There is currently a rapid increase in the growth of the biotech sector owing to major advances in scientific research. However, several scientific inventions are yet to receive a green light for patenting as these inventions are different in nature to the traditional subject matter of patents. Multiple tests and legal provisions are required to be put up with, whilst dealing with the concept of patenting and a sector like biotechnology.
The process is slightly more complex compared to other industries. There are significant differences when it comes to patenting of the composition of living organisms between India and the United States. To examine such differences, the ‘basic invention’ criteria must be used to figure out how such biotechnological patents are given the green light. India has been a stringent country in drafting such parent laws as it does not allow patenting of living organisms. On the other hand, the US has given a green light towards patenting created living organisms which are unique in nature.
This indicates a significant difference in the biotechnology industry between both countries. India and the US are seeing major growth in the biotech sector. This essay focuses on the legal provisions and precedents set in both the countries involving the patenting process to explain such gap in growth between India and the US.
Biotechnology is the process of involving living organisms for certain inventions that are required across the globe. Biotechnology has been an important field of study due to the contributions it has made in the name of medicine and science. Through the process of genetic engineering, multiple companies with their research teams have come up with various medicines saving several lives across the world due to the inventions made in the field. For instance, with the help of bio-patenting, medicines for Hepatitis C, HIV, Cancer, and other chronic or incurable diseases, have substantially increased the life expectancy of patients. Additionally, more than 730,000 children’s lives have been saved in the last 20 years in the United States because of advances in vaccines.
Thus, the increase in research and advances in the field of biotechnology have saved several lives. The drugs/ products involved in the biotech sector must be protected as there are several pharma companies which could come up with the same product, and claim the exclusive rights to it. To prevent such circumstances, the process of patenting allows the inventor to legally claim their product entirely to avoid copying of the inventions involved. There are 3 types of patents: Utility Patents, Design Patents and Plant Patents. Biotechnology products come under the utility patents section.
A Utility Patent is available for an invention or discovery of a new and useful machine, manufacturing process, composition of matter, or process. Each country has different processes as to how an invention can be patented, and inventions involving the biotech sector have several procedures to go through to be exclusively patented.
Several countries are contributing to the rising value of the biotech sector. India has around 3% share in the global biotech sector which lead to them being ranked 52nd in the Global Innovation Index Report 2019. The current value of the Indian biotech sector is 50 billion dollars. However, the US being a global biotech player with over 112 billion U.S. dollars of revenue is a few steps ahead compared to India.
The essay will now delve into the legal provisions and case laws of the countries which are required to be complied with in order to receive such patenting license.
INDIAN PATENT LAW
The Patents Act, 1920 governs and consolidates the law involving patenting of inventions in India. Only an invention can be patentable, and Section 3 of the Patents Act states what cannot be considered as inventions. Due to the lack of information given on what is patentable, there has been confusion and uncertainty, especially in the biotech sector.
Section 3(b) of the Patents Act, prevents patenting of any invention which could cause harm to animals, plant life, and the environment. If the invention involves causing harm to any life present in the ecosystem, the patent would be immediately rejected. Section 3(c) bars patents which involve the mere discovery of substances present in the environment. This section can be connected to the next provision, section 3(j) which bars patenting on plants (varieties and seeds too) and animals. This section had prevented companies such as Monsanto from patenting several varieties of cotton plants across the country. This law had prevented Monsanto from monopolizing the cotton sector. The Supreme Court of India had also refused to overrule a decision of the High Court that upheld Article 3 (J) of India’s Patent law, amended to implement the Trade-Related Intellectual Property Rights Agreement of the WTO. This had led to India banning such patenting claims as it poses a risk to research and innovation which would ultimately lead to the monopolization by the private sector.
AMERICAN PATENT LAW
35 U.S.C. 103 of the United States Patents Act, provides the conditions as to the patentability of an invention, and these conditions are given in order to avoid obviousness. The invention would be regarded as obvious when a person who specializes in the field finds that your product can be easily put together with existing input. This law is extremely relevant in the biotech sector as biotechnology involves merging several input examples. For a person to claim a patent over a product, the resulting invention must not be achieved by combining known references in a way that produces predictable results.
In India there is a lack of case laws involved in the biotech sector and the inventions coming out of it, however, the US has a few substantive case laws that defined what can be patentable in biotechnological inventions. In the case of Association for Molecular Pathology v. Myriad Genetics Inc, the degree of alteration and to what extent the product can be altered to regard it as an invention is defined. Judge Lourie of the US Supreme Court had found the chemical alteration to be dispositive, because isolating a particular strand of DNA creates a non naturally occurring molecule, even though the chemical alteration does not change the information transmitting quality of the DNA.
The question relating to patentability of micro-organisms first came before the US Supreme Court in Funk Bros. Seed Co. v. Kalo Inoculant Co. The case involved an invention relating to a mixed culture of Rhizobium bacteria capable of simultaneously inoculating the seeds of plants belonging to several cross-inoculation groups. The Court, in this case, held that the mere aggregation of species fell short of an invention within the meaning of the patent statute because the combination of species produced no new bacteria and no change in the six species of bacteria.
In the famous case of Diamond v. Chakraborty, the courts had observed that everything under the sun, that is made by man is patentable. The court had given a judgement stating that the ‘product of nature’ test is crucial in deciding whether the invention is made by a man or it had existed in nature or had been a product of nature. If the invention involved had been a product of nature, the patent would be disallowed as there is a lack of involvement of man’s efforts and had simply existed due to nature. This had led to the US allowing patenting of living organisms created which are unique in nature such as the bacterium in this case.
There are also several debates happening currently in the Congress regarding patenting of genes. The US Supreme Court in a landmark judgement had banned patenting of human genes due to the risk of decrease in medical research and innovation, as private companies will have to the exclusive right to disallow any research if the gene is owned by them.
CURRENT RULES AND PROVISIONS REQUIRED FOR PHARMACEUTICAL PATENTING IN INDIA AND THE U.S
In the medical field, Section 3(i), (method of treatment test) medicinal treatment includes a process of administering medicines orally (in form of tablets, capsules etc.) or through injectables, or topically or through a dermal patch and method of treatment by surgery for therapeutic or cosmetic purpose are not considered patentable. However, to claim patents in this field, the following guidelines must be taken into importance:
- The terms such as “diagnose an individual”, “obtaining test sample from the individual” and ” indication that the individual is susceptible to a disease” should be avoided.
- Specifying the process to be “in-vitro‟( work that is done outside a living organism) in the claim of the invention.
- Directing the invention and method purely for cosmetic purposes.
- BLAST (Basic Local Alignment Search Tool) search result for the claimed sequences can be submitted to demonstrate that the claimed sequences are a variant form of the known natural sequences having new substitutions.
The Patents Act had been introduced in 1970 and initially, the pharmaceutical sector had been kept on the sidelines, including the agrochemical products getting authorization for patenting. The reason patenting had been brought into the market was due to the amendment in 1999, where the nation had started to provide patenting of pharma and agrochemical products. Due to the nation’s obligation to TRIPS, the patents Act had been amended again in 2002.
In the US, there is no such complexity in the process of patenting medical devices provided the method meets the other requirements of patentability (eg, novelty and non-obviousness), methods of medical treatment are patentable subject matter. For example, in the most recent posting of Intellectual Property Update, it was noted that the jury’s finding of patent infringement against Medtronic involved the methods of using a tool to de-rotate multiple vertebrae of an affected spinal segment (and not necessarily the features of the tool itself).
The US patent law is the governing legislation of the products that are generated in the pharma industry. The FDA also plays a part in the checking of the said products. The term till the expiration of a patent is 20 years, and till then the patent holder has the right to sell and use the invention. Pharma patents include the way in which the product is created and the chemical components in the product involved. The Food and Drug Administration gives the company a 5 year period of exclusivity when a new chemical entity is used in a product, which does not allow other companies to submit an Abbreviated New Drug Application containing the same new chemical entity, thus obtaining full exclusivity to sell the invention for 5 years.
Several case laws have helped the US in framing the guidelines, and principles for allowing patenting of several inventions in the biotech sector. This had been necessary due to the complexity of the nature of the products arising from the biotech sector. The most important point of the Indian patent law to be highlighted is that any medical treatment that is required for animals and human beings to help them recover from a disease or to increase the monetary value, is not considered patentable under the Indian Patents Act, 1970. This can be connected to the Pharmaceutical sector where the ‘method treatment’ test is more complex in India compared to the US, as the medical devices only need to fill up the criteria of novelty and non-obviousness. To overcome this objection in India, the guidelines given above must be followed since India does not allow the patenting of living systems entirely and including any other processes to produce plants and animals. This can also be confirmed in the Monsanto case where the Supreme Court had upheld the High Court’s decision on the disallowance of patentability of plants and animals in whole, or in any part. In the US, the scenario is quite the opposite. As discussed earlier in the Diamond v. Chakraborty case, the US allows patenting of created living organisms that are unique in nature. The US patent law also allows patenting of DNA sequences, as the law considers it only as a composition of matter. Due to this law, the US has the power to grant patents for plants where a certain gene sequence has been added via biotechnological ways.
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