Application Of New Discoveries Research Articles

Neilson v. Harford: Shape and Form in Patent Law

Neilson v. Harford has cast a long shadow over patent law. For American courts in the nineteenth century, the 1841 case from the Court of Exchequer was an authority whose “correctness has never been doubted and denied.” More recently, Neilson served as the ostensible authority for some of the Supreme Court’s most significant changes to the doctrine of patent eligibility under § 101. Parker v. Flook took from Neilson the notion that fundamental principles cannot contribute to the patent-eligibility of a claim, and Mayo v. Prometheus relied on Neilson to support its requirement for unconventional application of new discoveries. Drawing on a complete account of the Neilson trial that has never been examined by legal scholars, this chapter shows that the true story of Neilson v. Harford is very different than the one told by the Supreme Court. The Court of Exchequer never treated fundamental principles as part of the prior art, nor did it require inventive application of new discoveries; Neilson’s patent was sustained largely because discovery required only well-known, routine, and conventional means for application. The central question in Neilson was to what extent Neilson’s invention – and by extension patents in general – were bound by shape and form. The Exchequer’s conclusion that Neilson’s patent transcended form was key to three of the Supreme Court’s foundational nineteenth century cases: Winans v. Denmead’s extension of infringement beyond the patentee’s embodiment; Tilghman v. Proctor’s separation of a process from its instrumentalities; and O’Reilly v. Morse’s delineation of the outer bounds of enablement. In particular, the Morse Court’s contrast between Neilson’s invention and Morse’s illustrates that Morse was based on conventional enablement reasoning, not on the unpatentability of scientific discoveries.

Athena Rising? Brief of Professors Jeffrey A. Lefstin and Peter S. Menell as <i>Amici Curiae</i> in Support of Petition for a Writ of Certiorari in <i>Athena Diagnostics v. Mayo Collaborative Services</i>

In Bilski v. Kappos (2010), this Court explained that its interpretation of 35 U.S.C. § 101 has been guided by over 150 years of historical practice. Yet two years later in Mayo Collaborative Services v. Prometheus Laboratories (2012), the Court triggered the most radical redefinition of patent-eligible subject matter in U.S. history by engrafting an inventive application requirement for patenting practical applications of scientific discoveries. Mayo based this requirement on three critical assumptions: (1) Congress has never addressed the question of the patentability of scientific discoveries; (2) foundational precedent of the English courts and of this Court excluded scientific discoveries and demanded inventive application as a condition of patent eligibility; and (3) a new extra-textual limitation on patentability was necessary to address the undue preemption of laws of nature and other scientific discoveries. Unfortunately, inadequate briefing in Mayo led the Court astray. The Nation’s patent statutes, stretching back to the founding era, unmistakably afford patent protection to technological innovations and scientific discoveries. Congress has expressly sought to encourage both technological inventions and scientific discoveries. The legislative concern has not been with preemption of inventive fields, which the durational limits and disclosure constraints of the Patent Act address, but rather with “min[ing]” the “exhaustless” “treasures” and “unlimited reach of science.” Specific legislative enactments in 1930, 1952, and 1954 refute any requirement of inventive application for patent eligibility. Furthermore, the Mayo briefs failed to address critical context and meaning of key cases bearing on patent eligibility of applications of scientific discoveries. Both Parker v. Flook (1978) and Mayo relied on a mistaken reading of Neilson v. Harford (1841) to conclude that English and American courts restricted patents to inventive applications of new discoveries. To the contrary, Neilson became the primary authority in England and the United States for the position that practical applications of discoveries were patentable without any invention in the means of application. Finally, contrary to Mayo’s supposition that a new extra-statutory doctrine was necessary to limit undue preemption of scientific discoveries, this Court has long held that this role was served by patent law’s express disclosure requirements. See O’Reilly v. Morse (1854) and subsequent cases. As reflected in the eight opinions in Athena Diagnostics, Inc. v. Mayo Collaborative Services, as well as clear signals in numerous other cases, the Patent Office’s frequent revision of examiner guidance documents, and legislative hearings, the Federal Circuit, district courts, Patent Office, and inventors have struggled unsuccessfully to apply the Mayo/Alice decisions coherently and predictably. These decisions have imposed massive costs upon all of these institutions and the public, thereby undermining the patent system. This case provides an ideal vehicle for the Supreme Court to revisit the standards for patent eligibility on the basis of thorough briefing of the proper statutory and jurisprudential considerations.

Strategic Partnerships and Open Innovation in the Biotechnology Industry in Belgium

IntroductionThe application of new discoveries and advances in science towards commercial use and for public purposes depends mainly upon actions by entrepreneurs who create new technology-based firms. However, in some industries, such as healthcare and biotechnology, the high cost of commercialization makes it unlikely that any new, small firm can succeed on its own. To

Strategic Partnerships and Open Innovation in the Biotechnology Industry in Belgium

IntroductionThe application of new discoveries and advances in science towards commercial use and for public purposes depends mainly upon actions by entrepreneurs who create new technology-based firms. However, in some industries, such as healthcare and biotechnology, the high cost of commercialization makes it unlikely that any new, small firm can succeed on its own. To

New IJH guidelines highlight greater transparency

Biomedical research has grown to become a truly international enterprise in which scientific advances are increasingly linked to financial, legal, social, and ethical issues of deep import. They have an impact not only on the conduct of experiments in laboratories or trials in clinical settings but importantly on the manner in which the results of such research are communicated as well. Such communications are a fundamental responsibility of all scientists, serving to push back the frontiers of human knowledge, promote better understanding and application of new discoveries, and accelerate discussion among peers and the general public. Indeed, it is no exaggeration to say that the dissemination of findings is fundamental to the success and sustainability of the scientific enterprise. At the International Journal of Hematology, we take the responsibilities associated with our role as stewards over the reporting of hematological research very seriously. It has always been the policy of the journal to coordinate the review of submitted manuscripts in a timely, fair, and constructive manner and to support authors in their efforts to gain the widest possible audience for their work. As part of this commitment, the editors have developed a set of guidelines to assist them in the process of creating manuscripts with an emphasis on quality, clarity, accessibility, and impact. We now feel, however, that it is time to revise these guidelines to bring them up to date with emerging global standards for the ethical publication of biomedical results and to make explicit a number of expectations that were tacit in the previous versions of the IJH ‘‘Information for Authors’’. These changes are in general conformity with the recommendations set forth in the Uniform Requirements for Manuscripts (URM) formulated by the International Council of Medical Journal Editors (ICMJE), which were developed ‘‘to help authors and editors in their mutual task of creating and distributing accurate, clear, and easily accessible reports of biomedical studies’’, and are available from the ICMJE website (http://www.icmje.org). Our newly revised ‘‘Information for Authors’’ document can be downloaded from the journal website at http://www. springer.com/medicine/internal/journal/12185. The main additions to the ‘‘Information for Authors’’ can be found in the expanded Editorial Policies section, which now outlines expectations for specific areas, such as the conduct of animal studies, authorship, reporting of potential conflicts of interest, and research on human subjects. These changes to our authors’ guide are by no means radical departures from the high ethical standards we believe are maintained in the great majority of laboratories and clinical research programs. We have made them explicit, however, in line with the growing international expectations for greater transparency, accountability, and disclosure on the part of scientific researchers. The new requirements for the disclosure of author affiliations or activities that could conceivably lead to conflicts of interest serve as a case in point. It is no longer safe to rely on the assumption that financial or other relationships on the part of authors will go unquestioned when scientific results are challenged. We have therefore followed the ICMJE in requiring that all authors accompany research submissions with a simple statement, in the form of a checklist, that describe any financial or personal relationships that might be perceived as potentially biasing the reporting of their findings. This is not to say that bias inevitably results from such relationships, only that their disclosure is an essential component in ensuring transparency and impartiality. The definition of authorship is a second area in which the new guidelines are more explicit. We require that all authors on an article’s byline ‘‘have made substantive

Abstract ES3-2: Challenges to Clinical Application of New Discoveries in the Genetics of Breast Cancer Predisposition

Abstract In the United States, testing for mutations in BRCA1 and BRCA2 has become a routine part of the management of individuals at risk for hereditary breast and ovarian cancer. Most providers accept the clinical utility of such testing. This acceptance rests upon a consensus that clinical management of mutation carriers should differ from that of non-carriers. The factors that justify differential management are: 1) the strength of the predisposition, 2) the strong association between mutation and risk in an individual, which allows presymptomatic testing, 3) the risks for component tumors that may not be evident from the family history, and 4) the availability of interventions that are perceived to be effective, even if the evidence base demonstrating such effectiveness is less than robust. Evolving evidence that affected mutation carriers may benefit from specific local or systemic treatment approaches further increases acceptance. Only a small number of breast cancer patients carry BRCA1 and BRCA2 mutations. A few more women carry other high penetrance alleles, but the clinical utility of testing for some of these (e.g. TP53) is less clear than for BRCA1/2, which illustrates that the strength of a predisposition is not the only determinant of clinical utility. High penetrance alleles only account for a small fraction of the hereditable risk of breast cancer. Several groups have described a number of rare variants of lesser risk (RR approximately 2), such as ATM, CHEK2, BRIP1, and PALB2). Large genome-wide association studies have identified additional common variants with even lower relative risks. The identification of these rare and common risk variants may provide important insights into breast cancer biology, but the clinical utility of testing is limited at the present time. We will discuss possible approaches to incorporating information about these risk variants into clinical practice. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr ES3-2.

Clinical and Translational Science: From Bench‐Bedside to Global Village

Clinical and Translational Science: From Bench‐Bedside to Global Village

Emerging drugs for the treatment of ulcerative colitis

Background: Ulcerative colitis (UC) is a chronic, relapsing inflammatory disorder of the colon for which the etiology is currently unknown. At present, strategies to treat UC are primarily targeted to control inflammation during active phases of disease as well as maintain remission during quiescence. As such, several unmet needs in the treatment of UC still remain. In recent years, basic research has led to the recognition of several key factors in the pathogenesis of UC, translating into the development of several novel therapeutic agents. Objective: The aim of this study is to review emerging therapies that may advance the treatment and improve the overall care of UC patients. Methods: An extensive literature search on published manuscripts and meeting proceedings has been performed to provide a comprehensive review of future drug therapies to treat UC. Results/conclusion: The translational application of new discoveries in the basic understanding of UC pathogenesis is continuing and critical for the development of novel treatment strategies. Design of novel biologic therapies to treat UC has the challenge of addressing potential safety issues, while more traditional drugs should be further developed to facilitate patient compliance to treat this chronic, debilitating disease.

Interview.

A new two-volume reference set edited by the Duke Institute for Genome Sciences & Policy (IGSP) Director Huntington Willard and Director of the IGSP's Center for Genomic Medicine Geoff Ginsburg covers the scientific foundations and practical applications of new discoveries in genomic medicine, as well as the ethical, legal/regulatory and social issues related to its practice. The books, entitled Genomic and Personalized Medicine, include chapters by many of the world's leading experts in the field, including several from Duke. Ginsburg spoke to Personalized Medicine about this more than 1500 page work that he calls the first definitive and comprehensive text on genomic and personalized medicine and what he hopes it will do for this rapidly emerging field.

The role of patents in establishing global telecommunications

In the 21st century we have access to virtually instantaneous communications: for instance, our interaction with the Internet has given us unlimited opportunities unknown to our forefathers. It all began with telegraphy, an innovative application of new discoveries in electricity and electromagnetism in the early 19th century. From around 1840 electrical communication systems became highly commercialised and eventually very profitable, attracting entrepreneurs and inventors such as Wheatstone, Thomson, Bell, Edison and Marconi who, between them, revolutionised communication systems in the late 19th century and led to global telecommunications by the early 20th century. This paper explores the role of patents in driving this telecommunications revolution.

Cellular Automata Music: An Interdisciplinary Project

Abstract Researchers from many branches of scientific knowledge have been attracted by the organizational principles found in music. Also music has been an interesting domain for the application of new discoveries in science, inviting people to combine artistic creativity with scientific methods. A new environment has emerged in the domain of musical composition; what is now called computer music. This project is an attempt to identify correlations among different disciplines such as biology, crystallography, computing and fluid mechanics in order to investigate the possibility of composing music inspired by a framework of interdisciplinary knowledge. We have selected cellular automata to play the central role on our research due to the fact that they have been used to model a wide range of scientific phenomena, such as chemical reactions, dynamic systems, chaotic systems, genetics, crystal growth, and so forth. This paper describes a prototype implementation of an experimental system for cellular automat...