This article is written by Pranav Sethi, from SVKM NMIMS School of law, Navi Mumbai. This article analyses observing the demand for Tocilizumab in India as a valid ground for questioning the centre by the Delhi HC.

Introduction 

‘Scrutinise actions of those in power each day.’ ~ Hon’ble Justice DY Chandrachud.

The judiciary is India’s third most powerful governance institution. The Legislature and the Executive are the other two organs. Making and enforcing legislation are their respective responsibilities. It is the government’s bedrock because the Judiciary is the only institution that can monitor and pass judgment when there is a conflict between both the Center and the State, between the State and the people, or between the states. The Judiciary’s decisions are obligatory on all parties involved, whether they are individuals or the government. In India, the judiciary is the guardian of human rights, the defender of democracy, and the promoter of unity and tranquility.

The problem of whether Indian judges are free of political interference is a difficult one to address. As we all know, the Supreme Court and High Courts in India are solely responsible for safeguarding the fundamental rights of Indian citizens. As a result, it is only natural that the Courts be granted broad powers in order for them to preserve peace and achieve the constitutional goal stated in the Preamble.

The importance of the judiciary’s position cannot be overstated. It is shifting away from conventional punishment approaches and towards more modern punishment methods. Our judiciary’s efforts were recognized and appreciated all over the world.

Control of Coronavirus-Induced Disease with Tocilizumab (COVID-19)

The mortality rate of the corona virus-induced disease (COVID-19) has been reported to be 3.7 percent (WHO), which is more than 10-fold greater than the influenza mortality rate. Patients with such risk factors tend to die as a result of an immune system overreaction to the virus, resulting in a cytokine storm with characteristics of Cytokine-Release Syndrome (CRS) and Macrophage Activation Syndrome (MAS), and Acute Respiratory Distress Syndrome (ARDS). Patients’ plasma levels of many pro-inflammatory cytokines are elevated, and COVID-19 properties of MAS include elevated ferritin, d-dimer, and low platelets.

Extreme Coronavirus Disease 2019 (COVID-19)-induced cytokine outbreak is linked to a high mortality rate. With high levels of Interleukin-6 (IL-6) found in COVID-19 related deaths in China, IL-6 is thought to be a key player in the cytokine storm. On compassionate grounds, Tocilizumab, a monoclonal antibody against the IL-6 receptor, is used to treat the COVID-19 cytokine storm.

In extreme COVID-19 patients, microbial T cells and inflammatory monocytes with high IL-6 secretion can reach the pulmonary circulation in large numbers, inciting an inflammatory storm and leading to an immune disorder.

Treatment with Tocilizumab lowers the risk of death in people

Tocilizumab is the very first approved IforL-6 blocking antibodies, and it is convenient and beneficial in the prevention of rheumatoid arthritis. Patients were given standardized care comprising lopinavir, methylprednisolone, various symptom relievers, and oxygen therapy, as prescribed by the COVID-19 Diagnosis and Treatment Protocol (7th edition). Tocilizumab therapy has shown encouraging results. Both of the patients’ temperatures soon returned to normal. All of the symptoms, including respiratory activity, progressed massively.

Order by Delhi High Court

The Delhi High Court has ordered the Union Health Ministry and Department of Pharmaceuticals to negotiate with Roche India, which supplies Tocilizumab in India, to ensure timely deliveries of the medication, which is recommended to a huge proportion of COVID-19 patients.

According to Justice Prathiba M Singh, representatives from the ministry and department will interact with members from Roche India and its suppliers in India to interact and evaluate the market demand for this drug in India.

The court stated in its notification issued on May 6 that, “They shall also discuss the modalities for import and supply of the drug as per the expected demand and further logistics for placing orders for the same.”

After Roche informed the bench that it had no official instructions from the central government and was unaware of the particular market demand in India, the court issued the order. Blocking the court ordered that the details of the conference, which will take place on Friday afternoon, be presented to it by May 9 evening.

The court also ordered central government standing counsel Anurag Ahluwalia, who was representing the ministry, to receive directions first from the Agency of the Controller General of Patents and submit the documents about the patents that were issued, if any, about Tocilizumab, as well as the functioning reports submitted in support of the patents. Roche was also told to submit an affidavit indicating that it would import 50,000 and 25,000 vials of the drug into India in mid-May and mid-June, respectively.

Under this respect, Roche stated that its distribution company, Cipla Ltd., would have more knowledge about delivery and services and requested that it be considered a party to the proceedings as well. The court granted the appeal, adding Cipla as a party to the case and setting a sentencing hearing for May 10.

The court was hearing a motion in support of two COVID-19 patients who had been recommended Tocilizumab by their specialists but couldn’t find it anywhere.

Plaintiffs request & market demand for the drug

One of the plaintiffs, who filed the petition on May 5, was given the drug after the court interfered, and the counsel for the Centre and the Delhi government said that they would make every initiative to get the appropriate dose to the second patient, who filed the petition on May 6.

Roche informed the jury on May 6 that the drug was not produced in India and that the rapid surge in demand was unanticipated.

According to the study, the market demand for overall consumption in 2019 was only around 8,900 vials for the whole year. Fortunately, India received a total of 2,10,000 vials from March 2020 to April 2021.

Court’s demand from Roche company 

The court demanded the following details from Roche, which is summarized below:

• Will it be possible to procure emergency supplies of the drug Tocilizumab from any of the production facilities developing the drug and have them made accessible in India for the treatment of COVID-19 patients?
• For the next four months, the amounts of the medication Tocilizumab will be made available in India, either directly or through its licensee(s).
• Since March 2020, how much of this drug – Tocilizumab – has been transported in India, either by the company itself or through its licensee(s) or authorized importer(s)?

Response from the manufacturer

On April 26, 2021, 11,000 vials were shipped in the most recent set. The company explained to the court that, “out of the stated package, 9,900 vials were delivered to the central government for delivery to COVID-19 connected ministries and 1,100 vials were distributed to other government agencies for administration to arthritis patients.”

It also informed the court that immediate permission had been issued for an ‘Antibody Cocktail Treatment’ that would be administered in India, and that this would be a diagnosis specially tailored for COVID-19, as opposed to Tocilizumab, which was developed as an arthritis drug and is now being studied for COVID-19.

Response from central & state government

The central government, according to Ahluwalia, doesn’t have storage of the drug despite what it did receive was circulated to the states, union territories (UTs), and other organizations. 

The Delhi government informed the court that it had already provided the remaining supply of 500 vials of the drug it had obtained and that it had no more.

It also advised the court that it does not gather data on Tocilizumab use from the hospitals or medical facilities that received the vials.

Tocilizumab Patent Functioning Records and Distribution

The absence of local production and low import volumes have resulted in a severe shortfall of Tocilizumab in India, according to all of the courts involved. According to reports, Hetero Labs, a Hyderabad-based drugmaker, has applied to the CDSCO for permission to manufacture Tocilizumab in India, though the agreement between Roche and Hetero, for this reason, is unclear.

Tocilizumab is currently imported and marketed in India by Cipla Limited, which is insufficient to meet the overall requirements of the second wave of COVID-19 (para 48(i) of the SC interim order).

Only because it was expressly given to the Supreme Court in the suo moto writ petition this knowledge became public. Conversely, as a matter of Form 27 disclosure, details about the quantity of invention manufactured/imported, licensees and sub-licensees, and whether the public demand was fairly met were previously necessary.

However, the above was not included in the most current amendment that addresses the declaration provisions and how to support and promote them.

In their absence, they are currently witnessing a proprietary drug that is possibly qualified for a Compulsory licensing grant, but for which no application has yet been filed. This case demonstrates the importance of whether the general public and pharmaceutical generic manufacturers should have to stay before a patentee/licensee is ordered by a court – as Roche was – to first clarify these crucial details of how a patent works. Waiting seems to have cost the public health system a lot of money in this situation.

In its submission to the Supreme Court (para 48(ii) of the SC interim order), the government stated that there were domestically developed and usable alternatives for Tocilizumab that were equivalent or better functioning (an effort to avoid blame for making the drug available).

Tocilizumab was running out of stock due to the public’s misconception that it was an imported medication.

Despite this, the Supreme Court had called on the government to provide the drug through import, licensed manufacturing, or Compulsory licensing (compulsory licensing) blocking the, and to investigate its cost.

Compulsory Licensing, Patent Working, and Form 27

Section 146(2) of the Indian Patent Act, 1970, interpreted with Rule 131(2) of the Patent Rules, 2003, allows all patentees and licensees to submit Form 27 of the Indian Patent Act on an annual basis to reveal exhaustive information on the commercial “working” of their patent. Failure to perform this duty could result in the patent being forced to be licensed. Section 84(1) of the Act allows for the issuance of a compulsory license if certain conditions are met.

1. The public’s fair expectations about the patented invention have not been met.
2. The patented invention is not available to the general public at a reasonable cost.
3. The patented invention is not used on Indian soil.

The government permits third parties to produce, utilize, or sell licensed products without any of the permission of the patentee by granting compulsory licenses.

Court findings

The court decided the Supreme Court’s findings in the interim order issued on May 2nd and the Division Bench of the Delhi High Court’s order issued on April 20th that they are struggling with the question of Tocilizumab scarcity.

The Supreme Court had directed the government to consider issuing compulsory licenses for COVID-19 drugs under the current patent law system to combat drug shortages such as Remdesivir and Tocilizumab.

It also suggested using Rules 19 and 20 of the Drugs Price Control Order to keep the prices of these drugs under control.

Correspondingly, the Delhi High Court’s Division Bench directed the central government to contact patent holders and urge them to urgently increase production on a “war footing,” to promote voluntary licenses, and, if that did not happen, to consider the Compulsory licensing options available under the Patents Act, 1970.

Currently, the court has determined that there is a major shortage of Tocilizumab across the country. Despite the allocation of Tocilizumab to states and union territories (UTs), including 500 vials to Delhi, the soaring demand was not met (paras 12, 13).

The court issued the following directions to the Central government, asking for details on (Para 14), stating that the drug was not being produced in India and that adequate supplies were not available for purchase by even those who were willing to buy it.

Conclusion 

One of the really important factors in protecting people’s rights in a functional democracy is an independent judiciary. We have seen that the nation’s judicial body has taken several steps in this pandemic, such as issuing notices to the central government. Also, the governments of Delhi, Maharashtra, Tamil Nadu, Gujarat, and West Bengal for the disgraceful condition of COVID-19 in those states, and directed the centre to issue procedures to make free COVID-19 testing in private clinics for people who belong to those states.

The instructions of the High Courts show that they work together to protect the Constitution’s most fundamental value: human life and dignity. The actions collectively call for the most effective monitoring of the COVID-19 pandemic, including keeping the public informed about medical infrastructure availability, adequate testing, fair distribution of vital resources and services, and preventing hoarding and illegal trade.

References 

• https://www.researchgate.net/publication/342766261_The_Role_of_Judiciary_in_India
• https://indianexpress.com/article/india/justice-dy-chandrachud-scrutinise-actions-of-those-in-power-each-day-6160685/
• https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-021-05912-3
• https://health.economictimes.indiatimes.com/amp/news/policy/delhi-hc-asks-centre-to-hold-meeting-with-roche-to-ensure-immediate-supply-of-Tocilizumab/82471655
• https://www.thehindu.com/news/cities/Delhi/coronavirus-delhi-high-court-asks-centre-to-hold-meeting-with-roche-to-ensure-immediate-supply-of-Tocilizumab/article34507339.ece
• https://www.livelaw.in/news-updates/delhi-high-court-covid-directions-for-availability-of-Tocilizumab-critically-ill-patients-173672
• https://spicyip.com/2021/05/delhi-hc-issues-order-on-Tocilizumab-shortage-seeks-patent-working-information-from-roche.html
• https://www.barandbench.com/news/litigation/covid19-delhi-high-court-centre-delhi-transparent-timely-allocation-Tocilizumab
• https://www.scconline.com/blog/?p=247927

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