Lessons learnt from patent case law in Europe in 2013 and 2014 Véron & Associés Seminar Paris Maison de la Recherche 6 February 2015 Isabelle Romet Paris Lyon 1. Main teachings of 2013-2014 (1/2) 1. Possible to limit a claim by adding features included only in the specification (and not in the initial claims) (see details below) 2 Véron & Associés 1
1. Main teachings of 2013-2014 (2/2) 2. Partial invalidation by a court still possible TGI Paris, 3 rd ch., 2 nd s., 21 November 2014, Ethypharm v. Astraezeneca (esomeprazol) 3. A claim limitation made after the decision refusing an SPC cannot be taken into account in a recourse against this decision: CA Paris, 30 May 2014, Syngenta v. French patent office CA Paris, 8 June 2012, Boehringer v. French patent office 3 2. Limitation by features of the description (further details) Accepted in Syngenta, CA Paris, div. 5, ch. 2, 25 October 2013 Refused in Boehringer, CA Paris, div. 5, ch. 1, 11 September 2013 However, Syngenta should prevail 4 Véron & Associés 2
Syngenta saga (1/2) Initial claim 8: "A fungicidal composition comprising a fungicidally effective amount of a compound according to claim 1, and a fungicidally acceptable carrier or diluent therefore" 5 Syngenta saga (2/2) Limited claim 8: "A fungicidal composition comprising a fungicidally effective amount of a compound according to claim 1, said composition comprising another compound having a biological activity chosen from the group consisting of: - a compound chosen from the group consisting of:[131 products] - an insecticide chosen from the group consisting of: [21 products] - a compound regulator of plant growth chosen from the group consisting of:[31 products] and a fungicidally acceptable carrier or diluent therefore" 6 Véron & Associés 3
Syngenta: procedural steps (1/3) Patent office, 6 May 2010: amendment refused on the grounds that: it is not a claim limitation the amendment claims relates to a different product which does not fall within the scope of the initial claims CA Paris, 7 September 2011: refusal approved on the grounds that: this is not a limitation because «it adds a new active principle selected in a long list, offering a considerable number of possible combinations» none of the initial claims mentions a second active principle 7 Syngenta: procedural steps (2/3) Cass. Com, 19 September 2013: quashes the decision of the cour d appel on the grounds that: it should have checked whether the subject matter of the amended claim was "disclosed directly and without ambiguity" in the specification of the granted patent CA Paris, 25 October 2013: amendment accepted on the grounds that: the limitation was "directly and without ambiguity supported by the initial description reproduced word for word" 8 Véron & Associés 4
Syngenta: procedural steps (3/3) CA Paris, 30 May 2014, about the SPC: dismisses the recourse against the decision of the French patent office because: this recourse is not a full review of the case but only a reexamination of the matter in the situation at the date of the patent office decision, i.e. before the limitation 9 Doubt raised by Boehringer saga (1/2) Initial claim 8: "Pharmaceutical compositions containing - a compound according to at least one of claims 1 to 6 (including telmisartan) or a physiologically acceptable salt according to claim 7 - possibly in addition to one or more inert carriers and/or diluents" 10 Véron & Associés 5
Doubt raised by Boehringer saga (2/2) Limited claim 7: "Pharmaceutical compositions containing - a compound according to at least one of claims 1 to 65 or a physiologically acceptable salt according to claim 76 possibly together with [19 products including HCTZ], - in addition to together with one or more inert carriers and/or diluents" 11 Boehringer, CA Paris, div. 5, ch. 1, 11 September 2013 The decision of the French patent office refusing the requested amendment is approved on the grounds that: the amendment does not narrow the claim to a list of combinations it adds to the claimed product a new active principle and protects a different subject matter 12 Véron & Associés 6
What to conclude? Is there a divergence between the two chambers of division 5 of the Cour d appel de Paris? Syngenta is more recent (25 October 2013) Boehringer relates to a specific scenario (combination of telmisartan and HCTZ with a discussion about an alleged speculation) 13 Thank you 1, rue Volney 75002 Paris Tel. +33 (0)1 47 03 62 62 Fax +33 (0)1 47 03 62 69 53, avenue Maréchal Foch 69006 Lyon Tel. +33 (0)4 72 69 39 39 Fax +33 (0)4 72 69 39 49 www.veron.com Véron & Associés 7
Post Grant Amendments - Germany - Dr. Henrik Timmann EPO Case Law (e.g. G 1/93; G1/03; T 1180/05; T 335/03) "Inescapable Trap" situation, when 1. claim contains an added feature which is not disclosed in the original application (Art. 123 (2) EPC) and 2. the added feature limits the scope of protection, so that it cannot be deleted without extending the scope of protection beyond the granted claims (Art. 123 (3) EPC) EPO is not willing to offer a solution, e.g. footnote - solution. Véron & Associés 8
German Case Law (1) 1. BGH Winkelmesseinrichtung (GRUR 2011, 40) concerns German national patent If the added feature only contains a limitation compared to the originally disclosed teaching, meaning that it it is merely further specifies the technical teaching and has not the effect that the claimed invention is an aliud to the orginally disclosed solution considered not to contain an extension beyond the application as filed and is simply disregarded when evaluating novelty and inventiveness over the prior art. German Case Law (2) 2. BPatG Zentrifugierorgan (not published, verdict of February 7, 2012, docket No. 1 Ni 18/10) Winkelmesseinrichtung was applied mutatis mutandis to the German part of an EP (w/o discussion). 3. BPatG Unterdruckwundverband (GRUR 2013, 609) Question remained open because added feature lead to an aliud. 4. BPatG Fettabsaugevorrichtung (GRUR-RR 2014, 484) Winkelmesseinrichtung cannot be applied to the German parts of EPs (appeal pending) Inescapable Trap for EPs Véron & Associés 9
6 February 2015 Patent law developments 2013-2014 The Netherlands POST GRANT AMENDMENTS Jan Pieter Hustinx Attorney-at-law Partner 6 February 2015 Post grant amendments Extensive body of historic case law on partial invalidation/surrender (Spiro v. Flamco doctrine) However, all this case law has become obsolete with the introduction of EPC 2000 in December 2007. Since then, Dutch practice is fully in sync with European standards. No dissonant decisions or surprises in case law. Basically, four flavours of post grant amendment: - Central amendment procedure at the EPO - Full or partial voluntary surrender of national EP part or patent: at any time, by filing of a deed of surrender and registration thereof in the Dutch Patent Office (except in so far licenses or other rights in or claims to the patent have been registered therein; art. 63 DPA 1995) 20 Véron & Associés 10
6 February 2015 Post grant amendments In infringement/invalidity proceedings: - By the Court, at the voluntary suggestion of the patentee of one or more fallback positions in (conditional) auxiliary requests: similar to EPO practice. - By the Court at its own initiative. Dutch courts are bound to assess whether partial maintenance of the claims is appropriate, irrespective of possible alternative claim sets suggested by the patentee. Permissibility of post-grant amendment subject to the same double barrel test as contained in art. 123(2) and 123(3) EPC (ex art. 75(1)(d) and (e) DPA 1995): no added matter compared with both the application and the patent as granted. Obviously, all other patentability requirements apply without limitation too. 21 6 February 2015 Post grant amendments Case law: DSC, 06/03/2009, Scimed v Medinol: Facts: After having obtained an amended patent in central amendment procedures with the EPO, Scimed submits its amended patent pending Supreme Court appeal proceedings regarding a CA decision in respect of the unamended patent. Scimed argues that, as a result of the retro-active effect of the central amendment art 68 EPC), any further debate on the correctness of the CA decision in appeal (to invalidate the patent in its original form) has become moot. DSC rules that, although this is correct, the national court nonetheless is held to assess whether the amended patent is valid: case referred back to the CA. 22 Véron & Associés 11
6 February 2015 Post grant amendments More recent case law is scarce: DC, 21/05/2014, Sanofi v Amylin: Facts: Sanofi and Amylin have been given the opportunity to comment on the consequences of partial invalidation of Amylin's patent on one of the remaining claims. Instead, Amylin suggests a further amendment to one of them. Sanofi objects on the basis that the further amendment could and should have been proposed earlier in the proceedings together with the auxiliary requests and before the intermediate decision of the court. The court agrees and invalidates the claim at issue without regard to the further amendment. Take away: There are in principle no limitations to the number of auxiliary requests, only to their timing: do not economize on fallback scenarios, at the risk of loss. 23 UK Patent Case Law Update Paris, 6 February 2015 Post-grant Amendments Dr. Penny Gilbert Tim Whitfield Véron & Associés 12
Post-grant Amendments A patent specification (GB or EP(UK)) may be amended post-grant under s.27/s.75, provided the amendment does not: - Disclose additional matter not present in the application as filed (s.76(3)(a)) - Extend the scope of protection conferred by the patent (s.76(3)(b)) - Lack support / clarity If infringement/revocation proceedings are under way, amendment must be made before the Court (s.75), and generally advertised to the public, with the other litigants and the Comptroller having the opportunity to object. Usually dealt with by the Court at trial of infringement/validity proceedings. Whilst discretion to permit amendments has been restricted, proposed amendments must be appropriate to the proceedings and not procedurally unfair. UK Court discourages patentee from seeking multiple amendments (contrast multiple auxiliary requests in the EPO). Post-grant Amendments Monkey Tower Limited v Ability International Limited [2014] EWHC 18 (Pat) - Hearing Officer held that some claims were anticipated, but allowed Ability a further opportunity to propose amendments after the decision. - Monkey Tower appealed this decision to the High Court, contending that the Hearing Officer had erred in principle by letting Ability have a further opportunity to propose amendments. - The Court held that there is no automatic right to such an opportunity once an interim decision has been handed down. In relation to procedural fairness, a Hearing Officer should consider : the resources already devoted by the parties to the proceedings; the extent of any re-litigation as a result of the amendment; the likelihood that a valid amendment could be proposed; and whether there was evidence that prejudice would be caused to applicant for revocation by the delay that would be occasioned by a post-decision amendment application. Véron & Associés 13
Post-grant Amendments EPO central amendment Recent trend (since March 2014) has seen the English courts adjourn proceedings pending the determination of applications for central amendment at the EPO. - Samsung v Apple (Court of Appeal) Appeal adjourned pending outcome of application for central amendment made by Samsung No evidence of prejudice to Apple - Rovi v Virgin Media (Patents Court) Trial adjourned following application by Rovi for central amendment Note - Court will resist any application for adjournment where the Court has the impression that the amendment is being used as a device - Kennametal Inc v Pramet (Court of Appeal) Application to stay revocation pending central amendment proceedings was refused: (i) a final judgment revoking the patent had been handed down, which was not the subject of an appeal, and (ii) Kennametal had not sought the amendment during the course of the proceedings. Appeal against refusal to stay pending, parties settled shortly before appeal hearing. Court of Appeal found that the points raised were important, and so stayed an appeal to give the Comptroller sufficient time to take a position on the issue. Véron & Associés 14