European Perspectives on Nanotechnology. Seizing Opportunities, Protecting Technology, and Avoiding Risks June 21, 2011

Transcription

1 European Perspectives on Nanotechnology Seizing Opportunities, Protecting Technology, and Avoiding Risks June 21,

2 Part A European Patents Overview What is Nanotechnology? The Definition of Nanotechnology used by the European Patent Office Searching Nanotechnology Patents Legal Requirements for Nanotechnology Patents t Examples Summarizing Remarks 2

3 Part A European Patents I. What is Nanotechnology Richard Feynman 1959: There is plenty of room at the bottom. Nori Taniguchi 1974: Nano-technology mainly consists of the processing of separation, consolidation and deformation of materials by one atom or one molecule. top-down: bottom-up: continuation and refinement of microtechnology assembly of a multitude of individual atoms or molecules 3

4 II. Definition of Nanotechnology used by the European Patent Office Part A European Patents Definition: The term nanotechnology covers entities with a controlled geometrical size of at least one functional component below 100 nanometers in one or more dimensions susceptible of making physical, chemical or biological effects available which are intrinsic to that size. It covers equipment and methods for controlled analysis, manipulation, processing, fabrication or measurement with a precision below 100 nanometers. 4

5 III. Searching Nanotechnology Patents Statistical Patent Analysis of the European Commission* Part A European Patents * 5

6 III. Searching Nanotechnology Patents Problem: Part A European Patents Nanotechnology is interdisciplinary There is no immediate classification at hand, differently to classical technical fields like Physics, Chemistry or Electrical Engineering Solution: Tagging of Nanotechnology Patents B82Y.. (since Jan. 2011), Y01N.. (out of use since May 2011) 6

7 III. Searching Nanotechnology Patents Part A European Patents Tagging Description Amount of Documents B82Y5 =Y01N2 Nanobiotechnology or Nanomedicene 21,896 B82Y10 =Y01N4 Nanotechnology for information processing, 52,263 storage and transmission B82Y15 =Y01N8 Nanotechnology for interacting, sensing and 17,900 actuating B82Y20 =Y01N10 Nanotechnology for Optics 27,737 B82Y25 =Y01N12 Nanomagnetism 20,302 B82Y30 =Y01N6 Nanotechnology for materials and surface 56,287 science B82Y35 (new) Methods or apparatus for measurement or analysis of nanostructures 119 B82Y40 (new) Manufacture or treatment of nanostructures res 245 Status: June 14, 2011 (espacenet search) 7

8 IV. Legal Requirements for Nanotechnology Patents Part A European Patents Problem: Does miniaturization justify the grant of a patent? How to treat the requirements for grant of a patent based on technical developments? Disclosure / Practicability Novelty Inventive Step Susceptibility to Industrial Application 8

9 Part A European Patents IV.1. Disclosure / Practicability The patent application has to disclose the invention with sufficient i information to enable the skilled person to implement the claimed technology. Example taken from the EPO-Brochure Nanotechnology and Patents *: It is not sufficient to say nanoelectrodes with a diameter of 5 nm were deposited onto a substrate when this cannot be done with commonly known methods. The precise conditions for carrying out the method have to be described. * org/service-support/publications/issues/nanotechnology html 9

10 Part A European Patents IV.2. Novelty Does selection of a subrange chosen from a broad parametric range make an invention novel? In general the answer is yes on behalf of the EPO, if the selected range is narrow compared with the known range sufficently far removed from any specific examples and the end points of the known range not an arbitrary miniaturization of a known particle (purposive selection) 10

11 IV.2. Novelty Part A European Patents Regarding the requirement of a purposive selection from a continuous range however, decisions T1233/05 and T0230/07 do away with this criterion when assessing novelty, and take it into account when assessing inventive step. 11

12 IV.2. Novelty Perspective of the German Federal Court of Justice Part A European Patents Selection of a subrange chosen from a broad (continuous) parametric range does not provide novelty. Selection of a single species selected from a group of species disclosed by a chemical structural formula is novel when the single species as such is not disclosed directly and unambigously ( Olanzapin, December 16, 2008) 12

13 Part A European Patents IV.3. Inventive Step Is the miniaturization of a known device inventive? Yes, if the invention provides a new technical advantage which was not to be found in the prior art and which was not obvious to arrive at. No, if the miniaturization is an arbitrary reduction of size without providing an additional or suprising effect. 13

14 Part A European Patents IV.3. Inventive Step Example taken from the EPO-Brochure Nanotechnology and Patents : Claimed was an invention relating to a field-effect transistor comprising i an insulating layer with a thickness of 3-18 nm. No particular effect produced by the film having this specific thickness was demonstrated. It was decided that the thickness range merely followed a trend towards miniaturization in semiconductor devices and did not involve an inventive step. 14

15 Part A European Patents V. Examples Fulleneres Wolfgang Krätschmer: Winner of the European Inventor Award 2010 in the Lifetime Achievement category In 1990, Wolfgang Krätschmer and Donald R. Huffman invented a method for producing fullerenes, which had been discovered in 1985 in form of C60. Buckminister fullerene C60 (Wikipedia) The according European Patent EP B1, issued January 21, 1998, comprised 87 patent claims, of which 35 were independent patent claims. 15

16 V. Examples Fulleneres Part A European Patents 16

17 V. Examples Fulleneres (selected claims of EP B1) Part A European Patents 17

18 Part A European Patents V. Examples - Construction TRL Technology Readiness Level (ObservatoryNano Factsheets March 2011) 18

19 Part A European Patents VI. Summarizing Remarks Inventors in the field of nanotechnology break new ground with respect to technology as well as patentability. This leads to a high risk based on missing judgements on patentability; but also great opportunities regarding g range of patent protection and possibilities to influence future judgements on patentability. 19

20 Part A European Patents Dr. Dorothée Weber-Bruls Partner Tel: +49 (0) dweber@jonesday.com Dr. Jochen H. Werth Associate Tel: +49 (0) jwerth@jonesday.com Jones Day Hochhaus am Park Grüneburgweg Frankfurt am Main Tel: +49 (0) Fax: +49 (0)

21 European Perspectives on Nanotechnology Seizing Opportunities, Protecting Technology, and Avoiding Risks The European Regulatory Framework Jones Day Webinar, June 21, 2011 Dr. Christian B. Fulda Overview I. Structure of European Nanotechnology Regulation II. Regulation of Chemical Substances III. Focus Product Regulation IV. Current Developments V. Outlook 2

22 I. Structure of European Nanotechnology Regulation no general nano-legislation regulation of chemical substances in general regulation of specific products general regulation of products mainstream regulations no common definition (weight vs. particle number concentration vs. size < 100nm?) 3 II. Regulation of Chemical Substances Declared substances in consumer products Source: multiple mentions possible 4

23 II. Regulation of Chemical Substances (cont ) Principle: obligation to register But: substance counts, not form (nano silver = silver) But: threshold of 1 ton/year Currently: recognize application in SDS; carbon & graphite removed from minimum risk substance list. Outlook: specific regulation of nanomaterials in revision III. Product Regulation Categories of Consumer Products Source: multiple mentions possible 6

24 III. Product Regulation (cont ) Subcategory "Health and Fitness" Source: multiple mentions possible 7 III. Product Regulation: Pharmaceuticals Principle: Marketing Authorization required for any pharmaceutical EMA speaks of nano if less than 1,000 nm, but so far, no specific nano regulation various approved products: liposomes (e.g. Caelyx, Mepact, Myocet) or API (e.g. Abraxane, Emend, Rapamune) difference between new active ingredient and drug delivery (new application) in theory, significant ifi difference in dossier and time required, however, typically, new efficacy 8

25 III. Product Regulation: Medical Devices Principle: Conformity assessment according to classification various existing med dev using nanotech (e.g. bandages with silver, catheters with nano-surfaces for bacteriostase, implants with nano surfaces for better compatibility, but also nano particles, e.g. iron oxide for magneto- hyperthermic tumor treatment: MagForce) no specific nano regulation so far, none deemed required for recast of directives but increased requirement for clinical trial due to recent amendment of general legislation 9 III. Product Regulation: Cosmetics New EU Regulation (in force as of 2013): Principle: No authorization required (except for specific applications coloring, UV filters, antidegradant). General requirement that cosmetics have to be safe. Exceptionally: Ban on specific substances. First European regulatory definition of nano: nanomaterial means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm; Labeling requirement: Adding (nano) to substance in list of ingredients. Notification requirement to European Commission. 10

26 III. Product Regulation: Food As additive (e.g. to improve shelf life): Authorization required (also for currently used substances which are altered by nanotechnology). As food proper: Authorization required as novel food, though no specific regulation in revision of regulation (in particular no specific labeling required). For packaging: No migration to food. NEW: Guidance on risk assessment of nanotech in food and feed chain (May 2011); defines nano as one size measurement between approx nm. 11 III. Product Regulation: Other Products biocides detergents textiles fuels (additives) dangerous substances in electric and electronic devices etc. pp. General regulation: General product safety directive, which governs the safety of products, including provisions on recalls for consumer products. 12

27 IV. Current Developments European repository of nanomaterials at Joint Research Center (since Feb 2011): benchmark for test results. On-going discussion on notification requirements for nanotech products. NGOs start setting up databases of nano products (e.g. nanotechproject.org, BUND). 13 V. Outlook Legislators and authorities continue to monitor the discussion on safety of nanotech products. European Parliament pushed for tighter regulation in 2009 regulation has not yet reached steady-state. Important to monitor third party research (universities etc.) into risks of nanotech. 14

28 Dr. Christian B. Fulda European Counsel Tel: +49 (0) com Jones Day Prinzregentenstraße München Tel: +49 (0) Fax: +49 (0)