Threats & Opportunities in Proceedings before the EPO with a brief update on the Unitary Patent MassMEDIC Jens Viktor Nørgaard & Peter Borg Gaarde September 13, 2013
Agenda Meet the speakers Threats & Opportunities in Proceedings before the EPO 12.09.2013 2
Speakers CV Peter Borg Gaarde European Patent Attorney Partner Certified Danish Patent Agent MSc (Physics), University of Copenhagen pbg@hoiberg.com Jens Viktor Nørgaard European Patent Attorney Partner, Head of Biotechnology & Plant sciences PhD (Biochemistry and Genetics) MSc (Forestry Science), Royal Veterinary and Agricultural University jvn@hoiberg.com 31.09.2013 3
Biotech/Chemistry Colleague Peter Holm European Patent Attorney Certified Danish Patent Agent PhD (Structural Biochemistry & Biophysics), Karolinska Institutet & Lund University MSc (Chemistry), University of Linköping Postdoc, University of Aarhus phm@hoiberg.com 12.09.2013 4
Høiberg A/S Brief bullets Høiberg was founded in 1995 by Susanne Høiberg, MD Høiberg has patent attorneys covering all technical fields Høiberg has Medicon Valley s largest IP group specializing in MedTech & Life Sciences Høiberg has more than 20 years of experience working with international clients 12.09.2013 5
Questions are Most Welcome 12.09.2013 6
EUROPE? 12.09.2013 7
European Patent Convention (EPC) 12.09.2013 8
European Union (EU) 12.09.2013 9
EU and EPO are not the same European Patent Organisation (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: ~16 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) 16 billion USD (USA: ~16 billion USD) 12.09.2013 10
The European Patent Organisation Article 4(3) EPC The task of the European Patent Organisation is to grant European Patents 12.09.2013 11
Threats & Opportunities Amendments Priority Novelty Inventive Step Diagnostic Methods Claims Divisionals 12.09.2013 12
Amendments 12.09.2013 13
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). 12.09.2013 14
Amendments Huge difference in practice! The EPO uses a 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) Selecting a preferred embodiment from a list is not considered a selection Easy fix when drafting: Combinations within multiple dependent claims are always disclosed 12.09.2013 15
Amendments Do s Disclose all embodiments in the specification (not just in the examples) Disclose any species, sub-genus, intervals in the description Add the technical effect Any preferred embodiments must be described as preferred Describe combinations of features Make all dependent claims multiple dependent PS: do this already in the priority document Don ts Don t make laundry lists Don t put fall back positions in the examples Don t keep the number of claims low 12.09.2013 16
Priority 12.09.2013 17
Priority Formal Right Article 87 EPC The right to priority belongs to the applicant or his successor in title. 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 12.09.2013 18
Priority Formal Right Successor in title Inventors are (still) applicants for many US provisionals Assignees are applicants for PCT/EP applications An employer does not automatically have the right to claim priority from an employee s US application 12.09.2013 19
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 12.09.2013 20
Priority Formal Right Case law: Neither "Employee Confidentiality and Inventions Agreement" nor a "Proprietary Information and Inventions Agreement constitute an assignment (J12/00) The transfer of priority rights must be proven in a formal way. It was reasonable to apply an especially high standard of proof as required for assignment of a European patent application by Art. 72 EPC i.e. in writing and signed by or for both parties. Transfer of priority right is separate from transfer of ownership (T62/05) US-assignment not valid? 12.09.2013 21
Claiming Priority Practice tips Do s Assign rights to a US-provisional to the applicant (assignee) during the priority year. Assign specifically the right to claim priority Have the assignment signed by assignee Don ts Don t assume that the right to claim priority automatically belongs to the employer Don t assume that formalitites can be fixed later 12.09.2013 22
Substantial Right to Priority Same strict test as for amendments ( directly and unambiguously derivable ) Effective date of a claim the filing/priority date on which a claim is directly and unambiguously derivable from the application documents 12.09.2013 23
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. 12.09.2013 24
Practise Tips Don ts Never, ever delete anything from a priority document. Even in case of an error. Do s Ensure all claims are adequately supported in priority document Include fall-back positions in priority document If at all possible, file a complete application from the beginning Update application by adding new text 12.09.2013 25
Novelty 12.09.2013 26
Novelty Absolut novelty is the requirement also in view of inventors own publications In Europe there is NO GRACE PERIOD Only exception is in the case of evident abuse non-prejudicial disclosures (6 months grace period) 12.09.2013 27
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. 12.09.2013 28
Selection Invention Examples 1. 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 2. 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 12.09.2013 29
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 12.09.2013 30
Inventive step 12.09.2013 31
Inventive Step Problem - Solution approach 1. Determine the closest prior art (CPA) Same purpose i.e. sets out to solve the same technical problem Most features in common Same or neighbouring technical field 2. Establish the differences between CPA and the claim State the technical effect of this difference Preferably derive technical effect from application 12.09.2013 32
Inventive Step Problem - Solution approach (continued) 3. Establish the objective technical problem solved in view of the CPA 4. Determine whether the solution to the problem is obvious There must be a reason to modify the prior art (could/would) 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 12.09.2013 33
Diagnostic Methods 12.09.2013 34
Diagnostic Use Diagnostic methods practised on the human or animal body are not patentable Products, substances and compositions for use in these methods are patentable Only a problem if diagnostic methods are performed on the living body 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 12.09.2013 35
Diagnostic Use Practise tips Do s Claim diagnostic uses! Claim data-collection methods (performed on the human/animal body) Don ts Avoid surgical steps in claims directed to diagnosis Avoid steps performed on the human/animal body in diagnostic claims 12.09.2013 36
Claims 12.09.2013 37
Claim challenges Problem Unity of invention Solution Stick to one claim in each claim category (with few exceptions): One method claim One apparatus claim If more than one claim, the EPO will issue an invitation to indicate which claim to search Amendments Multiple dependency allowed! Even between claim categories Clarity of claims Draft better claims with antecedent basis 12.09.2013 38
Claims Practice tips Do s Place the most important claims first Claim the more narrow genuses and subgenuses in the next claims Leave the list of species to later claims Find the common inventive concept Put it in the application Combine alternatives in one independent claim Multiple dependency because: Provides more specific protection Provides better fall back positions (post grant) Don ts Draft several independent claims in the same category 12.09.2013 39
Divisionals 12.09.2013 40
Divisionals A divisional application must be filed based 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) A new (=not raised in the first communication) unity objection gives rise to a new 24 months window Some legal uncertainty with respect to double patenting 12.09.2013 41
Divisionals Light at the end of the Tunnel The EPO s Administrative Council considers deleting the 24 months rule! 12.09.2013 42
Oppositions 12.09.2013 43
Opposition Oppositions must be filed within 9 months from the date of grant Can raise objections based on: Patentability (novelty, inventive step, statutory subject matter) Sufficiency Amendments Anyone can file an opposition even through strawman Patentability can be based on prior art cited during examination and on new prior art. 12.09.2013 44
Opposition Maintained Revoked Limited 31.05.2013 45
Opposition Procedure 1. Notice of opposition (within 9 months of date of grant) 2. Reply from patent proprietor 3. Summons to oral proceedings 4. Written submissions from both parties 5. Oral proceedings ending with announcement of decision 6. Decision can be appealed 12.09.2013 46
Advantages Efficient and predictable procedure 35 years of case law No estoppel effect patent can be challenged in court later Revocation for all EPC contracting states 12.09.2013 47
EUROPEAN PATENT WITH UNITARY EFFECT 12.09.2013 48
Participating countries Enhanced cooperation Italy and Spain have announced that they will not take part Poland has not yet signed All EU-countries can participate but only EU-countries 49
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 50
Summary EU patent EPO grants the Patent Automatic effect in 25 states, need validation in non-participating countries ONE renewal fee EP patent EPO grants the Patent Cheap Validate (translate & file) in each of 38 member states Pay renewal fees in each country Expensive 51
UNIFIED PATENT COURT 52
Court Proceedings in Europe Today 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 53
Court Structure Technically qualified judge Legally qualified judge Court of Appeal (Luxembourg) Local or Regional Divisions Central Division (Paris, London, Munich) Optional 31.05.2013 54
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 55
Will the Unitary Patent be a Success? Simpler one case for the whole of EU (except Spain) Cheaper? Faster Harmonized case law 56
Thank you for your attention 12.09.2013 57