The possibility of pandemic influenza arising from the avian influenza virus, H5N1, is of critical importance for global public health.   The need to safeguard the health of the poor and to provide fair access to needed medicines, diagnostics, and vaccines has put patent systems at the heart of the debate.   How do patents impact development and commercialization of products targeted against major world diseases?   Does the use of patents as a part of strategy to incentivize commercial development adversely and disproportionately affect some nations and populations?  Do internationally shared public health goals – such as addressing pandemic influenza – require different treatment of patents than public health challenges that are regional in nature?   Virtually all of the discussion of this topic occurs in the absence of a clear and transparent body of evidence.

The most strongly voiced concern is whether patents claiming influenza genomes, genes or proteins will compromise equitable access to products that are derived from them.    It is not surprising that the nations most strongly affected by avian flu are most deeply concerned about their ability to respond to current and projected public health needs.   Global health officials and national authorities seek clarity in the terms of access to health interventions to address pandemic influenza.   To address this concern, a factual basis for how much of the influenza genome, especially of the H5N1 virus and its derivatives, has been patented or has patents pending is needed.

If the extent of influenza genome-related patents can be determined, and their claims and impacts can be analyzed, then their potential effect can be meaningfully discussed and modeled.    To do this type of comprehensive analysis of genome-related patents will require a many avenues of investigation, new tools and diverse approaches.  The results of one component of this analysis – identification and interpretation of influenza sequences in claims of United States patents and patent applications – is presented in this landscape.   It is part of a wider study initiated by World Intellectual Property Organization (WIPO), and has been funded in part by PATH Vaccine Solution.  Other complementary approaches are reported on the WIPO web site.    Using the tools developed in this study, the next stages will examine critical jurisdictions whose patent systems are much less navigable.

Are influenza genomes recited in patent claims?  And if so, what portions of which genomes? Are genes from the influenza genome claimed in patents or applications?   Are proteins or variants from these genes claimed?

In the first phase of this study, the patents disclosing influenza sequences, and their claims were found by a search of the sequences themselves, rather than by a search using keywords.   Our approach incorporated sequence alignment tools to compare a representative sample of influenza nucleotide and amino acid sequences to collections of nucleotide and amino acid sequences that are specifically recited in the claims of granted patents and pending patent applications in the United States. A sequence-based approach may find patents and patent applications that aren’t found in conventional keyword-based searches.  In the effort to to perform a comprehensive patent landscape, the two approaches should be seen as complementary.

Photo caption: A Thai worker sprays disinfectant on chicken cages Tuesday, July 12, 2005, in the central province of Suphanburi, Thailand, 100 kilometers (60 miles) north of Bangkok. Photo courtesy of the U.S. Department of State (2005: The Year in Pictures-Strengthening Alliances and Defending Principles).