The Covid 19 pandemic has snatched the lives of approximately 40 lakhs of people around the world. Scientists around the world aimed for inventing vaccines the “only cure “that helps to tackle the SARS-COV-2 coronavirus from early 2020. COVAXIN India’s first indigenously developed vaccine and Covishield, manufactured by the Serum Institute India are the major vaccine sources in India. Until now only 46.9 % of the total Indian population is fully vaccinated. As against this, many countries around the world have even started giving booster doses to their citizens. Also, at the same time spreading of third wave of Covid is another concern. If the current manufactures cannot increase the production and government is reluctant to issue compulsory licensing, why can’t use reverse engineering technology for increasing vaccine production? This article discusses the use and possibility of reverse engineering in the manufacture of Covid vaccines.
What is Reverse Engineering?
Reverse Engineering in a simple sense is the act of deconstructing and is an invention to see how it works. It is done mostly to examine and learn how something works, but it is also often used to reproduce or improve the object. In other words, reverse engineering is as its name says the process of reversing the invention to get the same product with a better function. The objective is not mere improvement or duplication, reverse engineering is not re-engineering (mere modification). There is a lot of misconception that prevails around this process such as the end product of the reverse engineering will be the duplicate of the original product. It is not necessary to turn out like the original one with no differences. This Technology stands out from others because of its ability to compete with other advanced technologies and its affordability.
Legality of Reverse Engineering under the Patents Act 1970
The legality of reverse engineering is quite a controversial topic around the world of intellectual property. Whether the Indian patents Act 1970(Act) contains any sections to prevent reverse engineering? The answer is no, there is no specific provision against reverse engineering in the Indian Patents Act. However, the Copyrights Act 1957 protects software, computer programmes from reverse engineering. Whether the structure of the reverse engineered product is same to the original one? Do the end products contain any substantial improvement? Even if it is original or reverse engineered, invention must undergo triple tests which is prescribed under the patents act. Under section 2(1) (j), such as novelty, non-obviousness, capable of industrial application and it shouldn’t be an invention under section 3 and 4 of the Act. Section 3(d) of the Patents Act, has a significant role in the field of pharmaceuticals, have to prove known efficacy as per section 3(d).
Need for Reverse engineering
If the covid vaccine manufactures are reluctant to provide voluntary licenses to the generic manufactures and the central government is not clear on its stand against compulsory licensing, the solution is reverse engineering of vaccines in this situation of emergency. India’s vaccine scarcity has two major reasons. The first being population for which nothing much can be done. The second is the inadequacy of vaccine production capacity, which could be solved by this technique.
The mRNA sequence for the Pfizer/BioNTech vaccine public in December 2020 was made publicly available by the World Health Organisation., with the companies confirming its authenticity. It could be used positively by the researchers around the world. The other hopeful news is the previously unknown mRNA (messenger RNA) Sequence of SARS-COV-2 spike protein for immunisation which was determined by two scientists from Stanford University from the leftover drops of Morderna vaccine, through reverse engineering. This might not be the full recipe and intellectual property of the companies are still protected. This implies that with proper research and development it is possible to reverse engineer the vaccines.
It is true that the manufactures of covid vaccines have spent millions for the invention of vaccines within a short period of time. Nevertheless, there is no doubt that covid 19 pandemic is a national emergency. The significance of reverse engineering of Covid vaccines should be considered for the benefit of a large number of people.
The views are that of author’s own and not necessarily the views of IPTSE Academy. This blog is a platform for academic discussions and hence authors have been given flexibility to convey their thought process.
- S. Sonika Nair, What is an Invention, Reverse Engineering in the context of Indian Patents Act. 1970 file:///C:/Users/USER/Downloads/REVERSE_ENGINEERING___AN_EMERGING_AND_CONTENTIOUS_TECHNIQUE_IN_I_P_R_1335.pdf
- Lisa Winter, Scientist reverse engineer mRNA sequence of moderna vaccine, https://www.the-scientist.com/news-opinion/scientists-reverse-engineer-mrna-sequence-of-moderna-vaccine-68640
6th semester (3rd year LLB)
KLA, Trivandrum, Kerala