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Christopher M Holman - One of the best experts on this subject based on the ideXlab platform.
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helsinn v teva lingering ambiguity after the u s supreme court holds the aia did not alter the on sale bar to Patentability
Social Science Research Network, 2019Co-Authors: Christopher M HolmanAbstract:The American Innovation Act of 2011 (AIA) retained §102 of the pre-AIA Patent Act’s “in public use” and “on-sale” bars to Patentability, but introduced an additional “or otherwise available to the public” category of prior art. Federal Circuit precedent pre-dating the AIA has held that, as a general matter, a sale or offer for sale can create an on-sale bar to Patentability even if the sale or offer for sale is “secret” and does not render the invention available to the public. Some believed that the AIA’s introduction of the phrase “or otherwise available to the public” altered the meaning of “on sale,” introducing a requirement that a sale or offer for sale render an invention “available to the public” in order to create a statutory bar to Patentability. In other words, under this interpretation a “secret” offer for sale would no longer constitute an on-sale statutory bar. In January, 2019, the Supreme Court addressed this contention in Helsinn v. Teva, and essentially held that the AIA had not changed the meaning of “on sale” for purposes of §102. This article provides a historical overview of the pre-AIA on-sale bar, considers the argument that in enacting the AIA Congress intended to do away with non-public prior art, reviews Helsinn, including the decisions below and amicus curiae briefs filed with the Supreme Court in connection with the case, and concludes with a discussion of lingering questions with respect to the judicial interpretation of the on-sale and public use bars.
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Patentability standards for follow on pharmaceutical innovation
Social Science Research Network, 2018Co-Authors: Christopher M Holman, Timo Minssen, Eric M SolovyAbstract:Follow-on pharmaceutical innovation occurring after the initial discovery of a drug active ingredient plays a very important, but at times under-appreciated, role in providing innovative solutions to compelling medical needs. Examples of follow-on innovation include new forms of a drug with improved safety-efficacy profiles, new formulations and dosages providing improved patient outcomes, and new methods of using an established drug more safely or to treat new indications. Patents play a critical role in incentivizing the research, development, testing, and ultimately commercialization of follow-on pharmaceutical innovation, and in doing so provide substantial benefits for public health and patients’ quality of life. There is, however, a body of literature characterizing patents directed towards follow-on innovations as “secondary pharmaceutical patents”. Some have even gone so far as to propose that the criteria for Patentability should be enforced more stringently with respect to follow-on pharmaceutical inventions as compared to other inventions. The underlying assumption of such proposals is that follow-on pharmaceutical innovations are somehow secondary to other pharmaceutical innovation, and thus less deserving of patent protection. In this article, we refute the notion that follow-on pharmaceutical innovation should be categorically singled out for unfavorable treatment under the patent laws, and provide numerous examples of the value that follow-on innovation brings to medicine, and ultimately to patients. We also propose, in view of the minimum standards of Patentability required by international treaties including the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”), standards and best practices for assessing the Patentability of inventions arising out of follow-on pharmaceutical innovation. These are essentially the same stringent standards applicable to “primary” pharmaceutical innovation, and inventions in general. This article provides numerous examples from jurisdictions around the world in which patent offices and courts have applied the well-recognized requirements of Patentability, including patent eligibility, novelty, inventive step and industrial application, to follow-on pharmaceutical inventions, and in so doing have advanced innovation in public health and ultimately the lives of patients.
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Patentability standards for follow on pharmaceutical innovation
Biotechnology Law Report, 2018Co-Authors: Christopher M Holman, Timo Minssen, Eric M SolovyAbstract:Abstract Follow-on pharmaceutical innovation occurring after the initial discovery of a drug active ingredient plays an important, but at times underappreciated, role in providing innovative soluti...
Polk R Wagner - One of the best experts on this subject based on the ideXlab platform.
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the federal circuit and Patentability an empirical assessment of the law of obviousness
2006Co-Authors: Lee Petherbridge, Polk R WagnerAbstract:It is by now a cliche to suggest that the United States Court of Appeals for the Federal Circuit has weakened the standards for obtaining patents. In this article, we empirically assess that Court's performance on the ultimate question of Patentability - the requirement that a patentable invention must be nonobvious. Our findings suggest that the conventional wisdom may not be well-grounded, at least on this measure. Nowhere is the Federal Circuit's controversial role as the locus of judicial power in the U.S. Patent system more evident than in the context of the doctrine of obviousness under 35 U.S.C. Section 103. The determination of whether an invention was obvious to a person having ordinary skill in the art at the time the invention was made is the foundation of Patentability - and thus at the very core of the patent bargain. And the issue's status as a question of law, as well as the spare statutory language, means that the law of obviousness is entirely a creation of the courts. In the study reported here, we systematically examine the Federal Circuit's doctrine of obviousness. Using empirical data collected from a novel dataset spanning over fifteen years of jurisprudential pronouncements, we suggest that the Federal Circuit has developed a doctrine in this area that is relatively stable and appears reasonably predictable. Indeed, contrary to much recent commentary, these results suggest that the Federal Circuit's doctrinal toolkit - especially the much-discussed (and oft-maligned) teaching, suggestion, or motivation test for combinations of references - has not had a significant observable effect on the results of obviousness cases at that Court. Although this study falls short of painting a complete picture of the Federal Circuit's performance with respect to Patentability, the view that emerges is of a modern jurisprudence of obviousness that is more stable, more consistent, and more flexible than has been heretofore understood. These results, then, should give pause to those who argue for a radical reshaping of the Federal Circuit's doctrine under 35 U.S.C. Section 103.
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the federal circuit and Patentability an empirical assessment of the law of obviousness
Texas Law Review, 2006Co-Authors: Lee Petherbridge, Polk R WagnerAbstract:It is by now a cliche to suggest that the United States Court of Appeals for the Federal Circuit has weakened the standards for obtaining patents. In this Article, we empirically assess that court's performance on the ultimate question of Patentability-the requirement that a patentable invention must be "nonobvious." Our findings suggest that the conventional wisdom may not be well grounded, at least on this measure. Nowhere is the Federal Circuit's controversial role as the locus of judicial power in the U.S. patent system more evident than in the context of the doctrine of obviousness under 35 U.S.C. § 103. The determination of whether an invention was "obvious" to "a person having ordinary skill in the art" at the time the invention was made is the foundation of Patentability-and thus at the very core of the patent bargain. And the issue's status as a question of law, as well as the spare statutory language, means that the law of obviousness is entirely a creation of the courts. In the study reported here, we systematically examined the Federal Circuit's doctrine of obviousness. Using empirical data collected from a novel data set spanning more than fifteen years of jurisprudential pronouncements, we suggest that the Federal Circuit has developed a doctrine in this area that is relatively stable and appears reasonably predictable. Indeed, contrary to much recent commentary, these results suggest that the Federal Circuit's doctrinal tool kit-especially the much-discussed (and oft-maligned) "teaching, suggestion, or motivation" test for combinations of references-has not had a significant observable effect on the results of obviousness cases at that court. Although this study falls short of painting a complete picture of the Federal Circuit's performance with respect to Patentability, the view that emerges is of a modern jurisprudence of obviousness that is more stable, more consistent, and more flexible than has been heretofore understood. These results, then, should give pause to those who argue for a radical reshaping of the Federal Circuit's doctrine under 35 U.S.C. § 103. I. Introduction Nearly twenty-five years into the intentional experiment in institutional design that created it, the United States Court of Appeals for the Federal Circuit is unquestionably the most influential player in the U.S. patent system.1 And as the economic significance of patents to the national economy continues to increase,2 the central role played by the Federal Circuit has become increasingly visible,3 pronounced,4 and controversial.5 Nowhere is the importance of the Federal Circuit more apparent-and more discussed-than with respect to the standards for Patentability, the fundamental requirements for obtaining a patent grant. In this context, the court is cast in two critical roles: as the oversight authority for the administrative body that grants patents (the U.S. Patent and Trademark Office (PTO)) and as the sole appellate authority for litigated disputes involving already-issued patents. In determining Patentability, perhaps more than in any other aspect of the patent system, the centralization of legal power that is the core justification for the Federal Circuit6 is brought into sharp relief. In this study, we use a novel data set and well-tested techniques to empirically assess the Federal Circuit's performance7 in the realm of Patentability-specifically with respect to the court's doctrine of obviousness under 35 U.S.C. § 103. That section's requirement-that a patentable invention be nonobvious to a person having ordinary skill in the art at the time the invention was made8-is plainly the "ultimate condition of Patentability,"9 and thus lies at the core of the basic quid pro quo that is the foundation of patent theory. Assessing the law of obviousness is not only important to understanding the institutional role of the Federal Circuit; it is also of critical (and timely) importance in its own right. …
Eric M Solovy - One of the best experts on this subject based on the ideXlab platform.
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Patentability standards for follow on pharmaceutical innovation
Social Science Research Network, 2018Co-Authors: Christopher M Holman, Timo Minssen, Eric M SolovyAbstract:Follow-on pharmaceutical innovation occurring after the initial discovery of a drug active ingredient plays a very important, but at times under-appreciated, role in providing innovative solutions to compelling medical needs. Examples of follow-on innovation include new forms of a drug with improved safety-efficacy profiles, new formulations and dosages providing improved patient outcomes, and new methods of using an established drug more safely or to treat new indications. Patents play a critical role in incentivizing the research, development, testing, and ultimately commercialization of follow-on pharmaceutical innovation, and in doing so provide substantial benefits for public health and patients’ quality of life. There is, however, a body of literature characterizing patents directed towards follow-on innovations as “secondary pharmaceutical patents”. Some have even gone so far as to propose that the criteria for Patentability should be enforced more stringently with respect to follow-on pharmaceutical inventions as compared to other inventions. The underlying assumption of such proposals is that follow-on pharmaceutical innovations are somehow secondary to other pharmaceutical innovation, and thus less deserving of patent protection. In this article, we refute the notion that follow-on pharmaceutical innovation should be categorically singled out for unfavorable treatment under the patent laws, and provide numerous examples of the value that follow-on innovation brings to medicine, and ultimately to patients. We also propose, in view of the minimum standards of Patentability required by international treaties including the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”), standards and best practices for assessing the Patentability of inventions arising out of follow-on pharmaceutical innovation. These are essentially the same stringent standards applicable to “primary” pharmaceutical innovation, and inventions in general. This article provides numerous examples from jurisdictions around the world in which patent offices and courts have applied the well-recognized requirements of Patentability, including patent eligibility, novelty, inventive step and industrial application, to follow-on pharmaceutical inventions, and in so doing have advanced innovation in public health and ultimately the lives of patients.
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Patentability standards for follow on pharmaceutical innovation
Biotechnology Law Report, 2018Co-Authors: Christopher M Holman, Timo Minssen, Eric M SolovyAbstract:Abstract Follow-on pharmaceutical innovation occurring after the initial discovery of a drug active ingredient plays an important, but at times underappreciated, role in providing innovative soluti...
Hans-werner Denker - One of the best experts on this subject based on the ideXlab platform.
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totipotency pluripotency and Patentability
Stem Cells, 2008Co-Authors: Hans-werner DenkerAbstract:Hans-Werner Denker Institut fur Anatomie, Universitatsklinikum Essen, Essen, Germany Key Words: Embryonic stem cell totipotency, Human embryonic stem cells, Human embryos, Ethics, Patenting ABSTRACT In their article entitled "Commentary: Is totipotency of a human cell a sufficient reason to exclude its Patentability under the European law" (Stem Cells 2007; 25: 3026-3028), K. T. Vrtovec and B. Vrtovec conclude that arguments based on differentiation potential should not be an obstacle to patenting human embryonic stem cells (and related cells addressed as totipotent or pluripotent). While concentrating on formal legal aspects, however, these authors fail to consider a major biological and ethical argument already found in the literature, namely that an obstacle to patenting is to be seen in the potential of cells (e.g., of embryonic stem cell lines), if this potential allows (re)constitution of an embryo when tetraploid complementation is performed. STEM CELLS 2008; 26: 1656-1657 ________ ___________________________________________________________________ The article by Vrtovec and Vrtovec (1) concludes that arguments based on the differentiation potential should not be an obstacle to patenting human embryonic stem cells (and related cells referred to as totipotent or pluripotent). The authors propose that, in contrast to existing U.K. and European rulings, human totipotent cells should be considered patentable depending on their location and their method of derivation. In developing their argument, these authors refer to a publication of mine in a way that, unfortunately, is completely misleading because they fail to indicate the main message of it. The authors first cite correctly the European Commission and the U.K. Patent Office (“… human totipotent cells ha ve the potential to develop into an entire human body. In view of this potential, such cells are not patentable because the human body at the various stages of its formation and development is excluded from Patentability (…). The Patent Office will therefore not grant patent s for human totipotent ___________________________________________________________________________ Correspondence: Hans-Werner Denker, Prof. (em.) Dr.med., Dr.rer.nat., Institut fur Anatomie, Universitatsklinikum Essen, Hufelandstr. 55, D-45122 Essen, Germany. Telephone: 49-(0)201-403792; Fax: 49-(0)201-4377593; e-mail: hans-werner.denker@uni-due.de Received March 10, 2008; accepted for publication April 4, 2008; first published online in STEM CELLS EXPRESS April 10, 2008. DOI: 10.1634/stemcells.2008-0232
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Totipotency/Pluripotency and Patentability
Stem cells (Dayton Ohio), 2008Co-Authors: Hans-werner DenkerAbstract:Hans-Werner Denker Institut fur Anatomie, Universitatsklinikum Essen, Essen, Germany Key Words: Embryonic stem cell totipotency, Human embryonic stem cells, Human embryos, Ethics, Patenting ABSTRACT In their article entitled "Commentary: Is totipotency of a human cell a sufficient reason to exclude its Patentability under the European law" (Stem Cells 2007; 25: 3026-3028), K. T. Vrtovec and B. Vrtovec conclude that arguments based on differentiation potential should not be an obstacle to patenting human embryonic stem cells (and related cells addressed as totipotent or pluripotent). While concentrating on formal legal aspects, however, these authors fail to consider a major biological and ethical argument already found in the literature, namely that an obstacle to patenting is to be seen in the potential of cells (e.g., of embryonic stem cell lines), if this potential allows (re)constitution of an embryo when tetraploid complementation is performed. STEM CELLS 2008; 26: 1656-1657 ________ ___________________________________________________________________ The article by Vrtovec and Vrtovec (1) concludes that arguments based on the differentiation potential should not be an obstacle to patenting human embryonic stem cells (and related cells referred to as totipotent or pluripotent). The authors propose that, in contrast to existing U.K. and European rulings, human totipotent cells should be considered patentable depending on their location and their method of derivation. In developing their argument, these authors refer to a publication of mine in a way that, unfortunately, is completely misleading because they fail to indicate the main message of it. The authors first cite correctly the European Commission and the U.K. Patent Office (“… human totipotent cells ha ve the potential to develop into an entire human body. In view of this potential, such cells are not patentable because the human body at the various stages of its formation and development is excluded from Patentability (…). The Patent Office will therefore not grant patent s for human totipotent ___________________________________________________________________________ Correspondence: Hans-Werner Denker, Prof. (em.) Dr.med., Dr.rer.nat., Institut fur Anatomie, Universitatsklinikum Essen, Hufelandstr. 55, D-45122 Essen, Germany. Telephone: 49-(0)201-403792; Fax: 49-(0)201-4377593; e-mail: hans-werner.denker@uni-due.de Received March 10, 2008; accepted for publication April 4, 2008; first published online in STEM CELLS EXPRESS April 10, 2008. DOI: 10.1634/stemcells.2008-0232
Bernard Perbal - One of the best experts on this subject based on the ideXlab platform.
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Focus on the Patentability of computer programs.
Journal of cell communication and signaling, 2014Co-Authors: Bernard PerbalAbstract:The Nuts and Bolts section of our Journal (mirrored on the ICCNS society web site), is meant to provide a very practical way to share useful information, that goes beyond the scope of cell signaling and basic CCN protein biology. Considering the number of requests we have had for information related to protection of Intellectual Property (IP), I am pleased to initiate what will be a series of articles that will focus on various IP topics. The inaugural topic is the protection of computer programs. Some colleagues may wonder how and why the Patentability of computer programs is a topic of interest for scientists working on CCN proteins . . . As a matter of fact, to assist us in analyzing the potential involvement of CCN3 in human genetic diseases, we considered developing a computer program designed to analyze large amounts of data. Sharing the concepts and the computer program raised concerns regarding IP and protection of the software that we would handle. We believe that many colleagues have encountered similar problems. This article provides a short focus on computer program Patentability. It is aimed to provide basic legal information, and to help our readers in understanding the process. It is not intended to replace IP counselors or technology transfer departments. Future articles will address other practical aspects of IP protection.