# \[e-drug\] Global patent database for pharmaceuticals

**URL:** <https://talk.edrugplus.org/t/e-drug-global-patent-database-for-pharmaceuticals/30335>\
**Category:** e-drug\
**Created:** [August 8, 2008, 8:15am UTC](https://talk.edrugplus.org/t/e-drug-global-patent-database-for-pharmaceuticals/30335 "2008-08-08T08:15:00Z")\
**Posts on this page:** 5\
**Page:** 1

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**Author:** ![Ziyan\_Wang](https://avatars.discourse-cdn.com/v4/letter/z/ec9cab/32.png) [@Ziyan\_Wang](https://talk.edrugplus.org/u/Ziyan_Wang)\
**Post date:** [August 8, 2008, 8:15am UTC](https://talk.edrugplus.org/t/e-drug-global-patent-database-for-pharmaceuticals/30335/1 "2008-08-08T08:15:00Z")

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E-DRUG: Global patent database for pharmaceuticals  
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Dear e-druggers

I am currently working on generic promotion. I am wondering if you happen to know if there is a global patent database for pharmaceuticals which includes most medicines in the market and indicates the patent status, the date of patent expiration, generic competitioners, market share or pricing, etc, etc.? Hopefully it can be freely accessed.

Many thanks,

Ziyan Wang  
Research Assistant in LSE Health  
email: z.wang3@lse.ac.uk or ziyan.wang2007@gmail.com

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**Author:** ![Robert\_Weissman](https://avatars.discourse-cdn.com/v4/letter/r/4491bb/32.png) [@Robert\_Weissman](https://talk.edrugplus.org/u/Robert_Weissman)\
**Post date:** [August 8, 2008, 3:01pm UTC](https://talk.edrugplus.org/t/e-drug-global-patent-database-for-pharmaceuticals/30335/2 "2008-08-08T15:01:44Z")

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E-DRUG: Global patent database for pharmaceuticals (2)  
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Dear Ziyan Wang,

There is no such database.

Many of us are advocating for creation of a database, and this has been  
a contentious issue at the World Health Organization's Intergovernmental  
Working Group on Public Health, Innovation and Intellectual Property.

Here is a short background paper we did making the case for a patent  
database:

[http://www.essentialaction.org/access/index.php?/archives/152-The-Importance-of-a-Global-Patent-Database-for-Pharmaceuticals.html](http://www.essentialaction.org/access/index.php?/archives/152-The-Importance-of-a-Global-Patent-Database-for-Pharmaceuticals.html)

MSF in conjunction with WHO has in the past generated a database for  
patent status of ARVs. This is contained in the paper:  
Determining the patent status of essential medicines in developing  
countries. Health economics and drugs. EDM series No.17  
(WHO/EDM/PAR/2004.6).

The paper is linked here:

[http://mednet2.who.int/sourcesprices/references.htm](http://mednet2.who.int/sourcesprices/references.htm)

This focuses on selected countries only.

WHO has done follow-up work on this for ARVs, but the results remain  
unpublished.

As you'll see from looking at the material, there are very major  
obstacles to any person determining patent status for a drug globally,  
or even in a single country. (Indeed, we know from experience that  
sometimes even a national patent office is unable to determine whether  
there are patents covering a drug.)

The United States and Canada have systems that enable you to check  
easily whether a drug is patented in those countries, although at least  
in the case of the United States, this system does not cover most  
biologics, which constitute many of the most important new medicines.

The searchable U.S. system is available here:

[http://www.fda.gov/cder/ob/](http://www.fda.gov/cder/ob/)

You search for drug name, click on the formulation you want, then click  
on patent and exclusivity information.

This does not tell you whether the claimed patents are valid -- this can  
typically only be tested in litigation -- but it does tell you what is  
claimed.

It does not follow that patent claims in the United States have also  
been made in other countries. For newer drugs, however, it is likely  
that similar claims (at least on patents on the molecule) have been  
filed in other industrialized countries, in most middle-income  
countries, and in some poorer countries (depending in part on what  
conditions the molecule is thought to treat).

Robert Weissman  
Essential Action  
E-mail: \<rob@essential.org\>

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**Author:** ![Fortunak\_Joseph\_M](https://avatars.discourse-cdn.com/v4/letter/f/bcef8e/32.png) [@Fortunak\_Joseph\_M](https://talk.edrugplus.org/u/Fortunak_Joseph_M)\
**Post date:** [August 13, 2008, 4:22pm UTC](https://talk.edrugplus.org/t/e-drug-global-patent-database-for-pharmaceuticals/30335/3 "2008-08-13T16:22:07Z")

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E-DRUG: Global patent database for pharmaceuticals (4)  
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Dear Ziyan,

The world would be much more logical if there were such a database, wouldn't it?

Most drugs are "protected" by a family of patents that cover the active ingredient, formulation, crystalline forms, processes for manufacturing and use in various indications. Whether these patents are in force in various countries globally can also be very difficult to ascertain with certainty. Because of this there are very often disagreements between originator and generic companies on the dates when patent coverage expires on many drugs - leading to many, many lawsuits. This is what makes such a database very difficult to create and even more difficult to have complete confidence in.

Joseph

Joseph M. Fortunak  
Associate Professor, Chemistry and Pharmaceutical Sciences  
Howard University  
525 College Street NW  
Washington, DC 20069 USA  
+1 202 806 6880 (office)  
+1 301 928 7568 (mobile)  
jfortunak@comcast.net (preferred)

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**Author:** ![Kevin\_Outterson1](https://avatars.discourse-cdn.com/v4/letter/k/e480ec/32.png) [@Kevin\_Outterson1](https://talk.edrugplus.org/u/Kevin_Outterson1)\
**Post date:** [August 13, 2008, 5:59pm UTC](https://talk.edrugplus.org/t/e-drug-global-patent-database-for-pharmaceuticals/30335/4 "2008-08-13T17:59:43Z")

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E-DRUG: Global patent database for pharmaceuticals (5)  
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One alternative would be a globalized version of the FDA Orange Book, which addresses some of these issues.

Kevin Outterson  
Boston University School of Law  
E-mail: mko@bu.edu

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**Author:** ![Michele\_Forzley](https://avatars.discourse-cdn.com/v4/letter/m/c5a1d2/32.png) [@Michele\_Forzley](https://talk.edrugplus.org/u/Michele_Forzley)\
**Post date:** [August 13, 2008, 6:16pm UTC](https://talk.edrugplus.org/t/e-drug-global-patent-database-for-pharmaceuticals/30335/5 "2008-08-13T18:16:43Z")

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E-DRUG: Global patent database for pharmaceuticals (6) the world would have to be logical to have one!  
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Dear e-druggers,

Indeed the world would have to act more logically to have such a data base.

To have one several factors must be in place. Some of these are that  
national IP and drug laws are sufficiently harmonized that the data fields  
were indeed equally comparable, that countries have (1) functioning  
electronic systems that (a) identify what is patented, (b) that this  
information is cross referenced with what drugs hold marketing approval, and  
(c) with trademark status. National systems would have to be harmonized with  
the global data base so it could be kept up to date.

In addition, since patent status is but only one barrier to access, methods  
to identify and reduce other non-tariff barriers to drug access are as  
important and I would argue more important since most drugs are off patent.  
Non-tariff barriers include the multiple regulatory regimes many of which  
lack harmony with other regimes and are inadequate and/or non-transparent.  
In addition there is no central data base in which national health and drug  
laws can be found for use by any one who might need such information. Yes  
the WHO has the digest of health legislation but it is not complete by any  
means - developing countries and least developed country legal information (of any sort) is very hard to find if it can be found at all.

Since 2004 the Health Law Institute at Widener School of Law has been  
developing such a data base - it is no small feat but it is doable with  
adequate funding. A patent data base could be integrated easily.

Michele Forzley, JD, MPH  
Visiting Distinguished Professor of Law  
Health Law Institute  
Widener School of Law  
Wilmington, DE  
301-565-0680  
mdforzley@widener.edu
