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4 Trends in the Patenting and Licensing of Genomic and Protein Inventions and Their Impact on Biomedical Research
Pages 100-132

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From page 100...
... In addition, the committee engaged in three original research efforts: 1. a search for issued patents and published patent applications in selected biotechnology categories; 2.
From page 101...
... Cho, and W Cohen, Patents, Material Transfers, and Access to Research Inputs in Biomedical Research, June 2005, is available at http://www.uic.edu/~jwalsh/ NASreport.html.
From page 102...
... patents. 3The Georgetown University investigators observed this when recently adding pending DNA patent applications to their database.
From page 103...
... 103 2005 2004 Projected 2003 :Georgetown 2002 2001 SOURCE 2000 1999 total. 1998 1997 1996 mid-year on 1995 1994 based 1993 is 1992 1991 1990 Projection 1989 Issue 2005 1988 of 1987 Year 2005)
From page 104...
... 104 1200 University :Georgetown 1000 SOURCE 800 2005)
From page 105...
... they exhibit some variance in the number of related patents; and 4. there is some but varying industry involvement, represented by pharmaceutical or biotechnology firm patenting activity, licensing of university patents, or clinical testing or even marketing of therapeutic products.
From page 106...
... patent applications and, for comparison, patents and applications issued by the European Patent Office (EPO)
From page 107...
... Genes and gene regulation, gene expression profiling, and protein-protein interactions are by far the most active categories, followed by haplotypes and SNPs and databases. There are few protein structure patents and 6 This will be apparent in Table 4-2, in which some agricultural biotechnology firms appear as leading patent holders in some categories, especially genes and gene regulatory sequences and SNPs and haplotypes.
From page 108...
... 108 REAPING THE BENEFITS OF GENOMIC AND PROTEOMIC RESEARCH 12 10 8 Patents of 6 Number 4 2 0 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 Year FIGURE 4-4 Protein structure patent trends, 1995-2004. 1400 1200 1000 Patents 800 of 600 Number 400 200 0 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 Year FIGURE 4-5 Protein-protein interactions patent trends, 1995-2004.
From page 109...
... PATENTING AND LICENSING OF GENOMIC AND PROTEIN INVENTIONS 109 300 Animals Software Algorithms Database 250 200 patents of 150 number 100 50 0 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 Year FIGURE 4-6 Research tools patent trends, 1995-2004. 140 EGF CTLA4 120 NFkB 100 Patents 80 of 60 Number 40 20 0 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 Year FIGURE 4-7 Molecular pathway patent trends, 1995-2004.
From page 110...
... Greater conservatism on the part of USPTO is almost certainly a factor in the decline, perhaps especially in categories such as haplotypes and SNPs. Partly in response to criticisms of the standards being applied to genomic patent applications, the office conducted a broad review of its examination standards and practices and in January 2001 released new guidelines clarifying the written description and utility requirements.
From page 111...
... is substantial -- two-thirds to 90 percent or more by various calculations, and probably higher than the approval rates in the European and Japanese patent offices.10 The committee concluded that the patent landscape, which already is crowded in areas such as gene expression and protein-protein interactions, could become considerably more complex over time. 8Pressman et al.
From page 112...
... typically are dominated by biotechnology firms. The protein structure category has been led by pharmaceutical companies because of its proximity to drug discovery, while universities have been dominant in the modified animals category.
From page 113...
... PATENTING AND LICENSING OF GENOMIC AND PROTEIN INVENTIONS 113 80 Genes Assignee 70 Genes Inventor SNPs/Haps Assignee 60 SNPs/Haps Inventor patents 50 Expression profiling Assignee of Expression profiling Inventor 40 share 30 Percent 20 10 0 UK USA France Japan Germany Canada Israel Australia Belgium Netherlands Denmark Sweden Country Switzerland FIGURE 4-9 DNA patents: inventor and assignee country, 1995-2004. 80 Protein Structure Assignee 70 Protein Structure Inventor 60 Protein-protein Interactions Assignee Protein-protein Interactions Inventor 50 patents of 40 share 30 Percent 20 10 0 USA UK Canada Japan Israel Sweden France Netherlands Germany Australia Denmark Country FIGURE 4-10 Protein patents: inventor and assignee country, 1995-2004.
From page 114...
... 114 REAPING THE BENEFITS OF GENOMIC AND PROTEOMIC RESEARCH 100 Animals Assignee 80 Animals Inventor 70 Software Assignee Software Inventor 60 Algorithms Assignee patents of 50 Algorithms Inventor share 40 Databases Assignee Databases Inventor 30 Percent 20 10 0 USA UK Israel Canada France Japan India Rico Germany Sweden Netherlands Australia Zealand Greece Korea Puerto Denmark of Switzerland Country New Repub. FIGURE 4-11 Research tool patents: inventor and assignee country, 1995-2004.
From page 115...
... DHHS (96) Protein Structure 39 Abbott Labs (3)
From page 116...
... Government entities are indicated by bold typeface. TRENDS IN UNIVERSITY LICENSING OF GENOMIC AND PROTEOMIC INVENTIONS Licensing is the principal means of accessing the use of patented technology, and it occurs under terms that are infinitely varied and complex and whose effects are not straightforward.
From page 117...
... . · Nevertheless, the results underscore the fact that exclusivity is not a reliable indicator of the extent to which patented inventions are available for others to use.12 Some patents are licensed exclusively but to multiple entities for many different fields of use.
From page 118...
... In short, interview respondents reported practices broadly consistent with the NIH Research Tool guidelines issued in 1998 and with the Guidelines for Licensing of Genomic Inventions, which were in draft form and published for comment
From page 119...
... EFFECTS OF INTELLECTUAL PROPERTY PRACTICES ON RESEARCH13 The implications of patenting and licensing practices are likely to vary from one stage of research and development to another -- for example, basic, curiositydriven research; drug discovery and development; clinical and diagnostic testing -- and depend on a variety of circumstances, including the resources of the respective parties and their awareness of the existence and use of intellectual property. A patent on an upstream discovery may encourage downstream development if it gives a developer necessary protection from free riding by others.
From page 120...
... MDs are more likely to report not having their last request for a research material transfer fulfilled (41 percent versus 15 percent) , which suggests that the estimate given below of the incidence of being denied access to others' research materials may be conservative.
From page 121...
... Ten percent indicated that they were doing drug development, clinical research, or developing diagnostic tests, and almost 80 percent said they were performing basic research, with the remainder developing research tools or doing other work. About 70 percent are associated with research groups of 3 to 10 people; 20 percent were 1- or 2-investigator projects; and just fewer than 10 percent were groups of more than 10 people.
From page 122...
... Approximately 22 percent of academic respondents have been notified by their institutions to be careful with respect to patents on research inputs, up from 15 percent five years ago. Five percent have been notified at one time or another that their own research may be infringing upon another's intellectual property.
From page 123...
... Overall, the number of projects abandoned or delayed as a result of technology access difficulties is extremely small, as is the number of occasions in which investigators revise their protocols to avoid intellectual property issues or pay high costs to obtain one. Thus, it appears that for the time being, access to patents or information inputs into biomedical research rarely imposes a significant burden for academic biomedical researchers.
From page 124...
... 124 NF-kB 82 48 53 50 29 29 22 5 0 0 0 0 0 19 22 EGF 5 9 4 54 58 55 36 30 29 13 24 7 0 04 04 04 04 0 Pathways CTLA4 63 53 33 40 20 27 13 16 6 Other 58 59 47 45 33 21 15 15 3 33 Pathway and 9 7 23 23 23 13 1 60 60 46 41 36 32 14 Basic Research 213 Goal Goal 3 Research Drug Discovery 86 55 41 24 24 21 21 21 21 28 Research by 33 33 23 13 1 62 60 46 40 35 29 15 10 10 Random Sample 274 Projects, Pursuing Not for 2005. al., Important Potential et Reasons Terms Potential Benefit Promotion/Job 4-3 Competition Patents w/ Unlikely Walsh Social Commercial Income Funding Busy Feasible Scientifically Interesting Much Help Many Firm Patentable TABLE No Too Not Not Not Too Little Unreasonable Not Too New Little Little Not Respondents SOURCE:
From page 125...
... Institutions, aware that they currently enjoy no legal protection, 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 researchers' autonomy and their ignorance, or at best uncertainty, about what intellectual property applies in what circumstances.
From page 126...
... survey, the sample for which included research teams of significant size, did not indicate that intellectual property-related complications are greater in proportion to the number of investigators involved in the effort, but it is a reasonable presumption that such would be the case with more research inputs. Of course, the resources to address intellectual property complexities also are likely to be greater the more substantial the project.
From page 127...
... The adverse effects of patents nevertheless occur more frequently for those who work on the pathways than for the random sample of academic biomedical researchers. Investigators working on the three pathways were two to three times more likely to indicate a need for access to a third-party patent than researchers in the random sample and were more likely to report adverse consequences.
From page 128...
... About 60 percent of industry respondents and 75 percent of academic respondents initiated at least one request in the last two years. Approximately 40 percent of industry respondents and 69 percent of academic scientists had received such a request in the same period.
From page 129...
... · The consequences of being denied a tangible research input can be more severe than the inability to license another's intellectual property, because in the latter case work may proceed, albeit at some liability risk. The survey asked about four possible adverse impacts -- abandonment, delay, change in research approach, or the need to develop the research input in the requester's own laboratory.
From page 130...
... 130 Research by Industry 0.78 0.68 0.39 1.01 0.35 0.49 0.32 0.33 62 NF-kB 2.85 2.24 0.62 2.29 0.87 1.66 0.28 0.71 Respondents 26 1.2 0.7 0.2 1.2 1.1 0.7 0.9 0.8 Academic EGF 24 Inputs, Pathways CTLA4 0.83 0.45 0.27 0.93 1.02 0.68 0.58 0.69 21 Research 0.33 0.3 0.21 0.59 0.18 0.56 0.26 0.47 Other 23 Supplier Supplier Receiving Not Academic Industry 0.69 0.54 0.24 0.65 0.39 0.42 0.3 0.28 Basic Research 195 from Goal Effects 0.98 0.89 0.07 0.88 0.75 0.66 0.08 0.44 Research Drug Discovery 24 Respondents Adverse of 0.68 0.56 0.22 0.67 0.4 0.46 0.27 0.31 Random Sample 242 Industry and Number 2005. al., Approach Approach et Average Pathways for 4-5 Walsh month month and Research Research >1 In-house >1 In-house TABLE Goal Delay Change Abandon Make Delay Change Abandon Make Respondents SOURCE:
From page 131...
... The first concern is that a patent owner's refusal to make a single patented gene available for licensing on reasonable terms will inhibit follow-on research on the incidence of mutations in the gene as well as limit patient access to testing at a reasonable cost and the possibility of obtaining a second opinion on the result. Exclusive licenses also limit the opportunity for the development of improvements in the test and verification of the result.
From page 132...
... This situation could change dramatically as institutions increasingly realize that they enjoy no legal protection and concerns are raised about possible patent infringement liability; this may lead them to take more steps to raise awareness and regulate their behavior. Second, although the survey did not reveal significant differences in experience between investigators working independently and those working in multimember teams, the growing complexity of biomedical research may make intellectual property more problematic as work on a single gene or gene sequence gives way to research entailing far more extensive inputs, more and more of them patented.


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