The era of COVID-19 has posed a challenge to the pharmaceutical industry- both in terms of prices of medicines and shortage of vaccines. Recently, a 3 judge bench of Supreme Court of India took note of these issues in In Re. distribution of essential supplies and services during COVID-19, wherein, it followed a 'bounded deliberative approach'. Meaning thereby, it seeks to create a dialogue between the executive (the Centre and the state) and the judiciary (this court).

Thus, the court did not pass any binding opinion and the debate of compulsory licensing of covid-19 vaccines remains an open-ended question. Compulsory licensing refers to a grant of permission by a government to a manufacturer seeking the use of another party's patent without its consent, typically on grounds of public health and safety. In India, Chapter XVI of The Patent Act, 1970 ('act') provides for this concept including the procedure and relevant terms and conditions for it.

This article aims to critically evaluate the relevant provisions under the act in light of the shortage of vaccines in the era of COVID-19. For this purpose, the article is divided into two parts, i.e. (1) Relevant provisions under the act and (2) evaluating whether these provisions can be invoked or not.

Part A: Relevant Provisions Under the Act
Initially, the Patent and Design Act, 1911 had no provision in respect of compulsory licensing. Thereafter, the recommendations of the Bakshi Tekchand Committee lead to the insertion of Section 84: Section 94 in The Patent Act, 1970.

• Who can apply for the grant of the compulsory licensee? [Section 84]
  Any interested person may make an application in this regard to the Controller of Patents of relevant jurisdiction on expiry of 3 years from the grant of patent. However, the application must be accompanied by any of the following grounds, namely:
  
  1. Reasonable requirement of public notice is not met
  2. The patented invention is not available at a reasonable or affordable price
  3. The patented invention is not used in India
      
• Power of Central Government [Section 92 and Section 100]

Pursuant to Section 92 of the act the controller off-patent is empowered with a suo moto power to issue compulsory licenses if, the central government issues a notification in this regard on all or any of the grounds namely, national energy, extreme urgency, public Non-Commercial Use. Further section 100 of the act enables the central government to use patents for governmental purposes.

It is pertinent to mention here that the controller of patent exercises complete discretion while considering applications of compulsory licensing and takes into account relevant factors like nature of invention the capability of the applicant to use the product for public benefit and the reasonableness of the application.

Part B: Analysis Concerning Covid-19
As noted above pursuant to Section 92 of the act the central government is empowered to make a declaration in the official gazette regarding compulsory licensing in case of 'National Emergency', 'Public Health crisis' or 'extreme urgency'.

For now, in India apart from price sensitivity being a major concern, the availability of desired pharmaceutical products remains a great issue. As far as the legislative requirement is concerned, the World Health Organization has already considered the current pandemic as a public health crisis and a situation of a health emergency.

In addition to this, the ground reality of covid-19 statistics is sufficient enough to be categorized as a 'public health crisis. This pharmaceutical product would not only benefit the ultimate beneficiary but would also protect the nation at large- due to the underlying contagious nature of the virus. Moreover, the sufficiency of vaccines becomes an important tool to prepare for the potential third wave.

Through this medium, the government can allow the Pharmaceutical manufacturers to produce the generic version of patented medicine or vaccine for larger public good this would enable the smaller manufacturers to produce more quantity of the desired vaccine.

From the perspective of the Pharmaceutical sector, it is true that they would get a reasonable advantage by earning a license fee in return for such a license however the requirement of such compulsory license is not for Infinity rather a short-term license of one to two years would be sufficient enough to serve as a shield against the pandemic.

Opinions By The Indian Courts
While pointing out at the lack of availability of crucial drugs and vaccines the Delhi High Court in Rakesh Malhotra vs GNCTD mentioned that the central government should not 'hesitate to invoke compulsory licensing provision'. However, it further went on to state that the prior focus should be made 'to encourage the existing manufacturers to ramp up their production and to grant voluntary licenses'

Further, the three-judge bench of the Supreme Court (In Re. distribution of essential supplies and services during COVID-19) stated that the central government must consider their power of invoking the provisions for compulsory licensing under section 92 or section 100 of the act. Justice Ravindra Bhatt, even went on to emphasize over the situation being one of 'public health emergency' and thus is a perfect situation for the provisions to be in the boat however, this order has no binding effect and was given in exercise of review jurisdiction, as noted by the Court itself.

Conclusion
In present circumstances of uncertainty, the world is fighting a global pandemic and, in such scenario, the provisions of section 92 and section 100 of the act could prove to be potential saviours. At the international level, countries like Canada and Israel have already invoked similar provisions.

However, it is still doubtful that even after the grant of such a compulsory license the desired result could be achieved or not. It is due to the reliability of the patent holders upon imports for their raw material and storage requirements. Moreover, another challenge is the agreement with foreign entities like Oxford, which must remain untouched by the application of such provisions.

Thus, compulsory licensing may be a feasible option in terms of availability of vaccines however it raises many implementation issues with respect to the imports and the proper storage facilities for the desired product. Nonetheless, the sufficiency of vaccines becomes an important tool to prepare for the potential third wave.