Shedding Light on the Life Sciences: Patent Landscaping for Public Policymakers

The Life sciences offer tremendous promise for humanity – new medicines, better crops, a cleaner environment -while at the same time fuelling debates over such diverse questions as bioethics, access to medicines, food security, custodianship of the environment – even the very genetic identity of humanity. It is not, therefore, surprising that policymakers, consumers, industry bodies and others scrutinize developments in the life sciences closely and demand good quality, accessible information as the basis for effective regulation and sound policy decisions.

Patents offer pathways for generating, disseminating and implementing valuable new technologies for greater public welfare. But life sciences patents have been a source of controversy – consider recent debates concerning patents for stem cells, diagnostic tools and rice genes; or questions about the impact of patents on access to medicines and on transfer of environmentally friendly technology.

An essential function of the patent system is to deliver information to the public: informing the public is not an incidental benefit of the patent process but is built, by design, into the very foundations of the system. The patent system discloses:

• Legal information, including published details of what material is patented, with what legal scope, in what countries, in whose name, and when it passes into the public domain;
• Technological information, such as a patent’s so-called ‘teaching’ or technical disclosure, which is required to give a skilled reader all the information needed to put the new technology into practical effect.

Both of these aspects are important to life sciences policymakers, who are concerned not only with the substance of emerging technologies, but also with who holds exclusive rights over technologies, where and for how long.

This 'disclosure' in the past produced vast libraries of printed documents, which were costly and laborious to use effectively. Recent advances in information technology and broader Internet access mean that patent information is now much more readily available. Obviously, many important life sciences technologies are not published in patent documents. But the in-principle transparency of the patent system and greater practical accessibility make patent data a valuable resource for policymakers and analysts concerned with life sciences issues –for the content of patent documents, and increasingly for the guidance that can be extracted from collections of patent documents – not just point-by-point technical analysis but the prospect of reviewing the technology landscape.

Rice Genome Sequence. A patent landscape can help answer questions such as: How much of the rice genome has been patented? By whom? What is the practical impact of this for farmers, breeders and agricultural researchers? (Photo: Nature)

Patent landscaping: from raw data to knowledge

A patent landscape is an overview of patenting activity in a field of technology. A landscape normally seeks to answer specific policy or practical questions and to present complex information about this activity in a clear and accessible manner. Industry has long used patent landscapes to make strategic decisions on investments, research and development (R&D) directions, competitors' activity as well as on freedom to operate in introducing new products. Now, public policymakers are increasingly turning to landscaping to build a factual foundation before considering high level policy matters, especially in fields such as health, agriculture and the environment. Cheaper information technology, greater awareness of the patent system and a trend towards free access online to patent information have combined to put patent landscaping in reach of public sector policymakers as well. Landscaping can help answer questions such as:

• How much of the rice genome has been patented? By whom? What is the practical impact of this for farmers, breeders and agricultural researchers?
• How much of public‑funded medical research is being patented, and by whom? Which public institutions are most active in patenting key life sciences technologies like stem cells? In what countries are patents in force and where are they not in force for essential medicines? What does this pattern of patent holdings imply for procurement of medicines? When will these patents lapse or expire?
• Who are the new players in vaccine technology? How can developing countries plan to secure access to the current and future technologies for vaccine production?
• What are the trends in research on neglected diseases? What do patenting trends reveal about the changing role of developing countries in medical research?
• What is the geographical coverage of patents on key technologies in medicine, such as HIV/AIDS antiretroviral drugs; for plant biotechnology, such as agrobacterium-mediated transfer; for the environment, such as the use of algae to absorb CO₂ – and where is technology already in the public domain? What technological and commercial opportunities do these offer developing countries? What are the implications for multilateral agreements in the fields of health, plant genetic resources and the environment?

Concluding a comprehensive, definitive patent landscape in a major technological field such as HIV/AIDS treatments can be a massive endeavor, requiring considerable resources and expertise. It potentially entails an expert review of thousands of complex documents and fine assessments on their legal and technical content. A fully global landscape would strictly entail expert searches in over 100 patent offices worldwide. Any ‘finished’ report will be out of date within days, as further patent disclosures are published online. Keeping the landscape up-to-date for continuing reference can be just as resource intensive as its initial development. But the high cost and technical barriers are progressively declining. What once would have been a costly strategic landscape can now be prepared free of charge from a laptop with good Internet access.

Fortunately for life sciences policymakers, much practical guidance can be obtained from patent information systems without massive investment in resources, however the landscapes produced will be incomplete and limited in geographical coverage. Often what is needed for policy debate is an overview of broad trends, not detailed analysis. WIPO’s input to life sciences policy processes has shown, for instance, that

• international pharmaceutical patenting activity from several key developing countries has risen sharply this decade, starting from a low base;
• the number of applications to patent cell lines has risen sharply since 2000; they are mostly filed by public institutions, not private firms;
• the number and diversity of international patent applications concerning avian flu and the H5N1 form of the influenza virus have grown rapidly in the last two years;
• the mix of public and private ownership of technologies on key food crops differs dramatically depending on the economics of the crop concerned – patents relating to corn are largely in private hands, while those concerning the potato are more likely to be held in the public sector.

Mapping patent activity along the influenza vaccine development pipeline

Many valuable initiatives are under way to provide ever more reliable and sophisticated information products for life sciences policymakers. In April, WIPO organized a symposium on patent landscaping to further practical dialogue between life sciences policymakers and patent landscaping experts and to match policy needs with practical capacities. The initiative built on WIPO’s past collaboration with its UN partners: the Food and Agriculture Organization (FAO) on patent activity relating to key food crops, and the World Health Organization (WHO) on patenting issues relevant to current public health issues. Symposium participants reviewed several continuing landscaping projects under WIPO’s Life Sciences program:

Agricultural biotechnology: Working with the FAO, an expert team using inputs from India, Brazil, Europe and North America developed an overview of patent activities on gene promoters – key tools used in agricultural biotechnology. The landscaping contrasts the different technological and commercial patterns developed around several key food crops – soybeans, maize, potato and rice. This is intended to guide policymakers implementing the international system for benefit sharing resulting from the use of plant genetic resources in developing new agricultural products.

The rice genome: A landscape of patenting activity on rice in the U.S. was prepared by Cambia, an NGO involved in patent transparency issues. This landscape presented, in interactive graphic form, the scope of patents covering the chromosomes constituting the rice genome. It found that patent applications covered a wide spread of the rice genome (around 74%), many were “bulk sequence applications” published with claims to large numbers of sequences. But granted patents, with enforceable rights, covered only 0.26 percent of the rice genome. The most active players were multinational firms.

Ultrastructural details of an influenza virus particle (Courtesy of the CDC)

Landscapes on the influenza virus: To support work undertaken in partnership with the WHO on patent issues relating to the influenza virus, two complementary landscapes were developed, one by a team of public‑interest IP attorneys and another by Cambia. These landscapes responded to policy concerns that patents were sought over strains of the flu virus, potentially complicating the sharing of viruses that is critical for vaccine production and raising concerns about the sharing of benefits such as the accessibility of flu vaccines in the event of a pandemic.

Neglected diseases: Another landscape reviewed patenting activity directed towards neglected diseases classed as Type II, which are present in developed and developing countries but in a major proportion in the developing world (such as tuberculosis and HIV/AIDS), and Type III, which predominantly affect developing countries (African Sleeping Sickness or Trypanosomiasis, African River Blindness or Onchocersiasis, Leishmaniasis, Leprosy and Rabies). This extensive review of patents on treatments, prevention and diagnosis for each of these diseases was undertaken by an Indian Government specialist institution, the Unit for Research and Development of Information Products (URDIP). It showed considerable recent R&D activity directed towards these diseases, undertaken by a wide diversity of public and private players. Newly established firms are applying medical biotechnology to Type III neglected diseases, suggesting new players and new innovation pathways in these critical areas (although these are early‑stage technologies). The landscapes tracked linkages between patent filings and clinical trials, identified trends in the use of genetic resources and showed a complex pattern of comparative public sector and private sector activity. The survey not only provided valuable insights for policymakers, but also demonstrated new techniques for mining patent data.

Charting future directions

Good quality information about patenting activity is an essential input for some of the most critical international policy debates today. Yet patent information is unavoidably complex, constantly evolving, and difficult to capture in readily accessible form for a non-specialized audience. There are real risks associated with making judgments on the basis of limited patent landscapes without considering the full technical and legal context. Thus the demand for reliable patent landscaping in the life sciences is strong, and there are no shortcuts to meeting that demand.

One of the most challenging aspects of patent landscaping in the life sciences is the difficulty of working with and analyzing DNA and amino acid sequence listings. Patent offices and patent analysts labor with massive sets of sequence data. Progress in bioinformatics may enable sequences to link patent documents with other biotechnology data systems using sequence data – using the language of heredity to shed new light on the life sciences.

The WIPO symposium demonstrated that a key need is greater networking and pooling of resources among experts working in this field – both to ensure that the excellent initiatives under way in this field build upon one another and avoid duplication, as well as to promote the sharing of experience, know-how and landscaping techniques.

A positive feedback loop is developing: patent informatics are delivering increasingly focused and accessible information products for policymakers, who in turn can sharpen and distil their demands for patent information, leading in turn to increasingly more relevant and useful support. Patent landscaping is not a substitute for the policy debates and deliberations on the key life sciences issues of the day. But it can inform, support and strengthen the factual basis for discussions, so assisting the policymakers in those fields to set future directions on health, the environment and food security.