IP: Patent law & prosecution

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1 IP: Patent law & prosecution Tech Transfer course August 2018 Griet Den Herder, PhD, IP Manager

2 Patent law & organisations International : Vienna convention: treaty following principle of good faith Paris convention: EPC special agreement following PC World trade organisation (WTO) Patent Cooperation Treaty World Intellectual Property Organization (WIPO) Regional : European Patent Organisation (EPO) African Regional Intellectual Property Organization (ARIPO) Eurasian Patent Organization (EAPO) Patent Office of the Cooperation Council for the Arab States of the Gulf (GCC Patent office) National : All countries national authorities Most relevant: US, CA, AU, NZ, JP, CN, KR, BR,. Different routes for patent filing and obtaining rights for protection possible!

3 Example Patenting route Filing Examination Grant Priority year Publication 0 m 12 m 18m 30 m 3-10 y Publication PCT EP & US Priority Filing EP, UK, BE, US, EP, UK, BE, US, Filing (priority claim) International PCT Regional EPO National US Regional/ National Examination Regional Phase Entry: EP, National Phase entry: US, CA, AU, NZ, JP, KR, CN, Regional EPO National US Validation EP: designated states & translations US, CA, AU, NZ, JP, KR, CN EP: designated states & translations US Change in EP: Unitary patent! BE BE (No examination) BE valid patent ( innovation Tax )

4 Patent prosecution Interaction between applicants and a patent office regarding a patent application Pre-grant prosecution Applying for a patent FILING Negotiating with the patent office to obtain the grant of a patent EXAMINATION Examination onfiling and formalities Formal requirements Substantive examination Content: patentability and scope of invention/protection Decision: GRANT / REFUSAL Post-grant prosecution Opposition to the patent (Third party) Limitation/Revocation (Proprietor) Appeal

5 The European Patent Convention (EPC) Legal framework for the granting of European patents A uniform procedure for the EPC contracting states European Patent Office (EPO)

6 Patenting procedure

7 Patent Cooperation Treaty (PCT) International patent law treaty, since 1970 The PCT contracting states constitute a Union for cooperation in the filing, searching, and examination of applications Unified procedure for worldwide patent filing, but not for worldwide patent grant! PCT application = International application

8 PCT contracting states 1 th June 2018: 152 member states (most of the world, except Argentina, Bolivia, Ethiopia, Afghanistan, Myanmar,...)

9 Patenting procedure Filing Examination Grant Priority year International Phase National Phase 0 m 12 m 30 m 3-10 y Priority Filing International Filing National Phase Entry

10 Who is allowed to file? PCT Resident or national of PCT contracting states (closed system) Applicant= Natural or legal person Representation: according to national law of receiving office (RO) EPO Anyone! (open system) Applicant= Any natural or legal person If applicant has no residence or place of business within the territory of an EPC contracting state professional representative needed in all proceedings after the filing

11 Applicant versus inventor Applicant = who files the patent application The right to a European patent shall belong to the inventor If the inventor is an employee, national law determines the right to a European patent Flemish University Decree: inventions by employees belong to University German Arbeitnehmererfindungsgesetz regulates compensations to inventors/employees... Disputes about entitlement through national courts

12 Inventor is defined as: An inventor should have an intellectual contribution to the claims of the invention. So inventors might change during prosecution when claims are being reduced or amended. A person merely reducing the invention to practice is not considered an inventor: a person who worked with skill and diligence under direction someone who provided a research tool Different from authorship! Also not an inventor: - The person who heads the lab without contribution to conception or reduction to practice - Someone who should be rewarded for hard work - Personal friends, colleagues...

13 Language requirements PCT Prescribed language of the RO IB: any language EPO: any language National : official language or otherwise Translation needed when not: Language accepted by the ISA Language of publication* *Arabic, Chinese, English, French, German, Japanese, Korean, Portuguese, Russian, Spanish EPO Any language! Official languages of the EPO English, French, German Translation required when not in an EPO official language Language of translation becomes language of proceedings & publication

14 Content of a patent application PCT & EPO Request for grant Description of the invention Claim(s) (Drawings) Abstract

15 When to file? Too early: not enough support, narrow claim scope Too late: competitor has already filed (prior right) or has already published (prior art) Timing is critical!

16 Priority Any person who has duly filed an application for a patent... shall enjoy... in respect of the same invention, a right of priority during 12 months Consequence: the date determining the state of the art and determining which applicant filed first is for all countries determined by the priority date Paris Convention for the Protection of Industrial Property (177 countries) International filing: protection or priority in country not part of PCT? Check whether this country signed Paris Convention If not: application has to be filed in the country itself to obtain protection (at same time as other priority application)

17 Publish during priority year? Priority filing: 23 August 16: A Priority year Publish A + A* International filing: 23 August 17: A + A* Priority right in respect of the same invention (in the same state)!

18 Patenting procedure Filing Examination Grant Priority year Search International Phase National Phase 0 m 12 m 30 m 3-10 y Priority Filing International Filing National Phase Entry

19 Search Reports/ Written Opinions The European search report shall mention those documents... which may be taken into consideration in deciding whether the invention... is new and involves an inventive step ISR = International Search Report will be published together with patent application WO = Written Opinion Report on Patentability, will not be published (although open for public in the Patent Register after publication of the application)

20 ISR example

21

22 Patenting procedure Filing Examination Grant Priority year International Phase 0 m 12 m 18 m 30 m 3-10 y Publication National Phase Priority Filing International Filing National Phase Entry Publication of patent application (& ISR)

23 Publication Publication of the patent application is NOT the granted patent The granted patent is published after the examination procedure, claim scope is most likely different from the original application! Application content becomes part of the state of the art

24

25 Patenting procedure Filing Examination Grant Priority year International Phase Publication 0 m 12 m 18m 30/31 m 4-10 y National Phase Priority Filing International Filing National Phase Entry Regional Phase Entry: EP EURO-PCT National Phase Entry: US, CA, AU, NZ, JP, KR, CN,

26 Examination Filing Filing and prosecution (VIB) Priority Filing 0 m 23 Aug 16 International Filing 12 m 18 m VIB evaluation 23 Aug 17 PCT (all states) Search Report & Written Opinion ~23 Feb 18 Publication National Phase Entry 30 m 23 Feb 19 Elected states EP US CA AU JP 3 y 5 y 5 y 2 y 7 y Office Actions

27 Pre-grant prosecution: Examination Appeal by Applicant

28 Examining Division (ED) ED consists of three examiners 1 st member, 2 nd member and chairman 1 st member corresponds with the Applicant ED decides together whether to grant or refuse the application The claims are the most important part of the application for the ED, they define the scope or extend of protection Description and drawings are used to interpret the claims

29 Communication Applicant/ ED Correction of deficiencies mentioned in the opinion on the Search report Positive opinion : still possible to voluntarily amend the claims Negative opinion: mandatory to respond to written opinion within 6 months from the notification Written communication(s) from ED office action(s) May be followed by summons to Oral Proceedings if no agreement on claim scope is agreed upon within reasonable time frame

30 Amendments during prosecution A patent application may be amended in proceedings (claims) BUT not in such a way that it contains subject-matter which extends beyond the content of the application as filed Claim amendments must be supported by wording in the written description Everything must be in the application, you cannot change wording/add examples etc. Later filed examples may nevertheless be taken into account by the Examiner Depending on jurisdiction Depending on type of objection (e.g. Inventive step)

31 Office action example Amended claims contain subject matter beyond the content of the application as filed

32 Office action example Amended claim 1:

33 Office action example Summons to oral procs Allowable main claim:.. A complex of (i) an antibody fragment or a Nanobody specifically binding to the C-terminal epitope tag defined by SEQ ID NO: 1; and (ii) a fusion protein comprising a target protein and a heterologous C-terminal epitope tag defined by SEQ ID NO:1, further characterized in that said SEQ ID NO:1 represents the last four C-terminal amino acid residues of said fusion protein; and (iii) optionally a ligand bound to the target protein comprised in said fusion protein.

34 Refusal If the ED is considering refusal The Applicant has the right to be heard (Art. 113 EPC) The Applicant can ask to present arguments face to face in Oral Proceedings before the ED If at least two members of the ED are still not convinced Refusal

35 Patenting procedure Filing Examination Grant Priority year International Phase Publication National Phase 0 m 12 m 18m 30 m 3-10 y Publication Priority Filing International Filing National Phase Entry

36 Intention to grant At least two members of the ED agree that the application meets the requirements of the EPC R. 71(3) communication Request translation of the claims in the other two official EPO languages Approval of final text Publication of the mention of grant Publication of granted patent

37 and finally a granted Patent A European patent shall... confer on its proprietor from the date of publication of the mention of the grant, in each contracting state in respect of which it is granted, the same right as would be conferred by a national patent granted in that state Belgium: proprietor may forbid third party to make, sell, offer, use, import or stock But how does the scope of the granted claims compare to the scope of the originally filed claims?

38 A granted Patent: the icing on the cake! But not the cake itself... A patent doesn t give you freedom-to-operate If you are prevented from making and selling cakes, having nice icing doesn t help a lot. Essential to ensure freedom to operate before any commercial activity! Patent rights are not absolute, there are restrictions such as: Competition law or other national laws, Private- and experimental/research use exemption.

39 Patenting procedure Filing Examination Grant Priority year International Phase National Phase 0 m 12 m 30 m 3-10 y Postgrant Priority Filing International Filing National Phase Entry

40 Post grant prosecution Opposition to the patent (Third party) : aim improve quality Limitation/Revocation (Proprietor): restrict claim scope Appeal by any party adversely affected by a decision: second/last instance before the Board of Appeal.

41 Post-grant: Opposition A procedure for third party to challenge the validity of a granted patent Must be filed within 9 months of the mention of grant Allows the introduction of disclosures that may not have been available or found by the ED Allows the public to challenge the ED decision

42 Opposition Division (OD) The patent proprietor and the opponent battle it out amongst themselves The OD takes the final decision OD: three members, at least two did NOT take part in the Examination Proceedings Usually the 1 st examiner from the ED plus two others

43 OD decisions Revoke the patent in its entirety Maintain the patent in amended form Maintain the patent in unamended form (as granted)

44 Patenting procedure Costs

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