1. Supplementary Protection Certificates – Some Unresolved Issues Trevor Cook 28 September 2015

2. WilmerHale SPCs – Unresolved Issues  Issues currently before the Court of Justice  What is the effective date of a marketing authorisation? –AG Opinion on C-471/14, Seattle Genetics  Some issues not currently before the Court of Justice but raised or left unanswered by their past decisions …  An issue not currently before the Court of Justice but raised by the decision of the EFTA Court  SPCs and biological medicinal products –The consequences of E-16/14, Pharmaq AS v Intervet International BV …  Some issues as yet unaddressed by either the EU Court of Justice or the EFTA Court  SPCs and medical devices  SPCs and the Unitary Patent … 2

3. WilmerHale SPCs – Unresolved issues of the CJEU’s own making  Some issues not currently before the EU Court of Justice but which have been raised or left unanswered by their past decisions  What is the effect of amending a patent so that it for the first time becomes a basic patent that “identifies” the product of interest? –Questions as to this left unanswered in C ‑ 577/13 Actavis v Boehringer Ingelheim  When do patent “claims relate, implicitly but necessarily and specifically, to the active ingredient in question” as required of a basic patent for it to “identify” and thus protect the product of interest? –C-493/12 Eli Lilly  Can an “SPC squatter” secure an SPC on the basis of another’s MA? –CJEU observations at para 43 of C-493/12 Eli Lilly –cf C-181/95 Biogen v SKB  Is the existing case law as to what is a new “product” too restricted? –Can C ‑ 11/13 Bayer CropScience AG treating a safener as an active be applied to medicinal products in some way?  Can SPCs be secured for 2 nd medical uses of an active that have previously received an MA for a 1 st medical use of that active? –How can C-130/11 Neurim be more widely applied? 3

4. WilmerHale SPCs and Biological Medicinal Products  What if any are the consequences of  E-16/14, Pharmaq AS v Intervet International BV (9 April 2015)  Background  The original SPC Regulation was enacted in 1992  It was drafted from the perspective of small molecules –As to which there was already the concept of “essentially similar” medicinal products  It was not drafted from the perspective of biological medicinal products such as vaccines, monoclonal antibodies or other proteins with their inherent variability requiring that in part they be characterised by their production route  Article 10(4) procedure for granting authorisations for “similar” biological medicinal products was not enacted until 2004  The issue  Assuming one secures an SPC on the basis of the first MA for a protein (such as a monoclonal antibody)  What is the protective scope of such SPC, and does such scope extend to a “similar” biological medicinal product to such protein? 4

5. WilmerHale Basic definitions in Regulation 469/2009  Article 1, Definitions:  ‘(a) ‘medicinal product’ means any substance or combination of substances presented for treating or preventing disease ….;  ‘(b) ‘product’ means the active ingredient or combination of active ingredients of a medicinal product;  ‘(c) ‘basic patent’ means a patent which protects a product as defined in (b) as such, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate;’ 5

6. WilmerHale Regulation 469/2009 as to protective scope  Article 4, Subject-matter of protection:  ‘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. 6

7. WilmerHale Regulatory Definitions for Biological Medicinal Products  ‘A biological medicinal product is a product, the active substance of which is a biological substance.  ‘A biological substance is a substance that is produced by or extracted from a biological source and that needs for its characterisation and the determination of its quality a combination of physico-chemical-biological testing, together with the production process and its control.  ‘The following shall be considered as biological medicinal products :  immunological medicinal products [“and medicinal products derived from human blood and human plasma as defined, respectively in paragraphs (4) and (10) of Article 1; –ie includes vaccines, toxins, serums or allergen products  medicinal products falling within the scope of Part A of the Annex to Regulation (EEC) No 2309/93; –Ie includes medicinal products developed by means of recombinant DNA technology, hybridoma and monoclonal antibody methods.  advanced therapy medicinal products as defined in Part IV of this Annex’ (Para 3.2.1.1(b) of Part I of Annex I of Directive 2001/83/EC as amended) 7

8. WilmerHale Factual background to Pharmaq v Intervet  Medicinal product the subject of the Norwegian SPC is a vaccine against viral pancreatic disease in salmon based on SAV-1, one of the 6 strains of salmonid alpha virus  Competitor’s medicinal product is another such vaccine, but based on SAV-3, another of the 6 strains of virus.  Both fall within the scope of the basic patent for the SPC  Issues  Is the SPC valid under Article 2 of Regulation [469/2009], if the medicinal product based on SAV-1 was placed on the market in the EEA under a “special approval exemption” before it received a provisional MA? –and is a provisional MA an ‘administrative authorisation procedure’ for the purposes of Articles 2 and a ‘valid authorisation to place on the market’ for the purpose of Article of Regulation (EEC) No 1768/92?  If the SPC is valid, does its scope extend to vaccines based on SAV- 3? 8

9. WilmerHale Background to Pharmaq v Intervet  Prior case law referred to  C-392/97 Farmitalia Carlo Erba Srl –Although this was an Article 3(a) and 3(b) case about small molecules which may no longer be good law since C-322/10 Medeva  C-631/13 Arne Forsgren –Although this was an Article 1(b), 3(a) and 3(b) case  Submissions  Broad –SPC Holder – extends to therapeutically equivalent forms within the scope of the basic patent  Narrow –Competitor – cannot extend to strains of virus other than in the medicinal product for which MA granted –ESA – limited to product covered by the MA, and if product requires an “alternative MA” of its own it is not within the scope of protection –Commission – absent therapeutic equivalence, MA cannot extend to a virus strain it does not mention, but if virus strain can be marketed under that MA, then covered by that MA and by SPC 9

10. WilmerHale Pharmaq v Intervet (EFTA Court 9 April 2015) same active ingredient as the authorised medicinal product  ‘2) Pursuant to Article 4 of Regulation (EEC) No 1768/92, the scope of protection conferred by a supplementary protection certificate extends to a specific strain of a virus covered by the basic patent, but not referred to in the marketing authorisation for a virus vaccine relied on for the purposes of Article 3(b) of Regulation (EEC) No 1768/92, only if the specific strain constitutes the same active ingredient as the authorised medicinal product and has therapeutic effects falling within the therapeutic indications for which the marketing authorisation was granted. It is not relevant whether a medicinal product based on such other strain would require a separate marketing authorisation. The appreciation of such elements is a matter of fact which is to be determined by the national court.  ‘A supplementary protection certificate is invalid to the extent it is granted a wider scope than that set out in the relevant marketing authorisation.’ 10

11. WilmerHale Conclusions from Pharmaq v Intervet  The name given to the “active ingredient” of the alleged infringing product does not matter in assessing protective scope  But the “active ingredient” of the alleged infringing product must same “active ingredient” as the authorised medicinal product  constitute the same “active ingredient” as the authorised medicinal product and  have therapeutic effects falling within the therapeutic indications for which the marketing authorisation was granted.  [and infringe the basic patent]  It is not relevant whether a medicinal product based on such other “active ingredient” would require a separate MA.  The appreciation of such elements is a matter of fact which is to be determined by the national court.  A supplementary protection certificate is invalid to the extent it is granted a wider scope than that set out in the relevant MA. 11

12. WilmerHale Protective scope not limited per Pharmaq v Intervet  The name given to the active ingredient of the alleged infringing product does not matter  We are so told by the EFTA Court  MA for a ‘similar’ biological medicinal product will always have therapeutic effects falling within the therapeutic indications for which the MA for which the reference biological medicinal product was granted  As required by EFTA Court  A ‘similar’ biological product (as with all generic MAs for small molecules) has a separate MA to that of the originator  As there is no economic link between the two MA holders and so is not part of the same ‘global MA’  But in any event the EFTA Court says it is not relevant whether a medicinal product based on such other active ingredient would require a separate marketing authorisation. 12

13. WilmerHale Protective scope limited per Pharmaq v Intervet ?  The critical question as to protective scope  Does a “similar” biological medicinal product have the same “active ingredient” as the reference medicinal product?  And what if the second applicant chose not to adopt the Article 10(4) route for “similar” biological medicinal products, even though it could have done so?  Therefore the nature of the regulatory route by which an MA is secured cannot be determinative  Although it may impact the nature of the therapeutic indications  What is the “same” “active ingredient”?  “Active ingredient” is not generally used in EU pharma legislation, which tends to speak of “active substance”  “Same” is sometimes used in EU pharma legislation, along with, as to medicinal products, (historically) “essentially similar” as to small molecules and, in Article 10(4) “similar” biological medicinal products, but in unexpected ways … 13

14. WilmerHale But “same” often means different  Eg, as to small molecules  “‘generic medicinal product’ shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies.  “The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. In such cases, additional information providing proof of the safety and/or efficacy of the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant.  “The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form. …”  Article 10(2)(b) Directive 2001/83/EC as amended (emphasis added) 14

15. WilmerHale What is the “same” “active ingredient” in the context of biological medicinal products?  No doubt an autonomous concept in EU law  But informed to a degree by EU regulatory law  Which supports a flexible definition whereby the expressly different can be deemed, in the appropriate context, to be “the same”  Not affected by name, or it is suggested) by the particular regulatory route adopted  Informed by the aim of the SPC Regulation  So the decision in Pharmaq v Intervet should not be seen as overly problematic for the scope of SPC protection afforded biological medicinal products  But no doubt the EU Court of Justice will in due course be asked to clarify what it means by “the same” in the context of biological medicinal products  In just the same way as it has been asked, and will continue to be asked, what it means by “identified” or “specified” in the context of whether a product is protected by a potential basic patent. 15

16. WilmerHale Thank you  Trevor Cook (Legal Consultant, New York; Solicitor, England and Wales), is a partner in the Litigation/Controversy Department and a member of the Intellectual Property Litigation Practice at Wilmer Cutler Pickering Hale and Dorr LLP, based in New York.  trevor.cook@wilmerhale.com trevor.cook@wilmerhale.com