compulsory license of drugs

TRIPS Flexibilities & Exceptions Controversies Conclusion

Compulsory license of Drugs

Compulsory license of Drugs

MAHDY ALI AHMAD OSMANV Pharm.D

JSS College of pharmacy Ooty

Date : 2/9/2015


Content..

• Definition .

• Doha Declaration ( TRIPs agreement ) .

• Development Options .

• conditions that govern the use ofcompulsory licensing .

• Example .

• Reference .


Compulsory licensing

• What is compulsory licensing ?

• Compulsory licensing define as when a Government allows someone else to produce the patented product ( Drug ) or process without the consent of the patent owner.

• It is one of the flexibilities on patent protection included in the WTO’s ( World Trade Organization ) agreement on intellectual property — the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement.


Doha Declaration ( TRIPs agreement )

• This issue of compulsory licensing of drugs was addressed by the Doha Declaration Article 31b “[Voluntary License] may be waived by a Member in the case of a:?

• national emergency or other extreme urgency .• of public non-commercial use .• discriminatory price ( price controls ) .• refusal to supply Drugs.• Compulsory licensing could be granted for generic copies to

be produced and exported to countries who are unable to manufacture the drugs themselves .

• Only Canada, Netherlands and Norway have altered legislation to allow export under this waiver provided they are exported to certain countries (principally, those on the UN's list of least-developed countries and certain other countries).

https://en.wikipedia.org/wiki/Doha_Declaration


Cont….

• also every country that is a member of the WTO has the right under the TRIPs agreement to issue a compulsory license if there is a public health need incase( refusal to supply Drugs )

From the text of the agreement:

"Each member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted “.

• are this means withdrawal of patent right ?

No. The patent owner still has rights over the patent, including a all right.


Development Options

1. Parallel imports

“These are products marketed by the patent owner (or trademark ) in one country and imported into another country without the approval of the patent owner”

2. Utilize compulsory licensing for developed countries

• TRIPS Article 67: developed countries can applied for

assistance from others countries (Parallel imports).

3. Public – Private Partnerships

• TRIPS Article 7: " compulsory licensing also can be issue by government to Public – Private Partnerships or Private companies “


conditions that govern the use of

compulsory licensing by WTO members

• (a) government applying for a compulsory license should be have been unable to obtain a voluntary license from the patent owner .

• (b) if a compulsory license is issued, .adequate remuneration , must be paid to the patent-holder.

• (c) a compulsory license must be granted mainly to supply the domestic market.

• This incase of in cases of , public non-comercial use , discriminatory price ( price controls ) , refusal to supply Drugs )

TRIPS Flexibilities & Exceptions Controversies Conclusion• TRIPs also provides that the requirements for a compulsory license may be waived in certain situations :1.in case of national emergency(a state of emergency resulting from a danger or threat of danger to a nation ).2.in case extreme urgency (when victims will no longer be the ones obliged to find treatment ).

why in this cases only ?


Example,

• August 2003: Egypt declared a public-health emergency in Erectile Dysfunction and broke the patent on Viagra .

• During December 2006–January 2007, Thailand’s

Ministry of Public Health issued compulsory licenses

on three patented drugs.

• In 2007, Rwanda issued a compulsory license for

AIDS drugs that it could not produce locally and

applied for assistance from Canada .


Others conditions that govern the use ofcompulsory licensing:

• discriminatory price ( price controls ) after price negotiations with the patent-holder can broken down .Eg: Brazil had previously used the threat of compulsory licensing to pressure companies to lower prices of patented medicines, in 2001, Rocheaccepted a price reduction of 40% for nelfinavir .

• refusal to supply Drugs :

“ prohibition of use or procurement of products, services or

any other undertaking’s material or immaterial components by an undertaking in a dominant position may be know also “refusal to contract”.


Did You Hear About the Sorafenibtosylate?


In India

• In March 2012, India granted its first compulsory license ever. The license was granted to Indian generic drug manufacturer Natco Pharma Ltd for Sorafenib tosylate, a cancer drug patented by Bayer (patent owner German pharmaceutical giant BayerCorporation).

• “Sorafenib tosylate” The compound, used for the treatment of advanced stages of kidney and liver cancer, is sold by Bayer under the brand name Nexavar.

https://en.wikipedia.org/wiki/Sorafenib_tosylate

https://en.wikipedia.org/wiki/Bayer

https://en.wikipedia.org/wiki/Sorafenib_tosylate


References

• https://www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm

• Doha Declaration ( TRIPs agreement ) Articles

• [1] Baron, David, 2008. .Compulsory Licensing, Thailand, and Abbott Laboratories..Stanford Graduate School of Business Case P-66.

• [2] Cahoy, Daniel R., 2011. .Breaking Patents..Michigan Journal of International Law,

• [4] Daemmrich, Arthur A., and Aldo Musacchio, 2011. .Brazil: Leading the BRICs..Harvard Business School Case 9-711-024

• [5] Scherer, F. M., and Jayashree Watal, August 2003: Egypt declared a public-

health emergency in ..Viagra .Journal of Political Economy 90, 470-86.

https://www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm

compulsory license of drugs

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