The Experts below are selected from a list of 243 Experts worldwide ranked by ideXlab platform
Philippe Ducor - One of the best experts on this subject based on the ideXlab platform.
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Research tool patents and the Experimental Use exemption—a no-win situation?
Nature Biotechnology, 1999Co-Authors: Philippe DucorAbstract:BecaUse their very purpose is experimentation, applying the Experimental Use exemption to research tool patents requires a close analysis.
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research tool patents and the Experimental Use exemption a no win situation
Nature Biotechnology, 1999Co-Authors: Philippe DucorAbstract:BecaUse their very purpose is experimentation, applying the Experimental Use exemption to research tool patents requires a close analysis.
Jennifer Carter-johnson - One of the best experts on this subject based on the ideXlab platform.
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Ritalin to Roundup: Expanding the Pharmaceutical Industry Statutory Experimental Use Exception to Agriculture
2016Co-Authors: Jennifer Carter-johnsonAbstract:The modern agricultural biotechnology industry developed from a small cottage industry based on selective crop breeding into a multi-billion dollar industry based on the isolation and insertion of genes that code for commercially valuable crop traits. As it grew, the industry relied on patent protection to recoup its investment into new research and development of genetically engineered (GE) crops. A recent billion dollar patent infringement damage award to Monsanto based only on research activities of its competitors testifies to the importance of that patent protection.Had the Monsanto patent infringement case been between two pharmaceutical companies creating genetics-based drugs, the outcome would have been different. Instead of a one billion dollar award, the patent verdict would have been one of non-infringement. The difference between the two patent infringement cases lies with the Hatch-Waxman Act’s statutory Experimental Use exception.The Hatch-Waxman Act controls the regulation of generic drugs by the Food and Drug Administration (FDA). Along with an abbreviated generic drug approval process, the Hatch-Waxman Act includes a statutory Experimental Use exception to patent infringement allowing pharmaceutical companies to conduct research on patented drugs if the research might be Used in a regulatory submission to the FDA.This Article explores the history of the statutory Experimental Use exception and argues that it should apply to the agricultural biotechnology industry’s development of GE crops. The Supreme Court’s interpretation of the statute has resulted in a very broad Experimental Use exception, limited only by whether an invention is regulated by the FDA. Since GE crops are regulated by the FDA, the statutory Experimental Use exception should apply to their development. Such a broadening of the Experimental Use exception would have potentially vast impacts on the patent valuations as well as the structure of the entire agricultural biotechnology industry.
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Defining Limits to the Application of the Statutory Experimental Use Exception Within the Agricultural Biotechnology Industry
Michigan state law review, 2015Co-Authors: Jennifer Carter-johnsonAbstract:The Hatch–Waxman Act delineates a pathway for the approval of generic drugs by the Food and Drug Administration (FDA). In addition to an abbreviated generic drug approval process, the Hatch–Waxman Act added a new defense to patent infringement, a statutory Experimental Use exception. The statutory Experimental Use exception allows pharmaceutical companies to conduct research on patented technologies if the research might be Used in a regulatory submission to the FDA. In a separate article, I argued that the statutory Experimental Use exception should apply to the agricultural biotechnology industry’s development of genetically engineered crops. Arguments were based on the Supreme Court’s broad interpretation of the underlying statute and the FDA’s regulation of genetically engineered (GE) crops. Such an application of the Experimental Use exception would have a potentially large impact on the patent valuations within the agricultural biotechnology industry. This Article describes the limitations of the statutory Experimental Use exception of the Hatch–Waxman Act in light of the patent strategies employed by the agricultural biotechnology industry. Based on these limitations, this Article argues that intellectual property protection is still valuable to agricultural biotechnology companies if the statutory Experimental Use defense were available to the industry. Part I describes the development of the statutory Experimental Use exception and its evolution. Part II Associate Professor of Law, Michigan State University College of Law; J.D., University of Michigan, Ph.D. in Microbiology, University of Virginia. Many thanks for research assistance to Monique Patton, Geoff Leskie, Vani Gujuluva, and Jeff Carter-Johnson. I am especially indebted to the members of the Michigan State Law Review, especially William J. Cox, for their symposium organization, editorial efforts, and support. 510 Michigan State Law Review 2015:509 explains the intellectual property protection necessary for the agricultural biotechnology industry due to the regulations and long development timelines. Part III analyzes the case law surrounding the statutory Experimental Use exception in light of GE crop intellectual property protection to describe the reach of the statutory Experimental Use exception within the industry.
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Defining Limits to the Application of the Statutory Experimental Use Exception within the Agricultural Biotechnology Industry
2014Co-Authors: Jennifer Carter-johnsonAbstract:The Hatch–Waxman Act delineates a pathway for the approval of generic drugs by the Food and Drug Administration (FDA). In addition to an abbreviated generic drug approval process, the Hatch–Waxman Act added a new defense to patent infringement, a statutory Experimental Use exception. The statutory Experimental Use exception allows pharmaceutical companies to conduct research on patented technologies if the research might be Used in a regulatory submission to the FDA. In a separate article, I argued that the statutory Experimental Use exception should apply to the agricultural biotechnology industry’s development of genetically engineered crops. Arguments were based on the Supreme Court’s broad interpretation of the underlying statute and the FDA’s regulation of genetically engineered (GE) crops. Such an application of the Experimental Use exception would have a potentially large impact on the patent valuations within the agricultural biotechnology industry.This Article describes the limitations of the statutory Experimental Use exception of the Hatch–Waxman Act in light of the patent strategies employed by the agricultural biotechnology industry. Based on these limitations, this Article argues that intellectual property protection is still valuable to agricultural biotechnology companies if the statutory Experimental Use defense were available to the industry. Part I describes the development of the statutory Experimental Use exception and its evolution. Part II explains the intellectual property protection necessary for the agricultural biotechnology industry due to the regulations and long development timelines. Part III analyzes the case law surrounding the statutory Experimental Use exception in light of GE crop intellectual property protection to describe the reach of the statutory Experimental Use exception within the industry.
Akira Takeuchi - One of the best experts on this subject based on the ideXlab platform.
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learning by problem posing as sentence integration and Experimental Use
Artificial Intelligence in Education, 2007Co-Authors: Tsukasa Hirashima, Takuro Yokoyama, Masahiko Okamoto, Akira TakeuchiAbstract:In this paper, “problem-posing as sentence-integration” is proposed as a new design of learning using computer-based method. We also introduce an interactive learning environment for the problem-posing and report Experimental Use of the environment in elementary schools. We have already developed a computer-based learning environment for problem-posing as concept combination. However, we could understand that it was difficult for students of the lower grades. Problem-posing by sentence-integration is a framework to realize learning by problem-posing in the lower grades. Sentence-integration is a simple method than problem-posing by concept combination, but it is expected to keep the learning effect to refine problem schema. The learning environment was Used by 132 second grade students of two elementary schools to examine whether the lower grade students can pose problems in the environment or not. The effect of refinement of problem schema by the problem-posing was also analyzed by pre-test and post-test with excessive information problems. The students and teachers who were observers of the experiment accepted the learning environment as a Useful learning tool to realize learning by problem-posing through the questionnaires and additional comments. Although the results suggest the effect of refinement of problem schema by the problem-posing, it was only compared against a no instruction control condition. Therefore, as a future work, it is necessary to compare the learning against other instructions to examine its characteristics. tsukasa@isl.hiroshima-u.ac.jp
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AIED - Learning by Problem-Posing as Sentence-Integration and Experimental Use
2007Co-Authors: Tsukasa Hirashima, Takuro Yokoyama, Masahiko Okamoto, Akira TakeuchiAbstract:In this paper, “problem-posing as sentence-integration” is proposed as a new design of learning using computer-based method. We also introduce an interactive learning environment for the problem-posing and report Experimental Use of the environment in elementary schools. We have already developed a computer-based learning environment for problem-posing as concept combination. However, we could understand that it was difficult for students of the lower grades. Problem-posing by sentence-integration is a framework to realize learning by problem-posing in the lower grades. Sentence-integration is a simple method than problem-posing by concept combination, but it is expected to keep the learning effect to refine problem schema. The learning environment was Used by 132 second grade students of two elementary schools to examine whether the lower grade students can pose problems in the environment or not. The effect of refinement of problem schema by the problem-posing was also analyzed by pre-test and post-test with excessive information problems. The students and teachers who were observers of the experiment accepted the learning environment as a Useful learning tool to realize learning by problem-posing through the questionnaires and additional comments. Although the results suggest the effect of refinement of problem schema by the problem-posing, it was only compared against a no instruction control condition. Therefore, as a future work, it is necessary to compare the learning against other instructions to examine its characteristics. tsukasa@isl.hiroshima-u.ac.jp
Matthew Rimmer - One of the best experts on this subject based on the ideXlab platform.
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The freedom to tinker: patent law and Experimental Use
Expert Opinion on Therapeutic Patents, 2005Co-Authors: Matthew RimmerAbstract:This article considers the origins and the development of the defence of Experimental Use in patent law - the ’freedom to tinker'. It explores the impact of such an exemption upon a number of important industries - such as agriculture, biotechnology, and pharmaceutical drugs. This article takes a comparative approach in its analysis of patent law and Experimental Use. It highlights the competing norms, and lack of harmonization between a number of jurisdictions - including the United States, the European Union, and Australia. Section 2 provides a critique of the development of the common law defence of Experimental Use in the United States. It considers a series of precedents - including Roche Products Inc v Bolar Pharmaceuticals, Madey v Duke University, Integra Lifesciences I Ltd v Merck KgaA, and Applera v MJ Research. Section 3 explores the operation of patent law and Experimental Use in European jurisdictions. It looks at a number of significant precedents in the United Kingdom, the Netherlands, France, Italy, and Germany. Section 4 considers the policy debate in a number of forums over the defence of Experimental Use in Australia. It examines the controversy over Genetic Technologies Limited asking research organisations to obtain a licence in respect of its patents associated with non-coding DNA and genomic mapping. It also considers the inquiries of the Australian Law Reform Commission and the Advisory Council on Intellectual Property, as well as the impact of the TRIPS Agreement and the Australia-United States Free Trade Agreement. The conclusion contends that there is a need for a broad-based defence of Experimental Use for all the member states of the Organisation for Economic Co-operation and Development.
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Patents and Experimental Use: A Submission to the Advisory Council on Intellectual Property
2004Co-Authors: Matthew Rimmer, Krishna RajendraAbstract:ACIPA welcomes the opportunity to make a submission to the Advisory Council on Intellectual Property issues paper, "Patents And Experimental Use". It is concerned that there is great uncertainty whether researchers can rely upon a defence for Experimental Use. ACIPA recommends that the Commonwealth should amend the Patents Act 1990 (Cth) to establish a new defence to a claim of patent infringement based on the Use of a patented invention to study or experiment on the subject matter of the invention; for example, to investigate its properties or improve upon it. The legislation should make it clear that the existence of a commercial purpose or intention does not affect the availability of the defence. ACIPA believes that such a research exemption is in keeping with our international obligations. Indeed, it is of the opinion that a defence for Experimental Use is compatible both with the TRIPS Agreement of the World Trade Organization and the recently concluded United States- Australia Free Trade Agreement. ACIPA maintains that a defence for Experimental Use is a unique policy reform - becaUse it would enable researchers to Use a patented invention without either seeking permission from the patent owner or paying royalties. It can be distinguished by these characteristics from a number of other policy options. Thus, licensing, patent pools, and open source licensing depend very much up the patent holder providing permission for an invention to be shared in that way. Furthermore, compulsory licensing can compel a patent holder to give access to patented inventions - but the User is still obliged to pay royalties. Nonetheless, ACIPA observes that a defence for Experimental Use can be supplemented by additional reforms to patent law. The threshold patent criteria of novelty and inventive step could be tightened, in line with the dissenting judgment of Justice Kirby in Aktiebolaget Hassle v Alphapharm Pty Limited.4 The compulsory licensing provisions in the Patents Act 1990 (Cth) need to be modernised to reflect contemporary concerns about competition policy. There should be greater Use of creative licensing, patent pooling, and open source licensing to share patented technology. However, none of such reforms could be considered to be a substitute for the recognition of a defence of Experimental Use.
Tsukasa Hirashima - One of the best experts on this subject based on the ideXlab platform.
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Experimental Use of Learning Environment by Posing Problem for Learning Disability
Applied Computing & Information Technology, 2015Co-Authors: Sho Yamamoto, Tsukasa Hirashima, Akio OgiharaAbstract:In this paper, we described about a design of learning environment based on information structure and a realization of problem posing for learning disability. We design and developed software by modeling information structure of subject that is operated on software. In this research, we aimed at the domain of education and developed a learning environment for posing arithmetic word problem. Problem posing is well-known as effective learning. But students who have learning disability are impossible to learn by this exercise becaUse they cannot pose the problem from scratch and cannot read complex sentence. However, learner is able to pose a word problem by selecting three cards in our software. So we assumed that these learners are able to learn by problem posing by using our learning environment. Experimental Use is also reported.
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learning by problem posing as sentence integration and Experimental Use
Artificial Intelligence in Education, 2007Co-Authors: Tsukasa Hirashima, Takuro Yokoyama, Masahiko Okamoto, Akira TakeuchiAbstract:In this paper, “problem-posing as sentence-integration” is proposed as a new design of learning using computer-based method. We also introduce an interactive learning environment for the problem-posing and report Experimental Use of the environment in elementary schools. We have already developed a computer-based learning environment for problem-posing as concept combination. However, we could understand that it was difficult for students of the lower grades. Problem-posing by sentence-integration is a framework to realize learning by problem-posing in the lower grades. Sentence-integration is a simple method than problem-posing by concept combination, but it is expected to keep the learning effect to refine problem schema. The learning environment was Used by 132 second grade students of two elementary schools to examine whether the lower grade students can pose problems in the environment or not. The effect of refinement of problem schema by the problem-posing was also analyzed by pre-test and post-test with excessive information problems. The students and teachers who were observers of the experiment accepted the learning environment as a Useful learning tool to realize learning by problem-posing through the questionnaires and additional comments. Although the results suggest the effect of refinement of problem schema by the problem-posing, it was only compared against a no instruction control condition. Therefore, as a future work, it is necessary to compare the learning against other instructions to examine its characteristics. tsukasa@isl.hiroshima-u.ac.jp
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AIED - Learning by Problem-Posing as Sentence-Integration and Experimental Use
2007Co-Authors: Tsukasa Hirashima, Takuro Yokoyama, Masahiko Okamoto, Akira TakeuchiAbstract:In this paper, “problem-posing as sentence-integration” is proposed as a new design of learning using computer-based method. We also introduce an interactive learning environment for the problem-posing and report Experimental Use of the environment in elementary schools. We have already developed a computer-based learning environment for problem-posing as concept combination. However, we could understand that it was difficult for students of the lower grades. Problem-posing by sentence-integration is a framework to realize learning by problem-posing in the lower grades. Sentence-integration is a simple method than problem-posing by concept combination, but it is expected to keep the learning effect to refine problem schema. The learning environment was Used by 132 second grade students of two elementary schools to examine whether the lower grade students can pose problems in the environment or not. The effect of refinement of problem schema by the problem-posing was also analyzed by pre-test and post-test with excessive information problems. The students and teachers who were observers of the experiment accepted the learning environment as a Useful learning tool to realize learning by problem-posing through the questionnaires and additional comments. Although the results suggest the effect of refinement of problem schema by the problem-posing, it was only compared against a no instruction control condition. Therefore, as a future work, it is necessary to compare the learning against other instructions to examine its characteristics. tsukasa@isl.hiroshima-u.ac.jp
