E-DRUG: The Patent Pool Initiative in The Lancet - November 2009
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The Lancet Infectious Diseases, Volume 9, Issue
HIV drug patents in the spotlight
- Kelly Morris
[copied as fair use]
http://www.thelancet.com/journals/laninf/article/PIIS1473309909702725/fulltext?rss=yes
Access to HIV medicines has been highlighted recently, with advocates
applauding decisions by India and Brazil to reject the patenting of key
antiretroviral drugs. Although companies are increasingly instituting their
own initiatives to increase access, calls for the pharmaceutical industry to
join the UNITAID patent pool have grown louder.
On Sept 30, Médecins Sans Frontières (MSF) launched a campaign
<http://actionformsfaccess.org/>calling on companies to join the
UNITAID patent pool and asking the public
to make the same call. As the December goal for the UNITAID implementation
plan grows nearer, all parties are debating the role of patents in access to
HIV drugs and the advantages and challenges presented by a patent pool.
Several measures can increase access to HIV drugs, explains Michelle Childs
(MSF, Geneva, Switzerland). Under the World Trade Organization's
trade-related aspects of intellectual property rights (TRIPS), the least
developed countries are not required to grant patents on medicinal products
until 2016, allowing the use of generic HIV drugs at present. Because these
countries cannot afford even generic prices, most antiretroviral drugs are
purchased by international organisations, and lower prices mean greater
access. Countries other than least-developed countries can use compulsory
licenses to allow generic production and supply least developed countries
despite the existence of a patent. The other measures, says Childs, is to
have high patentability standards and an international patent pool.
The UNITAID patent pool could make drugs like tenofovir more accessible
Rejection of patents for tenofovir disoproxil fumarate (TDF) by Brazil and
tenofovir disoproxil and darunavir by India is important because TDF is part
of the WHO-recommended first-line antiretroviral regimen, and darunavir one
of the newest, most expensive antiretroviral drugs. The decisions were
possible because both countries have patent laws against so-called
evergreening—the patenting of a molecule with small chemical changes to a
patented parent molecule—and allow opposition to patents to be considered.
In both countries, civil society groups, including MSF (which purchases a
high proportion of India's antiretroviral drugs), filed pre-grant opposition
to the patents.
Gilead Sciences, the patent-owner for TDF, expressed surprise at the
decision. Gregg Alton (Gilead Sciences, Foster City, CA, USA), notes that
Brazil and India are the only two countries to have rejected the patent
application for TDF. Other countries where the drug is patented and the US
Patent Office concurred with the company that the synthesis of TDF shows
sufficient inventiveness compared with tenofovir, which was never used as a
drug, was injectable, and had poor tissue targeting. Gilead intends to ask
both countries to reconsider their patent application.
The rejection of a patent on TDF opens up the market for new generic
competitors to drive the price of TDF down in any country without a patent
on the drug, says Childs. However, Alton expressed concern that the
decisions will not reduce the price of the drug further given the measures
already implemented through the company's access programme. Notably, any
generic company in India can apply for a license to make TDF or TDF-based
products. Gilead's licensing agreement also allows companies to incorporate
the drug into fixed-dose combinations with other antiretroviral drugs.
Indian companies can export the drug to the world's poorest countries and
sell in India itself. Gilead receives a 5% royalty payment on finished
product sales.
Around 700 000 people in developing countries are receiving TDF, with about
half using a generic drug at about 50% of the cost of the branded drug,
which is sold at cost price in the poorest countries. Without patent
protection, research and development based pharmaceutical companies have
little incentive to enter into licensing agreements, says Gilead. Moreover,
in India, licensing agreements drove down the price of generic TDF produced
by Cipla, which does not have an agreement with Gilead.
The idea the antiretroviral drug patent pool that UNITAID is spearheading is
similar to such licensing agreements, but patents from different owners will
be pooled so generic manufacturers can enter into one agreement, rather than
two or three, to produce generic antiretroviral drugs and particularly
fixed-dose combinations. Such combinations are absolutely key for HIV care
in developing countries, says Ellen ‘t Hoen of UNITAID (Geneva,
Switzerland). The alternative—multiple pills—“is problematic at the
individual and logistic levels”, she told *TLID*. And, says Childs, “there
is a need to deal with the coming crisis of access to second-line and
third-line drugs”. This is a major reason why MSF has specified nine
companies that it is asking publicly to contribute patents of 21 products
and their combinations to the UNITAID patent pool. “Companies have an
opportunity to be part of a voluntary solution to this problem”, she says.
Another important role of the patent pool is to encourage the production of
paediatric formulations for children with HIV, most of whom live in
sub-Saharan Africa.
Overall, the signs are encouraging. For example, GlaxoSmithKline (GSK) has
been asked in a letter from several organisations, including UNICEF and MSF,
to join the patent pool. Stephen Rea (GSK, London, UK) notes that this year,
the company has relaxed its stance of intellectual property for patents and
extended their royalty-free licensing agreements, while recently announcing
a fund for children with HIV and establishment of new company with Pfizer
that will focus on the development of new HIV drugs. ‘t Hoen, says that GSK
is now actively engaging with UNITAID and “we are very happy with our
conversations”. Rea says, “more work needs to be done to research and
develop more fixed-dose combinations, and GSK will continue to discuss how
this should be addressed with organisations such as UNITAID and MSF”.
“The most important work is establishing where key stakeholders stand”,
particularly patent owners and generic manufacturers, explains ‘t Hoen.
Overall, Alton is positive about this process: “UNITAID is really good at
reaching out and understanding concerns of industry”. What ‘t Hoen describes
as “a big sticking point” for stakeholders, is the scope of the patent pool
in terms of countries. Patent owners seek to make profits from sales to
middle-income countries and would like restrictions on generic sales to
these countries, while generic manufacturers are keen that such countries
are included in the pool to increase the volume of their sales. One option
under discussion is an opt-out clause for patent owners specifying certain
countries. UNITAID is keen for stakeholders to define the terms of the
patent pool themselves, given what experience and concerns each party
“brings to the table”, says ‘t Hoen.
UNITAID is now “in overdrive to get an implementation plan to go to the
board in December”, says ‘t Hoen. To highlight and resolve the details of
concern, “we depend on the willingness of patent holders”, she says. “But
also political support is key.” Such support is getting “stronger and
stronger”, notes ‘t Hoen. As the journal went to press, the UK International
Development Minister Mike Foster was expected to launch further measures to
improve access to medicines at an industry government forum on Oct 12. The
huge access challenges faced and the potential of the patent pool solution
is “why the Department for International Development will continue to call
for the pharmaceutical industry to work with UNITAID on proposals for a
patent pool”, he comments. Veronica Oakeshott, advisor to the UK All-Party
Parliamentary Group on AIDS commented that “we are looking for Gilead and
GSK to lead the way.”
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UNITAID - Medicines Patent Pool Initiative
20 Avenue Appia // 1211 Geneva 27 // Switzerland
Tel +41 22 791 3778 // Fax +41 22 791 4890
utdmppi@gmail.com // borolim@who.int // www.unitaid.eu
What is a Patent Pool?
http://www.youtube.com/watch?v=Vj0dbFgjoh4
[Have a look at this little video- Moderator]