This article has been written by Divyani Newar pursuing Diploma in Advanced Contract Drafting, Negotiation and Dispute Resolution and edited by Shashwat Kaushik. This article discusses the patenting of biotech products in India and a comparison with the USA.
This article has been published by Sneha Mahawar.
Table of Contents
Introduction
The term “biotechnology” was first coined by a Hungarian engineer named Karl Ereky. It was used to describe the science and processes that enable things to be made from raw materials with the help of living organisms. In a 1917 German paper detailing his pig fattening facility, he coined the word “biotechnology” for the first time. He proposed the term “biotechnology” to describe the branch of technology related to living things, using the analogy of “chemical technology.”
Biotechnology is the use of biological processes for commercial, scientific, industrial, and other purposes. This includes genetically engineering microbes to produce drugs like antibiotics and hormones. Biotechnology is a cross-disciplinary science, and it intersects lives at multiple points, be it agriculture, industrial biotechnology, clean energy, biopharmaceuticals, or health care. Biotechnology is the genus, while modern biotechnology is the species or a subset.
The ability of a nation to innovate new technologies that compete at the cutting edge of the global market is largely correlated with that nation’s economic performance. It is commonly known that patents are crucial to the development of the biotechnology industry.
Because patent law was created to address the needs of industrial technology, there is an oddity when it comes to patenting biological products. The emergence of biotechnology demanded that patent rules be appropriately adjusted to meet the requirements of science and technology. To accommodate biotechnological innovation, the conventional idea of sufficient disclosure at the time of filing for a patent had to be modified.
Patent laws in india
In India, the patent laws are governed by the Patents Act, 1970 (amendments made in the years 1999, 2002 and 2005).
Regulating bodies in India
Biotech bodies in India, including the Department of Biotechnology (DBT), the Indian Council of Medical Research (ICMR), and the Council for Scientific and Industrial Research (CSIR), are among the largest bodies. The Biotechnology Regulatory Authority of India (BRAI) is a planned regulatory organisation to control the use of genetically modified organisms (GMOs).
The Office of the Controller General of Patents, Designs and Trademarks (CGPDTM), generally known as the Indian Patent Office, is an agency under the Department for Promotion of Industry and Internal Trade that administers the Indian Law of Patents, Designs and Trademarks.
General rules for patent
The Indian Patent Act of 1970 established the following criteria for a technique or product to qualify for a patent:
- Inventive step- For a product or technique to qualify for a patent in India, it must be novel and involve an inventive step.
- Capable of industrial application- It is possible to patent an innovation in India that relates to a good or a method that is applicable to the industry.
- Novelty- This means that prior to the date of the application, the invention must not have been disclosed to the public, not even by the inventor.
The patent must not, however, come under the definition of an invention that is not patentable, as stated in Chapter 2 (Inventions Not Patentable) of the Indian Patents Act, 1970.
Inventions that are not patentable
Section 3 and 4 of the Indian Patent Act, 1970, deal with inventions which are non-patentable
Section-3: What are not inventions
The following are not inventions within the meaning of this Act:
- An invention which is in contrast to the accepted natural laws
- An invention intended for exploitation in commercial form that is opposed to public morality and causes significant damage to life forms.
- The basic scientific principle is the discovery of natural occurrences of living or non-living things.
- The newly discovered form of known substance or new usage of a known substance, except if such process adds to the creation of a new product
- A substance acquired by a process of aggregation of components into a mixture
- The duplication of familiar tools or devices that function independently of each other is already known.
- Which is excluded by the Patents (Amendment) Act, 2002.
- A method used in agriculture and its subbranches.
- Process which is used for treatment of human beings such as medicine, surgery, cure, etc. incorporated in Page 9 of the Patents Act, 1970 or treatment alike for animals for the purpose of increasing their economic value along with their products.
- Parts of plants and animals in their entirety, except for microorganisms, which include species, varieties and seeds, most importantly, include the biological processes for producing plants and animals.
- Computer programmes, algorithms, mathematical methods or business practises.
- Any literary and aesthetic creation that includes drama, music, cinematography, television or artistic work.
- Method of carrying out or performing mental acts or playing games.
- Presentation of information.
- Integrated circuit topography.
- An invention of traditional knowledge, which in effect is made from duplication of components of properties known to all.
Section-4. Inventions relating to atomic energy are not patentable. Patents shall not be granted strictly for inventions that relate to atomic energy within subsection (1) of Section 20 of the Atomic Energy Act, 1962.
Patenting of biotechnology invention in india
Biotechnology has a vital role in covering and touching lives in various aspects. Biotechnology in recent years has created unprecedented opportunities not only for humankind but also for industrial development. It has become the world’s fastest growing technology. The pharmaceutical and agricultural sectors in India, a developing nation, are built in part on advanced biotechnology.
History of indian patent laws
The first piece of legislation related to Indian patents was Act VI of 1856. The Indian Patent and Design Act, 1911 repealed the earlier acts of 1872 and 1883. The 1911 Act was revised later, after independence in 1950. Legislation related to patents was established in the year 1970 and came into effect on April 20, 1972. The modification to the 1970 Act was the Patents (Modification) Amendment Act of 2002, which came into effect on May 20, 2003 and was later revised in 2005 and 2006.
Working of patent industry in India
India is among the top 12 destinations for biotechnology globally. The biotech industry in India comprises over 5000 companies. Today, a number of research institutes (public and private) are working in the area of modern biotechnology, with a strong scientific research system in the country. But one of the most important issues raised is with respect to legal characterization and Intellectual Property Protection (IPP).
It is an intellectual property right given for inventions. Granting a patent in India is for a particular period of 20 years (known as the protective period). After the end of the protective period, the patent becomes off-patent making the product patent open to use by anybody who wishes to produce it. After the patent period expires, anyone can create the product and enjoy the revenue generated from it.
The time and money required for biotechnology research are enormous. The grant of intellectual property rights (IPR) is a powerful instrument for safeguarding biotechnological inventions.
Given the division of the subject of biotechnology into numerous sub-disciplines, the process of establishing common law or guidelines for patents is complicated. Those subfields with distinct characteristics include genetics and tissue culture in plants and animals.
The strongest form of intellectual property protection is a patent, since it gives the owner of the rights the most control over how the content is used.
In India, patents are granted to enable patentees to enjoy their inventions and also to secure their inventions’ commercial potential.
India in relation with TRIPS
In reference to the patentability of biotechnological inventions, the Patents (Amendment) Act, 2002, provided substantial changes to Indian patent law. The law met the requirement of Article 27.3(b) of the TRIPS Agreement by specifically providing for the patentability of microorganisms.
India joined the World Trade Organisation (WTO) in 1995. Under the WTO, member countries had to comply with the TRIPS (Trade Related Aspects of Intellectual Property Rights) Agreement. It is a multilateral agreement of the World Trade Organisation in relation to intellectual property rights (IPR). Under the TRIPS Agreement, every member country had to shift from process patents to product patents.
India formally became a signatory member of the TRIPS Agreement in 1995 when it joined the World Trade Organisation (WTO) (Trade-Related Aspects of International Property Rights). India needed to change its current patent system to comply with TRIPS, subject to a few transitory provisions allowed for developing nations in Article 65 of TRIPS.
The TRIPS Agreement, to which India is a party as a member of the World Trade Organisation (WTO), mandates that biotechnological inventions, including plant varieties, receive some level of protection.
For different member countries, different time periods were given in order to comply with this agreement. The developed countries had to comply within a period of one year. For developing countries like India, the time period was 5 years. Within 5 years, they had to comply with this agreement. In case of any emergency, the developing countries can extend the time period to another 5 years along with the existing 5 years, making it 10 years. For least developed countries (LDC), the time period given was 11 years.
According to the TRIPS Agreement, every member country has to shift from process patents to product patents. The TRIPS-mandated process of extending the term of Indian chemical (including biotechnological) patents from seven to twenty years from filing, along with a shifted burden of proof for alleged infringement of process patents, will cooperate with the country’s biotechnology industry’s goal of setting the global standard for the production of generic biologics.
Vision set out
India’s biotech industry will reach US$80 billion by 2021, as per Dr. Jitendra Singh (Minister, Ministry of Science and Technology), by releasing India’s Biotechnology Report 2022. The goal of the government is to attain self sufficiency in the country in this sector. So the role of patents becomes extremely crucial to protecting the creation and efforts of the inventor as well as the biotechnology industry. The country strives to achieve excellence in research and as a means of income generation with the help of biotechnology and to promote innovation with respect to intellectual property rights, including biotechnological innovation, which is beneficial to all its people and contributes to social and economic welfare.
Patent trend and patenting of biotechnology invention in the USA
History of US Patent Laws
Since the country’s founding, the preservation of intellectual property rights (IPRs) has been essential to American economic strength. The U.S. Constitution’s Article 1 gave Congress the authority to advance the progress of science and useful arts by securing writers and inventors the exclusive right to their respective writings and discoveries for a certain period of time. The four types of intellectual property that the US acknowledges are copyrights, trademarks, trade secrets, and patents.
The workings of the patent industry in the US
Firms in developing countries have dominated innovation in biotechnology with extensive patenting, but the US has clearly dominated patenting, covering different application areas of biotechnology. These innovations have a high degree of scientific linkage and joint partnerships between industry and universities.
A patent is a limited monopoly that the US Federal Government grants. Notably, a patent only grants the right to prevent others from creating, using, or selling the claimed invention in the United States, as well as from bringing the invention into the country. It does not grant the right to practise an invention.
An inventor must submit a patent application, including one or more “claims,” to the United States Patent and Trademark Office (USPTO) in order to be granted a U.S. patent. A claim delineates the bounds of an inventor’s intellectual property in a manner similar to how a fence delineates a person’s real property.
Three standard categories of patents are issued by the USPTO:
- New and valuable processes, machines, manufactures, or compositions of materials, or any new and useful improvements covered under utility patents
- Patents for “any unique and novel kind of plant” covered under plant patents
- Designs that are “novel, unique, and decorative” for manufactured goods are covered by design patents.
Persons eligible for a patent in the US: Section 101 only permits “invention” or “discovery” as criteria for obtaining a patent. An inventor can therefore apply for a patent in the US. A patent may also be obtained by an inventor’s assignee for patent applications submitted after September 15, 2012. In either situation, the patent application must name the actual and first inventor(s), and those inventors must give an affidavit attesting to their authentic inventorship.
Biotechnology inventions must adhere to the same patent requirements as do all other sectors, and system administration presents the same difficulties. Obtaining a patent for a “finding” or “invention” requires the claimant to pass a four-part exam, regardless of the industry. It must be a novel discovery or invention, useful, non obviousness and sufficiently described.
USA in relation with TRIPS
The developed nations, along with the USA, estimated TRIPS to be advantageous for the developing nations because it would help the nations thrive with respect to competing with other nations in terms of innovation and technology and attract investment and trade with other nations.
The TRIPS in all its member states aims to harmonise intellectual property (IP) legislation with domestic legislation. Regarding this, the promoters, mainly the USA, have known to adapt their laws in accordance with gaining maximum protection and advantage over gaining benefits of resources related to patents.
Foreign investors led by the USA own a major part of the patents filed in India, which reflects the fact that TRIPS has contributed to the profits of the USA and the rest of the developed nations.
Vision set out
According to the U.S. Constitution, the goal of the patent system is “to advance the progress of science and useful arts by securing for a limited time to authors and inventors the exclusive right to their individual works and discoveries” (U.S. Constitution, Article 1, Section 8, Clause 8). Providing innovators with this privilege encourages innovation effectively.
An innovation is granted a patent in exchange for the disclosure of the creation and use processes. The healthcare industry in the US is anticipated to be the one where biotechnology will have the most impact. According to estimations, genetically based diagnostics and preventative care could help stop health care expenses in their tracks, an economic necessity for a nation that is reeling from the highest health care prices in the world, improving human abilities to forecast, prevent, diagnose, and cure illnesses and disorders in an effective manner.
The biotech industry in the US will play a significant role in ensuring global food, water, and energy security. Agricultural biotechnology is used by more than 13.3 million farmers worldwide to boost yields, stop insect and pest damage, and lessen the environmental effects of farming. In the energy sector, genetic expertise is being used to modify how plants convert solar energy into chemical energy, opening the door to new, more affordable, and ecologically acceptable types of biofuel.
Judgements on biotechnology patent innovations
Diamond vs. Chakrabarty (USA, 1980)
In this case, this verdict permitted microorganisms to be patented in the US. The decision to grant a patent for a bacterium that can break down crude oil was upheld by the Court of Customs and Patent Appeals on March 17, 1980, according to the Supreme Court of the United States (Pseudomonas putida). As a result, the Supreme Court acknowledged that the question of a patent’s eligibility has nothing to do with whether or not an invention is a living thing.
Association for Molecular Pathology vs. Myriad Genetics, Inc. (USA, 2013)
In this case, according to the U.S. Supreme Court, simply finding a specific DNA gene sequence is insufficient to justify granting the person who did so a complete and exclusive patent on that sequence. A gene sequence cannot be patented simply by being isolated and identified, as nothing was “made” in doing so (which patent law requires).
Conclusion
The strongest form of intellectual property protection is a patent, since it gives the owner of the rights the most control over how the content is used. Patenting in biotechnology is a crucial issue because it involves life forms. The potential for mankind to investigate and utilise biological resources is greatly anticipated by the use of current biotechnology in the agricultural, ecological, pharmaceutical and other sectors.
The biotechnology industry has contributed significantly to developments in patent laws. Because it involves the patenting of living things, biotechnology patenting raises complex concerns. Indian patent laws address this issue of patentability in this field without breaching the TRIPS Agreement.
The developed nations, along with the USA, estimated TRIPS to be advantageous for the developing nations because it would help the nations thrive with respect to competing with other nations in terms of innovation and technology and attract investment and trade with other nations.
The US can grant licences for plants that have had a specific quality advancement added using biotechnology methods for which it has laid out certain standards. Likewise, healthcare and agriculture are major areas where biotechnology has a major role to play in the present scenario to help reduce healthcare expenses and ensure global food security
References
- https://www.sbhambriadvocates.com
- https://www.mondaq.com
- https://lawsuperior.com/biotechnology-patenting-analysis-india-and-usa/ Biotechnology Patenting: Comparative Analysis between India and USA
- https://vakilsearch.com/blog/the-brief-history-of-patent-system-in-india/
- https://lawsuperior.com/biotechnology-patenting-analysis-india-and-usa/
- https://bnwjournal.com
- https://blog.ipleaders.in/types-of-patents/
- https://www.legalwiz.in/blog/know-all-about-different-types-of-patents
- https://www.liebertpub.com/doi/10.1089/blr.2020.29161.zmn
- https://www.bionity.com/en/encyclopedia/Monsanto_Canada_Inc._v._Schmeiser.html
- https://www.mondaq.com/india/patent/805794/monsanto-vs-nuziveedu-seeds-the-bt-cotton-judgment
- https://onlinelaw.wustl.edu/blog/case-study-association-for-molecular-pathology-v-myriad-genetics-inc/
- https://ssrana.in/ip-laws/patents/working-patent-statements-india/
- https://unctad.org/ippcaselaw/sites/default/files/ippcaselaw/2020-12/Diamond%20v.%20Chakrabarty%2C%20447%20U.S.%20Supreme%20Court%20%20303%20%281980%29_0.pdf
- https://www.wipo.int/patent-judicial-guide/en/full-guide/india
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