Issue #1 – 2019

Editorial Preface

“Some industries are different but some are more different than others. The pharmaceutical industry fits the latter category” (Scherer 1996:336). There is really no other industry where the nature of the products, the economics of research and development as well as the market structure and the societal implications of the industry’s strategic decisions are as unique as in the pharmaceutical industry. Furthermore, there is no other industry that tests the boundaries and effects of intellectual property (IP) rights on a national and international level as the pharmaceutical industry. The current issue of the Stockholm IP Law Review provides an eloquent presentation of pharma-related IP challenges exploring these from different angles and perspectives. Genetic engineering is one of the major challenges in modern pharmaceutical research. It opens up for revolutionary therapeutic applications and represents considerable commercial value. CRISPR technology is a central technological development in this respect, being also the subject-matter of intensive patenting activity and patent-related disputes. Thomas Hedner and Jean Lycke explore the extensive technological potential of CRISPR innovations as well as the patent landscape in the field and discuss future trends in what may be expected to be a central area of future medicinal research. Defining the concept of invention is without a doubt a challenge in the pharmaceutical sector. A new revolutionary invention might today consist of a new dosage regime or a second medical indication. Ester-Maria Elze discusses in her article how the novelty and inventive step requirement apply to dosage patents as well as the difficulties connected to their interpretation and enforcement on a national level. Claim drafting as well as enforcement of second medical indication patents are a complicated matter. Enforcement of second medical indication patents in Germany provides an interesting illustration of the difficulties of patent claim interpretation. As Clara Berrisch notes in her article, shaping the protection of second medical indication patents is still a work in progress. John Hornby analyses UK case-law concerning the application of the Actavis equivalence test. He concludes that the balance has clearly been shifted in the UK in the direction of legal uncertainty. Parties and their advisors are being left to distil some generalized (though perhaps not amorphous) idea of what the extent of a patent’s protection might be. A major challenge of exercising exclusive rights in the pharmaceutical sector concerns how pharmaceuticals are sold. Applying for a patent is not the only nor the last thing a product owner has to do before placing the product on the market; pharmaceutical products need to successfully go through the stringent and time-consuming marketing authorization procedure. As a compensation for the time spent between the patent application and the actual commercialization date, the Supplementary Protection Certificate (SPC) Regulation provides an up to five-year exclusive right. The scope of this right and in particular the interpretation of article 3(a) of the SPC Regulation, and the definition of the term “product”, are according to Lisa Åkerblom’s article one of the most complicated aspects of the Regulation and the result of a “cultural shock” and a less successful transplantation from their American counterparts. The interface between patent rights and marketing authorization, in particular with respect to skinny labelling is also in focus in the recent CJEU case of Warner Lambert Company, analyzed in the case note by Sofia Bergenstråhle and Valter Gran. The interplay between regulatory law and exclusive rights from an economic perspective is further explored by Ove Granstrand, who writes about the strategy of evergreening employed by pharmaceutical companies, with specific focus on the Losec case. Evergreening is generally the extension of the duration of an existing temporary monopolistic or market dominant position by various means or strategies.

The societal effects of patent protection of pharmaceutical products in particular on the international level are non-negligible. Katarina Foss-Solbrekk discusses how developing countries’ access to medicines is impeded by the patent system as well as how flexibilities in the international and national legal framework contribute to this end. The article shows that while exceptions to patent rights might not be as effective, they have however triggered a very interesting development of voluntary licensing, a company-centered initiative providing access to free or low-priced pharmaceuticals. Thus, instead of addressing public health concerns by means of compulsory licensing and generic alternatives, the pharma industry itself takes the responsibility to provide pharma with affordable modern medicines. Commercializing pharmaceutical products is of course not only about exclusive rights for the technology. Choosing an appropriate name for a new product is a daunting task.

In other industries, this is usually left to the creativity of the marketing department but in the pharmaceutical industry there is a considerable regulatory framework to take into account. The practical implications of this framework and its limitations on creativity in pharma branding is analyzed in Kristina Björnerstedt and Gunnel Nilsson’s article. Chemical molecules, gene sequences, patient security, expensive and lengthy research, international markets, innovative business models and prioritized public health concerns constitute necessary ingredients influencing the way the IP system is applied and interpreted in the pharma sector. And it is this unique interaction that makes pharma so special.

Åsa Hellstadius & Frantzeska Papadopoulou

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Evergreening and patent cliff hangers

– By Prof. Ove Granstrand –

The tragic 9/11 events in 2001 implied a delay in the court proceedings in Boston that dealt with a case involving AstraZeneca and its blockbuster drug Losec (Prilosec in the US). The key basic patent for this drug had been received by the Swedish company Astra in the US in 1981 (US patent # 4.255.431, issued March 10, 1981). Astra later merged with Zeneca in 1998-99, forming AstraZeneca (“AZ”). The delay in court proceedings in 2001, due to the unexpected and time-consuming involvement of the court in the 9/11 events, implied in turn that competitive entry of generica into the Losec market was also delayed. At this time media circulated an undemented estimate of 200 MUSD as the monthly profits reaped by AZ from this drug. These profits were to be heavily reduced by competitive entry which was sure to take place as soon as possible after the key patent expired, as generic drug manufacturers had prepared their ”springboards” for entry into this lucrative market.

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CRISPR/Cas9 system

– By Thomas Hedner and Jean Lycke –

ABSTRACT

The CRISPR/Cas9 discovery has emerged as a powerful technology tool to edit genomes, which allows researchers, innovators and life science entrepreneurs to alter DNA sequences and modify gene function in a range of species. The simplicity, high efficiency and seemingly broad use of the CRISPR/Cas9 system has led to hopes that this disruptive technology may have the potential to transform important sectors of biotechnology and medicine. The technology will enable users to make changes in the sequence or expression of virtually any gene, cell type or organism. The rapid progress in the development of CRISPR/Cas9-based technologies over the past years has been extraordinary. In spite of that, many outstanding questions remain to be addressed, and potentially interesting applications as well as potential risks yet need to be explored. Without doubt, the rapid advances and extensive commercial applicability of the CRISPR technologies is likely to a have a societal impact within the decades to come. In medicine, recent and future advances in the applicability of Cas9-based systems for genome and epigenome editing are likely to advance the technology forward to therapeutic applications, in respect to treatment of a variety of human diseases. In biotechnology, these techniques may be exploited in several respects to the benefit of society at large. In the biosciences, the CRISPR technology may have significant applications to make changes in the genome of various forms of organisms, including cells of domestic animals, cells of plants and various crops, bacteria, viruses and other cells. The technology may also find a future use in “de-extinction” of various animals such as the woolly mammoth and passenger pigeon. The recent discoveries and developments have led to extensive patenting efforts, resulting in some major patent disputes. The extensive patenting may risk creating a scenario, which could hamper the further development of this technology and ultimately limit full value creation of this technology for major societal and industrial stakeholders.

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Being equitable about equivalents

– By John Hornby –

Has Lord Neuberger in Actavis 1 introduced “an amorphous general inventive idea” 2 test to determine UK patent infringement by equivalents? Are “inessential integers”, once found extremely rarely 3, now to be embraced as part of normal UK practice? Have UK patent claims become “a puzzle game”?4

1.Actavis v Eli Lilly [2017] UKSC 48.
2.The Swedish Doctrine of Equivalence (2011) by Professor Bengt Domeij, Uppsala University, top of page 3, available in English at http://uu.diva-portal.org/smash/get/diva2:391087/FULLTEXT01.pdf.
3.Patents for Inventions, Blanco White, 5th Edition, paragraph 2-111.
4.Napp v Dr Reddy’s [2016] EWCA Civ 1053 at paragraph 71 per Floyd L.J. “A patent specification is not intended to be a puzzle game in which the skilled person must come up with his own theory as to what degree of precision was intended by the patentee.”

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Second medical use claims

– By Clara Berrisch –

ABSTRACT

Second medical use patents and their claims do not only represent highly valuable inventions for both originator and generic pharmaceutical companies, but have also been a topic of debate for many years. In particular, this is due to the fact that these inventions were originally not patentable under the European Patent Convention (EPC) in 1973 and thus required a special claim formulation, known as a Swiss-type claim. The later codification of this judge-made law in the course of the revision of the EPC in the year 2000 resulted in a different claim formulation, referred to as EPC 2000 claims. Since then, the impact of these different formulations on the respective scopes of protection conferred by both claim types has been a source of controversy and as such, much discussed. More recently, with the rise of the European-wide patent litigation surrounding Warner-Lambert’s patent for a substance marketed as Lyrica®, second medical use claims have also been a hot topic when it comes to infringement. The national courts, which are responsible for the enforcement of patent law in Europe, have thus been faced with the question of the scope of protection conferred by second medical use claims. Concurrently, through their decisions, the national courts also shape the scope of protection. This article’s main focus is how second medical use claims and especially their scopes of protection have developed throughout the years. It will firstly provide short background on the importance of second medical use inventions and the necessity to allow their patentability. Following this, it will outline the origin of both Swiss-type and EPC 2000 claims while focussing on the differences in their respective scope of protection. Lastly, it will analyse the recent developments in German case law on patent infringement, as well as their impact on the scope of protection of second medical use claims.

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Do rules experience culture shock

– By Lisa West Åkerblom –

ABSTRACT

In order to stimulate product development and innovation in the pharmaceutical industry, the United States Congress in 1984 enacted Title II of the Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), also known as the Hatch-Waxman Act. One goal of the Hatch-Waxman Act was to extend patent life to compensate patent holders for a portion of the patent term lost while awaiting review of the safety and efficacy of the product by the Federal Drug Administration. Influenced by the United States, the European Union (EU) introduced legislation in 1992 offering the possibility for a patent holder to apply for an additional time of protection as compensation for the regulatory delays caused by marketing authorization procedures. This additional time period of protection is granted in the form of a Supplementary Protection Certificate (SPC), governed by an EU Regulation.1 As the subject matter protected by the SPC, the product is defined as “the active ingredient or combination of active ingredients of a medicinal product.”2 The term product within the context of the SPC Regulation is an independent term which cannot be equated with the patented invention or marketing authorization.3 The product for which the SPC is sought must be protected by a basic patent in force,4 which is also a condition for patent term extension in the United States.5 The interpretation of product and its relation to the patent in force is a central condition to determine if a certificate may be granted.6 There has been divergence in the application of this condition by the national courts and a stream of requests for preliminary rulings. Legal uncertainty in interpretation remains due to the lack of clear guidance from the Court of Justice of the European Union (hereinafter “CJEU”). This article examines the material condition of the SPC Regulation requiring that a product be protected by a basic patent, from its origin in the United States to the legislation and institutions of the European Union, in order to investigate rules as an institutional phenomenon. Do the issues of interpretation with Article 3(a) of the SPC Regulation arise at the fault of the borrowed material legal solution itself, or do they occur from transplanting the solution from its native environment into a new legal system? The answer as the reader will discover is both.

1.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 (hereinafter “SPC Regulation”).
2.SPC Regulation, article 1(b).
3.The German Association for the Protection of Intellectual Property, Journal of Intellectual Property Law & Practice, 2013, vol 8, no. 9, p. 723, citing German Federal Court of Justice (BGH), GRUR 2002, p. 415 Sumatriptan.
4.SPC Regulation, article 3(a).
5.Title 35 United States Code §156(a)(1).
6.SPC Regulation, article 3(a).

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The patentability of Dosage Regimes

– By Ester-Maria Elze –

ABSTRACT

Despite the therapeutical benefits of dosage regimes, being granted and securing patent protection for these types of inventions has always been difficult. Historically dosage regimes have generally been excluded from patent law as these were held to either lack industrial application or were caught by the medical methods exclusions arguing that these inventions unjustifiably imited the medical profession’s choice of clinical practices. In 2010, the Enlarged Board of Appeal of the European Patent Office however held that dosage regimes are no longer excluded as such under the European Patent Convention 2000. In the post-EPC 2000 era the challenge is instead for dosage regimes to fulfill the requirements of novelty and inventive step. In seeking to bring greater clarity to the field of dosage regimes, this article aims at establishing what is required in order to be granted and enforce dosage regimes patents in Europe. In order to offer strategies to practitioners and potential patentees in regards to litigation as well as Research & Development tailoring, this article additionally contributes to the existing literature by providing for the first time, an empirical study of dosage regime patent decisions of the European Patent Office.

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Safeguarding public health

– By Katarina Foss-Solbrekk –

INTRODUCTION

In a world with an estimated population of 7.6 billion, 2 billion people lack access to medicines that are imperative to their health and survival. 1 Consequently, 15,000 deaths per day (more than half of the 5.6 million children who died before their fifth birthday in 2016) could have been prevented with the provision of essential health services. 2 In total, the World Health Organisation (WHO) estimates that at least 18 million people die needlessly each year from medicinal inaccessibility. 3 The geographical distribution of those unable to access medicines is concentrated in developing countries (DC) and least developed countries (LDCs). As a result, the same disease with a 90% cure rate in America can have a 90% death rate in Africa. 4 While there are many conclusions that one may draw from these figures, one thing is clear: the inability to access medicines in DCs and LDCs remains a pressing global problem, and one that prevails despite the safeguards present under international law. International human rights law protects the right to health, including access to medicine. Additionally, international intellectual property (IP) law permits compulsory licenses (CLs), offering countries a means to circumvent intellectual property rights (IPRs) to preserve public health, given that the unaffordability of medicines is attributed mainly to patent rights. While it is true that patent rights do not solely inhibit medical accessibility (socio-economic and political factors also play a role) it is also true that patent rights granted under the multilateral legal agreement on ‘Trade-Related Aspects of Intellectual Property Rights’ (TRIPS) 5 allow pharmaceutical companies to inflate prices well above marginal costs, thereby undermining the right to health. (Continued in Article)

1.World Health Organization, “Access to Medicine Index 2018 – Methodology Report,” 6.
2.UNICEF & United Nations Inter-Agency Group for Child Mortality Estimation, “Child Mortality Estimates: Global and Regional Under-Five, Infant and Neonatal Mortality Rates and Deaths” 19th October 2017.
3.Statistics obtained from documentary “Fire in the Blood” directed by Dylan Mohan Grey,
released on the 12st of February 2013; Devi Sridhar, “Improving Access to Essential Medicines: How Health Concerns can be Prioritised in the Global Governance System,” Public Health Ethics 1, no. 2, (2008): 83.
4.Donald G. McNeil Jr, “As Cancer Tears Through Africa, Drug Makers Draw Up Battle Plan,” The New York Times, 7th October 2017.
5.Agreement on Trade-Related Aspects of Intellectual Property Rights, 15th April 1994,
Marrakesh Agreement Establishing the WTO, Annex 1C, Legal Instruments – Results of the Uruguay Round, 33 I.L.M 1197 (1994) (hereinafter ‘TRIPS’).

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In Pursuit of Robinson Crusoe

– By Kristina Björnerstedt and Gunnel Nilsson –

Naming pharmaceuticals is a topic that has been thoroughly investigated and buzzed around, and where the world’s expertise agrees on at least one thing. With today’s increasingly dense jungle of brands, combined with the famously strict regulations of authorities such as the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the WHO (World Health Organization), the naming of pharmaceuticals is a true challenge. A series of legal, regulatory, linguistic and market-oriented hurdles must be overcome, not to mention the limited number of letters in the alphabet. However, with sufficient persistence and experience, devising a new pharmaceutical name remains feasible. When a pharmaceutical company develops a new medicine or new medical equipment, clinical studies are performed, lasting from a few weeks, up to a year or more depending on the issue studied. These studies take place in four different phases. (Continued in Article)

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The CJEU clarifies

– By Sofia Bergenstråhle and Valter Gran –

INTRODUCTION

Where to draw the line between the protection of new innovations within the pharmaceutical area, on the one hand, and the generic companies’ right to enter the market on the other, has been subject to discussion in patent law for a long time. The innovative pharmaceutical companies’ right to exclusively capitalise on their innovative research stands against the generic pharmaceutical companies’ right to compete in the EU market, which will likely result in lower prices and thereby in advantages from a social economic point of view.

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