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09/05/2015 Introducción a la OEP Enrique Molina Galán Director Biotecnología EPO La Haya Visita a Galicia, Julio 2010.

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Presentation on theme: "09/05/2015 Introducción a la OEP Enrique Molina Galán Director Biotecnología EPO La Haya Visita a Galicia, Julio 2010."— Presentation transcript:

1 09/05/2015 Introducción a la OEP Enrique Molina Galán Director Biotecnología EPO La Haya Visita a Galicia, Julio 2010

2 European Patent Organisation Member states: Albania Austria Belgium Bulgaria Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Iceland Ireland Italy Latvia Liechtenstein Lithuania Luxembourg Former Yugoslav Republic of Macedonia Malta Monaco Netherlands Norway Poland Portugal Romania San Marino Slovakia Slovenia Spain Sweden Switzerland Turkey United Kingdom Extension agreements: Bosnia-Herzegovina Montenegro Serbia A European intergovernmental institution, but not an EU institution Self-financing, i.e. revenue from fees covers operating and capital expenditure 37 member states a market of over 500 M citizens Single procedure & language

3 The European Patent Convention  The European Patent Convention (EPC) –provides the legal framework for the granting of European patents via a centralised procedure –establishes the European Patent Organisation  1973– Diplomatic Conference in Munich ► signature of the EPC by 16 countries  1977 – Entry into force of the EPC in 7 countries - marked as follows  Italy since 1.12.78

4 A bit of History  1973 Diplomatic conference setting up EPC  1977 EPC enters into force  1978 EPO starts operating and receives first European applications  2000 Diplomatic conference performs the first comprehensive overhaul of EPC; EPC 2000  2007 EPC 2000 enters into force

5 Structure of the European Patent Organisation The legislative body  made up of delegates from the member states  supervises the activities of the Office  has a specific legislative function European Patent Organisation Administrative Council European Patent Office The executive body  responsible for examining European patent applications

6 Structure Directorates-General Operations Thomas Hammer Operational Support Peter Vermeij Appeals Peter Messerli Administration Brian McGinley Legal/International Affairs Wim van der Eijk (ad interim) President Benoît Battistelli Presidential area Business Services Search Substantive Examination Opposition Patent Administration Quality Management Information Management Appeals Human Resources General Administration Language Service European and International Affairs International Legal Affairs and Patent Law Legal Services European Patent Academy Status: July 2010 Patent Information

7 Structure of EPO - Cluster Biotech Patent Administration Operational Support TH Patent Administration Operational Support M

8 Number of staff and locations Munich3 718 The Hague2 710 Berlin274 Vienna112 Brussels4 Total6 818 Around 60% (4000) are patent examiners Headquarters are in Munich

9 Staff from 31 different countries (2009) Country Number of staff ATAustria237 BEBelgium359 BGBulgaria35 CHSwitzerland74 CYCyprus8 CZCzech Republic20 ESSpain447 DEGermany1 851 DKDenmark75 EEEstonia7 FIFinland49 FRFrance1 225 GBUnited Kingdom507 GRGreece165 HUHungary29 IEIreland82 HRCroatia2 Country Number of staff ITItaly507 LTLithuania4 LULuxembourg69 LVLatvia5 MTMalta2 NLNetherlands609 SESweden125 PLPoland62 PTPortugal87 RORomania115 SISlovenia14 SKSlovakia15 TRTurkey29 Others2 Total6 818 ISIceland1

10 The Hague 4 buildings ViennaBerlin Munich 3 buildings Headquarters Brussels Bureau Locations The European Patent Office  Locations

11 “The fingerprint is the universally recognised hallmark of individuality and identification. Its adoption here in stylised form achieves the qualities necessary to the role of the EPO.” (Kilkenny Design Workshops, Ireland) The logo of the European Patent Office

12  Some figures

13 Applications filed Direct European filings Euro-PCT applications entering the regional phase

14 Applications by residence of applicant (2009)

15 Technical fields with the most filings (2009) 58 953 Number of applications

16 European patents granted

17 Patent revoked Patent maintained in amended form Opposition rejected 43.6% 30.1% 26.3% Oppositions in 2009 Oppositions were filed against 4.7% of granted European patents. Over one third of all opposed patents were revoked. 4.7% Oppositions Granted patents

18 JC Biotechnology: capacity and workload  260 examiners (1/3 TH, 2/3 MU)  Incoming searches: 9000/year  Request for examination: 6000/year  Oppositions filed: 170/year

19 2009  Applications filed EPO-wide: nearly 150 000 In biotech about 9000  European Patents granted: Almost 60 000 –About 40% of filed applications

20 Cost of a sample European patent 1) 1) Six states, ten-year term EPO fees Percentage of total EUR 4 600 14% Professional representation before the EPO Percentage of total EUR 10 000 32% Translation/publication in the contracting states Percentage of total EUR 7 000 22% National renewal fees Percentage of total EUR 10 000 32% Total costEUR 31 600 The European patent  Cost

21 Cost breakdown of a sample European patent 1) 1) Six states, ten-year term The European patent  Cost

22 Our role in the European patent system  We provide patent protection in up to 40 European countries based on a single application in one of the three official languages (German, English, French) European patent applications can be filed: –direct with the EPO –via the national patent offices of the contracting states –based on an international (PCT) application  We are also responsible for –limitation and revocation proceedings by patentees –opposition proceedings by third parties –appeal proceedings before the Boards of Appeal

23 Our role in the international (PCT) system  We process international patent applications –we act as a receiving office for international applications (PCT) –we carry out international search and preliminary examination procedures

24 Other services  Free online services –filing –fee payment –file inspection –tracking of legal status of applications  Free patent information services –online access to all European patent documents (updated weekly) –simple online searches in our database of over 60 million patent applications –helpdesk staffed by experts on the Japanese, Chinese and Korean patent systems  Training –conferences –workshops and seminars –e-learning

25 Patents

26 What is a patent?  A patent is a legal title granting its holder the right to prevent third parties from commercially using an invention without authorisation.  In return for this protection, the holder has to disclose the invention to the public.  Protection is granted: –for a limited period, generally 20 years –for a specific geographic area

27 What is patentable?  To be patentable, an invention must: –have a technical character (e.g. comprise a product, process or apparatus) –be new –involve an inventive step –be industrially applicable  Some innovations are not patentable under the EPC: –for example, mathematical methods or formulae, computer programs and business methods are as such not regarded as inventions –plant or animal varieties, methods for treatment and surgery of and diagnosis practised on the human or animal body and inventions whose commercial exploitation would be contrary to "ordre public" or morality (e.g. the cloning of human life or involving human embryonic stem cells) are examples of inventions excluded from patentability

28 Some examples of what IS patentable from the field of biotechnology  genes and nucleic acid molecules (e. g. disease-related genes for diagnosis, siRNA molecules for therapy)  proteins (e. g. insulin, erythropoietin for therapy, cellular receptors for drug screening)  enzymes (e. g. proteases for washing powder, cellulose degrading enzymes for producing of bio-fuels)  antibodies (e. g. for cancer treatment, pregnancy tests, or diagnostics)  viruses and virus sequences (e. g. hepatitis C virus and HIV for blood testing and the development of vaccines and therapies)  cells (e. g. haematopoietic stem cells for the treatment of leukaemia)  micro-organisms (e. g. bacteria for bioremediation, yeast for food production)  plants (e. g. herbicide resistant soybean, ‘golden rice’ which accumulates pro-vitamin A, drought-resistant plants, algae and genetically modified yeast for capturing CO2 from the atmosphere)  animals (e. g. disease models for research such as the genet ically modified ‘oncomouse’, donor animals for xenotransplantation, dairy animals which produce medicaments in milk)

29 Some examples of what IS NOT patentable from the field of biotechnology  sequences without a known function (e. g. expressed sequence tags (ESTs) resulting from automated sequencing)  genetically modified animals which suffer but are not associated with a substantial medical benefit. An example would be a genetically modified animal which is solely used to test cosmetics.  plant varieties (already protected under the Convention of the International Union for the Protection of New Varieties of Plants, UPOV) (e. g. Golden Delicious apples)  animal varieties (e. g. Holstein cattle)  human embryos  processes which necessarily involve the use and destruction of human embryos  human germ cells (sperm, oocytes)  human-animal chimera

30 European patent application Applicant Filing and formalities examination EPO Search and search report together with preliminary opinion on patentability Publication of application and search report Online access to application file and legal status information Public domain Grant of European patent Publication of patent specification Validation in designated states Refusal or withdrawal of application Substantive examination Overview of European patent grant procedure (I)

31 Applicant EPO Limitation or revocation proceedings Substantive examination Grant of European patent Refusal of application Opposition proceedings Appeal proceedings Overview of European patent grant procedure (II)

32 Fate of the biotech applications from search to grant Patent revoked Patent maintained in amended form Opposition rejected 38.3% 30.2% 31.5%

33 The EPO & Its role in innovation

34 Our mission As the patent office for Europe, we support innovation, competitiveness and economic growth across Europe through a commitment to high quality and efficient services delivered under the European Patent Convention.

35 The benefits of patents (I) For inventors, patents can  help safeguard financial returns from the commercial exploitation of the invention  give holders time to recoup their development costs  encourage further investment in R&D

36 The benefits of patents (II) For the economy in Europe, patents are a prime source of new technical knowledge. Patents can help:  identify new technological trends and new business partners  inspire further inventions  prevent the duplication of R&D in industry and universities European patents foster technical innovation, which is crucial to competitiveness and overall economic growth in Europe

37 Right balance is essential!  Protection  Incentive to innovate  Return on investment  Better market position  Disclosure  Sharing knowledge  Stepping stone  Innovation leaps Apply high patent standards!

38 Cornerstones to assure Quality and Efficiency  Granting with high presumption of validity –enabling disclosures –undisputed inventive contribution –commensurate scope of protection  Timeliness of grant procedure –dealing with increasing amounts of workload –minimising procedural delays –minimise legal uncertainty as early as possible

39 Quality at the EPO: four key ingredients Highly skilled / specialised examiners Rigorous controls and commitment to improvement Comprehensive search documentation Quality Thorough and consistent procedures

40 Knowledge based organisation  Highly skilled, thoroughly trained and very expert (more than 90% end professional career as examiner)  Highly specialised (260 in biotech)  Highly motivated (interesting job, attractive employment package, active concern for staff)

41 Danger: Ever growing number of pending applications Pending applications: 100.000 more every 4 years Growing gap (37.500 p.a.) That is 750 examiners capacity!!

42 Fee Reform entered into force 01/04/2009  Euro 12 per page from description page 36  Attention to Sequence Listings!

43 "Raising the Bar" Goal:  Improving the quality of incoming patent applications and streamlining the grant proceedings.

44 –when deemed appropriate the search can be restricted to one independent claim per category; –where a meaningful search is not possible, the applicant will be invited to clarify the subject-matter to be searched.  Examination will be limited to searched subject matter –a response to the search opinion will be mandatory –amendments and their basis shall be clearly identified. –amendments at applicants initiative are restricted –All that with associated tight time limits and severe sanctions! Raising the Bar: Meassures entering into force on 01.04.2010

45 Divisionals  time limits for the filing of divisional applications as of April 2010  voluntary divisional applications: to be filed within a period of two years from the first communication by the examining division in respect of the parent application  mandatory divisional applications: to be filed within a period of two years from the first objection of lack of unity

46 8 years 3,5 years Biotech pendency almost under control!

47 Workload sharing and avoiding duplication  European level –with National Patent Offices  EPN (European Patent Network)  UPP (Utilisation Pilot Project)  Worldwide –Trilateral; USPTO, JPO, EPO –IP5: As above plus SIPO and KIPO (Chinese and Korean Patent Offices)

48 IP5: Foundation Projects Developing common tools among the 5 Offices to support work-sharing:  –Common documentation database  –Common hybrid classification  –Sharing and documenting search strategies  –Common search and examination support tools  –Common access to search and examination results  –Common training policy  –Mutual machine translation  –Common application format

49 Further collaboration initiatives  Triway  PPH (Patent Prosecution Highway) –bilateral agreements And of course:  PCT (Patent Cooperation Treaty) –preferred option with a developed and well known infrastructure and procedures.

50 Community Patent  Imminent introduction or permanent Utopia? –Waiting 30 years on the shelves –Why?  Language regime  Common European Litigation System –2009; new attempts to clear the path!

51 Need more information? Tel. + 49 (0)89 2399 - 4636

52 Pending referrals before the EBoA  G1/07 surgical methods within diagnostic methods following G1/04  G1/08 essentially biological methods under Art 53(b)  G2/08 regime of administration  G3/08 computer programs

53  Upcoming changes in procedure as measures to keep and increase the quality of the applications and patents within efficient and streamlined granting process

54 JC Biotechnology: capacity and workload  260 examiners (1/3 TH, 2/3 MU)  Incoming searches: 9000/year  Request for examination: 6000/year

55 JC Biotechnology: production  9500 searches  6500 final examination actions (including withdrawals)  3000 published granted patents

56  Organisation  EPO role in innovation –mission statement, right balance = high quality  Quality (timely high presumption of validity) –rising the bar (procedural measures) –human capital / brain engine / empowering –better tools / process –avoid duplication  trilateral / IP5 / PPH / Triway  EPN

57 Stock evolution: searches

58 Stock evolution: examination

59 Ratio of stock and yearly production in examination (Pendency time in months) INTERNAL DRIVERS

60 Not so bad in Biotech! The Biotech cluster already renewed its strategy once and with good results! But we cannot afford to sit back! INTERNAL DRIVERS

61 Rule change proposals to Rules of the implementing regulations to the EPC2000 (CA29/09). (1/2) RuleAmendment R 62a On search: non compliance with R43.2: Applicant is asked for which claims, one per category, the search is to be carried out. Two months time limit; No response: Search limited to first claim in each category. In examination examiner after review demands limitation of application to claims searched. R 63 Similar to R 62a, but now for "complex applications"; Applicnat requested to file a statement indicating the subject-matter to be searched.If this is still not helpful, then a reasoned declaration or partial search report shall be issued replacing the ESR. In examination again: after review limitation to searched matter. R. 64 2 to 6 weeks time limit to reply to invitation to pay additional fees in case of non-unity now two months to align with above rules. R. 70a(1)(2) Obligation by applicant to reply to written opinion accompanying the ESR (EESR).

62 Rule change proposals to Rules of the implementing regulations to the EPC2000 (CA29/09). (2/2) RuleAmendment R 70a(3) If the applicant does not comply with or comment on an invitation in accordance with paragraph 1 or 2, the application shall be deemed to be withdrawn. R. 161 PRINCIPLES TO BE EXTENDED TO WORK DONE BY THE EPO ACTING AS ISA OR IPEA R. 137(2) Amendment of own volition once only after receipt of the SR and before the issue of the first office, together with reply to written opinion accompanying the SR. R137(3) No further amendment without consent of examiner. R137(4) Filing any amendments referred to in paragraphs 1 to 3, the applicant shall identify them and indicate the basis for them in the application as filed. If the Examining Division notes a failure to meet either requirement, it may request the correction of this deficiency within a period of one month.

63  Approved by the Administrative Council  Entry into force on First April 2009  Rule 63: in complex applications where a meaningful search is not possible, the applicant shall be invited to file (2 months) a statement indicating the subject matter to be searched.  if no answer is received in due time no search report or a partial search report to the extent that is possible shall be carried out.  ED shall request the applicant to limit the claims to the subject matter searched, unless the objection was unjustified. Upcoming Legal Changes

64  Rule 62(a): If application does not comply with Rule 43(2) (conditions for the application to contain more than one independent claim) the applicant shall be invited to indicate (2 months) the claims complying with Rule 43(2).  Search will be carried out on said basis  If no indication on time, search will be carried out on the basis of the first claim in each category. ED shall invite the applicant to restrict the claims to the subject matter searched, unless it finds the objection unjustified. In that case, search will be re-done

65  Rule 70a: Obligation to comment on the extended European search report + correct deficiencies  If not, application deemed to be withdrawn  Thus, the request for examination shall be accompanied by the response to the search opinion  Same principle when EPO acts as ISA or IPEA  Change in Rule 137, only 1 possibility to amend without consent of the ED (response to the search opinion) Upcoming Legal Changes

66  Modification of Rule 137:  when filing amendments the applicant shall identified them and indicate the basis in the application as filed.  Amended claims may not relate to unsearched subject matter under the new Rule 62a or 63  All changes shall enter into force the 01.04.2010 Upcoming Legal Changes

67  1983- First Trilateral Conference held in Washington. (Oct. 19).

68  Significant achievements  Paperless search capacity  Captured data through Trilateral data exchange and backfile conversion projects (bibliographic data, full text data, facsimile text, F-terms, and First page database)  Developed and adopted character coded and image data standards within Trilateral for data exchange  Produced specialised technology databases such as Trilateral DNA sequence database  Developed standards for mixed-mode software for CD-ROMs  Developed patent publication standards  Developed Trilateral DNA sequence format for filing biotechnology applications and PatentIn software for filing of patent applications involving nucleotide and amino acid sequence information.  Began converging classification systems  Development of common system architecture  TRINet used for access to Trilateral search systems, Trilateral dossiers for utilisation of search results, and electronic exchange of priority documents  Developed shared application processing framework between USPTO and EPO  Implementation of electronic filing  Developed and adopted international standard for Electronic Filing  Developed and adopted international standard for sequence submissions  Harmonisation of patent practices  Harmonised examination practices for various emerging technology fields as a result of Trilateral comparative studies  Led effort to revise search and examination guidelines to create international standard for examination processes by each PCT International Authority.  Led effort to focus discussion in SCP on "reduced package" for SPLT  Common Patent Information Dissemination policies  Developed world software standard for the searching, retrieving, displaying and printing of patent data collections on CD-Rom, DVD, Jukeboxes, hard disk or network: MimosaMimosa  Poster (pdf) Poster  Exchange of Priority Documents

69 Trilateral  Projects  Enhancing worksharing Enhancing worksharing  Mutual exploitation of work.  Developing the PCT Developing the PCT  Taking into account the current situation in which the PCT is widely used by applicants of the Trilateral regions, the Trilateral Offices continue their work in further enhancing the PCT administrative procedures.  Classification Classification  Efficiency of access to all patent collections classified by the IP5 offices.  Linguistic tools Linguistic tools  Machine translation services for translating patent documents.  Biotechnology Biotechnology  The Trilateral Biotechnology Working Group was initiated in 1988 with the agreed-upon mission of facilitating similar practice in an evolving area of technology and patent law with the goal of harmonization of practice among the Trilateral partners.  Patent information Patent information  How to achieve the maximum dissemination of patent information.  e-learning e-learning  Modules as pre-training materials for examiner exchanges and to promote mutual understanding of examination practices.  Examiner Exchange Examiner Exchange  A tool for enhancing understanding of patent systems and examination practices, building confidence among offices in work performed, and promoting the effectiveness of exchange of work results in order to maximize work sharing activities.  Information technology Information technology  The Trilateral Offices support the concept of building interoperability of its systems.

70 Trialateral  Biotechnology  Originally, the mission was to conduct a review of the documentation and search tools available in the three Offices in the area of biological sequences. The Trilateral Offices are currently co-operating, or have in the past, on various topics within the field of biotechnology, including but not limited to:  Report on the DNA Search Exchange Study, May 2004  Trilateral Project DR2 Report on Study on Single Nucleotide Polymorphism (SNP)/Haplotype Databases and Search Tools for Examiners (PDF471KB) Trilateral Project DR2 Report on Study on Single Nucleotide Polymorphism (SNP)/Haplotype Databases and Search Tools for Examiners  Trilateral Technical Conference: Study on Single Nucleotide Polymorphism (SNP)/Haplotype Databases and Search Tools for Examiners (status report; Trilateral Project DR2) (PDF469 KB) Trilateral Technical Conference: Study on Single Nucleotide Polymorphism (SNP)/Haplotype Databases and Search Tools for Examiners (status report; Trilateral Project DR2)  Examination Practice Relating to Single Nucleotide Polymorphisms (SNPs) and Haplotypes  Report (PDF 39,4 KB) Report  Annex 1 Comments of the EPO (PDF 27 KB) Annex 1 Comments of the EPO  Annex 2 Comments of the JPO (PDF 11,7 KB) Annex 2 Comments of the JPO  Annex 3 Comments of the USPTO (PDF 19,1 KB) Annex 3 Comments of the USPTO  Protein 3-Dimensional (3-D) structure related claims  Report (PDF 189 KB) Report  Annex 1 Comments of the EPO (PDF 32 KB) Annex 1 Comments of the EPO  Annex 2 Comments of the JPO (PDF 63 KB) Annex 2 Comments of the JPO  Annex 3 Comments of the USPTO (PDF 88 KB) Annex 3 Comments of the USPTO  Biotechnology Patent Practices: Reach-Through Claims November 2001  Report (PDF 273KB) Report  Annex 1 Comments of the USPTO (PDF 168KB) Annex 1  Annex 2 Comments of the EPO (PDF 85KB) Annex 2  Annex 3 Comments of the JPO(PDF 129KB) Annex 3  Mutual Understanding in Search and Examination: Nucleic Acid Molecule-related inventions whose functions are inferred based on sequence homology search  Report (PDF 179 KB) Report  Patentability of DNA fragments  Report (PDF 93 KB) Report  Annex 1(PDF 16 KB) Annex 1  Biotechnology Patent Practice, Project 24.1  Report (PDF 93 KB) Report  The Trilateral Search Guidebook in Biotechnology  Ver. I (PDF 216 KB) Ver. I  Ver. 2 (PDF 289 KB) Ver. 2

71 UPP  Utilisation Pilot Project (UPP)  The vision behind the Utilisation Pilot Project is that work carried out on a first filing at a NPO (National Office) can be further utilised for a subsequent filing by:  The Applicant  The EPO  It is expected that this can benefit the patent system within Europe.  The Utilisation Pilot Project will test the utilisation vision over a period of approximately 18 months. It will qualify and quantify the benefits, impacts, costs and required process changes on:  National Offices  Applicants  The EPO The key participants in the project are the National Offices, applicants, and the European Patent Office. Participating in the pilot are the national offices of Austria, Denmark, Germany, and the UK. The project will also consult with National Offices not actively participating in the pilot as well as EPO stakeholders.

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