When navigating the world of patents and patentable inventions, we come across essential requirements which an invention shall fulfil to get a patent and Section 3[1] of the Indian Patents Act, 1970, which provides a list of inventions which are non-patentable under section 3 (d) of the Act. Section 3(b)[2] restricts the grant of patents for inventions which are injurious to life forms and the environment. Here, the question arises: to what extent can an invention be considered injurious enough to be denied patentability? This article establishes a connection between morality and patents. Further, it aims to clarify the ambiguous words of the provision by analysing the case of Harvard Oncomouse.
Introduction
In today’s age, the scope of Intellectual Property Rights (IPR) is expanding exponentially with the aid of extensive technology and modern equipment. IPR is a concept that is recognised worldwide, granting rights and protection to various established fields of Intellectual Property (IP) such as Copyright, Patents, Trademarks, Designs, Geographical Indications, Semiconductor Integrated Circuits, Plant Varieties and Biological Diversity in order to facilitate fair trade and safeguard the intellectual labour, all while upholding public policy[3].
In India, the law of patents is governed via the Indian Patents Act 1970, with notable amendments in 2002 and 2005. A patent is an exclusive right granted to the true and first inventor of an invention for a period of 20 years from the date of filing. Section 2(1)(j)[4] of the act defines “invention” as a new/novel product or a process that includes an inventive step and is capable of industrial application. The invention also includes an improvement capable of independently meeting the aforestated criteria. Section 2(1)(j)[5] defines inventive step as technical advancement, having economic significance, or both compared to existing knowledge.
It’s not necessary that when a subject matter qualifies all the three criteria of patentability it will benefit society. Hence, various provisions under the act, such as section 3[6] and section 4[7] of the act, lay out criteria for inventions disqualified from grant of patent. In this article, we will understand the bar on the patentability of an invention when it causes some serious prejudice to a life form, against public order and morality.
Morality and Public Policy in Patent
Morality and public policy have a significant role in patents. First of all, the right to patent is granted to the inventor in order to reward his/her intellectual labour fairly. Then the exclusive right protection lasts for a period of 20 years so that upon its expiry, the invention is available to the public at large, and society can also benefit from it. Further, we witness provisions of compulsory licensing (Sections 82 to 94), surrender and revocation of patents (Sections 63 to 66), Section 47[8], and the use and acquisition of patent by the Central Government for their own use; these provisions govern the use of patents on the basis of public policy and morality.
Amendment of 2002 in the Patent Act, 1970
Article 27[9] of the Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS) establishes general principles of patentability. The exclusion part of the second clause grants member countries certain rights to exclude the following inventions from patentability to protect public order and morality. They include any inventions contrary to human, plant, animal and environment, not limited to exposition defined and barred by the law[10].
Section 3[11] of the act is very important as it lays out a negative list, stating the products or processes that won’t be considered as an invention, despite qualifying the essentials of the patent criteria. Section 3(b)[12] of the act was amended in 2002 to incorporate the regulations laid out in Article 27[13] of TRIPS; it states that any invention whose primary use or intended use or commercial exploitation would go against the public order or morality or the invention causes serious prejudice to human, animal or plant life or health or to the environment will not be considered as an invention. Examples: inventions related to theft, gambling, human cloning, etc.
Harvard Oncomouse Case[14]:
Facts
In the early 1980s a group of researchers at Harvard Medical School invented one of the world’s first transgenic mice for furthering cancer research. They induced an oncogene in the mouse’s DNA, which made the mouse vulnerable to cancer and develop tumours. The creators of “Oncomouse”, on behalf of the institution, filed for a patent in the USA, Canada and the European Patent Office (EPO)[15].
Issues Raised
- Upon meeting the essential patentability requirements, should parents be granted regarding living animals and their varieties, specifically for higher stature animals such as mammals?
- How should moral implications and public policy be affected in regard to transgenic animals and their suffering?
The case was fought in various jurisdictions, and each country has given different perspectives on the issues raised[16].
United States of America
Harvard University was granted a patent by the US Patent Office in the year 1998. It described the mouse as “a transgenic non-human mammal whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal or an ancestor of said mammal, at an embryonic stage…”. The matter of patents on human beings and modifications to the human genomes was explicitly excluded, considering the legal and moral concerns[17].
European Patent Office
The oncomouse case was considered at length in front of the European Patent Office (EPO), and the final decision was given by the Appellate Board in 2004. The board applied Article 53(a)[18] which states non-grant of a patent for “inventions the commercial exploitation of which would be contrary to “ordre public” or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States” and Article 53(b)[19] stating non-grant of patent for, ”plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof”.
The EPO stated that the oncomouse didn’t qualify under the definition of animal variety, and so it doesn’t qualify under Article 53(b)[20]. It was further stated that a ban on patenting “animal varieties” under the article didn’t implicate a ban on the patenting of animals.
The EPO came up with the Utilitarian test in order to address and balance public order & morality. The test was set out to compare positive aspects with the negative ones. In this case, the positive aspect was the benefits occurring from the use of oncomouse in furtherance of cancer research for humans and was weighed against the morally negative aspect of suffering caused to the oncomice.
In furtherance of the test, other factors were also considered, such as environmental harm, which turned out to be neutral and public discontent, which was also recorded as neutral after considering the evidence based on European demographics.
Thus, the EPO gave its judgment in favour of granting of patent to the oncomouse. Since the test results specified that the positive aspects and utility of oncomouse in furtherance of cancer research greatly overpassed the negative aspect of morality and suffering caused to the oncomice.
Later, in 1992, Upjohn Pharmaceuticals put a similar case of genetically modified mice before the EPO. In this case, the transgenic mouse was being used to advance the treatment of human baldness and wool production mechanisms. This infusion resulted in the loss of all hair in the mouse. EPO used the same utilitarian approach to weigh out the positive aspects and negative aspects, but here, the latter prevailed over the former. The mouse was not guaranteed patent as it was against morality, and the use wasn’t as essential as oncomouse[21].
Canada
When the case was filed in the Canadian patent office, the patent officer rejected the request for patent prima facie on the basis that their law didn’t include animals in the definition of the invention. Regardless, another claim on the patent process for producing the oncomouse was allowed to go forward.
The Supreme Court of Canada gave its final verdict in the year 2002. The court stated that higher life forms and mammals were not subject to the definition of the invention, which mainly focuses on the manufacture or composition of matter, as per the Patent Act 1869. The act previewed “Manufacture” as a non-living mechanical product or a process and “Composition of matter” as a mixture of ingredients or substances by a person. The judges distinguished that the lower life forms were subjected to the composition of matter while the higher life forms were disqualified. So, the court qualified microorganisms and transgenic animals as a composition of matter and approved a patent while rejecting the patent claim on the body of the oncomouse.
The court pointed to the Patent Act, 1869, and stated that the drafters left out the subject matter of the patentability of higher life forms while drafting the act. The court recommended that the patentability of life higher forms was very controversial and the parliament must engage in a public debate to discuss the subject matter’s social standpoint, morality and legislative stance. The court concluded by stating that, scientific alteration of the genetics of an animal (not a higher life form), which doesn’t exist in nature in that altered form, will qualify under “composition of matter” under the Patent Act[22].
Conclusion
Creating and patenting transgenic animals proposes a moral and ethical dilemma in the field of patents. The oncomouse case showcases the diverse reasoning and standpoints of various jurisdictions across the world. The case has outlined patentability requirements, patentable subject matter and ethical dimensions of patentability on life forms which stand controversial with public order. It can be concluded that patentability of higher life forms, such as mammals, is barred across the world as of now. In India, Section 3(b)[23] of the Patent Act, 1970 doesn’t allow an invention to be patented that will drastically affect humans, plants, environment while going against public policy or morality. Upon hitting Section 3(b)[24] of the Indian Patent Act, 1970, the inventor must prove to the controller that the invention’s positive aspects outweigh the negative aspects and ensure he/she has taken the necessary steps to minimise the negative effects, then only the invention will have a chance to be patented, subject to discretion of the controller of patents.
Author: Hardik Manwani, UPES Dehradun
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