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

Law and Practice 2012: The CJEU, Europe and beyondTuesday 22 May 2012

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

SPC BLOG SEMINAR

FALLOUT FROM MEDEVA, GEORGETOWN ET AL.

& DAIICHI SANKYO

Dr Dolores Cassidy

Irish Patents Office

22/05/2012

MEDEVA – CJEU JUDGMENT 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.

GEORGETOWN 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.

DAIICHI SANKYO

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.

‘SPECIFIED’/‘IDENTIFIED’ 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?

MISMATCH BETWEEN PATENT 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 1st MA?

1ST MA FOR COMBINATION

1ST MA FOR COMBINATION

2ND MA FOR SINGLE COMPONENT

BUT… what is the date of the 1st MA for A?

3RD MA FOR COMBINATION

FAMOXADONE – PATENT IE66407 IE SPC No. 1999/006

1st MA – Famoxadone and Flusilazole [24/04/1998 (UK) and 10/12/1998 (IE)]

SPC expiry 23/04/2012

IE SPC No. 2000/011 2nd MA – Famoxadone

[24/03/2000 (IE)] SPC expiry 23/03/2015

IE SPC No. 2002/032 3rd MA - Famoxadone and Cymoxanil

[11/12/1997 (CH) and 14/05/2002(IE)] SPC expiry 10/12/2012

ONE SPC/PATENT QUESTION?(IN)FAMOUS PARAGRAPH 28 OF BIOGEN 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]

BIOGEN – ADVOCATE GENERAL’S OPINION

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.

ADVOCATE GENERAL’S OPINION 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 2nd 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 1st MA.

ADVOCATE GENERAL’S OPINION 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.

PROPOSAL FOR SPC REGULATION

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.

Thank you…

Questions???

SPCs in Italy: a never-ending story

Micaela ModianoSPC Blog seminar

22 May 2012

MILANVia Meravigli, 1620123 - Milan Italy

tel +39 02 8590.7777fax +39 02 863.860

OTHER OFFICES

Munich – GermanyLugano – SwitzerlandAlicante – Spain

[email protected]

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


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OTHER OFFICES


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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)




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OTHER OFFICES


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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




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OTHER OFFICES


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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...




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OTHER OFFICES


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AFTER 2002 - THE LITIGATION

expiry date calculation




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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???




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OTHER OFFICES


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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)




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OTHER OFFICES


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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)




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OTHER OFFICES


[email protected]

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




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OTHER OFFICES


[email protected]

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




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OTHER OFFICES


[email protected]

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?




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OTHER OFFICES


[email protected]

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): yesCourt of Trieste (2011): yes, then no!Court of Rome (2012): no!!!




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OTHER OFFICES


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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)




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OTHER OFFICES


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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."




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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."




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2012 - THE PRODIGAL SON

Italian IP Code amended in 2012

• last-year rule abolished!

is this the end???




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2012 - THE INTERPRETATION/1

Abolition of last-year rule

pro-originator: applying for an MA is always an infringement/threat to infringe!




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OTHER OFFICES


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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




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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???




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OTHER OFFICES


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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 lawsstill pending for 1 Italian law




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OTHER OFFICES


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AFTER 2012 - LOOKING AHEAD…

stay put for the next episode of this story...




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Are there any questions?



C-130/11 Neurim Pharmaceuticals

Presented by

Hugh Goodfellow

SPC Blog Seminar

22nd May 2012

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.

Background

– But the IPO objected under Article 3(d)

– Also Prime-X (Art 13)

The IPO said the first relevant authorisation was for Regulin

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.”

Regulin patent

Background

Neurim’s patent

Scope of Regulin MA

Scope of Circadin MA

Clear blue water

Written procedure

– IPO: continues to object based on existing CJEU Case Law

– Portugal: objects based on TRIPS

– Commission: aligned with Neurim

– Hearing: 15th March

– Opinion: 3rd May

– Judgment: September - 4 months after AG opinion?

What did Neurim argue?– We faced head-on the requirement for 2nd 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

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)

What did the Portuguese Gov’t argue?

2008EU marketing authorisation

1990 201820152010

SPC?

SPC?

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 TRIPSWould allow ever-greening

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?

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

A-G Trstenjak opinionAn 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

A-G Trstenjak opinionAn 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 specificpatent

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

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)

Why Neurim’s solution is the right one1. 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.

Why Neurim’s solution is the right one6. 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.

Thank you for listening

SPCs in UPCSPCs in UPC

Jean-Frederic Gaultier

Current Proposal and TimetableCurrent 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

SPCsSPCsDraft 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. »

SPCsSPCs– 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. »

Open questionsOpen 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

The SPC/PTE quiz…and Medeva

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….

The SPC Quiz

1 In Australia the grant of PTE can be opposed. What is the deadline for opposition – 3 months or 6 months from the publication of allowance?

2 Korea and Japan: One of these countries allows foreign clinical trials data to be included in calculating PTE, one does not. Which is which?

3 Which country has a PTE system that is tied to the PTE of 21 other Recognised Countries? Israel or Singapore?

4 In 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

5 Are patents on medical devices eligible for PTE in Japan?

The SPC Quiz

6 USA and Singapore: One will grant PTE for a food additive, one will not. Which is which?

7 In Japan, can PTE be granted if the patent is still pending when the regulatory approval has been granted?

8 In 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?

9 In 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?

10 PTE 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

11 How many readers receive the SPC blog updates (as of last Sunday)?

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?

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

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

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

The Answers

• 1 3 months

• 2 Korea does not allow overseas trial data, Japan does

• 3 Israel

• 4 b

• 5 no

• 6 USA will grant PTE, Singapore will not

• 7 no

• 8 yes

• 9 yes

• 10 a

• 11 1451

And now the questions…

For more informationplease contact:

Robert [email protected]

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

Documents

ma spc

b spc aba b slide

spc application

spc protection

combination patent

ma famoxadone

qa slide

active ingredients