Current Challenges in Japan's Pharmaceutical Patent Regulatory Framework

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

Reaching a milestone in pharmaceutical patenting in Brazil.

The national patent regime had amended Patent Acton innovation as per requirement for protecting pharmaceutical product patents among member states of World Trade Organisation. In this respect, the study was conducted to understand patentability nature and prosecution timelines forpatent protected indigenous dairy technologies. Investigators had examined 28 herbal pharmaceutical patent grant(s) from grassroots innovators/outstanding knowledge holders. Patent applications were filed between 2007-2014, prosecution were held and accorded patent grant during 2019-2022. The study noted that Section 3 (d), (e) and (p) were principal factors involved while defending veterinary pharmaceutical patent applications. About 46 percent did not have Section 3 (d) objections inferring these medicinal practices followed by dairy farmers were unique. It was observed that majority of patent grants were in productcategory illustrating transformation of national patent regime from process patent to product-patent grant system. Overall time taken for availing grant was about ten years with an average prosecution period of 2.6 years. Therapeutic efficacy, synergisticaction and suitable claim amendments are pertinent features in responding to prosecution stages. These pharmaceutical product patents from social innovation are of interest to dairy industry. These experimental wisdom provide cost effective sustainable technologies for dairy health system and repurpose existing knowledge of local communities. It is paramount to nurture this bottom-up approach for improvising sustainable dairy health service delivery system.

In a note published in The Lancet in December 1915, Frederic Twort described the discovery of an infectious, filterable agent that causes the glassy transformation and eventual killing of bacteria, now identified as Staphylococcus hyicus [1]. Two years later, Felix d'Herelle independently described an invisible microbe antagonistic to dysentery bacilli in a note to the Comptes Rendus de l'Academie des Sciences [2]. These two reports are the first published descriptions of bacteriophages, a term coined by d'Herelle, who foresaw the therapeutic potential of these newly identified bacteriolytic agents. > The key issue is whether phage therapy medicinal products (PTMPs) require a marketing authorization or not. Yet, phage therapy, despite varying degrees of success during the 20th century, never made it into widespread clinical use owing to the discovery of antibiotics [3]. However, the increasing antibiotic resistance among major pathogens such as Staphylococcus or Mycobacterium has become a critical public health problem—in the European Union (EU) alone, around 25,000 patients die each year from an infection with drug‐resistant bacteria (http://ecdc.europa.eu/en/publications/publications/0909\_ter\_the\_bacterial\_challenge\_time\_to\_react.pdf). Although difficult to estimate, the annual global death toll attributable to antimicrobial resistance might range from the hundreds of thousands to as much as millions in the coming decades (https://amr-review.org/sites/default/files/AMR%20Review%20Paper%20-%20Tackling%20a%20crisis%20for%20the%20health%20and%20wealth%20of%20nations\_1.pdf). In light of this growing health crisis, phage therapy has attracted renewed interest as an alternative to antibiotics [3]. ### Regulatory challenges for phage therapy However, this reemergence raises regulatory concerns. There has been intense discussion on how to classify phage‐based therapeutics within the EU's regulatory framework [4], [5], [6] with some consensus among Members States' regulatory authorities and the European Medicines Agency that these would be regulated as biological medicinal products [7]. Nonetheless, positions still vary because the current medicinal product regulation is not well suited for this unorthodox therapeutic …

In Brazil, if patent prosecution takes more than 10 years, this extra period is added to the regular 20-year term. This paper analyses all pharmaceutical patents granted by the Brazilian National Institute of Industrial Property (INPI) with term extension and later discusses some intellectual property and health policy implications. On average, pharmaceutical patent applications wait seven years after substantive examination is requested before being examined, which takes only three and a half years. Furthermore, the role of the Brazilian Health Regulatory Agency (Anvisa) in providing prior consent has a marginal effect in prolonging the prosecution. Therefore, the extension of pharmaceutical patents' term is caused by the number of pending applications per examiner, which halts the prosecution for double the time it takes to examine the applications. Thus, proper solutions should focus on reducing the backlog per examiner at the INPI, which has caused the extension of 92% of the pharmaceutical patents in three and a half years, on average. We concluded that the Brazilian pharmaceutical patenting policy is biased towards the patentee. This imbalance will only be effectively corrected when the INPI is financially and administratively autonomous to reduce the ratio between the pharmaceutical patent application backlog and the number of examiners.

ABSTRACTIntroduction: Pharmaceutical regulation has always attempted to balance the public health objective to make safe and effective drugs available for patients while providing commercial incentives through patents. Here we discuss whether it is still possible to find a balance between the incentives on the supply side and the regulatory framework on the demand side.Areas covered: The current regulatory framework on pharmaceutical exclusivity has been harshly criticized by many experts, arguing about whether it is still fit for public purposes and needs. Here we envisage a different scenario without ‘revolutionizing’ the whole present system.The main radical change should concern the present management of pharmaceutical patents by introducing a specific agency dedicated to them. Secondly, specific pharmaceutical patents could be restricted to compounds for one (or more) declared indication(s). Thirdly, pharmaceutical patents should be kept only for compounds that start a first clinical trial within five years from the granting date.Expert opinion: We think it is time to reconsider the regulation of pharmaceutical patents in the light of their relevance in terms of public health. New models of enhancing research investments are required for long-term sustainability of public pharmaceutical expenditure and the EU can still play a leading role

It has been reported that pharmaceutical patents account for a significant part of patents worldwide. In order to appraise pharmaceutical patents in Jordan, preliminarily‐accepted patents published in the Official Gazette over the past 20 years were screened, and the bibliographic data of the identified pharmaceutical patents were entered into a custom built database. Of the 973 patents published since 1992, 36% were identified as pharmaceutical patents. However, the contribution from domestic applicants was modest accounting for a mere 7% of pharmaceutical patents. Data analysis has revealed that the contribution of pharmaceutical patents to published patents has doubled upon the enactment of the Agreement on Trade‐Related Aspects of Intellectual Property Rights (TRIPS)‐consistent Patent Law of 1999, from 24% to 48%. However, the increase in the patenting activity in the pharmaceutical sector was not accompanied by an increase in the overall patenting activity. Further analysis has revealed the leading applicants, the patent status, and the main categories of published pharmaceutical patents. It was concluded that pharmaceutical patents account for a significant part of patents in Jordan, with marginal contribution from domestic applicants. It was also noted that the currently adopted patent information system could be further improved by the introduction of electronic search services.

The WTO agreement on Trade- Related Aspect of Intellectual Property Rights (TRIPS) evolved some significant flexibilities in the Intellectual Property Rights on pharmaceutical product, especially regarding right of access to affordable medicine for the developing and least developed countries people as recognized in its Doha Declaration and in a related post-declaration decision. However, provisions of granting uniform character of pharmaceutical patents in all developing and lest developed countries put forward a strong debate over the globe for ensuring access to essential medicine to the poorer section of the member states of the WTO. Though Bangladesh, as a least developed country, has extended time up to 2016 to implement the pharmaceutical patent complying with the provisions of the TRIPS, such flexibilities seem to be a great challenge especially for Bangladesh where local technological capabilities and developed infrastructures to produce generic version of medicine still in nascent stage. In this context, this article demonstrates whether, in term of socio-economical conditions of the developing and least developed countries, this Western-style of IP provisions, is suited for Bangladesh. This paper seeks to explore and argue that in the absence of a strong institutional innovative capacity and the local technical expertise, whether Bangladesh’s pharmaceuticals sector can be able to supply marginal-cost substitutes of essential drug to other developing and least developed countries in the frame work of TRIPS flexibilities. To find out an effective and comprehensive solution this paper concentrates on theinnovative capacity and competitiveness of the pharmaceutical sector and status of current pharmaceutical regulation and patent law in Bangladesh.IIUC Studies Vol.10 & 11 December 2014: 111-126

The covid-19 pandemic and the anti-SARS-CoV-2 vaccines have once again brought to the fore the issue of patents in the health sector. The current European panorama on the patenting of pharmaceuticals is rather confused and difficult to understand, characterized by a precarious (dis)balance between the commercial incentives guaranteed to the industry by supply-side patents and the regulatory framework in support of public interests on the demand side. Here, we first focus on a regulatory analysis of pharmaceutical patenting and more in general on market exclusivity within the European Union, and then set out some proposals for a radical reform of European legislation. In particular, we believe that there are three major critical issues on the subject that must be addressed and reformed as soon as possible: 1. the management of pharmaceutical patents through the European Patent Office and the parallel network of national offices, 2. the excess of discretion of pharmaceutical companies in the filing of patents and 3. the short duration of market exclusivity on drugs. In fact, the right moment has come to definitively reform the European legislation on pharmaceutical patents in line with the tradition of continental welfare.

Financial Inclusion has been on the global policy agenda, including in the Southern African Development Community (SADC), for many years. Global standards-setting bodies, such as the United Nations, the Group of 20 countries, the Alliance for Financial Inclusion, the Financial Action Task Force (FATF), and the World Bank have committed to various financial inclusion policy initiatives. These bodies have recently introduced financial inclusion as part of their traditional policy and regulatory objectives, such as financial stability, integrity and consumer protection. Due to their varying mandates, these bodies often recommend conflicting approaches on the same objective when they pursue these objectives together with financial inclusion. Also, the international policy and regulatory framework on financial inclusion remains fragmented due to the haphazard policy and regulatory approach of these bodies. The Alliance for Financial Inclusion (AFI) and the Work Bank have developed policies and principles on how to develop national financial inclusion strategies. Various countries in Africa and in the SADC region have adopted different types of financial inclusion strategies based on the recommendations of these standards setting bodies. However, the AFI and the World Bank policies and principles are in the form of an international soft law. They are not effectively applied and implemented at regional and national level. These policies and principles do not impose specific national FI frameworks. This chapter critically analyses the current international policy framework on financial inclusion. It determines whether it is effective to impose obligations on countries to promote financial inclusion, focusing on setting policy and regulatory benchmarks for SADC countries. It discusses the framework and the principles introduced in the AFI and the World Bank’s National Financial Inclusion Strategy Reference Framework and the Template for the Design of National Financial Inclusion Strategy. The main aim of this chapter is to determine ways to formulate a responsive International Financial Inclusion Strategy with effective enforcement and institutional frameworks and how national financial inclusion frameworks, including in the SADC countries may implement and effectively enforce their financial inclusion frameworks. It further discusses a possible introduction of an Integrated Framework for Financial Inclusion that adopts an Inclusion-Stability, Integrity and Protection theory (‘I-SIP theory’) as an international standard. This theory requires national policy makers in the SADC region to pursue and optimise the linkage of financial inclusion with all the core objectives of financial stability, financial integrity and financial consumer protection. It also draws lessons of key enforcement mechanisms from the FATF’s anti-money laundering and countering of terror financing enforcement mechanisms to benchmark the regulatory, institutional and enforcement frameworks to promote global financial inclusion.

A new and comprehensive treaty on intellectual property rights was established in 1994, within the framework of the World Trade Organization (WTO). It is called the Agreement on Trade-Related Aspects of Intellectual Property Rights -- the TRIPS agreement for short, it requires all WTO member countries to adopt in their laws minimum standards of protection for patents, trademarks, copyrights and other intellectual property rights. It has substantially limited the freedom that countries enjoyed until then to design and implement their own intellectual property systems. The agreement established a common set of standards for all countries, without differentiating on the basis of socioeconomic and technological development. Developing countries, however, were allowed a transition period in which they could delay implementation of the new standards for specified amounts of time. Although it has many implications for public health, the TRIPS agreement was negotiated with little or no participation from public health authorities. The obligations it sets forth to protect inventions include the following: recognizing patents for pharmaceuticals without distinction between imported and locally produced products; granting patent protection for at least 20 years from the date of application; limiting the scope of exemptions from patent rights; and effectively enforcing patent rights through administrative and judicial mechanisms. Under this agreement all WTO member countries are now bound to grant patents for pharmaceutical products. This obligation did not exist under previous international conventions. The agreement also provides compulsory protection against "unfair commercial use" of data submitted for the marketing approval of new pharmaceutical products. Complying with the TRIPS agreement in these respects has posed a special challenge for developing countries and raised considerable concerns from a public health perspective. These may be summarized as follows. First, the patent holder can exclude direct competition, and charge higher prices for patented medicines than would have prevailed in a competitive market. Life-saving drugs can thus be made unaffordable, as has been seen particularly dramatically in the case of HIV/AIDS in sub-Saharan Africa. Second, most developing countries are excluded from the benefits of protection for inventions because they lack the scientific infrastructure and the capital needed for research and development (R&D). High costs and the need for economies of scale place the development of patentable pharmaceuticals beyond the reach of most of them. Third, the pharmaceutical companies that do invest in R&D focus mainly on the diseases likely to held the highest return for their shareholders. Diseases of the poor, such as malaria, tuberculosis and bloody diarrhoea are thus neglected. Fourth, despite some theories and expectations to the contrary, the TRIPS agreement has not stimulated increased foreign direct investment or technology transfer in pharmaceuticals production in developing countries. The experience of some Latin American countries has been the opposite: after the adoption of product patents for medicines, many local firms have been denationalized and several plants have been closed down. Fifth, a significant part of industry's R&D expenditure goes not on developing new drugs but on expanding the coverage and lifetime of patent protection for existing ones. This is done by patenting minor improvements or modifications such as new crystalline forms, isomers, combinations and formulations. These considerations do not mean that patents cannot help to stimulate costly research on much needed new drugs. They do suggest, however, that strengthened intellectual property rights will affect developing countries differently from technologically advanced ones. …

This article compares national approaches towards secondary pharmaceutical patents. Because secondary patents can extend periods of exclusivity and delay generic competition, they can raise prices and reduce access to medicines. Little is known about what measures and policies countries have enacted to address applications for secondary pharmaceutical patents, how they function, and whether, in practice, these measures limit secondary patents. We analyse the cases of India and Brazil. We assemble data on pharmaceutical patent applications filed in the two countries, code each application to identify which constitute secondary applications and examine outcomes for each application in both countries. The data indicate that Brazil is less likely to grant applications than India, but in both countries, the measures designed to limit secondary patents are having little direct effect. This suggests, on the one hand, that critics of these policies, such as the transnational pharmaceutical sector and foreign governments, may be more worried than they should be. On the other hand, champions of the policies, such as NGOs and international organizations, may have cause for concern that laws on the books are not having the expected impact on patent outcomes in practice. Our findings also suggest that, at the drug level, the effects of countries’ approaches towards secondary patents need to be understood in the context of their broader approaches towards Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) implementation, including when and how they introduced pharmaceutical patents in the 1990s and 2000s.

Neodevelopmental patent regimes aim to facilitate local actors’ access to knowledge and also encourage incremental innovations. The case of pharmaceutical patent examination in Brazil illustrates political contradictions between these objectives. Brazil’s patent law includes the Ministry of Health in the examination of pharmaceutical patent applications. Though widely celebrated as a health-oriented policy, the Brazilian experience has become fraught with tensions and subject to decreasing levels of both stability and enforcement. I show how one pillar of the neodevelopmental regime, the array of initiatives to encourage incremental innovations, has fostered the acquisition of innovative capabilities in the Brazilian pharmaceutical sector, and how these new capabilities have altered actors’ policy preferences and thus contributed to the erosion of the coalition in support of the other pillar of the neodevelopmental regime, the health-oriented approach to examining pharmaceutical patents. The analysis of capability-derived preference formation points to an endogenous process of coalitional change.

The regulation of new medical applications has always been lagging behind the science that enabled these therapies in the first place, but emerging therapeutic approaches are pushing the boundaries harder than ever. Although fundamental principles around safety, efficacy and quality are cast in stone, new interpretations and greater flexibility are required for the clinical use of advanced medicines and treatments without introducing unacceptable risks. There are also ethical considerations that, although not new, are amplified by the potential of emerging therapies to address previously untreatable conditions. All major regulatory bodies, such as the US Food and Drug Administration (FDA) and the European Medical Agency (EMA), have for some years been aware of the challenges posed in particular by Advanced Therapy Medicinal Products (ATMPs). These roughly include three categories: gene therapy medicinal products (GTMPs), somatic cell therapy medicinal products (SCTMPs) and tissue‐engineered products (TEPs), many of which have emerged from the “omics” revolution and stem cell research. > All major regulatory bodies […] have for some years been aware of the challenges posed in particular by Advanced Therapy Medicinal Products ### Advanced Therapy Medicinal Products Both GTMPs and SCTMPs involve ex vivo manipulation of cells, but with a crucial difference in terms of manufacture and function. GTMPs deliver recombinant DNA to specific target cells in the body, whereas SCTMPs are whole cells or tissues genetically manipulated to change their biological characteristics or functions for preventing, diagnosing or treating disease. These cells can be autologous, coming from the patient, allogeneic from another human being or xenogeneic from animals. One recent example of GMTP is recombinant viral vaccines against cancer engineered from an immunogenic virus particle to express tumour antigens, cytokines or both [1]. SCTMPs were the first AMPs to be tested clinically in 1997 for corneal epithelial stem cell transplantation. Since then, the technique has been …

The impact of biotechnology on the pharmaceutical industry has increased significantly over the last few years, firstly as a method for developing and producing new drugs, and secondly as a tool for improving the process of drug discovery. A series of forthcoming papers will analyse how biotechnology is entering patent applications in pharmaceuticals and which countries and firms or research institutions are driving these developments. This first paper concentrates on two particular sets of biotechnological methods: immunological (comprising antigenes and antibodies) and transformation methods. It can be shown that immunological methods for pharmaceutical preparations diffused in this technological field rather rapidly after their initial introduction. Transformation methods, the basic tools of genetic engineering, have gained more significance within pharmaceutical research and development over recent years. Both of these trends have been driven mainly by companies and research institutions in the US and Europe. While pharmaceutical patents in general are filed mainly by multinational pharmaceutical companies, smaller firms and research institutions are among the most active patenters in relation to the analysed biotechnological methods. Only three of the top twenty patent applicants in total pharmaceuticals are also among the top twenty applicants in each of the biotechnological sub-areas analysed. This analysis supports the notion that smaller firms and research institutions are playing a major role in driving the development of biotechnology-based pharmaceuticals.