COVID-19 Drug Regulation Patent

Delhi HC Issues Order on Tocilizumab Shortage, Seeks Patent Working Information from Roche


A 20 ml vial of tocilizumab, marketed by Cipla (image from here)

This evening, the Delhi High Court passed an interim order issuing important directions on the shortage of the drug Tocilizumab in Delhi hospitals. The case arose from a petition by the brother of a Covid-19 patient, who had been prescribed a tocilizumab injection (Actemra 400g) by the doctor, but could not be administered the same due to the unavailability of the drug. Owing to the rapidly deteriorating condition of the patient, the petitioner had approached the court with the urgent plea. The petition, which was against the GNCTD, the Drug Controller of Delhi, Drugs Controller General of India and the Union of India through the Secretary, Department of Pharmaceuticals, also impleaded the manufacturer of tocilizumab – Roche Products (India) Pvt. Ltd.  While the GNCTD and the Central government assured the court that they would make efforts to provide the drug to the patient, the court passed certain important directions relating to the availability of the drug.

In dealing with the issue of the shortage of tocilizumab, the court considered at length the observations of the Supreme Court in the interim order released on 2nd May (discussed here and here), as well as that of the Division Bench of the Delhi High court in its 20th April order. It noted that the Apex court had asked the Central government to combat the shortage of drugs such as remdesivir and tocilizumab by considering the granting of compulsory licenses for Covid-19 drugs under the existing patent law framework. It had also recommended controlling the prices of these drugs by invoking Rules 19 and 20 of Drugs Price Control Order. Similarly, the Division Bench of Delhi High Court had ordered the Central government to reach out to the patent holders to immediately ramp up manufacturing at ‘war footing’, to encourage voluntary licenses, and if the same did not materialize, to consider the CL options available under the Patents Act, 1970.

Presently, the court concluded that there was a case of extreme shortage of tocilizumab, countrywide. Despite allocation of tocilizumab to states and UTs, which included 500 vials to Delhi, the same failed to meet the soaring demand (paras 12, 13). Noting, from the SC order, that the drug was not being manufactured in India and that adequate quantities were not available for purchase by even those who were willing to buy it, the court issued the following directions to the Central government, seeking information on (Para 14):

  • The remaining stock of tocilizumab available for distribution in Delhi
  • Details of entities to whom approvals have been granted for manufacturing, marketing, importing or selling of tocilizumab in India.
  • The stock of tocilizumab so far consumed from the 500 vials allocated to Delhi, as well as if any remained.

From Roche, the court sought the following information, reproduced directly:

  1. Whether immediate quantities of the drug Tocilizumab can be obtained from any of  the manufacturing units engaged in manufacture of the said drug,  and made available in India,  for the purpose of  administration  to Covid-19 patients in India?
  2. The quantities of the drug Tocilizumab to be made available in India either through itself or through its licensee(s) in India on a monthly basis  for the next four months.
  3. What is the total quantity of this drug – Tocilizumab, that has been imported/sold in India, since March 2020 – either by the company itself or through its licensee(s) or approved importer(s) in India.

Patent Working Information and Availability of Tocilizumab

It is clear from the discussions of all the courts concerned that there is a dire shortage of tocilizumab in India, owing to the absence of local manufacturing and low import quantities. It has been reported that a Hyderabad-based drugmaker Hetero Labs has sought permission from the CDSCO to manufacture tocilizumab in India – though the arrangement between Roche and Hetero for this purpose is not clear. At the moment, only Cipla Limited imports and markets tocilizumab in India and the same is not meeting the overwhelming needs of the 2nd wave of Covid-19 (para 48(i) of SC interim order). This information only came to light because it was specifically provided to the Supreme Court in the suo motu writ petition. However, details regarding quantum of invention manufactured/imported, licensees and sub-licensees, and information regarding public requirement being reasonably met was previously required as part of Form 27 disclosure. The same was however excluded by a recent amendment which Pankhuri critiques here. As she argues, these disclosure requirements support and facilitate the CL regime. In their absence, we are witnessing at present, a patented drug that is likely fit for a CL grant, except no application for it has been filed so far. This case forms an illustrative example for consideration as to whether the public and potential generic manufacturers should have to wait till a patentee/licensee is directed by a court – as Roche has been – to find out these important details regarding the working of a patent. In this case, the waiting seems to have had significant public health costs.

The Central government in its statement to the Supreme Court (para 48(ii) of SC interim order) had insisted that there were equal or better performing substitutes of tocilizumab that were domestically produced and available (an attempt to shirk off responsibility from making the drug available?). The reason tocilizumab was going out of stocks is because of the public perception that it is an imported drug. The Supreme Court had nevertheless asked the government to provide for the drug through import, licensed manufacturing or CL, and look into its pricing. With Delhi high court specifically lending support to this recommendation, it remains to be seen what course the Central government takes with regard to tocilizumab, or its Indian-manufactured substitutes.

(All this aside – readers may also want to check outthis article, which questions why many of these drugs are being prescribed in the first place).

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