1. Supplementary Protection Certificates Phillip Johnson

2. Supplementary Protection Certificates Regulation 469/2009 concerning the creation of a supplementary protection certificate for medicinal products; Regulation 1610/96 concerning the creation of a supplementary protection certificate for plant protection products; Regulation 1901/2006 on medicinal products for paediatric use.

3. Marketing Authorisation

4. Community Code National marketing authorisations and Mutual Recognition of authorisations Directive 2001/83/EC on the Community code relating to medicinal products for human use (‘national marketing authorisation’ and ‘mutual recognition’) Centralised marketing authorisation procedure Regulation (EC) No. 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

5. The restriction Article 6 of Directive 2001/83/EC No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EEC) No. 2309/93

6. Marketing Authorisations Medicines and Healthcare products Regulatory Agency (MHRA) Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994 European Medicines Agency (EMEA) Regulation (EC) No. 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

7. Nature of SPCs Separate application needed for each Member State

8. Applications must be made to the UK Intellectual Property Office

9. “Medicinal Product ” ‘medicinal product’ means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances 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 of Regulation (EC) No. 469/2009

10. Conditions for grant Article 3 Conditions for obtaining a certificate A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application: (a) the product is protected by a basic patent in force; (b) a valid authorization to place the product on the market as a medicinal product has been granted… (c) the product has not already been the subject of a certificate; (d) the authorization referred to in (b) is the first authorization to place the product on the market as a medicinal product.

11. “the product is protected by a basic patent in force”

12. Based on national patent law it should be noted that one of the conditions for obtaining a certificate is that the product should be protected by a basic patent in force…. in the absence of Community harmonisation of patent law, the extent of patent protection can be determined only in the light of the non-Community rules which govern patents. …the protection conferred by the certificate cannot exceed the scope of the protection conferred by the basic patent... [and so] whether a product is protected by a basic patent, reference must be made to the rules which govern that patent. C-392/97 Farmitalia [2000] RPC 580

13. “the supplementary protection certificate for medicinal products must be interpreted as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate.” C-322/10 Medeva [2011] ECR I-12051 Followed C-630/10 University of Queensland [2011] ECR I-12231 And C-6/11 Daiichi Sankyo Company [2011] ECR I-12255 (although the wording is “identified rather than specified” Expressly claimed

14. A bit more clarity The identification can be by a structural and functional definition (or just a functional definition) of a product. What is important is that claims relate, implicitly but necessarily and specifically, to the active ingredient in question. C-493/12 Eli Lilly and Company Ltd v Human Genome Sciences [2014] RPC 21 But some construction rules probably don’t apply – “comprising”.. Medeva BV v Comptroller General of Patents, Designs and Trade Marks [2012] EWCA Civ 523

15. Accordingly… a supplementary protection certificate may not be granted “where the active ingredient specified in the application, even though identified in the wording of the claims of the basic patent as an active ingredient forming part of a combination in conjunction with another active ingredient, is not the subject of any claim relating to that active ingredient alone.” C-518/10 Yeda [2011] ECR I-2209

16. “a valid authorization to place the product on the market as a medicinal product has been granted…”

17. Relevant authorisation The grant of a supplementary protection certificate pursuant is, in accordance with Article 3(b) of that regulation, conditional on a valid authorization to place the product on the market as a medicinal product having been granted in the Member State in which the application is submitted and at the date of that application. C-110/95 Yamanouchi Pharma [1997] ECR I-3251

18. Must be under the relevant scheme “a product, such as that at issue in the main proceedings, which was placed on the market in the EU as a medicinal product for human use before obtaining a marketing authorisation …[under the relevant EU regime] may not, therefore, be the subject of a supplementary protection certificate.” C-195/09 Synthon [2011] ECR I-7011 (this was where the drug was marketed and approved under the old German system in 1976 and in 2002 a marketing authorisations was obtained under the EU system)

19. Not to emergency regime An authorisation under the regime in article 8 or article 26(3) of Directive 2001/82/EC (this allows for limited authorisations for where a disease is a temporary epidemic in animals) is not an authorisation for the purposes of the regime E-16/14 Pharmaq (9 April 2015) (EFTA Court)

20. New product – not authorisation The fact that a [new] marketing authorisation must be obtained for the… product which has a different proportion of active chemical compound to impurity from that of the former … product is not relevant for the purposes of establishing whether or not the constituent products of those … products are the same. C-258/99 BASF [2001] ECR I-3643

21. Impurities Two products which differ only in the proportion of the active chemical compound to the impurity they contain, one having a greater percentage of the impurity than the other, must be regarded as the same product… C-258/99 BASF [2001] ECR I-3643

22. A supplementary protection certificate may be granted for an active ingredient specified in the wording of the claims of the basic patent relied on, where the medicinal product for which the marketing authorisation is submitted in support of the supplementary protection certificate application contains not only that active ingredient but also other active ingredients. C-322/10 Medeva [2011] ECR I-12051 Followed C-630/10 University of Queensland [2011] ECR I-12231 And C-422/10 University of Georgetown [2011] ECR I-12157 Authorisations and Combinations

23. Active and non-active combination Article 1(b)… must be interpreted so as not to include in the concept of ‘combination of active ingredients of a medicinal product’ a combination of two substances, only one of which has therapeutic effects of its own for a specific indication, the other rendering possible a pharmaceutical form of the medicinal product which is necessary for the therapeutic efficacy of the first substance for that indication. C-431/04 MIT [2006] ECR I-4089 C-210/13 Glaxosmithkline [2014] RPC 7 (also applies to adjuvant, which is a pharmacological agent which modifies the effect of another agent)

24. Covalent bonded actives Where an active ingredient is covalently bound to another active ingredient an SPC can be granted where the first active ingredient produces a pharmacological, immunological or metabolic action of its own: C-631/13 Forsgen (15 January 2015)

25. “not already the subject of a certificate”

26. One patented product, one SPC It is only possible to get one SPC per patented product: C-181/95 Biogen Inc v SKB [1997] ECR I-357 C-322/10 Medeva [2011] ECR I-12051 C-630/10 University of Queensland [2011] ECR I-12231 C-422/10 University of Georgetown [2011] ECR I-12157 The basic patent claimed multiple active ingredients. The marketing authorisation was for a combination of active ingredients. The proprietor of the basic patent gets an SPC for on active; that proprietor can make a subsequent application for another SPC for one of the other actives covered by the basic patent (and part of the combination in the MA) C-484/12 University of Georgetown II (12 December 2013)

27. But… Where the basic patent includes a claim for the active ingredient alone and a second claim for it in combination, and an SPC has been granted for the active in the sole claim it is not possible to get a second SPC for it in combination (in this case the claim was added by amendment). C-577/13 Actavis v Boehringer (12 March 2015)

28. And the reason: Part I C-443/12 Actavis v Sanofi [2014] RPC 20: ‘…the basic objective of Regulation No 469/2009 is to compensate for the delay to the marketing of what constitutes the core inventive advance that is the subject of the basic patent, namely, in the main proceedings, irbesartan. In the light of the need, referred to in recital 10 in the preamble to that regulation, to take into account all the interests at stake, including those of public health, if it were accepted that all subsequent marketing of that active ingredient in conjunction with an unlimited number of other active ingredients, not protected as such by the basic patent but simply referred to in the wording of the claims of the patent in general terms, such as, in the case of the patent in the main proceedings, ‘beta-blocking compound’, ‘calcium antagonist’, ‘diuretic’, ‘non-steroidal anti-inflammatory’ or ‘tranquilizer’, conferred entitlement to multiple SPCs, that would be contrary to the requirement to balance the interests of the pharmaceutical industry and those of public health as regards the encouragement of research within the European Union by the use of SPCs.

29. And the reason: Part 2 C-443/12 Actavis v Sanofi [2014] RPC 20: It follows that, in such a situation, Article 3(c) of Regulation No 469/2009 precludes a patent holder from obtaining, on the basis of one and the same basic patent, more than one SPC in connection with irbesartan, since such SPCs would in fact be connected, wholly or in part, with the same product …. On the other hand, if a combination consisting of an innovative active ingredient in respect of which an SPC has already been granted and another active ingredient, which is not protected as such by the patent in question, is the subject of a new basic patent within the meaning of Article 1(c) of that regulation, the new patent could, in so far as it covered a totally separate innovation, confer entitlement to an SPC for that new combination that is subsequently placed on the market. [ie a new SPC is possible where one active is known (and has had an SPC), but the other active is from a different patent (and has not had an SPC)]

30. Multiple patent holders Where a medicinal product is covered by several basic patents, [the Regulation] does not preclude the grant of a supplementary protection certificate to each holder of a basic patent. C-181/95 Biogen Inc. v Smithkline Beecham [1997] ECR I-357

31. Having a copy of the authorization is irrelevant Where the basic patent and the authorization to place the product on the market as a medicinal product are held by different persons and the patent holder is unable to provide a copy of that authorization, an application for a certificate must not be refused on that ground alone. C-181/95 Biogen Inc. v Smithkline Beecham [1997] ECR I-357

32. “the authorization referred is the first authorization to place the product on the market as a medicinal product.”

33. Other types of authorisation So far as concerns medicinal products for human use, the concept of ‘first authorisation to place... on the market... in the Community refers solely to the first authorisation required under provisions on medicinal products granted in any of the Member States, and does not therefore refer to authorisations required under legislation on pricing of or reimbursement for medicinal products. C-127/00 Hässle AB [2003] ECR I-14781

34. Not medical device Medical devices, even though they go through similar approvals under Directive 93/42/EEC are not eligible for SPCs Cerus (BL O/141/14); Leibiz (BL O/328/14) A device may be approved as a medical device (under Directive 93/42/EC) in some Member States and as a medicinal product (under Directive 2001/83/EC) in others: C-109/12 Laboratoires Lyocentre (3 October 2013) But still (following Lyocentre) something approved under Directive 93/42/EEC is not entitled to an SPC: Angiotech (BL O/466/15)

35. Second medical uses The grant of a supplementary protection certificate in a Member State of the Community on the basis of a medicinal product for human use authorised in that Member State is precluded by an authorisation to place the product on the market as a veterinary medicinal product granted in another Member State of the Community. C-31/03 Pharmacia Italia [2004] ECR I-10001 But now: a marketing authorisation for a new therapeutic indication is a new marketing authorisation for the purposes of the regime. Thus, an indication that an active ingredient works on animals is a different indication from it working on humans as well. Only where the marketing authorisation of the first medicinal product, comprising the product and authorised for a therapeutic use corresponding to that protected by the patent relied upon for the purposes of the application for the SPC, may it be considered to be the first authorisation of ‘that product’ as a medicinal product exploiting that new use within the meaning of the regime C-130/11 Neurim Pharmaceuticals [2013] RPC 23

36. But… An SPC cannot be granted where the effect of the active ingredient is not covered by the therapeutic indication in the marketing authorisation C-631/13 Forsgren (15 January 2015)

37. The Application Process

38. Who may apply? The patent holder or successor may apply for the SPC

39. The Application Needs to specify: a)The name and address of applicant; b)The name and address of the agent; c)The number of the basic patent and its title; d)The name of the product (and whether it is a plant product or a pharmaceutical product); e)The number and date of the first authorisation for placing the product on the market in the Community. Must also include: a)A copy of the Marketing Authorisation (issued by Medicines and Healthcare Regulation Agency (MHRA) or European Medicines Agency (EMEA); b)Fee. Article 8 of Regulation (EC) No. 469/2009

40. Time for making application The application for the SPC must be made: a)within six months of the first marketing authorisation being granted; or if later; b)within six months of the grant of the basic patent. Article 7 of Regulation (EC) No. 469/2009

41. Formalities Examination a)It is in the required form (including requirements of documents under the Patents Rules 2007); b)Lodged within the prescribed period; c)Accompanied by a copy of the product licence for the UK; d)Contains, where appropriate, the documents relating to the first authorisation in the Community; e)Whether the basic patent is force.

42. Substantive Examination a)Whether the product is covered by the basic patent; b)Whether a valid authorisation has been provided for placing the product on the market; c)Whether the product has not already been made the subject of a certificate;

43. Grant of SPC On grant a certification is issued, it contains: a)The application number; b)States the end of the period of protection for the SPC; c)The date the SPC enters force (subject to payment of fees).

44. Publication On grant (or rejection) a notification is published in the Patents Journal. It includes: a)Name and address of holder; b)Number and title of basic patent; c)Number and date of Marketing Authorisations (first and relevant); d)Duration of certificate.

45. Scope of protection and revocation

46. Scope of Protection An SPC provides the same protection as the basic patent, but it only extends to the product covered by the Marketing Authorisation. Articles 4 and 5 of Regulation (EC) 469/2009 Where something is covered by the basic patent, but not referred to in the MA, it is only covered by the SPC if it is the same active ingredient as covered by the MA (eg a biosimilar). An SPC is invalid to the extent it is broader than the product (or particular indication) covered by the Marketing Authorisation E-16/14 Pharmaq (9 April 2015) (EFTA Court)

47. Effect of certificate The holder of a certificate can oppose all those uses of the product contained in a medicinal product (or plant protection product) as the patent proprietor could oppose before the expiry of the patent. C-322/10 Medeva [2011] ECR I-12051 C-422/10 Georgetown University [2011] ECR I-12157 C-630/10 University of Queensland [2011] ECR I-12231 Where a medicinal product (or plant protection product) includes more than one product and one of those products is protected by a certificate it is possible to prevent the sale of the entire medicinal product. C-442/11 Novartis v Actavis (9 February 2012)

48. Term of protection Article 13 Duration of the certificate 1. The certificate shall take effect at the end of the lawful term of the basic patent for a period 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 authorization to place the product on the market in the Community reduced by a period of five years. 2. Notwithstanding paragraph 1, the duration of the certificate may not exceed five years from the date on which it takes effect.

49. Time limit starts The time limit starts with the date the marketing authorisation was given to the addressee of the decision (ie the date of the notification and not the date of the authorisation) C-471/14 Seattle Genetics (6 October 2015)

50. Examples Example 1 The date of filing of a patent application is 1 June 2005. The marketing authorisation is granted on 1 May 2014. The period elapsed is eight years and eleven months. This period should be reduced by five years. The protected period is three years and eleven months. Example 2 The date of filing of a patent application is 1 June 2000. The marketing authorisation is granted on 1 May 2014. The period elapsed is thirteen years and eleven months. This period should be reduced by five years. The protected period is eight years and eleven months. This is greater than the maximum five year period and so the protected period is set at five years.

51. Paediatric extensions Where a person holds an SPC in relation to a paediatric medicine then they are entitled to an additional six months of protection. Article 13(3) Regulation (EC) No. 469/2009 and Article 36 Regulation (EC) No. 1901/2006 It is possible to get negative term SPCs (which become positive once the Paediatric extension is granted) C-125/10 Merck Sharp & Dolme [2011] ECR I-12987

52. Examples Example 1A The date of filing of a patent application is 1 June 2005. The marketing authorisation is granted on 1 May 2014 and the results for the studies of the paediatric investigation plan are included. The period elapsed is eight years and eleven months. This period should be reduced by five years and then increased by six months. The protected period is four years and five months. Example 2A The date of filing of a patent application is 1 June 2000. The marketing authorisation is granted on 1 May 2014 and the results for the studies of the paediatric investigation plan are included. The period elapsed is thirteen years and eleven months. This period should be reduced by five years. The protected period is eight years and eleven months. This is greater than the maximum five-year period and so the protected period is set at five years and then increased by six months. The total protected period is five years and six months.

53. Invalidity An SPC can be declared invalid on the following grounds: a)It did not satisfy the requirements of grant; b)The basic patent lapses before its lawful term ends; c)The basic patent is revoked or (after the patent expires) such grounds exist.

54. Otherwise: Article 19 The general rules applying to patents usually apply to SPCs such as threats, assignment, Crown use and so forth.

55. The End…