Queensland reference: request for information

One of The SPC Blog's readers has emailed an urgent request.

Does anyone happen to have a copy of the decision of the original High Court of Justice (England and Wales) decision of 14 December 2010 in The University of Queensland, CSL Ltd v Comptroller-General of Patents, Designs and Trade Marks -- the ruling to refer to the Court of Justice of the European Union the questions which were addressed by that Court by order in Case C-630/10?

If anyone can supply the text of this decision, which does not appear to have been posted on BAILII, The SPC Blog will be happy to make it available to all.

Note: since posting this, The SPC Blog has received a copy of the decision thanks to the kindness of Brian Cordery (Bristows); it can be accessed here.

Merck ruling and non-positive term: new article

“European court ruling on SPCs brings relief to industry” is the title of an article by Mike Snodin (Potter Clarkson) that has been published in the January 2012 edition of Scrip Regulatory Affairs: it discusses the Court of Justice's ruling in Case C-125/10 (Merck; sitagliptin). Referring back to an earlier article, co-authored with John Miles, which introduced the concept of zero or negative term SPCs, Mike notes that the Court of Justice has effectively adopted Model A of that article in preference to Model C. In this respect, according to Mike’s new article:

“The innovative pharmaceutical industry will welcome the acceptance of SPCs having non-positive terms, as this increases the number of patents upon which useful (extended) SPC protection can be based. It also irons out a potential peculiarity (a perverse incentive to delay authorisation of new products in order to obtain longer post-marketing exclusivity) that would have existed if the court had reached a contrary decision. 

An unusual aspect of the decision is that the court adopted different approaches for ruling upon the two questions that it addressed. That is, for approving the validity of SPCs with non-positive term, the decision looks to the combined objectives of the SPC Regulation and the Paediatric Regulation. On the other hand, for ruling out the use of SPCs to obtain post-marketing exclusivity greater than 15 years and six months (ie for deciding to adopt Model A in preference to Model C from the above-mentioned 2007 RAJ Pharma article), the decision looks only to a provision of the SPC Regulation. 

The adoption of Model A in preference to Model C may have disappointed some in the innovative industry, as it means that conducting (often mandatory) clinical trials in the paediatric population will not always lead to a “reward” of an extended post-marketing monopoly period. This is because those patent holders obtaining authorisation of products four years six months or less after patent filing will not be able to obtain grant of extended SPCs with a positive term (though it appears that they may not be prevented from obtaining extended SPCs with zero or negative term). 

Nevertheless, it is possible to view the decision to limit combined patent and SPC protection to a maximum of 15 years and six months as being consistent with the intention of the Paediatric Regulation, even if the manner in which that intention is put into effect (by way of unextended SPCs with non-positive term) was never contemplated by the legislators.”

Mike’s article then discusses the possibility of (negative term) SPCs expiring before the patent upon which they are based, concluding that any concerns on this point are likely to be short-lived, as:

“Firstly, more and more newly authorised medicinal products will have been subject to the provisions of Article 7 of the Paediatric Regulation. Those provisions are such that, in the absence of a relevant waiver, data from paediatric trials must be submitted at the same time as data from clinical trials involving adults. For such new products, it is therefore likely that applications for extension of SPC term will be submitted at the same time as applications for unextended SPCs. 

Secondly, from 26 January 2012, the deadline for applying for an extension of SPC term will be brought forward 18 months (to two years before SPC expiry). This should provide national patent offices ample time to grant extensions of term before expiry of even a negative term SPC.
Taken together, these two factors should ultimately eliminate any chances of (unextended) SPCs reaching expiry before the patents upon which they are based.”

You can read Mike's article in full here.

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.