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Full-Text Articles in Law
Recent Pto Guidance Charts A New Course Through The Patent Eligibility Quagmire, Christopher M. Holman
Recent Pto Guidance Charts A New Course Through The Patent Eligibility Quagmire, Christopher M. Holman
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In a span of four years, 2010-2014, the U.S. Supreme Court issued four decisions that have dramatically altered patent eligibility jurisprudence: Bilski, Mayo, Myriad, and Alice. Ever since Bilski was decided, the PTO has struggled to apply the new patent eligibility jurisprudence in a consistent and predictable manner. The two part framework for assessing patent eligibility, as set for in Alice and Mayo, is stated at a high level of abstraction, and the Supreme Court has given little concrete guidance as to how it is to be applied beyond the specific claims at issue in its precedent. At times, the …
Vanda V. West-Ward Pharmaceuticals: Good News For The Patent Eligibility Of Diagnostics And Personalized Medicine, With Some Important Caveats, Christopher M. Holman
Vanda V. West-Ward Pharmaceuticals: Good News For The Patent Eligibility Of Diagnostics And Personalized Medicine, With Some Important Caveats, Christopher M. Holman
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In Mayo v. Prometheus, decided in 2011, the U.S. Supreme Court invalidated patent claims directed towards diagnostic methods useful in the optimization of drug dosage for the needs of an individual patient, i.e., an example of personalized medicine, based on the Court’s determination that the claims were directed towards a patent ineligible law of nature. Notably, the claims in Mayo did not recite a step of applying the information generated by the test, e.g., a step of administering the drug to a patient at the optimized dosage. Some, including this author, have speculated that inclusion of such a step might …
Praxair V. Mallinckrodt: An Expanded Interpretation Of The Printed Matter Doctrine With Important Implications For Biotechnology, Christopher M. Holman
Praxair V. Mallinckrodt: An Expanded Interpretation Of The Printed Matter Doctrine With Important Implications For Biotechnology, Christopher M. Holman
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Although the “printed matter doctrine” has a long history in U.S. patent law, until recently it has played a relatively minor role in policing patent-ability, so much so that an article published in 1994 essentially wrote it off as nothing more than an “archaic common law has-been.” Although the doctrine is rooted in the concept of patent eligibility, it is never mentioned in recent patent eligibility decisions of the U.S. Supreme Court such as Mayo and Alice, and patent law treatises and casebooks tend to give the doctrine little if any coverage. At its core, the printed matter doctrine has …
The Mayo Framework Is Bad For Your Health, Christopher M. Holman
The Mayo Framework Is Bad For Your Health, Christopher M. Holman
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This Article begins by providing a brief historical retrospective of the development of the patent eligibility doctrine, and then delves into the related questions of: (1) what are the Supreme Court’s policy objectives for the recent reinvigoration of the patent eligibility doctrine; and (2) has it achieved those objectives? The article then discusses three important out-standing questions regarding the application of the new test for patent eligibility: (1) what constitutes a natural phenomenon; (2) what constitutes an inventive step; and (3) what, if any, role does preemption play in the analysis? The article then provides four examples of recent lower …
Mayo, Myriad, And The Future Of Innovation In Molecular Diagnostics And Personalized Medicine, Christopher M. Holman
Mayo, Myriad, And The Future Of Innovation In Molecular Diagnostics And Personalized Medicine, Christopher M. Holman
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Contrary to popular perception, the Supreme Court’s recent decision in Association for Molecular Pathology v. Myriad Genetics, Inc., finding certain patent claims reciting isolated genomic DNA molecules patent ineligible is likely to have a relatively minor impact on the patenting of diagnostics and personalized medicine. Method claims generally play a much more important role than isolated DNA claims in the patenting of innovations in this important technological sector, and the Court’s earlier decision in Mayo v. Prometheus Labs that held claims directed towards non-genetic methods of personalized medicine to be patent ineligible will likely prove significantly more problematic in this …
Bilski: Assessing The Impact Of A Newly Invigorated Patent Eligibility Doctrine On The Pharmaceutical Industry And The Future Of Personalized Medicine, Christopher M. Holman
Bilski: Assessing The Impact Of A Newly Invigorated Patent Eligibility Doctrine On The Pharmaceutical Industry And The Future Of Personalized Medicine, Christopher M. Holman
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The patent eligibility doctrine serves a gatekeeper role in excluding from patent protection natural phenomena, principles of nature, abstract ideas, and mental processes. Beginning around 1980, the U.S. patent system embarked upon a pronounced expansion in its definition of patent eligible subject matter, particularly with respect to software and business method inventions, but also in the life sciences. In recent years, however, we have seen a backlash, with many critics from the public and private sectors arguing that the threshold for patent eligibility needs to be raised in order to ensure that patents fulfill their constitutional objective of encouraging innovation …
The Role Of Patent Eligibility In Policing Claim Scope, Christopher M. Holman
The Role Of Patent Eligibility In Policing Claim Scope, Christopher M. Holman
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Bilski v. Kappos (Bilski II) empowered the lower courts to deploy patent eligibility as a doctrinal tool for policing claim scope. Because Bilski II leaves the test for patent eligibility largely undefined, the lower courts and PTO, in particular the Federal Circuit, could actively invoke the doctrine as a “wildcard” to invalidate patent claims deemed unduly broad, or otherwise “unworthy” by the court. Judge Rader made a similar observation recently with respect to the Lilly written description requirement, another doctrine of patentability for which the criteria for compliance remains largely undefined. However, early indications suggest that the Federal Circuit and …