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BY-NC-ND 3.0 license Open Access Published by De Gruyter June 19, 2014

Nano is nano is nano or: nanotechnology – a European legal perspective

  • Christian Fulda

    Christian B. Fulda studied Law in Tübingen, Geneva, and Berlin (Humboldt University) and did his legal traineeship in Berlin and Brussels. He wrote his PhD with Prof. Tomuschat on Democracy and pacta sunt servanda in international public law at Humboldt University. He received scholarships from the German National Scholarship Foundation both for his legal studies and his PhD. Dr. Fulda was admitted to the bar in 2002 and was made partner with Jones Day in 2012. He advises international clients in particular on EU regulatory matters.

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    , Dorothée Weber-Bruls

    Dorothée Weber-Bruls studied Physics at the Goethe University in Frankfurt, Germany, with a major focus on solid state physics. For her PhD, with the title Electron phonon coupling in the Kondo regime, she conducted measurements at the Max Planck Institute and the Laue-Langevin Institute in Grenoble, France. After a short postdoc, she decided in 1992 to become a patent attorney. In 2009, she joined the international law firm Jones Day at the Frankfurt office as partner. In parallel, she lectures patent law since 2003 at the Goethe University of Frankfurt where she is also active in the alumni council representing the faculty of Physics. Dr. Weber-Bruls is also one of the trustees of the Museum of World Cultures in Frankfurt.

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    and Jochen Werth

    Jochen H. Werth studied Physics at the Gerhard Mercator University in Duisburg, Germany, with a major focus on computational physics. In his dissertation, which was supported by a scholarship of the German Research Foundation, he researched the interaction of electrically charged nano particles in suspensions using computer simulations. He was admitted as a German patent attorney in 2010 and joined Jones Day in 2011 as associate.

From the journal Nanotechnology Reviews

Abstract

In Europe, nanotechnology is perceived as one of the innovative technologies that may drive technological progress. At the same time, Europe historically has followed an approach to cautiously but proactively regulate new technologies, instead of taking a wait-and-see approach. This article discusses how the European legal system bridges the requirements of regulation and the opportunities of innovation. It focuses in particular on the question of the definition of nanotechnology, as any legislation has to start with a clear understanding of its scope, which typically is achieved by definitions. The article, in part 1, addresses the current state of play when it comes to regulation of nanotechnology in the European Union. In part 2, we discuss how nanotechnology is approached under the European patent system and how the upcoming new European patent system may see a convergence of innovation and regulation.

1 Nanotechnology in European regulation

1.1 Overview

Considering that nanotechnology is a relatively young technology, it is not surprising that the European legislator is still catching up with scientific developments. Nonetheless, as various products using nanotechnology already have reached the internal market of the EU, and as it is one of the objectives of the EU to ensure free movement of goods within the internal market, the EU legislator has introduced nanotechnology regulation, including definitions, in order to harmonize the approach of Member States to goods using nanotechnology, and to prevent barriers to trade within the EU.

There is no one single EU legislation covering each and every use of nanotechnology, which is attributable to the fact that a) historically, different product regulations have developed at different times, resulting in separate bodies of legislation for different products, and b) somewhat related to the different historical developments, different products require different legislation.

The European legislator has so far decided not to regulate the respective technological processes, i.e., the application of nanotechnology, but rather the outcome of such processes, i.e., the material that results from the application of nanotechnology – the nanomaterial. While currently only a few European legislative acts incorporate a definition of nanomaterial to enable specific provisions for nanomaterials, all acts do include a provision that the European Commission shall adapt the definition of engineered nanomaterials referring to technical and scientific progress or to definitions agreed at international level. Future legislation will (most likely) incorporate the new “Recommendation for a definition by the European Commission” discussed in more detail below, which would serve as a “ribbon” holding the various strands of regulation together.

1.2 Individual legislation

1.2.1 Regulation (EC) No. 1223/2009 of November 30, 2009 of the European Parliament and of the Council on cosmetic products (“Cosmetics Regulation”)

The new regulation for cosmetics was the first to include a definition for nanomaterials:

“Nanomaterial” means an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm [1].

The fact that the Cosmetics Regulation was the frontrunner among the European legislative acts dealing with nanotechnology was somewhat an historic coincidence: the regulation was up for adoption just shortly after the European Parliament had called for the introduction of a comprehensive science-based definition of nanomaterials in EU legislation [2]. We acknowledge, however, that cosmetic products were among the first to bring the use of nanomaterials to the attention of a wider public, and hence the legislator, thinking only of silver dioxide and titan dioxide used as blockers of UV light in skin products. The legislation explicitly acknowledges the existence of various definitions and the constant technical and scientific development and, therefore, empowers the European Commission to update the definition (without going through the full legislative process) [3].

The Cosmetics Regulation does not classify products containing nanomaterials as hazardous or otherwise restrict the use of nanotechnology in cosmetics, but takes a “transparency” approach: products containing a nanomaterial have to add the designation “(nano)” to the substance in the (mandatory) list of ingredients [4]. In addition, the fact that a product contains nanomaterials (as defined) has to be pre-notified to the European Commission [5], which allows the European Commission to track and control the use of nanomaterials in cosmetic products.

1.2.2 Commission Regulation (EU) No. 10/2011 of January 14, 2011 on plastic materials and articles intended to come into contact with food

Against the background of repeated health scares resulting from contaminated or manipulated food, it does not come as a surprise that another area of intense regulation is the food sector. The regulation for food packaging uses a different definition of nanomaterials:

“Engineered nanomaterial” means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates, or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale.

Properties that are characteristic of the nanoscale include:

Those related to the large specific surface area of the materials considered and/or specific physicochemical properties that are different from those of the non-nanoform of the same material.

This more expanded definition, compared with the definition in the Cosmetics Regulation, anticipated the adoption of a recommendation of the European Commission later that year.

1.2.3 EU Commission Recommendation of October 18, 2011 on the definition of nanomaterial

In October 2011, the EU Commission published a recommendation for a definition of nanomaterial [6] (the “Commission Recommendation”). As already evidenced by the title of the document, this recommendation – addressed to the Member States, EU agencies, and economic operators alike – is legally nonbinding but intended to serve as starting point for all future legislation.

The Commission stated that the definition should be used as a reference for identifying nanomaterials for legislative and policy purposes in the European Union. This definition will only become legally binding, when it is incorporated into legislation. In case it becomes part of legislation, then guidance to that legislation should be developed to indicate how requirements can be fulfilled. With its definition, the Commission solely intended to identify substances within a specific size range and explicitly did not aim to classify nanomaterials as inherently hazardous. The European Commission based its recommended definition mainly on a reference report by the European Commission Joint Research Centre and a scientific opinion by the Scientific Committee on Emerging and Newly Identified Health Risks.

The comprehensive definition reads [7]:

2. “Nanomaterial” means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm–100 nm.

In specific cases and where warranted by concerns for the environment, health, safety or competitiveness, the number size distribution threshold of 50% may be replaced by a threshold between 1% and 50%.

3. By derogation from point 2, fullerenes, graphene flakes, and single-wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.

4. For the purposes of point 2, “particle,” “agglomerate,” and “aggregate’” are defined as follows:

(a) “particle” means a minute piece of matter with defined physical boundaries;

(b) “agglomerate” means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components;

(c) “aggregate” means a particle comprising of strongly bound or fused particles.

5. Where technically feasible and requested in specific legislation, compliance with the definition in point 2 may be determined on the basis of the specific surface area by volume. A material should be considered as falling under the definition in point 2 where the specific surface area by volume of the material is >60 m2/cm3. However, a material which, based on its number size distribution, is a nanomaterial, should be considered as complying with the definition in point 2 even if the material has a specific surface area lower than 60 m2/cm3.

The Commission foresees a review of the definition by December 2014, particularly focusing on the appropriateness of the number size distribution threshold of 50%. In this context, it is worth mentioning that the Commission, when adopting the recommendation, acknowledged that there was no unequivocal scientific basis to suggest a specific value for the size distribution below which materials containing particles in the size range of 1 nm–100 nm are not expected to exhibit properties specific to nanomaterials. The Commission reported that the scientific advice was to use a statistical approach based on standard deviation with a threshold value of 0.15%. However, and here the political angle becomes apparent, the Commission pointed out that this would have resulted in a widespread occurrence of materials that would be covered by a threshold and recalled the need to tailor the scope of the definition for use in a regulatory context [8]. The recommendation of a higher threshold of 50%, and providing at the same time the leeway for a lower threshold if warranted by the specific requirements of a given legislation, is a nice example of political considerations trumping scientific recommendations.

It is further worth noting, from a technological perspective, that the Commission acknowledged that measuring the size and size distribution in nanomaterials is challenging in many cases and that different measurement methods may not provide comparable results. The Joint Research Center has accordingly been tasked (since February 2011) as repository for nanomaterials, which serves as benchmark for test results.

1.2.4 Regulation (EU) No. 528/2012 of the European Parliament and of the Council of May 22, 2012 concerning the making available on the market and use of biocidal products

On 22 May 2012, a new regulation for biocidal products was adopted (the “Biocidal Product Regulation”). This Biocidal Product Regulation was the first to include the new definition. The possibility to deviate from the 50% threshold as included in the Commission Recommendation was not adopted. Yet, the following sentence was included:

The Commission may, at the request of a Member State, decide, by means of implementing acts, whether a substance is a nanomaterial, having regard in particular to Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomaterial, and whether a specific product or group of products is a biocidal product or a treated article or neither.

This may open the possibility to define specific definition criteria for certain nanomaterials in biocides.

1.2.5 Proposal for a regulation on medical devices, amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009

Among the product-specific regulations, the one on medical devices is currently under review in the context of the so-called “Recast.” The Recast includes the proposal of a (directly applicable) Regulation on medical Devices (the “Draft MD Regulation”) [9]. The Draft MD Regulation also includes the new definition [10]. So far, the possibility to deviate from the 50% threshold in line with the Commission Recommendation has not been used in the Draft MD Regulation [11].

2 Nanotechnology in the European patent system

2.1 Overview

In the second half of 2015, extensive changes in the legal environment for patents in Europe are to be expected, having considerable impact on monopolizing inventions from the nanotechnology environment: With the “European patent with unitary effect,” for the very first time, the grant of single patents with uniform coverage of (almost) the entire territory of the European Union will be available. Even more groundbreaking, the introduction of the new “Unified Patent Court” will establish a new legal basis for patent enforcement, as well as invalidation. While patent law previously was in the domain of the Member States, albeit somewhat harmonized by the European Patent Convention (which is not part of the European Union legislation, but an international treaty going beyond the EU), now for the first time, patent law has an interface with European Union law. This may lead to a convergence of patent law approaches to the definition of nanomaterials and the regulatory definition discussed above.

This section is intended as a short guide through the patent jungle of classifications, regulations, and case law within Europe for nanotechnology inventors/applicants. For this purpose, we provide a brief overview of classifying nanotechnology inventions and trends in filing statistics of respective patent applications. We describe in brief the current patent system and some peculiarities of the above-mentioned, forthcoming changes in Europe, highlighting their impact on nanotechnology patenting.

2.2 Filing statistics of patent applications for nanotechnology inventions

Patent documents not only describe technologies very precisely but are also administrated by patent offices to be easily searchable. This is in particular true when it comes to nanotechnology.

Generally, any patent office records the technical field of incoming patent applications using a hierarchical patent classification system, usually based on the International Patent Classification (IPC) [12]. The European Patent Office (EPO) and the U.S. Patent and Trademark Office (USPTO) use a common system with the name “Cooperative Patent Classification System” (CPC) [13], established in 2010. The classification indicates the technical field(s) on which the invention seeks protection (main classes) and technical areas the patent document provides information on (additional classes). The classification of a patent application is therefore an important tool for finding technical information in patent databases.

For classification purposes, the offices define a “nano-structure” as “an entity having at least one nano-sized functional component that makes physical, chemical or biological properties or effects available, which are uniquely attributable to the nano-scale,” where the term “nano-scale” is defined as “a controlled geometrical size below 100 nm in one or more dimensions” [14].

Inventions in the field of nanotechnology are classified under the IPC Class B82, which contains one “substantial” subclass: B82B for “nano-structures formed by manipulation of individual atoms, molecules, or limited collections of atoms or molecules as discrete units; manufacture or treatment thereof.” A further subclass B82Y is an “indexing class” for search purposes, covering “specific uses or applications of nano-structures; measurement or analysis of nano-structures; manufacture or treatment of nano-structures,” as follows from Table 1:

Table 1

Nanotechnology subclasses in the International Patent Classification.

CodeTitle
B82YNanotechnology
B82Y5/00Nano-biotechnology or nano-medicine, e.g., protein engineering or drug delivery
B82Y10/00Nanotechnology for information processing, storage, or transmission, e.g., quantum
computing or single electron logic
B82Y15/00Nanotechnology for interacting, sensing, or actuating, e.g., quantum dots as markers
in protein assays or molecular motors
B82Y20/00Nano-optics, e.g., quantum optics or photonic crystals
B82Y25/00Nano-magnetism, e.g., magnetoimpedance, anisotropic magnetoresistance, giant magnetoresistance or tunneling magnetoresistance
B82Y30/00Nanotechnology for materials or surface science, e.g., nano-composites
B82Y35/00Methods or apparatus for measurement or analysis of nano-structures
B82Y40/00Manufacture or treatment of nano-structures
B82Y99/00Subject matter not provided for in other groups of this sub-class

B82Y thus comprises not only all applications classified in B82B but also applications covering such aspects of nano-structures, which are classified elsewhere in the IPC. For example, in class A61K9/51, nano-capsules for medicinal preparations or in class C01B31/02 carbon nano-structures, e.g., bucky balls and nanotubes [15], can be found. To complement subclass B82B, the CPC contains an additional subclass B82T, which serves as an “indexing scheme relating to aspects of nano-structures not covered by subclass B82B.”

The World Intellectual Property Office (WIPO) provides a statistics toolkit on its webpage [16] based on the classification of applications. Figure 1 [17] shows the development of the number of patent publications in the technical area of “micro-structural and nanotechnology” [18] of all Asian patent offices (“Asia”), European patent offices (“Europe”), North American patent offices (“North America”) and the total number of patent publications of all patent offices for which data is available to the WIPO (“World”). The number of patent documents has continuously increased over the last 20 years, except for North America where there is a decrease since 2004. Patent publications, 3115, have been published in 2011 worldwide. The Asian patent offices have published a total of 2030 patent documents, more than twice than those of the European and North American patent offices together.

Figure 1 Number of patent publications in the area of micro-structural and nanotechnology.
Figure 1

Number of patent publications in the area of micro-structural and nanotechnology.

The dominance of Asian patent offices in publishing nanotechnology patent documents since 1990 has an impact on search strategy. It follows that patent searches should not be restricted to English language publications but should at least also include documents published in Chinese, Korean, and Japanese languages. To this end, the publicly available machine translation service recently introduced by the EPO [19] might be useful to facilitate preliminary searches.

Thus, searches for nanotechnology patent documents, in particular, to find out whether an invention is new or whether it might be covered by a patent of a competitor, are facilitated by the IPC class B82 and a special focus on patent portfolios originating from Asia should be considered.

2.3 Obtaining and enforcing patent protection in Europe – the status quo

In order to obtain a nanotechnology patent, novelty and an inventive step have to be confirmed by a patent office. It also has to be confirmed that the respective technical invention is susceptible to industrial applications and is adequately disclosed.

Currently, patent protection for an invention with effect for one or more European countries can be achieved in two different ways: on the one hand, by deposition of national patent applications at the respective national patent offices to obtain a national patent, and on the other hand, by deposition of a European patent application at the EPO, which issues a so-called European patent. The said European patent does not directly provide protection in the member states of the European Patent Convention (EPC), but only after a validation in each individual state in which protection is desired. Such a validation often comprises the filing of a translation and requires the payment of national fees at the national offices. The respective costs are widely seen as a major disadvantage in Europe compared to the competing patent systems in the U.S. and Asia.

Also, all patent-related law suits (patent infringement as well as invalidation actions) are exclusively subject to national legislation and case law, regardless of whether a patent has been issued by a national patent office or is a European patent. For European patents, even divergent court decisions may occur in different jurisdictions, leading to legal uncertainty [20]. This legal uncertainty and the high costs associated with the independent court proceedings are generally regarded as a significant drawback of the European patent litigation system.

As the field of nanotechnology is rather young, it is not surprising that there is some uncertainty on how the patent offices, as well as national courts, decide particular issues relating to novelty and inventive step. Besides national differences, it has to be taken into account that case law developed slightly different approaches in dealing with inventions in the field of engineering compared to those in chemistry/biology, such that the interdisciplinary nature of nanotechnology-related inventions makes the application process even more complicated. Following the top-down approach, according to which nanotechnology is a refinement of microtechnology, the field of engineering seems appropriate, whereas the bottom-up approach, according to which an assembly of a multitude of individual atoms or molecules is given, speaks in favor of the field of chemistry/biology.

In case an invention is related to a selection of a sub-range chosen from a broad parametric range, the EPO confirms patentability [21] if the selected range is

  • narrow compared with the known range;

  • sufficiently far remote to any specific examples and the end point of the known range; and

  • not an arbitrary miniaturization of a known particle but rather a purposive selection.

The German Federal Court of Justice presently bases its decisions on the following findings:

  • Selections of a sub-range chosen from a broad (continuous) parametric range in general do not provide novelty [22]. (This is often applicable in the field of engineering.) Selections of a single species selected from a group of species disclosed by a chemical structural formula are novel when the single species as such is not disclosed directly and unambiguously [23].

Thus, the applicant’s choice of the patent office(s), in particular, European or nationally, is of particular importance for a nanotechnology invention.

2.4 The European patent with unitary effect

The risks or opportunities in nanotechnology patenting, depending on the perspective, will grow with the introduction of the new European patent system for the so-called European patent with unitary effect [24] or simply unitary patent.

Figure 2 provides an overview of the 38 member states and two extension states of the EPC and their affiliation to the European Union (EU) and the system of the European patent with unitary effect.

Figure 2 Member States and Extension States of the European Patent Convention and their participation in the European patent with unitary effect.
Figure 2

Member States and Extension States of the European Patent Convention and their participation in the European patent with unitary effect.

For the present 25 states participating in the unitary patent system, the unitary patent will form an alternative to national validation(s) of a European patent. As soon as the new regulations will be applied, it will be possible to choose between the unitary patent forming a “unitary validation” of the patent in all participating states of the EU or a conventional validation of the patent in one or more of the said participating states. A combination of the unitary patent and a validation in at least one of the said participating states is not possible.

For requesting a unitary patent, the patent must have been granted by the EPO with the same set of claims for all participating states. After a transition period of at least 6 years, which necessitates filing of a single translation, no translations of the patent have to be filed to validate the patent with unitary effect.

The unitary patent will provide uniform protection and have equal effect in all participating states. It may not be limited, transferred, or revoked in a single country, but rather may lapse only in respect of all participating states. Thus, it will not be possible for the patent proprietor to transfer national parts of the patent to a third party, even not to a subsidiary company within the same corporate structure. However, it will be possible to license the unitary patent with respect to the whole or part of the territories of the participating states.

The place of business/residence of the applicant at the time of depositing application documents at the EPO will decide on the law, which will be applicable when it comes to treating the patent (application) as an object of property. If this place is not located within the territory of a state participating in the new patent system, for example, if the patent is originating from an Asian applicant without a branch in any of the participating states, German law will be applicable as the main seat of the EPO is in Germany. In view of differences between the jurisdictions of the participating states, it might be interesting for companies to “choose” a jurisdiction by utilizing an existing or establishing a new place of business in a selected participating state. If, for example, German law is to be applied, entries of ownership of a patent in the patent register provide only declaratory effect, and in case a patent is owned by two or more parties, each party might transfer its share without approval of the other proprietor(s).

2.5 The Unified Patent Court system

The Unified Patent Court (UPC) will obtain exclusive competence for all European patents and patent applications pending before the EPO, i.e., for both conventional European patents and unitary patents, in respect of legal validity and enforcement.

Currently, only Spain and Poland do not participate in the Agreement on the UPC [25], while Italy, not participating in the unitary patent, has joined the said Agreement. The UPC will comprise a Court of First Instance, a Court of Appeal, and a Patent Mediation and Arbitration Center. Its decisions will cover in each case all states in which the patent is granted protection and which are member states of the agreement.

The Court of First Instance will have local/regional divisions and a central division seated in Paris with two sub-divisions, one in London for dealing with cases related to chemistry including pharmaceuticals and human necessities (classes A and C of the IPC) and the other one in Munich for dealing with cases related to mechanical engineering (class F of the IPC). Thus, the nanotechnology class B28 will be associated with Paris. But as nanotechnology inventions can and will be found in different main classes, there will be room for a kind of forum shopping. Working on the intersection of physics, chemistry, and biology, a wide range of possible claim formulations will enable applicants to put a focus on the desired class.

It remains to be seen whether the UPC will follow existing national or European case law doctrines or will establish its own case law. Assuming that the sub-division in Germany will rely upon present German case law, which for a certain nanotechnology invention is favorable, Munich can be selected as the venue by wording a new European patent application such that it would fall into IPC class F for mechanical engineering. If, for example, a use of a newly developed nano-structure can, for example, be described as a miniature gear, a first independent claim simply should be directed to such a gear.

We note, however, that the UPC is required to apply European Union law, which includes the regulatory legislation discussed above. It remains to be seen whether the UPC will apply, for example, the Commission Recommendation in relation to the definition of nanotechnology, as reflected in recent EU regulation.

3 Conclusion

Scientists in the field of nanotechnology break new ground not only with respect to technology but also participate in building up a rapidly growing legal landscape. The regulatory framework in Europe has already reached a high level of sophistication, which draws on scientific assessment, but takes the liberty to take a political approach to regulation where it is deemed to be appropriate from a pragmatic perspective. The patent system is at the doorstep of an unprecedented harmonization and integration. This creates ample opportunities, with a new challenge just waiting around the corner. As the European patent system, for the first time, interlinks with European Union legislation, it is likely that we will see convergence, over time, between the regulatory and the patent law approaches to the definition of nanomaterials.


Corresponding authors: Christian Fulda, Jones Day, Prinzregentenstr. 11, 80538 Munich, Germany, e-mail: ; and Dorothée Weber-Bruls, Jones Day, NEXTOWER, Thurn-und-Taxis-Platz 6, 60313 Frankfurt am Main, Germany, e-mail:

About the authors

Christian Fulda

Christian B. Fulda studied Law in Tübingen, Geneva, and Berlin (Humboldt University) and did his legal traineeship in Berlin and Brussels. He wrote his PhD with Prof. Tomuschat on Democracy and pacta sunt servanda in international public law at Humboldt University. He received scholarships from the German National Scholarship Foundation both for his legal studies and his PhD. Dr. Fulda was admitted to the bar in 2002 and was made partner with Jones Day in 2012. He advises international clients in particular on EU regulatory matters.

Dorothée Weber-Bruls

Dorothée Weber-Bruls studied Physics at the Goethe University in Frankfurt, Germany, with a major focus on solid state physics. For her PhD, with the title Electron phonon coupling in the Kondo regime, she conducted measurements at the Max Planck Institute and the Laue-Langevin Institute in Grenoble, France. After a short postdoc, she decided in 1992 to become a patent attorney. In 2009, she joined the international law firm Jones Day at the Frankfurt office as partner. In parallel, she lectures patent law since 2003 at the Goethe University of Frankfurt where she is also active in the alumni council representing the faculty of Physics. Dr. Weber-Bruls is also one of the trustees of the Museum of World Cultures in Frankfurt.

Jochen Werth

Jochen H. Werth studied Physics at the Gerhard Mercator University in Duisburg, Germany, with a major focus on computational physics. In his dissertation, which was supported by a scholarship of the German Research Foundation, he researched the interaction of electrically charged nano particles in suspensions using computer simulations. He was admitted as a German patent attorney in 2010 and joined Jones Day in 2011 as associate.

Acknowledgments

The authors wish to acknowledge the assistance of Gregor Störzinger, attorney-at-law at Jones Day, for his assistance in researching the European regulatory landscape of nanomaterials.

References

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[22] Cf. decision of December 7, 1999, in the case X ZR 40/95 (“Inkrustierungsinhibitoren”) of the Bundesgerichtshof (German Federal Court of Justice), available at: http://www.bundesgerichtshof.de/DE/Entscheidungen/EntscheidungenBGH/entscheidungenBGH_node.html.Search in Google Scholar

[23] Cf. decision of December 16, 2008, in the case X ZR 89/07 (“Olanzapin”) of the Bundesgerichtshof (German Federal Court of Justice), available at: http://www.bundesgerichtshof.de/DE/Entscheidungen/EntscheidungenBGH/entscheidungenBGH_node.html.Search in Google Scholar

[24] The legal framework for the new European patent with unitary effect has been established with the adoption of Regulation (EU) No. 1257/2012 and Regulation (EU) No. 1260/2012. Both regulations entered into force on January 20, 2013, but will not be applied until the date the Agreement on a Unified Patent Court will enter into force, i.e., until a date most likely in the course of 2014 or 2015. The instrument of enhanced cooperation between the member states of the European Union has been used to adopt the two regulations: except Spain and Italy, all then member states of the European Union take part in the new European patent with unitary effect. Croatia, which joined the EU on July 1, 2013, is invited to join the new system.Search in Google Scholar

[25] The agreement has the status of an intergovernmental agreement and does not form directly part of the agreement system of the EU. On February 19, 2013, the Agreement on a Unified Patent Court has been signed by 25 member states of the European Union. Croatia, which joined the EU on July 1, 2013, is invited to join the agreement.Search in Google Scholar


Article note

Dr. Christian B. Fulda is attorney-at-law, Dr. Dorothée Weber-Bruls and Dr. Jochen Werth are patent attorneys at Jones Day. The views expressed in this article are those of the authors and not necessarily of Jones Day or any of its clients.


Received: 2014-3-7
Accepted: 2014-4-1
Published Online: 2014-6-19
Published in Print: 2014-8-1

©2014 by De Gruyter

This article is distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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