Stanley P. Kowalski

Patent data mining: A tool for accelerating HIV vaccine innovation

Global access to advanced vaccine technologies is challenged by the interrelated components of intellectual property (IP) management strategies, technology transfer (legal and technical) capabilities and the capacity necessary for accelerating R&D, commercialization and delivery of vaccines. Due to a negative association with the management of IP, patents are often overlooked as a vast resource of freely available, information akin to scientific journals as well as business and technological information and trends fundamental for formulating policies and IP management strategies. Therefore, a fundamental step towards facilitating global vaccine access will be the assembly, organization and analysis of patent landscapes, to identify the amount of patenting, ownership (assignees) and fields of technology covered. This is critical for making informed decisions (e.g., identifying licensees, building research and product development collaborations, and ascertaining freedom to operate). Such information is of particular interest to the HIV vaccine community where the HIV Vaccine Enterprise, have voiced concern that IP rights (particularly patents and trade secrets) may prevent data and materials sharing, delaying progress in research and development of a HIV vaccine. We have compiled and analyzed a representative HIV vaccine patent landscape for a prime-boost, DNA/adenoviral vaccine platform, as an example for identifying obstacles, maximizing opportunities and making informed IP management strategy decisions towards the development and deployment of an efficacious HIV vaccine.

Harnessing the power of patent information to accelerate innovation

Access to information drives innovation. Patents are a unique source of information containing not only legal but also technical, business, and potentially policy‐related information. Mining patents for information is an acquired skill that requires training and practice, familiarity with both legal and technical nomenclature and jargon, facile knowledge of the database used, and an appreciation of strategic approaches to efficient searching and information management. Once mastered patent information can facilitate the transformation of a resource‐based economy to a knowledge‐based economy. Essential to this process in developing countries is the active participation of the country in legal and technical transfer of innovations including patent searching to identify technologies of interest, patent owners, and the extent of patent rights (geographical and claims).

Freedom-to-Operate in the Crop Sciences: Principles

Research and development in the crop sciences is increasingly impacted by the risk of infringing the intellectual property rights (IPRs; e.g., patents) and tangible property rights (TPRs; e.g., material transfer agreements) of others. Since crop science products now entail such a high degree of technical complexity, and the processes and components to make such products are so ubiquitously available, the potential for such infringement is simply omnipresent. A freedom to operate (FTO) analysis is a tool that provides the requisite information so as to systematically, and prophylactically, assess such legal risks, which can then be managed and significantly diminished. FTO, therefore, is the ability to proceed with research, development and commercialization of a crop science product, while fully accounting for any potential risks of infringing activity, i.e., whether a product can be made, used, sold, offered for sale, or exported, with a minimal risk of infringing the unlicensed IPRs or TPRs of another.

Book Review: Intellectual property, medicine and health: Current debates

Intellectual property, medicine and health: Current debates Johanna Gibson Ashgate, Farnham, England and Burlington, VT, USA, 2009, hardback, 223pp., ISBN: 978-0754672180

Freedom-to-Operate in the Crop Sciences: Procedure

Freedom to operate (FTO) is the ability to proceed with research, development and commercialization of a crop science product, while fully accounting for any potential risks of infringing activity, that is, whether a product can be made, used, sold, offered for sale, or exported, with a minimal risk of infringing the unlicensed intellectual property rights (IPRs) or tangible property rights (TPRs) of another. An FTO analysis begins with the ‘FTO team’ systematically dissecting the crop science product into the components, combination of components, processes and germplasm that went into its research and development. This is followed by generating a series of FTO analytical questions, whereby each piece of the product is carefully scrutinized for the presence of potential IPRs, TPRs and germplasm property rights held by other parties. Finally, patent counsel may render an FTO opinion, indicating the likelihood of the risk of infringing the unlicensed IPRs or TPRs of another should research, development or commercialization proceed. FTO is not absolute. The proprietary landscape is in a continual state of flux, both in time and in space, as in the case where patents issue/expire in countries around the world. Therefore, an FTO analysis is a risk-management tool which is only applicable for a given product, at a given time, in a given jurisdiction, and, as such, must to periodically updated.