[e-drug] Global patent database for pharmaceuticals

e-drug
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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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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

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

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unpublished.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/

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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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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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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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