Model text for public non-commercial use of pharmaceutical patent(s)

Download the Word file of this text here.

By virtue of (insert reference to provision in relevant legislation) the (insert name of relevant ministry/authority) is empowered to exercise the right under any patent without prior authorization of the patent holder. The objective of this provision is to explicitly authorise the government or contractor to lawfully exercise on a non-exclusive basis any patent right for non-commercial purposes. Approximately (insert number) people in the country are affected by (insert name of disease). Currently (insert number) people are in need of treatment. It is Government policy to extend access to treatment of (insert name of disease) to all in need. The product(s) (insert name(s) of product(s)) are patent protected. The budget allocated for health services for (insert name of disease) for the fiscal year (insert year) is limited to (insert amount of money available to treat the people currently in need). The limited budget and high prices of the medicine make the purchase of the medicines unaffordable for the Government. According to the World Trade Organization Doha Declaration on the TRIPS Agreement and Public Health, each member has the right to protect public health; in particular, to promote access to medicines for all. The Doha Declaration specifically has clarified the right of Governments to grant compulsory licences, including for public non-commercial purposes. Therefore, the Department of (insert relevant department/ministry) hereby notifies, by virtue of (insert relevant sections of patent law) that it is now exercising the rights under patents (listed in annex 1) claiming medicine X (insert name or INN of medicine) sold under trade name Y (insert brand name of originator). In this regard, the (insert relevant ministry/authority) entrusts the (insert procurement entity e.g. central medical store or manufacturing facility) to exercise the right in its name in accordance with (insert relevant section of the patent law) subject to the following conditions:

  1. the rights shall be exercised to satisfy the needs identified above;
  2. they shall be exercised from this day on until (insert date / the expiry of the relevant patents/ until the purpose for which the use by the Government was authorised ceases to exist).
  3. a royalty fee of (insert value) per cent of the total sale value of drug having the aforesaid generic name by the (insert name of procurement entity or manufacturing entity) shall be paid to the patent holder.

The (insert relevant ministry/authority), shall promptly notify the patent holder. It is hereby announced. Given on the (insert date). (annex 1 listing relevant patents).

Other ML&P tools