Indication-Specific Generic Uptake of Imatinib Demonstrates the Impact of Skinny Labeling

PURPOSE Generic competition can be delayed if brand-name manufacturers obtain additional patents on supplemental uses. The US Food and Drug Administration allows generic drug manufacturers to market versions with skinny labels that exclude patent-protected indications. This study assessed whether use of generic versions of imatinib varied between indications included and excluded from the skinny labels. METHODS In this cross-sectional study, we identified adult patients covered by commercial insurance or Medicare Advantage plans who initiated imatinib from February 2016 (first generic availability) to September 2020. Generic versions were introduced with skinny labels that included indications covering treatment of chronic myelogenous leukemia (CML) but excluded treatment of gastrointestinal stromal tumors (GISTs) because of remaining patent protections. Logistic regression was used to determine whether use of generic versus brand-name imatinib differed between patients with a diagnosis of CML or GIST, adjusting for demographics, insurance type, prior use of brand-name drugs, and calendar month. RESULTS Among 2,000 initiators, 934 (47%) had CML and 686 (34%) had GIST. Within 3 years after generics entered the market, more than 90% of initiators in both groups used generic imatinib. Initiation of generic imatinib was slightly lower among patients with GIST than among patients with CML (85% v 88%; adjusted odds ratio 0.56; 95% CI, 0.39 to 0.80; P ≤ .001). CONCLUSION Generic versions of imatinib were dispensed frequently for indications both included (CML) and excluded (GIST) from the skinny labeling, although patients with GIST were slightly less likely to receive a generic version. The skinny labeling pathway allowed generics to enter the market before patent protection for treating patients with GIST expired, facilitating lower drug prices.

SEPs licensing across the supply chain: an antitrust perspective

The rise of the Internet of Things (IoT) and the development of 5G are set to add a new layer of complexity to the current practice of standard essential patents (SEPs) licensing. While, until recently, the debate has centred on the nature of fair, reasonable and non-discriminatory (FRAND) commitments and the mechanisms to avoid hold-up and reverse hold-up problems between licensors and licensees, a new hotly-debated issue has now emerged. At its core is the question of whether SEP holders should be required to grant a FRAND licence to any implementer seeking a licence, including component makers (the so-called ‘licence-to-all’ approach), or if they should be allowed freely to target the supply-chain level at which the licence is to be granted (the so-called ‘access-for-all’ approach). After providing an up-to-date overview of the current legal and economic debate, this article focuses on the most recent antitrust case law dealing with the matter on both sides of the Atlantic and argues that no sound economic and legal bases which favour licence-to-all solutions can be identified. * The authors would like to thank the anonymous referees, Luigi Federico Signorini and the participants in the 2021 Annual Conference of European Policy for Intellectual Property (EPIP), in the 38th Annual Conference of the European Law and Economics Association (EALE), in the TILTing Perspectives 2021 (Tilburg University), and in the 16th Annual Conference of the Academic Society for Competition Law (ASCOLA). The study was conducted as part of the research activities promoted by the DEEP-IN (Digital Ecosystem, Economic Policy and Innovation) Research Network. The author is grateful for the financial support received. Any opinions expressed in this paper are personal and are not to be attributed to the Bank of Italy. The first is Half-Causation Branching, which allows the logical mapping of the inventing space, within which the imaginary invention is located. Implementing this tool reveals two alternative nearby inventions, which if left out of the sought patent protection would render any eventually granted patent practically worthless. Following that, Half-Causation Encapsulation comes to the rescue by allowing the encapsulation of the original imaginary invention, plus the two alternative nearby ones, all in a manner that provides the all-important unity of invention On the one hand, patent agents are not supposed to contribute to their client’s inventive concept to the extent that they become co-inventors. On the other hand, scientists and engineers are not supposed to dedicate so much time and effort to learning about complex patent laws as to become patent agents. Arguably, each should aim to excel in their discipline. However, a structured dialogue should be considerably helpful to each and to the patent process as a whole. It is proposed that Half-Causation, with its logical structure, can provide a basis for such a dialogue. Besides targeting a readership in patent practices and theory, this paper should be of interest to multiple readerships, for example in engineering design, medical discovery and philosophy of technology.

How Half-Causation can enlighten the drafting of patent claims

The author’s 2019 article ‘If You Wish to Invent Then Follow the Half-Causation Method’ presented ‘Half-Causation’, which is a philosophical model for the systemization of the invention process. It consists of five phases of reasoning, each terminating with taking a ‘logical branch’. This paper has two objectives. The first (and preliminary) objective is to introduce a readership in patent practices (and theory) to Half-Causation. The second (and primary) objective is to highlight how Half-Causation can be practically useful to patent practitioners (and perhaps ultimately theorists), specifically in terms of enlightening the drafting of patent claims. In order to do this effectively, the reader is presented with a case which they can engage with to see for themselves how Half-Causation can help, step by step. The presented case was the subject of the USPTO’s 2019 patent drafting competition. It consists of rather convoluted instructions received from an ‘imaginary’ client about their ‘imaginary’ invention. The case is an excellent opportunity to illustrate how Half-Causation as a philosophical model can be practically useful. Two Half-Causation tools are implemented. The first is Half-Causation Branching, which allows the logical mapping of the inventing space, within which the imaginary invention is located. Implementing this tool reveals two alternative nearby inventions, which if left out of the sought patent protection would render any eventually granted patent practically worthless. Following that, Half-Causation Encapsulation comes to the rescue by allowing the encapsulation of the original imaginary invention, plus the two alternative nearby ones, all in a manner that provides the all-important unity of invention On the one hand, patent agents are not supposed to contribute to their client’s inventive concept to the extent that they become co-inventors. On the other hand, scientists and engineers are not supposed to dedicate so much time and effort to learning about complex patent laws as to become patent agents. Arguably, each should aim to excel in their discipline. However, a structured dialogue should be considerably helpful to each and to the patent process as a whole. It is proposed that Half-Causation, with its logical structure, can provide a basis for such a dialogue. Besides targeting a readership in patent practices and theory, this paper should be of interest to multiple readerships, for example in engineering design, medical discovery and philosophy of technology.

Comparative efficacy of transdermal forms for alopecia therapy

Introduction. Alopecia is a polyetiological disorder characterized by hair loss and reducing their number per unit area. Baldness causes psychological and social discomfort to patients, in connection with what an important task is to develop formulations that are more effective than the reference agents.Aim. Investigate the possibility of applying the original substance Y in several dosage forms for the treatment of alopecia in comparison with reference drugs: minoxidil and burdock oil.Materials and methods. The research subject was the original substance Y, for which several dosage forms were made: gel, alcohol and oil compositions. The study on the effectiveness and safety of the developed formulations was carried out on 9 groups of male C57BL/6 mice. Depilation with further assessment of the percentage of hair follicles in the growth and resting phases was tested as a pre-clinical model of alopecia. In the study of the mechanism of action of substance Y, chemiluminescent assay was performed compared with natural antioxidant quercetin in the system luminol – 2,2'-azo-bis(2-amidinopropane)dihydrochloride, in potassium-phosphate buffer medium (pH = 7.4). Statistical processing of the results was carried out using two-way ANOVA using GraphPad Prism 8.0.2, USA software at the level of statistical significance of differences p < 0.05 and p < 0.005.Results and discussion. Based on the results of histological analysis and visual changes, it was found that the effectiveness of the topical forms of substance Y decreases in the following order: gel, alcohol form, oil composition. The use of a combination of the gel base with the test substance Y resulted to the appearance of a larger number of hair follicles in the growth phase than when using the reference preparation – 2 % minoxidil solution (the differences are statistically significant). Chemiluminescent assessment of antioxidant activity showed the lack of antioxidant effect in substance Y.Conclusion. The study combines two pharmaceutical profiles: technological and pharmacological. In the course of the experiments, the prospects of the gel form of the original substance Y for topical therapy of alopecia were shown. In the near future, it is planned to study the mechanism of action of substance Y, as well as registration of patent protection for a new drug.

Selection achievement in animal husbandry as an object of intellectual property rights and international experience in its protection

Intellectual property rights are enshrined in the Universal Declaration of Human Rights. A patent for an animal breed is the exclusive right of the inventor to his selection achievement, it is a legal monopoly provided by the state, and patent protection prevents commercial use without the consent of its owner. Today's challenges are directly related to food security. The practical application of breeding achievements in animal husbandry, in particular, is the genetic improvement of animals from the «economic side», which directly affects the level of investment and rewards for breeders, and thus the need for effective legal protection of intellectual property rights. Based on the analysis of normative legal acts regulating the procedure for obtaining legal protection of selection achievements in animal husbandry, the article examines problematic positions and suggests ways to resolve conflicts in the legal regulation of these issues. The methods of our study were chosen taking into account the purpose and objectives of the study. The study used philosophical, general scientific and special legal methods of scientific knowledge. Keywords: object of intellectual property right, selection achievement, selection achievement in animal husbandry, protection of intellectual property right

Patent Protection Requires a Human Inventor

Dabus/Taiwan

Copyright and Patent Protection of Cloud Storage Software in the BRICS Member States

In the BRICS Member States, serious attention is paid to Information Technology development in terms of both technology and law. These countries are at the forefront in the development of the digital economy and digital innovations. Cloud storage software is an important element in this sector and is intensively applied in civil law transactions. The processes of approval, storage and sorting of documents are being automated on the basis of the relevant computer programs. This helps companies and government agencies to systemize their operations. At present, the most pressing issues are those related to copyright and copyright holders of computer programs since software code may be copied, even illegally or unconscientiously, and used as the basis for another software product. Cloud storage software is copyright-protected, but, depending on the scope of its use, additional patent protection may be required. Given the rapid development of the IT sector, a software product may be one of the components in an invention subject to patenting. The article focuses on the relationship between copyright and patent protection of software and offers a comparison of the approaches taken by the BRICS countries. Approaches taken by Germany as a European Union Member State and the United States of America are shown in the all-out comparison. The article also analyzes the views of academics on the relationship between copyright and patent protection of software.