Explained: Why Compulsory Licensing of Drugs in Interest COVID-19 Patients

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We may take note of the fact that the Patents Act provides for Compulsory Licensing of Drugs under Section 84, and Special Provision for Compulsory Licenses or Notifications by the Central Government, under Section 92. Section 100 provides the power of the Central Government to use inventions for purposes of the Government.

Panchkula (ABC Live India): The Delhi High Court in case W.P. (C) 3031/2020 titled Rakesh Malhotra Vs Government of National Capital Territory of India And Ors ruled that Government to immediately reach out to the manufacturers/ patent holders/ licensees so as to forthwith ramp up the production capacities of the above, and all such other medications, as are essential for treatment of Covid positive patients.

We may take note of the fact that the Patents Act provides for Compulsory Licenses under Section 84, and Special Provision for Compulsory Licenses or Notifications by the Central Government, under Section 92.

Section 100 provides the power of the Central Government to use inventions for purposes of the Government Government should use its extraordinary provisions of law for enhancing the availability of  required emergency drugs and medical equipment.

Looking to the present day situation, there can be no doubt that a case is made out for exercise of its power by the Central Government/ Controller under the aforesaid provisions of law.

At the same time, the interests of the Patent holders/ licensees should be kept in mind, since it on account of their investments, inventions and hard work that such like medicines are made available to the public at large.

The best course would be encouraging the existing manufacturers to ramp up their production on a war footing.

They should also be encouraged to grant voluntary licenses to other entities to manufacture the requisite drugs. However, if such efforts do not fructify soon enough, the Government/ Controller should not hesitate to invoke their jurisdiction and powers under the aforesaid provisions of the Patents Act, since the lives of thousands of people are being lost each day in the country due to COVID. The lives of the people take priority over everything else.

Even if such like powers are exercised, the patent holders/ manufacturers can be adequately compensated by fixation of fair license fee. The Central Government should swing into action in terms of this order in this regard without any delay, and report progress on the next date of hearing.  

There are a number of other drugs which are being used for treatment Covid-19 patients, such as Tocilizumab, Favipiravir, Ivermectin, Dexamathasone, Methylprednisolone, Dalteparin, Enoxaparin, HCQ and Baricitinib.

As per news reports, there are shortages of some, if not all, of the aforesaid drugs. Looking to the emergent situation, we direct the Central Government to immediately reach out to the manufacturers/ patent holders/ licensees so as to forthwith ramp up the production capacities of the above, and all such other medications, as are essential for treatment of Covid positive patients.

We may take note of the fact that the Patents Act provides for Compulsory Licenses under Section 84, and Special Provision for Compulsory Licenses or Notifications by the Central Government, under Section 92. Section 100 provides the power of the Central Government to use inventions for purposes of the Government.


Read Full Judgment in Rakesh Malhotra Vs Government of National Capital Territory of India And Ors

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