Source: https://www.ip.mpg.de/de/personen/romandini-roberto.html
Timestamp: 2019-04-20 21:19:41+00:00

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Roberto Romandini obtained his degree in law from the University of Pisa and his LL.M. degree from the University of Munich with specialization in patent law. He wrote his Ph.D. thesis on the patentability of human stem cells at the Max Planck Institute for Intellectual Property and Competition Law. He then practiced IP Law at a leading IP law firm in Milan for 5 years. Since 2013 he has been working as Senior Research Fellow at the Max Planck Institute for Innovation and Competition in Munich. His special area of interest is European and international patent law, legal protection of biotechnological inventions, plant variety rights and trade secrets.
Die Patentierbarkeit von menschlichen Stammzellen - Eine vergleichende Betrachtung des europäischen, deutschen und italienischen Patentrechts (Schriftenreihe zum Gewerblichen Rechtsschutz), Heymanns, Köln 2012, 502 S.
Patentability of Pharmaceutical Inventions Under TRIPS: Domestic Court Practice as a Test for International Policy Space, in: Bryan Mercurio, Daria Kim (Hg.), Contemporary Issues in Pharmaceutical Patent Law - Setting the Framework and Exploring Policy Options (Routledge research in intellectual property), Routledge, London; New York 2017, 9 - 46 (gemeinsam mit Henning Grosse Ruse-Khan).
Developing a Common Patent System – Lessons to Be Learned from the European Experience, in: Elizabeth Siew-Kuan Ng, Graeme W. Austin (Hg.), International Intellectual Property and the ASEAN Way – Pathways to Interoperability, Cambridge University Press, Cambridge (UK) 2017, 254 - 290 (gemeinsam mit Reto M. Hilty).
Art. 3(a) SPC legislation: An analysis of the CJEU’s ruling in Teva (C-121/17) and a proposal for its implementation, GRUR Int 68, 1 (2019), 9 - 24.
Flexibilities Under TRIPS: An Analysis of the Proposal for Reforming Brazilian Patent Law, 15 J. Marshall Rev. Intell. Prop. L. 150-212 (2016).
Chapter 18.5 - Antibiotics, in: Roberto Romandini, Reto M. Hilty, Annette Kur (Hg.), Study on the Legal Aspects of Supplementary Protection Certificates in the EU - Final Report, European Commission, Brussels 2018, 435 - 447 (gemeinsam mit Pedro Henrique D. Batista).
This article examines the leeway the TRIPS Agreement grants to WTO Members to define their own standard of patentability in the field of pharmaceutical inventions. To this end, the contribution adopts an anecdotal approach: instead of abstractly analyzing the boundaries set by Article 27 TRIPS, it takes up specific questions related to patentability raised before national judges where the TRIPS consistency of a domestic practice or interpretation has been an issue. In this context, this article answers the questions whether or not Article 27 TRIPS allows for (i) denying composition claims for naturally occurring substances; (ii) ruling out absolute product protection in all or specific technical fields, and excluding from patent protection (iii) new forms of known substances when they do not show an improvement in known efficacy and (iv) new uses of known substances. The conclusions drawn on the above-mentioned issues are relevant for several reasons. De lege lata, they will outline the interpretative leeway national judges enjoy when applying their domestic patent laws. De lege ferenda, they will serve as examples for the flexibility WTO members have in reforming internal legislation to pursue specific national policy in the field of public health and pharmaceutical innovation. One might add that just because the TRIPS Agreement grants a specific flexibility to WTO members does not mean that in all instances it is sound policy to make use of it, or use it in a particular way. Whether and when this is the case depends on the aims and the context of a possible reform of the domestic legislation. A last section hence explores possible purposes and effects of some of the measures addressed.
Commentary to artt. 81 sexies-octies Italian Intellectual Property Code, in: Luigi Carlo Ubertazzi (Hg.), Commentario breve alle leggi su proprietà intellettuale e concorrenza, 5. Aufl., Cedam, Padova 2013, 390 - 394.
Commentary to artt. 81 ter Italian Intellectual Property Code, in: Luigi Carlo Ubertazzi (Hg.), Commentario breve alle leggi su proprietà intellettuale e concorrenza, 5. Aufl., Cedam, Padova 2013, 380.
Commentary to artt. 162 Italian Intellectual Property Code, in: Luigi Carlo Ubertazzi (Hg.), Commentario breve alle leggi su proprietà intellettuale e concorrenza, 5. Aufl., Cedam, Padova 2013, 702 - 705.
La durata del brevetto e dell'esclusiva, in: Massimo Scuffi, Mario Franzosi (Hg.), Il diritto industriale italiano, Vol. 1, Diritto sostanziale, CEDAM, Padova 2013, 703 - 710.
La disciplina del brevetto europeo nella fase nazionale, in: Massimo Scuffi, Mario Franzosi (Hg.), Il diritto industriale italiano, Vol. 1, Diritto sostanziale, CEDAM, Padova 2013, 729 - 766.
I modelli di utilità, in: Massimo Scuffi, Mario Franzosi (Hg.), Il diritto industriale italiano, Vol. 1, Diritto sostanziale, CEDAM, Padova 2013, 835 - 868.
Le facoltà esclusive conferite dal brevetto, in: Massimo Scuffi, Mario Franzosi (Hg.), Il diritto industriale italiano, Vol. 1, Diritto sostanziale, CEDAM, Padova 2013, 645 - 674.
Commentary to the Act n. 78/2006 - Implementation of the Directive 98/44/EU on the legal protection of the biotechnological inventions, in: Piergaetano Marchetti, Luigi Carlo Ubertazzi (Hg.), Commentario breve alle leggi su proprietà intellettuale e concorrenza - antitrust, concorrenza sleale, pubblicità marchi, brevetti, diritto d'autore, CEDAM, Padova 2007, 1368 - 1397.
Commentary to Article 50 of the Italian Intellectual Property Code, in: Vincenzo Piccarreta, Francesco Terrano (Hg.), Il nuovo diritto industriale - guida alla disciplina introdotta dal D.Lgs. 10 febbraio 2005, n. 30, Codice della proprietà industriale, Il sole 24 ore, Milano 2007, 150 - 158.
The ﬁeld of antimicrobials is considered to be facing a crisis. Increasing microbial resistance is creating a demand for new drugs, which however is not being matched by privately funded R&D. The reasons for this market failure are of a technical and economic nature. The present article analyzes what changes to IP- based incentives are conceivable in the European Union (EU) in order to address the antimicrobial crisis. Since the assessment of the suitability of the analyzed options depends on interdisciplinary research, this article also proposes a research agenda to be considered for the implementation of public policies in this ﬁeld.
Art. 3(a) SPC legislation: An analysis of the CJEU’s ruling in Teva (EUGH Aktenzeichen C-121/17) and a proposal for its implementation, GRUR Int 68, 1 (2019), 9 - 24.
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.
La brevettabilità del materiale biologico ottenuto da partenoti, Giurisprudenza italiana 8/9 (2016), 1897 - 1906.
Flexibilities Under TRIPS: An Analysis of the Proposal for Reforming Brazilian Patent Law, Review of intellectual property law 15, 2 (2016), 150 - 212.
This article analyses the proposal for reforming the Brazilian patent system pending before the Brazilian Parliament as Bill No. 5402/13. The proposed legislation addresses such issues as the assumed insufficiency of the inventive step requirement in preventing unjustified “monopolies”, the proliferation of so-called secondary patents, and the extension of market exclusivity positions through strategic filings, which are being debated also in Europe and the US. In analyzing the reform attempt, this article pursues two purposes. First, starting from the provisions of the Bill, it explores the flexibilities that WTO members enjoy under the TRIPS Agreement in designing rules and procedures in their patent acts. Second, it examines whether the changes proposed by Bill No. 5402/13 are consistent with its proclaimed goals, such as the aim to reserve patent protection only to “genuine innovations”, to hamper so-called “evergreening” practices by pharmaceutical applicants and to foster incremental innovations by domestic actors. Specific attention is given in this regard to the proposals to introduce: (i) as separate criteria for patentability a “significant technical advance” in all technological fields and an “enhanced efficacy” in the chemical sector; (ii) a general prohibition of use patents; and (iii) a pre-grant and post-grant opposition system.
La sentenza Brüstle sulla tutelabilità delle cellule staminali embrionali: implicazioni practiche e guiridiche, Rivista di diritto civile 58, II (2012), 336 - 350.
La distinzione tra brevetti e modelli di utilità: una diversa interpretazione della disciplina positiva, Rivista di Diritto Industriale 60, I (2011), 200 - 225.
Stellungnahme zum Referentenentwurf eines Gesetzes zur Anpassung patentrechtlicher Vorschriften auf Grund der europäischen Patentreform, 2016, 15 S. (gemeinsam mit Reto M. Hilty, Matthias Lamping).
Comments of the Max-Planck-Institute for Intellectual Property and Competition Law on the Preliminary Set of Provisions for the Rules of Procedure of the Unified Patent Court, 2013, 10 S. (gemeinsam mit Thomas Jaeger et al.).
This text is a re-formatted version of comments submitted by the Max Planck Institute for Intellectual Property and Competition Law in the public consultation on the 15th draft for Rules of Procedure for the Unified Patent Court conducted between June and October 2013. The comments focus on those Rules and do, in particular, not duplicate criticism for the Unitary Patent Package voiced elsewhere. Three fundamental aspects of particular importance for the functionality of the procedural regime are identified: Warranting uniformity, safeguarding autonomy and establishing an adequate balance of rights and obligations between the parties. The comments underline that, within the strict bounds imposed by the Unitary Patent Package, the Rules offer a well elaborated and substantially comprehensive framework for patent litigation procedures. Nonetheless, certain parts fall short of answering to the requirements imposed by the complexities of the system in which they are embedded. In particular, the Rules should not shy away from suggesting solutions in politically delicate areas if essential for the overall balance and functioning of the system. This concerns, for example, the exercise of discretion regarding the choice of options pursuant to Art. 33(3) UPC or the balancing of interests in the context of granting injunctive relief.
Supplementary Protection Certificates: What issues are now settled and which remain in flux?

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