The impact of the Budapest Treaty on Indian Microorganisms

December 1, 2023

This article has been written by Mr. Daniel Samy, a law graduate in 2023-year, student at M.S. College of Law, Thane.

What is the Treaty of Budapest?

Microorganisms and non-biological and microbiological processes may be patentable under TRIPS agreement Article 27(3)(b). Yet, there are intricate rules and processes that must be followed to obtain a patent for living things that may be useful in the medical, agricultural, or other industries.

First off, only inventions that include genetically modifying microorganisms and adding novel, beneficial traits that weren’t present in their native state are eligible for patent protection. A person skilled in the art must also be able to carry out the same experiment and obtain the same outcome for microorganisms to be eligible for patent protection.

Nevertheless, because microorganisms alter who they are in their natural habitat, it is difficult for others to properly experiment or innovate.

The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, also known as the Budapest Treaty, was modified in 1980 and went into effect in 1977 to address these problems.

The primary goal of this treaty is to fulfill patenting requirements through the deposit of living organisms. It acknowledges the placement of microorganisms in culture collections that have received governmental approval.

The inventor is required by the Budapest Treaty to deposit a strain of the microbe in a culture collection facility since it is difficult to reproduce a microorganism from the disclosure given in the patent specification.

Now, 82 nations have ratified this treaty. A nation must be a party to the Paris Convention to join the Budapest Treaty.

Principal attributes and benefits of the Budapest Treaty.

The primary characteristic of the Budapest Treaty is the requirement for member nations to permit inventors to deposit microorganisms in a pure and viable form to obtain patents. For the same reason, it must acknowledge depository banks referred to as the “International Depository Authority” (IDA). An IDA must be established and maintained in accordance with the depositor’s rules, regulations, and guidelines as specified in the Treaty.

An IDA’s home member nation is required to guarantee to WIPO’s Director General that the organization abides by the terms of the Treaty. Microorganism deposits from both inside and outside the nation where an IDA is located are accepted.

The second benefit is that the term “microorganism” can be interpreted broadly because it is not defined in the Budapest Treaty. This includes the deposit of biological material, which is required for the patent specification to disclose it, particularly when it comes to inventions that are related to the food and pharmaceutical industries.

Currently, in addition to microorganisms, other materials that can be deposited include plasmids, cell lines, fungi, yeast, RNA, and plant and animal cells.

The absence of the requirement to deposit the microorganism in each nation where the inventor is requesting patent protection is the third characteristic of the Budapest Treaty. To initiate the patent procedure with all national patent offices of the Treaty member countries, the microorganism only needs to be deposited in any IDA. The benefit of only having to make the deposit once is thus enjoyed by the inventor.

The principal provision of the treaty is that states or contracting states that permit the deposit of microorganisms for patent procedures must acknowledge such microorganisms with any International Depository Authority.

Since it is exceedingly difficult to provide a written statement for a microorganism, the disclosure of the organisms is the primary requirement for the grant of a patent under this treaty. It is necessary to submit or deposit such an invention with the appropriate, accredited institution. In this case, microorganisms include biological deposits, which are crucial to deposit for patents and, more significantly, in the food and pharmaceutical industries.

This characteristic additionally renders the member nations appealing to an innovator who plans to pursue patent protection across multiple jurisdictions. This process will allow the inventor to save both money and time.

By creating a standardized system for deposits, identification, and the provision of microorganism samples, the Treaty also improves depositor security. As of October 1, 2018, there are forty-seven IDAs.

Giving the patent international recognition is the primary goal of the treaty, which relieves the applicant of the need to apply in every nation. According to the treaty, recognition of the microorganism by the International Depository

Institution will suffice for recognition by the national patent offices as well, provided that the regional offices also accept the treaty’s effects. The following are some instances of declarations used by regional offices to acknowledge the effects of treaties:

EUROPEAN OFFICE FOR PATENTS
EUROPEAN ENTITY FOR PATENTS
African Regional Organization for Intellectual Property

The treaty is more appealing to the contracting states’ patent systems, and, above all, it is very advantageous to the depositor, who saves money by not having to travel to each country to file an application for recognition and time because it offers international, national, and regional recognition on one platform.

By providing such recognition, the treaty also validates the depositor’s security because the sample is being served and deposited in a single location and follows a standard process for patent grant.

In the United Kingdom, four in the Republic of Korea, three in China, India, Italy, and the United States of America, two in Australia, Japan, Poland, the Russian Federation, and Spain, and one in each of Belgium, Bulgaria, Canada, Chile, the Czech Republic, Finland, France, Germany, Hungary, Latvia, Mexico, Morocco, the Netherlands, Slovakia, and Switzerland were among the 48 such authorities as of July 28, 2020.

DIAMOND VS. CHAKRABARTY CASE STUDY

In the history of US patent law, the Diamond v. Chakrabarty case is significant. Dr. Ananda Chakrabarty filed a patent application in this case for a genetically modified bacteria that can degrade oil. The case helped establish the notion that genetically modified microorganisms can be patented and raised concerns regarding the patentability of living things.

The U.S. Supreme Court ruled in Dr. Chakrabarty’s favor in 1980, concluding that the bacterium qualified for a patent because it was a novel and useful composition of matter. According to the Court, the fact that a living thing is alive does not preclude it from being patented provided it satisfies the requirements of novelty, non-obviousness, and utility.

This decision was important because it broadened the scope of what could be patented to include living things, which encouraged more money to be spent on biotechnology R&D. The ruling also contributed to the establishment of the patentability of genes and other biological materials; a concept that has grown to be crucial to the biotechnology sector.

But there has also been a lot of discussion and criticism surrounding the case, with some contending that patenting living things is unethical and limits access to necessary resources and technologies. The case continues to influence the conversation regarding patents’ place in the biotechnology sector and whether living things can be patentable.

In summary, the Diamond v. Chakrabarty case established the principle that genetically modified microorganisms are patentable and was a seminal case in American patent law. The case has influenced the discussion surrounding the patentability of living forms and had a significant effect on the biotechnology sector.

CASE STUDY: DESIGNER AND PATENTS CONTROLLER VS. DIMMINACO AG

A case concerning patent law that was heard in Indian courts was DIMMINACO AG v. Controller of Patents & Designs. In this case, DIMMINACO AG filed a patent application for a method of producing dimethyl carbonate (DMC) with the use of an innovative catalyst. The application was denied by the Controller of Patents and Designs on the grounds that the claimed method was clearly a modification of an existing process and thus ineligible for patent protection.

DIMMINACO AG filed an appeal of the ruling, claiming that the process under claim was novel, creative, and patentable. The company was successful in getting its patent application granted by the Indian courts, who determined that the claimed method was new and nt obvious.

The case is noteworthy because it highlights how crucial it is to evaluate an invention’s novelty and non-obviousness to determine whether it can be patentable. It also highlights the necessity of precise and well-defined patent standards to evaluate patent applications in an impartial and consistent manner.

In conclusion, an Indian patent law case involving a patent application to produce dimethyl carbonate was DIMMINACO AG v. Controller of Patents and Designs. The case underscores the need for precise and well-defined patent standards and shows how crucial it is to evaluate an invention’s novelty and non-obviousness when determining its patentability.

Indian Role

Plants and animals in whole or in any part thereof, other than microorganisms, but including seeds, varieties, and species and essentially biological processes for production or propagation of plants and animals, are not inventions, according to Section 3(j) of the Patents Act, 1970. Microorganisms were not patentable in India prior to the 2002 Amendment. Microorganism patenting has been permitted because of India’s accession to the TRIPS agreement.

Certain requirements are outlined in Section 10(4)(d)(ii). If the biological material described by the applicant in the specification does not meet the requirements of clauses (a) and (b), and if the material is not publicly accessible.

In this case, in accordance with the Budapest Treaty, the application must be fulfilled by depositing the materials to an IDA. The first requirement is that, in accordance with Rule 13(8) of the Patent Rules, the applicant must deposit the microorganisms in the IDA before the date of filing in India and must mention the deposit in the patent application within three months of filing.

Furthermore, the name, address, and deposit number of the depository institution, along with all other characteristics that are required for accurate identification, must be supplied.

The geographic origin of the biological material specified in the specification must also be provided by the applicant. Before a patent can be granted on an application, the applicant must obtain approval from the National Biodiversity Authority of India if the application’s geographical origin is in India.

The Microbial Culture Collection at the National Centre for Cell Science in Pune, India, and the Microbial Type Culture Collection and Gene Bank at the Institute of Microbial Technology in Chandigarh, India, are the two IDA units in India.

Conclusion

In summary, the field of patent law pertaining to the patentability of genes, viruses, and microorganisms is intricate and contentious. If these biotechnology innovations meet the requirements for novelty, non-obviousness, and utility and are fully and precisely described in the patent application, they may be eligible for patent protection.

For biotechnology businesses and researchers, patenting these inventions can offer invaluable protection, enabling them to market their discoveries and recover their financial outlays. However, patenting genes, viruses, and microbes can also give rise to questions about monopolies in the biotech sector and about access to necessary medications and technologies.

Therefore, it is imperative that policymakers and patent office’s find a middle ground between protecting inventors’ rights and guaranteeing the public’s access to vital technologies. It is possible to guarantee that patent applications are assessed consistently and equitably, and that only genuinely innovative and practical inventions receive patents by establishing guidelines for assessing biotechnology applications in patents.

Furthermore, there are ongoing discussions concerning the moral and ethical ramifications of patenting genetic material and living things. These arguments emphasize the necessity of continuing the conversation and examining the patent system to make sure it is just, equal, and serves the public interest.

For website article or blog references: This article was originally published on the below website. The link for the same is herein.

December 1, 2023