Maximizing Patent Prosecution Opportunities in Europe: Tactics for Counsel When Drafting U.S.-Origin Applications

Transcription

1 Presenting a live 90-minute webinar with interactive Q&A Maximizing Patent Prosecution Opportunities in Europe: Tactics for Counsel When Drafting U.S.-Origin Applications Navigating Differing USPTO and EPO Legal Standards While Maintaining U.S. Patent Strategy THURSDAY, JANUARY 23, pm Eastern 12pm Central 11am Mountain 10am Pacific Today s faculty features: Rebecca M. McNeill, VIVICAR Law, PLLC, Boston Jens Viktor Nørgaard, Partner, Head of Biotechnology & Plant Sciences, HØIBERG, Denmark The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions ed to registrants for additional information. If you have any questions, please contact Customer Service at ext. 10.

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4 Maximizing Patent Prosecution Opportunities in Europe: Tactics for Counsel When Drafting US-Origin Applications Jens Viktor Nørgaard, HØIBERG A/S Rebecca McNeill, VIVICAR Law, PLLC January 23,

5 Outline EPC/EU Scope EPO s Literal Approach to Documents Amendments Priority Novelty Inventive Step Enablement/Sufficiency of Disclosure Unity Divisionals Unified Patent 5

6 Europe EPO Approach to Reading Documents 6

7 European Patent Convention (EPC) 7

8 European Union (EU) 8

9 EU vs EPO European Patent Office (EPO) 38 states may be designated in a European Patent Application 2 states are extension states Total population of ~600 million (USA: ~316 million) GDP(EPC) 20 billion USD (USA: ~15.7 billion USD) European Union (EU) 28 states All 28 EU member states can be designated in a European Patent application Total population of ~500 million (USA: ~316 million) GDP (EU) billion USD (USA: ~15.7 billion USD) 9

10 European Patent with Unitary effect AKA the EU patent or Unitary Patent At present 25 countries (green) are participants: 27 EU countries minus Italy and Spain. Spain, Croatia (red) will not join Patent or Court Italy (yellow) will join Unified Court Poland (pink) may in time join Patent Non EU countries (blue) are not participants 10

11 European Reading Literal Approach to Documents EPO Approach to Reading Documents 11

12 Directly and unambiguously derivable When reading prior art Amendments compared to the application as filed When you compare to the priority document 12

13 Combinations must be explicitly made No cherry picking An interval is an interval. A genus is a genus. 13

14 Enablement Same standard for applications and prior art Non-enabled prior art does not anticipate 14

15 Motivation to Combine Required for combinations within a document Documents can only be combined if there is a motivation 15

16 Amendments Amendments in the EPO 16

17 Amendments No statutory differences between EPC and 35 U.S.C. US: No amendment shall introduce new matter into the disclosure of the invention (35 USC 132 (a)). EPO: A European patent application or a European patent may not be amended in such a way that it contains subject-matter which extends beyond the content of the application as filed (Art 123(2) EPC). 17

18 Amendments vs. Written Description 35 U.S.C. 112 (a) In General. The specification shall contain a written description of the invention, Often used as a basis for rejecting new matter. 18

19 Amendments Difference in practice: Disclosure test ( directly and unambiguously derivable ). The disclosure must be exactly the same. Almost verbatim basis. The EPO does not accept arbitrary selections from two or more lists (no cherry picking; no selection invention within application) No combinations of features from different embodiments/aspects Selecting a preferred embodiment from a list is not considered a selection Combinations within multiple dependent claims are always disclosed (easy fix)! 19

20 Amendments Typical US challenges Different features are not prioritized or claimed separately results in selection from more than one list (can also give inventive step challenges) US application with several independent claims need to be combined into one independent EP claim 20

21 Amendments Do s Don ts Disclose all embodiments in the specification (not just in the examples). Disclose any species, sub-genus, intervals in the description. Add the technical effect. If possible, describe preferred embodiments as preferred Alternatively, put preferred embodiments in separate dependent claims Speculative embodiments consider leaving them out Describe combinations of features Add one generic independent encompassing all US-type independent claims Make all dependent claims multiple dependent. PS: do this already in the priority document Don t make laundry lists Don t put fall back positions only in the examples Don t keep the number of claims low 21

22 Priority Priority 22

23 Priority Formal Right Article 87 EPC (1) Any person who has duly filed, in or for (a) any State party to the Paris Convention for the Protection of Industrial Property or (b) any Member of the World Trade Organization, an application for a patent, a utility model or a utility certificate, or his successor in title, shall enjoy, for the purpose of filing a European patent application in respect of the same invention, a right of priority during a period of twelve months from the date of filing of the first application. The right to priority must exist at the date of filing the regular (PCT or EP) application Transfer of the right to priority must be done in writing during the priority year 23

24 Priority Formal Right Successor in title Inventors are applicants for many US provisionals Assignees are applicants for EURO-PCT/EP applications An employer does not automatically have the right to claim priority from an inventor s US application 24

25 Priority Formal Right Evidence of transfer of right to priority Guidelines for examination in the EPO: The transfer of the application (or of the priority right as such) must have taken place before the filing date of the later European application and must be a transfer valid under the relevant national provisions. Proof of this transfer can be filed later. (Guidelines A- III 6.1) (T 19/87 and T 1008/96) US-assignment signed during priority year should be valid 25

26 Priority Formal Right Neither "Employee Confidentiality and Inventions Agreement" nor a "Proprietary Information and Inventions Agreement constitute an assignment (J 12/00) Invention Disclosure Form signed by inventor? 26

27 Priority Practice tips Do s File US provisionals in the name of the assignee (easy fix) Assign rights to a US-provisional to the applicant (assignee) during the priority year. 27

28 Substantive Right to Priority Same test as for amendments ( directly and unambiguously derivable ) Effective date of a claim the filing/priority date on which the subject-matter of a claim is directly and unambiguously derivable from the application documents Any one claim may claim different priorities 28

29 Practice Tips Caution Be cautious in deleting anything from a priority document. If you discover errors, take care in correcting/deleting them. Do s Ensure all claims are adequately supported in priority document Include fallback positions in priority document File a complete application from the beginning Update application by adding new text If there is an error, add the correction cautiously 29

30 Threats - Priority Priority: US provisional containing scientists manuscript ( coversheet provisional ) Manuscript published during priority year PCT application is filed with complete specification and claims. Effective date of claims? - Priority date or PCT date Manuscript citable as prior art for claims not directly and unambiguously derivable from priority document. 30

31 Priority - Opportunities Black box prior art (citability before publication) Applications are citable for purposes of novelty from their filing/priority date (equivalent to 102 (e) prior art) Applications with more details generate stronger prior art 31

32 Novelty Novelty 32

33 Novelty Absolute novelty (including in view of inventors own publications) In Europe there is NO GRACE PERIOD Only significant exception used is in the case of evident abuse non-prejudicial disclosures (6 mo. grace period) 33

34 Novelty Selection Inventions Selection from discrete embodiments: A selection is novel if the combination is made from two or more lists of some length and if the selection results in a new technical teaching, i.e. not an arbitrary selection. Selection from interval: A selection is novel if: It is narrow It is sufficiently far removed from specific numbers (e.g. end points ) The narrow interval results in a new technical teaching. 34

35 Selection Invention Examples 1. Prior art is a multi-gene application describing 5000 genes and all imaginable diseases: Claim directed to use of one gene/protein for treatment of one specific disorder supported by data is a novel selection 2. Prior art describes composition with 7 different constituents with broad intervals: Claim describes composition with same 7 constituents with narrower intervals and new technical effect (multiple selection invention). Data must demonstrate existence of technical effect within the claimed area and not outside. 3. Prior art describes Markush formula with several possible substituents in different positions: Claim describes one compound or a narrow Markush formula supported by functional data. 35

36 Novelty Threats and Opportunities Threats Bad priority applications will haunt you Publication before priority date Publication during priority year Opportunities Draft applications directed to selection inventions Draft applications with multiple lines of defense to prevent competitors from making selections within your invention Draft applications with many details to generate stronger prior art 36

37 Inventive Step Inventive step 37

38 Inventive Step Problem - Solution approach 1. Determine the closest prior art (CPA, aka the primary reference) Same purpose i.e., sets out to solve the same technical problem Most features in common Same or neighboring technical field 2. Establish the differences between CPA and the claim 3. Establish the objective technical problem solved in view of the CPA 38

39 Inventive Step Problem - Solution approach (continued) 4. Determine whether the solution to the problem is obvious There must be a reason to modify the prior art (would not could) Can be based on combination of 2-(3) documents (or common general knowledge) 5. Support for an inventive step Unexpected results Going against a prejudice Secondary indicia: Long felt need, commercial success, failure of others 39

40 Enablement/Sufficiency of Disclosure Enablement 40

41 Enablement / Sufficiency of Disclosure There is Sufficiency of Disclosure (Art 83 EPC) if the specification discloses at least one way of practicing the invention. Burden of evidence for sufficiency is lower than for US enablement In particular with regard to use/method of treatment claims In vitro data are often accepted as sufficient Later filed evidence is taken into consideration Data on one species may support a broad genus 41

42 Support for Broad Claims Broad claims may be supported by a few examples if it is plausible that the invention works throughout the scope of the claims Examples: EPO accepts claims with 70% sequence identity and a functional limitation on the basis of one sequence (no structure/function relationship required) EPO does not require election of species for Markush claims First medical use claims are granted based on one enabled indication EPO accepts second medical use directed to treatment of groups of indications 42

43 2. Isolated nucleic acid molecule comprising a nucleotide sequence encoding an alcohol dehydrogenase having an amino acid sequence with at least 70% amino acid sequence identity to SEQ ID NO: 2. 43

44 Broad Claims Opportunities Describe and claim the broad genuses Include lower % identity in disclosure than you would if pursuing only the US Describe and claim sub-genuses Generalize your method of treatment claims 44

45 Patentable Subject Matter Patentable Subject Matter 45

46 First Medical Use A compound for use in medical treatment is patentable in Europe The first inventor of a medical use of a compound is entitled to a claim covering any medical use Claim format: Compound X for use as a medicament 46

47 Second Medical Use Novelty for second (or further) medical use(s) of a known medicament may be obtained through for example: A new disease or group of diseases A new group of individuals to be treated A new dosage A new formulation A new treatment regimen Enlarged Board of Appeal has laid out the basis for patentability of second medical treatment in several decisions Claim format: Compound X for use in the treatment of disease Y. Use of compound X for preparation of a medicament for the treatment of disease Y. 47

48 Dosage Claims Uncertainty? Recent European dosage claim patent was validated in DE, FR, GB Came to three different conclusions Problem: Harmonized application process but non-harmonized litigation Solution: Harmonization via Unified Patent Court 48

49 Androgenic Alopecia Claim 1 Use of finasteride for the preparation of a medicament for oral administration useful for the treatment of androgenic alopecia in a person, wherein the dosage amount is about 0.05 to 1.0 mg. Prior art Use of finasteride to treat hyperandrogenic conditions by oral or topical administration; Use of finasteride by topical administration for treating androgenic alopecia which is also a hyperandrogenic condition. 49

50 Dosage Regimen Region/Country EPO G2/08 United Kingdom Result Novelty and inventive step Novelty and inventive step Germany Invalid - lack of novelty Part of the patent claims specifying the dosage related to the administration and were disregarded in the assessment of novelty France Non patentable Therapeutic method 50

51 Diagnostic Use Diagnostic methods practiced on the human or animal body are not patentable Diagnostic methods practiced on a sample are patentable Also relevant to consider any (non-statutory) surgical step involved in the diagnosis Non-statutory surgical steps are those that present a substantial health risk for the subject and require the intervention of a physician 51

52 Products of Nature/Natural Processes Isolated DNA and natural processes are still patentable in Europe Isolated DNA, protein, antibodies, etc. Personalized medicine processes, such as dosing processes Continue to prepare applications reciting this subject matter in disclosure consider claims-like multiple dependent embodiments to support various combinations 52

53 Patentable Subject Matter Practice Tips Do s Claim diagnostic methods! Claim the diagnostic method separately from any surgical step. Claim broad medical uses Groups of indications Disclose and Claim Myriad/Prometheus Type Subject Matter Don ts Do not include surgical steps in claims directed to treatment or diagnosis 53

54 Unity of Invention and Divisionals 54

55 Restriction/Unity Compound Species Claim Types A B C D Compounds Method of manufacture Method of treatment Formulation Screening assay Primary US Division EPO Division 55

56 Unity Definition Same or corresponding technical features which together provide an inventive contribution over the state of the art ( special technical features ) Examples of special technical features: Common structure Same essential structural element (intermediate and final products) A significant structural element (Markush claims) Common function Common manufacturing steps A priori same invention: Apparatus and product made by apparatus Method of manufacturing, product, and method of use 56

57 Unity Opportunities No division among: protein, DNA, cell, vector, antibody, method of expressing, medical use, screening assays Different scope for different claim categories possible Narrow product claim Broad use-claim Broad manufacturing claim 57

58 Unity Objections raised at search stage No possibility to amend claims to overcome prior art to provide a special technical feature Left at the mercy of the examiner - often they divide claims more or less arbitrarily into different inventions Potentially very expensive to pay search fees for all inventions Protests rarely successful (not possible at EP-stage) Not possible to claim unsearched subject matter at a later stage of prosecution 58

59 Unity Threats and Opportunities Do s Place the most important invention first in the claims Claim the more narrow genuses and sub-genuses in the next claims Leave the list of species to later claims Find the common inventive concept Combine alternatives in one independent claim Don ts Draft several independent claims in the same category (may provoke a unity objection) 59

60 Divisionals Previously divisional applications were due on any pending application within 24 months from the first communication under Art 94(3) EPC (Office Action) or R 71(3) EPC (Notice of Allowance) In October 2013, the EPO Administrative Council amended these provisions. As of April 1, 2014, divisional applications may be filed so long as the parent application is pending. Eliminates the 24-month window. 60

61 Unified Patent Court Unified Patent Court 61

62 Participating countries All EU-countries can participate but only EU-countries Enhanced cooperation Italy and Spain have announced that they will not take part Poland has not yet signed 62

63 European Patent with Unitary effect Aka the EU patent or Unitary Patent At present 25 countries (green) are participants: 27 EU countries minus Italy and Spain. Spain, Croatia (red) will not join Patent or Court Italy (yellow) will join Unified Court Poland (pink) may in time join Patent Non EU countries (blue) are not participants 63

64 European Patent with Unitary effect AKA the EU patent or the Unitary Patent Granted with same set of claims in all 25 countries Provides uniform protection having equal effect in all the participating Member States. If it is limited, transferred, revoked or lapses, it does so in respect of all participating EU patent Member States An EU patent may be licensed in respect of the whole or part of the territories of the participating EU patent Member States 64

65 European Patent Today 1. European patent application designating 38 states 2. Grant of the European patent 3. Validation (translate + file) in each contracting state of choice GB DE FR SE DK FI NL PL GR ES IT CH NO TR IS etc. 4. Payment of annual renewal fees in each country chosen 65

66 European Patent with Unitary Effect 1. European patent application designating 38 states 2. Grant of the European patent 3. Request for unitary effect in EUP member States, validate in rest EP patent with unitary effect in 25 Member States ES IT not participating CH NO TR IS etc. non-eu countries 25 Member States 4. One renewal fee 4. Renewal fees for each country 66

67 The Language issue - Translations Ultimately: For a granted European Patent no further translations are required for an EU patent (Regulation 1260/2012. Art. 3) European patents are published with a specification / description in either English, French or German, with the claims translated to all three languages. Machine translations will suffice 67

68 Language transition phase Transition phase until high quality machine translation is available max 12 years from 1. January Quality of machine translations evaluated after 6 years and every other year therefrom: If the EP patent is granted in French or German translate full patent to English If the EP patent is granted in English translate full patent to any other official language of the European Union* *TIP: If entering ES or IT, choose Spanish or Italian otherwise Estonian translations are not expensive 68

69 Renewal fee for EU Patent Estimated costs for renewing a European patent in 25 EU states: Starting from about EUR per year increasing to about EUR per year Estimated costs for renewing an EU Patent in 25 EU states: Starting from about EUR per year increasing to about EUR per year 69

70 Summary EP patent EPO grants the Patent EU patent EPO grants the Patent Automatic effect in 25 states, need validation in non-participating countries ONE renewal fee Cheap Validate (translate & file) in each of 38 member states Pay renewal fees in each country Expensive 70

71 Unified Patent Court 71

72 Court Proceedings in Europe Today National and different court systems Infringement and validity heard by different courts in e.g. Germany Infringement and validity heard by same court in most countries Reality: 75% of all patent cases in EU are heard in Germany (in German) 72

73 Enforcement with Unified Patent Court One injunction, infringement or invalidity action with effect for (almost all) EU states First instance: Local courts (one country), Regional courts (several countries), or Central court with 3 chambers Munich (mechanics) Paris (electronics) London (chemistry, pharma, biotech) Appellate court in Luxembourg 73

74 Court Structure Technically qualified judge Legally qualified judge Court of Appeal (Luxembourg) Local or Regional Divisions Central Division (Paris, London, Munich) Optional 74

75 Which Patents? Unified Patent Court has exclusive jurisdiction over: European Patents with Unitary Effect European Patents (other than those with Unitary Effect)* Supplementary Protection Certificates * special provisions for EP patents (and their SPCs): For a period of 7 years after entry into force, cases can be brought before national courts At the end of the 7 years period, patent proprietors and applicants can opt out of the Unified Patent Court 75

76 Where to Sue? In the country where the infringement takes place Central Division when defendant is domiciled outside EU In the country where the defendant is domiciled 76

77 Language Language of the country where the court resides Possibility to use an EPO language Possibility to use language of the granted patent Central division: language of the granted patent Possibility to obtain translation of documents and during oral proceedings 77

78 Who can represent Attorneys competent to represent before a national court European Patent Attorneys with European Patent Litigation Certificate Attorneys can be assisted by European Patent Attorneys who can speak at oral hearings 78

79 Procedure Written procedure with Statement of claim Defence (within 3 months) Reply to defence, Counterclaim, Reply to counterclaim, Rejoinder (1-2 months) Interim conference Oral proceedings (at least 2 months notice) Procedure for the award of damages Procedures for cost orders 79

80 Scepticism Short deadlines Similar speedy procedures apply in Germany, UK, Netherlands today All your eggs in one basket One trial in one language before one court with one set of attorneys => cost savings Forum shopping Forum shopping applies even more today The appellate level will ensure uniform application of the law. 80

81 Will the Unitary Patent be a Success? Simpler one case for the (whole of) EU (except Spain) Cheaper? Faster Harmonized case law Less forum shopping Better? time will show 81

82 Thank You and Questions Jens Viktor Nørgaard Rebecca M. McNeill