[Ip-health] Essential Inventions request to Canada for compulsory license to manufacture and export generic gleevec

[James Love]

Essential Inventions has notified the Canadian government of its
intention to request "open" compulsory license for the manufacture and
export of Imatinib Mesylate, under the new Canadian law implementing the
August 30, 2003 decision of the WTO providing a =93solution=94 to paragraph
6 of the Doha Declaration on TRIPS and Public Health.  Novartis now
sells Imatinib Mesylate under the brand names Gleevec or Glivec, for
very high prices (in some countries, $75 to $150 per day for the rest of
your life), as a treatment for various forms of cancer.  The government
of India is enforcing Exclusive Marketing Rights (EMRs) for certain
versions of Imatinib Mesylate.  Some countries have expressed interest
in importing generic versions of Imatinib Mesylate.

An "open" compulsory license would permit any generic firm to
manufacture and export generic forms of Gleevec.  If Canada approves the
Essential Inventions request, it will be the first use of paragraph 6 of
the Doha Declaration.

In the first six months of 2004 Novartis reported Gleevec sales of $757
million, an increase of 47 percent from the year before.  Information on
the development of Gleevec is found here:
http://www.cptech.org/ip/health/gleevec/

Jamie


<------------Letter to Canadian government------------->

Essential Inventions, Inc.
P.O. Box 19405 Washington D.C. 20036 - http://www.essentialinventions.org
Voice +1.202. 387.8030 - fax+1.202.234.5176

14 December 2004

Honourable Ujjal Dosanjh
Minister of Health
Health Canada
Brooke Claxton Bldg; Tunney=92s Pasture
P.L. 0906 C
Ottawa, Ontario, Canada
K 1A 0K9

Via fax +1.613.952.1154 and post

Honourable Ujjal Dosanjh:

We applaud Canada for being the first country to enact legislation and
issue draft regulations to provide badly needed medicines and medical
devices to developing countries.  This farsighted leadership is critical
in the global campaign for equal access to medicine and health care. The
purpose of our letter is to register our intent to pursue, under your
new law, the export of Imatinib Mesylate from Canada at an affordable
cost to certain countries not defined as high-income countries by the
World Bank.

To this end, we are asking the Canadian government to issue a
non-exclusive =93open=94 compulsory license to authorize any qualified
entity to manufacture and distribute Imatinib Mesylate to any country
that qualifies under the provisions of Bill C-9 (the Jean Chr=E9tien
Pledge to Africa).

Imatinib Mesylate is used to treat certain rare forms of cancer,
including chronic myeloid leukemia (CML) and gastrointestinal stromal
tumors (GIST).  The Canadian patent owner is Novartis, which markets the
product under the trade name of Gleevec.  Currently the Novartis price
for Gleevec in Canada is $ 35,000 to $ 70,000 (CAD) per year.  Novartis
has sought to charge similar price world wide, including in developing
countries.

Essential Inventions is a non-profit organization, which is incorporated
in the United States, and operates in several countries.  On March 10,
2004, we asked Novartis for a voluntary license to its patents on
Imatinib Mesylate, in order to provide an affordable supply of the
product in countries not defined as high income by the World Bank.
Novartis has yet to respond.  We are now seeking a compulsory license to
the Novartis patents on Imatinib Mesylate in order to become a Canadian
manufacture and exporter of Imatinib Mesylate (in cooperation with firms
currently manufacturing generic products in Canada for the Canadian
market).


Page two

We have reviewed the Canadian legislation, regulations and official
commentary and have the following questions regarding our request.


a)=09To whom (and in what format and with what justification) do we submit
our request for Imatinib Mesylate to be added to the list of qualifying
pharmaceutical products?


b)=09Some importing countries require evidence that one can manufacture
and export a product before issuing a compulsory license for import of a
patented product.  If Canada requires evidence that a compulsory license
will be issued in the importing country, before it agrees to issue a
compulsory license to manufacture and export a product, it will be
difficult for the Jean Chr=E9tien Pledge to Africa to serve the needs of
certain countries.  In such cases, is it possible to obtain a
provisional authorization for the compulsory license, subject to
Essential Inventions (or any other party) satisfying the requirements
that it obtain the compulsory license (and TRIPS notification) in the
importing country?

Please direct us to the persons in your Ministry that we should work
with to pursue this request.

Thank you.


Sincerely,

Terry Gardiner
CEO
Essential Inventions, Inc.



--
James Love, Director, CPTech, http://www.cptech.org

Consumer Project on Technology in Washington, DC
PO Box 19367, Washington, DC 20036, USA
Tel.:  1.202.387.8030, fax: 1.202.234.5176

Consumer Project on Technology in Geneva
1 Route des  Morillons, CP 2100, 1211 Geneva 2, Switzerland
Tel: +41 22 791 6727

Mobile +1.202.361.3040
james.love@cptech.org