Patentability Requirements Research Articles

A PATENTABILITY REQUIREMENT AND INDUSTRY-TARGETED R&D

I introduce a minimum innovation size required for patents into a Schumpeterian growth model. We show that to satisfy the patentability requirement for minimum innovation size, each research and development (R&D) firm targets only industries in which the incumbent's technology is of sufficient obsolescence. This is because the technological gap between innovator and incumbent is greater in industries using older technologies. Although the increase in minimum innovation size reduces the number of industries targeted for R&D, it also increases the amount of R&D investment directed at those targeted industries. Consequently, introducing a minimum innovation size has a nonmonotonic (or negative) effect on the aggregate flow of innovations. Further, by deriving the endogenous long-run distribution of innovation size, we show that an increase in minimum innovation size reduces the mean innovation size. This implies that even if the patent office only grants patents for superior innovations, it causes innovators to produce generally inferior-quality innovations.

The Antitrusting of Patentability

Deciding a patent’s validity is costly, and so is deciding it incorrectly. Judges and juries must expend significant resources in order to reach a patent validity determination that is properly informed by the relevant facts. At the same time, patent validity determinations reached quickly and cheaply may conserve resources today while creating future costs. Wrongly preserving an invalid patent can distort the competitive market and enable abuses, such as nuisance litigation. Meanwhile, wrongly striking down a valid patent can undermine incentives for continued investment and commercialization in knowledge assets. Courts facing patent validity issues have begun to strike this balance in favor of conserving resources today—in a manner that is strikingly similar to per se analysis in antitrust law. A per se rule disposes of supposedly easy cases without engaging in the more fact-intensive “rule of reason” analysis. However, although antitrust jurisprudence cautions against per se rules because of the risk of error and imposes important requirements for the use of per se rules, recent patent jurisprudence has borrowed incautiously from antitrust. This Article explains how the requirements for patentability enable the use of per se analysis, describes how the proper conditions for antitrust per se analysis would translate into patent law, and argues that current use of antitrust-style judicial shortcuts do not satisfy these conditions in patent law. The Article concludes with a set of proposals for recalibrating the present costs of reaching informed patent validity decisions against the future costs that arise from generating decisions incorrectly.

From a Means to an End: Patenting in the 1999 Danish ‘Act on Inventions’ and its Effect on Research Practice

This paper examines the potential pitfalls for academic research associated with goal displacements in the implementation of goals and indicators of research commercialization. We ask why patenting has come to serve as the key policy indicator of innovative capacity and what consequences this has for the organization of academic research. To address these questions, the paper presents a case study from Denmark on, firstly, why and how the 1999 Danish ‘Act on Inventions’ introduced patenting as a central instrument to Danish science policy and, secondly, the effects the Act has had on Danish university organization and research practices. We trace why and how commercialization was introduced as an important objective in Danish science policy since the 1980s. The increased focus on patents is explained as an isomorphic adjustment to an international ‘science policy field,’ manifested in particular through OECD statistics, where patenting has come to serve as a key metric in international rankings. In a second step, we examine what effects the patenting requirements have had on organization and research practice at a Danish university. We show that in practice ‘number of patents’ changed from serving as an indicator of innovative capacity to being a policy goal in itself, thus in effect producing a goal displacement that is potentially damaging for both academic research and innovation capacity of the surrounding society. As a consequence of this goal displacement, active scientists now increasingly engage in patenting primarily as a means to fulfill organizational targets and to increase their ‘fundability,’ rather than to promote commercial applications of their research. In conclusion, we discuss how these unfulfilled policy ambitions have led to a retrospective redefinition of policy goals rather than an adjustment of the actual policy tools.

Ontology-based GFML agent for patent technology requirement evaluation and recommendation

Patent technology requirement evaluation and recommendation are critical for patent strategy, patent management, and patent usage in an organization. This paper proposes a patent technology evaluation and recommendation agent based on a soft-computing approach to enhance patent expansibility and technology transfer. First, we investigate the relationship between patent technology and patent owners, such as academic institutes or organizations, and integrate the collected patent data with the characteristics of organizations to establish a popular patent ontology for general academic institutes or organizations. Then, the patent’s suitability for a specific organization is determined based on concepts extracted using Chinese Knowledge Information Processing. Next, we refer to the Japan Patent Office evaluation index and intellectual property quotient to describe the knowledge base and rule base of the patent quality evaluation agent by using fuzzy markup language (FML). A comprehensive patent quality evaluation mechanism is implemented, and the genetic algorithm is adopted to improve the performance of the proposed agent. Additionally, the patent requirement level evaluation mechanism infers the patent requirement level according to the basic information of an organization. Finally, we present a novel FML-based patent requirement recommendation agent to recommend a patent for an organization by considering the suitability of the patent technology for such an organization, the results of the comprehensive patent quality evaluation process, and the results of the evaluation of the demander’s patent requirements. According to the results, the proposed agent is feasible for patent recommendation. In the future, we will combine an intelligent robot with the GFML agent to assist humans or organizations in recommending an appropriate patent.

Dosing regimens in second medical use patents

: In the pharmaceutical field, the development of new drugs requires sophisticated understanding of pathophysiological mechanisms in order to identify and characterize potential biomolecular targets and proceed with clinical trials. In this context, protection of research and development results is a vital stage for guaranteeing financial return on the heavy investments in the area. One strategy to achieve this objective is to exploit second-use patents, usually drafted in the format "use of compound X characterized by the fact that it is used in preparing a drug for disease Y". Considering the possible social impact and lack of specific guidelines in Brazil, this article reviews the principal cases related to dosing regimens in Europe and analyzes the positions of the European Patent Office (EPO) and German and UK judiciary systems on the requirements for patentability and scope of protection, aimed at contributing to the technical debate on the topic.

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, first and foremost, that the wide uptake of 3D printing does not challenge the basic premises of patent law. As regards patentability, 3D printing does not upset patentability theory in general: it does not challenge prevailing concepts of patentable subject matter, nor current patentability requirements. On the other hand, digitized fabrication might well challenge the type/token dichotomy on which patent ontology is founded. As regards infringement, 3D printing does not really upset infringement theory either: it does not fundamentally alter the scope of rights, concepts or direct/indirect infringement assessment traditions. The paper further concludes that the emergence of 3D printing and the decentralization of production it entails, may lead to a wider and more dispersed scale of infringement, and does call 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.

Knowledge management and intellectual capacitation through patent and technology transfer

It is expedient to introduce that this excerpt is the conclusion of the Chapter in book published earlier by the speaker as: J.A. Ajienka & S.E. Iyuke. A paradigm shift: Patent, publish and product. The evolution of entrepreneurial University. University of Port Harcourt Press, Port Harcourt, pp. 47 - 60. ISBN 978-2954-04-7, 2015. The article commences with many attempts made by writers to give precise definition for an 'invention', which is a key requirement for patentability, but no single definition has been accepted by all and sundry, as a result, each country is allowed to provide its own regulations within their legal and judicial dispensation. Thus citing the case between Crossley Radio Corporation v. Canadian General electric Co Ltd (1936) D.L.R. 508, it was ruled that „It would be idle to attempt a comprehensive definition. In certain cases, the decision must necessarily be the result of nicety. It is a question of fact and degree depending upon practical considerations to a large extent rather than upon legal interpretation. On the other hand, the Nigerian Patents and Design Act 5 (PDA) attempts to define what constitutes an 'invention' for the purposes of granting a patent, whereby Section 1 of the Act stipulates the circumstances under which an invention could be considered patentable. Consequently, having shown the parallels between publications and patent specifications, is it true therefore that filing a patent application means that a publication cannot be submitted by the inventor(s)? The following answers are therefore proposed for the inevitable question as:• Although publishing does constrain the options available to the applicant in patenting his/her research findings, as for South Africa, a provisional patent application can be filed, which gives the applicant a priority date recognized internationally through the Paris Convention. This gives a period of one year before the next decisions have to be made. Thus papers on the invention may be published after such a filing has been effected.• One exception to this is the USA, where the inventor can publish up to one year before filing a US patent application, but proper records must be kept in the form of log books with dates, time and signed.• The United States allows a patent to be granted to the first to invent provided emphasis is placed on keeping dated and signed notebooks of one‟s research. There is also a new Act in the US, the America Invents Act (AIA) which prescribes first to file.• In the rest of the world, a valid patent is granted to the first to file.Keywords: Knowledge Management. Intellectual Capacitation, Patency and jurisprudence

Requisitos de patentabilidad de las invenciones en Cuba Apuntes desde el Derecho comparado

The investigation carried out an analysis of the patentability requirements of inventions and the challenges that arise with regard to patentability exclusion. For this purpose, an article was elaborated that analyzes the basic requirements of a patent system and at the same time defines the general causes that affect the irregular generic content prohibitions that are manifested in the recognition of a labor invention. It also addressed some of the reasons for the lack of uniform interpretation and recognition in modern patent systems of inventions for non-patentable materials.

The Complexity of Using the Patent Standards Under TRIPS for the Promotion of Domestic Industrial Development in Developing Countries in the Absence of Local Working Requirements: Rethinking the Role

This article confronts the most basic question, which is whether in its traditional legislative intent the principle of patent working requirements would as an instrument of government policy in the mist of global value chains definitely guarantee industrial growth for developing countries and least developed countries LDCs. The author argues that globalization has promoted an increasing fragmentation of production, that is, in a dynamic economic efficiency and open trade environment, much of manufacturing today is trade in components from different sources, and seeking to produce all of them locally would be contrary to division of labour and undermines the very existence of the WTO’s mandate to preserve the basic principles and to further the overriding objectives underlying the multilateral trading system, which is to reduce barriers to trade and to the elimination of discriminatory treatment in international trade relations. Therefore, a key distinction in thinking about policy is that as an instrument of government policy the patent working requirement is, on its own, insufficient, less prudence and not the smartest route to secure rapid socio-economic growth, as countries have more to lose from a confrontational scenario of implementing patent working requirements, and more to gain when they join the global supply chain to exploit its numerous opportunities.

In Defense of Secondary Pharmaceutical Patents: A Response to the UN's Guidelines for Pharmaceutical Patent Examination

In 2015 the United Nations Development Programme issued a document entitled Guidelines for Pharmaceutical Patent Examination: Examining Pharmaceutical Patents from a Public Health Perspective (the “Guidelines”). The heart of the Guidelines is a category-by-category examination of eight types of “secondary” pharmaceutical patent claims: Markush claims; selection patents; polymorphs; enantiomers; salts; ethers and esters; compositions; doses; combinations; prodrugs; metabolites; and new medical uses. The Guidelines advise patent offices to apply heightened patentability requirements to these claims in a manner that would effectively deny patent protection to important pharmaceutical innovations currently afforded patent protection. In particular, the Guidelines postulate that many forms of pharmaceutical innovation are inherently routine, and absent some sort of exceptional circumstance should be treated as obvious/non-inventive, and hence unpatentable. In my experience, however, the Guidelines’ assumption that many types of pharmaceutical inventions are inherently obvious and undeserving of patent protection is incorrect, and based on an oversimplified view of how these inventions come about. This article provides an evidence-based response to the Guidelines that refutes, or at least qualifies, some of the significant conclusions and recommendations set forth by its author.

Patenting Bioprinting-Technologies in the US and Europe The 5th Element in the 3rd Dimension

The opportunities and the broader implications of bioprinting raise a wide variety of crucial legal issues. These may range from the regulation of the science and its’ societal effects to questions regarding the commercialization of the technology. Regarding commercialization aspects, one issue that must be addressed concerns the question of what types of products and uses should be regarded as protectable subject matter under the relevant intellectual property right (IPR) frameworks. Considering that the availability IPRs is one of the factors that might have a great impact on where the greatest investments and scientific efforts in this technology will be made, this is an utterly important question. In addition to trade secrets, copyrights, trademarks and other IPR-related rights, patents will most likely play a major role in that respect and will be at the focus of this paper. In this paper, we examine and discuss what sorts of bioprinting - inventions are being patented or would be - protectable under European and US patent laws. Rather than focusing on the highly relevant questions that 3D printing poses for patent infringement doctrines, IP governance, user-generated solutions and research exemptions, this paper concentrates on the question of patentable subject matter and patentability. To this end, we start out by (1) briefly describing the relevant state of the art in bioprinting. This allows us to better describe and understand the current bioprinting patent landscape (2), and to examine in how far any future inventions stemming from such technology would meet the most basic U.S. and European patent requirements (3). A related question is of course, if some bioprinting technologies should be categorically excluded from patentability, i.e. even when meeting the most basic patent criteria. We address this specific issue by discussing patent-limitations and morality exclusions from patent law (4), which will allow us to complete the paper with some concluding remarks (5).

Direito Humano à Saúde, Acesso a Medicamentos e Propriedade Industrial: Interpretação do Conceito de Invenção e dos Requisitos de Patenteabilidade no Âmbito Farmacêutico

O objetivo do artigo é colaborar com a discussão sobre a possibilidade de harmonização dos critérios de análise dos pedidos de patente para medicamentos. Apresenta reflexões sobre interpretação do conceito de invenção e dos requisitos de patenteabilidade, para observar se tal iniciativa de harmonização contribuiria com o acesso a medicamentos e com a proteção do direito humano à saúde. Esta análise utiliza como método de abordagem o dedutivo e de procedimento o monográfico, baseando-se (a) de doutrina nacional e estrangeira (b) de instrumentos legais internacionais e legislações estrangeiras e (c) leis e decretos nacionais, além de regulamentações adotadas administrativamente.

Biotechnology patenting caught between Union law and EPC law: European bundle patents, unitary patents and intentional harmonization of decisions in the internal market

Although in the European Union (the Union) the substantive rules for the patenting of biotechnological inventions are governed by Directive 98/44, the actual examination and grant of patents in Europe is provided by the European Patent Office (EPO), which is not part of the Union legal order and acts according to a non-Union legal instrument, the European Patent Convention (EPC). This hybrid situation results in legal uncertainty and can lead to partly inconsistent applications of patentability requirements, since the EPO is not bound to Union law and cannot refer questions to the Court of Justice of the EU (CJEU). Thus, there is no guarantee that the Union and Unified Patent Court (UPC) judiciaries, on the one hand, and the EPO judiciaries, on the other hand, will come to comparable conclusions regarding the patenting of identical biotechnological subject-matter in the Union, irrespective of whether it concerns a classic European patent or a unitary patent. However, the unitary patent is introduced in the framework of fostering the functioning of the internal market and ensuring undistorted competition, and it provides uniform protection. The CJEU has given a very limited interpretation only to this concept of uniformity, leaving room for inconsistent decisions. Hence, it would appear that only intentional, determined harmonization efforts of the diverse judiciaries involved can increase consistency between decisions of the Union and the non-Union legal systems, although the judiciaries are unrelated. This call for coherency becomes even more pressing with the establishment of the unitary patent. Given this complex situation it may be questioned whether in the Union the law-makers of Directive 98/44 can fully achieve their aim in regulating and harmonizing biotechnology patenting.

Pharmaceutical patent law: the Canadian perspective.

This article provides an overview of the patent regime in Canada, with a focus on issues most relevant to the pharmaceutical industry. The process of applying for a patent is discussed, as well as enforcement and litigation. Recent developments in the case law dealing with patentability requirements - novelty, obviousness, utility and sufficiency - are reviewed. Finally, the impact of recently negotiated trade agreements on Canadian patent law is addressed. In this article, we aim to provide an overview of the patent regime in Canada, with a focus on issues that are particularly relevant to the pharmaceutical industry.

Separating sheep from goats: a European view on the patent eligibility of biomedical diagnostic methods

The Supreme Court’s decisions in Mayo, Myriad and Alice, as well as the CAFC’s in Roslin focused widespread attention on the formulation of patent-eligibility exclusions for specific biological material and diagnostic methods. The debate recently intensified with the CAFC’s Sequenom decision and denial of a rehearing en banc. The claims at issue in U.S. Patent No. 6,258,540 (“US ’540 patent”) are directed to methods of genetic testing by detecting and amplifying paternally inherited fetal cell-free DNA (cffDNA) from maternal blood and plasma. Before the development of this non-invasive prenatal diagnostic test, patients were placed at higher risk and maternal plasma was routinely discarded as waste. A reluctant CAFC formulaically interpreted the Supreme Court-devised bifurcated test to identify patent ineligible subject matter and invalidated the patent for this ground-breaking method. Notably, Judge Linn wrote that this innovation deserves patent protection, but that the “sweeping language of the test” established in Mayo requires a determination that the claims are patent ineligible. On March 21, 2016 Sequenom Inc. filed for certiorari and the issue may once again find itself at the Supreme Court. As framed by Sequenom, the question presented is: Whether a novel method is patent-eligible where: (1) a researcher is the first to discover a natural phenomenon; (2) that unique knowledge motivates him to apply a new combination of known techniques to that discovery; and (3) he thereby achieves a previously impossible result without preempting other uses of the discovery? Interestingly, in Europe the EPO upheld essentially the same claims. European equivalents of the patents considered in Myriad, Mayo, Alice and Roslin were also treated differently than in the US. Hence, these cases undermine the global integration of patent standards and provide fodder for discussing patentability requirements at an international level. Referring to these developments, our paper discusses these issues from a comparative European perspective. Section 1 provides a very brief summary of the European patent framework and case law regarding medical diagnostic methods. Leaving aside national peculiarities that would exceed the limitations of this study we focus on the EPO’s patent eligibility approach vis-a-vis medical diagnostic methods similar to those in Sequenom v. Ariosa. Section 2 discusses our findings and the differences between the US and European approaches from a broader innovation and patent policy perspective providing the basis for concluding remarks in section 3.

Subject Matter Eligibility in the Information Age

Patent systems have not successfully adjusted to the advent of the Information Age. Law developed during the Industrial Age generates harmful distortions when faced with process-based inventions that result in new and useful information. Congress and the courts have attempted solutions, but they are unsatisfying in aspects of repeatability and lack of coherent separation of subject matter eligibility and patentability, with such separation seemingly implicit in the scheme of the patent act. A unifying doctrine of eligibility for information inventions is needed that adheres to standing patent law, court procedures, and normative expectations. Courts should require that process-based inventions have an identified result, which should be construed as a matter of law. Current Markman procedures should be expanded and treated as both eligibility and probable cause phases of the validity inquiry. There is a bar on inventions considered to be abstract ideas, as well as a bar on patenting printed material. These longstanding bars exist because virtually any human activity may be characterized as a process, thus bringing unlimited patent rights into direct conflict with other Constitutional rights. Despite those bars, thousands of computer and biotech patents have issued that constructively cover information and/or the utility derived therefrom. Finding disqualifying abstraction in eligibility and disqualifying abstraction in patentability requires different tests. If a process-based invention’s result is found to comprise information, a new test for eligibility should be applied. The literal root of the word abstract means to “draw away”, or consume. The proposed eligibility test requires that the information-consumer of a process-based invention’s result may not be a human being. Because non-human intelligences are a new fact in the world, products of human ingenuity, and essential actors in the Information Age, if the information-consumer is non-human, the information result of such a process-based invention should be patent eligible, subject to statutory and common law patentability requirements. The current Alice test should be applied to the patentability inquiry. In this paper, I describe the statutory basis to support this new doctrine, apply the new doctrine to past cases and well-known inventions, and examine other proposed approaches to solving these problems, each of which falls short for various reasons. This proposed new test, focusing on the information-consumer, is simple to apply across the arts; is technology neutral, intuitively appropriate, empowering of innovation, and highly fitted to American ideals.

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.

Determining Inventive Step or Nonobviousness for a Patent Requirement in View of the Formation Process of an Invention

Regarding the criteria for determining the inventive step or nonobviousness (unobviousness) for a patent requirement of a patent invention, the conventional approach in the court decisions and examination standard of Japan, USA and EPO focused on acts, for example, whether or not the act to invent in the invention claimed in the application was “suggested” or “motivated” by the prior arts. On the other hand, Author regarded “conception based on a principle” and “establishment of a model” as the most important stage by analyzing the formation process of an invention. Especially, principles (typically in physics and chemistry) are important; furthermore, they are objective as the object of acts of the inventions. Therefore, I would like to propose a way in order to compare the applied invention with the prior arts. That is, we should set the “principle” and “ways of their utilization” as the object to analyze and judge their difference between the said invention and the arts. If the degree of the difference is large, an inventive step can be recognized. Because the problem to be solved does not consist of the contents of an invention, it should not be focused too much. In this article, the various factors in order to recognize differences with reference to principles and ways of their utilization were explained in a good order. Because the determination of the principles and their utilization seems to be made more objectively compared to that of acts, it can exclude hindsights. Up to now, this kind of discussion in this article has not yet been made.

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.

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.