Patenting In Genetic Testings: An Overview

Aditi Ladda, Intern

INTRODUCTION

Biotechnology is defined as the application of science and engineering in the direct use of living organisms or products or parts of the living organisms in their natural or modified forms. [1]. It deals with recombining the DNA technologies, which is further used to reform the genetic material of living cells to produce new substances and perform new functions. The biotechnological inventions in the patent system include inventions like biological, microbiological, genetic engineering, medical, and agriculture.

Article 27(1) of the Trade-Related Aspects of Intellectual Property Rights TRIPS Agreement states that there must not be any form of discrimination in granting patents for inventions in any field of technology, subject to specific clauses. Therefore, biotechnological inventions are patentable subject matter.

DNA/RNA PATENTING

Patenting of DNA and genes sequences refers to the patenting of a process involving identification, isolation of DNA, associated materials of RNA, and substances such as proteins and peptides related to DNA. The guidelines and rules of the European Patent Office clarified that DNA and gene sequences are synthetic molecules isolated from the organisms and are produced as recombinant molecules existing in the natural sense are patentable subject matter.

In the case of Funk Brothers Seed Co v Kalo Inoculant Co. [2], the US Supreme Court stated that claimed inventions are a ‘discovery of the phenomena of nature. Therefore, a ‘gene’ cannot be termed as an invention. The Court did not explicitly overrule Funk Brothers, limiting its holding in the subsequent decisions.

In Diamond v Chakraborty[3], the bacteria had been altered by the human intervention, and it generated two energy plasmids which were quite uncommon for the existing bacteria. The 35 USC 101[4] is a statute granting a patent to a person who ‘invents or discovers a new and effective composition of matter. Thus, the inventor’s discovery can be a subject matter of the patent if he successfully isolates a genetic composition from its original state and processes it through the various purifying steps, which leads to separating the gene from its natural molecule.

Ultimately in the case of In re Bergstrom[5], it was held by the Federal Court of appeals that scientists can patent the purified forms of two human hormones as the purified forms do not have any natural occurrence.

ESSENTIALS FOR PATENTING THE BIOTECHNOLOGICAL INVENTIONS

There are three basic requirements for an invention to be patented under Indian Law:

1. Novelty: Section 2(1) (j) of the Indian Patents Act provides that the invention must be new and different from the ‘prior art. Prior to the filing of the application, it should not have been published or used anywhere in the world. In the case of patenting a gene, the applicant must successfully prove that the identity of the gene was not known, and he was the first person to define its utility. A claimed gene is considered novel if it covers isolated and purified genes.

2. Non- Obviousness: The invention must not be an obvious one. Non-obviousness in biotechnology where success in experimentation and invention of new properties carry significant weight. It is crucial to identify a particular gene among the vast amounts of DNA existing in a cell. Therefore, a gene sequence or a gene may fall under the non-obviousness category.

3. Utility: DNA sequences, such as genes, ESTs, or SNPs, have a wide variety of applications. DNA is used for producing proteins or diagnostics and even in forensic sciences. The DNA sequences help identify the disease-causing genes and identify the ESTs and SPN s that help to picture out the disease-causing nature of the gene and production of the said DNA fragments. With the help of this knowledge, it is easier to treat the patient’s genome as the gene is made simple.

The inventor must provide sufficient specification in case of gene/DNA specification patent ability. In many cases, the disclosures fail to describe the inventions sufficiently, leading to the patent's invalidation.

Section 3 of the Indian Patent Act, 1970 provides an extensive list of all inventions cannot be covered under the Act. The inventions pertaining to DNA molecules or sequences must not be against public order and morality.

PUBLIC ORDER AND MORALITY

The subject matter of the patent must not be contrary to public order and morality. Section 27.2 of the TRIPS Agreement clearly states that members may exclude from patent ability any such inventions as is ‘necessary to protect public order or morality, including human, plant or animal life.’ The same has been incorporated under section 3 (b) of the Indian Patent Act. The inherited Breast Cancer BRCA case highlighted the importance of the acceptability of gene patents by the general public. The BRCA gene patents have been a subject matter of great scrutiny and opposition over the past few years.

CONCLUSION

Biotechnology has emerged as a major contributor to the expansion of medical research and development. There is a large class of diseases that the drugs developed by bio-technologies may treat. Seeing the various precedents and the experimentation conducted in biotechnology, it is proved that gene technologies are beginning to provide important tools for diagnostics. Once it has been established that the patent claim is novel, non-obvious, useful, genes and gene products can get patented. It is essential to provide a wider blanket and set a higher utility standard before granting the patent. Patenting and protecting genetic inventions will foster developments in various fields and benefit society in the long run.

[1] Section 3(1) Canada Environmental Protection Act.

[2] Funk Bros Seed Co v Kalo Inoculant Co, 333 US 127 (1948).

[3] Diamond v Chakraborty 447US 303.

[4] 35 USC101 ‘Whoever invents or discovers any new and useful process, the machine, manufacture, or composition of matter, or any

new and useful improvement thereof may obtain a patent, therefore, subject to the conditions and requirements of this title.

[5] 427 F 2d at 1401-02.