Basic Patent Research Articles

SPC squatting

Abstract Supplementary protection certificates (SPCs) for pharmaceutical products are an important complement to patent protection which is often inadequate in commercial terms. SPCs are designed to ensure that originators can amortize their high investments in research and clinical trials. But unlike in the USA, for example, the European SPC is not simply a patent term extension. Rather, it is a unique form of intellectual property right whose subject matter is not the overall patented invention, but the active ingredient or combination of active ingredients of a patented and authorized pharmaceutical product. This link between the basic patent and market authorization has led to many questions of interpretation and Court of Justice of the European Union (CJEU) rulings since the SPC Regulation was adopted. An issue that has not yet been decided by the CJEU concerns the discrepancy between the ownership of the patent and the marketing authorisation under pharmaceutical law. This scenario, in which a patent proprietor relies on the marketing authorisation of a third party (possibly even a competitor) in said patent proprietor’s application for an SPC, is also referred to as “SPC squatting”. The following article discusses the admissibility of such a practice de lege lata, which also becomes relevant in light of current reform efforts by the legislator.

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.

Exploring new uses for existing drugs: innovative mechanisms to fund independent clinical research

BackgroundFinding new therapeutic uses for existing medicines could lead to safe, affordable and timely new treatment options for patients with high medical needs. However, due to a lack of economic incentives, pharmaceutical developers are rarely interested to invest in research with approved medicines, especially when they are out of basic patent or regulatory protection. Consequently, potential new uses for these medicines are mainly studied in independent clinical trials initiated and led by researchers from academia, research institutes, or collaborative groups. Yet, additional financial support is needed to conduct expensive phase III clinical trials to confirm the results from exploratory research.MethodsIn this study, scientific and grey literature was searched to identify and evaluate new mechanisms for funding clinical trials with repurposed medicines. Semi-structured interviews were conducted with 16 European stakeholders with expertise in clinical research, funding mechanisms and/or drug repurposing between November 2018 and February 2019 to consider the future perspectives of applying new funding mechanisms.ResultsTraditional grant funding awarded by government and philanthropic organisations or companies is well known and widely implemented in all research fields. In contrast, only little research has focused on the application potential of newer mechanisms to fund independent clinical research, such as social impact bonds, crowdfunding or public-private partnerships. Interviewees stated that there is a substantial need for additional financial support in health research, especially in areas where there is limited commercial interest. However, the implementation of new funding mechanisms is facing several practical and financial challenges, such as a lack of expertise and guidelines, high transaction costs and difficulties to measure health outcomes. Furthermore, interviewees highlighted the need for increased collaboration and centralisation at a European and international level to make clinical research more efficient and reduce the need for additional funding.ConclusionsNew funding mechanisms to support clinical research may become more important in the future but the unresolved issues identified in the current study warrant further exploration.

Innovation of traditional Chinese medicine compounds and patent layout strategy with Lianhua Qingwen Formula as example

The innovation and patent layout of traditional Chinese medicine compounds reflects the innovation level of the traditio-nal Chinese medicine industry to a certain extent. Lianhua Qingwen Formula was taken as an example to analyze the innovation and patent layout of traditional Chinese medicine compounds. The study first proposed an innovative technology system for traditional Chinese medicine compounds, and then analyzed the advantages and disadvantages of Lianhua Qingwen Formula in innovation and patent layout based on 56 patents and other relevant patents. The analysis results showed that Lianhua Qingwen Formula had the following characte-ristics in terms of patent layout. In terms of innovation technical route, the patented technical route of Lianhua Qingwen Formula was mainly based on the composition and preparation of granules as the first choice, followed by corresponding process improvements, new uses, and detection methods as the main improvement routes. In terms of the corresponding patent layout, the basic patent protection scope of Lianhua Qingwen Formula completely covered marketed drugs, and then took new functions as the main layout strategy for subsequent patent applications. With the advancement of modern technical means, the preparation process and testing methods have been optimized continuously. At the same time, the international patent layout was given the priority in domestic patent application. Based on the above characteristics, the study gave suggestions for follow-up innovation and patent work for Lianhua Qingwen Formula, so as to provide enlightenment for other traditional Chinese medicine companies in exploring original innovation of traditional Chinese medicine compounds, improving innovative methods, and enhancing the ability of patent layout of innovative achievements.

TEVA UK LIMITED v GILEAD SCIENCES, INC

Abstract 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

On-Label or Off-Label? Overcoming Regulatory and Financial Barriers to Bring Repurposed Medicines to Cancer Patients.

Repurposing of medicines has gained a lot of interest from the research community in recent years as it could offer safe, timely, and affordable new treatment options for cancer patients with high unmet needs. Increasingly, questions arise on how new uses will be translated into clinical practice, especially in case of marketed medicinal products that are out of basic patent or regulatory protection. The aim of this study was to portray the regulatory framework relevant for making repurposed medicines available to cancer patients in Europe and propose specific policy recommendations to address the current regulatory and financial barriers. We outlined two routes relevant to the clinical adoption of a repurposed medicine. First, a new indication can be approved, and thus brought on-label, via the marketing authorization procedures established in European and national legislation. Such procedures initiate a detailed and independent assessment of the quality and the benefit-risk balance of a medicinal product in a specific indication, benefiting both prescribers and patients as it reassures them that the scientific evidence is robust. However, the process of marketing authorization for new therapeutic indications entails a high administrative burden and significant costs while the return-on-investment for the pharmaceutical industry is expected to be low or absent for medicines that are out of basic patent and regulatory protection. Moreover, most of the repurposing research is conducted by independent or academic researchers who do not have the expertise or resources to get involved in regulatory procedures. A second option is to prescribe a medicine off-label for the new indication, which is managed at the national level in Europe. While off-label use could provide timely access to treatments for patients with urgent medical needs, it also entails important safety, liability and financial risks for patients, physicians, and society at large. In view of that, we recommend finding solutions to facilitate bringing new uses on-label, for example by developing a collaborative framework between not-for-profit and academic organizations, pharmaceutical industry, health technology assessment bodies, payers, and regulators.

Lies don't travel far: Article 3(c) of the SPC Regulation from a German perspective

Germany, Higher Regional Court of Düsseldorf, I-2 U 63/18, 15 March 2019 According to the Court of Justice of the European Union, Article 3(c) of the SPC Regulation precludes the holder of a patent on the basis of which a first SPC has been granted for an active ingredient thereby claimed from obtaining a second SPC for a combination if that active ingredient constitutes the sole ‘subject-matter of the invention’ (Case C-577/13) and the other active substance is not protected as such by the patent (Case C-443/12). However, this case law has raised questions that remain unanswered. In a recent decision, the Higher Regional Court of Düsseldorf sought to address the problem of how the ‘subject-matter of the invention’ is determined in case the patent is objectively incorrect. Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate (SPC) for medicinal products is a European piece of legislation in the larger context of patent term extensions. However, it is not a patent per se whose term is open for extension but rather a ‘part’ of it. This ‘part’ must be protected by the patent (Article 3(a) of Regulation No 469/2009) and relate to a ‘product’, which is defined in Article 1(b) of Regulation No 469/2009 as an active ingredient or combination of active ingredients of a medicinal product. However, the Court of Justice of the European Union (CJEU) does not seem to apply this definition in a strict or literal sense. Judge Meier-Beck of the German Federal Court of Justice (Bundesgerichtshof), writing extra-judicially (Meier-Beck, GRUR Int 2018, 657, 661), has suggested that the term ‘product’ is subject to a ‘valuation … under SPC law’. Therefore, if an active ingredient and a combination of that active ingredient and another substance have the same ‘value’ for the invention covered by the basic patent, Article 3(c) of Regulation No 469/2009 precludes the grant of a second SPC whenever one of them (either the active ingredient or the combination) has already been the subject of a first SPC. Now, the Higher Regional Court of Düsseldorf has put flesh on this suggestion to give a better understanding of how to tackle Article 3(c) of Regulation No 469/2009.

Looking for legal compromise in implementation the supplementary protection certificate

The implementation of supplementary protection of inventions on medicines need to search and to keep balance between the interests of patent holder and interests of society in such sensitive sphere as health care.The both Ukrainian drafts of law contains the article which regulates the grant of the SPC and determines the procedure. However, both drafts do not determine the basic patent for which the SPC could be granted. The big gap of the drafts is also the absence of scope of the patent rights for which the SPC could be granted. Basing on the EU experi­ence the scope of the SPC should be determined and restricted by the scope of the patent for which the first marketing authorization was granted in a market. We could not avoid the abuse of patent rights without such restriction. We also should link the right on SPC with the first appearance of medical product in the world market and its’ registration in national market in Ukraine. Ukraine should grant SPC on really innovative medical products which come to the national market not later then 1 year from the date of its’ first appearance in the market.The Article 220 of Association Agreement between Ukraine and EU determines that The Parties recognise that medicinal and plant protection products protected by a patent in their respective territory may be subject to an administrative authorisation procedure before being put on their market. They recognise that the period that elapses between the filing of the application for a patent and the first authorisation to place the product on their respective market, as defined for that purpose by the relevant legislation, may shorten the period of effective protection under the patent.The Parties shall provide for a further period of protection for a medicinal or plant protection product which is protected by a patent and which has been subject to an ad­ministrative authorisation procedure, that period being equal to the period referred to in paragraph 1, reduced by a period of five years.In the case of medicinal products for which paediatric studies have been carried out, and the results of those studies are reflected in the product information, the Parties shall provide for a further six-month extension of the period of protection referred to in para­graph 2 of this Article.Thus, the article determines only principles of SPC, all internal legal rules could by determined by the country-party itself. Ukraine should impellent id SPC only bas­ing on the same legal grounds like in EU.

Teva UK Ltd v Gilead Sciences Inc

Abstract 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

Art. 3(a) SPC Legislation: An Analysis of the CJEU’s Ruling in Teva (C-121/2017) and a Proposal for Its Implementation

On 25 July 2018 the Grand Chamber of the CJEU delivered the eagerly awaited decision on Art. 3(a) Reg. 469/2009 following the referral by Justice Arnold in Teva (C-121/2017). In answering the question what it means to be protected by the basic patent under Art. 3(a) Reg. 469/2009, the CJEU formulated a two-pronged requirement. In order to be eligible for a supplementary protection certificate (SPC) the product (i) must necessarily fall under the invention covered by the basic patent and (ii) be specifically identifiable in that patent. This further formula in the case law following Medeva (C-322/10) is open to a number of interpretations, the most restrictive of which is that the CJEU has adopted a core-inventive-advance test with the first prong and required an individual disclosure of the product with the second prong. This article proposes a purposive implementation of the decision which takes into account the policy goals underlying the CJEU case law. These goals are to prevent multiple SPCs for the same product in conjunction with a number of other active ingredients (“evergreening”), unless such combinations represent a “totally separate innovation” (C-443/12), and to prevent the grant of a certificate for monotherapy products that were developed by a third unrelated entity after the priority date of the basic patent. In order to achieve the first goal, an inventive-advance test is necessary, but also sufficient. In order to ensure the second goal, requiring a disclosure of the product in an individualized form is in some cases sufficient, but not necessary where the patentee has, after the priority date of the basic patent, developed the product and obtained the MA submitted in support of the application for a certificate. In view of the persistent lack of clarity of the case law, the article concludes with some thoughts on the role of the CJEU, the task of the lawmakers and the implication of the Unified Patent Court Agreement (UPCA) for the operation of the SPC system.

A Ray of Light in Muddy Waters? The CJEU Rules on Combination SPCs in C-121/17 Teva v Gilead

On July 25th 2018, the Court of Justice of the European Union (CJEU) rendered its decision in C-121/17 Teva v Gilead , and thereby delivered yet another judgement on the interpretation of crucial provisions in the Regulation No 469/2009 concerning supplementary protection certificates (SPCs) for medicinal products (the SPC regulation). This time the CJEU attempted to clarify the meaning of article 3(a) of the SPC regulation.Article 3 (a) requires that the “product” that is the subject of the SPC must be “protected by a basic patent in force”. Notwithstanding its central significance for SPC applicants, patent offices, attorneys and Courts, it has for many years not been clear what is exactly protected by a basic patent for SPC purposes, especially in applications where protection is sought for a combination of active ingredients of the medicinal product.To bring some clarity into these murky waters, a series of referrals for preliminary rulings have reached the CJEU in recent years under the Article 267 TEU procedure. This paper discusses C-121/17 Teva v Gilead, which presents the most recent decision by the CJEU in these matters.. (Less)

WS5-3 - Development of an HDAC/PI3K dual inhibitor in academia

We have developed an HDAC/PI3K dual inhibitor as a novel molecular target agent for cancer therapy. With supports of Ministry of Education, Culture, Sports, Science and Technology (MEXT) and Japan Agency for Medical Research and Development (AMED), the seed research has been developed for a non-clinical proof of concept (POC) study, non-GLP toxicity test and in vivo pharmacokinetics test towards clinical trials. We have applied to the United States and Europe for the basic patent as well as a novel method of the industrial manufacturing process of the drug via PCT. We have negotiated with drug industries for collaborative investigation or a license out now. During the process of a drug development, we have realized that, unlike pure scientific research, know-hows are required for inexperienced university researchers. In addition to research and development expenses, the know-how including strategies for both an intellectual property and a pharmaceutical affair, strategic technical assistance of the drug development and assistance of progress management are desired earnestly. Also, we have realized that the consciousness change of the university side including the action to a study being aware of an exit strategy was necessary, targeting not only academic value but also market value. To accelerate the drug development from university and from Japan, further enhancement of cooperation with industry, government and university is necessary.

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.

Comparative Analysis of the Extension Mechanisms of Medicine Patent: A Criticism of the Brazilian System

It states, through the comparison of patent systems, that the solution of the European system (and the Portuguese one, consequently), which is related to the limits of the problem posed in the previous paragraph, is more e_cient because it preserves the incentives for innovation – by predicting supplementary protection – but it limits the strategic use of the term of the patent application procedure and it avoids unreasonable extension of the exclusive shopping term, by predicting a maximum limit for this additional protection, as well as it predicts a material limit (content), when working with a new industrial law not derived from basic patent. What is a_rmed in the previous paragraph, as well as all the research proposed, starts from a value assertion, with the support of the theoretical framework used here - the jurist Joao Paulo Remedio Marques and the political economist Walter Eucken 1

Dr. S. Donald (Don) Stookey (1915–2014): Pioneering Researcher and Adventurer

Don Stookey was a special person by any measure: an unassuming optimist, eminent scientist and inventor, adventurer, and a beloved family man. Don Stookey, the father of glass-ceramics, was a pioneer in inducing and understanding internal nucleation phenomena in glass. His early work on dense opal glasses and photosensitive precipitation of gold and silver in glass led to an amazing series of inventions: Fotalite®, a photosensitive opal, chemically machined Fotoform® and Fotoceram®, and TiO2-nucleated Pyroceram™ products including missile nosecones and oven-proof cookware. He received a basic patent on glass-ceramics which was contested and affirmed in court. Don was able to demonstrate a clear photochromic glass that showed reversible darkening for thousands of cycles. This material became a fixture in the ophthalmic industry. He went on to invent a full-color polychromatic glass capable of yielding a permanent patterned and monolithic stained glass. In his life outside science, Don chaired an interfaith group that founded a home for the elderly in Corning. He was also a wilderness enthusiast, surviving a plane crash in the Arctic and two boat capsizings. Even In his later years, he continued fishing off the coast of Florida and on Lake Ontario, and went solo on a trip to the Patagonian Andes.

ELI LILLY & CO LTD v HUMAN GENOME SCIENCES, INC

H1 Supplementary Patent Certificate – Antibodies for use in the treatment of inflammatory diseases – Construction of art.3(a) of the SPC Regulation – Single active ingredient – Whether protected by basic patent – Whether infringement test applicable – Extent of invention – Whether protection available where active ingredient not specifically referred to – Whether functional definition sufficiently specific – Marketing authorisation obtained by third party – Reference to Court of Justice of the European Union – Interpretation of judgment of Court of Justice – Whether declaration appropriate

Analysis of minimum target prices for production of entecavir to treat hepatitis B in high- and low-income countries

BackgroundIn 2013, an estimated 686,000 people died from hepatitis B virus (HBV) infection worldwide. Mass treatment programmes for hepatitis B will require very low drug costs. International treatment guidelines recommend first-line monotherapy with either entecavir or tenofovir disoproxil fumarate (TDF). While the basic patent on TDF expires in 2017/8, entecavir is already generic in several countries, including the US. The chemical structure of entecavir is related to abacavir, which costs <$200 per person-year in low-income countries. MethodsThe clinical efficacy, chemical structures, daily doses, routes of chemical synthesis, costs of raw materials and patent expiry dates were analysed for entecavir and TDF. Costs of sustainable, generic production were calculated for entecavir, and compared with published originator and generic prices in high- and low-income countries. ResultsWith a daily dose of 0.5 mg, one year's supply of entecavir treatment requires <0.2g of active pharmaceutical ingredient (API) per person, estimated to cost $4/year, based on quotations of API production from generic suppliers. With an additional $20 per year for formulation/packaging and a 50% profit margin, entecavir was estimated to cost a minimum of $36/person-year, substantially lower than current originator and generic prices. Entecavir is no longer under patent protection in the USA, China, Brazil and South Africa, with European expiry in 2017. Given differences in daily dosing, production volumes for entecavir would be 600 times lower than TDF (300 mg once daily) for treating the same numbers of patients. ConclusionsMass treatment for hepatitis B with generic entecavir could be achieved at very low cost in all countries, provided that important projections can be met in terms of pricing for the API and finished dosage form.

Recent Decisions of the European Court of Justice of the European Union on Supplementary Protection Certificates: A Few Answers-Many Questions.

Recent Decisions of the European Court of Justice of the European Union on Supplementary Protection Certificates: A Few Answers-Many Questions.