This article is written by Panya Sethi, a third year BBA.LLB student at Symbiosis Law School, Noida

NEED FOR BUDAPEST TREATY

Article 27(3)(b) Microorganisms and non-biological or microbiological processes may be patented under the TRIPS agreement.” However, there are stringent rules and processes that must be followed in order to get a patent for a living creature that has potential medicinal, agricultural, or other applications.

The first rule is that patents are only given for innovations that entail genetically modifying microorganisms in order to bring new useful qualities that are lacking in the wild form. The ability of a person versed in the art to replicate the experiment and get the same result is another prerequisite for obtaining a patent on a microorganism. But microbes alter their nature in their natural habitat, making it harder for others to properly explore and innovate.

“The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, as revised in 1980, was an international treaty that came into force in 1977 to address such concerns.”

The primary motivation behind this Treaty is to facilitate the legal deposit of living beings for patent purposes. In other words, it validates the practice of depositing microorganisms in sanctioned culture collections. The Budapest Treaty mandates the deposit of a strain in a culture collection center since it is difficult to reproduce a microbe from the information given in the patent specification. As of right now, 82 nations have signed on as participants in this Treaty. A nation must be a signatory to both the Paris Convention and the Budapest Treaty in order to join both agreements.

INTRODUCTION

The Budapest Treaty was initiated in 1977 and is focused on a specific stage of the worldwide patent cycle: microorganisms. The Budapest Agreement on the International Recognition of the Deposit of Microorganisms for the Purpose of Patent Procedure was modified on September 26, 1980. This agreement was first signed on April 28, 1977. As a result of the Budapest Agreement, it may no longer be necessary to have microorganisms in every nation in order to maintain patent protection.

In 1980, after being ratified or acceded to by the minimum number of States (five), the Budapest Treaty entered into force. In 1981 and 2002, amendments were made to the Budapest Treaty implementing regulations.

No matter where the microorganism’s depository authority is situated, all Treaty nations are obligated to honor the patent on the microbe. This effectively eliminates the need to file patent applications for microorganisms with the patent offices of each individual country in which protection is desired. By recognizing a single globally recognized deposit with a single international depositary authority, the Budapest System offers a workable commercial option for pursuing patents involving biological material in over 80 nations (IDA).

As per the terms of the settlement, a microorganism’s storage with an “international depositary authority” will satisfy the storage requirements of treaty members’ national patent laws. If you need to store organic material, you may trust an “international depositary authority” since it has established procedures to ensure compliance with the Budapest Settlement. Such procedures include requirements that the deposit be available for the duration of the patent and that samples be furnished solely to those individuals or entities that are authorized to do so.

Establishing “international depositary authorities” has several advantages for both patent applicants and contracting nations. The necessity for patent applicants to maintain physical locations in many of the countries in which they pursue patent protection is much reduced. The costs of patent candidates are greatly reduced since a single deposit with any “global depositary authority” will satisfy the public exposure requirements of any component state. Participation from a single authority as a shop enhances security and provides structure to the flow of the business. The states who have agreed to the settlement gain because they may use the universal standards set out therein to ensure the continued success of their retail sectors and public access. The states no longer have to establish a recognized depositary in order to fulfill public patentability exposure requirements.

DISCLOSURE AND REQUIREMENT FOR DEPOSIT

Fundamental to the functioning of patent law is the need that the nuances of a work be made fully transparent to the public. Adequate disclosure occurs when a development is represented in sufficient detail for a person skilled in the craftsmanship to recapitulate the effect of the development; hence, the disclosure should equip the average master with access to the appropriate offices to recreate the development for himself. 

As a rule, a textual description is used to disclose information, and illustrations are only used to clarify or clarify the description. Inventions that make use of novel microorganisms (i.e., those not readily accessible to the general population) pose difficulties in terms of disclosure, since it is not always possible to guarantee repetition via textual description alone. If an organism were to be isolated from soil and then “improved” by mutation and subsequent selection, it would be very difficult to explain the strain and its selection in sufficient detail for another person to reliably isolate the identical strain from dirt. It is possible that the microbe itself would be regarded as crucial to the disclosure in this scenario. Additionally, the written disclosure of the invention may be deemed inadequate if the microorganism was not widely accessible to the public. In light of this line of thinking, the intellectual property offices in a growing number of nations now require or strongly encourage that novel microorganisms used in inventions be deposited in an approved culture collection. The microorganism would subsequently be made accessible to the public via the culture collection at the appropriate time throughout the patenting process.

INTERNATIONAL DEPOSITARY AUTHORITY AND RECOGNITION OF SINGLE DEPOSIT

“Whenever a contracting state allows or mandates the storage of microorganisms for the purposes of a patent technique, that state must recognize any such storage done in any IDA, wherever such IDA may be located. For similar reasons, any IDA should be relied upon if an intergovernmental modern property organization (such as the European Patent Office) files a standard declaration with the Director General of WIPO acknowledging the arrangements of the Settlement and the Rules for its own patent purposes.”

To become an IDA, a group must first be formally recognized as such by the contracting state in whose territory the group is located. In addition to formal recognition, the contracting state must provide substantial assurances that the group agrees to and will continue to comply with the requirements of the agreement and the rules. The most important are that all investors will have access to the IDA on the same terms, that the IDA will accept and store microorganisms deposited with it for the full time period determined in the Settlement, and that only those who are authorized to receive the microorganisms will be allowed to conduct trials on them. 

“INDIAN POSITION

Section 3(j) of the Patents Act, 1970 stipulates what are not considered inventions” – “Plants and animals in whole or 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.” In India, microorganisms were not patentable until an amendment in 2002. With India’s recent accession to the TRIPS agreement, the country now permits the patenting of microorganisms.

Section 10(4)(d)(ii) lays forth a set of requirements that must be met. If the biological material described by the applicant in the specification does not fall under either (a) or (b), and if it is not publicly accessible, then the applicant must provide evidence that it is not. In this case, the application cannot be finalized until the required materials have been deposited to an IDA in accordance with the Budapest Treaty. Most importantly, the microorganisms must have been stored in the IDA for at least ninety days prior to the date of recording in India, and the applicant must have abandoned all references to the installment within ninety days of documenting the patent application (Rule 13(8) of the Patent Standards). All identifying information, such as the depositor’s name, the depository bank’s address, and the deposit date and number, must be included.

The application is also required to disclose the location from where the specified biological material was sourced. If India is the country of origin, the candidate must be approved by the Public Biodiversity Authority of India before a patent may be issued.

“There are two IDA locations in India; the first is the Microbial Culture Assortment at the Public Place for Cell Science in Pune, and the second is the Microbial Sort Culture Assortment and Quality Bank at the Foundation for Microbial Innovation in Chandigarh.”

PURPOSE OF TREATY

The primary goal of the agreement is to facilitate worldwide recognition of the patent, relieving the candidate of the need to file separate applications in each participating nation. According to the agreement, if a microorganism is recognized by the Global Safe Foundation, it should be sufficient for recognition under public patent offices as well, provided that local patent offices recognize the impact of the contract. These regional offices may make such a proclamation in order to acknowledge the treaty’s impact by doing things like:

• “EUROPEAN PATENT OFFICE
• EURASIAN PATENT ORGANISATION
• AFRICAN REGIONAL INTELLECTUAL PROPERTY ORGANISATION” 

The agreement is preferable for the patent system of the contracting states and is especially helpful for the contributor because it saves him time and money by providing worldwide, public, and local recognition through a single platform, rather than requiring him to file separate applications in each country. In addition to ensuring the investor’s safety via the service of such an acknowledgement, the settlement also provides a standardized process for patent award by having the example served and stored in a central location. “On July 28, 2020, there were 48 such experts: 7 in the Unified Realm, 4 in the Republic of Korea, 3 in China, India, Italy, and the United States of America, 2 in Australia, Japan, Poland, the Russian League, and Spain, and 1 in each of the following countries: Belgium, Bulgaria, Canada, Chile, the Czech Republic, Finland, France, Germany, Hungary, Latvia, Mexico, Morocco, the Netherlands, Slovakia, and Switzerland.”

CONCLUSION

Recovering a patent system that is recognized on the international stage, by public patent offices, and by local offices was a huge step forward in 1977, as it mitigated many issues that people would have faced in the subsequent and later eras had it not been for the general public’s progressive attitude toward innovation and progress. The concept of acknowledgment unquestionably sets aside the time and money of individuals, and the global depositary authority being a particularly special power, it gives a complete feeling of safety to the contributors as the example of microorganisms is only kept in the sole hands of the worldwide expert for stores.

REFERENCES

1. https://www.intepat.com/blog/understanding-the-budapest-treaty/ 

2. https://www.wipo.int/treaties/en/registration/budapest/ 

3. https://www.wipo.int/budapest/en/ 

4. https://www.uspto.gov/ip-policy/patent-policy/budapest-treaty 

5. https://cil.nus.edu.sg/wp-content/uploads/2015/12/Ses5-14.-Guide-to-the-Deposit-of-Microorganisms-under-the-Budapest-Treaty-2015.pdf 

6. https://www.mondaq.com/india/patent/996992/international-aspect-of-patents-for-microorganisms-budapest-treaty-1977