GETTING PATENT PROTECTION FOR ELECTRONIC CIGARETTES
Author: Prateek Charan
Co-Author: Shivangi Pandia
National Law University, Nagpur
Electronic Cigarettes were introduced as an alternative to the traditional cigarettes with their proposed benefits including tar-less intake smoking experience. They have, though, formed a multi-million dollar business across the globe, yet they have been subjected to doubts over their authenticity and safety. E-Cigarettes, ever since their inception, has become quite famous amongst the young children who like the smoking experience which comes without any tar, however, once addicted to e-cigarettes, there is little denying the fact that they would be tempted to try out the traditional cigarette. Other than their addictive nature, they have been known to blast often in the mouth or hands of the smoker and cause severe burns. These are some of the many reasons why many countries, including India, have denied them patent protection and have also banned them in the country over justifying reasons for health and safety. Although the international IPR regime frowns upon such bans, the Indian legislature has been seen to care less about that facet of law. But with the continuously incoming applications for patent protection on one side and the consideration of health and safety on the other side, what shall be the future of E-Cigarettes in India?
People have yet not been completely tried out all the types of cigarettes and here we have the new mode of electronic cigarette coming into the market. This E-Cigarette is said to contain nicotine but without as against the traditional cigarettes it does not contain the detrimental tar. Its formation and model can be accessed easily online since it is mandatory to avail the patent information to the public when you apply for patent protection. In it, there is an electro-thermal vaporization nozzle which is installed into the air suction end of the shell that works on some control circuits to turn the nicotine solution into smoke. It was argued that the pros of this invention are ‘tar-less smoking’, thus, plummeting the risks associated with cancer while the smoker still receives the same smoking experience. Now, unlike the traditional cigarette, this E-Cig is not lighted with a matchstick or a lighter, it is rather self-heating.
The first move away from the traditional cigarette was made in the year 1967 by Herbert A. Gilbert. It was basically a non-tobacco cigarette intended to be a safe and harmless alternative to traditional cigarettes. Later in the year 2003, it was a Chinese pharmacist, Hon Lik, who came up with the present E-Cigarette. His idea was to create a device through which nicotine could be inhaled in a safer and cleaner way.
The success of the e-cigarettes can be inferred from the fact that in 2005 there were only 150 e-cigarette inventions available in publicly available patents information, but by 2015 there were over 500 inventions. As of the latest information, the total has reached well over 700 inventions, possible because a single invention can be covered by many patents. This invention has attracted users to such an extent that it is, as of 2018, a $14.05 billion industry and is likely to grow, by the end of 2022, to an estimated $29.39 billion industry.
Despite the success of this technology, it has failed to set foot in India legally, i.e. it has failed to impress the Indian Government to grant it patent protection.
In India, the government has shown a stern hand to the e-cigarettes and has stopped them from entering the Indian market and it has all been possible because of the enactment of “The Prohibition of Electronic Cigarettes (Production, Manufacture, Import, Export, Transport, Sale, Distribution, Storage and Advertisement) Act, 2019 on the 5th of December, 2019”. Owing to this legislation the Controllers at the Indian Patent Office (IPO) now hesitate in allowing a claim directed towards e-cigarettes. The prime ground raised against it is the Section 3(b) of Patents Act, 1970, which reads “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 is not patentable”.
Howsoever strong this argument may be, the international documents are contrary to it. Article 4quater of Paris Convention, 1883, reads “the grant of a patent shall not be refused and a patent shall not be invalidated on the ground that the sale of the patented product or of a product obtained by means of a patented process is subject to restrictions or limitations resulting from the domestic law.” A similar provision can be seen in Article 27 of the TRIPS Agreement, 1994.
As per the latest “Manual of Patent Office Practice and Procedure” issued in November 2019, IPO intends to put the e-cigarettes into the category of the invention that “causes serious prejudice to humans” under section 3(b). This stance that the IPO has taken against the E-cigarettes is a troublesome issue for those having patent applications for e-cigarettes and associated products pending at the IPO for examination. This is a scenario not just in India but in many other countries either strict restrictions have been imposed or the e-cigarettes are completely banned.
A contrario, there is only one country that has completely put a ban on the production and selling of tobacco and products using tobacco as raw material, i.e. Bhutan, including therein traditional cigarettes.
Choosing between the devil and the deep blue sea
The situation before the national authorities is now to decide between the two choices none of which is favorable. Choosing traditional cigarette, which is now the passive choice that every country, except Bhutan, has made is a prime cause of many types of Cancer and many other chronic diseases. On the other hand, the prime causes why countries have either banned or put restrictions on e-cigarettes are that owing to the million flavors that it was providing many young children were using e-cigarettes more and more, especially the teens. Moreover, there were no scientifically proven health benefits and also because of the dearth of substantiation pertaining to the assumed curative properties of these products.
One lesser-known aspect of this invention is that it also, sometimes and that too on its own, also takes up the responsibilities of a fire-cracker. This fear has crept up the sleeves of the government so much that the federal agency Food and Drug Administration (FDA) of the USA has even given tips to avoid battery explosions of vape. As per a study, in the year 2016 alone, an estimated 1007 burn injuries were reported in the United States itself. One might argue that such explosions also occur in smart-phones and that they are not banned, but then again smart-phones fulfill a lot more essential purposes than e-cigarettes do.
A proposed Solution
Owing to the facts, the concern against the usage and allowance of e-cigarettes is real. As per a report of CDC, above 20% of high school going students in the US were found utilizing e-cigarette in the year 2018, a rise of about 78% from last year. A similar scenario was found out in UK. Thus the prime cause of reluctance in its acceptance is the fact that these flavored e-cigarettes can make the students slowly become addicted to traditional cigarettes.
The ironical situation still remains to be that while strict regulations as to the restricted sale of e-cigarettes to people above 18+ years of age can solve the problem of its use by younger children, nothing can be done to avoid the harmful effects of smoking and yet the government allows the traditional cigarettes to be sold and bans the e-cigarettes.
The Subsisting Challenge
A challenge posed by this situation is that if patent protection is not granted by the IPO to this e-cigarette, then it will soon become publicly available for use and production locally by anybody and then it will be more difficult to place regulations to keep it in check for then it would be made by numerous local manufacturers and owing to the absence of any records, it will be difficult to curb that menace. However, if the patent is allowed, the holder of the right to manufacture and sell can be restricted by regulations concerning its sale and if anybody else comes up with its manufacturing then a lawsuit can clear up the situation. Moreover, the ban on the e-cigarettes through the present legislation would supersede the patent right anyway, even if granted.
Another anomaly is the contradicting views held by different political parties in India. It would not be wise to discard completely the possibility that the new government might allow patent protection to these e-cigarettes, and if that is done it would be a great loss to the existing patent holders waiting for protection of their device in India since by then they would have lost a great deal of fortune that they could have made had the ban imposed been lifted, also they would be left to fight the possible local manufacturers of e-cigarettes in every nook and corner.
Though some countries have put a ban on the use of such e-cigarettes through their national legislations, the international regime is kind of backing them up and is calling such acts of the national governments and legislatures to rebuke. However, owing to these recent campaigns of “Make in India”, I think the e-cigarette fraternity, which originated in China, will have tough days ahead trying to get an acceptable place in India. Finally, the best possible option with the government, considering the pros and cons of the situation, is that the ban on these e-cigarettes continues to exist. Indian population is younger than ever and this invention, if legally available in the markets, would start an era which would then become hard to put an end to. It is thus best that, keeping in mind all considerations, public health should be given the upper hand over economic rights and the ban should continue and they should not be granted patent protection in India. Also, if public health is the defense that the government is taking up, then it should also consider regulating traditional cigarettes that are sold on every nook and corner of the country and that creates new respiratory diseases every now and then.
 Who invented the vape?, Vaping Post, https://www.vapingpost.com/who-invented-the-vape/.
 E-Cigarette Use Among Youth and Young Adults, Centers for Disease Control and Prevention (2016), https://www.cdc.gov/tobacco/data_statistics/sgr/e-cigarettes/pdfs/2016_SGR_Chap_1_508.pdf.
 About Electronic Cigarettes, Centers for Disease Control and Prevention, cdc.gov/tobacco/basic_information/e-cigarettes/about-e-cigarettes.html.
 The History of E-Cigarettes, Dental Care, https://www.dentalcare.com/en-us/professional-education/ce-courses/ce451/the-history-of-e-cigarettes.
 Martinne Geller & Ben Hirschler, Pay per Puff? E-Cigarette Boom Sparks Race for New Patents, Scientific American (November 2014), https://www.scientificamerican.com/article/pay-per-puff-e-cigarette-boom-sparks-race-for-new-patents/.
 Steve Brachmann, Patent Filings Increase for E-Cigarettes, 3-D Printing and Machine Learning, IP WATCHDOG (March 2018), https://www.ipwatchdog.com/2018/03/23/patent-filing-increase-e-cigarettes-3-d-printing-machine-learning/id=94905/.
 E-Cigarettes (Vaping) Global Market Report, The Business Research Company (January 2020), https://www.thebusinessresearchcompany.com/report/e-cigarettes-vaping-global-market-report.
 Manual of Patent Office Practice and Procedure, The Office of Controller General of Patents, Designs & Trademarks (November 2019), http://www.ipindia.nic.in/writereaddata/Portal/Images/pdf/Manual_for_Patent_Office_Practice_and_Procedure_.pdf.
 Siddharth Cavale, et al., India, South Korea latest to take steps on e-cigarettes, Thomson Reuters (September 2019), https://uk.reuters.com/article/us-india-ecigarettes-factbox/factbox-india-south-korea-latest-to-take-steps-on-e-cigarettes-idUKKBN1W51DI.
 Gayatri Parameswaran, Bhutan smokers huff and puff over tobacco ban, Al Jazeera (September 2012), https://www.aljazeera.com/indepth/features/2012/09/201292095920757761.html.
 Health Effects of Cigarette Smoking, Centers for Disease Control and Prevention, https://www.cdc.gov/tobacco/data_statistics/fact_sheets/health_effects/effects_cig_smoking/index.htm.
 Arman Azad, This teen’s vape exploded, shattering his jaw, CNN(June 2019), https://edition.cnn.com/2019/06/19/health/e-cigarette-vape-explode-teen-study/index.html.
 Tips to help avoid “Vape” Battery Explosions, FDA, https://www.fda.gov/tobacco-products/products-ingredients-components/tips-help-avoid-vape-battery-explosions.
 Christopher M. Seitz & Zubair Kabir, Burn injuries caused by e-cigarette explosions: A Systematic Review of Pubished Cases, Tobacco Prevention Cessation (September 2018), http://www.tobaccopreventioncessation.com/Burn-injuries-caused-by-e-cigarette-explosions-nA-systematic-review-of-published,94664,0,2.html.
 Lorraine Martin & James Reihill, Here are all the valid health reasons why so many countries are banning vapes, Science Alert (September 2019), https://www.sciencealert.com/more-and-more-countries-are-banning-e-cigarettes.
 Rachel Grana, Neal Benowitz & Stanton A. Glantz, Background Paper on E-Cigarettes, World Health Organization Tobacco Free Initiative (December 2013), https://escholarship.org/uc/item/13p2b72n.