Geertrui Van Overwalle

Models for facilitating access to patents on genetic inventions

The genetics community is increasingly concerned that patents might lead to restricted access to research and health care. We explore various measures that are designed to render patented genetic inventions accessible to further use in research, and to diagnosis and/or treatment. They include the often-recited research or experimental-use exemption, conventional one-to-one licensing and compulsory licensing, as well as patent pools and clearing-house mechanisms. The last two alternatives deserve special attention in the area of human genetics.

Patent pools and diagnostic testing

There is increasing concern that overlapping patents in the field of genetics will create a costly and legally complex situation known as a patent thicket, which, along with the associated issues of accumulating royalty payments, can act as a disincentive for innovation. One potential means of preventing this is for the patent holders to enter into a so-called patent pool, such as those established in the electronics and telecommunications industries. Precedents for these also exist in the field of genetics, notably with the patents pertaining to the SARS genome. In this review, we initially address the patent pool concept in general and its application in genetics. Following this, we will explore patent pools in the diagnostic field in more detail, and examine some existing and novel examples of patent pools in genetics.

Gene Patents and Collaborative Licensing Models: Patent Pools, Clearinghouses, Open Source Models and Liability Regimes

Gene Patents And Collaborative Licensing Models Patent Pools Clearinghouses Open Source Models And *FREE* gene patents and collaborative licensing models patent pools clearinghouses open source models and a aa aaa aaaa aaacn aaah aaai aaas aab aabb aac aacc aace aachen aacom aacs aacsb aad aadvantage aae aaf aafp aag aah aai aaj aal aalborg aalib aaliyah aall aalto aam ...www mit edu a aa aaa aaaa aaacn aaah aaai aaas aab aabb aac aacc aace aachen aacom aacs aacsb aad aadvantage aae aaf aafp aag aah aai aaj aal aalborg aalib aaliyah aall aalto aamConcerns have been expressed that gene patents might result in restricted access to research and health care. The exponential growth of patents claiming human DNA sequences might result in patent thickets, royalty stacking and, ultimately, a ‘tragedy of the anti-commons’ in genetics. The essays in this book explore models designed to render patented genetic inventions accessible for further use in research, diagnosis or treatment. The models include patent pools, clearing house mechanisms, open source structures and liability regimes. They are analysed by scholars and practitioners in genetics, law, economics and philosophy. The volume looks beyond theoretical and scholarly analysis by conducting empirical investigation of existing examples of collaborative licensing models. Those models are examined from a theoretical perspective and tested in a set of operational cases. This combined approach is unique in its kind and prompts well founded and realistic solutions to problems in the current gene patent landscape.• Descriptions of major models currently used to deal with patent thickets enable the reader to develop a complete view of the models and evaluate existing operational examples • Case studies describe how each model functions, and the critical evaluations enable the reader to compare the advantages and disadvantages of the various models • Concluding chapters analyse and compare solutions put forward by the various authors, thereby examining openings for the future.

Turning Patent Swords into Shares

Compulsory licenses and patent pools will assist modern patent law in fueling genetic test development. The decision earlier this year in the U.S. District Court to deny patent protection for isolated human genes and associated diagnostic methods (1) shocked the biotech community. The case related to genetic tests for familial breast and ovarian cancer developed by the company Myriad Genetics. The product claims (used to describe the compound in question) were directed to isolated DNA containing human BRCA1 and BRCA2 gene sequences. The method claims (used to describe the activity exercised upon the compound) covered the process of identifying certain mutations in the BRCA genes. The court held that the claimed isolated DNA “is not markedly different from native DNA as it exists in nature” and constitutes unpatentable subject matter (1). The court also ruled that the claimed method is “directed only to the abstract mental process of comparing or analyzing gene sequences,” fails the so-called “machine or transformation test” (2), and is unpatentable as well (1).

Analysing DNA Patents in Relation with Diagnostic Genetic Testing

In the ongoing debate concerning DNA patents, there is a need for empirical data. We aim at creating this data set for DNA patents related to diagnostic genetic testing. To this end we developed two tools to facilitate this process. First, we set up a search strategy to find the relevant patents. Second, we provide a claim classification template to assist the user in the assessment of the subject matter covered by the patent claims and in creating a comprehensive overview of the patent situation within this field. These tools have been used in a pilot study on 11 selected hereditary disorders. In addition, a detailed analysis of the familial breast and ovarian cancer genes patents retrieved by the developed search strategy and their claim classification, after meticulous reading of the documents, allowed us to better describe the problems which medical geneticists and researchers might face when dealing with the patented technology.

The fate and future of patents on human genes and genetic diagnostic methods.

Since the 1970s, patents on human genes and genetic diagnostic methods have been granted under the assumption that they stimulate the development of diagnostic methods and therapeutic products. However, the principles and practices of patenting vary between jurisdictions. Do patent holders, researchers, clinicians and patients really benefit from this heterogeneous patent system? We discuss the problems that result from the current system and suggest how they might be solved by altering the way in which patents are granted and/or licensed.

Gene and genetic diagnostic method patent claims: a comparison under current European and US patent law

The paper focuses on the fundamental debate that is going on in Europe and the United States about whether genes and genetic diagnostic methods are to be regarded as inventions or subject matter eligible for patent protection, or whether they are discoveries or principles of nature and thus excluded from patentability. The study further explores some possible scenarios of American influences on European patent applications with respect to genetic diagnostic methods. Our analysis points out that patent eligibility for genes and genetic diagnostic methods, as discussed in the United States in the Association of Molecular Pathology versus US Patent and Trademark Office decision, is based on a different reasoning compared with the European Patent Convention.

Patent pools and clearinghouses in the life sciences

The biopharmaceutical industry is slowly absorbing the idea of collaborative patent licensing models. Recently, two patent pools for developing countries have been launched: the Pool for Open Innovation against Neglected Tropical Diseases initiated by GlaxoSmithKline (GSK), which is referred to as the BIO Ventures for Global Health (BVGH) pool, and the Medicines Patent Pool (MPP) initiated by UNITAID. Various organizations have recommended using pools or clearinghouses beyond the humanitarian dimension where many patents are owned by many different actors. As a first attempt, MPEG LA, which administers patent pools in various technology fields, is now setting up a clearinghouse for patents related to molecular diagnostics. These examples as well as the results from an empirical study provide useful insights for the design and administration of future pools and clearinghouses in the life sciences.

Impact of gene patents on diagnostic testing: a new patent landscaping method applied to spinocerebellar ataxia

Recent reports in Europe and the United States raise concern about the potential negative impact of gene patents on the freedom to operate of diagnosticians and on the access of patients to genetic diagnostic services. Patents, historically seen as legal instruments to trigger innovation, could cause undesired side effects in the public health domain. Clear empirical evidence on the alleged hindering effect of gene patents is still scarce. We therefore developed a patent categorization method to determine which gene patents could indeed be problematic. The method is applied to patents relevant for genetic testing of spinocerebellar ataxia (SCA). The SCA test is probably the most widely used DNA test in (adult) neurology, as well as one of the most challenging due to the heterogeneity of the disease. Typically tested as a gene panel covering the five common SCA subtypes, we show that the patenting of SCA genes and testing methods and the associated licensing conditions could have far-reaching consequences on legitimate access to this gene panel. Moreover, with genetic testing being increasingly standardized, simply ignoring patents is unlikely to hold out indefinitely. This paper aims to differentiate among so-called ‘gene patents’ by lifting out the truly problematic ones. In doing so, awareness is raised among all stakeholders in the genetic diagnostics field who are not necessarily familiar with the ins and outs of patenting and licensing.

Intellectual property policies in early-phase research in public-private partnerships

Knowledge-sharing strategies differ depending on the nature of the research objectives of public–private partnerships, but information about such strategies is often vague.