Patentable Subject Matter Research Articles

Código Ingenios y el sistema de patentes: ¿una propuesta innovadora o la receta hacia un estancamiento tecnológico?

El Código Orgánico de Economía Social del Conocimiento e Innovación (Código Ingenios) es un nuevo proyecto que se discute en la Asamblea ecuatoriana que tiene como fin democratizar el conocimiento, concibiendo a éste como un bien de interés público. El Código Ingenios en los elementos de fondo del sistema de propiedad intelectual -inclusive los derechos de patentes- es consistente con lo establecido por el Acuerdo sobre los aspectos de los Derechos de Propiedad Intelectual relacionados con el Comercio (ADPIC). No obstante, introduce cambios sustantivos en lo referente al material patentable, las exclusiones de patentabilidad y las excepciones de patentabilidad. Estas modificaciones no solo pueden ser consideradas contrarias al ADPIC, sino que podrían ir en contra de la innovación, generando un estancamiento tecnológico en el país y disuadiendo las inversiones en investigación y desarrollo.

Pharmaceutical patent protection: the United States and Japan in comparative perspective.

Pharmaceutical Patent AnalystVol. 6, No. 1 Special ReportPharmaceutical patent protection: the United States and Japan in comparative perspectiveShinya Kimura & Carlyn A BurtonShinya Kimura*Author for correspondence: E-mail Address: kimura@oshaliang.com Osha Liang Consulting K.K., Level 28, Shinagawa Intercity Tower A, 2-15-1 Konan, Minato-ku, Tokyo, JapanSearch for more papers by this author & Carlyn A Burton Osha Liang LLP, Two Houston Center, 909 Fannin, Suite 3500, Houston, TX, USASearch for more papers by this authorPublished Online:3 Feb 2017https://doi.org/10.4155/ppa-2016-0039AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit View articleKeywords: intellectual propertypharmaceutical patentthe USA and JapanReferences1 Pallin v. Singer, 36 USPQ 2d 1050 (D. Vt. 1995).Google Scholar2 35 U.S.C. § 287(c)(2)(C).Google Scholar3 35 U.S.C. § 271 (b) and (c).Google Scholar4 Examination Guidelines for Patent and Utility Model in Japan, Part III, Chapter 1 Eligibility for Patent and Industrial Applicability (Main Paragraph of Article 29(1) of the Patent Act).Google Scholar5 Tokyo High Court, Hei 12 (Gyoke) No. 65 (2002).Google Scholar6 M.P.E.P. § 2111.02.Google Scholar7 Examination Guidelines for Patent and Utility Model in Japan, Part III Chapter 2 Section 4 Claims Including Specific Expressions.Google Scholar8 Examination Handbook for Patent and Utility Model in Japan, Annex B, Chapter 3 Medicinal Inventions.Google Scholar9 Tokyo District Court, Hei 2 (Wa) No. 12094 (1992).Google Scholar10 Tokyo High Court, Hei 10 (Gyoke) No. 308 (2000).Google Scholar11 Tokyo High Court, Hei 10 (Gyoke) No. 401 (2001).Google Scholar12 In re Thorpe, 777 F.2d 695 (Fed. Cir. 1985).Google Scholar13 M.P.E.P. § 2113.Google Scholar14 Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340 (Fed. Cir. 2009).Google Scholar15 Supreme Court of Japan, Hei 24 (Ju) No. 1204 (2015).Google Scholar16 Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __ (2013).Google Scholar17 Mayo Collaborative Serv. v. Prometheus Labs., Inc., 566 U.S. __ (2012).Google Scholar18 Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. __ (2014).Google Scholar19 2014 Interim Guidance on Patent Subject Matter Eligibility.Google Scholar20 M.P.E.P. § 2111.Google Scholar21 Examination Handbook for Patent and Utility Model in Japan, Annex B, Chapter 2 Biological Inventions.Google Scholar22 Altman D, Sweeney C, Yasui T. Preparing effective experimental data for pharmaceutical patent applications from US and Japanese perspectives. Pharm. Pat. Anal. 3(5), 469–473 (2014).Link, CAS, Google Scholar23 M.P.E.P. § 2164.03.Google Scholar24 United States v. Telectronics, Inc., 857 F.2d 778 (Fed. Cir. 1988).Google Scholar25 Allergan, Inc., v. Sandoz Inc., 796 F.3d 1293 (Fed. Cir. 2015).Google Scholar26 M.P.E.P. § 2163.Google Scholar27 Falkner v. Inglis, 448 F.3d 1357 (Fed. Cir. 2006).Google Scholar28 Examination Guidelines for Patent and Utility Model in Japan, Part III Chapter 2 Section 2 Inventive Step.Google Scholar29 Tokyo High Court, Hei 8 (Gyoke) No. 201 (1998).Google Scholar30 Tokyo High Court, Hei 15 (Gyoke) No. 104 (2003).Google Scholar31 Intellectual Property High Court, Hei 17 (Gyoke) No. 10042 (2005).Google Scholar32 35 U.S.C. § 287(c)(2)(A).Google Scholar33 Intellectual Property High Court, Hei 17 (Ne) No. 10125 (2006).Google ScholarFiguresReferencesRelatedDetailsCited ByBiological deposits for patenting purposes under the Budapest TreatyMicrobiology Australia, Vol. 40, No. 3 Vol. 6, No. 1 Follow us on social media for the latest updates Metrics Downloaded 77 times History Published online 3 February 2017 Published in print January 2017 Information© Future Science LtdKeywordsintellectual propertypharmaceutical patentthe USA and JapanFinancial & competing interests disclosureThe authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.No writing assistance was utilized in the production of this manuscript.PDF download

Patent Subject Matter Eligibility

We address a fundamental question: “What is patentable subject matter under the patent act?” The present confusion and rise in opportunistic patent litigation seen in the U.S. today is due to the three judicially created exceptions to the U.S. Patent Act’s broad patent-eligibility principles: ‘laws of nature, natural phenomena, and abstract ideas’ whose scope and validity are questionable. Here we examine the exceptions from the perspective of post-1900 understanding of physics, mathematics, algorithms, computations, life sciences, and information theory. We conclude that the exceptions are irrational and anachronistic. The judiciary’s lack of expertise in science, technology, engineering, and mathematics (STEM) has made the patent system unstable by continuing to err in holding that the laws of Nature are known to mankind and form “part of the storehouse of knowledge of all men” and “free to all men and reserved exclusively to none.” In fact, the real laws of Nature are unknown and likely to remain so forever; physicists “know” them only as conjectures open to refutation. We also point out deep existing connections between biotechnology and software and explain why both are patentable subject matter — they are two sides of the same coin. Our perspective leads us to suggest a definition for patentable subject matter and provide fundamental tests for patentability. Finally, for efficient working of the patent system, we suggest the creation of a statutory body, the Patent Validation Board, whose decisions on patent validity and extent of patent infringement will be final and binding on the courts. The courts should decide only non-STEM matters, e.g., damages.

O Estranho Caso da Patente Americana n. 9.430.468 de Double Blind Peer Review de 30 de Agosto de 2016

O Patent and Trademark Office dos Estados Unidos concedeu, em 30 de agosto de 2016, a Patente n. 9.430.468 para um programa de revisão cega por pares de artigos acadêmicos para uma empresa holandesa. A concessão da carta patente causa muita espécie no meio acadêmico porque se trata de uma ideia em abstrato que vem sendo utilizada por inúmeros programas de computador inclusive por alguns de software livre. O presente artigo analisa a referida patente, sob a ótica comparada do direito norte-americano, sob o marco teórico nietzschiano da justiça como troca para demonstrar que não se trata de matéria patenteável.

Whither gene patenting and the patenting of diagnostic methods post-Mayo and Myriad? The need for certainty in navigating the high seas of policy

ABSTRACTThis paper is prompted by a series of recent high-profile decisions emanating from the apex courts in the US and Australia – namely, Mayo and Myriad – on the patent eligibility of gene-based inventions. Adopting a comparative approach, this paper critically examines whether isolated gene sequences and diagnostic methods qualify as patentable subject matter in several leading jurisdictions, including the US, Australia, Europe and the UK. An attempt will also be made, after carefully considering various arguments on both sides of the policy debate, at predicting what the future might hold (or, perhaps more accurately, at suggesting what the future ought to be) for gene patenting and the patenting of diagnostic methods in the global biotechnology landscape.

Beyond abstraction: applying the brakes to runaway patent ineligibility.

Journal of Law and the Biosciences, 697–703 doi:10.1093/jlb/lsw055 Advance Access Publication 22 November 2016 Response Beyond abstraction: applying the brakes to runaway patent ineligibility Dan L. Burk School of Law, University of California-Irvine, 401 East Peltason Drive, Irvine, CA 92697, USA Corresponding author: E-mail: dburk@law.uci.edu INTRODUCTION I was pleased to read and am now pleased to respond to the commentaries by Minssen and Schwartz 1 and by Thambisetty 2 on my article Dolly and Alice. 3 Each of these com- mentaries offers a welcome comparative perspective to the doctrinal quandaries that I initially pointed out, indicating some prescription for the American patent eligibility problem based upon the parallel European experience. But it seems already clear that the American courts, responding to an avalanche of lower court patent invalidations based on the Alice patent eligibility test, have already begun fashioning their own idiosyncratic response to the common global difficulty of distinguishing patentable subject matter. A set of recent opinions makes clear the de- termination of the United States Court of Appeals for the Federal Circuit to apply the brakes to runaway abstraction analysis under the Alice test. In some respects this re- sponse may indeed parallel that in other jurisdictions, but in major respects it departs from the prescriptions detailed by the commentators. APPLYING THE BR AKES Recent subject matter opinions by the United States Supreme court have thrown patent eligibility into some disarray, so there is a natural tendency to hope that the Supreme Court might intervene to sort out the chaos in the lower courts. Minssen and Schwartz look particularly to the Federal Circuit’s opinion in Ariosa Diagnostics v Sequenom, Inc., 4 hoping that it might be taken up by the Supreme Court as an additional opportunity to Timo Minssen & Robert M. Schwartz, Separating Sheep from Goats: A European View on the Patent Eligibility of Biomedical Diagnostic Methods, 3 J. L. & B IOSCI . 365 (2016). Siva Thambisetty, Alice and ‘Something More’: The Drift Towards European Patent Jurisprudence, 3 J. L. & B IOSCI . Dan L. Burk, Dolly and Alice, 3 J. L. & B IOSCI . 606 (2015). 788 F.3d 1371 (Fed. Cir. 2015). C The Author 2016. Published by Oxford University Press on behalf of Duke University School of Law, Harvard Law School, Oxford University Press, and Stanford Law School. This is an Open Access arti- cle distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distri- bution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

Alice and 'something more': the drift towards European patent jurisprudence.

On the face of it the doctrinal lines of disagreement around subject matter eligibility in US law and the invention requirement, as it is known in Europe, could not be further apart. The US statute is silent as to what does not constitute patentable subject matter, while the European Patent Convention takes a much more formal approach. Unpatentable subject matter is listed, categorized either as things not to be regarded as inventions under Article 52(2) ; or as exceptions to patentability under a small number of umbrella contexts. Professor Burk’s incisive analysis of the two-pronged test of subject matter eligibility in Alice and its place within recent decisions by the SC is monitory in three particular aspects of direct relevance to the many decisions of the European Patent Office (EPO) on the ‘invention’ requirement. First, the use and development of a common denominator across excluded categories. Second, the seeping of patentability criteria into eligibility. Third, the nascent focus on the language of the claims which so far the US Supreme Court has declaimed. I will address each of these points in turn, comparing the direction of legal ideas around patent eligibility in both systems of law, before drawing conclusions.

D’Arcy v. Myriad Genetics: A Demand for the “Made” or “Non-Information” and Clear Subject Matter?

In October 2015, the High Court of Australia (HCA) handed down D’Arcy v. Myriad Genetics and overturned the Full Court of the Federal Court of Australia by holding that key product claims from Myriad Genetics’ BRCA1 gene patent did not constitute manners of manufacture. Two years earlier, the Supreme Court of the United States (SCOTUS) had similarly ruled against certain product claims from Myriad Genetics’ BRCA1 and BRCA2 patents, finding that simply isolated genetic sequences are not patentable subject matter. From their results, one could easily make the mistake of seeing the two decisions as being identical and placing Australia and the US at odds with Europe. However, as this article highlights, Australian law is conceptually different from US law and, strictly speaking, the HCA did not rule that isolated genetic sequences can never constitute patentable subject matter. However, at the end of the day, it is arguable that the laws are very similar in effect. This article examines the HCA decision and compares and contrasts it to that of SCOTUS.

Patenting Pharmaceuticals in China

The pharmaceutical industry is developing fast in China and the market is getting more mature in recent years, which draws the attention of multinational producers and investors. Patent protection is important for the commercialization of pharmaceuticals in China. This article will introduce the prosecution and enforcement of pharmaceuticals in China, in view of the amendments to the Chinese Patent Law, particularly the upcoming fourth amendments to the Patent Law. Particular issues in connection with the prosecution of pharmaceuticals will focus on patentable subject matter, sufficient disclosure, medical use claims. Further, specific issues in relation to patent term, patent linkage, regulatory exclusivity and Bolar exemption will also be highlighted. Current problems and perspectives of the authors will be addressed.

An examination of Article 27 of the TRIPS Agreement in relation to the provisions on patentable subject matter under the PDA in Nigeria

Article 27 of the TRIPS Agreement remains the most controversial provision of the TRIPS Agreement. This provision on patentable subject matter stipulates what is permissible under patent law. This article evaluates the Patent and Designs Act by considering the extent of compliance of the Act as provided by the TRIPS Agreement. To this end, the paper proceeds in four parts excluding the introduction. In the first section, it situates the discussion within the general framework of Patent and Designs Act. The next section, turns to an examination of the compliancy of the law. Finally, in the fourth and fifth sections, it analyses the modifications necessary against the backdrop of the examination carried out in the previous section. In the concluding section, a summary of the compliance of the law in relation to the TRIPS Agreement is provided.

I Think, Therefore I Invent: Creative Computers and the Future of Patent Law

An innovation revolution is on the horizon. Artificial intelligence has been generating inventive output for decades, and now the continued and exponential growth in computing power is poised to take creative machines from novelties to major drivers of economic growth. A creative singularity is foreseeable in which computers overtake human inventors as the primary source of new discoveries.In some cases, a computer’s output constitutes patentable subject matter, and the computer rather than a person meets the requirements for inventorship. Despite this, and despite the fact that the Patent Office has already granted patents for inventions by computers, the issue of computer inventorship has never been explicitly considered by the courts, Congress, or the Patent Office. Yet the issue of whether a computer can be an inventor is an eminently practical one — not only do inventors have ownership rights in a patent, but failure to list an inventor can result in a patent being held invalid or unenforceable.Drawing on dynamic principles of statutory interpretation and taking analogies from the copyright context, this article argues that creative computers should be considered inventors under the Patent and Copyright Clause of the Constitution. Treating nonhumans as inventors would incentivize the creation of intellectual property by encouraging the development of creative computers. The article proceeds to address a host of challenges that would result from computer inventorship, ranging from ownership of computer-based inventions, to displacement of human inventors, to the need for consumer protection policies.This analysis applies more broadly to nonhuman creators of intellectual property, and explains why the Copyright Office came to the wrong conclusion with its Human Authorship Requirement. Just as permitting computer inventorship will further promote the progress of science, so too will permitting animal authorship promote the useful arts by creating new incentives for people.Finally, computer inventorship provides insight into other areas of patent law. For instance, computers could replace the hypothetical skilled person that courts use to judge inventiveness. This would provide justification for raising the bar to patentability and would address one of the most serious criticisms of the patent system — that too many patents of questionable value are issued. Creative computers may require a rethinking of the baseline standard for inventiveness, and potentially of the entire patent system.

3d Printing and Patent Law: A Disruptive Technology Disrupting Patent Law?

Concerns have been raised that the upsurge of 3D printing technology would disrupt the patent system. The central question the present paper aims to address is whether and to what extent the emergence of 3D printing technology indeed urges us to rethink patent law. The paper splits up this question by looking at two facets in more depth – patentability and infringement – through the lens of pertinent European and US law. In order to provide a better understanding on the reach of patentability and infringement theory and practice and their possible interpretation in a 3D printing context, a set of different scenarios is established covering the perspectives from rights holders (inventors/producers) and users (hobbyists/consumers). The paper concludes that the wide uptake of 3D printing does not fundamentally challenge the premises of patent law. 3D printing does not upset patentability theory in general: it does not challenge prevailing concepts of patentable subject matter, nor current patentability requirements. However, digitized fabrication challenges the type/token dichotomy on which patent ontology is founded. 3D printing does not boulverse infringement theory either: it does not fundamentally alter the scope of rights, concepts or direct/indirect infringement assessment traditions. However, the emergence of 3D printing and the decentralization of production it entails, may lead to a wider and more dispersed scale of infringement, putting into question the adequacy of current enforcement tools and strategies. A lack of adequate enforcement tools might well undermine the innovation incentive rationale dominating current patent law.

Legal policy implication in industrial application terminology as second patentability requirement on biotechnological inventions

To establish the utility of biotechnology, a hybrid of basic science research and applied science invention, is not an easy task. The conviction becomes twice as hard in the case patent offices or courts traditionally acknowledge that only applied technology inventions are a patentable subject matter. This paper investigates the impacts of employing ‘industrial applicability” and “useful” terminologies as choice terms for second patentability requirement. Countries can choose their terms of second patentability requirement. Malaysia has chosen industrial applicability. The concept, definition and standard of industrial applicability are comparatively higher compared to “useful” jurisdiction. The actual choice of terms is important, and more complicated, than mere preference of terms. The small details can potentially influence the future of an industry, and the rate of local technological progression. In the context of biotechnology, it determines the survival of the local players, as well as the budding local biotechnology industry. Ironically, it is neither the fault of policy makers, nor of law drafters. A part of the fault is attributed to the nature of biotechnology as an invention, and to the lack of technological capabilities of the key players in local biotechnology.

Rethinking Patentable Subject Matter and Related Issues

There is a critical need to rethink about patentable subject matter. In particular, because high speed mechanization of arithmetic and the formalism within which it is practiced has brought about a sweeping change in the way novel and non-obvious ideas across technologies can be simulated, tested, refined, and patentable products and processes invented. The purpose of the patent system is to encourage the appearance of inventions in commerce that would otherwise not happen, at least rapidly enough, without patent protection. To fulfill the patenting needs of society in the post-industrial economy requires a reassessment of what is patentable and the likely human source of patentable inventions in a world where inventors, by definition, are a miniscule part of the population. This reassessment has become necessary because the inventor is no longer a gifted artisan, mechanic, engineer or technologist of eras preceding the mid-twentieth century but likely a gifted university graduate well-versed in science, technology, engineering, and mathematics (STEM) in a social structure where not only higher education is rapidly spreading but is increasingly a basic requirement in the job market. The inventor is also far less likely to be a member of an independent team or an individual inventor but rather a willing employee inventor working for a company focused on building a patent portfolio according to a business strategy and to which company his inventions will be assigned.

Software patents are falling down

Implications of the U.S. Supreme Court's new test for patentable subject matter.

Dolly and Alice.

The opinion of the United States Court of Appeals for the Federal Circuit, In re Roslin Institute, rejecting patent claims to mammals cloned from somatic cells, was rendered about a month before the United States Supreme Court's decision in Alice Corp. v. CLS Bank International. The Alice opinion explicitly sets out the standard for determining whether an invention falls within statutory patentable subject matter. Thus one is thus left to wonder what the Roslin opinion might have looked like had it been decided only a few weeks later, after the Alice decision was published, with the benefit of the Supreme Court's further direction on patentable subject matter. In this essay I explore whether in hindsight the Alice standard might have dictated a different outcome in Roslin, suggesting how the two-part test articulated by the Supreme Court in Alice might apply to a ‘products of nature’ analysis for cloned mammals. Drawing on that analysis, I then use the Roslin case as a vehicle to highlight certain issues with the Supreme Court's current subject matter jurisprudence as applied to biotechnology. By juxtaposing Dolly with Alice, it becomes clear that the Supreme Court has revivified a number of dormant biotechnology patent problems in the guise of subject matter analysis.

Intellectual Property and Biofuels: The Energy Crisis, Food Security, and Climate Change

In light of larger public policy debates over intellectual property and climate change, this article considers patent practice, law, and policy in respect of biofuels. This debate has significant implications for public policy discussions in respect of energy independence, food security, and climate change. The first section of the paper provides a network analysis of patents in respect of biofuels across the three generations. It provides empirical research in respect of patent subject matter, ownership, and strategy in respect of biofuels. The second section provides a case study of significant patent litigation over biofuels. There is an examination of the biofuels patent litigation between the Danish company Novozymes, and Danisco and DuPont. The third section examines flexibilities in respect of patent law and clean technologies in the context of the case study of biofuels. In particular, it explores the debate over substantive doctrinal matters in respect of biofuels – such as patentable subject matter, technology transfer, patent pools, compulsory licensing, and disclosure requirements. The conclusion explores the relevance of the debate over patent law and biofuels to the larger public policy discussions over energy independence, food security, and climate change.

Intellectual Property and Biofuels: The Energy Crisis, Food Security, and Climate Change

In light of larger public policy debates over intellectual property and climate change, this article considers patent practice, law, and policy in respect of biofuels. This debate has significant implications for public policy discussions in respect of energy independence, food security, and climate change. The first section of the paper provides a network analysis of patents in respect of biofuels across the three generations. It provides empirical research in respect of patent subject matter, ownership, and strategy in respect of biofuels. The second section provides a case study of significant patent litigation over biofuels. There is an examination of the biofuels patent litigation between the Danish company Novozymes, and Danisco and DuPont. The third section examines flexibilities in respect of patent law and clean technologies in the context of the case study of biofuels. In particular, it explores the debate over substantive doctrinal matters in respect of biofuels – such as patentable subject matter, technology transfer, patent pools, compulsory licensing, and disclosure requirements. The conclusion explores the relevance of the debate over patent law and biofuels to the larger public policy discussions over energy independence, food security, and climate change.

Patent protection of diagnostic technology: will recent US Supreme Court decisions change patent strategy?

Introduction: Varietas delectat Diagnostic technologies are one of the major fields in pharmaceutical industry. Diagnostic technology is a key feature for modern medicine such as personalized medicine or tailor-made treatments or companion diagnostics/drugs, as the modern medicine shifts its focus from treatment to prevention. However, patent protection of diagnostic technology is not simple, since a variety of countries have their own, unique protection policy in intellectual property regarding pharmaceutical and medical technologies. Europe and Japan are known to have restriction in obtaining patents relating to medical treatment and diagnostic technologies by excluding methods of treatment, surgery and diagnosis from patentable or patent-eligible subject matter. On the other hand, the USA has been said to have flexibility in obtaining patent protection for medical technologies, and the United States Patent and Trademark Office (USPTO) has been said to allow any category relating to medical technologies, and thus methods of treatment, surgery and diagnosis are not explicitly excluded from patent eligible subject matter in their patent act. Not only is there geographical diversity but also chronological diversity within the same country or region, which could be drastic and game changing. Notably, recent decisions held by the Supreme Court of the United States have stipulated that certain range of diagnostic methods may not be patentable because such methods are excluded from patent protection by excluding such from patent eligible subject matter. In this commentary, I will discuss how recent changes in law/case law have already had and/or will have impact on the patent practice regarding patent protection, f ocusing diagnostic technology.

Don't Throw Out Fetal-Diagnostic Innovation with the Bathwater: Why Ariosa v. Sequenom Is an Ideal Vehicle for Constructing a Sound Patent-Eligibility Framework

Over the past five years, the U.S. Supreme Court has reinvigorated patentable subject-matter limitations, issuing four significant decisions after nearly three dormant decades. These decisions reflect justifiable concerns about the patenting of abstract business methods and laws of nature. Just as importantly, they reveal internal inconsistencies and confusion about the scope of patentable subject matter and tension with the centuries-old fabric of patent-eligibility jurisprudence. As Justice Breyer remarked at the oral argument in Alice Corp. v. CLS Bank Int’l (2014), the Mayo (2012) decision did no more than “sketch an outer shell of the content” of the patent-eligibility test, leaving much of the substance to be developed by the patent bar in conjunction with the Federal Circuit.The Federal Circuit’s recent decision in Ariosa v. Sequenom uncritically accepts an expansive reading of Mayo that conflicts with insights from Myriad and Alice, thereby jeopardizing patent protection for diagnostic testing and other vital fields of biomedical research and possibly others. This amicus brief urges the Federal Circuit to grant en banc review in Ariosa v. Sequenom to ventilate critical issues left unanswered by the Supreme Court’s patent-eligibility decisions. Although some language in Mayo could be interpreted to set forth unconventional or inventive application as a possible test for patent-eligibility, Mayo suggests two other possibilities for an “inventive concept”: non-preemptive application; and non-generic application – that is, more than a statement of a natural law coupled with an instruction to apply it. While the panel was correct to perceive that Mayo describes preemption as the underlying justification for the patent-eligibility doctrine, not the operative test, we believe that the panel was incorrect to conclude that Mayo dictates unconventional or inventive application.