The WSJ debate: what's your view?

Writing on the IPKat weblog -- a general interest intellectual property blog which many readers of this blog do not get to read -- England-based Australian lawyer Catherine Lee has posted this summary of "Should Patents on Pharmaceuticals Be Extended to Encourage Innovation?", a Wall Street Journal feature in the form of a debate between Josh Bloom (director of Chemical and Pharmaceutical Sciences at the American Council on Science) and Els Torreele (director of the Access to Essential Medicines Initiative of the Open Society Foundation's Public Health Program) as to whether pharma patents should be incentivised by longer patents or funded through the infusion of funds within a regulatory environment.

Readers who wish to give Catherine the benefit of their opinion are invited to do so.

Planting another seed

The SPC blog has received information that there may be yet another CJEU referral on the way....our informant reports as follows:

In the Hussar case (C-229/09) the CJEU concluded that it is possible to obtain an SPC for a plant protection product on the basis of a provisional marketing approval granted in accordance with Art. 8(1) of directive 91/414 EPC (which requires a level of testing equivalent to that necessary in order to obtain a definite marketing approval issued under the conditions laid down in Art. 4 of that directive).

Due to the considerable legal uncertainty prior to Hussar (which was further compounded by conflicting information provided by the GPTO at that time), a number of SPC applications had been filed in Germany on the basis of a so-called “emergency approval” granted in accordance with Art. 8(4), (which unlike the provisional or definite approval is issued for a limited period not exceeding 120 days).

In the case at hand (SPC filing number DE 12 2004 000 021.0) , an SPC application was filed within six months of the issue of such an emergency approval, which by this time had already expired. The provisional Art 8(1) approval issued shortly after the filing date of the SPC application, followed by the subsequent definite approval in accordance with Art. 4.

Oral proceedings were held in December before the Federal Patent Court, which is evidently now minded to refer the case to the CJEU in February 2012.

While the exact wording of the questions to be referred to CJEU is not yet available, it would appear that the central issues are as follows:

1. For the purpose of the application of Article 3(1)(b) of Regulation No 1610/96, must account be taken exclusively of a Marketing Authorisation under Article 4 or 8(1) of Directive 91/414 EEC or can a certificate also be issued pursuant to a Marketing Authorisation which has been granted on the basis of Article 8(4) of Directive 91/414 EEC? 

2. For the purpose of the application of Article 3(1)(b) of Regulation No 1610/96, must the authorisation to place the product on the market still be valid at the application date of the SPC?

The SPC blog will let you know if and when we hear more....

Jut one SPC per patent? What the Court of Justice really said

Following Martijn de Lange's recent post, "'Just one SPC per patent': time for some number-crunching" (here), our friend and colleague Herwig von Morze has written this defence of the view that a single basic patent can support more than one SPC. He first quotes para.41 of the Court of Justice (ECJ) ruling in Medeva which states:

“Second, where a patent protects a product, in accordance with Article 3(c) of Regulation No 469/2009, only one certificate may be granted for that basic patent (see Biogen, paragraph 28)" 

and then explains that this statement

"may create the impression that each basic patent can only give rise to one certificate, regardless of how many different products this patent covers. However, this impression of the statement is misguided as it ignores Medeva’s (Biogen’s) reference to Art. 3(c) of Reg. 469/2009.  Art. 3(c) does not limit the number of certificates per basic patent to one in general terms but limits this number to one for a specific product. Art. 3 as a whole does not, and cannot, address a situation concerning an assortment of products covered by a basic patent, but defines the granting requirements for a single product. It is noteworthy that Art. 3(a) to (d) uses the definite article “the” product and not “a” product. If a certificate for a product covered by a basic patent would rule out a certificate for another product, then the indefinite article would have been used in Art. 3(c). Therefore para. 28 of Biogen and similarly para. 41 of Medeva must be read and supplemented in conformity with Art. 3 (c) as follows:

“Under Article 3(c) of the Regulation, however, only one certificate may be granted for a product for each basic patent.”

The statement in Medeva para. 41 does not create new law: it just repeats Biogen para. 28 which has been in place since 1997. To my knowledge there are no court decisions denying a certificate for a product covered by a basic patent where that basic patent already gave rise to an earlier certificate covering another product based on Biogen para. 28. However, if other SPC readers have different information, will they please come forward.

Daiichi (Case C-6/11) may be of relevance for the interpretation of Biogen para. 28/Medeva para. 41. It deals with a situation where the claims of a basic patent are limited to a single active ingredient A and the subject of the marketing authorization is directed to A+B. According to the decision, no SPC is possible for the combination A+B, because this combination is not identified (specified) in the claims of the basic patent, as required by Art. 3(a). However, Daiichi raised no objection pursuant to Art. 3(c), although previously a SPC had issued for A supported by the same basic patent, a fact before the British court and the ECJ. The ECJ’s ruling would at least imply that a SPC would have been possible for A+B, had the patent claims identified (specified) this combination. This further supports the opinion expressed here that, contrary to one impression created by  Biogen para. 28/Medeva para. 41, a single basic patent would be capable of supporting more than one SPC (one for the product A and another one for the product A+B)".

The SPC Blog thanks Herwig for his close analysis of the ipsissima verba of the ECJ and hopes to hear from any readers who have information concerning court decisions denying a certificate for a product covered by a basic patent where that basic patent previously gave rise to an earlier certificate covering another product based on Biogen para. 28.

"Just one SPC per patent": time for some number-crunching

Blog reader and (more significantly in this context) Netherlands Patent Office examiner Martijn de Lange offers us some real data against which to measure the impact of Court of Justice jurisprudence.  He writes:

"Your readers are probably aware of the fact that the Court of Justice of the European Union recently stated in its judgement on case C-322/10 Medeva that only one SPC can be granted per patent. In the past the Netherlands Patent Office, like other national offices, did not find it objectionable to grant multiple SPCs on the basis of the same patent. 

Out of curiosity I have collected some data from our database to determine the extent of the matter. Over the years the Netherlands Patent Office has received a total of 968 SPC applications (medicinal products and plant protection products combined). Out of those 968 applications, 205 SPC applications are without a unique basic patent: 

- 97 SPC applications were granted
- 25 SPC applications were abandoned
- 32 SPC applications were refused
- 51 SPC applications are still pending, of which eight are before the Court of the Hague after refusal by the Netherlands Patent Office 

There are 73 patents that have been used as basic patent for two or more SPCs applications: 

- 30 basic patents with two or more SPCs granted. Of those 30, 12 are no longer 'alive', i.e. the SPCs have expired or the patent and/or SPCs were nullified. 18 still concern at least one SPC that has not yet expired.
- 13 basic patents with one or more SPCs granted and one or more applications pending.
- Eight basic patents with no SPC granted and two or more applications pending. 

The rest are basic patents with one or no SPC granted and no cases pending".

This blog thanks Martijn for compiling these figures and hopes that this offering may trigger some comparative data from other offices. It would be interesting to see if there were any substantial differences, given the efforts that have gone into producing a relatively homogeneous legal and commercial environment for patent extensions in the single European market.

Extending patent term: forthcoming seminar

On Monday 19 March there's a one-day seminar coming up in London. Hosted at the Rembrandt Hotel, it's organised by Management Forum and its title is "Extending Patents for Medicines in Europe, the US and Japan". Paul Inman (Wragge & Co LLP) is in the chair and the speakers are Oliver Kingsbury (Elkington and Fife), Hideaki Kobayashi (Ohno and Partners, Japan) and Anthony Tridico (Finnegan, Belgium). Further information and registration details are available from Management Forum.

As easy as (a), (b) -- but maybe not (c) and (d)?

Following yesterday's post, which featured De Brauw's handy table that summarised the current position now that the Court of Justice has given a whole battery of judgments and orders regarding SPC subject matter, The SPC Blog has now heard from John Miles (Potter Clarkson). John -- who was the agent for Georgetown University et al. in Case C-422/10 -- makes reference to his own firm's newsletter coverage of the Yeda, Queensland and Daiichi cases (you can find it here, under the heading “Supplementary Protection Certificates: Some further twists”) and adds:

"You will see that we have speculated that Yeda could be interpreted to suggest that explicit naming of active ingredients in the claims is not necessary to satisfy the “specified in the wording of the claim” test that comes from Medeva. We also point to the difference in wording between Medeva (“specified”) and the other cases (“identified”) but conclude that no difference is meant".

Regarding the De Brauw table, he adds:

"this only takes account of the situation under Articles 3(a) and 3(b), and not 3(c) and 3(d). It is not entirely clear that all of the SPC applications necessarily satisfy Articles 3(c) and 3(d) even if they do satisfy Articles 3(a) and 3(b), and it will be interesting to see if and how the English courts consider this point".

What do other readers think?

After the recent batch of SPC rulings, where are we?

The SPC Blog thanks Tjibbe Douma (De Brauw Blackstone Westbroek N.V.) for drawing its attention to a neat explanatory diagram which appeared in that firm's Legal Alert of December 2011 and which represents, in schematic form, the position which follows the recent batch of Court of Justice rulings and orders that has clarified the status of SPCs relating to product-by-process claims and combination products.

Summary of the present situation for easy reference: what do the decisions mean in practice

CASE	Basic Patent Claims:	MA in place for:	SPC
Medeva	Combination A+B	A +B +C+D multi-disease vaccine	A+B
Yeda	Combination A+B	A (+C)	No SPC possible
Queensland Several basic patents	1.     A+B 2.     C 3.     D	A+B+C+D	1.     A+B (based on patent 1) 2.     C (based on patent 2) 3.     D (based on patent 3)
Queensland Product through process	A claimed in the wording as (in)direct product of the process claim	A (+B + C)	A
Queensland a contrario Product through process	A product of process but A not specified in the wording of the claim	A (+B + C)	No SPC possible
Daiichi	A	A+B combination therapy	A

Details of these cases can be found on The SPC Blog and/or on the De Brauw website's Legal Alerts and Newsletters (here).

Happy New Year -- and news of an event

You may have noticed that The SPC Blog has been in hibernation over the winter break -- but now that its readers are (nearly all) back at their desks, it's time for the blog to roar into action again.

We have news of an upcoming event. Jean-Claude Alexandre Ho (Conference Manager Intellectual Property, FORUM Institut für Management GmbH) has informed The SPC Blog that he is organising an SPC seminar on 29 February 2012 in London. The star attractions at this event are the German authors/practitioners Christopher Brückner and Peter von Czettritz, whose blockbuster book on SPCs was published last year. Christopher and Peter will be presenting their SPC commentary which, Jean-Claude informs us, participants in the seminar will receive. Full details of the seminar programme can be found here.

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)

******************************************** 

"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).

********************************************

“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).

********************************************

"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).

********************************************

"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).

********************************************

"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)