The Importance of a Global Patent Database for Pharmaceuticals

The World Health Organizations’s Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) is considering at the 2008 World Health Assembly a proposal to create a user-friendly, public, global database on the status of health-related patents in all countries.

Essential Action urges adoption of this proposal, which could meaningfully advance public health objectives, including efficient pharmaceutical procurement, in developing countries.

A summary of our briefing note, and the full text, follow on the continuation of this post.

ESSENTIAL ACTION BRIEFING NOTE FOR WHA IGWG:
THE IMPORTANCE OF A GLOBAL PATENT DATABASE FOR PHARMACEUTICALS

Full text available below in html and here as an rtf document: PatentDatabaseMay18.rtf

Executive Summary:

A proposal before the WHO’s Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) at the 2008 World Health Assembly 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 the databases, in particular by developing countries and 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, including the promotion of innovation, and facilitating access to medicines in developing countries. 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.

Essential Action has worked with numerous national patent offices in developing countries 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. Patent and registration information is important for a variety of reasons. Examples include:

– 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. [2]

***Essential Action recommends that WHO member countries agree to the proposed – and currently bracketed – language in Element 5.1(c) of the 3 May 2008 White paper of the IGWG Draft global strategy, which proposes a user-friendly global patent database be compiled, maintained and updated to contribute to innovation and promote public health.***

References:
[1] See Element 5.1 (c), World Health Organization (WHO), “The White Paper (Advance copy in English only) of the IGWG “Outcome Document at 14.00 hours, Saturday 3 May 2008, Draft global strategy on public health, innovation and intellectual property,” available at, http://www.who.int/phi/documents/IGWG_Outcome_document03Maypm.pdf

[2]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: .

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For More Information, Contact:

Sarah Rimmington, (Geneva, week of May 29, 2008) +41 (0)78 847 0562, [email protected]

Robert Weissman, (Washington, DC) (+1) 202-387-8030, [email protected]

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

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Full text of the briefing note:

Essential Action
P.O. Box 19405, Washington, DC 20036, USA
Tel: 1-202-387-8030 • Fax: 1-202-234-5176 www.essentialaction.org/access

BRIEFING NOTE FOR WHO IGWG

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 at the 2008 World Health Assembly 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 the databases, in particular by developing countries and to strengthen national capacities of analysis and the quality of patents.] ”

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 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. Additionally, WHO has conducted a recent pilot program to identify patents on essential medicines. 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.

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. 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.

May 2008
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For More Information, Contact:

Sarah Rimmington, (Geneva, week of May 29, 2008) +41 (0)78 847 0562 [email protected]

Robert Weissman, (Washington, DC) (+1) 202-387-8030, [email protected]

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