A general principle inherent to granting patents is to encourage inventions and promote scientific research. Providing an alternative to cigarettes through scientific intervention, incorporating rapid technological advancements, is a step towards countering the harmful effects of tobacco. However, the rejection of patents for inventions that could provide an alternative to conventional cigarettes based on misinformation and preconceived notions is detrimental to further research and development and obstructs the progress that innovation can deliver.
Recently, the Calcutta High Court had the opportunity to deal with Section 3(b) of the Patents Act, which was arbitrarily invoked by the patent office without going into details of the invention at hand and providing any scientific evidence as to how the subject invention causes serious prejudice to human health. The Calcutta High Court has decided three patent appeals and set aside the decision of the Controller of Patents where the patent applications were refused under Section 3(b) of the Patents Act, 1970. The Court has remanded the matter back to the patent office for reconsideration since the impugned orders were either non-reasoned or passed in violation of the principle of natural justice.
For example, in R J Reynolds Tobacco vs The Controller General of Patents, Designs and Trademarks & Anr. IPDPTA/31/2023, the Court held that the refusal order was passed by the Controller on a preconceived notion that an invention related to tobacco products is seriously harmful to human health. The Court held that the understanding of the Controller in this regard was bereft of any reason or evidence. The Court also held that the Controller, in the refusal order, did not deal with the subject invention or any evidence adduced by the appellant. Although the Court did not interpret Section 3(b) of the Patents Act, the remand order clarified that the Controller cannot simply refuse an invention on a preconceived notion, and the Controller must apply an independent application of mind as to whether the claimed subject matter is seriously prejudicial to human health.
In another case of ITC Limited vs the Controller of Patents, Designs & Trademarks, IPDPTA No. 121 of 2023, the impugned order was set aside. The matter was remanded back for violation of the principle of natural justice as the documents relied on by the Controller to refuse the patent application were not served or intimated either in the examination report or in the hearing notice. However, this time, the Court went a little further and held that the grant of a patent should not be refused on the ground that the sale of the patented product or a product obtained by means of a patented process is subject to restrictions and limitations resulting from the domestic law. The Court also observed that the patents are granted to encourage inventions and to secure that the inventions work in India on a commercial scale and to the fullest extent that is reasonably practicable without undue delay. The patents granted do not prohibit the Central Government from taking measures to protect public health.
In yet another case of ITC Limited vs the Controller of Patents, Designs & Trademark IPDPTA/13/2024, the Calcutta High Court remanded the matter back to the Patent office for the reason that the reliance on the three additional documents which have been cited in the impugned order without providing an opportunity to the appellant to deal with the same was in a violation of the principle of natural justice. However, this time, the Court has interpreted the provision of Section 3(b). The Court held that to apply the provision of Section 3(b), it is necessary for the Controller to identify the primary or intended use. The primary or intended use can only be identified by going through the invention at hand in detail. Primary or intended use cannot be based on a preconceived notion that all tobacco-related products would cause serious prejudice to human health; rather, it should be based on scientific evidence. The Court further held that once the primary or intended use of the proposed invention is determined, the second question arises whether the primary or intended use is contrary to public order or morality or causes serious prejudice to human, animal, plant life or health or to the environment. The Court held that the Controller should focus on the intent principle of Section 3(b), not the harm or effect principle. For the intent principle, there must be a nexus between how the mind has been applied to the matters in issue and the conclusion based thereon. The Court held that tobacco products are not per se unpatentable in India.
It is abundantly clear from the above decisions of the Calcutta High Court and also from other refusal orders which are pending adjudications before the Delhi High Court that some Controllers are arbitrarily refusing the grant of patents on inventions which relate to tobacco products or aerosol-generating devices based on a preconceived notion that it will cause serious prejudice to human health without going into details of the invention at hand and without considering whether the invention actually reduces the harmful effect of existing tobacco products.
In this regard, the 161st Report of the Parliamentary Standing Committee on Commerce, in Section 12.1(i), has aptly recommended amending the provision of Section 3(b) of the Patents Act because the widely worded provision of Section 3 (b) is without any sufficient guidance or safeguards against arbitrary exercise of power by the Controller which may lead to refusal of socially useful inventions as well. The arbitrariness is apparent when the patentability of an invention is refused based on the Government’s ban on ENDS devices. On a closer look at Section 3(d) of the Prohibition of Electronic Cigarettes (Production, Manufacture, Import, Export, Transport, Sale, Distribution, Storage and Advertisement) Act, 2019, it will be clear that the Act does not put a blanket ban on electronic cigarettes. Section 3(d) of the Act:
(d) “electronic cigarette” means an electronic device that heats a substance, with or without nicotine and flavours, to create an aerosol for inhalation and includes all forms of Electronic Nicotine Delivery Systems, Heat Not Burn Products, e-Hookah and the like devices, by whatever name called and whatever shape, size or form it may have, but does not include any product licensed under the Drugs and Cosmetics Act, 1940.
The definition of the electronic cigarette excludes those products which are licensed under the Drug and Cosmetics Act, 1940. Refusal under Section 3(b) curtails the statutory right of the Patent Applicant even before the patent applicant could apply for a license under the Drugs and Cosmetics Act, 1940. Moreover, the Patent Office is not mandated to act as a regulator and deny protection if it is banned. This Act deals with the sale, manufacture, import and export and not with the grant or non-grant of a patent for an invention. Also, it is a complete misunderstanding that a grant of a patent confers a consequential affirmative right to sell or commercialise the product.
Even if assuming that the fear of the patent office is real and that the grant of the invention related to the aerosol-generating devices or tobacco products may cause serious prejudice to human health, how will the non-granting (refusal) of a patent allay that fear? Non-granting of the patent on that invention will give everyone the opportunity to work on that invention. Therefore, regulating the right to sell or commercialise is not within the power and purview of the Patent Office; rather, it falls within the realm of the central Government. The patentability of the invention should be decided based on the provisions of the Patents Act. The Calcutta High Court has already given an interpretation of the provision of Section 3(b) in the second ITC case. However, to settle the law on patentability under Section 3(b), some additional considerations need to be considered. Section 3(b) of the Patents Act recites:
an invention the primary or intended use or commercial exploitation of which could be contrary public order or morality, or which causes serious prejudice to human, animal or plant life or health or to the environment;
The provision of Section 3(b) is widely worded and uses the “OR” operator seven times. Therefore, when multiple “OR” operators are used within a single clause in a statute, the clause should be interpreted disjunctively, meaning each condition separated by “OR” is considered an alternative. The entire clause is satisfied if any of the listed conditions are met. The interpretation of this clause can be understood by the table below, where the use of the “OR” operator has been placed in parallel rows.
|
An Invention | The primary use |
of which could be contrary | public order | |
| morality | ||||
| intended use | ||||
| which causes serious prejudice to | human, animal | |||
| plant life | ||||
| commercial exploitation | health | |||
| the environment |
Section 3(b) of the Patents Act has two prongs, i.e., 1) an invention, the primary or secondary use or commercial exploitation of which could be contrary to public order or morality, and 2) an invention, the primary or secondary use or commercial exploitation, which causes serious prejudice to human, animal or plant life or health or the environment. In Balsinor Nagrik Co-op. Bank Ltd. vs Babubhai S Pandya (AIR (1987) SC 849), it was held that it is a canon of interpretation of statute that the construction of a section of a statute is to be made all parts together, and it is not permissible to omit any part of it.
Therefore, to invoke the serious prejudice prong of section 3(b), it is necessary to find out the primary or intended use of the invention in hand and not the effect or harm that it may cause. This can be better understood by way of an example. Let us consider that in the prior art, there existed aerosol-generating articles that used internal or external heating elements that required periodic cleaning. If used for a prolonged period of time, these aerosol-generating articles would not generate a consistent flavour.
An invention was made to provide a technical solution to the above problem, which replaces the heating element with a susceptor that utilises induction heating and, therefore, does away with the requirement of periodic cleaning of the prior art heating element. In this context, the invention is limited to the aspects of having a susceptor as a heating element. Therefore, the primary or intended or commercial exploitation has to be considered by this susceptor only to decide whether it causes serious prejudice to humans or not, and the use of the whole aerosol-generating article is already available in the prior art.
Therefore, to refuse an application under Section 3(b), the Patent Office must check the nexus between the intended use of the actual invention and whether it causes serious prejudice or not. Also, to conclude that the invention causes serious prejudice, it must be backed by scientific evidence after an independent analysis of the subject invention.
The next word, which needs to be interpreted in section 3(b), is the use of the word “serious” and what the measure of “serious” is. To understand this, it is important to note that Section 3(b) of the Patents Act was amended, and the word “serious prejudice” was introduced in the Indian Patents Act by the Patents Amendment Act, 2002 (no. 38 of 2002), which came into effect from May 20, 2003. Before the amendment, Section 3(b) provision read as follows:
What are not inventions: 3(b)- an invention the primary or intended use of which would be contrary to law or morality or injurious to public health;
The word “injurious” has been replaced with the words “serious prejudice”. Injurious and prejudiced can be equated, and therefore, the intention of the legislature to add the prefix “serious” was to increase the threshold for an invention to be regarded as a non-patentable subject matter under Section 3(b) of the Patents Act, 1970. A review of similar provisions to Section 3(b) in other corresponding jurisdictions reveals that the exclusions which are mandated by the legislature are:
(a) processes for cloning human beings;
(b) processes for modifying the germ-line genetic identity of human beings;
(c) uses of human embryos for industrial or commercial purposes;
(d) processes for modifying the genetic identity of animals, which are likely to cause them to suffer from such processes.
The above examples show that the exclusion is for inventions inherently dangerous to public health or morality. Most IP jurisdictions have also clarified that exploitation in this provision shall not be considered contrary to public order or morality solely on the grounds of being prohibited, limited and regulated by legal or administrative provisions (Article 53(a) of the European Patent Convention).
In conclusion, the decision as discussed above in ITC casts a duty on the Controllers of Patent to do an independent analysis of the invention at hand and find an answer to questions about what the primary and intended use of the invention is and whether the primary or intended use of the invention is causing serious prejudice to human health or not. A preconceived notion that all tobacco-related products or aerosol-generating devices will cause serious prejudice to human health without any scientific evidence will act as counterproductive to the growth and promotion of innovation and an antithesis to the patent system.
India, being a signatory of TRIPS and the Paris Convention, must respect the provisions of Article 27(2) of TRIPS and Article 4quarter of the Paris Convention, which state that the patentability of an invention cannot be denied merely based on restrictions and limitations resulting from some domestic law. The above decisions on Section 3(b) by the Calcutta High Court will guide the Patent Office in future examination of the patent applications related to aerosol-generating devices and articles.
Authors: Manisha Singh and Manish Aryan
First Published by: Mondaq here