Claim amendments - a case for national proceedings in the life science field?

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1 Claim amendments - a case for national proceedings in the life science field? Dr. Leo Polz German Patent Attorney European Patent Attorney Partner Dott. Marco Benedetto Italian Patent Attorney European Patent Attorney Partner Dr. Nadja G. Muncke British Chartered Patent Attorney Partner European Patent Attorney Silvia Bertran Valls European Patent Attorney 1 Life Science IP Seminar 2017

2 The EPO 2 Life Science IP Seminar 2017

3 STATISTICS Outcomes of EPO Examination Appeal Decisions Dismissal Grant Remittal Life Science All* Boards of Appeal * Source of data: 3 Life Science IP Seminar 2017

4 STATISTICS Inter partes decisions on Art. 123(2) EPC 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Amendment not allowed allowed Patentee friendly: , Patentee unfriendly: , (3.3.08) 4 Life Science IP Seminar 2017

5 Central Limitation at the EPO The EPO s central limitation procedure allows a patent proprietor to amend a patent granted by the EPO using a single central procedure. Any amendments made at the EPO are effective in all countries in which the patent is in force. The procedure is available for all patents granted by the EPO that are still in force (including those granted before EPC 2000 came into force). 5 Life Science IP Seminar 2017

6 Central Limitation at the EPO Written Request No need to explain the reasons for the amendment. No need to file new citations Should explain the basis for the amendment in the application as originally filed. EPO Examination Checking the amendments are clear, supported by the description, do not add matter beyond the as-filed application and do not extend the protection. No checking whether the amended claims are novel and inventive. Allowance and Publication Once the amendments are allowed, the patent proprietor must file a translation of the amended claims in each of the official languages of the EPO. The amended patent specification is then published by the EPO. 6 Life Science IP Seminar 2017

7 Central Limitation at the EPO Key features of the central limitation procedure: A request for limitation may be filed at any time during the life of the patent except when opposition proceedings are pending. If an opposition is filed while limitation proceedings are pending, the limitation proceedings are terminated. The procedure is ex parte, so a third party cannot intervene. The limited patent has a retroactive effect in all countries. The effect of patent is as though it had been granted in limited form. The limitation procedure can be used as many times as the patent proprietor wishes provided that each successive use is a further limitation. The procedure usually takes less than a year, but can be faster or slower. 7 Life Science IP Seminar 2017

8 Central Limitation at the EPO Recommendations The EPO central limitation procedure is a convenient and cost-effective way to amend a patent that has been granted by the EPO. This procedure is recommended in preference to national procedures if the patent has been granted by the EPO. However, the procedure should not be used if the patent proprietor wants to make amendments that are effective in only some of the designated states of the patent i.e. only one or a few countries. 8 Life Science IP Seminar 2017

9 General Principles Why are amendments restricted? Applicant should not be allowed any unfair advantage when amending and should not be able to improve his position Third parties must have legal certainty These principles are set out in Art 123 EPC 9 Life Science IP Seminar 2017

10 General Principles Art 123(2) EPC: The European patent application or 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. 10 Life Science IP Seminar 2017

11 General Principles Admissibility The admissibility of amendments under Art. 123(2) EPC is to be decided solely on the basis of examining whether the amendments are directly and unambiguously derivable from the application as filed by the skilled person. (T 288/92) The skilled person can use common general knowledge and can take into account implicit and explicit disclosures. 11 Life Science IP Seminar

12 General Principles Explicit Disclosure: Literal support not required No requirement to use the exact wording from the application as filed (but it is generally a good idea to do so!) (T 667/08) Implicit Disclosure: the clear and unambiguous consequence of what is explicitly disclosed (e.g. in view of basic scientific laws) Product inevitably resulting from adequately described production process (T 12/81, T 270/97) 12 Life Science IP Seminar

13 Germany 13 Life Science IP Seminar 2017

14 National amendment of patents in Germany A patent proprietor may make the following types of amendments to his German patent after grant: voluntary amendments by starting limitation proceedings; amendments in response to a challenge by a third party to the validity of the patent during an opposition or during nullity proceedings. 14 Post-Grant Amendment of National Patents in Key European Jurisdictions

15 National amendment of patents in Germany Limitation proceedings before the German Patent and Trademark Office (DPMA) An application to amend can be made at any time after grant. The patent proprietor must provide details of the prior art which caused the limitation to be requested, and he must explain the reasons for the request. The DPMA: checks whether the amendment is clear, whether it adds matter and whether it extends the scope of protection provided by the patent; but does not check whether the limited claims are novel and inventive or whether it is necessary to limit the claims. 15 Post-Grant Amendment of National Patents in Key European Jurisdictions

16 National amendment of patents in Germany Amendment during opposition or nullity proceedings: DPMA Opposition proceedings take place before the DPMA. Nullity proceedings take place before the Federal Patent Court. In both types of proceedings, a requested amendment is examined to determine: whether the amendment is clear; whether it adds matter; whether it extends the scope of protection; and whether the amended claims are novel and inventive. Federal Patent Court 16 Post-Grant Amendment of National Patents in Key European Jurisdictions

17 National amendment of patents in Germany All of the following forms of amendment are permitted in all types of German amendment proceedings: deletion of one or more claims ( abandonment ); incorporation of one or more dependent claims into an independent claim; amendment of an independent claim by incorporation of a previously unclaimed feature from the description or drawings of the granted patent. 17 Post-Grant Amendment of National Patents in Key European Jurisdictions

18 National amendment of patents in Germany Effect of amendments in Germany: All amendments have a retroactive effect to the date of grant of the patent, except abandonments All amendments have effect with respect to all third parties. This effect is applicable to matters past and closed. A deemed infringer can, if a subsequent limitation brings his acts outside the scope of the patent, seek amendment of the Court s decision and reversal of penalties, e.g. return of paid damages. 18 Post-Grant Amendment of National Patents in Key European Jurisdictions

19 National amendment of patents in Germany Legal Basis essentially the same as EPC Original Disclosure: everything that is directly and unambiguously derivable from the original disclosure Unallowable Amendments: Added subject matter that the skilled person can derive only with the aid of his common general knowledge or by modification of the disclosed teaching ( aliud ) 19 Post-Grant Amendment of National Patents in Key European Jurisdictions

20 National amendment of patents in Germany No binding effect: German Courts and GPTO are independent form each other and from EPO BUT: Requirement for mutual acknowledgment of decisions of other Infringement and Revocation Courts - including instances of EPO and other courts of EPC member states (BGH Xa ZB 10/09 Walzenformgebungsmaschine) 20 Post-Grant Amendment of National Patents in Key European Jurisdictions

21 Admissibility of Amendments Claim Interpretation is required: Subject matter of the claim has to be determined before examination of added matter (BGH X ZR 101/13 Polymerschaum II) Legal Basis Art 69 EPC + Protocol, 14 PatG The extent of the protection conferred by a European patent or a European patent application shall be determined by the claims. Nevertheless, the description and drawings shall be used to interpret the claims. 21 Life Science IP Seminar 2017

22 Admissibility of Amendments Content of Disclosure: Determination of the Content of Disclosure is a Point of Law, not a Question of Fact Meaning of a technical feature has to be considered for determination of content of disclosure The same standard is not necessarily be required for a feature that contributes less to the invention than a for a feature that is essential for the invention (4 Ni 7/15 Bioreaktor) 22 Life Science IP Seminar 2017

23 Correction of Inadmissible Amendment In case of (intermediate) Generalization Deletion of unallowably generalized feature (BGH X ZR 43/09 Integrationselement) If deletion results in extension of granted scope (Art. 123(3) EPC): Limiting feature remains in Patent Claim No rights can be derived from the unallowably added feature 23 Life Science IP Seminar 2017

24 Implicit Disclosure BGH X ZR 77/12 Proteintrennung Implicitly disclosed can be anything that the skilled person considers self-evident in order to perform the claimed teaching. Taking into account something self-evident does not allow to supplement the original disclosure by general knowledge, but merely assists to determine the content of the disclosure in its entirety. 24 Life Science IP Seminar 2017

25 Implicit Disclosure BGH X ZR 77/12 Proteintrennung EP : Claim 1 concerns a purification method for FVIII from human plasma Last step involves freeze-drying of FVIII solution Prior Art: FVIII concentrate for pharmaceutical use No lyophilization step mentioned 25 Life Science IP Seminar 2017

26 Implicit Disclosure BGH X ZR 77/12 Proteintrennung The Court: A (literally undisclosed) measure of a manufacturing process for a pharmaceutical composition may be comprised by the original discosure, if it is necessary to render the composition (protein concentrate) suitable for pharmaceuctical application (lyophylisation), and if said measure was common general praxis at the priority date to achieve this aim. Claim 1 of EP not novel! 26 Life Science IP Seminar 2017

27 United Kingdom 27 Life Science IP Seminar 2017

28 UK Patents Act 1977 as amended - Amendments Amendments after grant (section 27 Patents Act 1977) 27(1) [..], the comptroller may, on an application made by the proprietor of a patent, allow the specification of the patent to be amended subject to such conditions, if any, as he thinks fit. - discretionary - upon application by proprietor - must provide reasons and any relevant art - will be published, can be opposed - urgency not highly relevant any more - must lead to valid claims: no added matter (section 76(3)(a)), not extension of scope (section 76(3)(b)) 28 Life Science IP Seminar 2017

29 UK Patents Act 1977 as amended - Amendments Amendments after grant, during infringement or revocation proceedings (section 75) 75-(1) In any proceedings before the court or the comptroller in which the validity of a patent may be put in issue the court or, as the case may be, the comptroller may, subject to section 76 below, allow the proprietor of the patent to amend the specification of the patent [ ]. added on 13 December (5) In considering whether or not to allow an amendment proposed under this section, the court or the comptroller shall have regard to any relevant principles applicable under the European Patent Convention. Request for amendment can be made on a conditional or on an unconditional basis. 29 Life Science IP Seminar 2017

30 UK Patents Act 1977 as amended - Amendments Smith Kline & French Laboratories Ltd v Evans Medical Ltd [1989] FSR 561 (i) the onus to establish that amendment should be allowed is upon the patentee and full disclosure must be made of all relevant matters; (ii) amendment will be allowed provided the amendments are permitted under the Act and no circumstances arise which would lead the court to refuse the amendment; (iii) it is in the public interest that amendment is sought promptly, so a patentee who delays for an unreasonable period before seeking amendment must show reasonable grounds for his delay; This principle is no longer relevant in light of s.75(5). (iv) a patentee who seeks to obtain an unfair advantage from a patent, which he knows or should have known should be amended, will not be allowed to amend; (v) the court is concerned with the conduct of the patentee and not with the merit of the invention. This principle is no longer relevant in light of s.75(5). 30 Life Science IP Seminar 2017

31 Warner-Lambert v Generics [2016] EWCA Civ 1006 Warner-Lambert v Generics [2016] EWCA Civ 1006 Amendment September 2015: [2015] EWHC 2548: Arnold J: certain claims lack sufficiency of disclosure October 2015: Warner-Lambert made a conditional application to amend the patent. Opposed by Mylan and Actavis. November 2015: [2015] EWHC 3370 Arnold J struck out application to amend claim 3 as an abuse of the process of the court May 2016: Court of Appeal [2016] EWCA Civ 1006 Confirmed upheld Arnold J s decision 31 Life Science IP Seminar 2017

32 Warner-Lambert v Generics [2016] EWCA Civ 1006 Arnold J: 148. [ ], I consider that the application to amend claim 3 is an abuse of process because it could and should have been made prior to trial. Warner-Lambert not only had ample opportunity to make a conditional application to amend prior to trial, but also ought to have appreciated, for the reasons explained above, that it needed to do so if it wished to contend a claim limited in that manner would be independently valid. If the amendment application was allowed to proceed, it could not be determined fairly without a second trial on validity. Furthermore, there is a risk that such a second trial would delay the overall resolution of the dispute. Accordingly, in my view, the amendment application amounts to unjust harassment of Mylan and Actavis. It would also be contrary to the interests of other generic suppliers of pregabalin. It is true that the consequence (subject to the outcome of the appeals) will be that claim 3 is invalid and must be deleted, but that consequence is attributable to Warner - Lambert electing to defend the insufficiency attack on claim 3 in the way in which it did, which proved unsuccessful (subject to the outcome of the appeals), and not making a conditional application to amend before trial. As the cases show, Warner-Lambert is not the first patentee to have made that mistake. 32 Life Science IP Seminar 2017

33 UK Patents Act 1977 as amended - Amendments Section 76: Amendment of applications and patents not to include added matter 76 (3) No amendment of the specification of a patent shall be allowed under section 27(1), 73 or 75 if it - (a) results in the specification disclosing additional matter, or (b) extends the protection conferred by the patent 33 Life Science IP Seminar 2017

34 Napp v Ratiopharm ([2009] EWCA Civ252 Napp v Ratiopharm ([2009] EWCA Civ252 Summary on added matter (point 71 of the decision) Bonzel v Internvention (No 3) [1991] RPC 553 To compare the two disclosures and decide whether any subject matter relevant to the invention has been added whether by deletion or addition. The comparison is strict in the sense that subject matter will be added unless such matter is clearly and unambiguously disclosed in the application either explicitly or implicitly. Richardson Vick s Patent [1995] RPC 568 I think the test of added matter is whether a skilled man would, upon looking at the amended specification, learn anything about the invention which he could not learn from the unamended specification. 34 Life Science IP Seminar 2017

35 Hospira v Genentech, Court of appeal, [2016] EWCA Civ 780 EP(UK) , EP(UK) Claim 1 ( 628 as amended): 1. A formulation comprising a lyophilized mixture of a lyoprotectant, a buffer, a surfactant and an antibody, wherein a molar ratio of lyoprotectant:antiboy is moles lyoprotectant : 1 mole antibody, wherein the lyoprotectant is trehalose or sucrose, wherein the buffer is histidine, wherein the surfactant is polysorbate 20 and wherein the antibody is a monoclonal antibody humab4d5-8, obtainable by lyophilizing a solution containing 25 mg/ml humab4d5-8, 5mM histidine ph 6.0, 60 mm trehalose and 0.01% polysorbate 20. Protein concentration 187. Starting from the 628 patent in its amended form including proposed claim 1, no doubt the first thing a skilled person seeking to put it into practice would do would be to consider repeating the lyophilisation of the Table 5 Solution. But I believe they would understand claim 1 to teach them that they would produce a stable formulation by lyophilising a solution with a higher protein concentration provided only that the lyophilised material was obtainable by the lyophilisation of the Table 5 solution, in other words provided that the Table 5 molar ratio was maintained. Taking that approach is something taught in the document as amended. It is new information. I find the amendment adds matter. (High Court) 35 Life Science IP Seminar 2017

36 Merck Sharp & Dohme v Shionogi, [2016] EWHC 2989 EP(UK) Use of a compound of formula (I) : [ ] for the preparation of a pharmaceutical composition for use as an integrase inhibitor for preventing or treating a viral disease. Judge cited EPO s case law on selections from lists Unconditional amendment/claims as granted: No added matter. It is true that the shrinkage involved a degree of selection from multiple lists, but there was no singling out of specific compounds, or specific classes of compounds. Thus the skilled team is not taught anything different about the invention as a result of the limitation. Proposed 2 nd conditional amendment: Added matter. It singles out a specific combination of restriction on R 1 and Z 1, Z 2 and Z 3 respectively which is not hinted at in the Application. It therefore does teach the skilled team something new about the invention. Moreover, [..] this is not an accident: the purpose of the amendment is to exclude compounds which don t work. 36 Life Science IP Seminar 2017

37 Idenix v Gilead, [2016] EWCA Civ 1089 EP(UK) Claim 1: 1. A compound of Formula (IX): or a pharmaceutically acceptable salt thereof, wherein: R1 and R2 are independently H; phosphate; straight chained, branched or cyclic alkyl; acyl; CO-alkyl; CO-aryl; CO-alkoxyalkyl; CO-aryloxyalkyl; CO-substituted aryl; sulfonate ester; benzyl, wherein the phenyl group is optionally substituted with one or more substituents; alkylsulfonyl; arylsulfonyl; aralkylsulfonyl; a lipid; an amino acid; a carbohydrate; a peptide; or a cholesterol; X is O; Base* is a purine or pyrimidine base; R12 is C(Y3)3; Y3 is H; and R13 is fluoro. 37 Life Science IP Seminar 2017

38 Idenix v Gilead, [2016] EWCA Civ 1089 Claim 4 as granted: Restricted the definition of Base to eights specific bases. Added matter (no disclosure in application of this particular set of bases) Amendment to claim 1: Idenix sought to amend to delete compounds unlikely to have antiviral activity. Added matter (no disclosure of this subgroup or of their activity). 38 Life Science IP Seminar 2017

39 Italy 39 Life Science IP Seminar 2017

40 The standard applied to allowability of amendments Summary - Amendments (voluntary) filed by the Applicant during the patent prosecution before IPTO (Art. 172 co. 2 IPC) - Amendments after receiving the Search report - Patent limitation (voluntary) before IPTO (Art. 79 co. 1 IPC) - Patent limitation in the invalidity proceedings (Art. 79 co. 3 IPC) - Consequences of amendments 40 Life Science IP Seminar

41 The standard applied to allowability of amendments Amendments (voluntary) filed by the Applicant during the patent prosecution before IPTO (Art. 172 co. 2 IPC) - Art. 172 co. 2 CPI states: The applicant, prior to the IPTO granting a title (i.e. Patent) [ ], in case a petition has been filed, may rectify, as to non-substantial profiles, the originally filed application [ ]; - [ ] in respect of an application for an invention patent [ ], the Applicant may integrate also by new examples, or to restrict the description, the claims or the originally filed drawings [ ]. 41 Life Science IP Seminar

42 Differences in national prosecution or post-grant proceedings Amendments after receiving the Search report - For Italian national filing as first filing (priority application) - Search report carried out by the EPO and received via IPTO (no charges for the applicant!) - Different filings on the same day having the same disclosure but different sets of claims (e.g. composition and use claims) receive both a Search report free of charge - Amendments permitted after receiving the Search report from the IPTO, but before 21 months from the filing date (Art. 5 M.D ) 42 Life Science IP Seminar

43 The standard applied to allowability of amendments Patent limitation (voluntary) before IPTO (Art. 79 co. 1 IPC) - Art. 79 co. 1 IPC states: A patent may be limited, upon filing by its holder of a request, to which the description, the claims and the modified drawings must be attached. - After grant, without any time limit restriction - The limitation may not extend the protection as conferred by the granted patent 43 Life Science IP Seminar

44 The standard applied to allowability of amendments 1. Patent limitation in the invalidity proceedings (Art. 79 co. 3 IPC) - Art. 79 co. 3 IPC states: In a proceeding concerning nullity, the owner of the patent has the right to submit to the Court, at any stage or instance of judgment, modified claims that remain within the limits of the content of the patent application as initially filed and that do not extend the protection conferred by the patent granted; Art. 79 co. 3 IPC has been introduced to avoid any different treatment between national and European patents (Art. 138 co. 3 EPC) 44 Life Science IP Seminar

45 The standard applied to allowability of amendments 2. Patent limitation in the invalidity proceedings (Art. 79 co. 3 IPC) - What does at any stage or instance of judgment mean? (T. Milano 15/11/2012; T. Milano 11/6/2014, n. 7708) - Two opposite extremes: abuse of the patent procedure and legal certainty of third party (T. Milano n. 714/2017 & 15/9/2012) - Limit for an amendment: within the limits of the content of the patent application as initially filed and that does not extend the protection conferred by the patent granted (Art co. (c) IPC; Art. 123 (2) & Art. 123 (3) EPC) - Date of effectiveness of the amendment (T. Milano 5377/2015) 45 Life Science IP Seminar

46 The standard applied to allowability of amendments Consequence of unallowable amendments - Invalidity: Art. 76 co. 1(c) IPC) states: A patent is invalid: c) if the object of the patent extends beyond the contents of the initial application or the protection of the patent has been extended; - The sanction (invalidity) provides the principle of preserving the public interest and legal certainty of third party 46 Life Science IP Seminar

47 Differences in national prosecution or post-grant proceedings Consequence of national and EP s centralized amendments - Applicability of Art. 79 co. 3-bis: When there is both a limitation of the European patent following a limitation procedure as per the European Patent Convention, and a limitation of the same European patent with effect in Italy following a national procedure, the scope of protection conferred by the patent is determined taking into account each of the limitations established. 47 Life Science IP Seminar

48 Spain 48 Life Science IP Seminar 2017

49 National Amendments of Patents in Spain Amendments (voluntary) filed by the Applicant during the patent prosecution before SPTO (Art. 48 Law 24/2015) - Art states: With the exception of obvious errors, the interested party may only modify the claims during the grant procedure as allowed by the present law, and subject to what is established by the rules. The possibility of modifying the claims includes the modification of the description and, where appropriate, the drawings or biological sequences [ ]. 49 Life Science IP Seminar

50 National Amendments of Patents in Spain - Art and 48.6 Law 24/2015 state: - The patent application or the patent may not be modified in such a way that its subject matter exceeds the content of the application as initially filed. - In the opposition or limitation proceedings the patent may not be modified in a way that extends the protection it confers. 50 Life Science IP Seminar

51 National Amendments of Patents in Spain Limitation requested by the Proprietor after grant before SPTO (Art. 105 Law 24/2015) Art : At the request of the Proprietor, the granted patent may be revoked or limited by modifying the claims at any time during its legal life, including the period of validity of the supplementary protection certificates (SPCs), if applicable. But the request may not be filed during the opposition period or while opposition or limitation proceedings are on-going (Art.41.3 of the rules for implementation of Law 24/2015) Art : When a judicial proceeding on the validity of the patent is pending the request for limitation, addressed to the SPTO, shall be authorized by the Judge or Court that knows the proceedings. 51 Life Science IP Seminar

52 National Amendments of Patents in Spain Patent limitation in the nullity proceedings (Art. 43 of the rules for implementation of Law 24/2015) - When judicial proceedings regarding the validity of the registered patent are in progress, the SPTO will inform the Judge/Court about the request for limitation - Once limitation proceedings are concluded, the SPTO shall inform the Judge/Court of its decision and provide a copy of the patent as modified 52 Life Science IP Seminar

53 National Amendments of Patents in Spain Consequence of unallowable amendments - Grounds of nullity (Art Law 24/2015): c) when the subject-matter of the patent extends beyond the contents of the application as filed; d) when the protection conferred by the patent has been extended - The sanction (nullity) follows the principle of preserving the public interest and the legal certainty of third parties 53 Life Science IP Seminar

54 Thank you for your attention! Dr. Leo Polz German Patent Attorney European Patent Attorney Partner Dr. Nadja G. Muncke British Chartered Patent Attorney Partner European Patent Attorney Dott. Marco Benedetto Italian Patent Attorney European Patent Attorney Partner Silvia Bertran Valls European Patent Attorney 54 Life Science IP Seminar 2017