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Pages 1-18

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From page 1...
... Complementing the traditional hypothesis-driven study of single genes or proteins is the option of studying many genes or proteins simultaneously. This sea change has occurred while both universities and industry have been aggressively seeking and defending intellectual property protection for discoveries, many of them well upstream of commercial application.
From page 2...
... OVERALL CONCLUSIONS The committee found that the number of projects abandoned or delayed as a result of difficulties in technology access is reported to be small, as is the number of occasions in which investigators revise their protocols to avoid intellectual property issues or in which they pay high costs to obtain intellectual property. Thus, for the time being, it appears that access to patented inventions or information inputs into biomedical research rarely imposes a significant burden for biomedical researchers.
From page 3...
... First, institutions, as they become aware that they may enjoy no protection from legal liability,1 may become more concerned about their potential patent infringement liability and take more active steps to raise researchers' awareness or even to try to regulate their behavior. The latter could be both burdensome on research and largely ineffective because of the autonomy of academic researchers and their ignorance -- or at best uncertainty-about what intellectual property laws apply in what circumstances.
From page 4...
... For almost 20 years, GenBank, the European Molecular Biology Laboratory, and the DNA Data Bank of Japan have collaborated to create nucleic acid
From page 5...
... Structural biology data in published patent applications and issued patents are presented in such a form that they are not readily incorporated into the Protein Data Bank (PDB) for the benefit of the larger scientific community.
From page 6...
... to establish mechanisms for the efficient transfer of structural biology data in published patent applica tions and issued patents to the PDB for the benefit of the larger scientific community. To the extent feasible within commercial constraints, all researchers, including those in the private sector, should be encouraged to submit their sequence data to GenBank, the DNA Databank of Japan, or the European Molecular Biology Laboratory and to submit their pro tein structure data to the PDB.
From page 7...
... Independent of such exclusive consideration, the same intellectual property rights could be licensed nonexclusively for diagnostic testing or as a research probe to study gene expression under varying physiological conditions."4 The committee endorses these NIH policies, in particular the principles that patent recipients should analyze whether further research, development, and private investment are needed to realize the usefulness of their research results and that proprietary or exclusive means of dissemination should be pursued only when there is a compelling need. Also, whenever possible, licenses should be limited to relatively narrow and specific commercial application rather than as blanket exclusive licenses for uses that cannot be anticipated at the moment.
From page 8...
... The committee recognizes the value of patents when follow-on private investment adds social value by bringing products and services to market, and while this is to be commended, licensing should be done in ways that permit continued research and avoid logjams, undue royalty stacking, and anti-commons problems. Because NIH issued these policies as guidance documents, grantees and contractors are not required to comply with them.
From page 9...
... In addition, to support the dissemination of biological research materials to the scientific research community, institutions use Material Transfer Agreements (MTAs) in handling the exchange of research materials with the research community.
From page 10...
... The patent application must satisfy certain disclosure requirements, including a written description of the invention, an enabling disclosure that allows a person of ordinary skill in the field to make and use the invention without undue experimentation, and disclosure of the best mode contemplated by the inventor of carrying out the invention. The exclusion of abstract ideas from patent protection traditionally has been more important for information technology than for biotechnology, but some genomics and proteomics research has the potential to confuse or even to blur the boundaries between abstract ideas and applications.
From page 11...
... Nonobviousness determinations require that one look to the prior art and assess whether a person of ordinary skills could replicate the invention, whether such a person would be motivated to do so, and whether he or she would have a reasonable chance of success. The previous National Academies' committee recommended that the Federal Circuit abandon the rule announced in Bell and Deuel that, essentially, prevents the consideration of the technical difficulty faced in obtaining pre-existing genetic sequences.
From page 12...
... If it is determined to be essential to allowing research to proceed and medical practice to advance in the coming years, those who are discovering associations between sequence variants and traits should eschew patents. Failing that, the best practices established by NIH and the broader scientific community should be followed.
From page 13...
... FACILITATE RESEARCH ACCESS TO PATENTED INVENTIONS THROUGH LICENSING AND SHIELDING FROM LIABILITY FOR INFRINGEMENT Experimental Use Exemption Academic scientists commonly assume that their research is shielded by law from intellectual property infringement liability (NRC, 1997)
From page 14...
... The committee believes that there should be a statutory exemption from infringement for experimentation on a patented invention. Recommendation 10: Congress should consider exempting research "on" inventions from patent infringement liability.
From page 15...
... Recommendation 11: NIH should undertake a study of potential university, government, and industry arrangements for the pooling and cross-licensing of genomic and proteomic patents, as well as research tools. Such proposed sharing arrangements are being pursued in agricultural biotechnology by the Public Intellectual Property Resource for Agriculture and the Biological Innovation for Open Society initiative in different ways.
From page 16...
... On the other hand, the exclusive practice of any medical procedure or clinical diagnostic test is an important issue for the medical profession and raises important questions of public health and science policy. For example, the performance of a gene-based clinical test in an academic setting often generates rich databases of newly detected genetic variations that can be correlated with an array of clinical phenotypes.
From page 17...
... Furthermore, the practice of gene-based diagnostic tests by academic laboratories on the large and heterogeneous patient populations of the academic medical center generates rich databases of newly detected genetic variations that can be correlated with an array of clinical phenotypes. Such admixed medical practice and research provides important new information about the mutational repertory of specific disease-linked genes, as well as the phenotypic correlations that provide new insights into disease mechanisms and identify potential new targets for therapeutic intervention.
From page 18...
... Recommendation 13: Owners of patents that control access to genomic- or proteomic-based diagnostic tests should establish procedures that provide for indepen dent verification of test results. Congress should consider whether it is in the interest of the public's health to create an exemption to patent infringement liability to deal with situations where patent owners de cline to allow independent verification of their tests.


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