[Ip-health] IGWG Briefing Note: Importance of a Global Patent Database for Pharmaceuticals

[Sarah Rimmington]

This is a multi-part message in MIME format.
--
Essential Action Briefing Note
April 2008
THE IMPORTANCE OF A GLOBAL PATENT DATABASE FOR PHARMACEUTICALS

A proposal before the WHO's Intergovernmental Working Group on Public
Health, Innovation and Intellectual Property is to "[to compile,
maintain and update user friendly global databases on the status of
health-related patents in all countries and facilitate widespread access
to these databases, in particular by developing countries, [as well
as]/[to] strengthen national capacities of analysis and the quality of
patents.]1"

Adoption and implementation of such a global patent database on
health-related inventions would advance important public health
objectives. Although there are technical challenges in compiling such a
database, these can be overcome. As a policy matter, it is very hard to
imagine a legitimate basis for opposing such a proposal.

Disclosure is Central to the Patent System

The patent system is supposed to be one of disclosure. Not only is the
basic fact of a patent claim supposed to be public knowledge, but the
very provision of a patent is supposed to embody a trade-off whereby the
means to make the underlying invention is publicized in exchange for
grant of the patent monopoly.

Patent Information for Pharmaceuticals is Commonly Not Available in
Developing Countries

There are significant obstacles to identifying the patent status of any
particular product even in rich countries. There are many patents filed
on most pharmaceutical products, and very complicated patent landscapes
for health products such as vaccines. Patent applications may be easily
searchable, but the patent applications typically do not reference end
products -- in significant part because they are filed before end
products are even known. Patents on medical products also commonly
involve very technical claims that are comprehensible only to persons
with substantial scientific training.

These obstacles can typically be overcome in rich countries, however, by
one of two means. First, commercial services are available to do patent
searches. Such services are often very expensive, but can develop the
patent landscape of a product. Second, in countries such as the United
States, pharmaceutical registration systems may involve listing of
patents for most pharmaceutical products. These listing mechanisms may,
as in the U.S. case, harmfully delay introduction of generic competition
(by denying generic firms the right to register a product if a patent is
claimed to cover it -- an arrangement known as "linkage," because it
links registration to patent status), but they do make patent
information publicly available for covered products.

In many developing countries, however, neither of these options is
available, and pharmaceutical patent information is effectively secret
from all but the patent holder. Commercial services may not exist, or
may be prohibitively expensive for public health agencies and
organizations. And patent registries commonly are not available.

Essential Action has worked with numerous national patent offices to
investigate the patent status of important medicines, and it is
frequently the case that the patent offices cannot identify patents
related to particular products, or can only do so with enormous difficulty.

Coordinated Global Efforts Can Identify Patents

Several patent mapping efforts have demonstrated that, with sufficient
time and expertise, and modest resourcing, the barriers to identifying
patents in developing countries can be overcome.

Medecins Sans Frontieres, in conjunction with UNAIDS and WHO, has
developed patent landscapes for HIV/AIDS medicines in many developing
countries. [2] Additionally, WHO has conducted a recent pilot program to
identify patents on essential medicines. [3] Even if unable to identify
all patents in all circumstances, these efforts have been successful,
and show that development of a global patent database is feasible. These
efforts also have pioneered the appropriate methodologies to identify
patent landscapes in developing countries. Although this information
must be obtained at the national level, preliminary work -- with global
application -- must be done in rich country patent offices. There are
thus built-in economies of scale to undertaking global -- rather than
only country-by-country -- patent searches.

An established system for maintaining and elaborating a global patent
database would also be well positioned to facilitate voluntary
information sharing from patent-holding pharmaceutical companies. This
would dramatically ease the burden of patent searches.

The Importance of Patent Disclosure

Patent and registration information is important for a variety of
reasons. Government agencies, NGOs or others cannot make determinations
about efficient procurement options if they cannot ascertain patent
status; and inadequate information on patent status has in some cases
interfered with efficient procurement of HIV/AIDS medicines. Generic
firms are unable to determine when they can enter the market (whether
they have "freedom to operate") if they do not know whether products are
patented. Researchers may be inhibited from investigating certain areas
if they cannot identify whether patents cover information in their field
of inquiry. [4]

The case of avian flu vividly illustrates the importance of patent
disclosure and the need for a global patent database. With a peak of
concern over avian flu in late 2005, countries paid special attention to
stockpiling the anti-viral oseltamivir (brand name Tamiflu), in advance
of a possible outbreak of avian flu among humans. Because of the
shortfall of supply, plus price concerns, many countries were eager to
obtain generic versions of oseltamivir. But there was considerable
uncertainty in many developing countries about the patent status of
oseltamivir. Countries did not know if they were free to purchase or
manufacture generic versions of the drug, or if they must obtain
licenses -- voluntary or compulsory -- in order to legally purchase or
manufacture generic versions. Many countries were slow to seek generic
versions of the product because of the misapprehension that it was
patented in their country. Some even began the process of issuing
compulsory licenses -- until the manufacturer, Roche, finally informed
them that there were no patents covering the drug in their countries.
[5] To be clear: even the governments themselves were unaware of, and
not easily able to determine, patent status of the drug in their countries.

Patent information is not a trade secret. Patents are conferred by
governments in exchange for disclosures of the underlying inventions.
The purpose of the system is defeated -- and public health objectives
potentially seriously undermined -- when the very fact of whether a
product is covered by a patent (and which patents) is not public. A
global patent database covering health-related inventions would cure
this problem.

April 2008


---------
For More Information, contact:

Sarah Rimmington, (Geneva, week of April 28, 2008 only)
(+41)(0)76-269-2246), srimmington@essentialinformation.org

Robert Weissman, (Washington, DC) (+1) 202-387-8030, rob@essential.org

Essential Action
PO Box 19405
Washington, DC 20036
www.essentialaction.org/access



1. World Health Organization (WHO), Intergovernmental Working Group on
Public Health, Innovation and Intellectual Property (IGWG), =93Draft
global strategy and plan of action on public health, innovation and
intellectual property,=94 First Revision, December 14 2007, 36(5.1.c), p.
14, available at http://www.who.int/gb/phi/
2. Pascale Boulet, Legal Advisor, Medecins Sans Frontieres,
"Health-Related Patent Landscaping: Patent Information Needs & Current
Policy Concerns," World Intellectual Property Organization (WIPO)
Symposium on Public Policy Patent Landscaping in the Life Sciences:
Provisional Program, April 8, 2008, available at:
<www.wipo.int/meetings/en/2008/lifesciences/patent_landscaping/program.html=
>.
3. Precious Matsoso, Director, Department of Technical Cooperation for
Essential Medicines, Drugs and Traditional Medicines, WHO, "Public
Policy Patent Landscape in the Life Sciences: Public health policy
context," World Intellectual Property Organization (WIPO) Symposium on
Public Policy Patent Landscaping in the Life Sciences: Provisional
Program, April 8, 2008, available at:
<www.wipo.int/meetings/en/2008/lifesciences/patent_landscaping/program.html=
>.
4. Professor Frederick Abbott, Florida State University College of Law,
"Patent Landscaping in the Field of Medicines: Policy and Technical
Options," World Intellectual Property Organization (WIPO) Symposium on
Public Policy Patent Landscaping in the Life Sciences: Provisional
Program, April 8, 2008, available at:
<www.wipo.int/meetings/en/2008/lifesciences/patent_landscaping/program.html=
>.
5. Rey E. Requejo, "Roche okays local Tamiflu production," Manila
Standard Today, November 25, 2005; Karima Anjani, "Indonesia says will
make Tamiflu," Reuters, November 25, 2005.

--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: (202) 387-8030
Cell: (202) 422-2687
www.essentialaction.org/access/

--
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d4217802\charrsid4217802 A proposal before the WHO's Intergovernmental Work=
ing Grou=0Dp on Public Health, Innovation and Intellectual Property is to "=
}{\insrsid4217802\charrsid4217802 =0D[to compile, maintain and update user =
friendly global databases on the status of health-related patents in all co=
untries and facilitate widespread access to these databases, in particular =
by d=0Developing countries, [as well as]/[to] strengthen national capacitie=
s of analysis and the quality of patents.]}{\cs16\super\insrsid6776588\char=
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hftn }{\fs20\insrsid6776588\charrsid6776588 =0D World Health Organization (=
WHO), Intergovernmental Working Group on Public Health, Innovation and Inte=
llectual Property (IGWG), \ldblquote Draft global strategy and plan of acti=
on on public health, innovation and intellectual property,\rdblquote =0D Fi=
rst Revision, December 14 2007, 36(5.1.c), p. 14, available at }{\fs20\cf1\=
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rsid4217802 {\cf1\insrsid4217802\charrsid4217802 =0D\par Adoption and imple=
mentation of such a global patent database on health-related inventions wou=
ld advance important public health objectives. Al=0Dthough there are techni=
cal challenges in compiling such a database, these can be overcome. As a po=
licy matter, it is very hard to imagine a legitimate basis for opposing suc=
h a proposal.=0D\par =0D\par }{\b\cf1\insrsid4217802\charrsid4217802 Disclo=
sure is Central to the Patent System=0D\par }{\cf1\insrsid4217802\charrsid4=
217802 =0D\par The patent system is sup=0Dposed to be one of disclosure. No=
t only is the basic fact of a patent claim supposed to be public knowledge,=
 but the very provision of a patent is supposed to embody a trade-off where=
by the means to make the underlying invention is publicized in exchange =0D=
for grant of the patent monopoly. =0D\par =0D\par }{\b\cf1\insrsid4217802\c=
harrsid4217802 Patent Information for Pharmaceuticals is Commonly Not Avail=
able in Developing Countries=0D\par }{\cf1\insrsid4217802\charrsid4217802 =
=0D\par There are significant obstacles to identifying the patent status of=
 any particular product even in rich countries. There are many p=0Datents f=
iled on most pharmaceutical products, and very complicated patent landscape=
s for health products such as vaccines. Patent applications may be easily s=
earchable, but the patent applications typically do not reference end produ=
cts -- in significant =0Dpart because they are filed before end products ar=
e even known. Patents on medical products also commonly involve very techni=
cal claims that are comprehensible only to persons with substantial scienti=
fic training. =0D\par =0D\par These obstacles can typically be overcome=0D =
in rich countries, however, by one of two means. First, commercial services=
 are available to do patent searches. Such services are often very expensiv=
e, but can develop the patent landscape of a product. Second, in countries =
such as the United States, ph=0Da=0Drmaceutical registration systems may in=
volve listing of patents for most pharmaceutical products. These listing me=
chanisms may, as in the U.S. case, harmfully delay introduction of generic =
competition (by denying generic firms the right to register a prod=0Duct if=
 a patent is claimed to cover it -- an arrangement known as "linkage," beca=
use it links registration to patent status), but they do make patent inform=
ation publicly available for covered products.=0D\par =0D\par In many devel=
oping countries, however, neither of the=0Dse options is available, and pha=
rmaceutical patent information is effectively secret from all but the paten=
t holder. Commercial services may not exist, or may be prohibitively expens=
ive for public health agencies and organizations. And patent registries c=
=0Dommonly are not available.=0D\par =0D\par Essential Action has worked wi=
th numerous national patent offices to investigate the patent status of imp=
ortant medicines, and it is frequently the case that the patent offices can=
not identify patents related to particular produc=0Dts, or can only do so w=
ith enormous difficulty.=0D\par =0D\par }{\b\cf1\insrsid4217802\charrsid421=
7802 Coordinated Global Efforts Can Identify Patents}{\cf1\insrsid4217802\c=
harrsid4217802 =0D\par =0D\par Several patent mapping efforts have demonstr=
ated that, with sufficient time and expertise, and modest resourcing, the b=
arriers to identifying patents in developing countries can be overcome.=0D\=
par =0D\par Medecins Sans Frontieres, in conjunction with UNAIDS and WHO, h=
as developed patent landscapes for HIV/AIDS medicines in many developing co=
untries.}{\cs16\cf1\super\insrsid4217802\charrsid4217802 \chftn {\footnote =
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super\insrsid6776588\charrsid4217802 \chftn }{=0D\fs20\insrsid6776588\charr=
sid4217802  Pascale Boulet, Legal Advisor, Medecins Sans Frontieres, "Healt=
h-Related Patent Landscaping: Patent Information Needs & Current Policy Con=
cerns," World Intellectual Property Organization (WIPO) }{=0D\fs20\cf1\insr=
sid6776588\charrsid4217802 Symposium on Public Policy Patent Landscaping in=
 the Life Sciences: Provisional Program, }{\fs20\insrsid6776588\charrsid421=
7802 April 8, 2008, available at: }{\fs20\cf1\insrsid6776588\charrsid421780=
2 =0D<www.wipo.int/meetings/en/2008/lifesciences/patent_landscaping/program=
.html>.}}}{\cf1\insrsid4217802\charrsid4217802  Additionally, WHO has condu=
cted a recent pilot program to identify patents on essential medicines.}{=
=0D\cs16\cf1\super\insrsid4217802\charrsid4217802 \chftn {\footnote \pard\p=
lain \ql \li0\ri0\nowidctlpar\tx560\tx1120\tx1680\tx2240\tx2800\tx3360\tx39=
20\tx4480\tx5040\tx5600\tx6160\tx6720\faauto\rin0\lin0\itap0\pararsid421780=
2 =0D\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs16\fs20\super\i=
nsrsid6776588\charrsid4217802 \chftn }{\fs20\insrsid6776588\charrsid4217802=
 =0D Precious Matsoso, Director, Department of Technical Cooperation for Es=
sential Medicines, Drugs and Traditional Medicines, WHO, "Public Policy Pat=
ent La=0Dndscape in the Life Sciences: Public health policy context," World=
 Intellectual Property Organization (WIPO) Symposium on Public Policy Paten=
t Landscaping in the Life Sciences: Provisional Program, April 8, 2008, ava=
ilable at: <www.wipo.int/meetings/en/20=0D08/lifesciences/patent_landscapin=
g/program.html>.}}}{\cf1\insrsid4217802\charrsid4217802 =0D Even if unable =
to identify all patents in all circumstances, these efforts have been succe=
ssful, and show that development of a global patent database is feasible. T=
hese efforts also have pioneered the appropriate methodologies to=0D identi=
fy patent landscapes in developing countries. Although this information mus=
t be obtained at the national level, preliminary work -- with global applic=
ation -- must be done in rich country patent offices. There are thus built-=
in economies of scale t=0Do undertaking global -- rather than only country-=
by-country -- patent searches.=0D\par =0D\par An established system for mai=
ntaining and elaborating a global patent database would also be well positi=
oned to facilitate voluntary information sharing from patent-holding pha=0D=
rmaceutical companies. This would dramatically ease the burden of patent se=
arches.=0D\par =0D\par }{\b\cf1\insrsid4217802\charrsid4217802 The Importan=
ce of Patent Disclosure=0D\par }{\cf1\insrsid4217802\charrsid4217802 =0D\pa=
r Patent and registration information is important for a variety of reasons=
. Government agencies, NGOs or others cannot make determinatio=0Dns about e=
fficient procurement options if they cannot ascertain patent status; and in=
adequate information on patent status has in some cases interfered with eff=
icient procurement of HIV/AIDS medicines. Generic firms are unable to deter=
mine when they can e=0Dnter the market (whether they have "freedom to opera=
te") if they do not know whether products are patented. Researchers may be =
inhibited from investigating certain areas if they cannot identify whether =
patents cover information in their field of inquiry.}=0D{\cs16\cf1\super\in=
srsid4217802\charrsid4217802 \chftn {\footnote \pard\plain \ql \li0\ri0\now=
idctlpar\tx560\tx1120\tx1680\tx2240\tx2800\tx3360\tx3920\tx4480\tx5040\tx56=
00\tx6160\tx6720\faauto\rin0\lin0\itap0\pararsid4217802 =0D\lang1033\langfe=
1033\cgrid\langnp1033\langfenp1033 {\cs16\fs20\super\insrsid6776588\charrsi=
d4217802 \chftn }{\fs20\insrsid6776588\charrsid4217802 =0D Professor Freder=
ick Abbott, Florida State University College of Law, "Patent Landscaping in=
 the Field of Medicines: Policy and Technical Options," World Intellectual =
Property Organization (WIPO) }{\fs20\cf1\insrsid6776588\charrsid4217802 Sym=
posium =0Don Public Policy Patent Landscaping in the Life Sciences: Provisi=
onal Program, }{\fs20\insrsid6776588\charrsid4217802 April 8, 2008, availab=
le at: }{\fs20\cf1\insrsid6776588\charrsid4217802 =0D<www.wipo.int/meetings=
/en/2008/lifesciences/patent_landscaping/program.html>.}}}{\cf1\insrsid4217=
802\charrsid4217802 =0D\par =0D\par The case of avian flu vividly illustrat=
es the importance of patent disclosure and the need for a global patent dat=
abase. With a peak of concern over avian flu in late 2005, countries paid s=
pecial attention to stockpiling the anti-viral oseltamivir (brand =0Dn=0Dam=
e Tamiflu), in advance of a possible outbreak of avian flu among humans. Be=
cause of the shortfall of supply, plus price concerns, many countries were =
eager to obtain generic versions of oseltamivir. But there was considerable=
 uncertainty in many develop=0Di=0Dng countries about the patent status of =
oseltamivir. Countries did not know if they were free to purchase or manufa=
cture generic versions of the drug, or if they must obtain licenses -- volu=
ntary or compulsory -- in order to legally purchase or manufactur=0De=0D ge=
neric versions. Many countries were slow to seek generic versions of the pr=
oduct because of the misapprehension that it was patented in their country.=
 Some even began the process of issuing compulsory licenses -- until the ma=
nufacturer, Roche, finally =0Dinformed them that there were no patents cove=
ring the drug in their countries.}{\cs16\f1\cf1\super\insrsid4217802\charrs=
id4217802 \chftn {\footnote \pard\plain \ql \li0\ri0\widctlpar\aspalpha\asp=
num\faauto\adjustright\rin0\lin0\itap0\pararsid4217802 =0D\lang1033\langfe1=
033\cgrid\langnp1033\langfenp1033 {\cs16\fs20\super\insrsid6776588\charrsid=
4217802 \chftn }{\fs20\insrsid6776588\charrsid4217802  Rey E. Requejo, "Roc=
he okays local Tamiflu production," Manila Standard Today, November 25, 200=
5; }{=0D\fs20\cf1\insrsid6776588\charrsid4217802 Karima Anjani, "Indonesia =
says will make Tamiflu," Reuters, November 25, 2005.}}}{\cf1\insrsid4217802=
\charrsid4217802  }{\ul\cf1\insrsid4217802\charrsid4217802 =0DTo be clear: =
even the governments themselves were unaware of, and not easily able to det=
ermine, patent status of the drug in their countries.}{\cf1\insrsid4217802\=
charrsid4217802 =0D\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faaut=
o\adjustright\rin0\lin0\itap0 {\insrsid4217802\charrsid4217802 =0D\par Pate=
nt information is not a trade =0Dsecret. Patents are conferred by governmen=
ts in exchange for disclosures of the underlying inventions. The purpose of=
 the system is defeated -- and public health objectives potentially serious=
ly undermined -- when the very fact of whether a product is cov=0Dered by a=
 patent (and which patents) is not public. A global patent database coverin=
g health-related inventions would cure this problem.=0D\par =0D\par April 2=
008=0D\par =0D\par ---------=0D\par }\pard \ql \li0\ri0\widctlpar\aspalpha\=
aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4217802 {\b\cf1\insrsid42=
17802\charrsid6776588 For More Information, contact:=0D\par {\listtext\pard=
\plain\f3\cf1\insrsid4217802\charrsid6776588 \loch\af3\dbch\af0\hich\f3 \u-=
3913\'b7\tab}}\pard \ql \fi-360\li720\ri0\widctlpar\jclisttab\tx720\aspalph=
a\aspnum\faauto\ls1\adjustright\rin0\lin720\itap0\pararsid4217802 {=0D\b\cf=
1\insrsid4217802\charrsid6776588 Sarah Rimmington}{\cf1\insrsid4217802\char=
rsid4217802 , (Geneva, week of April 28, 2008 only) (+41)(0)76-269-2246), }=
{\cf1\insrsid6776588\charrsid6776588 srimmington@essentialinformation.org}{=
=0D\cf1\insrsid6776588\charrsid4217802 =0D\par {\listtext\pard\plain\f3\cf1=
\insrsid4217802\charrsid6776588 \loch\af3\dbch\af0\hich\f3 \u-3913\'b7\tab}=
}{\b\cf1\insrsid4217802\charrsid6776588 Robert Weissman}{\cf1\insrsid421780=
2\charrsid4217802 , (Washington, DC) (+1) 202-387-8030, rob@essential.org=
=0D=0D\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright=
\rin0\lin0\itap0\pararsid4217802 {\cf1\insrsid4217802\charrsid4217802 =0D\p=
ar }{\b\cf1\insrsid4217802\charrsid6776588 Essential Action=0D\par }{\cf1\i=
nsrsid4217802\charrsid4217802 PO Box 19405=0D\par Washington, DC 20036=0D\p=
ar }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\li=
n0\itap0 {\cf1\insrsid4217802\charrsid4217802 www.essentialaction.org/acces=
s}{\insrsid4217802\charrsid4217802 =0D\par }}