Patent-eligible Subject Matter Research Articles

Abstract ideas and patent-eligible subject matter in the US patent system: who can provide guidance in this uncertain legal landscape?

Abstract ideas and patent-eligible subject matter in the US patent system: who can provide guidance in this uncertain legal landscape?

To Promote Innovation, Congress Should Abolish the Supreme Court Created Exceptions to 35 U.S. Code s.101

Recent Supreme Court decisions have caused havoc in the Biotechnology and Software industries in the U.S. by vastly increasing the number of U.S. patents being invalidated based on the patent eligible subject matter requirements of 35 U.S.C. §101. As a result, the spotlight on 35 U.S.C. §101 is increasing and there are discussions amongst the patent bar for how best to address the unintended consequences. I here argue that Congress should abolish the Supreme Court-promulgated, non-statutory exceptions to 35 U.S.C. §101, in toto, because they: 1) run directly in conflict with the express statutory language of 35 U.S.C. §101 and its Congressional intent; 2) have been extremely difficult to implement in practice by the U.S. Patent and Trademark Office, the District courts and the Court of Appeals for the Federal Circuit; 3) offer no significant benefit that outweighs the havoc and harm caused to public and private innovation-driven industries; 4) run in direct contrast to the laws of other industrialized nations on this narrow legal issue; and 5) otherwise greatly discourage current and future innovators from developing and commercializing their new discoveries and technologies in America.

How Alice Affects Bioinformatics Patent Applications?

The U.S. Supreme Court’s decision regarding patent-eligible subject matter in Alice Corp. v. CLS Bank has been in effect for more than five years, and it has made a significant impact on inventions in the life science industry. Statistics have shown that patent applications and allowance rate decreased significantly after Alice due to legal uncertainties created by this decision. This work develops a causal empirical study (using difference-in-difference regressions) of Alice and carefully explores how this decision impacts patent examiners and patent applicants in bioinformatics. We deploy and analyze patent application data between 2012 and 2016 for all the U.S. Patent and Trademark Office (“PTO”) office actions in bioinformatics and manufacturing devices, a total of 0.14 million patent office actions and patentee responses. Patent applications in bioinformatics are defined as broad and narrow according to specific technology centers or art units and compared with the patent applications in manufacturing devices before and after Alice. We find that applicants in bioinformatics, regardless of the broad or narrow definitions, received more Sec. 101 rejections after Alice, and they are positively associated with Alice-based rejections. Alice-based rejections are not always positively associated with other types of statutory rejections (i.e., Sec. 102, Sec. 103, and Sec. 112 rejections). Moreover, applicants gradually filed fewer patent applications, compared to the time period before Alice, with the greatest reduction in patent applications occurring in June 2014, when the Alice decision was delivered by the Supreme Court. In addition, patentees received many more Sec. 101 rejections based on Alice, but these applicants also faced difficulties in overcoming these rejections, especially in the sub-areas of data processing and combinatorial chemistry technology in bioinformatics. Due to the high costs of patenting on bioinformatics imposed by Alice, this study suggests legislation by Congress is the best hope to bring more certainty to this area of patent law.

Patentability and de-extinct animals in Europe: the patented woolly mammoth?

Abstract De-extinction is a hot topic within conservation science but the potential patentability of de-extinct animals in Europe has hitherto been unexplored. This article addresses this lacuna, examining the legal, commercial, and ethical implications of patenting de-extinct animals under European patent law. The article is organized into four parts. Part I explores the reasons why patents are relevant and may be applied for in this context. Part II provides an overview of the scientific techniques currently being used in de-extinction projects, setting the foundation for the analysis of patentability which follows. Part III then critically assesses whether recreated animals would qualify as patent eligible subject matter under European patent law. It also investigates the extent to which European patent exclusions such as those on animal varieties, essentially biological processes, and the morality provisions might apply and whether recreated animals would meet the novelty requirement for patentability. Part IV concludes by highlighting the possible ramifications of patenting such animals, elucidating the chasm between the cultural and symbolic significance held by such animals, and their lack of differential treatment in the patent law sphere. It argues that de-extinction reignites questions around the scope of patents, and the role of ethical considerations within patent decision-making which warrant urgent reconsideration.

Testimony of Joshua D. Sarnoff Senate Committee on the Judiciary, Subcommittee on Intellectual Property Hearing: The State of Patent Eligibility in America: Part I

“This written testimony of Joshua D. Sarnoff, Professor of Law, DePaul University was submitted to the Intellectual Property Subcommittee of the Senate Judiciary Committee for its hearing on June 4, 2019, and addresses the Legislative Draft of May 22, 2019 to revise patent eligible subject matter. The testimony makes nine basic points: (1) the current uncertainty in eligibility doctrine does not justify the pending legislative efforts to eliminate existing protection for the public domain of scientific, natural, and fundamental discoveries (science, nature, and ideas); (2) the pending legislative revision proposals do not address the root causes of the doctrinal uncertainty; (3) the pending proposals, by restricting the public domain and displacing line-drawing creativity judgments, would not harmonize U.S. patent law with that of other countries; (4) the current, judicially interpreted requirement of Section 101 to treat ineligible novel discoveries of science, nature, and ideas as prior art against applicants claiming applications thereof is good innovation and moral policy; (5) by minimizing reliance on eligibility doctrine to determine patent validity, the pending proposals would increase uncertainty in and costs of the patent system; (6) the pending proposals would expand the utility patent system to aesthetic and other forms of non-technological creativity, by removing consideration of the kind of novel creativity from eligibility determinations; (7) expanding the patent system to eliminate the exclusions for science, nature, and ideas and to authorize as eligible claims to most or all practical, applications of nontechnological creativity likely will be held unconstitutional, generating further legal uncertainty; (8) trying to avoid those results by more clearly defining specific, practical and technological utility will prove at least as difficult as addressing directly the requisite kind of eligible creativity through Section 101's eligible novelty doctrine; and (9) if Congress proceeds to revise eligibility doctrine, it should adopt specific measures to minimize uncertainty, litigation, and the need for further legislative revisions.”

Does Alice Target Patent Trolls?

The Supreme Court upended the patent world in the past decade with a series of decisions restricting the scope of patent-eligible subject matter. The culmination of those cases – Alice v. CLS Bank -- has been at the center of a firestorm of controversy in the five years since it was decided. AAs we show in this paper, it has also been the basis of nearly a thousand court decisions. We evaluate how Alice and similar Supreme Court decisions on patentable subject matter have been used in the courts five years in. Using a comprehensive dataset we hand-coded of every district court decision and subsequent appeals to the Federal Circuit involving patentable subject matter, we explore not only how patent owners fare in patentable subject matter cases but how a variety of factors, including industry, the nature of the patent owner, and the judicial venue may influence those results. While we confirm some conventional wisdom, we upend other assumptions common in the legal and policy debates over patent eligible subject matter. In particular, we find that once in court, biotech/life science innovations are more likely to survive patentable subject matter challenges than software/IT innovations. Most surprisingly we find that the entities most likely to lose their patents at this stage are not patent trolls but individual inventors and inventor-started companies. Our findings have important implications for current legislative and judicial disputes over patent reform. As biotech worries about deterrence of new innovation and software worries about patent trolls dominate the debates, we may be ignoring some of the most important effects of Alice.

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.

Courts continue to clarify what is patent eligible subject matter

Courts continue to clarify what is patent eligible subject matter

Joshua D. Sarnoff Answers to Questions for the Record of Senator Richard Blumenthal, Submitted to Senate Judiciary Committee Chairman, Hon. Lindsay O. Graham June 4, 2019 Subcommittee on Intellectual Property Hearing on 'The State of Patent Eligibility in America: Part I'

These written responses to Senator Hirono’s questions followed the testimony of Joshua D. Sarnoff, Professor of Law, DePaul University submitted to the Intellectual Property Subcommittee of the Senate Judiciary Committee following its hearing on June 4, 2019 to revise patent eligible subject matter. The responses address: (1) ”whether Congress needs to revise or to address inconsistency in the application of current eligibility doctrine; (2) how to understand a “field of technology,” what we can learn from other jurisdictions that apply a technology test, and how to amend the bill if it continues to focus on technology; (3) clarifying what kinds of inventions or what fields of technology should be explicitly excluded from patent eligibility; (4) how to clarify standards for disclosure and functional claiming under Section 112; (5) whether to codify obviousness-type double patenting and how the doctrine relates to pharmaceutical pricing; and (6) the lack of due process or takings concerns should Congress codify current exemptions or expand eligibility, and the potential concern for a constitutional taking should Congress restrict eligibility and apply the change retrospectively to issued patents.

BRIEF OF AMICI CURIAE INTELLECTUAL PROPERTY AND INNOVATION PROFESSORS, ENGINE ADVOCACY, AND THE R STREET INSTITUTE IN SUPPORT OF PETITIONERS, Hikma Pharms. USA Inc. v. Vanda Pharms. USA Inc., No. 18-817 (U.S. Supreme Court)

The Federal Circuit’s decision below directly conflicts with this Court’s patentable subject matter precedent by upholding patent claims to routine, conventional applications of a law of nature. If allowed to stand, the decision will eviscerate this Court’s unanimous and repeated determinations that such claims lack the “inventive concept” that is required of patentable subject matter. Alice Corp. Pty. Ltd. v. CLS Bank Int’l., 573 U.S. 208, 217 (2014); Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 72 (2012). The divided Federal Circuit panel held the claims at issue here were not “directed to” a law of nature because they claim a “specific method of treatment.” Pet. App. 35a. This interpretation of the term “directed to” is incompatible with the Court’s usage in Alice, 573 U.S. 208. It is also directly at odds with the Court’s invalidation of the method-of-treatment claims at issue in Mayo, 566 U.S. 66, on patentable subject matter grounds. The Mayo decision reaffirmed the principle that patentability requires more than simply directing a practitioner to apply an otherwise ineligible natural law in a “routine, conventional” way. 566 U.S. at 73. The panel in this case sought to distinguish Mayo on the grounds that the patent at issue explicitly recites the step of adjusting a drug dose in applying a natural law, whereas the dose adjustment was merely implicit in the claims invalidated in Mayo. This distinction is untenable, as it depends on the “draftsman’s art,” Alice, 573 U.S. at 224, and ignores this Court’s repeated ruling that mere specificity is not sufficient to transform a natural law into patent eligible subject matter. Mayo, 566 U.S. at 88-89 (citing Parker v. Flook, 437 U.S. 584 (1978)). The Federal Circuit is obligated to follow this Court’s guidance by elaborating the limits on 35 U.S.C. § 101 patent eligible subject matter in a manner that conforms with the legal interpretation and rationale set out in this Court’s precedents. The decision below shirks that duty. This Court has adopted a two-step framework for analyzing patentable subject matter in order to ensure that patents are awarded only to claims that add an “inventive concept” to the underlying natural law. The Federal Circuit majority’s interpretation of this analysis would render this framework toothless because no method of treatment applying a discovered law of nature would ever be considered “directed to” that law of nature, regardless of whether the claim adds only “well-understood, routine, conventional activity” to the otherwise-ineligible subject matter. Mayo, 566 U.S. at 73. The harmful consequences of this decision are real and immediate. The U.S. Patent and Trademark Office (USPTO) has issued guidance that explicitly adopts the reasoning of the majority’s holding and instructs examiners that “method of treatment” claims that apply natural relationships should be considered per se eligible subject matter so long as integrated into a practical application — such as a treatment claim — even if that application is uncreative, routine, or conventional, once the ineligible discovery has been made. This guidance, like the decision below, ignores the standards of § 101 articulated by this Court for patentable subject matter in general and for medical treatment patents in particular. Moreover, the reasoning of the decision below need not apply only to medical treatment patents. It is thus likely that the decision’s erroneous interpretation of “directed to” will be extended to other classes of patents, enabling clever patent drafters to avoid the critical second step of this Court’s patent eligible subject matter analysis. The decision below is exceptionally important. The Federal Circuit’s and USPTO’s disregard of Mayo and Alice are unmistakable and growing. Review and correction by this Court are vital now, before the harmful effects of the decision and its implementation by the USPTO become widespread. Only immediate review will prevent thousands of ineligible patents from being improperly issued and improperly upheld in the courts below and remaining in effect until some potential future opportunity for this Court to consider and invalidate them. Left uncorrected, the Federal Circuit’s decision and the USPTO guidance based on it will allow the piecemeal appropriation of the public domain. Patent law carefully limits the subject matter of patents to ensure the existence of a robust and unrestricted public domain for routine and conventional uses of the laws of nature, even if those laws are newly discovered. Patents must not be allowed to monopolize the basic ideas and natural laws that provide the foundation for medical innovation, research and treatment. If they do, downstream innovation will be hampered or blocked and vital medical practices and decisions will face undue interference.

Bioethical issues regarding patenting gene editing technologies

CRISPR-Cas9을 사용한 유전자 편집 기술은 유전자 치료를 통한 질병 극복과 유전병 대물림을 없앨 수 있는 가능성을 열어준다. 이 혁신적 기술에 대한 특허 출원이 빠른 속도로 증가하고 있다. 특허요건을 충족하는 발명이라면 특허를 허여해야 하지만, 아직 해결되지 않은 과학적 불확실성으로 인한 안정성의 문제와 미래 세대에 대한 자율성 침해, 우생학적 조작 가능성 등 잠재된 윤리적 문제는그 발명에 특허권을 부여해도 되는지 의문을 제기한다. 기술을 독점배타적으로 소유할 수 있는 권리를 허락한다는 것은 그 기술에 대한 사회적 및 경제적 통제 력을 주는 것이기도 하다. 또한 기술을 통해 윤리적인 문제가 사회 속으로 확산 되는 것을 방조하는 것은 공익을 추구하는 특허제도의 본래 목적에도 어긋난다. 이에 본 논문은 먼저 자연 상태의 CRISPR와 Cas9으로부터 만들어진 CRISPR-Cas9이 과연 특허법으로 보호해야 하는 대상인가 검토하는 것에서부터 출발한다. 그리고 “위험한 지식” CRISPR-Cas9과 특허의 관계, 사전예방원칙과 특허의 관계, 특허 대상 확대에도 불구하고 단일 특허법을 적용하는 문제, 연구의 탈순수성과 복잡화에 따른 윤리적·법적 문제에 관한 논의를 통해 유전자 편집 기술 관련 특허심사에서의 윤리적 판단에 요구되는 전문성이 특별하다는 결론에 이르렀다. 한국 특허시스템이 CRISPR-Cas9을 사용한 인간유전자 편집에 관한 발명을 심사하는 데 있어서 인간 존엄성의 수호와 책임 있는 윤리적 판단을 하기 위해서는 현행 기술 위주의 1인 심사 방식을 지양하고, 해당 기술에 대한 윤리적 판단을 함께 해줄 윤리심사위원회를 설치하거나 윤리담당 심사관이 포함된 다인심사체제를 도입할 것을 필자는 제안한다.The gene editing technology using CRISPR-Cas9 opens up the possibility of overcoming disease through gene therapy and eliminating genetic inheritance. Patent applications for the innovative technology are increasing rapidly. Patents must be granted for inventions that meet the patentability requirements, but the potential ethical issues such as stability caused by unresolved scientific uncertainty, violation of the autonomy of future generations, and eugenic manipulation raise questions of granting patents to the invention. Allowing the exclusive right on the technology is also giving a social and economic control over the technology. Aiding the spread of ethical issues into society through the use of technology is against to the original purpose of the patent system that pursues the public interest. Accordingly, this paper begins first by examining whether the CRISPR-Cas9 made from the natural CRISPR and the natural Cas9 is patent-eligible subject matter or not. And more specifically, building on discussions about the relationship between the ‘dangerous knowledge’ CRISPR-Cas9 and the patent, the relationship between the precautionary principle and the patent, the irrationality of applying only one patent law even as the number of patent subject matter increases, and the ethical and legal issues that arise as research becomes more complex and interconnected with business and other issues, this paper conclude that the expertise required in ethical judgment regarding patenting gene editing technologies is important and particular. In examining inventions on human genetic editing using CRISPR-Cas9, the Korean patent system needs to be changed for the protection of human dignity and responsible ethical judgment. As part of this, I propose to set up an ethical review committee that will make ethical judgments about the technology or a multiple examiner system that includes ethics judges, rather than the current technology-based one-person screening method.

Risk Regulation and Innovation: The Case of Rights-Encumbered Biomedical Data Silos

Recent Supreme Court cases on patent-eligible subject matter are likely to exacerbate the longstanding problem of biomedical data fragmentation. For each data silo, multiple overlapping legal claims and claimants must be addressed to achieve the benefits of pooling. Commentators who have discussed the data aggregation challenge have generally focused on possibilities created through public funding, through collective action by research participants, or through pressure by payers. This Article emphasizes the important role of risk regulators, most notably the precedent offered by risk regulation in the area of clinical trial data. While U.S. risk regulators have taken some positive steps, the recent actions of their European counterpart, the European Medicines Agency (EMA), have been particularly creative. Indeed, because data is a global public good, the EMA's actions create a global baseline for access. Private-sector data pooling spurred by threats of regulatory action is also a positive development. Finally, in those advanced economies that have such exclusivity, data exclusivity that runs concurrently with any patents emerges as an attractive mechanism for balancing the interests of initial and subsequent data generators. In elucidating the role of risk regulators, this Article contributes another chapter to the rich legal and economic literature discussing whether, and how, risk and social regulation can promote socially valuable innovation. As contrasted with much of this literature, however, the Article focuses not on innovation induced by efforts to comply with regulation but instead on regulation as a force for creating a data infrastructure for future innovation.

Digital Design Protection in Europe: Law, Trends, and Emerging Issues

Digital designs - that is, designs for display on electronic screens - have recently burst onto the intellectual property (IP) stage. While in the U.S. a smattering of legal studies have recently addressed the question of digital design as a copyright-, trademark- and patent-eligible subject matter, a European perspective is still lacking in the literature. This study provides an overview of basic legal background to the protection of digital designs in Europe, explores firms'actual digital design protection behaviors, and highlights some important practical and doctrinal issues that warrant further study

The Supreme Court's Quiet Revolution in Induced Patent Infringement

The Supreme Court over the last decade or so has reengaged with patent law. While much attention has been paid to the Court’s reworking of what constitutes patent eligible subject matter and enhancing tools to combat “patent trolls,” what many have missed is the Court’s reworking of the contours of active inducement of patent infringement under 35 U.S.C. § 271(b). The Court has taken the same number of § 271(b) cases as subject matter eligibility cases – four. Yet this reworking has not garnered much attention in the literature. This article offers the first comprehensive assessment of the Court’s efforts to define active inducement. In so doing, it identifies the surprising significance of the Court’s most recent case, Commil USA, LLC v. Cisco Systems, Inc., where the Court held that a good faith belief on the part of the accused inducer cannot negate the mental state required for inducement – the intent to induce acts of infringement. In so doing, the Court moved away from its policy of encouraging challenges to patent validity as articulated in Lear, Inc. v. Adkins and its progeny. This step away from Lear is significant and surprising, particularly where critiques of the patent system suggest there are too many invalid patents creating issues for competition. This article critiques these aspects of Commil and then addresses lingering, unanswered questions. In particular, this article suggests that a good faith belief that the induced acts are not infringing, which remains as a defense, should only act as a shield against past damages and not against prospective relief such as injunctions or ongoing royalties. The courts so far have failed to appreciate this important temporal dynamic.

Restoring the Legislative Framework for Patenting Applications of Scientific Discoveries

In Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012), the Supreme Court triggered the most radical redefinition of patent-eligible subject matter in U.S. history by engrafting onto § 101 an inventive application requirement for patenting practical applications of scientific discoveries.The Nation’s patent statutes, stretching back to the founding era, unmistakably afford patent protection to technological innovations and practical applications of scientific discoveries. The legislative record contains no hint of a second, “inventive application” hurdle for patent-eligibility of scientific discoveries. To the contrary, statutory text and legislative history reflect the clear intention to encourage “inventors and discoverers” to reveal the “mysteries of nature,” whether or not they are inventively applied.The Supreme Court derived the “inventive application” requirement from Neilson v. Harford (1841). This brief explains the profound misinterpretation that led the Supreme Court astray and urges the Court to grant certiorari in Sequenom v. Ariosa Diagnostics so as to restore the patentability framework that Congress intended.

From the Bench to the Pharmacy: Protecting Innovation During Vaccine Development and Commercialization.

Patentable inventions may be made during the development of a vaccine, and patents on such inventions can help to protect the vaccine from competition. This chapter introduces several patent law concepts, including patent eligible subject matter, written description, enablement, novelty, and nonobviousness, by following a hypothetical vaccine development timeline that begins with the discovery of a previously unknown virus and ends with the commercial launch of a vaccine against the virus. Regulatory exclusivity, freedom to operate, and lifecycle management considerations are also discussed.

Ariosa Diagnostics v. Sequenom: Metastasis of Mayo and Myriad and the Evisceration of Patent Eligibility for Molecular Diagnostics

This Note critiques how recent Supreme Court and Federal Circuit opinions have eviscerated patent eligibility for molecular diagnostic technologies, exemplified by Ariosa Diagnostics, Inc. v. Sequenom, Inc. This Note explores the origins of the judicially created “law of nature/natural phenomena” exceptions to statutory patent-eligible subject matter and examines how the courts have expanded them to limit, jeopardize or foreclose patent eligibility for molecular diagnostics specifically and practical applications of new scientific discoveries broadly.

Learning from Successes and Failures of Registration of Patent Applications Based on Physical Ergonomics Research

Objective: The present study suggested practical measures for successful patent registration based on a review of success and failure cases of patent application filed based on inventions obtained from physical ergonomics research. Background: The protection of intellectual property (IP) contributes to economic growth and competitiveness and facilitates innovation and creativity. IP rights are pursued on research findings for effective technology transfer and commercialization; however, a patent application can be rejected if patentability requirements such as patent eligible subject matter, utility for industrial application, novelty, or nonobviousness are not satisfied. Method: Three successful and three failed cases of patent applications based on physical ergonomics research were reviewed, critical reasons for their successes and failures were examined, and measures were proposed to avoid failures in patent registration. Results: The following measures were identified based on the patent application case review. First, abstract ideas including logical procedures and/or mathematical formulas need to include use of tangible apparatus and methods in idea realization. Second, the provision of grace period inventor disclosure exception needs to be properly followed in case an invention is disclosed before filing of patent application. Lastly, a comprehensive analysis of prior art published or publicly known anywhere in the world and a claim preparation of distinguished, non-trivial features compared to prior art solutions are needed to avoid possible violation of novelty and nonobviousness. Application: The proposed measures can help to prepare a patent application with patent eligibility.

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.

Patentability of Stem Cells in the United States.

Until recently, the patentability of stem cells was well established within the judicial and statutory framework in the United States. However, the shifting landscape of patent law, particularly with regard to patent-eligible subject matter under 35 U.S.C. §101, presents new challenges to the patentability of stem cells. In this paper, we discuss the legal precedent that paved the way for stem cell patents, including Diamond v. Chakrabarty and In re Bergy. Additionally, we review recent Supreme Court cases and recent guidance issued by the U.S. Patent and Trademark Office that impose new limitations on patent-eligible subject matter and thereby threaten the patentability of stem cells in the United States.