PATENTIBILITY OF BIOTECHNOLOGY
“The potential for synthetic biology and biotechnology is vast; we all have an opportunity to create the future together.”
- Ryan Bethencourt
Biotechnology is technology based on biology, harnessing cellular and biomolecular processes to develop technologies and products that help improve our lives and the health of our planet. Modern biotechnology provides quintessential measures to address formidable diseases, minimize environmental hazards, lessen hunger, use conventional energy and have safer industrial processes.[i]
A patent is an intellectual property right which grants exclusive rights through a sovereign state to an inventor or assignee to make, use, and sell an invention for a limited period of time in exchange for detailed public disclosure of an invention.[ii]
According to the TRIPS Agreement[iii], patents are available for any invention in any and all fields of technology. But the issue of the patentability of biological materials has triggered widespread discussions and has to deal with a number of challenges[iv] vis-a-vis:-
(i) ADMINISTRATIVE CHALLENGES like patent backlogs, application processing delays, poor patent quality and excessive litigation due to the USPTO’s[v] mushrooming workload;
(ii) LEGAL CHALLENGES like defining necessary degree of alteration to naturally occurring matter to qualify as “patentable”, identifying patentable utility, novelty, non-obviousness, describing altered genomic and proteomic material, classifying patent infringement, protecting IP rights, particularly abroad;
(iii) INNOVATION CHALLENGES like finding where the genuine intellectual property is duly protected, encouraging the openness, liberty, and symbiosis upon which scientific processes flourish, clarifying between pure research versus commercial pursuit for purposes of patent infringement indemnification, nurturing the sharing of biomedical data as an open platform to drive innovation, reducing policy and legal uncertainty.
(iv) ETHICAL CHALLENGES like addressing public concerns regarding human alteration of genetic codes, coping with unintended scientific, social, environmental, and public health consequences from DNA manipulation, making lifesaving biomedicine available to those who can’t afford it while continuing to incentivize innovation, protecting the privacy of personal genomic information.
There is, currently, no clear international consensus on treatment of biotechnology. Various reports produced by the WIPO[vi] and OECD[vii] based on separate studies have only strived to amplify governments’ awareness of the potential problems and to offer some suggested solutions. Plethoric controversies clouding the patentability of biotechnology can merely pave way for short-term developments at a national and regional level.[viii]
In the 1980 Chakrabarty ruling[ix], the US Supreme Court held that isolating the products from nature converts them into patentable subject matter. However, subsequent rulings in Myriad[x] decision and follow-on decisions[xi], focusing more on whether any changes were made to the genes in question, stripped away patent protection from various areas of the biotechnology industry. The Indian case of Dimminaco (2012)[xii] clarified that if the end product is a commercial and vendible entity, the presence of the living organism in the end product cannot be a bar to the patentability of the process.
Presently, patentable biotechnology includes[xiii]:-
- Methods for producing or analyzing proteins, their use in an analysis method or in a medicinal product.
- Proteins, DNA sequences, microorganisms and constituents of the human body already existing in nature, if they are isolated from their natural environment or produced by a technical procedure, and previously not described.
- A gene, which is isolated and given new task as medicinal product or diagnostic tool.
- Genetically modified products, like plants and animals.
Despite ongoing debate over biotechnological patentability, it is undeniable that sans protection, any development is difficult. For the greater good of mankind, biotechnology should not only be encouraged but also protected to ensure collective growth and knowledge exchange through secure patent system.
[ii] Bhatt J. Legal Service India. What is a Patent? See http://www.legalserviceindia.com/articles/ptwy.htm, last visited on 13/11/17.
[iii] Agreement on the Trade-Related Aspects of Intellectual Property Rights.
[iv] Raidt, J. (2014). Patents and Biotechnology. US Chamber of Commerce Foundation.
[v] U.S. Patent and Trademark Office.
[vi] World Intellectual Property Organization, the United Nations permanent body primarily responsible for international cooperation in intellectual property.
[vii] Organization for Economic Cooperation and Development.
[viii] Groombridge, B. (1992). Intellectual property rights for biotechnology. Global biodiversity: Status of the Earth's living resources, 495-499.
[ix] United States Supreme Court, Diamond v. Chakrabarty, (1980)
[x] Supreme Court Of The United States, Association For Molecular Pathology et al. v. Myriad Genetics, Inc., et al.(2013).
[xi] Supreme Court of the United States, Mayo Collaborative ServicesS, DBA Mayo Medical Laboratories, et al. v. Prometheus Laboratories, Inc., (2012);
United States Court of Appeals for the Federal Circuit Ariosa Diagnostics, Inc., Natera, Inc. Plaintiffs –Appellees, DNA Diagnostics Center, Inc., Counterclaim Defendant-Appellee v. Sequenom, Inc., Sequenom Center For Molecular Medicine, LLC, Defendants-Appellants, ISIS Innovation Limited, Defendant,(2015).
[xii] Calcutta High Court, Dimminaco A.G. v. Controller of Patents Designs and Ors.(2012).
[xiii] PRV, Biotechnology and Patents, see https://www.prv.se/en/patents/applying-for-a-patent/before-the-application/what-cannot-be-patented/biotechnology-and-patents/, last visited on 14/11/17.
Author: Suparna Mukherjee
College: University of Calcutta
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