After the Rulings, the Reasoned Orders: a note on Queensland and Daiichi

On my travels and beset by some miserable connectivity, I've not been able to keep the flow of posts going as I would have liked. It is therefore with both thanks and apologies that I bring you this note which The SPC Blog received from Marjan Noor and Andrew Hutchinson (Simmons & Simmons LLP) last week:

"We had not seen much commentary on the above Reasoned Orders so bring them to your attention. Queensland is particularly interesting in relation to process patents:

Queensland, paras 40-41:

40 … just as Article 3(a) of Regulation No 469/2009 precludes the grant of a SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent (Medeva, paragraph 25), where the basic patent relied on in support of a SPC application relates to the process by which a product is obtained, that provision also precludes a SPC being granted for a product other than that identified in the wording of the claims of that patent as the product deriving from that process. The grant of a SPC is not conditional on whether it is possible to obtain a product directly as a result of the process by which the product is obtained, where that process has been the subject of a patent.

41 The answer to Question 6 is therefore that, in the case of a basic patent relating to a process by which a product is obtained, Article 3(a) of Regulation No 469/2009 precludes a SPC being granted for a product other than that identified in the wording of the claims of that patent as the product deriving from the process in question. Whether it is possible to obtain the product directly as a result of that process is irrelevant in that regard."

Many of the paragraphs in all three reasoned orders are the same and include the same references to the Medeva judgment. The conclusions in Case C-6/11 Daiichi follow Yeda and emphasise the need for an active ingredient to be "identified in the wording of the claims". Queensland takes this principle and applies it to process patents, which are required to identify the product of the process; the process alone seems to be insufficient. Queensland also repeats Medeva's "one SPC per patent rule" in the context of process patents".

After Medeva: what the commentators say ...

With regard to patent extension as in most other areas, we depend on the 
commentators to tell us what they see as happening from their vantage points

Following last week's ruling of the Court of Justice of the European Union in Case C-322/10 Medeva, The SPC Blog has received comments and opinions from so many people -- readers and others -- that it has been difficult to sift through them all.  The blog records below some of the first impressions of those who work in the field:

"The confirmation of the Attorney General’s opinion that a “mis-match” between an SPC and an MA is not fatal to that SPC application is welcome to the research-based pharmaceutical industry. However, every issue relating to the SPC protection of combination products has by no means been resolved. Also, many in the pharmaceutical industry will be disappointed that the CJEU has not adopted the infringement test argued for by Medeva and the UK Government" (Tim Powell: Powell Gilbert LLP)

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"This decision has far-reaching consequences. It means that innovative pharmaceutical companies can benefit from SPCs for their patents also if the relevant MA was granted for a combination product that is only partly disclosed by the patent relied on. For countries where the disclosure test was applied (such as the Netherlands) the possibility to obtain SPCs has been broadened. It also means that SPCs cannot be granted for active ingredients A + B, if the MA is in place for A + B and the wording of the claims of the patent only specify A. This means a limitation of the granting practice in countries where the infringement test was used (where SPCs for A + B were granted). 

Following the CJ decision, this has already led to the Court of Rome ruling (on 25 November) that Novartis cannot invoke its (Italian) SPC granted for a combination product that was not fully disclosed by its patent [noted by The SPC Blog here]. Several issues regarding both the application for SPCs and the protection granted by a valid SPC remain unresolved and are the subject of several other referrals to the CJ regarding the interpretation of the SPC Regulation. Medeva does provide possibilities for the pharmaceutical industry and companies should currently apply for SPCs as long as one of the active ingredients of the relevant MA is specified in the wording of the claims of the patent" (Gertjan Kuipers and Tjibbe Douma: De Brauw Blackstone Westbroek).

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“The CJEU rulings are welcome and have confirmed a relatively broad scope of SPC protection covering all combinations of a particular active ingredient with others, providing that the active ingredient is supported by the underlying patent. 

This is, perhaps, not as narrow a view of SPC protection as it was feared the Court of Justice might support. They have also expressed the legal position succinctly - the circumstances where you cannot obtain an SPC are now clearer. 

In essence, the CJEU has confirmed that it should not be possible to obtain SPC protection claiming active ingredients that owe nothing to the disclosure in the underlying patent. They have also avoided imposing the harsh result predicted by UK judges in previous cases such as Gilead” (Will James: Marks & Clerk Solicitors).

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"Although these decisions bring some much needed clarity to the application of the SPC regulations to combination drugs, we foresee several issues that remain unclear, particularly the meaning of “specified in the wording of the claims” in relation to Article 3(a). A brief review of the French, German and Spanish versions of the current decisions does not seem to remove the ambiguity, although they possibly lean towards a more restrictive approach than that implied by the English-language decisions" (Hugh Goodfellow and Daniel Wise, Carpmaels & Ransford).

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"The Medeva decision makes it clear that SPCs on combination products do not need to mirror the exact combination that is the subject of the marketing authorisation. Instead a patentee must match its SPC product to the active ingredients ‘specified’ in its patent. That SPC can then be enforced, it would seem, against any medicinal product containing (rather than matching) the active(s) the subject of the SPC. 

However, as ever, further questions are raised. What is meant by “specified”: do claims for classes of products and Markush formulae “specify” the individual actives they cover? Where does this leave biologic patents that claim, for example, antibodies to a particular antigen without disclosing the antibody? Is it really the intention that a patent can only ever have one SPC or is the CJEU’s decision limited to the single active A/combination A+B scenario? Has the CJEU stated that a single active SPC can be enforced against a combination? The wording of the CJEU decision is not clear. 

This is sadly another decision that raises as many important questions as it answers" (Marjan Noor and Andrew Hutchinson, Simmons & Simmons LLP).

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"In the quest for minimizing an alleged extension of protection for combination products, the CJEU has now come up with an answer which is primarily economically beneficial to the authorities charging applicants official fees for long specifications, and in reality confers a broader protection than would have been possible if using the infringement test to define the product, which may not be in the public interest.

On a constructive approach to the new legal situation, the best advice looking forward is for patent drafters to develop standard lists of all known active ingredients (approved or in the pipeline) in order to keep all options open for including combinations in the patent claims either in divisional applications, when time allows for that, or by limiting the patent using the central limitation procedure at the EPO" (Sidsel Hauge: Awapatent)

New pharma patent booklet available

Martin Paltnoi (CEO, MPS Business Services Ltd) has emailed The SPC Blog with news that he has produced a booklet, Pharmaceutical Patents - A Practical Guide which, he informs us, is written in a concise and easily digested manner the purpose of which is to give those interested a thumbnail sketch of the relevant issues concerning pharmaceutical intellectual property: They can become a little more informed without having to wade through the detail. This booklet includes a section on SPCs.  Anyone interested should contact MPA here or phone Martin on +44 (0)1707 654850.

Yeda, by Order of the Court

Somehow, with all the excitement of the unified patent court and the unitary patent system for Europe buzzing round his ears, this member of The SPC Blog team quite forgot that Case C‑518/10, Yeda Research and Development Company Ltd, Aventis Holdings Inc v Comptroller General of Patents, Designs and Trade Marks, a reference for a preliminary ruling from the Court of Appeal (England and Wales), was still in the pipeline. This case has sped through the judicial corridors of Luxembourg, arriving in November 2010 and departing -- in the form of an Order -- on 25 November which was handed down this morning.

The following is written in substantial reliance on a very helpful note prepared by Hugh Goodfellow (Carpmaels & Ransford), sent to this weblog by his colleague Edward Oates.

Yeda held a basic patent for a therapeutic composition that includeda monoclonal antibody and an anti-neoplastic agent. The marketing authorisation which Yeda cited in support of its SPC application related to a medicinal product (Erbitux) which contained the antibody alone (cetuximab) but mentioned that the antibody was indicated to be used in combination with the anti-neoplastic agent (irinotecan).

In its SPC filing strategy, Yeda attempted to cover two options, by filing one SPC application that identified the product merely as "cetuximab" and another application for "cetuximab in combination with irinotecan". The UK IPO refused both SPC applications.

• The "cetuximab" SPC application was refused for failing to satisfy the requirements of Article 3(a) of the SPC Regulation because the basic patent did not protect the specified product. 
• The combination SPC application was refused under Article 3(b) of the Regulation because the referenced marketing authorisation related to the active ingredient cetuximab alone. 

Yeda appealed this decision to the High Court for England and Wales, arguing that its patent allowed it to oppose any use by a third party of the active ingredient cetuximab, including use as a single agent treatment, because such use would constitute indirect (or contributory) infringement of its patent for the purpose of Section 60(2) of the UK Patents Act 1977. Yeda therefore said that, for the purposes of the application of Article 3(a), the active ingredient at issue was protected by the patent. While this initial appeal was unsuccessful, the Court of Appeal was persuaded that the law was not clear and referred the matter to the Court of Justice for a preliminary ruling.

The Court of Justice considered that the referred question was, for all essential purposes, answered by the judgment in Medeva (C-322/10) and therefore delivered a Reasoned Order. The Court's language is closely modelled on that used Medeva and concludes that Article 3(a) precludes the grant of a SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent. The ruling of the Court is therefore as follows:

"Article 3(a) ... must be interpreted as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate 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".

Observing that this Order will come as no surprise to commentators in the field following Medeva, Hugh adds that we might expect to see further Reasoned Orders, for example in the Queensland and Daiichi referrals. He continues:

"It will be interesting to see whether the Court's reasoning in this case could be avoided in future cases by using different claim language, e.g. by using method features to define the combination therapy. Would such claims still be considered to specify the active ingredient as "forming part of a combination in conjunction with another active ingredient? Another approach, which does not appear to have been pleaded in Yeda, would have been to argue that the patent is for an "application" of the active ingredient in the sense of Article 1(c) (with the "application" being a combination therapy with the other active ingredient). Unfortunately, however, the CJEU's order is couched in terms that will make it difficult to run such an argument in the future".

[Corrected post] That elusive Explanatory Memorandum ...

This is an amended and corrected version of the post that originally went out last night.  The SPC Blog thanks Micaela Modiano (Modiano & Partners) for her help.

The SPC Blog has just received the following request from a reader who is currently doing some research into supplementary protection certificates:

"Do you know how I can find the Explanatory Memorandum to the SPC Regulation? I have searched on the internet and at eur-lex.europa.eu/LexUriServ, but cannot trace it".

Micaela writes:

"I too had difficulties finding it in the past, so I ended up writing to the Eur-Lex Helpdesk Publications Office and they sent it to me via email (at the time, the only available version was in Greek...). It is possible that despite my request they have not yet included it in the same webpage where the Greek version can be found, and this may be why the reader could not find it. I therefore attach it to this email so that the reader (and all SPC blog fans) now have it. What Eur-Lex does not do for us, we do for ourselves...".

The Explanatory Memorandum  to the Proposal for a European Parliament and Council Regulation (EC), of 11 April 1990, concerning the creation of a supplementary protection certificate for medicinal products (COM(90) 101 final - SYN 255) can now be accessed here.

I've also located the Explanatory Memorandum to the Proposal for a European Parliament and Council Regulation (EC), of 9 December 1994, concerning the creation of a supplementary protection certificate for plant protection products (COM(94) 579 final), which can be accessed here.

Negative term SPCs: judgment now available

Further to today's earlier post, here is the judgment of the Court of Justice in Case C-125/10 Merck Sharp & Dohme Corp v Deutsches Patent- und Markenamt.  It is surprisingly short, being just 46 paragraphs in length.  The active part of the decision reads as follows:

Article 13 of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, as amended by Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006, read in conjunction with Article 36 of Regulation No 1901/2006, must be interpreted as meaning that medicinal products can be the object of the grant of a supplementary protection certificate where the period that has elapsed between the date of lodging the basic patent application and the first marketing authorisation in the European Union is less than five years. In such a case, the period of the paediatric extension provided for by the latter regulation starts to run from the date determined by deducting from the patent expiry date the difference between five years and the duration of the period which elapsed between the lodging of the patent application and the grant of the first marketing authorisation.

Court of Justice gives go-ahead to negative term SPCs

The Court of Justice of the European Union gave its ruling this morning in Case C-125/10 Merck Sharp & Dohme Corporation. Infuriatingly, the recently-redesigned Curia website hasn't yet managed to make the ruling accessible -- but The SPC Blog has received the following information from Hogan Lovells LLP, which successfully represented Merck & Co. in these proceedings.  According to the Hogan Lovells media release, the Court of Justice has it ruled that negative term supplementary patent certificates (SPCs) are permissible:

" ... The decision means the SPC protection for the diabetes drug Januvia can be extended by two and a half months until mid-September 2022. This extension would reward Merck’s efforts to research and provide valuable information on the effects of Januvia in the child population. 

The issue came to the fore in 2007 when Merck applied for a negative SPC extension for Januvia in several EU countries. Januvia is Merck's registered trade mark for the active ingredient sitagliptin. 

Bulgaria, the Netherlands, and the United Kingdom granted negative term SPCs; Greece granted a zero term SPC; various other states, including Germany, refused to grant any SPC at all. 

In Germany Merck took its case against the national patent office to the Federal Patent Court, which referred the matter to the CJEU, asking whether it is permissible to grant negative or zero term SPCs. Merck was represented before the CJEU by Dr. Andreas von Falck and Miriam Gundt of Hogan Lovells' Dusseldorf office, and by Dr. Monica Heinemann of patent attorney firm Abitz & Partner. 

... In 2006 a six month extension to the SPC term was introduced to incentivize innovators to investigate and report on whether their products are suitable for use in the pediatric population. Prior to the introduction of this incentive, many products were used to treat the pediatric population without having been studied or authorized for such use ...

A negative term SPC, as the name suggests, offers a negative term of SPC protection after patent expiry because the period between filing the patent and wining marketing authorisation is less than five years. 

The value of a negative term SPC is that it forms the basis for an SPC extension of up to six months to reward studies of the medicine in the pediatric population ...".

The SPC Blog expects the judgment to be accessible here once it materialises online. At present all that is available is the Advocate General's Opinion, discussed on The SPC Blog here and indeed elsewhere.