Everything about Patenting in Biotechnology

You can read the Essentials, Development, Considerations, and Landmark Cases.

Essentials Steps for Filing Patent Application for Biotech Invention:

Step 1: Defining the Composition of Process.

Step 2: Identifying Difference Between Traditional Knowledge and your Invention.

Step 3: Establishing Efficacy of the composition or process.

Step 4: Conduct Patentability Search.

Step 5: Apply for NBA permission.

Step 6: Apply for Patenting process.

Step 7: Submit NBA Permission/Agreement before Grant of the patent.

Overview:

Biotechnology is the result of intellectual labour, an application of human ingenuity to biological processes. Human intervention differentiates the biotechnological process from the biological process. Naturally, the biological process takes place without human intervention. When there is human intervention in this biological process, it results in producing new things previously not in existence. These non-naturally occurring, human-made, and synthetically produced biotechnology inventions should be protected to get the desired fruits and encourage further research and development.

This effort of intellectual labour deserves protection under patent law.

Biotechnology is a combination of advanced technologies bridging biology with chemistry, biochemistry, microbiology, protein engineering, and genetic engineering. Biotechnology, when utilised towards practical application, is multidisciplinary, requiring a team approach directed at targeted goals. The significant factors lying at the base of India’s biotechnology potential are the scientific and technical pool of human resources and the country’s rich biodiversity. Hence it has a vast scope to be exploited for patenting technologies. Also, granting Intellectual Property Rights (I.P.R.) is an effective tool to protect biotechnology inventions Since research and development in biotechnology is highly time-consuming and requires enormous investment.

Evolution of patent law in concern with biotechnology:

The evolution of patent law dates back to nineteen sixties. The famous “Red Dove” case of 1969 confirmed the rejection by the German Patent Office of a method for breeding Doves with red plumage only because the method was not repeatable. It was the first case to open the doors to patenting biotechnological inventions. However, the path-breaking decision of patenting biotechnology inventions can be found in Chakraborty’s case. In 1972, Ananda M. Chakrabarty, a microbiologist, filed a patent application for the protection of a genetically engineered bacteria capable of breaking down multiple components of crude oil. Any naturally existing bacteria do not possess such properties. The first two claims involving the process and the carrier material were allowed, but the third claim for the patentability of the bacteria was rejected on the ground that there was no coverage for the bacteria within section 101 of the patent law. The examiner argued that the claimed microorganisms were “products of nature” and thus were not patentable as living things were not patentable subject matter. On rejection by The Patent Office Board of Appeals, finally, the issue reached the Supreme Court. Chief Justice Burger delivered the court’s opinion that; Chakraborty’s microorganism is not available. Naturally, it is human-made and a novel invention capable of industrial application; hence, it is eligible for a patent. After this decision, USPTO started issuing patents on biotechnology inventions.

Patenting of plants and related inventions:

The journey of patent law in patenting biotechnology inventions has not been confined to microorganisms but has continued to extend to the patent protection of transgenic plants.

In 1986, in Expart Hibberd, the U.S. patent office board of appeals overturned the refusal of a patent examiner who had argued that the invention was the product of nature. With this decision, the USPTO began issuing patents protecting biotechnological inventions in plants. After this decision, B.T. Cotton and B.T. Rice were patented in 1992 and B.T. soybean in 1994. Ever since the development of the first transgenic plants, a wide diversity of patents have been sought, ranging from the tissue culture methods to the composition of the newly introduced D.N.A. construct.

However, patenting plants is supposed to be unethical or prejudicial to the nation’s interests in agriculture-based countries like India. According to Indian Patent Act 1070, plants, or any part thereof, are not allowed to be patented. India joined Trade-Related Aspects of Intellectual Property Rights (TRIPS) in 1995, under which genetically modified plants were made patentable under the patent law. Patenting the process for genetic modification of the plant is a one-way patent holder can indirectly claim patent rights on the G.M. plant. But this cannot be a sure shot getaway as genetically engineered cotton cell lines granted to Agracetus in 1994 also drew a public outcry and protests from Indian cotton growers, which eventually was revoked under section 66 of the Patents Act.

Although essential biological processes for the production of plants cannot be patented, new plant varieties produced by conventional breeding may be protected through a sui generis system to protect plant varieties with a safeguard to protect farmers’ rights under the Plant Variety Protection and Farmers’ Rights Act (2001). Similarly, genetically modified plant varieties are also considered patentable in U.K., Europe and U.S.A. However, commercial production of any G.M. crop variety requires many licenses and patents. In addition, under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement of the World Trade Organization, most developing countries are now expected to put their own I.P.R. systems in place, including I.P.R. for plants.

Patenting of Animals:

Animal models are indispensable tools for screening novel molecules for various diseases. However, the standards for the patentability of animal biotechnological inventions must be determined responsibly and evaluated accurately.

In 1987 USPTO issued a statement stating: The USPTO now considers non-naturally occurring, non-human, multicellular living organisms, including animals, to be a patentable subject matter within the scope of 35 U.S.C. 101.

35 U.S.C. 101   Inventions patentable

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

However, sections 3(i) and 3(j) of the Indian Patent Act prohibit patenting surgical processes and animals. Hence animal models are not patentable in India. But tools used for diagnosis, treatment, and testing of animal diseases and research in animal sciences are patentable. E.g. A device for diagnosing sub-clinical mastitis in Dairy animals is granted by Indian Patent Office.

Section 3 of Indian Patent Act

What are not inventions

(i) any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products.

(j) plants and animals in whole or any part thereof other than micro­ organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals;

Patenting of Cells and Genes:

The advent of recombinant D.N.A. technology, gene splicing, and gene manipulation have poised towards patenting cells and genes. But patenting human genes and stem cells is primarily seen as ethically controversial. Also, many gene patents submitted are extensive, thus granting the inventor’s rights over all future applications of a protected D.N.A. sequence. Thus, such patents often limit research and diagnosis instead of stimulating research.

According to section 3(j) of the Patents, Act 1970, ‘plants and animals in whole or any part other than microorganisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals are not patentable. Stem cells and cell lines are considered to fall under the phrase ‘any part thereof’ and hence are excluded from patentability. However, in vitro methods of differentiating, isolating and culturing stem cells may be eligible as patentable subject matter, provided it is novel, involves an inventive step and has industrial applicability.

Examples of Biotechnology inventions which may be eligible for patenting are enlisted in

Essential considerations in patenting biotechnology:

Biotechnology researchers in many developing countries are unaware of the proper patenting procedure. Besides, filing patent applications relating to biotechnology requires a due care to be taken in additional disclosure requirements to pass the stricter examination tests successfully. Such inventions are subjected to N.B.A. (National Biodiversity Authority) approvals, and the traditional knowledge-based clauses are a few critical of those.

N.B.A. (National Biodiversity Authority) approvals:

Section 6 of the Biological Diversity Act, 2002 mandates prior approval from the N.B.A. before applying for I.P.R. originating from an Indian biological resource or the valuable Knowledge related to it. The N.B.A. considers requests and then grants or refuses the same for undertaking any activity as per sections 3, 4, and 6 of the Act. These approvals are vital to prevent the exploitation of bioresources and check Biopiracy. The Act also provides for benefit sharing fees and royalties for the conservers of biological resources, creators and holders of Knowledge and information relating to the uses of biological resources.

NBA Section 6. Application for intellectual property rights not to be made without approval of National

Biodiversity Authority.—(1) No person shall apply for any intellectual property right, by whatever name called, in or outside India for any invention based on any research or information on a biological resource obtained from India without obtaining the previous approval of the National Biodiversity Authority before making such application: Provided that if a person applies for a patent, permission of the National Biodiversity Authority may be obtained after the acceptance of the patent but before the sealing of the patent by the patent authority concerned: Provided further that the National Biodiversity Authority shall dispose of the application for permission made to it within a period of ninety days from the date of receipt thereof.

(2) The National Biodiversity Authority may, while granting the approval under this section, impose benefit sharing fee or royalty or both or impose conditions including the sharing of financial benefits arising out of the commercial utilization of such rights.

(3) The provisions of this section shall not apply to any person making an application for any right under any law relating to protection of plant varieties enacted by Parliament.

(4) Where any right is granted under law referred to in sub-section (3), the concerned authority granting such right shall endorse a copy of such document granting the right to the National Biodiversity Authority.

NBA Section 55. Penalties.—(1) Whoever contravenes or attempts to contravene or abets the contravention of the provisions of section 3 or section 4 or section 6 shall be punishable with imprisonment for a term which may extend to five years, or with fine which may extend to ten lakh rupees and where the damage caused exceeds ten lakh rupees such fine may commensurate with the damage caused, or with both.

Besides, suppose biological material described in a patent specification is not available to the public and cannot be described adequately as per the provisions of the Indian Patent Act. In that case, such material must be deposited with an International Depository Authority (I.D.A.) under the Budapest Treaty on or before the date of filing of the complete patent specification.

International depository Authorities available in India include

Traditional Knowledge:

Traditional Knowledge is a living corpus of Knowledge that has evolved within a small society and had sustained and passed on from generation to generation within a community. This Knowledge eventually becomes the cultural identity of the community. Such traditional knowledge methods are not protected by traditional intellectual property laws. India specifically has significantly contributed to freeing traditional Knowledge from the monopoly of Patents and creating the Traditional Knowledge Digital Library (TKDL).

Turmeric Patent Revocation details:

In a remarkable case of Turmeric Patent, the inventors approached UPPTO claiming a method of promoting the healing of a wound in a patient by way of administering an adequate amount of turmeric to the patient, orally or applied topically. Indian Council of Scientific & Industrial Research (CSIR) approached the USPTO to revoke this Patent in the capacity of an interested person who can start re-examination trials on the grounds of traditional Knowledge to prove the lack of novelty in the patented invention.

As a result, USPTO revoked the turmeric patent on the ground of prior art, as the evidence submitted by CSIR proved an evident lack of novelty, non-obviousness and inventive steps, which are essential prerequisites for any patent to be granted.

Neem Patent Revocation details:

One more such case chases back to 1985 when the first U.S. patent on a stable storage composition for Neem seed extract was issued. This swirled a lot of feelings in India as this Patent had claimed their Knowledge, which belonged to the people of India for ages. Another possible implication was that the traditional use of Neem in India would be seen as patent infringement if they were to gain a patent in the country; besides, the possibility of the Patent driving up the price of Neem seeds was also strong.

A US-based Foundation filed a plea for re-examination on the arguments that the invention lacked non-obviousness, taking into account the prior use of Neem in India. But the petition was rejected due to the geographical limitation in the U.S. patent legislature concerning prior use. Following this, the opposition division discovered that the alleged prior use occurred in 1985 in the Pune District of Maharashtra, India. An Indian agronomist, Mr Phadke, had developed a commercial Neem product in India without claiming patent protection and was a witness on behalf of the opponents. During his work, he also conducted extensive field trials in collaboration with other Indian farmers. This Indian traditional Knowledge became a ground to dismiss the auxiliary request of the patentee, and the Patent was entirely revoked on the grounds of lacking an inventive step compared to the prior art that the Indian Traditional Knowledge represented.

Summary

Biotechnology is booming in many developing countries, including agriculture and health sciences. In addition to protecting inventions, patents may encourage and promote scientific research. However, limited understanding and recognition of the importance of I.P.R.s due to difficulty of access, difficulty in understanding techno-legal documents, etc., become a challenge. But, with increasing importance and emphasis on I.P.R.s, in both the non-profit and the for-profit sectors, researchers and scientists are recommended to become aware of the basics of intellectual property rights, especially patents. Merits and demerits of any technology go hand in hand, but one should take the positive aspect of I.P.R.s to deliver a fruitful impact on research and development.