Supplementary Protection Certificates 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.

Challenging the Refusal to Grant a Second Supplementary Protection Certificate

Challenging the Refusal to Grant a Second Supplementary Protection Certificate

Supplementary protection of intellectual property rights for medicines

The article discusses the issue of extending the legal protection of intellectual property rights for medicines. The research aims to provide a comprehensive overview of the problems related to the implementation of Supplementary Protection Certificates (SPCs) in national legislation and possible solutions. The study also seeks to draw conclusions and make proposals for improving the regulatory framework for the SPCs of medicines. The work utilizes general scientific and specialized methods of scientific cognition, including dialectical, formal-logical, systemic-structural, comparative legal, as well as modeling, analysis, and synthesis methods, which collectively contributed to the organization, planning, and conduct of the research. The study is based on scientific publications from databases and search systems (PubMed, JAMA, Scopus, Springer, BMC, Oxford Academic), international and national regulatory acts, statistical studies by international organizations (Precedence Research), patents for inventions related to medicines, recommendations by national government bodies, as well as prescriptions and guidelines from international and national experts. Considering the analysis of statistical data on the development and implementation of medicines, it has been determined that original biological medicines are a major factor in the rising prices of treating conditions such as diabetes, oncological diseases, and others. Examples of patents for medicines owned by global pharmaceutical companies (Gilead, Bayer Intellectual Property Gmbh, etc.) that have ensured their commercial success and competitive advantages are examined. It has been established that patent protection provides the right holder with the opportunity to maintain a monopoly in the market, thereby compensating for the time spent on the development and research of original medicinal products. Legislative approaches to regulating relationships concerning the supplementary protection of inventions related to medicines in the form of SPCs in Ukraine and the EU are identified. The exclusivity periods for regulatory data protection for medicines in the EU are outlined. Based on the conducted research, it is concluded that the application of the SPC mechanism is a tool to achieve a balance between the protection of intellectual property rights and access to original medicines. Timely entry of generics and biosimilars to the market contributes to reducing market prices but negatively impacts the profitability of manufacturers of original medicines. Attention is drawn to problematic aspects of the legislative implementation of the SPC mechanism in Ukraine, which leads to incorrect interpretation and implementation of relevant provisions and necessitates updating. In light of the aforementioned, there is an urgent need in Ukraine to implement, update, and improve the legislative mechanism for regulating SPCs.

Answering a challenging question: is the SPC Regulation still fit for purpose in a changed pharmaceutical industry?

Building on a technology-centric framework, this book questions whether the system of supplementary protection certificates (SPC) for medicinal products established in Europe in the 1990s is still fit for purpose in light of the current pharmaceutical innovation landscape. After comprehensively setting the stage by describing the legal and economic environment surrounding the pharmaceutical market, the book rapidly dives into in-depth analysis of regulatory texts and case law, establishing itself as a key reference for practitioners, scholars, judges and legislators in life sciences. Traditionally, the pharmaceutical industry was focused on patenting small-molecule medicines. Over the last decades, the industry has pivoted towards biotechnological medicinal innovation and is increasingly securing secondary patents for new indications, formulations, dosages and so forth. The SPC Regulation was built to serve the former model. The book aims to assess whether these technological developments and go-to-market patenting strategies challenge the nearly unchanged SPC system. The main output of the book is a systematic and well-balanced disentanglement of the case law surrounding the SPC Regulation, which lays out the evolution and inconsistency of the decisions of the Court of Justice of the European Union and their application to biotechnological medicinal products and secondary innovation. This technical differentiation benefits greatly from the scientific expertise of the book’s author and her ability to dissect said subject matter with ease and precision. The incorporation of historical materials, opinions by advocate generals, national judgments and summary tables augments the strength of the author’s arguments.

Revisiting the Framework for Compulsory Licensing of Patents in the European Union – Reflections on the European Commission’s Initiative

Abstract Within the scope of its initiative on ‘Compulsory Licensing in the EU’,8 the European Commission launched a call for evidence on 1 April 2022 and a public consultation on 7 July 2022 with the aim of gathering views from stakeholders. The objective of this initiative is to explore the possibility of revising the framework for compulsory licensing in the EU to make it more ‘adequately prepared and coordinated to tackle future crises’.9 The authors of this position paper welcome the Commission’s attempt to reinvigorate the public discourse on this important subject. Depending on the issue to be addressed and the extent of the Commission’s willingness to reform, different regulatory approaches are conceivable. Subject to compatibility with the principles of subsidiarity and proportionality, these include: Rather than making concrete recommendations on the regulatory approach, this paper addresses selected aspects by way of a preliminary, non-exhaustive note on: the proposed reform’s scope and the grounds for a compulsory licence; the requirements of prior negotiation and licensing failure; government use; procedural matters; compulsory licences for patent applications and products; the relation with other regulations and sui generis regimes (i.e. trade secret protection, regulatory data protection and supplementary protection certificates); the concept of adequate remuneration; compulsory licences for European patents with unitary effect; and the exhaustion of products placed on the market under a compulsory licence. – soft law measures, such as guidelines and recommendations; – harmonisation of national laws (substantive and/or procedural);10 – judicial cooperation (i.e. mutual recognition of judgments and of decisions in extrajudicial cases);11 – centralisation of granting and/or judicial review competences; – creation of a supranational compulsory licence; – or any combination thereof.

The Supplementary Protection Certificate for Medicinal Products: Recent Developments and Outlook

The Supplementary Protection Certificate for Medicinal Products: Recent Developments and Outlook

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.

Supplementary Protection Certificates in Europe: Clarity at Last?

Supplementary Protection Certificates in Europe: Clarity at Last?

Revocation of a Supplementary Protection Certificate after Expiry

Journal Article Revocation of a Supplementary Protection Certificate after Expiry Get access GRUR International, Volume 70, Issue 8, August 2021, Pages 782–785, https://doi.org/10.1093/grurint/ikab075 Published: 21 June 2021

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.

Brexit – The Consequences for Pharmaceutical Patents and Supplementary Protection Certificates

Now that the UK has left the EU, and the transition period following this departure is over, we have a clearer view on the implications of Brexit on intellectual property rights and the consequences for UK based pharmaceutical companies.  Although little has changed for UK applicants wishing to obtain a European patent via the European Patent Office, the UK’s withdrawal from the Unified Patent Court and Unitary Patent is a huge blow to the realisation of the long awaited Unitary Patent system.  Meanwhile, breaking away from the EU has also had effects on how UK pharmaceutical companies can apply for supplementary protection certificates (SPCs), with further intricacies due to the Northern Ireland Protocol.  The introduction of a new manufacturing waiver for medicinal products protected by SPCs in the UK and EU will allow pharmaceutical companies more leeway with regards to stockpiling and export provisions. Perhaps most interesting of all is how UK and EU laws will diverge over the following years, now that the UK is no longer under the jurisdiction of the Court of Justice of the European Union.

Przywilej produkcyjny (SPC MW) i jego wpływ na interes społeczny w zakresie zdrowia publicznego

The length of innovative medicinal product protection time is related to the economic interest of the pharmaceutical companies and the interest in public health. To perform the tasks of patent protection of medicinal products, bearing in mind the interest in the field of public health, its maximum length must be determined by law. Due to the applicable law, the actual term of protection of innovative medicinal products is extended to the benefit of producers of innovative drugs. Regulation (EU) 2019/933 of the European Parliament and of the council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products introduces a legal instrument, supplementary protection certificate manufacturing waiver (SPC MW), implementing the limits of the maximum duration of legal protection granted based on the supplementary protection certificate (SPC). According to estimated data, SPC MW may bring savings of the European public health sector in the amount of EUR 3.1 billion and savings of the National Health Fund in the amount of PLN 500 million annually. However, a final assessment of the economic and social impact on public health will only be possible after the entry into force of the new legal instrument.

Sertifikat o dodatnoj zaštiti - nedavne odluke suda pravde Evropske Unije

In recent years, public health systems in high-income countries have been heavily exposed to pressures due to high drug prices. High drug prices are affected by market monopolies that pharmaceutical companies have thanks to patents, i.e. the exclusive rights granted to them for drugs. An additional factor affecting high drug prices is the extended forms of intellectual property protection, including the extension of the exclusivity period after the expiration of a patent for medical devices. The supplementary protection certificate as a form of a supplementary protection for pharmaceutical products in the European Union is regulated by the Regulation 469/2009. This form of protection is also known in the national patent regulations. Since the entry into force of the Regulation 469/2009, there has been debated the question of whether the supplementary protection certificate should be available for new therapeutic uses of previously approved active ingredients. In addition, the subject of interpretation was also the Article 3(a) of the Regulation 469/2009 requiring that the "product" (i.e. the active ingredient or combination of active ingredients) being the subject matter of the SPC application, should be "protected by the basic patent". The author analyzes several important decisions of the EU Court of Justice, with an emphasis put on the recent verdicts in both the "Santen" and "Royality Pharma" cases. In the grounds of these cases, there have widely been discussed the issue concerning the encouragements given to pharmaceutical companies being involved into medical researches in order to stimulate their investment into innovation treatments.

Interpretation of ‘Product’ Under Arts. 1(b) and 3(d) of the SPC Regulation

Interpretation of ‘Product’ Under Arts. 1(b) and 3(d) of the SPC Regulation

Scope of Protection of Supplementary Protection Certificates

Scope of Protection of Supplementary Protection Certificates

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.

The export and stockpiling waivers: new exceptions for supplementary protection certificates

Supplementary protection certificates (SPCs) play a central function in the balance between innovation and competition in the European pharmaceutical sector. SPCs have a crucial importance for the pharmaceutical industry, since 86 per cent of the new drug products introduced in the European Union (EU) have an SPC in at least one country, and on average an SPC in 18–19 countries.1 For 49 per cent of medicines, SPCs and regulatory data protection are the last exclusivity to expire, while patents account for the other 51 per cent.2 SPCs redress the loss of exclusivity that patent holders experience as a result of the pharmaceutical development and marketing authorization processes.3 Once the patent term expires, an SPC grants temporary exclusivity for a maximum period of 5 years, or 15 years from the marketing of the active ingredient. The rationale is that, without SPCs, the period that elapses between the filing of a patent and the market authorization would be insufficient to recover the investment sunk into pharmaceutical research and development.4 Moreover, SPCs are also intended to incentivize research in new active ingredients and, by doing so, strengthen the innovative industry.5

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.

The Export and Stockpiling Waivers: New Exceptions for Supplementary Protection Certificates

Regulation (EU) 2019/933 of 20 May 2019 enacted two new exceptions applicable to supplementary protection certificates. Pursuant to these exceptions, and during the pendency of a certificate, it is possible to manufacture in the European Union with the goal to export to third countries where no patent protection exists, and it is also possible to manufacture and stockpile generic versions of a product protected by a certificate as to enable entry into the market as from day one after the expiration of the certificate. The objectives of the new Regulation touch the core of the economics of the pharmaceutical industry in terms of competitiveness, entry to market, job creation and public health protection. The impact is estimated in billions of Euros and tens of thousands of new jobs. The effect goes beyond Europe since one of the exceptions is intended to satisfy the needs of third countries. Moreover, the normative model developed may be transplanted by countries adopting similar types of sui generis exclusivity. This article examines the new legal regime and the legal challenges ahead.