made microorganism is patentable subject matter (under 35 U.S.C Section 101) since it is genetically modified and is created with the help of human intervention. It was further elucidated that the microorganism created by Chakrabarty qualifies as a patentable subject matter since his claims pertain to a “non-naturally occurring manufacture or composition of matter” which is a product of human ingenuity. Thus, Diamond v. Chakrabarty was a landmark judgment that opened new doors for microbiology patents.
International efforts to facilitate the patenting of microorganisms: The Budapest Treaty
The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purpose of Patent Procedure is a treaty that facilitates the “deposits of microorganisms at an international depositary authority to be recognized for the purpose of patent procedure”. Generally, it is rather complicated to provide a written statement of a microorganism for patenting purposes. Thus, the Budapest Treaty facilitates the disclosure or depositing of microorganisms for patenting. Under this Treaty, it is mandatory to provide a biological deposit of the microorganism to a specialized institution as a part of the patenting procedure. Moreover, the Treaty also enables the international recognition of microbiological patents. Ergo, if an inventor’s application is recognized by the International Depository Institution, the applicant need not file the patent in each and every patent office globally.
The Budapest Treaty does not explicitly define the term ‘microorganism’. Moreover, the IDA (International Depositary Authority) has time and again accepted biological materials that do not fall under the definition of ‘microorganism’. Eukaryotic cell lines, plant spores, genetic vectors, and purified nucleic acids are some of the materials that can be deposited under the Budapest Treaty for patenting purposes. Currently, over 85 countries are signatories to the Budapest Treaty. According to the USPTO, the establishment of the IDA is imperative since it is the only authority that is capable of safely storing biological materials. Additionally, the biological deposits that are submitted to the IDA will remain available for the life of the patent. Since the IDA operates as per the procedures specified under the Budapest Treaty, the biological deposit samples will only be furnished to parties who are entitled to receive them. Using a single authority such as the IDA will also ensure a mechanism of distribution of the deposit.
Laws in India and process for patenting microorganisms
The protection of microorganisms was introduced into Indian patent law through the case of Dimminaco A.G v. Controller of Patents and Designs. In Dimminaco, the Assistance Controller of Patents and Designs refused a patent to a process of preparation of infectious Bursitis vaccine due to the fact that the process required the usage of a live virus. However, the Calcutta High Court adjudicated that the process cannot be refused a patent since the product created with the help of the live organism was novel, non-obvious, and was capable of industrial application. Thus, section 3(j) of the Patents Act, 1970 has ever since then, permitted the patenting of microorganisms. In order to obtain a patent, the applicant must fill out the necessary forms (as mentioned in the second schedule of Patents Rules, 2003) and must pay the requisite fee. Additionally, the applicant must provide a detailed description of information pertaining to the microorganism-related invention. After the applicant makes a request for examination, the patent is published in a journal which is made available to the public for opposition purposes. Once the objections, if any, are solved, the patent is granted to the applicant. Although the patenting of microorganisms has been subjected to heated debates for several years, it also comes with several advantages. For one, since microorganisms play a crucial role in numerous industries the patenting of the same may fuel further research and development which is imperative in today’s day and age.