42 nd AIPPI Congress, Paris Supplementary protection certificates (SPCs) (Skeleton) Workshop Pharma I 5 October 2010, 9:00 to 10:30 am Moderator: Élisabeth-Thouret Lemaître, from Lavoix, France Speakers: André Bourgouin, from Beaufour Ipsen, France Richard Ebbink, from Brinkhof, The Netherlands Marie Manley, from Bristows, UK Matteo Orsingher, from Orsingher Avvocati Associati, Italy Isabelle Romet, from Véron & Associés, France Alexa von Uexküll, from Vossius and Partner, Germany
Contents: 1. Introduction 2. Products eligible for a protection by a SPC 3. Who can file the SPC? 4. The product must be covered by the basic patent 5. The product must not be covered by a previous SPC 6. First marketing authorization and duration of the SPC 7. Scope of the SPC 2
1. Introduction By Élisabeth Thouret Lemaître from Lavoix, France 3
INTRODUCTION (1) Regulation (EC) 469/2009 codifying Regulation 1768/92 SPC Regulation aims to remedy to the erosion of the duration of the patent protection due to the lengthy regulatory process leading to the grant of the market approval (MA) 4
INTRODUCTION (2) The SPC may be filed for a product if a patent is in force and the MA is obtained The SPC is filed within six months from the first MA in the EEA (i.e the Swiss/Liechtenstein case) The SPC is filed nationally 5
INTRODUCTION (3) The maximum duration of the SPC is 5 years (+ 6 months if paediatric extension applies) The SPC covers every medical use of the product authorised before its expiration 6
2. Products eligible for a protection by a SPC Supplementary protection certificates By Matteo Orsingher, Orsingher - Avvocati Associati Milan - Italy 7
Article 2 of Regulation No. 469/2009 A medicinal product [ Any substance or combination of substances presented for treating or preventing disease in human beings or animals or which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals -Article 1 a) of Reg.469/2009] Active ingredient OR combination of active ingredients [Article 1 b) of Reg.469/2009 + ECJ cases C-431/04, MIT and C-202/05, Yissum] Active ingredient OR combination of active ingredients [Article 1 b) of Reg.469/2009 + ECJ cases C-431/04, MIT and C-202/05, Yissum] Diagnosis products acting in vitro: NO [France has specific caselaw] Medical devices: DEBATED [Germany/NL have taken favourable approach if an active ingredient is incorporated as integral part of the device and the device underwent the same level of scrutiny (Dir. 2001/83/EC)] Covered by a patent Subject to a MA 8
3. Who can file the SPC? By Matteo Orsingher, Orsingher - Avvocati Associati Milan - Italy 9
3. Who can file the SPC? Patent holder vs. assignee The certificate shall be granted to the holder of the basic patent or his successor in title [Article 6 of Reg. 469/2009] Patent holder vs. MA holder The basic patent and the MA can be held by different entities [ECJ Case C-181/95, Biogen] It is preferable that a contractual relationship exists between the patent holder and the MA holder [Italian case law and practice] As a result: it is safer to be the patent holder! 10
4. The product must be covered by the basic patent By Alexa von Uexküll, Vossius and Partner, Germany 11
4. The product must be covered by the basic patent Article 3 a) of Regulation No. 469/2009 "A certificate shall be granted if, in the Member State if (a) the product is protected by a basic patent in force;" 12
Article 3(a) When is the product protected by a basic patent in force? Supplementary protection certificates Does the product have to be literally covered by the patent or does it suffice if it falls within the scope of equivalence? Idarubicin/Farmitalia C-382/97 13
FSC Germany Idarubicin I (Farmitalia) approved product must be covered by the scope of protection of the basic patent, i.e. literal wording and scope of equivalence definition of the product should not extend beyond the scope of the patent 14
The Disclosure Test vs the Infringement Test Supplementary protection certificates 1. The Disclosure Test : The combination must be disclosed or identifiable in the basic patent (GB, FR, DE, SE) 2. The Infringement Test The combination must infringe the patent pursuant to Article 69 EPC(CH, NO, CZ) 15
Combination of active ingredients Fosinopril Approved Product: fosinopril + hydrochlorothiazide Basic Patent: fosinopril CH: SPC granted 16
Combination of active ingredients Takeda Lansoprazole Approved Product: combination of lansoprazole and clarithromycin Basic Patent: only lansoprazole SPC refused: GB, FR, DE 17
Combination of active ingredients Gilead tenofovir Approved Product: Tenofovir + emtricitabine Basic Patent: Tenofovir + "compound of claim 1 together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients" GB, FR: SPC granted DE: SPC refused 18
Medeva C-322/10 Basic patent: Method claim for the preparation of an acellular B. pertussis vaccine Approved Product (Government health policy): Multi-vaccine against: Whooping cough Diphtheria Tetanus Polio Meningitis 19
Medeva ECJ Referral C-322/10 Clarification Article 3(a) "the product is protected by a basic patent in force" of the Regulation 469/2009 1. The ECJ in Farmitalia does not clearly address the issue how the national courts should interpret Articles 3(a) and 3(b); 2. The fact that there is no harmonisation in European patent law means that there is a need for a European concept of what 'protection by a basic patent in force' means separate to any particular meaning in national law. 20
Medeva ECJ Referral C-322/10 Clarification Article 3(a) "the product is protected by a basic patent in force" of the Regulation 469/2009 1. What is meant by "the product is protected by a basic patent in force" in Article 3(a) of the Regulation what are the criteria for deciding this? 2. Should different criteria be applied when the product comprises more than one active ingredient? 3. Are there further or different criteria if the product is a multi-disease vaccine? 4. Is a multi-disease vaccine protected by a basic patent" if one antigen of the vaccine is covered by the patent? 5. Is a multi-disease vaccine protected by a basic patent" if all antigen of the vaccine is covered by the patent? 21
5. The product must not be covered by a previous SPC Supplementary protection certificates By Richard Ebbink, from Brinkhof, The Netherlands 22
Article 3(c) requires that the product has not already been the subject of an SPC Question: what if a product is covered by several patents to different patentees? ECJ: an SPC may then be granted to each holder Biogen (1997) Question: what if several patents are held by the same patentee? Biogen provides no direct answer Answer probably no (cf. Article 3(2) of the Plant Protection Regulation EC 1610/96) Could transfer of patent to another holder be a solution? Question: what if the product is not the same? No problem to get an SPC for product A + B if an SPC for A separately and/or B separately exists already, based on another basic patent Provided they are different products 23
Different product means different active ingredient, means different therapeutic effect If B has no therapeutic effect of its own (is an excipient, or has a dosing effect, or is an impurity) an SPC for the combination A + B will not be granted, even if there is a different basic patent English High Court, Takeda (2003); Paris Court of Appeal, (2008) Will an SPC be granted for patented enantiomers ( A, B ) if there already exists an SPC for the racemate ( A + B ) based on a different patent? If the enantiomers are different products, yes German Supreme Court, Escitalopram (2009); English Court of Appeal, Daiichi (2009) If the racemate and the enantiomers are disclosed in the same patent, an SPC must be applied for on the basis of the first marketing approval under the patent be that MA for the racemate or for an enatiomer. A subsequent MA for a different mixture will not be considered the first MA - German Patent Nullity Court, Fusilade (2000). 24
6. First marketing authorization and duration of the SPC By Marie Manley, from Bristows, UK 25
6.1 Valid Marketing Authorisation The definition implies that the MA must have been granted in accordance with the Medicinal Code Should the MA be granted in accordance with Medicinal Code (as amended)? Case pending at the CJEU: referral by UK / High Court - Mr Justice Floyd (Synthon v Merz Pharma) (C-195/09) Case pending at the CJEU: referred by UK / Court of Appeal (Generics (UK) Limited v Synaptech Inc (C-427/09)) However, Novartis SPC Case appears to contradict this Indeed the CJEU ruled that a Swiss MA is relevant for the calculation of the duration of the SPC (if granted before any MA in the EEA as it is recognised in Liechtenstein (Novartis (C-207/03) / Millenium (C-252/03)) Is a CE certificate equivalent to a valid marketing authorisation? YES: Yttrium-90 Glass Microspheres (German Federal Patent Court, 26 January 2010) (active implantable device) 26
6.2 First Authorisation to place the product on the market The determination of what qualifies as the first authorisation is essentially relevant for: Benefiting from the SPC Regulation on the first place (application of Article 20 formerly Articles 19 and 19a ) => the so-called cut-off dates Qualifying for an SPC (Article 3) Calculating the duration of the SPC (Article 13) Should the wording authorisation to place... on the market be interpreted differently depending on which provision they appear in? The CJEU confirmed that these words should have the same meaning throughout the SPC Regulation (Hässle Case (C-127/00)) BUT then the Novartis SPC case... 27
6.2 First Authorisation to place the product on the market (cont.) What constitutes the first authorisation to place a product on the market? First authorisation to place a product on the market means first marketing authorisation, NOT authorisations required under national legislation on pricing of or reimbursement for medicinal products (Hässle Case (C- 127/00)) Generics (UK) v Daiichi Pharmaceutical (2009, Court of Appeal) Will an authorisation for a veterinary product count as a first authorisation? YES: Pharmacia Italia (C-31/03) Neurim Pharmaceuticals (UKIPO, 15 December 2009) 28
6.3 Duration of SPCs Art 13 states that the duration of an SPC is: "... equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the Community reduced by a period of five years" (Emphasis added) Subject to 5 years cap Watch out for the paediatric extension! + 6 months extension (if in compliance with the requirements of the Paediatric Regulation 1901/2006) - Merck cases: Cancidas, Cozaar. 29
How to calculate the SPC duration Generic Launch MA PE SPC Basic Patent Protection 6 m RDP & Marketing Protection 6 m 2y 1995 12y 2007 2015 2017 2018 2020 Patent End of basic Patent Protection Pediatric Extension Application End of SPC Protection RDP & Marketing Protection Supplementary Protection Certificate (SPC) Basic Patent Protection SPC : 12 5 = 7 but 5 max Pediatric Extension 30
Can we have a negative or zero SPC? Merck s case background: Basic Patent Protection SPC 3m&14d PE +2m&16d 4y 8m &17d RDP & marketing protection 05/07/02 Patent 21/03/07 MA 2017 20/03/22 05/07/22 End of basic Patent Protection Duration of the SPC: (4y 8m & 17d) (5y) = 3m &14d 31
The Merck case The Merck Case BL 0/108/08 Decision of the Hearing Officer: negative SPC should be granted This expression has been used rather loosely to cover not only the special case where the calculation gives an answer of precisely zero, but also all cases where the term comes out with a negative value. It has not however been argued by the applicants in their skeleton arguments, and I can find no basis in either Regulation for concluding, the negative values should be rounded up to zero for purposes of calculating the period of the SPC. The logic of such a view should be immediately apparent to anyone who has paid money into a bank account that is showing an overdrawn balance. (Emphasis added) 32
The Merck case (cont.) Other national patent offices opinion on negative SPCs have been: negative term SPC granted UK and NL negative term SPC rejected PT, SI, DE (but: NB the German Federal Patent Court has decided to refer a question for preliminary ruling on negative term SPCs to the CJEU in the Sitagliptin case, Case 15 W (pat) 36/08, Merck case, C-125/10), zero term SPC GR The German Federal Patent Court has decided to refer a question for preliminary ruling on negative term SPCs to the Court of Justice of the European Union in the Sitagliptin case (Case 15 W (pat) 36/08): "Can an SPC be granted for a medicament if the period between the filing of the application for the basic patent and the time point of first authorization for marketing in the Community is shorter than five years?" 33
7. Scope of the SPC By Isabelle Romet, from Véron & Associés, France 34
Main question Is the scope of a SPC designating the active ingredient A: limited to the drugs having A as active ingredient, or comparable to the scope of a patent claiming A? 35
Practical question Is a SPC designating the active ingredient A infringed by: a drug containing A + B a drug containing A (a variant of A) 36
Provisions of Regulation No. 469/2009 Article 4, «Subject-matter of protection»: Supplementary protection certificates «Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall extend only to the product covered by the authorization to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorized before the expiry of the certificate.» Article 5, «Effects of the certificate»: «Subject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations.» 37
Explanatory Memorandum of 11 April 1990 «43. The effects of the certificate on the subject to which it refers as described in Article 4 are the same as those of the basic patent. The patent system has hitherto constitued the best tool to encourage research. It is therefore not surprising, in view of the objective of this Regulation, that the certificate grants the same rights, subject to the same limitations. 44. Consequently, in the case of a basic patent covering a product, the rights granted by the certificate will be the same as those granted by the patent, but limited to any use of the product authorized prior to the expiry of the patent.» (1) (1) COM (90) 101 final-syn 255 of 11 April 1990, OJ 1990, C114, 43 and 44, pages 22 and 23 38
Regulation (EEC) No. 1610/96 concerning SPC for plant protection products Recital (13): «(13) Whereas the certificate confers the same rights as those conferred by the basic patent; whereas, consequently, where the basic patent covers an active substance and its various derivatives (salts and esters), the certificate confers the same protection;» Recital (17): «(17) Whereas the detailed rules in recitals ( ), 13 ( ) of this Regulation are also valid, mutatis mutandis, for the interpretation in particular of ( ) Article 4 ( ) of Council Regulation (EEC) No. 1768/92.» 39
CJEU, 16 September 1999, Farmitalia Carlo Erba (C-392/97) Supplementary protection certificates «( ) where a product in the form referred to in the marketing autorisation is protected by a basic patent in force, the supplementary protection certificate is capable of covering the product, as a medicinal product, in any of the forms enjoying the protection of the basic patent.» (operative part, 1) 40
One decision in France (2) The paediatric extension of the SPC designating A (Losartan) Was found infringed By a product containing A + B (Losartan and HCTZ, 2 active ingredients) (2) Paris Court of 1st instance, preliminary injunction, 12 February 2010, Du Pont de Nemours / Mylan, appealed 41
Opposite decisions in Belgium (3) The paediatric extension of the SPC designating Losartan Was found not infringed By the drug comprising Losartan and HCTZ Because the latter was the subject matter of another SPC with no paediatric extension (3) Brussels commercial Court of 1st instance, 12 February 2010, upheld on 17 February 2010, Du Pont de Nemours, Merck Sharp & Dohme / Mylan 42
Contributory infringement of a SPC? Two Italian decisions (4) A SPC designating a product containing A + B Was found infringed By the manufacturing of the active principle A (4) Court of Rome, 4 June 2003 Court of Milan, 17 September 1998 43
Infringement of a SPC by the manufacturing of the active ingredient formulated abroad One Belgian decision, 20 November 2008, CNRS, Pierre Fabre Médicament / Ajinomoto Omnichem 44
Thank you for your attention 45