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This article is written by Abhishek Sharma, pursuing Diploma in Intellectual Property, Media and Entertainment Laws from LawSikho. The article has been edited by Aatima Bhatia(Associate, LawSikho) and Smriti Katiyar (Associate, LawSikho).

Introduction

The patent is a kind of intellectual property right, a legal document awarded by the Government of a State, which provides an exclusive right to the patent holder, vis-à-vis his patented product, for a fixed number of years. Inventor is also provided with Monopoly rights over the product. The patentability criteria are provided in Indian Patent Act 1970, in Section 3 (k) of the Act.

Moreover, Section 2 of the Act, says that anything that is novel(new) with commercial value and industrial utility can be patented. Novelty means an invention that is not present in the public domain or as common public knowledge. Anything, which is already in use, or known to the public, simply becomes a non-patentable subject matter. Inventive step means that there has been some sort of technological advancement to the existing technology. Industrial utility means that the subject matter can be commercially used and be developed for mass utilization.

A microorganism refers to a living organism that is microscopic. The study related to microorganisms is called microbiology. Microorganisms can be categorized as bacteria, fungi and protists, though it does not cover viruses and prions. Many virologists consider viruses to be non-living as they hardly fulfil all the necessary conditions of life. Viruses can only replicate themselves by infecting the cells of the host. Micro-organisms are mostly unicellular or cell-cluster microscopic organisms.

The subject covering the patentability of the microorganisms is very tricky and irregular. The World Trade Organisation Agreement i.e Trade-Related Aspects of Intellectual property Rights (TRIPS), is a multilateral agreement covering IP. The important thing is that Section 27 of TRIPS allows microorganisms to be patented, and thus in precedence many nations are now allowing microorganisms to be Patented.

Significance of patenting microorganisms

The question arises that, why on earth is there a need to patent micro-organisms, the answer simply lies that is to further conduct research. Moreover, the genetic material of these microorganisms is used as raw material by bio- technologists. The first-ever patent that was granted for microorganisms was awarded to Louis Pasteur in 1873. The claim made by Louis Pasteur was that the concerned invention furnished better quality of beer from the same quantity and quality of work through the process of fermentation. 

Condition in the U.S

The most important case that came up in the United States of America, regarding the patentability of Microorganisms is Diamond vs. Chakraborty. The brief facts of the historic case were as follows, Ananda Mohan Chakrabarty, a General Electric genetic engineer, developed a bacterium now known as Pseudomonas Putida (derived from the genus Pseudomonas), which is capable of metabolizing the hydrocarbons that make up Crude oil. No naturally occurring bacteria exhibit this property and are used in the field of bioremediation or biodegradation of oil.
In 1972, Chakrabarty filed a patent application that was assigned to General Electric Co. Chakrabarty’s 36 claims consisted of three types: (1) method claims for the method for producing the bacteria; (2) Claims about an inoculum consisting of a carrier material floating in the water and the new bacteria; and (3) claims about the bacteria itself. The patent examiner admitted claims belonging to the first two categories, but rejected the third for two reasons: first, microorganisms are a “natural product” and second, as living beings, they are not patentable subject matter under Section 101 of Title 35 USC. The Supreme Court agreed and ruled on June 16, 1980, that a living human-made microorganism is patentable under Section 101 and that the defendant’s microorganism is a “manufacture” or “composition of matter” within the meaning of this Law. The patent was granted on March 31, 1981.

Condition in India

Article 27 (3) (b) of the TRIPS Agreement allows the Member States to reject patents on “plants and animals, other than microorganisms, and essentially biological processes for the production of plants or animals other than non-biological processes and microbiological”. Therefore, the TRIPS Agreement obliges all signatories to renew patents on microorganisms, non-biological and microbiological processes. Furthermore, parts of animals and plants, as well as modified plants and animals, are not expressly included in the exception, so TRIPS may also require the patenting of biological organisms. In accordance with TRIPS, the Patents Act of 1970, as amended in June 2002, grants patent rights to new microorganisms. Section 3 (j) of the Law excludes from patentability “plants and animals, totally or partially, that are not microorganisms, but that include seeds, varieties and species and essentially biological processes for the production or propagation of plants and animals”. The 2002 amendment to the Indian Patent Law added a statement to the chemical process stating; Chemical processes include biochemical, biotechnological, and microbiological processes. Other areas with microorganisms are also patentable in India. For example, both a synergistic composition containing the new or known microorganism and a method that uses microorganisms to produce a substance can be patented. The biosynthesis process of a new microorganism is also patentable. Microorganisms that are lyophilized as final products are patentable.

The law does not specify the scope of the patentable invention but specifically restricts non-patentable subject matter. But even before the amendment, Calcutta High Court was concerned about the question of whether a process that uses live microorganisms as an end product can be patented. At this point, it should be noted that the definition of the invention at issue in the proceeding has been modified since the decision in this case. The applicant had previously applied for a patent for the production process of a vaccine to protect poultry from infectious bursal disease. The patent examiner stated that the process was not an invention, as the final product produced by the process contained a living organism and was therefore not patentable. The applicant appealed the controller’s decision to the Calcutta High Court. The person in charge alleged that a patent is only granted for a process that leads to an article, substance or manufacture, and a vaccine with a living organism is not an article, substance or manufacture. The court used the normal meaning of the manufacturing dictionary, as it was not defined in the Patent Law, stating that “after going through the manufacturing process through the inventive process, the material in question has undergone a change and becomes a material “that differs from the starting material ”. The court determined that this meaning does not exclude the manufacturing process of a product containing a living substance from being patentable.

The court ruled that no law excluded a living end product from the definition of production. Furthermore, the court ruled that “since the patent application process leads to a salable product, it is certainly a substance after going through the manufacturing process.” Ultimately, the court concluded that “a new and useful art or process is an invention” and, because the process is new and useful, “is apparently patentable under Section 5 along with Section 2 (j) ( i) “of the Patent Law. The court ruled that “when the final product is a new article, the process leading to its manufacture is an invention.” Although the definition of the invention has been changed, this change could actually improve the court’s inventive argument, because now the elements of manufacture, article or substance are no longer needed. Rather, the new definition simply requires a new, non-obvious and useful product or process. As noted above, the court ruled that the vaccine was new and useful and did not discuss the final product containing live material to reach this conclusion. However, other changes in the law can change the outcome of the case. For example, Section 3 (j) was added to the patent law after this case and now excludes essentially biological processes for the production or propagation of plants and animals from the definition of the invention. In this case, the court warned that applications for patentability must “be examined by the controller according to the principle of Article 3” of the Patent Law.

Conclusion

Microorganisms with human interference, accompanied by novelty, utility and industrial applicability, are patentable. Technological advances in microbiology, genetics, etc. have complicated the problems associated with patenting microorganisms. Therefore, the scientific aspects and the legal design of the invention must be carried out with due care and consideration. Although the Monsanto case was very technical, the Supreme Court lost the opportunity to rule on the facts of the matter. The fact that the subject of many biotech products is incredibly complex, especially when it comes to a living organism. In fact, they are not man-made, these themes are really a “black box” and are therefore practically impossible to describe. Full disclosure of an invention is a prerequisite for patent protection. In all other technologies, all aspects of the elements of the invention are known. In jurisdictions that allow biotechnology to be patented, a concession is made to this basic requirement, namely the deposit of samples of the patented matter. These deposits are part of the “complete description” of the invention and the deposit is intended to “supplement” the complete description.


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