The ethics of intellectual property has always been a highly debated issue, and spans a range of issues, not least around what kind of patentable subject matter can be regarded as ethically permissible. Jurisdictions, including India, try to tackle this issue by legislating for it in the laws, and excluding inventions that may be morally questionable, but such laws are inherently subjective, and open to interpretation. This note examines the questions that have arisen around inventions related to the tobacco industry in India in this context.
In recent years, numerous patents for inventions related to the tobacco industry have been granted in India. For example, one of the top filers in this domain (British American Tobacco, which has a 24% of the total filings in this domain in India), recently said that it was ready to test “potential COVID-19 vaccine using proteins from tobacco leaves” on humans, after the vaccine generated a positive immune response in pre-clinical trials. This is doubly relevant given that in the current scenario, researchers and scientists are trying every possible ingredient, formula, and method, to develop vaccines to tackle Covid-19 as early as possible.
However, some Controllers at the Indian Patent Office (IPO) still express apprehensions to grant patents to tobacco-related inventions. We conducted a title-based search of about 440 applications filed in the IPO, of which we found 126 applications had been granted, but the rest were in the examination stage or had died. A summary study of First Examination Reports also revealed that several rejections were made under Section 3(b) (without any further reason or explanation provided), suggesting that this issue warrants further study.
This apprehension against tobacco-related inventions is presumably driven by the anti-tobacco messaging and policy that has been pushed over the years (i.e., the consumption and use of any tobacco product is injurious to health). It is further exacerbated when laws that are unfavourable to the tobacco industry are passed – such as the ban on commerce related to electronic cigarettes that received presidential assent towards the end of 2019.
The Indian Patents Act 1970 anticipates such ethical concerns in Section 3(b), which states that “an invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment” are not patentable. However, the manner in which Section 3(b) has been applied in India raises several questions, some of which are discussed here.
Applying Section 3(b) to tobacco-related inventions
Section 3(b) excludes from patentability inventions that, among other things, cause “serious prejudice” to human health. Undeniably, there exists significant public health literature around the adverse effects of tobacco consumption (termed in Indian policy parlance as being “injurious” to health). However, the interpretive jump from the terms “injurious” to “serious prejudice” is not clearly or theoretically evident so as to warrant instant exclusion from patentability.
Also, Section 3(b) as it currently stands, is worded slightly different from its previous avatar, before the Patents (Amendment) Act 2002 came into force. The older version of the provision stated that, “an invention the primary or intended use of which would be contrary to law or morality or injurious to public health;” was not patentable. The amended version replaced the word “injurious” with the phrase “serious prejudice”. This suggests that the intention of the legislature was deliberate and sought to distinguish between the two terms, as “injurious” and “serious prejudice” are not actually synonymous or interchangeable. Had the lawmakers intended these two terms to be the same, an amendment would not have been necessary. Further, it is useful to note that Section 3(b) and the Patents Act, 1970, as amended as a whole, provide no clarity on what “serious prejudice” might actually mean.
Some examples considered non-patentable under Section 3(b), such as a method for adulteration of food, may be found in official guidelines sources, such as the Manual of Patent Office Practice and Procedure, but there is no equivalent reference to tobacco-related inventions in such guidelines. In this scenario, an outright denial of patentability for such inventions could be construed as being grossly unfair to applicants.
The absence of jurisprudence on the applicability of Section 3(b) to tobacco-related inventions opens up further scope for interpretation of this provision, and leaves room for the IPO to tackle applications for such inventions in many ways that may not necessarily lead to an outright denial.
Firstly, when examining such applications, the IPO should consider that many of the claimed inventions related to the tobacco industry only have an indirect correspondence and bearing to any actual tobacco product. For example, a claimed invention may relate to a method/apparatus that may assist with the manufacture, processing, packaging, etc., of tobacco products, but the claimed invention may simply not be part of the tobacco product itself. In such a case, the test for the examining authority (i.e., the Controller at the IPO) should simply be whether the method/apparatus, in itself, is in any way contrary to public order, morality, health, or life, or not. In other words, a claimed invention should be examined and/or awarded merit only on the basis of what that method/apparatus is, rather than on the likely applications of such method/apparatus.
In any case, it is useful to keep in mind that applicants generally tend not to limit their claimed inventions to use within a single industry alone (this applies to applications relating to inventions for the tobacco industry as much as any other). Such intentions can be clearly comprehended and substantiated by the language used in the claims/description. For example, broader language and terminologies, such as ‘rod-shaped objects’, as may be used in the claims/description to refer to cigarettes, or the like, clearly highlight the intention to notto limit the method/apparatus’ use to cigarettes alone, but rather cover any object that may include a shape equivalent to that of a conventional cigarette. Ideally, there should be no apprehensions in such cases, and it becomes prudent to interpret such claimed inventions based on what the claimed invention could do, rather than purely on what it does do.
Secondly, even if the claimed invention has a direct correspondence and bearing to any actual tobacco product or a smoking article, the IPO should consider the larger existing regulatory environment that impacts such products. In the case of tobacco products, for instance, there is no outright ban on their manufacture or distribution; and, indeed, both the sale and consumption of tobacco products remain legal activities in the country. In this context, if the IPO were to prevent relevant applications from converting to patents without any backing from regulatory action, it could be arguably deemed overreach on the part of the IPO and could amount to a denial of legitimate right to the applicants concerned.
It is relevant to also note that the functioning of the tobacco industry is governed by the Tobacco Board Act, 1975. One among the many functions of the Tobacco Board, as outlined in section 8(2)(i) of its parent Act, is the “sponsoring, assisting, co-coordinating or encouraging of scientific, technological and economic research for promotion of tobacco industry”. Thus, it is clear that the tobacco industry in India as a whole is regulated by law, backed by statutory authority, with legislative safeguards in place to ensure the development of the industry (incidentally, India is the third-largest producer and exporter of tobacco products in the world). An invocation of Section 3(b) of the Patents Act, even while legislation like the Tobacco Board Act, 1975, subsists simultaneously on the statute book, becomes problematic. It goes without saying that such apprehensions particularly discourage manufacturers of tobacco products to further innovate and bring out newer technologies in their field, including those technologies that may make the very consumption of tobacco products less injurious.
While examining tobacco-related patent applications, the IPO should consider that many of the claimed inventions related to the tobacco industry only have an indirect correspondence and bearing to any actual tobacco product. Such tobacco related patent applications should be examined and/or awarded merit based on the novelty, inventive step criteria, and other relevant formal requirements. The invoking of Section 3(b), which is a highly subjective provision, and remains as yet inadequately tested in courts of law, to deny patents to inventions undeniably leave applicants in limbo and doubt, given the time, money, and effort, they have spent on innovating and researching new technologies.