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Evergreening and patent cliff CRISPR/Cas9 system and gene Being equitable about hangers editing tools equivalents Ove Granstrand Thomas Hedner and Jean Lyckel John Hornby Page 4 Page 12 Page 24 Second medical use claims Do rules experience culture The patentability of Dosage and scope of protection shock? Regimes Clara Berrisch Lisa West Åkerblom Ester-Maria Elze Page 38 Page 48 Page 60 Safeguarding public health In pursuit of Robinson Crusoe The CJEU clarifies the effects in the wake of hegemonic Kristina Björnerstedt of skinny labelling intellectual property rights and Gunnel Nilsson Sofia Bergenstråhle Katarina Foss-Solbrekk Page 94 and Valter Gran Page 76 Page 98 Editorial Preface “Some industries are different but some are more different than others. The discusses how developing countries’ access to medicines is EDITOR-IN-CHIEF pharmaceutical industry fits the latter category” (Scherer 1996:336). There is impeded by the patent system as well as how flexibilities in really no other industry where the nature of the products, the economics of the international and national legal framework contribute Silvia A. Carretta research and development as well as the market structure and the societal to this end. The article shows that while exceptions to implications of the industry’s strategic decisions are as unique as in the patent rights might not be as effective, they have however pharmaceutical industry. Furthermore, there is no other industry that tests triggered a very interesting development of voluntary the boundaries and effects of intellectual property (IP) rights on a national and licensing, a company-centered initiative providing access international level as the pharmaceutical industry. to free or low-priced pharmaceuticals. Thus, instead of The current issue of the Stockholm IP Law Review provides an eloquent addressing public health concerns by means of compulsory presentation of pharma-related IP challenges exploring these from different licensing and generic alternatives, the pharma industry angles and perspectives. itself takes the responsibility to provide pharma with Genetic engineering is one of the major challenges in modern pharmaceutical affordable modern medicines. research. It opens up for revolutionary therapeutic applications and represents Commercializing pharmaceutical products is of course EDITOR considerable commercial value. CRISPR technology is a central technological not only about exclusive rights for the technology. Choosing development in this respect, being also the subject-matter of intensive patenting an appropriate name for a new product is a daunting task. Aida Conde activity and patent-related disputes. Thomas Hedner and Jean Lycke explore In other industries, this is usually left to the creativity of the extensive technological potential of CRISPR innovations as well as the the marketing department but in the pharmaceutical patent landscape in the field and discuss future trends in what may be expected industry there is a considerable regulatory framework to to be a central area of future medicinal research. take into account. The practical implications of this frame- Defining the concept of invention is without a doubt a challenge in the pharma- work and its limitations on creativity in pharma branding ceutical sector. A new revolutionary invention might today consist of a new is analyzed in Kristina Björnerstedt and Gunnel Nilsson’s dosage regime or a second medical indication. Ester-Maria Elze discusses in her article. article how the novelty and inventive step requirement apply to dosage patents Chemical molecules, gene sequences, patient security, as well as the difficulties connected to their interpretation and enforcement expensive and lengthy research, international markets, on a national level. Claim drafting as well as enforcement of second medical innovative business models and prioritized public health CONTACT US PUBLICATION OFFICER Do you want to publish in the review? indication patents are a complicated matter. Enforcement of second medical concerns constitute necessary ingredients influencing the For ordering, general comments and indication patents in Germany provides an interesting illustration of the diffi- way the IP system is applied and interpreted in the pharma Anna Sfetsiou questions please contact us at culties of patent claim interpretation. As Clara Berrisch notes in her article, sector. And it is this unique interaction that makes pharma [email protected] shaping the protection of second medical indication patents is still a work in so special. CONTENT EDITORS progress. Frantzeska Papadopoulou Åsa Hellstadius John Hornby analyses UK case-law concerning the application of the Actavis Åsa Hellstadius & Frantzeska Papadopoulou equivalence test. He concludes that the balance has clearly been shifted in the BOARD OF DIRECTORS UK in the direction of legal uncertainty. Parties and their advisors are being left Associate Professor Frantzeska Papadopoulou, Department of Law, to distil some generalized (though perhaps not amorphous) idea of what the Stockholm University extent of a patent’s protection might be. A major challenge of exercising exclusive rights in the pharmaceutical sector Associate Professor Åsa Hellstadius, Department of Law, Stockholm concerns how pharmaceuticals are sold. Applying for a patent is not the only University nor the last thing a product owner has to do before placing the product on the EDITOR Lisa West Åkerblom Jur. Dr. Richard Wessman, market; pharmaceutical products need to successfully go through the stringent Counsel Advokat, Vinge Law Firm and time-consuming marketing authorization procedure. As a compensation for the time spent between the patent application and the actual commercialization Associate Professor Marcus Holgersson, Chalmers date, the Supplementary Protection Certificate (SPC) Regulation provides an up University of Technology to five-year exclusive right. The scope of this right and in particular the inter- pretation of article 3(a) of the SPC Regulation, and the definition of the term Mats Lundberg, Managing Partner and Managing Director, Groth & Co “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 WEBPAGE www.stockholmiplawreview.com transplantation from their American counterparts. The interface between PROGRAM DIRECTOR PROGRAM DIRECTOR patent rights and marketing authorization, in particular with respect to skinny CO-FOUNDER CO-FOUNDER TWITTER labelling is also in focus in the recent CJEU case of Warner Lambert Company, Frantzeska Papadopoulou Åsa Hellstadius twitter.com/siplawreview analyzed in the case note by Sofia Bergenstråhle and Valter Gran. EDITOR GRAPHIC DESIGN AND PRODUCTION The interplay between regulatory law and exclusive rights from an economic Katherine Galilee Jojo Form perspective is further explored by Ove Granstrand, who writes about the strategy General note on copyright: of evergreening employed by pharmaceutical companies, with specific focus on Stockholm IP Law Review has obtained the Losec case. Evergreening is generally the extension of the duration of an the consent from the copyright existing temporary monopolistic or market dominant position by various means owners of each work submitted for and published in this issue. or strategies. The societal effects of patent protection of pharmaceutical products in parti- ISSN 2003-2382 cular on the international level are non-negligible. Katarina Foss-Solbrekk – 3 – STOCKHOLM INTELLECTUAL PROPERTY LAW REVIEW VOLUME 2, ISSUE 1, JUNE 2019 ISSN 2003-2382 Evergreening and patent cliff hangers1 By Prof. Ove Granstrand, Chalmers Univ. (Dept of Mathematical Sciences) and Cambridge Univ. (Centre for Technology Management) 1. PROBLEM BACKGROUND 1.3 The evergreening approach 2. EVERGREENING DEFINED AND 2.2 How evergreening is used 1.1 A tragic windfall Thus, all in all, extending the effective patent protection DESCRIBED This paper aims to explore the phenomenon of evergreen- of Losec and its successor Nexium in a second product ing by means of IP strategies in general, and patent strate- The tragic 9/11 events in 2001 implied a delay in the court 2.1 Evergreening defined generation, i.e. what is referred to as evergreening, brid- gies in particular. If, e.g., an innovation through wide- proceedings in Boston that dealt with a case involving Evergreening in a general sense refers to the extension of ging the patent cliff had become a strategic issue for AZ spread adoption and diffusion has led to a high growth AstraZeneca and its blockbuster drug Losec (Prilosec in the duration of an existing temporary monopolistic or with powerful incentives to invent various strategies to rate in a market with a low rate of technological substitu- the US). The key basic patent for this drug had been received market dominant position by various means or strategies. that effect. tions, high switching costs and steep learning curves, by the Swedish company Astra in the US in 1981 (US We can then talk more specifically about evergreening of AZ is not a unique case in this respect and many firms then any prolongation of a dominant market position patent # 4.255.431, issued March 10, 1981). Astra later merged sales or profits from products, technologies, services and engage in various forms of evergreening. This is trouble- pays off handsomely. Traditionally evergreening involves with Zeneca in 1998-99, forming AstraZeneca (“AZ”). The equity.
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