1. Law and Practice 2012: The CJEU, Europe and beyond Tuesday 22 May 2012

2. Agenda 14.00 Chairman's introduction Dr Robert Stephen, Olswang LLP 14.10 Medeva - the fall out Dr Dolores Cassidy, Irish Patents Office 14.35 SPC protection in Italy Dr Micaela Modiano, Modiano & Partners 15.00 Break 15.20 Neurim - the hearing and AG's opinion Hugh Goodfellow, Carpmaels & Ransford 15.40 SPCs - the central European patent and court Jean-Frédéric Gaultier, Clifford Chance LLP 15.55 Medeva around the world and the SPC quiz 16.20 Q&A

3. SPC BLOG SEMINAR F ALLOUT FROM M EDEVA, G EORGETOWN ET AL. & D AIICHI S ANKYO Dr Dolores Cassidy Irish Patents Office 22/05/2012

4. M EDEVA – CJEU J UDGMENT Article 3(a ) …must be interpreted as precluding the IPO from granting an SPC 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. Article 3(b ) … does not preclude the IPO from granting an SPC for a combination of two active ingredients, corresponding to that 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 application for a special protection certificate contains not only that combination of the two active ingredients but also other active ingredients.

5. G EORGETOWN ET AL. Article 3(b) …must be interpreted as meaning that, provided the other requirements laid down in Article 3 are also met, that provision does not preclude (IPO) from granting an SPC 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.

6. D AIICHI S ANKYO Article 3(a) …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 identified in the wording of the claims of the basic patent relied on in support of the application for such a certificate.

7. ‘S PECIFIED ’/‘I DENTIFIED ’ IN THE WORDING OF THE CLAIM ?? Named using recognised nomenclature system or exact chemical structure given Identified as part of Markush formula? Included as part of class of compounds, e.g. antibiotic, diuretic? Another therapeutic substance?

8. M ISMATCH BETWEEN P ATENT AND MA SPC can be issued for one or more components of a multicomponent medicinal product. MA for “A+B” can now be used as the basis of an SPC application for “A”, “B” or “A+B”. What implications does this have for the date of the 1 st MA?

9. 1 ST MA FOR COMBINATION Patent for A MA A+B SPC ABA+B

10. 1 ST MA FOR COMBINATION Patent for A and A+B MA A+B SPC ABA+B

11. 2 ND MA FOR SINGLE COMPONENT Patent 2 for A MA for A SPC for A BUT… what is the date of the 1 st MA for A?

12. 3 RD MA FOR COMBINATION Patent 3 for C and A + C MA A+C AC

13. F AMOXADONE – P ATENT IE66407 IE SPC No. 1999/006 1 st MA – Famoxadone and Flusilazole [24/04/1998 (UK) and 10/12/1998 (IE)] SPC expiry 23/04/2012 IE SPC No. 2000/011 2 nd MA – Famoxadone [24/03/2000 (IE)] SPC expiry 23/03/2015 IE SPC No. 2002/032 3 rd MA - Famoxadone and Cymoxanil [11/12/1997 (CH) and 14/05/2002(IE)] SPC expiry 10/12/2012

14. O NE SPC/P ATENT QUESTION ? (I N ) FAMOUS P ARAGRAPH 28 OF B IOGEN C- 181/95 Where a product is protected by a number of basic patents in force, which may belong to a number of patent holders, each of those patents may be designated for the purpose of the procedure for the grant of a certificate. Under Article 3(c) of the Regulation, however, only one certificate may be granted for each basic patent. [3(c) Product has not already been the subject of a certificate]

15. BIOGEN – A DVOCATE G ENERAL ’ S O PINION 53… similar products could be authorised that did not fall within scope of SPC. This potential problem could be countered by permitting the holder of a patent either to acquire new certificates in respect of new products which rely on its invention and which are authorised to be marketed as medicinal products, or to extend the protection of an existing certificate to other such new products.

16. A DVOCATE G ENERAL ’ S O PINION COND … It is nowhere stated that a patent can be the subject of only one certificate, or of a certificate only in respect of one medicinal product, as the same patent may be used for widely differing medicinal products (as well as for very similar, competing ones, as in the present hypothesis). However…only 2 nd option consistent with objective of Art. 3(c). A certificate the material scope of which had been extended by reference to other medicinal products authorised before its expiry would retain its original temporal scope, determined by reference to date of 1 st MA.

17. A DVOCATE G ENERAL ’ S O PINION COND … Furthermore, permitting the material extension of the certificate to other authorized medicinal products would reflect and expand the policy underlying the provision in Article 4 of the Regulation for the extension of the protection of the certificate to any further use of the initial product as a medicinal product that has been authorised before the expiry of the certificate. Thus, just as every product should be able to give rise, where necessary, to certificates in relation to a number of associated patents in different hands, the material scope of every certificate should be capable of extension to uses of the related patent in a number of different products.

18. P ROPOSAL FOR SPC R EGULATION The certificate does not protect the expired patent in its entirety. It protects only the product authorised to be placed on the market. The term “product” is not understood to mean proprietary medicinal product or a medicinal product in the wider sense, but in the narrower sense of product used in patent law which, when applied to the chemical and pharmaceutical field, means the active ingredient. It is often the case on the chemical and pharmaceutical field that a patent protects a series of products based on the same formula. However, only some of these products will be subsequently developed and possible only one will be put on the market. In such a case, the certificate will only protect the product covered by the authorisation and not all of the products protected by the patent.

19. Thank you… Questions???

20. SPCs in Italy: a never-ending story Micaela Modiano SPC Blog seminar 22 May 2012

21. MILAN Via Meravigli, 16 20123 - Milan Italy tel +39 02 8590.7777 fax +39 02 863.860 OTHER OFFICES Munich – Germany Lugano – Switzerland Alicante – Spain www.modiano.com info@modiano.com BEFORE THE 1992 SPC REGULATION... Italy already had an SPC legislation! contained in the Italian inventions law duration of "old" Italian SPCs: up to 18 years! number of "old" Italian SPCs: ca. 400 (out of ca. 1200) expiry dates of "old" Italian SPCs: up to 2014! Strictly confidential - All rights reserved - No reproduction or diffusion without written authorisation SPCs in Italy: a never-ending story

22. MILAN Via Meravigli, 16 20123 - Milan Italy tel +39 02 8590.7777 fax +39 02 863.860 OTHER OFFICES Munich – Germany Lugano – Switzerland Alicante – Spain www.modiano.com info@modiano.com AFTER THE 1992 SPC REGULATION... coexistence of "old" Italian SPCs (duration: up to 18 years) and "new" Italian SPCs granted under SPC Regulation (duration: up to 5 years) Strictly confidential - All rights reserved - No reproduction or diffusion without written authorisation SPCs in Italy: a never-ending story

23. MILAN Via Meravigli, 16 20123 - Milan Italy tel +39 02 8590.7777 fax +39 02 863.860 OTHER OFFICES Munich – Germany Lugano – Switzerland Alicante – Spain www.modiano.com info@modiano.com 2002 - THE ALIGNMENT? Italian law passed in 2002 - provisions shortens the duration of "old" Italian SPCs (6 months for each solar year...) generic companies may apply for generic MAs only 1 year in advance of the expiry date of the "old" Italian SPCs Strictly confidential - All rights reserved - No reproduction or diffusion without written authorisation SPCs in Italy: a never-ending story

24. MILAN Via Meravigli, 16 20123 - Milan Italy tel +39 02 8590.7777 fax +39 02 863.860 OTHER OFFICES Munich – Germany Lugano – Switzerland Alicante – Spain www.modiano.com info@modiano.com AFTER 2002 - THE CONFUSION!/1 questions on 2002 law - duration what is the exact new expiry date of "old" Italian SPCs? duration of "old" Italian SPCs still not the same as per SPC Regulation... Strictly confidential - All rights reserved - No reproduction or diffusion without written authorisation SPCs in Italy: a never-ending story

25. MILAN Via Meravigli, 16 20123 - Milan Italy tel +39 02 8590.7777 fax +39 02 863.860 OTHER OFFICES Munich – Germany Lugano – Switzerland Alicante – Spain www.modiano.com info@modiano.com AFTER 2002 - THE LITIGATION expiry date calculation Strictly confidential - All rights reserved - No reproduction or diffusion without written authorisation SPCs in Italy: a never-ending story

26. MILAN Via Meravigli, 16 20123 - Milan Italy tel +39 02 8590.7777 fax +39 02 863.860 OTHER OFFICES Munich – Germany Lugano – Switzerland Alicante – Spain www.modiano.com info@modiano.com AFTER 2002 - MORE CONFUSION! further questions on 2002 law - infringement does the last-year rule apply also to "new" Italian SPCs? does the last-year rule apply also to patents without SPCs? if not, is applying for a generic MA more than 1 year in advance an infringement??? Strictly confidential - All rights reserved - No reproduction or diffusion without written authorisation SPCs in Italy: a never-ending story

27. MILAN Via Meravigli, 16 20123 - Milan Italy tel +39 02 8590.7777 fax +39 02 863.860 OTHER OFFICES Munich – Germany Lugano – Switzerland Alicante – Spain www.modiano.com info@modiano.com 2008 - THE CLOSURE (FOR DURATION) Italian law passed in 2008 explanation re: how to calculate expiry date of "old" Italian SPCs (still not the same as per SPC Regulation... expiry dates up to 2011!) Italian PTO must issue yearly list of SPC expiry dates (both "old" and "new" SPCs) Strictly confidential - All rights reserved - No reproduction or diffusion without written authorisation SPCs in Italy: a never-ending story

28. MILAN Via Meravigli, 16 20123 - Milan Italy tel +39 02 8590.7777 fax +39 02 863.860 OTHER OFFICES Munich – Germany Lugano – Switzerland Alicante – Spain www.modiano.com info@modiano.com AFTER 2002 - MORE LITIGATION/1 is applying for a generic MA more than 1 year in advance of a patent without SPC an infringement/threat of infringement??? Court of Rome (2006): yes Court of Milan (2009): no (3 decisions) Strictly confidential - All rights reserved - No reproduction or diffusion without written authorisation SPCs in Italy: a never-ending story

29. MILAN Via Meravigli, 16 20123 - Milan Italy tel +39 02 8590.7777 fax +39 02 863.860 OTHER OFFICES Munich – Germany Lugano – Switzerland Alicante – Spain www.modiano.com info@modiano.com AFTER 2002 - MORE LITIGATION/2 is applying for a generic MA more than 1 year in advance of a patent with a "new" Italian SPC an infringement/threat of infringement??? Court of Milan (2009): no Strictly confidential - All rights reserved - No reproduction or diffusion without written authorisation SPCs in Italy: a never-ending story

30. MILAN Via Meravigli, 16 20123 - Milan Italy tel +39 02 8590.7777 fax +39 02 863.860 OTHER OFFICES Munich – Germany Lugano – Switzerland Alicante – Spain www.modiano.com info@modiano.com 2010 - THE "CREATIVE" CHANGE Italian IP Code amended in 2010 (no authority to do so!) generic companies may apply for generic MAs only 1 year in advance of the expiry date of (a) the patent on the API (b) the "old" or "new" Italian SPC if applicable (c) the pediatric extension if applicable Strictly confidential - All rights reserved - No reproduction or diffusion without written authorisation SPCs in Italy: a never-ending story

31. MILAN Via Meravigli, 16 20123 - Milan Italy tel +39 02 8590.7777 fax +39 02 863.860 OTHER OFFICES Munich – Germany Lugano – Switzerland Alicante – Spain www.modiano.com info@modiano.com AFTER 2010 - NEW CONFUSION! questions on 2010 IP Code change: what is the meaning of the last-year rule? infringement/threat of infringement??? what is the sanction for breaking the last-year rule? does the last-year rule relate to IP law or to regulatory law? Strictly confidential - All rights reserved - No reproduction or diffusion without written authorisation SPCs in Italy: a never-ending story

32. MILAN Via Meravigli, 16 20123 - Milan Italy tel +39 02 8590.7777 fax +39 02 863.860 OTHER OFFICES Munich – Germany Lugano – Switzerland Alicante – Spain www.modiano.com info@modiano.com AFTER 2010 - NEW LITIGATION! is applying for a generic MA more than 1 year in advance of THE expiry date an infringement/threat of infringement??? Court of Milan (2010): no Court of Turin (2011): yes Court of Trieste (2011): yes, then no! Court of Rome (2012): no!!! Strictly confidential - All rights reserved - No reproduction or diffusion without written authorisation SPCs in Italy: a never-ending story

33. MILAN Via Meravigli, 16 20123 - Milan Italy tel +39 02 8590.7777 fax +39 02 863.860 OTHER OFFICES Munich – Germany Lugano – Switzerland Alicante – Spain www.modiano.com info@modiano.com 2011 - THE "BIG BROTHER" EU Commission: infringement proceedings against Italy (art. 258 of the Treaty on the Functioning of the European Union (TFEU)) due to "patent linkage" provisions in Italian law (no. 4188/2010) Strictly confidential - All rights reserved - No reproduction or diffusion without written authorisation SPCs in Italy: a never-ending story

34. MILAN Via Meravigli, 16 20123 - Milan Italy tel +39 02 8590.7777 fax +39 02 863.860 OTHER OFFICES Munich – Germany Lugano – Switzerland Alicante – Spain www.modiano.com info@modiano.com LATER IN 2011 - THE PRESS RELEASE/1 EU Commission: "According to Directive 2001/83/EC on the Community code for medicinal products for human use, the processing of marketing authorisation procedures can be carried out without being affected by the protection of industrial and commercial property interests." Strictly confidential - All rights reserved - No reproduction or diffusion without written authorisation SPCs in Italy: a never-ending story

35. MILAN Via Meravigli, 16 20123 - Milan Italy tel +39 02 8590.7777 fax +39 02 863.860 OTHER OFFICES Munich – Germany Lugano – Switzerland Alicante – Spain www.modiano.com info@modiano.com LATER IN 2011 - THE PRESS RELEASE/2 EU Commission: "In Italy, a law prevents manufacturers of generic products to submit their request for marketing authorisation prior to the penultimate year of the lifetime of a patent on a reference product.... the Commission asks Italy to ensure full compliance with European law." Strictly confidential - All rights reserved - No reproduction or diffusion without written authorisation SPCs in Italy: a never-ending story

36. MILAN Via Meravigli, 16 20123 - Milan Italy tel +39 02 8590.7777 fax +39 02 863.860 OTHER OFFICES Munich – Germany Lugano – Switzerland Alicante – Spain www.modiano.com info@modiano.com 2012 - THE PRODIGAL SON Italian IP Code amended in 2012 last-year rule abolished! is this the end??? Strictly confidential - All rights reserved - No reproduction or diffusion without written authorisation SPCs in Italy: a never-ending story

37. MILAN Via Meravigli, 16 20123 - Milan Italy tel +39 02 8590.7777 fax +39 02 863.860 OTHER OFFICES Munich – Germany Lugano – Switzerland Alicante – Spain www.modiano.com info@modiano.com 2012 - THE INTERPRETATION/1 Abolition of last-year rule pro-originator:  applying for an MA is always an infringement/threat to infringe! Strictly confidential - All rights reserved - No reproduction or diffusion without written authorisation SPCs in Italy: a never-ending story

38. MILAN Via Meravigli, 16 20123 - Milan Italy tel +39 02 8590.7777 fax +39 02 863.860 OTHER OFFICES Munich – Germany Lugano – Switzerland Alicante – Spain www.modiano.com info@modiano.com 2012 - THE INTERPRETATION/2 Abolition of last-year rule pro-generics:  applying for an MA is never an infringement supported by EU Commission statements parallel proposed change to Italian IP Code (explicit reference to infringement proceedings) "travaux préparatoires" of Italian parliament Strictly confidential - All rights reserved - No reproduction or diffusion without written authorisation SPCs in Italy: a never-ending story

39. MILAN Via Meravigli, 16 20123 - Milan Italy tel +39 02 8590.7777 fax +39 02 863.860 OTHER OFFICES Munich – Germany Lugano – Switzerland Alicante – Spain www.modiano.com info@modiano.com 2012 - FIRST THE NON-FUTURE? refused legislative proposal: Italian PTO list to include also expiry dates of patents for which no SPC was granted (no explicit limitation to patents on APIs)  already excluded from 1 Italian law why is this proposal relevant??? Strictly confidential - All rights reserved - No reproduction or diffusion without written authorisation SPCs in Italy: a never-ending story

40. MILAN Via Meravigli, 16 20123 - Milan Italy tel +39 02 8590.7777 fax +39 02 863.860 OTHER OFFICES Munich – Germany Lugano – Switzerland Alicante – Spain www.modiano.com info@modiano.com 2012 - THEN THE FUTURE? pending Italian legislative proposal: Italian Regulatory Agency decisions on price reimbursement: only effective after expiry dates indicated in Italian PTO list (no explicit limitation to SPC expiry dates)  already excluded from 2 Italian laws  still pending for 1 Italian law Strictly confidential - All rights reserved - No reproduction or diffusion without written authorisation SPCs in Italy: a never-ending story

41. MILAN Via Meravigli, 16 20123 - Milan Italy tel +39 02 8590.7777 fax +39 02 863.860 OTHER OFFICES Munich – Germany Lugano – Switzerland Alicante – Spain www.modiano.com info@modiano.com AFTER 2012 - LOOKING AHEAD… stay put for the next episode of this story... Strictly confidential - All rights reserved - No reproduction or diffusion without written authorisation SPCs in Italy: a never-ending story

42. MILAN Via Meravigli, 16 20123 - Milan Italy tel +39 02 8590.7777 fax +39 02 863.860 OTHER OFFICES Munich – Germany Lugano – Switzerland Alicante – Spain www.modiano.com info@modiano.com Are there any questions? Strictly confidential - All rights reserved - No reproduction or diffusion without written authorisation SPCs in Italy: a never-ending story

43. C-130/11 Neurim Pharmaceuticals Presented by Hugh Goodfellow SPC Blog Seminar 22 nd May 2012

44. Background –Neurim developed Circadin –It took over 15 years to get marketing authorisation –A full application for marketing approval was required –Neurim naturally applied for an SPC.

45. Background –But the IPO objected under Article 3(d) –Also Prime-X (Art 13) The IPO said the first relevant authorisation was for Regulin

46. Background –IPO: “more than a degree of sympathy” with Neurim –High Court: “tenable arguments” –Court of Appeal: CJEU referral and… –“We consider that Neurim’s arguments are not only tenable: in our view they are right.” –“In short, if Neurim are wrong, then the Regulation will not have achieved its key objectives for large areas of pharmaceutical research: it will not be fit for purpose. Whether that is so or not is clearly a matter for the EU’s highest court.”

47. Regulin patent Background Neurim’s patent Scope of Regulin MA Scope of Circadin MA Clear blue water

48. Written procedure –IPO: continues to object based on existing CJEU Case Law –Portugal: objects based on TRIPS –Commission: aligned with Neurim –Hearing: 15 th March –Opinion: 3 rd May –Judgment: September - 4 months after AG opinion?

49. What did Neurim argue? –We faced head-on the requirement for 2 nd medical use protection in Europe. –If you have an innovation, you can have an SPC. No policy reason why re-positioning of an existing drug should be any different. –1) makes link between patented innovation and drug MA –2) Article 4 – “Within the limits of protection…” –3) Recital 14 of the PPR, in conjunction with Farmitalia – salts –4) Gives effect to the underlying policy of the SPC Regn –Commission aligned with Neurim

50. What did the UK Gov’t argue? –Raised Pharmacia C-31/03, MIT C-431/04 and Yissum C- 202/05 –Raised Medeva C-322/10 –Raised Synthon C-195/09 (A-G Mengozzi’s opinion)

51. What did the Portuguese Gov’t argue? 2008 EU marketing authorisation 1990 201820152010 SPC? Generic compound per se patent Specific compound per se patent (selection invention) Specific dosage form (e.g. tablet) New medical indication Optimized method of manufacture Data & marketing exclusivity SPC? +1? 2016: first possible generic application 2018 or 2019: first possible generic marketing Neurim solution is contrary to TRIPS Would allow ever-greening

52. A-G Trstenjak opinion –Literal interpretation –Result of that literal interpretation –Assess result with reference to scheme and objectives of the Regulation –Then answer the first question –How can answer be classified in the Court’s Case Law?

53. A-G Trstenjak opinion –Art 1c) refers to 3 different types of patent –Product may therefore be protected by more than one basic patent in force, within meaning of Art 3a) –So, in principle, Art 3a) permits grant of >1 SPC per product –Same with Art 3b) – both human and veterinary Directives are referenced, so both form a possible basis for SPCs for products used as actives in different medicinal products –Same with Art 3c) – Biogen/AHP

54. A-G Trstenjak opinion An SPC may be granted only on the basis of the first authorisation which permits that product to be placed on the market as a medicinal product which is within the scope of protection conferred by the basic patent in the Member state in which the SPC application is made. –In other words, only if the earlier MA allowed its holder to work within the scope of the patent should the MA count under Article 3(d). –E.g. #1: Compound per se patent Scope of earlier MA, e.g. cancer treatment. Scope of MA relied on for SPC application, e.g. Alzheimer’s treatment. 3(d) objection

55. A-G Trstenjak opinion An SPC may be granted only on the basis of the first authorisation which permits that product to be placed on the market as a medicinal product which is within the scope of protection conferred by the basic patent in the Member state in which the SPC application is made. –In other words, only if the earlier MA allowed its holder to work within the scope of the patent should the MA count under Article 3(d). –E.g. #2: More specific patent Scope of earlier MA, e.g. cancer treatment. Scope of MA relied on for SPC application, e.g. new formulation for Alzheimer’s treatment. No 3(d) objection

56. Question 4 More specific patent Scope of earlier MA. Scope of later MA relied on for SPC application. Required full regulatory application Introduced a regulatory condition into the equation: –The later marketing authorisation required a full application for marketing approval in accordance with Article 8(3) of Directive 2001/83/EC (formerly a full application under Article 4 of Directive 65/65/EEC)

57. Why Neurim’s solution is the right one 1.It gives a result that is in accordance with a teleological interpretation. 2.Article 3(d) will not apply in cases where the subject- matter of the earlier MA is different from the innovation embodied in the patent on which the SPC application is based. 3.Avoids evergreening earlier MA. 4.Avoids harsh consequences of IPO’s approach. 5.It finds legislative basis in Plant SPC Regulation 1610/96, Recital 14.

58. Why Neurim’s solution is the right one 6.Consistent with jurisprudence from the German Bundespatentgericht, the High Court and the Court of Appeal. 7.Reflects the fact that pharmaceutical research increasingly involves new formulations of old active substances. Moreover, it reflects the consequential amendments that were made to the EPC 2000. 8.Recently adopted by Japan whose patent term extension system drove the founding of the SPC system. 9.Consistent with patent law where the novelty test = infringement test.

59. Thank you for listening

60. SPCs in UPC Jean-Frederic Gaultier

61. Current Proposal and Timetable A package: –Two draft Regulations (Unitary Patent + Translation) –Draft Agreement on Unified Patent Court –Draft Rules of Proceedings Political agreement by the end of June 2012? Inter-governmental conference in 2013? Ratfication by a number of States by 2015? Transitional period of 5 to 7 years

62. SPCs Draft agreement on a Unified Patent Court and draft Statute no 16741/11 of 11 November 2011 –Article 3 - Scope of Application: « This Agreement shall apply to any: (…) (b) supplementary protection certificate issued for a patent; » –Article 2 - Definitions: « (9) "Supplementary protection certificate" means a supplementary protection certificate granted under Regulation (EC) No 469/20091or under Regulation (EC) No 1610/96. »

63. SPCs –Article 15 - Competence of the Court « (1) The Court shall have exclusive competence in respect of: (a) actions for actual or threatened infringements of patents and supplementary protection certificates and related defences, including counterclaims concerning licences; » Note no 17539/11 from the Presidency to Coreper of 24 November 2011: « The Contracting Member States consider that the availability of supplementary protection certificates for pharmaceutical and plant protection products should be ensured in accordance with Regulation 469/2009 and Regulation 1610/96, for which the Commission should present proposals in due to time and as necessary. »

64. Open questions SPCs on domestic patents –No change? SPCs on EP patents –Grant –Recourse against grant decisions –Infringement and validity SPCs on unitary patents –Grant –Recourse against grant decisions –Infringement and validity

65. The SPC/PTE quiz…and Medeva

66. Around the world with Medeva We asked general PTE and some specific Medeva-like questions to Australia Singapore Korea Japan USA Israel Taiwan Russia Quiz and other….

67. The SPC Quiz 1In Australia the grant of PTE can be opposed. What is the deadline for opposition – 3 months or 6 months from the publication of allowance? 2Korea and Japan: One of these countries allows foreign clinical trials data to be included in calculating PTE, one does not. Which is which? 3Which country has a PTE system that is tied to the PTE of 21 other Recognised Countries? Israel or Singapore? 4In Russia, does a patent which discloses an active agent and its activity in the description need to specifically claim the compound or active agent to serve as basis for PTE, or is a more general claim, such as a Markush claim, allowed? a) yes - the compound or active agent should be specifically disclosed and claimed b) no - a more general claim is allowed for extension 5Are patents on medical devices eligible for PTE in Japan?

68. The SPC Quiz 6USA and Singapore: One will grant PTE for a food additive, one will not. Which is which? 7In Japan, can PTE be granted if the patent is still pending when the regulatory approval has been granted? 8In Japan, can a change in a dosage form of a (previously authorised) drug be used to obtain a new PTE where the new dosage form is claimed in the patent, described in the new marketing approval and is different from the dosage form of the previous approval? 9In the USA, is the PTE period affected by the due diligence on the part of the applicant while seeking regulatory approval during the regulatory review period? 10PTE may be granted in Taiwan: a) where it takes more that two years after publication of the patent application to acquire regulatory approval; or b) where it takes more that two years after the application date to acquire regulatory approval 11How many readers receive the SPC blog updates (as of last Sunday)?

69. Questions Patent discloses and claims only 1 component (A) of a 2 component medicine (A+B), where A+B is the product which has marketing approval. Can this patent and marketing approval be used to obtain a PTE? If answer to (i) is yes, what will the PTE application form specify as the product, A or A+B? Does the answer to (i) or (ii) depend on whether A has been authorized before individually. Does a patent need to specifically disclose and claim the compound or active agent to serve as a basis for PTE (for example A for a PTE to A; A+B for a PTE to A+B), or is it sufficient that the claims of the patent generically covers the active agent or agents? Does PTE granted to A+B prevent sale of the combination of A+B+C, where A+B+C needs a separate Marketing Authorization?

70. Question 1 – patent on A, MA is A+B Patent discloses and claims A but not B, and MA is A+B – PTE? CAVEAT! Australia – yes to A if A+B is first authorisation to A Singapore – potentially yes Taiwan – potentially yes USA – potentially yes Korea - no Japan - potentially yes if A is the first use Israel –yes, potentially to A if first MA for A Russia - no

71. Question 2 – need to specifically claim? CAVEAT! Japan – no Korea – no – generic (Markush) is OK USA – no legal requirement for patent to specifically claim the active Taiwan – no, generic is OK Singapore - [don’t specify the exact product] Australia – no, but must be some fair basis for a claim Russia – no, Markush is OK Israel – active must be ‘claimed’, but potentially could be claimed generically

72. PTE on A+B – will it prevent sale of A+B+C? CAVEAT! US – Likely no Korea – Likely no Taiwan – yes Japan – possibly yes if same indication Australia – possibly yes, but may be facts that lead to opposite view Singapore –possibly not Russia – yes Israel – PTE on A+B not possible but protection may not be limited to medicinal preparations with only 1 ingredient

73. The Answers 13 months 2Korea does not allow overseas trial data, Japan does 3Israel 4b 5no 6USA will grant PTE, Singapore will not 7no 8yes 9yes 10a 111451

74. And now the questions… For more information please contact: Robert Stephen robert.stephen@olswang.com