Patent Eligibility Research Articles

Limitations on Patenting Inventions Based on Marine Genetic Resources of Areas beyond National Jurisdiction

This article discusses limitations on patenting inventions based on marine genetic resources of areas beyond national jurisdiction. First, it considers that patent protection for these inventions is compatible with losc. Next, it propounds that to further equitable access to new knowledge of the genetic resources, patentability requirements should be shaped to reward human creativity in applying discoveries only. Accordingly, discoveries of naturally occurring dna sequences and the like from the genetic resources should be deemed as a “familiar part of prior art” and that other inventive concepts should be required to meet the patent eligibility requirement. Finally, it contends that it is not justified to require patentees to share any benefits derived from the utilization of inventions based on the genetic resources of the Area.

Implications of the America Invents Act for R&D Managers: Connecting the Patent Life Cycle with the Technology Development Process

OVERVIEW:Protecting intellectual property is crucial for R&D managers. The Leahy-Smith America Invents Act (AIA), which overhauled the US patent system in order to reduce litigation and bring US patent practices into line with international systems, offers new opportunities and challenges in this arena. AIA focuses on improving efficiency, increasing transparency, and harmonizing with other national patent regimes. In pursuit of these aims, the law introduced several key changes: eliminating the requirement for “best mode” disclosure, expanding the definition of prior art, moving from first-to-invent to first-to-file as the key criteria for patent eligibility, and adding post-grant review, among others. Using two familiar frameworks, the patent life cycle and the Stage-Gate model for new product development, the paper explores how AIA impacts R&D managers' considerations around intellectual property. The law comes with added risks for R&D managers, who now must evaluate the commercial potential of innovation much earlier (with a larger set of stakeholders), while maintaining more secrecy than was required under the old regime. The demands of AIA require that R&D managers become more important members of the enterprise's strategic team.

Caught Between a Rock and a Hard Place: How Limelight Compounds the Challenges Facing Biotechnology Innovators After Mayo and Myriad

The Supreme Court’s decision in Limelight Networks v. Akamai Technologies limiting the ability of patentees to establish liability in cases of divided infringement effectively undermines the value of method claims. The combined impact of Limelight and the Court’s previous patent eligibility decisions in Mayo and Myriad will be particularly felt in the area of personalized medicine and diagnostics, but could also threaten a broad swath of other important innovations in biotechnology and pharmaceuticals. Some of the potentially dire consequences of Limelight for some patentees, particularly in the biotechnology and pharma sectors, are reviewed in this article. But there could be a light at the end of the tunnel. While Limelight appears to have shut the door to using 35 USC 271(b) to hold a divided infringer liable under a theory of inducement, the Supreme Court explicitly pointed out that its decision did not necessarily preclude the Federal Circuit from revisiting its decision in Muniauction and to reinterpret 271(a) in a manner that would allow a patent owner to hold at least certain parties liable for active participation in a concerted act of divided infringement. Limelight appears to have closed the door with respect to liability for divided infringement under 271(b), but it seems safe to assume that in the future litigants will urge the Federal Circuit to expand 271(a) in a manner that would hold at least some divided infringer’s liable.

The Patent Eligibility of Personalized Medicine Technologies

First Prize Orr Postdoctoral Student Writing Competition 2014Personalized medicine holds great promise for improving the diagnosis, treatment, and management of cancer. Personalized cancer therapie...

A patent perspective on US stem cell research.

What are the implications of recent US Supreme Court decisions on the patent eligibility of stem cells?

How to protect the intellectual property of I-O and consulting psychology interventions and gain a competitive advantage: Secrecy, copyright, and patent eligibility through empirical components.

How to protect the intellectual property of I-O and consulting psychology interventions and gain a competitive advantage: Secrecy, copyright, and patent eligibility through empirical components.

The United States Patent & Trademark Office's Current View on Patent Eligibility

The United States Patent & Trademark Office's Current View on Patent Eligibility

Subjecting Software Subject-Matter to Limitations that Matter

This paper addresses the patent eligibility of software inventions by providing a historical journey through the various software Court cases and proposing a novel construct as a method for analyzing and determining patentability of software inventions. Briefly, this construct relates to mapping the hardware resources, e.g. CPU, RAM, memory, power supply, etc. that mirror the actual execution of the software program as a way of satisfying various requirements that caselaw has struggled with over the years for software inventions.

In AMP v. Myriad, the Supreme Court Provides an Analytical Framework for Patent Eligibility of Product Claims That Is Different from That for Method Claims

Biotechnology Law ReportVol. 33, No. 2 Symposium on MyriadIn AMP v. Myriad, the Supreme Court Provides an Analytical Framework for Patent Eligibility of Product Claims That Is Different from That for Method ClaimsDebora Plehn-Dujowich and Roy P. IssacDebora Plehn-DujowichSearch for more papers by this author and Roy P. IssacSearch for more papers by this authorPublished Online:16 Apr 2014https://doi.org/10.1089/blr.2014.9987AboutSectionsView articleView Full TextPDF/EPUB ToolsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetails Volume 33Issue 2Apr 2014 InformationCopyright 2014, Mary Ann Liebert, Inc.To cite this article:Debora Plehn-Dujowich and Roy P. Issac.In AMP v. Myriad, the Supreme Court Provides an Analytical Framework for Patent Eligibility of Product Claims That Is Different from That for Method Claims.Biotechnology Law Report.Apr 2014.81-89.http://doi.org/10.1089/blr.2014.9987Published in Volume: 33 Issue 2: April 16, 2014PDF download

District Court's Interpretation of Mayo in Ariosa Diagnostics Does Not Bode Well for Patent Eligibility of Diagnostics and Personalized Medicine

Biotechnology Law ReportVol. 33, No. 2 The Holman ReportDistrict Court's Interpretation of Mayo in Ariosa Diagnostics Does Not Bode Well for Patent Eligibility of Diagnostics and Personalized MedicineChristopher M. HolmanChristopher M. HolmanSearch for more papers by this authorPublished Online:16 Apr 2014https://doi.org/10.1089/blr.2014.9990AboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetailsCited bySocial Work and Genetics2 August 2019Congress Considering Legislation Intended to Reverse the Recent Trend Toward Devaluation of the U.S. Patent Right Christopher M. Holman9 October 2018 | Biotechnology Law Report, Vol. 37, No. 5Mayo Update: Some Reason for Guarded Optimism Christopher M. Holman1 October 2016 | Biotechnology Law Report, Vol. 35, No. 5Do Biotech Patent Lawsuits Really “Overwhelmingly Lose?”: A Response to Our Divided Patent System Christopher M. Holman21 April 2015 | Biotechnology Law Report, Vol. 34, No. 2Caught Between a Rock and a Hard Place: How Limelight Compounds the Challenges Facing Biotechnology Innovators After Mayo and Myriad Christopher M. Holman14 August 2014 | Biotechnology Law Report, Vol. 33, No. 4 Volume 33Issue 2Apr 2014 InformationCopyright 2014, Mary Ann Liebert, Inc.To cite this article:Christopher M. Holman.District Court's Interpretation of Mayo in Ariosa Diagnostics Does Not Bode Well for Patent Eligibility of Diagnostics and Personalized Medicine.Biotechnology Law Report.Apr 2014.46-48.http://doi.org/10.1089/blr.2014.9990Published in Volume: 33 Issue 2: April 16, 2014PDF download

US Patent Office issues guidelines on natural product patent eligibility

US Patent Office issues guidelines on natural product patent eligibility

Rethinking Patent Eligibility for the Modern Scientific Age

As reflected in the Federal Circuit’s fractured opinion in CLS Bank v. Alice Corp., there is no greater confusion in contemporary patent law than that surrounding the scope of patent eligibility limitations. This Supreme Court amicus brief in that case traces the roots of the court-made doctrines excluding patents on laws of nature, physical phenomena, and abstract ideas. It argues that a test of inventive application neither serves the underlying purposes of the patent system nor comports with the process of modern technological advance. As a result of advances in scientific understanding and methods over the past 150 years, many if not most inventions today explicate, manipulate, and control physical, chemical, biological, and digital phenomena at elemental, molecular, algorithmic, and systemic levels. Doctrines that treat conventional application of even newly discovered computer algorithms, molecular pathways, and chemical synthesis as unpatentable threaten to exclude much of the inventive thrust of modern research. Mayo’s requirement for unconventional application shifts scientists’ efforts from the valuable scientific and technological advances that society seeks toward surmounting an amorphous test of non-obvious implementation. Specific and practical application, in conjunction with the technological arts limitation explicated in Justice Stevens’s concurrence in Bilski, would better serve as the test for patent eligibility in the modern scientific and technological age.Particularly in light of past experience, setting inventive application as the test for patent eligibility threatens to undermine invention incentives, hamper patent prosecution, and greatly complicate patent litigation. While recognizing that the problems posed by patents on software and other computer-implemented inventions are real, this brief contends that patent eligibility doctrines beyond requiring specific application and categorical exclusion of business methods and other non-technological processes are poorly suited to address those concerns. It therefore concludes that the Supreme Court should turn away from the Funk Brothers/Flook/Mayo paradigm, and instead focus on elucidating the statutory requirements of patentability. By clarifying the constitutional and jurisprudential foundation for subject matter exclusions, the Court can promote legislative and administrative solutions that more directly address the evolving needs of the patent system.

A New Theory for Patent Subject Matter Eligibility: A Veblenian Perspective

A new theory for patent subject matter eligibility is presented that attempts to unify and clarify Supreme Court precedent surrounding the preemption doctrine and a long-standing insistence on an inventive contribution or quid pro quo to justify any patent grant. An economic approach is adopted, taking influence from Thorstein Veblen's industrial/pecuniary dichotomy. It is suggested that the alleged solution to an underlying (technical) problem should be assessed, and only claims that recite a productive, technical solution should be deemed to satisfy patent eligibility requirements in the United States. Such an approach would decrease reliance on the machine-or-transformation test and would allow courts and the Patent Office to limit patentability to contributions to the common stock of technical proficiency that deal with productive wealth creation, while at the same time excluding from patent eligibility pecuniary activities that relate only to unproductive wealth extraction.

Inventive Application: A History

The Supreme Court’s recent cases on patent-eligible subject matter have struggled to draw the line between unpatentable fundamental principles, such as laws of nature and abstract ideas, and patentable inventions. In Mayo v. Prometheus, the Court suggested that only “inventive applications” of fundamental principles fell within the domain of the patent system. Both Mayo and its intellectual forebear, Parker v. Flook, anchored this doctrine in Neilson v. Harford, the famous “hot blast” case decided by the Court of Exchequer in 1841.But the Supreme Court has founded the inventive application doctrine on a basic misapprehension. Neilson’s patent on the hot blast was sustained not because his application was inventive, but because it was entirely conventional and obvious. In both England and the United States, the hot blast cases taught that inventors could patent any practical application of a new discovery, regardless of the application’s novelty or inventiveness. And for over one hundred years, American authority consistently maintained that practical application distinguished unpatentable discovery from patentable invention.The inventive application test in fact originated in 1948, in Funk Brothers v. Kalo Inoculant, which departed radically from the established standard of patent eligibility. In the wake of Funk Brothers, the lower courts struck down a series of patents unquestionably within the technological arts — arguably the precise innovations the patent system sought to promote. This history is largely forgotten today, but it should serve as a cautionary tale of the patents that could be invalidated if the Court maintains inventive application as the test for patent eligibility.

Novartis v Union of India and the Person Skilled in the Art: A Missed Opportunity

The Indian Supreme Court’s decision in Novartis v Union of India (UOI), decided earlier this year, formalizes a concerted and focused attempt by Indian law-makers to reject trivial secondary pharmaceutical inventions. The SC concluded that S 3(d) of the Indian Patents Act made new forms of known substances ineligible for patents in the absence of ‘enhanced efficacy’, which in this case was defined as ‘therapeutic efficacy’. This paper argues that the SC wrongly ignored the context of S 3 and Chapter II of the Act, which is a medley of exclusions, exceptions and ineligible subject matter each of which can be differentiated by the need to involve the person skilled in the art standard. In this case a greater appreciation of the flexibility afforded by this notional standard as part of a broader non-obviousness enquiry would have led the SC to a more conventional legal option. Instead the SC’s adoption of the patent eligibility route has paradoxically left it much less room to manoeuver the law around secondary pharmaceutical inventions.

Debugging Software's Schemas

In computer terminology, a schema is a model to describe structures for containing and processing data. A flawed schema in the computer world is a bug; the result may be unexpected behavior or even system shutdown. In cognitive theory, a schema is a structure or framework that helps organize and interpret information. Incorrect schema in this realm can lead to flawed decision making or understanding. These two worlds – computer science and cognitive science – have collided at the intersection of eligibility for patent protection of software and computer-related inventions; unfortunately, the resulting system is in dire need of debugging. The frameworks that are currently influencing decision making about software patents include the analysis that software patents are generally bad (the bad patent schema) and that software patent holders are problematic (the troll schema). These schemas have been created and maintained through various cognitive biases, resulting in flaws that are negatively impacting the conversation about patent eligibility for software and computer-related inventions. With awareness of these biases, it is possible to minimize the negative impact. But even if we are able to eliminate the biases, there exists an even bigger bug in the system: the framework underlying the discussions about software patents is incorrect. Although the primary question affecting the patent eligibility of these inventions is whether they are abstract ideas, the framework has very little, if anything, to do with that question. With an incorrect structure driving the discussion, reaching a correct result is unlikely.

Novartis v Union of India and the person skilled in the art: a missed opportunity

The Indian Supreme Court’s (SC) decision in Novartis v Union of India (UOI), decided earlier this year, formalizes a concerted and focused attempt by Indian law-makers to reject trivial secondary pharmaceutical inventions. The SC concluded that S 3(d) of the Indian Patents Act made new forms of known substances ineligible for patents in the absence of ‘enhanced efficacy’, which in this case was defined as ‘therapeutic efficacy’. This paper argues that the SC wrongly ignored the context of S 3 and Chapter II of the Act, which is a medley of exclusions, exceptions and ineligible subject matter, each of which can be differentiated by the need to involve the person skilled in the art standard. In this case a greater appreciation of the flexibility afforded by this notional standard as part of a broader non-obviousness enquiry would have led the SC to a more conventional and legitimate legal option. Instead the SC’s adoption of the patent eligibility route has paradoxically left it much less room to manoeuver the law around secondary pharmaceutical inventions.

Brief of Amici Curiae: The Application Developers Alliance, Wild Tangent, Inc. v. Ultramercial, LLC, et al, No. 13-255 (S. Ct. 2013)

Brief amicus curiae urging the Supreme Court to grant certiorari, arguing that the Federal Circuit Court of Appeals has worsened critical flaws in the patent system that deeply affect amicus, an association of mobile application developers. Unlike other innovators, app developers work exclusively with software, and most are small businesses with little capital. As overly broad software patents have proliferated in recent years, non-practicing patent assertion entities have launched a wave of litigation and intimidation that has made it extremely difficult for many app developers to operate. The Federal Circuit’s decision in this case exacerbates these problems by adding to its deep internal divisions over the proper threshold for patent eligibility. Furthermore, by announcing an overly permissive standard for eligibility, the Federal Circuit has immeasurably worsened the patent litigation crisis for app developers and small innovators everywhere.

Patenting medical procedures - a comprehensive review

‘A book may be good for nothing; or there may be only one thing in it worth knowing; are we to read it all through?’ (Samuel Johnson) This section is dedicated to the review of ideas, articles, books, films and other media. It will include replies (and rejoinders) to articles, the evaluation of new ideas or proposals, and reviews of books and articles both directly and indirectly related to intellectual property law. After receiving my copy of Patenting Medical and Genetic Diagnostic Methods, which explores the scope of patent protection for methods of medical treatment and genetic diagnostic methods in the United States under 35 USC 101, I was fascinated by the prospect of reviewing a maiden effort in an area which is complex, critical and interesting for a reviewer who is a lawyer, a pharmacist and a business person. The resurgence of the issue of patenting methods of medical treatments, in particular diagnostic methods, and the issue of patent eligibility of process claims involving laws of nature after the recent Prometheus decision, make the timing of the book perfect.

Feeling Funk-y: Human Gene Patents in AMP v. Myriad

In a stunning reversal of the long-standing practice of the U.S. Patent & Trademark Office permitting the patenting of human DNA, the Supreme Court unanimously held on June 13, 2013, in Association for Molecular Pathology v. Myriad Genetics, Inc., that an isolated segment of human DNA, such as a gene, is not eligible for patent protection under 35 USC x101. The decision suggests that more human intervention beyond mere cleaving of this naturally occurring molecule from its natural environment is required. The Court did not prevent patent protection on all genetic materials, however, as it also held that a type of nonnaturally occurring molecule known as complementary DNA was patent eligible. The Court’s analysis of these DNA-based claims was guided by two precedents, Funk Brothers Seed Co. v. Kalo Inoculant Co. and Diamond v. Chakrabarty, which addressed the patent eligibility of biological organisms. In this article, we examine these two precedents, how the Supreme Court applied them in its decision in Myriad, and some potential implications of the Myriad decision.