Worldwide: The Global IP Scorecard For Pharma & Biotech Compulsory Licenses

Last Updated: 22 October 2007
Article by Duncan Bucknell

Please feel free to add to or comment on the scorecard at www.duncanbucknell.com/scorecards.

Countries, Products, Timing And Updates

There's been a lot of buzz lately about various developing countries ordering Compulsory Licenses. This scorecard tracks the countries, the products, timing of the ordered Licenses and provides updates as they arise.

Compulsory Licenses, (under Article 31 of TRIPS) have traditionally been ordered to enable access to medicines to people in developing countries who would otherwise not be able to afford them. The Licenses have typically been granted in respect of medicines to treat diseases such HIV/AIDS and other infectious diseases.

Part of the buzz which has recently arisen surrounds allegations that some countries have used the mechanism to drive down drug prices.

Other similar mechanisms, such as those under the 'Paragraph 6' system are also be tracked in this Scorecard. The Paragraph 6 system was implemented in the 30 August 2003 Decision of the WTO. Paragraph 6 refers to Paragraph 6 of the DOHA Declaration on TRIPS. The mechanism basically enables importation of cheaper medicines for countries which are too poor to manufacture the medicines themselves. Paragraph 6 states:

"6. We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002."

For a detailed report on Compulsory Licenses in many countries, see the Knowledge Ecxology International site.

For a nice summary of some recent developments up to 13 August 2007, see the Patent Docs blog.)

Background information on this case:

Article 31 of TRIPS states:

Article 31 Other Use Without Authorization of the Right Holder

Where the law of a Member allows for other use of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government, the following provisions shall be respected:

  • authorization of such use shall be considered on its individual merits;
  • such use may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use. In situations of national emergency or other circumstances of extreme urgency, the right holder shall, nevertheless, be notified as soon as reasonably practicable. In the case of public non-commercial use, where the government or contractor, without making a patent search, knows or has demonstrable grounds to know that a valid patent is or will be used by or for the government, the right holder shall be informed promptly;
  • the scope and duration of such use shall be limited to the purpose for which it was authorized, and in the case of semi-conductor technology shall only be for public non-commercial use or to remedy a practice determined after judicial or administrative process to be anti-competitive;
  • such use shall be non-exclusive;
  • such use shall be non-assignable, except with that part of the enterprise or goodwill which enjoys such use;
  • any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use;
  • authorization for such use shall be liable, subject to adequate protection of the legitimate interests of the persons so authorized, to be terminated if and when the circumstances which led to it cease to exist and are unlikely to recur. The competent authority shall have the authority to review, upon motivated request, the continued existence of these circumstances;
  • the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization;
  • the legal validity of any decision relating to the authorization of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member;
  • any decision relating to the remuneration provided in respect of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member;
  • Members are not obliged to apply the conditions set forth in subparagraphs (b) and
  • where such use is permitted to remedy a practice determined after judicial or administrative process to be anti-competitive. The need to correct anti-competitive practices may be taken into account in determining the amount of remuneration in such cases. Competent authorities shall have the authority to refuse termination of authorization if and when the conditions which led to such authorization are likely to recur;
  • where such use is authorized to permit the exploitation of a patent ("the second patent") which cannot be exploited without infringing another patent ("the first patent"), the following additional conditions shall apply:
    • the invention claimed in the second patent shall involve an important technical advance of considerable economic significance in relation to the invention claimed in the first patent;
    • the owner of the first patent shall be entitled to a cross-licence on reasonable terms to use the invention claimed in the second patent; and
    • the use authorized in respect of the first patent shall be non-assignable except with the assignment of the second patent.

Updates by Country

Argentina

Aug 14, 2007

18 October 2005

Argentina announces intention to grant Compulsory License for Tamiflu (Oseltamivir). It later transpires that the patent was never granted in Argentina.

Duncan

 

Brazil

Aug 14, 2007

6 July 2007

Brazil grants Compulsory License in relation to Abbott's Kaletra.

Duncan

 
 

Aug 14, 2007

4 May 2007

Brazil grants a compulsory license for Merck's HIV/AIDS drug Efavirenz.

Duncan

 

Canada

Oct 4, 2007

The WTO received from Canada, on 4 October 2007, the first notification from any government that it has authorized a company to make a generic version of a patented medicine for export under special WTO provisions agreed in 2003. The triple combination AIDS therapy drug, TriAvir, can now be made and exported to Rwanda, which is unable to manufacture the medicine itself.

Earlier, on 17 July, Rwanda informed the WTO that it intends to import 260,000 packs of TriAvir — a fixed-dose combination product of Zidovudine, Lamivudine and Nevirapine — over two years. The drug is to be made in Canada by Apotex, Inc and is called ApoTriavir by the manufacturer.

Links: WTO release; IPKat comment

Duncan

 
 

Aug 14, 2007

14 May 2004

Canada amends its Patent law to allow Canadian manufacturers to export to countries which lack the ability to manufacture pharmaceuticals - but only in respect of drugs listed in Schedule 1 to the Act.

Drugs that have been aded to Schedule 1 include:

lamivudine nevirarpine zidovudine tablets

Tamiflu (oseltamivir)

Duncan

 

Aug 14, 2007

October 18, 2001
Health Canada granted a Comulsory License in relation to the Bayer's ciprofloxacin and authorized generic manufacture to build a stockpile as protection against an attack of anthrax.

Duncan

 

Ecuador

Aug 14, 2007

2003

Petitions by local manufacturer (Acromax) for Compulsory License for Combivir (Lamivudine and AZT) refused, appealed and refused again.

GSK agrees to supply HIV/AIDS drugs at a discount.

Duncan

 
 

Eritrea

Aug 14, 2007

5 June 2005

Eritrea issues compulsory licenses for importation into Eritrea of generic HIV-AIDS medicines

Duncan

 
 

Europe

Aug 14, 2007

July 2007

European Union Trade Commissioner sends a letter to the Thai government, warning that it should not take further action to force drugmakers to drop drug prices.

Duncan

 
 

Ghana

Aug 14, 2007

October 2005

Ghana issues compulsory licenses for importation into Ghana of Indian generic HIV/AIDS medicines.

Duncan

 
 

Guinea

Aug 14, 2007

18 April 2005

Guinea issues compulsory licenses for importation on patents on drugs to treat HIV-AIDS

Duncan

 
 

Indonesia

Aug 14, 2007

March 2007

Indonesia issues a compulsory license for patents on the AIDS drug efavirenz

Duncan

 
 

Aug 14, 2007

5 October 2004

Indonesia issues a Compulsory License to manufacture generic versions of lamivudine and nevirapine (both HIV/AIDS drugs).

Duncan

 

Israel

Aug 14, 2007

January 1992

Israel grants Compulsory License to manufacture Bio-Hep-B under Biogen patent. Biogen's appeal was unsuccessful.

The patent expired in 1999 before the Supreme Court ruled on the dispute.

Duncan

 
 

Italy

Aug 14, 2007

21 March 2007

Italy grants Compulsory License in relation to Finasteride and related generic drugs for two years prior to the 2009 expiration of patent monopoly (Complementary Protection Certificate).

Duncan

 
 

Korea, republic of

Aug 14, 2007

January 2002

Korea rejects application for Compulsory License of Novartis' Glivec.

Duncan

 
 

Malaysia

Aug 14, 2007

29 September 2004

Malaysisa issues a compulsory license to import from India didanosine (ddI), zidovudine (AZT) and lamivudine zidovidine (Combivir).

Duncan

 
 

Mozambique

Aug 14, 2007

5 April 5 2004

Mozambique's issues compulsory license for lamivudine, stavudine and nevirapine.

Duncan

 
 

Rwanda

Jul 19, 2007

19 July 2007

Rwanda becomes the first country to notify the WTO that it intends to use the Paragraph 6 system (of the DOHA Declaration).

Paragraph 6 is designed for those countries that do not have the facilities to manufacture pharmaceuticals and so allows importation.

IPKat post

Notification protocol

Duncan

 
 

Thailand

Aug 14, 2007

April 2007

After weeks of negotiations and public debate (and statements about withdrawing drugs from Thailand), Abbott agrees to provide discounted AIDS drugs (Kaletra/Aluvia) to Thailand.

Duncan

 
 

Feb 1, 2007

Thailand announces two more Compulsory Licenses, this time:

Plavix, a heart disease drug made by Bristol-Myers Squibb and Sanofi-Aventis.

Kaletra, an HIV/AIDS drug made by Abbott Laboratories

Duncan

 

Dec 6, 2006

Thailand government issues a compulsory license on Merck's AIDS drug, Efavirenz. Thailand was criticised for failing to first contact Merck.

Duncan

 

United states

Aug 14, 2007

30 April 2007

The US Trade Representative elevatesThailand the Priority Watch list in its annual 'Special 301' Report. The USTR cites a concern that the past year has been characterized by an overall deterioration in the protection and enforcement of IP in Thailand.
The Report then specifically cites the recent grant of Compulsory Licenses as further evidence of weakening respect for patents.

Duncan

 
 

Zambia

Aug 14, 2007

21 September 2004

Zambia issues a compulsory license for lamivudine, stavudine and nevirapine.

Duncan

 
 

Zimbabwe

Aug 14, 2007

May 2002

Zimbabwe declares Period of Emergency which enables it to ignore antiretroviral drug patents for 6 months via a compulsory license.

In 2003, the period of emergency was extended by five years (until 31 December 2008).

Duncan

 

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