Compulsory license of Drugs

1. TRIPS Flexibilities & Exceptions Controversies Conclusion
Compulsory license of Drugs
Compulsory license of Drugs
MAHDY ALI AHMAD OSMAN
V Pharm.D
JSS College of pharmacy Ooty
Date : 2/9/2015

2. TRIPS Flexibilities & Exceptions Controversies Conclusion
Content..
• Definition .
• Doha Declaration ( TRIPs agreement ) .
• Development Options .
• conditions that govern the use of
compulsory licensing .
• Example .
• Reference .

3. TRIPS Flexibilities & Exceptions Controversies Conclusion
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.

4. TRIPS Flexibilities & Exceptions Controversies Conclusion
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).

5. TRIPS Flexibilities & Exceptions Controversies Conclusion
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.

6. TRIPS Flexibilities & Exceptions Controversies Conclusion
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 “

7. TRIPS Flexibilities & Exceptions Controversies Conclusion
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 )

8. 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 ?

9. TRIPS Flexibilities & Exceptions Controversies Conclusion
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 .

10. TRIPS Flexibilities & Exceptions Controversies Conclusion
Others conditions that govern the use of
compulsory 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, Roche
accepted 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”.

11. TRIPS Flexibilities & Exceptions Controversies Conclusion
Did You Hear About the Sorafenib
tosylate?

12. TRIPS Flexibilities & Exceptions Controversies Conclusion
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 Bayer
Corporation).
• “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.

13. TRIPS Flexibilities & Exceptions Controversies Conclusion

14. TRIPS Flexibilities & Exceptions Controversies Conclusion
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.

15. TRIPS Flexibilities & Exceptions Controversies Conclusion