Lessons learnt 6 February 2015

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1 Patent infringement Lessons learnt from patent case law in Europe in 2013 and 2014 Véron & Associés Seminar Paris Maison de la Recherche Sabine Agé Paris Lyon Patent infringement Bolar exemption (1/2) Art. L d) French IPC 1 : the studies and assays required to obtain a marketing authorization for a medicine, as well as the acts necessary to their completion and for obtaining the market authorization Scope of these provisions: 1. Acts to obtain a marketing authorization (MA) for non-generic products? 2. Acts to obtain a MA outside of France? 3. Supply of patent-protected product to a company which intends to use the product in tests necessary to obtain marketing authorization? 1 implementing Directive No. 2004/27/EC 2 Véron & Associés 1

2 Patent infringement Bolar exemption (2/2) 1. Acts to obtain a MA for non-generic products? Lilly France v. Sanofi Aventis Deutschland GmbH, TGI Paris, presiding judge, 15 December 2014: acts performed for obtaining a MA for a biosimilar (of insulin glargine) are exempted 2. Acts for obtaining MAs outside of France? Same decision: acts performed in France after the MA grant for France, to obtain Mas abroad, are exempted 3. Supply of patent-protected product to a company which intends to use the product in tests necessary to obtain marketing authorization? No guidance from CJEU after withdrawal of referral in Astellas Pharma Inc. v. Polpharma SA (C-661/13) 3 Patent infringement Prior Use Art. L French IPC: Any person who, within the territory in which this Book applies, at the filing date or priority date of a patent was, in good faith, in possession of the invention which is the subject matter of the patent shall enjoy a personal right to exploit that invention despite the existence of the patent. Prior use can be asserted even if the product according to the invention has not been put on the market: evidence of real and effective preparations for exploiting the invention is sufficient (Balipro v. Vinmer, TGI Paris, 6 June 2013) 4 Véron & Associés 2

3 Patent infringement Estoppel Well established case law according which the patentee cannot take a contradicting position on the scope of a patent claims: during examination or opposition of the patent and when construing their scope in the framework of patent infringement proceedings New illustration in a somewhat different context in Gestra v. Eurovia Béton, Cass. Com., 21 January 2014: the alleged infringer who paid royalties during more than 4 years pursuant to a license under the asserted patent cannot state without contradicting itself that it did not implement this patent 5 Patent infringement Infringement by equivalence Lessons learnt from UK, DE, NL case law? 6 Véron & Associés 3

4 Patent infringement Contributory infringement Lessons learnt from UK, DE, NL case law? 7 Thank you 1, rue Volney Paris Tel. +33 (0) Fax +33 (0) , avenue Maréchal Foch Lyon Tel. +33 (0) Fax +33 (0) Véron & Associés 4

5 Contributory Infringement Infringement by Equivalence Roche/Bolar Exemption - Germany - Max v. Rospatt Overview Contributory infringement Use patents Doctrine of equivalence Roche/Bolar exemption Véron & Associés 5

6 Contributory Infringement Contributory infringement by foreign supplier OLG Karlsruhe GRUR 2014, 59 MP2 Geräte delivery of essential element in Germany does not require direct delivery delivery to third party outside Germany sufficient if supplier knows that the end destination is in Germany Use Patents OLG Karlsruhe GRUR 2014, 764 Use Patent product directly infringes use claim if its appearance implies the patented use to the customer appearance refers to the products as such as well as to ist packaging, instruction manual, package insert and the like Véron & Associés 6

7 Doctrine of Equivalence BGH GRUR 2014, 852 if the man skilled in the art understands the claimed teaching as a selection of one of several embodiments disclosed in the specification the other embodiments cannot be regarded as equivalents Doctrine of Equivalence In recent time the Düsseldorf courts have handled the doctrine of equivalence more generous compared to previous years: OLG Düsseldorf GRUR-RR 2014, 185 WC-Sitzgelenk (reversed LG Düsseldorf) open bore with ring recess equals blindhole Véron & Associés 7

8 Doctrine of Equivalence LG Düsseldorf , 4b O 114/12 - Pemetrexeddikalium use of pemetrexed dipotassium is equivalent to use of pemetrexed disodium Roche/Bolar Exemption OLG Düsseldorf GRUR-RR 2014, 100 Marktzulassungsprivileg referral for preliminary ruling to the ECJ (C-661/13) referral withdrawn after case was settled Véron & Associés 8

9 Roche/Bolar Exemption OLG Düsseldorf Preliminary Opinion commercial third party supplier is covered by privilege if he can legimately assume that supplied products are exclusively used for privileged trials must take measures to ensure exclusive use (e.g. undertaking, warning etc.) 28 U.S.C to Take Discovery for Use in Foreign Proceedings evidence must be in US grant in discretion of Judge can be granted ex parte document production company witness - Fed. R. Civ. P. 30(b)(6) protective order Véron & Associés 9

10 Thank you! Patent law developments The Netherlands CONTRIBUTORY INFRINGEMENT Gertjan Kuipers Attorney-at-law Partner Véron & Associés 10

11 3 February 2015 Contributory Infringement CA The Hague 27 January 2015: Novartis v Sun Novartis Sun VGZ (Insurance) EP689 (Patented: Zoledronine Acid) Market Authorisation (Generic Zoledronine Acid) Tender (For primary prescribed drug for VGZ patients) Patent for treatment of Osteoporosis Carve-out for osteoporosis Sun wins tender For treatment of both Osteoporosis and Paget Permit for treatment of Paget Contributory Infringement? 21 3 February 2015 Contributory Infringement CA The Hague 27 January 2015: Novartis v Sun Held Since Sun knew that VGZ's policy would inevitably lead to the use of the drug for treatment of Osteoporosis as well it should have done everything within its power to prevent such use. It had failed to do so. (par. 4.34) 1. Sun had sent an indicating that its Generic was to be used for treatment of Paget since Novartis held a patent for such treatment. It also indicated that the e- mail concerned a formality only. The DC held that this was insufficient. It should have indicated that it was not to be used for treatment of Osteoporosis. (par. 4.35) 2. Sun was not able to produce any evidence that it had tried to convince VGZ to split the tender for treatment for Paget and Osteoporosis. (par. 4.36). Sun's participation in the tender constituted contributory infringement. Véron & Associés 11

12 3 February 2015 The Coffee Battle 23 Patent law developments The Netherlands IINFRINGEMENT BY EQUIVALENCE Jan Pieter Hustinx Attorney-at-law Partner Véron & Associés 12

13 EQUIVALENCE From "free-for-all"to "nothing at all" Historic perspective Traditionally: "essence of the invention" important view point when establishing the scope of protection of a patent. Art. 69 EPC a l'hollandaise: not so much the literal text of the claims, but their perceived purported matters. Yardstick for equivalent infringement FWR test: equivalent measures are measures which perform essentially the same function, in essentially the same way to lead to essentially the same result. Minor stupidities of the patentee thus easily overlooked. E.g. see DSC, 22/03/2002, V. Bentum v. Kool: even if, as the CA had assumed, the embodiment used by the defendant was obvious at the time the claims were drafted and the patentee failed to claim this embodiment, there was no reason to assume that the patentee had intended to limit the scope of protection to exclude this embodiment: CA failed to sufficiently consider the fair protection to be afforded to patentee 25 EQUIVALENCE From "free-for-all" to "nothing at all" Historic perspective (ctd.) DSC, 25/05/2012, AGA v. Occlutech: demise of the essence doctrine - After first having noted (in 2007) that "the essence of the invention" is not necessarily the point of departure for interpretation of the claims, but "a viewpoint" to be taken into account in light of article 69 EPC, the DSC noted in AGA v. Occlutech that courts do not always have to take into account the essence: whether they do depends on the circumstances of the case, including in particular the patent specification: i.e. back to the patent text. Winds of change: - DSC, 04/04/2014, Medinol v Abbott: rethinking the scope of protection 26 Véron & Associés 13

14 Infringement DSC 4 April 2014: Medinol v Abbott Medinol (EP920): claimed stent included feature: "in its extended form having a patterned shape, comprising first meander patterns extending in a first direction and second meander patterns extending in a second direction, different form the first direction." Specification and drawings EP 920 refer only to "out phase" stents: Abbott markets an "in phase" stent 27 Scope of protection DSC 4 April 2014: Medinol v Abbott Court of Appeal There are no indications that in-phase patterns were claimed and therefore they fell outside the scope. Abbott (appeal to DSC) Descriptions and drawings cannot limit literal interpretation, only expand it. Bundesgerichtshof (FYI) There are no indications that in-phase patterns were excluded and therefore they fell within the scope. Urteil des X. Zivilsenats vom X ZR 19/11 Dutch Supreme Court The CA's interpretation was correct, as it had used the wording of the claims as a starting point and interpreted them in the light of the drawings, descriptions, and prior art. 28 Véron & Associés 14

15 Relevant date for interpretation v. infringement DSC 4 April 2014: Medinol v Abbott STEP 1: SCOPE OF PROTECTION Balancing literal interpretation and interpretation in which the claims are a mere guideline (cf. art. 1 Protocol to art. 69 EPC) Court must take due account of any equivalents known to the skilled man (cf. art. 2 Protocol to art. 69 EPC) Relevant date: Priority date because scope of protection is determined by what the invention has added in comparison to the prior art STEP 2: INFRINGEMENT Assess whether the person skilled in the art would understand the product or process falls within scope of protection (especially taking into account equivalents) Relevant date: Date of (alleged) infringement 29 Back to equivalence DC, 18/06/2014, MBI v. Shimano Case revolved around the question whether the feature "at least two sets of pawls" may encompass by equivalence "at least two (sets of one) pawl(s)". Based on FWR test, there were sound arguments to contend that two pawls in the context of the invention perform essentially the same function, in essentially the same way to lead to essentially the same result. Arguably, number of pawls in light of the essence of the invention was irrelevant. However, the court held (with reference to Medinol v. Abbott) that because scope of protection is to be determined from the perspective of the skilled man on the priority date, and is to take into account equivalents at that moment, equivalents that were foreseeable at the priority date, but not claimed, must be outside the scope of protection. The court then held that such foreseeable equivalents cannot subsequently play any role in assessing infringement by equivalence either. 30 Véron & Associés 15

16 Foreseeable equivalents exception confirmed DC, 23/07/2014, Bayer v. Sandoz Gist of MBI v. Shimano: scope of infringement by equivalence limited (at best) to equivalent measures which were not foreseeable at the priority date. If "foreseeable equivalents" are no longer to be taken into account in the equivalent infringement test, then "legal certainty of third parties" fully prevails, But what about "the fair protection for the patentee"? Yet, MBI v. Shimano confirmed verbatim in Bayer v. Sandoz a month later: "Medinol v. Abbott teaches that the scope of protection of a European patent is to be assessed from the perspective of the skilled man at the priority date. Foreseeable equivalents have to be taken into account in this assessment. As a rule there will be little room for any additional protection by equivalence, because foreseeable equivalents have already been taken into account. Only unforeseeable equivalents can play a role when assessing infringement". 31 Equivalence final conclusion In brief: Only measures which perform essentially the same function, in essentially the same way to lead to essentially the same result as a claimed feature, but were not foreseeable at the priority date, may under current case law amount to equivalent infringement. This effectively tolls the death bell of the doctrine of equivalence in the Netherlands. Have Dutch judges changed coats with the Germans? (LG Düsseldorf, 03/04/2014, Pemetrexed-di-kalium) 32 Véron & Associés 16

17 UK Patent Case Law Update Paris, Infringement Dr. Penny Gilbert Tim Whitfield Contributory infringement Warner-Lambert Company, LLC v Actavis Group Ptc EHF & Others [2015] EWHC 72 (Pat) - Second medical use patent concerning pregabalin for treating pain. Claim in Swiss Form. - Interim injunction sought to require Actavis to take steps to ensure that pharmacists would refrain from supplying its product for use in the patented indication. - Mr Justice Arnold refused the interim injunction on the basis that there was no serious issue to be tried. Swiss form claim is a process claim (use of substance X for the preparation of a medicament for treating indication Y). Infringement allegation under s.60(1)(c) product of an infringing process. Key issue was for treating pain. Accepted that for means suitable and intended for. Was Actavis (skinny label) product intended for treating pain? Argument about whose intention is relevant - it is the intention of the manufacturer (and not the prescriber) that matters. What is required to show intention W-L sought to argue by analogy to s.60(2) contributory infringement and the requirement there that the person supplying the means essential have knowledge that the means would be intended to put the invention into effect. This failed the intention for contributory infringement is that of the ultimate user, and it is sufficient if the supplier of the means knows (or it is objectively obvious) that an ultimate user will intend to work the invention. Held that subjective intention of the manufacturer is needed; mere foreseeability is not enough. As Actavis MA did not extended to pain, and W-L had no basis upon which to allege that Actavis intended its product to be used off-label, it was held that there was no serious issue to be tried on the pleadings. A self standing allegation of s.60(2) infringement was not pursued Actavis product was not means for putting the invention into effect, as that could only have already been done by the act of manufacture. Véron & Associés 17

18 Bolar Exemption Revisions to Bolar exemption implementation in UK law existing wording directly linked to the abridged procedures of Directives 2001/82 and 2001/83 (s.60(5)(i)). Recent amendments (in force from October 2014) to the experimental use defence in s.60 of the UK Patents Act 1977, exempting acts done for the purpose of medicinal product assessment from infringement. Medicinal product assessment defined as: - any testing, course of testing or other activity undertaken with a view to providing data for any of the following purposes: (a) (b) (c) obtaining or varying an authorisation to sell or supply, or offer to sell or supply, a medicinal product (whether in the United Kingdom or elsewhere); complying with any regulatory requirement imposed (whether in the United Kingdom or elsewhere) in relation to such an authorisation; enabling a government or public authority (whether in the United Kingdom or elsewhere), or a person (whether in the United Kingdom or elsewhere) with functions of: (i) (ii) providing health care on behalf of such a government or public authority, or providing advice to, or on behalf of, such a government or public authority about the provision of health care, to carry out an assessment of suitability of a medicinal product for human use for the purpose of determining whether to use it, or recommend its use, in the provision of health care. Revisions leave the original Bolar provision (s.60(5)(i)) unchanged, but arguably redundant. New exemption broader in providing protection for acts done by originators as well as generics, and for the purpose of obtaining authorisations outside Europe. Remains to be seen whether the medicinal product assessment needs to be the only or dominant purpose of the relevant acts (as is the case under the existing case law (Corevalve v Edwards)), or if commercial activity having an experimental element is now also exempt. Véron & Associés 18