Patenting Genes and Life Forms: Laws and Ethical Issues

Analyzing the intersection of science and patents

A patent plays a pivotal role in safeguarding an innovation by bestowing the inventor with exclusive rights that are enforceable for a certain period of time. Biotechnology is a dynamic domain that is brimming with innovation. Over the years, patent laws have evolved to accommodate biotechnology-related inventions as well.  According to a study published by the National Institute of Science, Technology, and Development, there has been a steady increase of 3% in the number of biotechnology patents filed at the Indian Patent Office since 2001. Most notably, genetic engineering and stem cell technologies have moved to the forefront in the biotechnology industry. Genetic engineering involves processes wherein recombinant DNA (otherwise referred to as rDNA) technologies are used to alter the genetic makeup of a living organism. Technologies such as genetic engineering are also used to alter the genetic makeup of life forms to create modified plants, organisms, and livestock for commercial and research purposes.

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Diamond v. Chakrabarty: An overview on the rise of biotechnology patents

The patenting of lifeforms and other parts of living organisms, particularly in the biotechnology, medical, and pharmaceutical sectors has been one of the most controversial issues in recent years. The patenting of life forms was first contested in Diamond v. Chakrabarty. In this case, the Patent Office rejected Ananda Chakrabarty’s patent application for a bacterium that was genetically engineered to break down oil spills. It was contended that Chakrabarty’s bacterium was a living organism and that patent protection would not subsist upon the same. However, upon appeal, in 1980, the Supreme Court of the United States held that the bacterium was not a product of nature. Instead, it was created with the help of human intervention and hence, can be awarded a patent. The Diamond v. Chakrabarty judgment opened the doors for new possibilities in the realm of biotechnology patents. In the 1980s, American patent offices managed to award patents to a plant and a mouse (products that are created by altering genes and changing the genetic makeup of the organisms).

Patentability of life science-related inventions: Mayo-Myriad exceptions

Today’s guidelines determining the patentability of life forms can be traced back to the cases of Mayo Collaborative Services v. Prometheus Labs and Association for Molecular Pathology v. Myriad Genetics. Both the cases have managed to establish an analytical framework for determining whether a claim (pertaining to a life-science-related invention) is patent-eligible under 35 U.S.C S. 101. In Mayo, three judicial exceptions to patentability were established. According to the judgment, methods of administering a thiopurine drug, detecting metabolites of that drug, and determining whether to change the dosage based on the detected level of metabolite was not a patentable subject matter. In 2013, in order to adjudicate Myriad, the Supreme Court of the United States relied on Mayo to produce judicial exceptions that would specifically deal with products of nature. In Myriad the Court adjudicated that naturally occurring DNA segments, when isolated from their natural environments, are products of nature that cannot be patented. However, the Court added that cDNA (DNA that lacks the naturally occurring non-coding introns) are patentable since cDNA does not naturally occur in nature. 

Gene patenting: Relevant laws in India

Legislations pertaining to gene patenting and patenting of life forms have been established through the Indian Biotechnology Guidelines, 2013, and the Manual of Patent Office Practice and Procedure, 2005. As per the regulations enlisted under the Manual of Patent Office Practice and Procedure, 2005, recombinant DNA, plasmids and the processes involved in manufacturing the same (which require human intervention) are patentable. Moreover, kits that are created using antibodies, amino acid sequences, or gene sequences are patentable as per the Manual. In order to receive a patent, it is imperative that the recombinant DNA is novel in nature and is created through a substantial level of human intervention. Additionally, the Indian Biotechnology Guidelines, 2013 elucidates that a gene that is recombinant in nature and consists of an inventive step along with an industrial application is patentable.

Dimminaco AG v. Controller of Patent Designs and Ors is a landmark judgment that has significantly impacted laws concerning the patenting of life forms in India. Dimminaco AG, a Swiss company was refused a patent for the preparation of a live vaccine for Bursitis.  The Controller of Patents contended that the end product consisted of a living organism and hence, it is not susceptible to patent protection. However, the High Court held that the final product resulted in an item that has industrial applicability. Consequently, today, patent protection is not just restricted to processes wherein microorganisms are involved. Instead, products that consist of microorganisms are also granted patents as per section 3(j) of the Indian Patents Act. 

Ethical issues and negative repercussions concerning the patentability of genes and life forms

The patenting of genes and life forms has been subject to heated debates for several years. Firstly, the prospect of patents on genetically modified resources such as livestock or plants may result in severe distributional implications. In other words, corporates owning patents over genetically modified crops or livestock may pave the way for them to significantly dominate global agriculture. One of the dire consequences of corporate domination over global agriculture is the negative impact it may have on the economic viability of agriculture in poorer countries. Secondly, several experts have noted that intellectual property regimes that exist in developed countries that facilitate the legal protection of genetic resources may permit corporates, biologists, and scientists to procure genetic resources from third-world countries. This phenomenon is commonly termed “bio-piracy”. Lastly, one of the most prominent objections to the patenting of genes and life forms is the commodification and objectification of life forms which is commonly perceived as something that is uncalled for. It has been argued that the commodification of life forms for commercial purposes translates to the objectification of its dignity and autonomy. While the debate against patenting of life forms and genes is arguably justified, granting such patents comes with certain advantages as well. For instance, granting patents for inventions that are the products of genetic engineering may incentivize scientists and researchers which may result in further research and development that is crucial in today’s day and age.

Author: Sanjana, a BBA LLB student of  Symbiosis Law School (Hyderabad),  in case of any queries please contact/write back GLOBAL PATENT FILING at support@globalpatentfiling.com.

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