Key issues of legal regulation of the supplementary protection of inventions in the field of pharmacy in the national legislation of Ukraine

Keywords: supplementary protection certificate, basic patent, procedure for obtainingsupplementary protection certificate Key issues of legal regulation of the supplementary protection of inventionsin the field of pharmacy in the national legislation of UkraineThe article is devoted to the study of key issues of legal regulation of supplementaryprotection of inventions after the adoption of the Law of Ukraine «On Amendmentsto Certain Legislative Acts of Ukraine on Patent Legislation Reform» in the absenceof bylaws to regulate the procedure for issuing supplementary protection certificates.The study also highlights the main shortcomings and gaps in the regulation ofcertain issues of application of supplementary protection certificates in the currentLaw of Ukraine «On protection of rights to inventions and utility models.»The author in details analyses European Union approaches to definition of thesubject matter of the supplementary protection, providing criteria which are recommendedto use in order to decide whether the product is covered by the basicpatent in force. Also, the paper is focusing on the issues related to verification ofdata and materials provided together with the application for a certificate — suchas whether the requirement that the medicinal product must be submitted formarketing authorization in Ukraine no later than during one year after it’s first marketing authorization in the world, whether the authorization provided is thefirst authorization in Ukraine, etc.Another problem which is highlighted in the study is the application of the rule tosubmit the petition for obtaining supplementary protection to those patents and marketingauthorizations which were issued before the amendments to the Law came inforce, as this question remained unresolved due to the lack of transitional provisionsin the Law. Also author points out the necessity to align the provisions of the Article271 of the Law of Ukraine «On Protection of Rights to Inventions and Utility Models»regarding the definition of the subject matter of supplementary protection in accordancewith patent legislation by excluding application of the medicinal product fromthe list as it is not patentable according to Ukrainian law. In addition, the author emphasizedthe urge to adopt relevant bylaws (procedure) regulating the issue of certificatesof supplementary protection.

Product, Medicinal Product, Basic Patent: The Relationship of Concepts in Regulation 469/2009 Overlooked by the CJEU

The CJEU Santen judgment defined the concept of a product for the purposes of Regulation 469/2009 on the supplementary protection certificate for medicinal products (Regulation (EC) No. 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (Codified version), [2009] OJ L152/1, as last amended by Regulation (EU) 2019/933 of 20 May 2019, [2019] OJ L153/1). Leaving aside the practical implications of this judgment in terms of the possibility of obtaining a supplementary protection certificate for a product protected by a patent for a second or further medical application (“application patent”), it is worth considering the reasoning the Court relies on to arrive at the thesis it formulates. While the Court’s response and the resulting impact will be treated differently depending on whether the actual extension of patent protection in the pharmaceutical industry is assessed as appropriate and desirable or whether the justification for said protection is questioned, the manner in which the provisions of Regulation 469/2009 are proposed to be interpreted raises doubts as to whether the final outcome of the interpretation is correct.

Changing paradigm of supplementary protection of inventions in the national legislation of Ukraine

Key words: patent term extension, supplementary protection, supplementary protectioncertificate, drug patents, patent legislation reform The article is mainly aimed at distinguishingtwo mechanism: patent term extension which used to be applied inUkraine before the patent reform, and supplementary protection certificates whichwere introduced to national legislation in 2020.Patent term extension in the way it was provided in the Ukrainian Patent Law is arather simple mechanism that didn’t require much regulations. It used to provide additionalperiod of patent monopolies which was equal to the period which elapsed betweenthe date on which the patent application was filed and the date of the marketingauthorisation, not more than 5 years. Since there were no limitation on the type ofpatent (basic patent) or requirement of the first marketing authorization, this regimeprovided an opportunity to extend not only basic patent term, but also all secondarypatents related to one drug. This created a situation when duration of patent monopolyfor one drug exceeded 35 years.Provided that national pharmaceutical industry is oriented on manufacturing ofgeneric drugs, supplementary protection certificates are more appropriate forUkraine. Firstly, this is due to the limitation of effective patent life to 15 years whichis more feasible considering the national context. Another positive thing about SPCsis some uncertainty in relation to definition of the subject matter and scope of SPCprotection. That means that the country can have some freedom in determining theways of its interpretation. However, it should be noted that such indeterminacy is agrey zone. Thus, it is necessary to consider how the country can benefit from the supplementaryprotection regimen. Since the pharmaceutical sphere is very sensitive,the SPC issues have direct effect on public health and access to treatment. So, the articlejustifies the general idea that implementation of new legislation provisions shallbe aligned with both ensuring pharmaceutical innovations and guaranteeing that thepublic health needs are still a priority. Therefore, considering the long-term negativeeffect of the patent term extension regimen, the new SPC approach should be as balancedas possible.

TEVA UK LIMITED v GILEAD SCIENCES, INC

H1 Supplementary protection certificates – Anti-retroviral medication – Validity – Combination of active ingredients – Construction of art. 3(a) of the SPC Regulation – Whether product “protected by the basic patent in force” – Whether extent of protection the relevant test – Issue referred to Court of Justice – Interpretation and application of judgment of Court of Justice – Appeal to Court of Appeal

Analysis of the strength of patents of russian research institutions

This paper study problem of the efficiency of management of intellectual property (IP) of research institutes and universities, proposes criteria and method of an assessment of the patent strength. The basic patent index and the average strength of patents were calculated for the institutes of SB RAS, Novosibirsk State University (NSU), Indian Institutes of Technology Delhi, and PJSC “Sibur Holding”. The results showed that the IP of institutes and NSU has a low level of protection, which explains its low demand in the market. The average strength of patents and the basic patent index are the indicators that can be recommended for inclusion into the reporting indices of the efficiency of management of IP of research institutes and universities.

Teva UK Ltd v Gilead Sciences Inc

Supplementary protection certificates – Anti-retroviral medication – Validity – Combination of active ingredients – Construction of art.3(a) of the SPC Regulation – Whether product “protected by the basic patent in force” – Whether extent of protection the relevant test – Issue referred to Court of Justice – Interpretation and application of judgment of Court of Justice

Synthetic Biology Research and Innovation Profile 2018: Publications and Patents

A profile of synthetic biology research and innovation is presented using data on publications and patents worldwide and for the UK and selected benchmark countries. The search approach used to identify synthetic biology publications identifies a core set of synthetic biology papers, extracts and refines keywords from these core records, searches for additional papers using those keywords, and supplements with articles published in dedicated synthetic biology journals and curated synthetic biology special collections. For the period from 2000 through to mid-July 2018, 11,369 synthetic biology publication records are identified worldwide. For patents, the search approach uses the same keywords as for publications then identifies further patents using a citation-tree search algorithm. The search covered patents by priority year from 2003 to early August 2018. Following geographical matching, 8,460 synthetic biology basic patent records were identified worldwide. Using this data, analyses of publications are presented which look at the growth of synthetic biology outputs, top countries and leading organizations, international co-authoring, leading subject categories, citations, synthetic biology on the map of science, and funding sponsorship. For patents, the analysis examines growth in patenting, national variations in publications compared with patenting, leading patent assignees, and the positioning of synthetic biology on a visualized map of patents.

Sandoz & Hexal v Searle & Janssen Sciences Ireland: What is the formula for patent term extensions?

In Sandoz Ltd & Hexal AG v G.D. Searle LLC & Janssen Sciences Ireland UC [2017] EWHC 987 (Pat), the UK High Court held that an active ingredient in a pharmaceutical product that was claimed only by reference to a Markush formula and not expressly referred to in the patent was “protected” by a basic patent for the purposes of obtaining a patent term extension under the European Union Supplementary Protection Certificate Regulations. This decision will be welcomed by practitioners in adding some clarity to the interpretation of previous decisions of the Court of Justice of the European Union relating to the definition of what is protected by a basic patent in this extremely commercially important and fast-moving area of jurisprudence. The implication of this decision is discussed further in this report.

Predictability and KSR's Fundamental Change to Nonobviousness in Patent Law

In KSR International Co. v. Teleflex, Inc., the Supreme Court addressed the doctrine of nonobviousness, the ultimate question of patentability, for the first time in thirty years. In mandating a flexible approach to deciding nonobviousness, the KSR opinion introduced two predictability standards for determining nonobviousness. The Court described predictability of use (hereinafter termed "Type I predictability" )-whether the inventor used the prior art in a predictable manner to create the invention-and predictability of the result (hereinafter termed "Type II predictability")-whether the invention produced a predictable result-both as a means for proving obviousness. Although Type I predictability is easily explained as part of the flexible approach endorsed by KSR, Type II predictability represents a potentially radical shift in the nonobviousness doctrine. Instead of focusing on whether reasons already existed to create the invention, like Type I predictability does, a Type II predictability analysis takes the invention's creation as a given and examines instead the invention's operation. Type II predictability moves the analysis away from the gap between the prior art and the invention to the invention only. The United States Patent and Trademark Office ("USPTO"), the Federal Circuit, and lower courts are using Type II predictability fairly extensively after KSR. The problem with this usage is that Type II predictability runs counter to statutory language, introduces hindsight bias, discriminates against certain technologies, and conflicts with basic patent theory. Accordingly, the USPTO and courts need to reconsider the use of Type II predictability and their interpretation of KSR.