The SPC blog

The WSJ debate: what's your view?

2012-01-25T18:16:00.000Z

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

2012-01-23T15:18:00.000Z

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

2012-01-22T13:03:00.000Z

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

2012-01-19T17:22:00.000Z

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

2012-01-16T09:36:00.000Z

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)?

2012-01-13T12:25:00.000Z

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?

2012-01-12T23:14:00.000Z

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

2012-01-11T18:11:00.000Z

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

2011-12-19T19:05:00.000Z

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 ...

2011-12-12T22:49:00.000Z

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)

New pharma patent booklet available

2011-12-12T08:06:00.000Z

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

2011-12-09T14:40:00.000Z

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 ...

2011-12-08T23:14:00.019Z

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

2011-12-08T14:18:00.000Z

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

2011-12-08T12:46:00.003Z

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.

Court of Rome applies Medeva, suspends provisional relief

2011-11-27T22:27:00.000Z

From Evelina Marchesoni (Bird & Bird) comes an update to The SPC Blog's recent post on the Italian proceedings on valsartan and hydrochlorotiazide.She writes:

"On 11 November 2011 the Court of Rome granted a preliminary injunction requested by Novartis enforcing its SPC no. C-UB1999P000648, expiring on September 25, 2012 and covering the medicinal product “Cotareg” (valsartan + HCTZ).

In his decision the dudge ordered Mylan to stop manufacturing, commercializing, advertising, distributing, importing, exporting, storing and/or offering in any form (including the request of insertion in the so called “transparency list”) the generic products of Cotareg.

Mylan appealed against this interim order and, after the issue of the decision of the Court of Justice in Case C-322/10 Medeva and Case C-422/10 Georgetown, sought an application to stay the preliminary injunction pending appeal.

Mylan pointed out that, also in light of the Court of Justice's ruling, Novartis’s certificate claiming the combination of valsartan and HCTZ was invalid according to Article 3(a) of the Regulation, as it referred to a basic patent, EP 0 443 983, which did not provide such a combination.

By his decision, issued on 25 November 2011, the President of the IP Division of the Court of Rome, considering that on 24 November 2011 the decisions from the ECJ were published and they affirmed that Art.3(a) of the Regulation should 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 specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate”, ordered the provisional suspension of the preliminary injunction decision.

This short decision of the Court of Rome, which you can access in full here (in Italian) probably constituted the first application in Europe of the interpretation of the Court of Justice decisions in the Medeva and Georgetown cases.

Discussion of the appeal is scheduled for 16 December 2011".

Thank you, Evelina, for this information, which is much appreciated.

AIPPI UK Group holds rapid response seminar on Medeva, Georgetown

2011-11-27T21:48:00.000Z

The SPC Blog is pleased to announce that the AIPPI UK Group has organised a rapid response seminar which will enable interested parties to get together and discuss the repercussions of last week's rulings in Medeva and Georgetown, briefly noted here and here on this weblog.

Details of the seminar are as follows:

Tuesday 29 November 2011, 5.30pm for 6pm

SPCs for combination products –

Rapid Response to

CJEU Medeva and Georgetown judgment

Hugh Goodfellow

Partner, Carpmaels & Ransford

Venue:

Carpmaels & Ransford

One Southampton Row, London WC1B 5HA

Drinks will be served afterwards

There are a number of combination product cases pending before the Court of Justice of the European Union that, when taken together, probe almost every aspect of the Regulation’s requirements for a valid SPC to be obtained. The CJEU’s judgment in the Medeva and Georgetown cases has been handed down on Thursday 24 November, the first in the series of cases referred to that court. Following up the AIPPI event on the topic in September, Hugh Goodfellow. Partner at Carpmaels & Ransford, has agreed to host a Rapid Response, to provide the opportunity to discuss and debate the implications of this Judgment.

If you would like to attend this event, whether you are a member or not, please register at:

www.aippi.org.uk/medeva

This course is directed at all levels of practitioners with an interest in intellectual property and will provide them with an understanding of current issues and future potential developments in the law of supplementary protection certificates. Attendance is free.

SRA and IPReg, and (pending approval) BSB, CPD: 1.5 hours. AIPPI United Kingdom is accredited under the Solicitors Regulation Authority’s and the Bar Standards Board’s CPD schemes.

Georgetown ruling also out

2011-11-24T10:55:00.000Z

Also delivered today is the judgment of the Court of Justice of the European Union in Case C‑422/10, Georgetown University, University of Rochester, Loyola University of Chicago v Comptroller General of Patents, Designs and Trade Marks, this being a reference for a preliminary ruling from the Patents Court, England and Wales.

The Georgetown SPC applications

A pappilomavirus

In June 1993 Georgetown University applied for a European patent entitled ‘Papillomavirus vaccine’, for a human papillomavirus (PV) L1 protein capable of inducing neutralising antibodies against papillomavirus virions. There are many human papillomavirus (HPV) genotypes, which are grouped according to the similarity of their DNA sequences. Types 6 and 11 are responsible for condylomas, whereas types 16 and 18 are responsible for precancerous lesions in the genital region and also cervical cancer. The Georgetown University patent claims included a vaccine for the prevention of papillomavirus infection, comprising at least that protein, or fragment thereof, of, among others, HPV‑16, HPV‑18 or HPV‑16 and HPV‑18 together. That patent, granted on 12 December 2007, is due to expire on 23 June 2013.

In December 2007, relying on a marketing authorisation (MA) granted to Sanofi Pasteur in September 2006 for the medicinal product Gardasil, containing HPV‑6, HPV‑11, HPV‑16 and HPV‑18 purified proteins obtained from yeast cells (Saccharomyces cerevisiae), Georgetown University filed four SPC applications, identifying the product as ‘the recombinant L1 protein’ of HPV‑6, HPV‑11, HPV‑16 and HPV‑18 (SCP/GB07/079, SCP/GB07/073, SCP/GB07/080 and SCP/GB07/078), respectively. Relying on an MA granted to GlaxoSmithKline Biologicals in September 2007 for the medicinal product Cervarix, containing HPV‑16 and HPV‑18 purified proteins obtained from insect cells (Trichoplusia ni), Georgetown University filed two SPC applications identifying the product as ‘the recombinant L1 protein of papillomavirus type 16 as expressed by an insect cell’ (SCP/GB07/071) and ‘the recombinant L1 protein of papillomavirus type 18 as expressed by an insect cell’ (SPC/GB07/70), respectively.

The UK IPO rejected all these applications for failure to comply with the condition laid down in Article 3(b) of Regulation 469/2009, since the medicinal product for which the MA was granted contained more active ingredients than those for which SPC protection was sought.

The Rochester SPC applications

In March 1994 the University of Rochester applied for a patent entitled ‘Production of human papillomavirus capsid protein and virus-like particles’ for ‘a method of expressing the human papillomavirus capsid protein coding sequence of type 6 ([HPV]-6), type 11 ([HPV]-11) …’. The patent claims included a ‘purified recombinant human papilloma virus-like particle or capsomere which comprises human papillomavirus 16 ([HPV]-16) L1 capsid protein expressed from an L1 protein coding sequence …’ and ‘… a multivalent vaccine comprising a virus-like particle from different human papilloma viruses’. That patent was granted on 25 May 2005 and is due to expire on 7 March 2014.

T IPO granted the University of Rochester SPCs based on the MAs for Gardasil and Cervarix, identifying the product as ‘the combination of the virus-like particles of the recombinant Ll protein of human papillomavirus types 6, 11, 16 and 18’ (SCP/GB07/018) and ‘the combination of the virus-like particles of the recombinant Ll protein of human papillomavirus types 16 et 18’ (SCP/GB07/076). However, it refused to grant a SPC based on the MA for Cervarix identifying the product as ‘the virus-like particle of the recombinant L1 protein of human papillomavirus type 16 as expressed in an insect cell’ (SCP/GB07/075), for failure to comply with the condition laid down in Article 3(b).

The Loyola SPC application

In October 1995 Loyola University of Chicago applied for a patent entitled ‘Papilloma virus-like particles, fusion proteins and process for producing same’. The patent claims included ‘recombinant-produced papilloma virus-like particles that are formed after expression of the viral structure proteins Ll or Ll and L2, characterised in that one or more sections of the Ll protein are deleted, wherein the ability to form virus-like particles remains’. That patent was granted on 10 May 2006 and is due to expire on 8 October 2015.

The UK IPO granted a SPC to Loyola University of Chicago identifying the product as ‘the combination of the virus-like particle of the recombinant L1 protein of human papillomavirus types 16 and 18’ based on the MA for Cervarix (SCP/GB07/077). However, it refused to grant a SPC based on the MA for Cervarix identifying the product as ‘the virus-like particle of the recombinant L1 protein of human papillomavirus type 16 as expressed in an insect cell’ (SCP/GB07/069), since the application thus worded, based on the MA for Cervarix, failed to comply with the conditions laid down in Article 3(b).

The appeal and reference

The Patents Court, before which all three SPC applicants appealed, decided to stay the proceedings and refer the following question to the Court for a preliminary ruling, which is worded in the same terms as the sixth question referred by the Court of Appeal (England and Wales) in Case C 322/10 Medeva.

‘Does … Regulation [No 469/2009] and, in particular, Article 3(b), permit the grant of a [SPC] for a single active ingredient or combination of active ingredients where:
(a) a basic patent in force protects the single active ingredient or combination of active ingredients within the meaning of Article 3(a) of … Regulation [No 469/2009]; and
(b) a medicinal product containing the single active ingredient or combination of active ingredients together with one or more other active ingredients is the subject of a valid authorisation granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC which is the first [MA] that places the single active ingredient or combination of active ingredients on the market?’

Initially this case was joined with Case C‑322/010 for the purposes of the oral procedure and the judgment. However, in view of the factual differences between the situations at issue in the main proceedings, the cases were disjoined.

This morning the Court ruled as follows:

"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 the competent industrial property office of a Member State from granting a supplementary protection certificate 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".

As with this morning's earlier post on Medeva, comments will follow in due course.

Medeva ruling now out

2011-11-24T10:26:00.001Z

The Court of Justice of the European Union gave its ruling this morning in Case C‑322/10, Medeva BV v Comptroller General of Patents, Designs and Trade Marks, a reference for a preliminary ruling from the Court of Appeal (England and Wales).

Bordetella pertussis

In brief, in April 1990 Medeva applied for a European patent for a method for the preparation of an acellular vaccine against Bordetella pertussis (whooping cough agent), also known as ‘Pa’. This preparation consisted of a combination of two antigens as active ingredients -- pertactin and filamentous haemagglutinin (‘filamentous haemagglutinin antigen’). Their ratio was such as to provide a synergistic effect in vaccine potency. The patent was granted by the EPO on 18 February 2009, expiring on 25 April 2010.

Medeva filed five SPC applications with the UK's IPO, seeking supplementary protection for DTPa-IPV/HIB vaccines covering diphtheria (D), tetanus (T), whooping cough (Pa), poliomyelitis (IPV) and/or meningitis (Haemophilus influenzae, also known as ‘HIB’). In support of those applications, Medeva submitted marketing authorisations (MAs) granted by the French, German and UK authorities for a range of medicinal products each of which contained, in addition to the combination of pertactin and filamentous haemagglutinin, between eight and 11 other active ingredients.

In November 2009 the IPO refused to grant the SPCs applied for. In the case of four of the applications, more active components or ingredients were specified in the applications for SPCs covering those components than were identified in the wording of the claims of the basic patent, and they were not therefore protected by the basic patent under Article 3(a) of Regulation 469/2009. As for the fifth application, while the active components or ingredients identified in the patent were the same as those specified in the SPC application (ie combination of pertactin and filamentous haemagglutinin), the MAs submitted in support of that application did not fulfil the conditions laid down in Article 3(b) since they related to medicinal products containing nine active ingredients, that is to say vaccines which did not contain only the active components or ingredients specified in the SPC application and in the patent claims.

Medeva appealed unsuccessfully to the High Court and then again to the Court of Appeal, which stayed the proceedings and referred the following questions for a preliminary ruling:

‘1 Regulation No 469/2009 … recognises, amongst the other purposes identified in the recitals, the need for the grant of an SPC by each of the Member States of the Community to holders of national or European patents to be under the same conditions, as indicated in recitals 7 and 8 [in the preamble to that regulation]. In the absence of Community harmonisation of patent law, what is meant in Article 3(a) of … Regulation [No 469/2009] by “the product is protected by a basic patent in force” and what are the criteria for deciding this?

2 In a case like the present one involving a medicinal product comprising more than one active ingredient, are there further or different criteria for determining whether or not “the product is protected by a basic patent” according to Article 3(a) of … Regulation [No 469/2009] and, if so, what are those further or different criteria?

3 In a case like the present one involving a multi-disease vaccine, are there further or different criteria for determining whether or not “the product is protected by a basic patent” according to Article 3(a) of … Regulation [No 469/2009] and, if so, what are those further or different criteria?

4 For the purposes of Article 3(a) [of Regulation No 469/2009], is a multi-disease vaccine comprising multiple antigens “protected by a basic patent” if one antigen of the vaccine is “protected by the basic patent in force”?

5 For the purposes of Article 3(a) [of Regulation No 469/2009], is a multi-disease vaccine comprising multiple antigens “protected by a basic patent” if all antigens directed against one disease are “protected by the basic patent in force”?
…
6 Does … Regulation [No 469/2009] and, in particular, Article 3(b), permit the grant of a [SPC] for a single active ingredient or combination of active ingredients where:
(a) a basic patent in force protects the single active ingredient or combination of active ingredients within the meaning of Article 3(a) of the SPC Regulation; and
(b) a medicinal product containing the single active ingredient or combination of active ingredients together with one or more other active ingredients is the subject of a valid authorisation granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC which is the first [MA] that places the single active ingredient or combination of active ingredients on the market?’

The Court has just ruled as follows:

"1. Article 3(a) of Regulation ... 469/2009 ... 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 specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate.

2. Article 3(b) of Regulation ... 469/2009 must be interpreted as meaning that, provided the other requirements laid down in Article 3 are also met, that provision does not preclude the competent industrial property office of a Member State from granting a supplementary protection certificate 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".

Comments to follow, as well as a post on this morning's other ruling in Georgetown.

Spain: court orders change in practice in ganirelix ruling

2011-11-17T23:03:00.000Z

The SPC Blog has learned from its friend Herwig von Morze that it has been the long-established practice of the Spanish Patent Office to refuse the grant of an active ingredient with its salts. Now, however, following an appeal to the Spanish Federal Court, the Spanish Patent Office has been ordered to grant an SPC for ganirelix and its salts based on the rationale of the Farmitalia decision.

We are chasing up further information on this decision and hope to be able to report on it in greater detail soon.

Düsseldorf Novartis/Actavis order now in English too

2011-11-16T11:38:00.000Z

In "Düsseldorf valsartan/HTC proceedings referred for preliminary ruling" (here) The SPC Blog received an update from Thomas Bopp and Henrik Holzapfel (Gleiss Lutz, Düsseldorf, acting for the Actavis defendanta) on the proceedings in Novartis/Actavis before the Düsseldorf District Court. The update contained the order of that court in the original German, here.

The SPC Blog has since received two English translations of the order of the Düsseldorf District Court.

The first translation to arrive came from Cordula Tellman and Frank-Erich Hufnagel (Freshfields Bruckhaus Deringer LLP), which you can read as a pdf file here. As Cordula and Fran-Erich kindly explain, the Court reconfirms the position which it expressed in its ruling in the previous preliminary injunction proceedings: that is, a protection certificate granted for a single active ingredient (e.g. valsartan) would be infringed by a medicinal product containing this single active ingredient, even if combined with another active ingredient (e.g. valsartan + hydrochlorothiazide). The Court discusses in detail the arguments brought forward by the parties and gives extensive reasoning for its opinion that the SPC is infringed (see in particular paragraphs 17, 20, 22, 24, 28 and 30 of the order).

The second translation, which arrived in a welter of emails following the resumption of this blogger's internet connectivity, came from Thomas and Henrik. You can read it as a pdf file here.

The SPC Blog is grateful to the lawyers of both firms for their efforts to make the ruling and the reasoning of the Düsseldorf court both available and accessible to the SPC community and for their enthusiasm for the subject.

Düsseldorf valsartan/HTC proceedings referred for preliminary ruling

2011-11-13T14:02:00.000Z

Düsseldorf District Court

The SPC Blog has received from Thomas Bopp and Henrik Holzapfel (Gleiss Lutz, Düsseldorf) an important update on the proceedings between Novartis on the one hand and Actavis Deutschland GmbH and Actavis Malta Ltd on the other before the Düsseldorf District Court (Thomas and Henrik are representing the two Actavis companies in the action on the merits pending before the Düsseldorf District Court). This is what they have told us:

"The SPC Blog entries of 21 and 24 March 2011 (here and here, respectively) provided the following information:

1. On 8 March 2011, the Düsseldorf District Court held in preliminary injunction proceedings (case nos. 4b O 280/10 and 4b O 287/10) that Actavis' products containing the active ingredients valsartan and hydrochlorothiazide (HCT) would infringe Novartis' German SPC relating to valsartan (DE 196 75 036).

2. The Düsseldorf District Court ordered Novartis to file actions on the merits.
On 8 April 2011, Novartis filed such action on the merits (jointly) against Actavis Germany and Actavis Malta (case no. 4b O 66/11).

The latest news is that that on 8 November 2011 the Düsseldorf District Court decided to stay the infringement proceedings.

The question of whether the scope of protection of an SPC which has an active ingredient as its subject matter also extends to a combination of this active ingredient with a further active ingredient was regarded as decisive for the outcome of the infringement proceedings. Obviously, this question is precisely what the dispute between the parties is about. The court did not want to decide the question. It was considered necessary that the interpretation of Articles 5, 4 SPC Regulation be clarified by the Court of Justice of the European Union (CJEU). The Düsseldorf District Court referred the following question for a preliminary ruling to the CJEU:

"Must Articles 5, 4 of EC Regulation No. 469/2009 be interpreted to mean that the protection conferred by a certificate granted for a single active ingredient (in this case valsartan) extends to an embodiment that contains this single active ingredient in combination with another active ingredient (in this case valsartan + hydrochlorothiazide)?"
The Düsseldorf District Court also summarised the parties' pleadings, which differ to a certain extent from those in the parallel UK proceedings (where the High Court made a referral which is already pending before the CJEU as Case C-442/11)".

Thomas and Henrik have kindly sent us the order of the Düsseldorf District Court that the proceedings are stayed and referred to the CJEU, which readers can access here.

Valsartan and hydrochlorothiazide combination: Rome rules

2011-11-13T12:40:00.001Z

From Daniela Ampollini (Trevisan & Cuonzo Avvocati, Parma, Italy) comes information concerning a recent decision of the Court of Rome concerning a Novartis combination SPC, which this weblog reproduces here with grateful thanks:

"On 11 November 2011 the IP Chamber of the Court of Rome granted the motion for preliminary injunction requested by Novartis AG and Novartis Farma S.p.A. against Mylan S.p.A. on the basis of Novartis’ Italian valsartan and hydrochlorothiazide SPC, the active ingredients in Novartis’ Co-Diovan medicinal product (which is marketed in Italy as Co-Tareg).

The motion had been filed within the context of a nullity action initiated last September by Mylan, aiming at the revocation of Novartis’ SPC for alleged violation the provisions of the SPC Regulation, in which action Novartis had cross-claimed for infringement of its rights.

The grounds of invalidity raised by Mylan were substantially based on the assumption that: (i) the SPC would be invalid as the medicinal product Co-Diovan would not be “protected by a basic patent in force” considering that the basic patent EP 443983 did not claim the combination of valsartan and hydrochlrorothiazyde as such and that the “infringement test” (according to which a product is protected by a patent if it “infringes” the patent) would not be the correct test to use in interpreting Art. 3(a) of the SPC Regulation; and (ii) Art. 3(c) of the SPC Regulaton would have also been breached by the valsaran and hydrochlorothiazide SPC as another SPC on valsartan had already been granted based on the same EP ‘983 patent.

The Court of Rome first noted that the urgency requirement had been met sinceNovartis had produced pre-orders, indicating that Mylan had pre-marketed the drug, as well as the fact that Mylan had officially communicated to the association of Italian wholesalers that its generic version of Co-Diovan would be in the market as of 15 November 2011 (i.e. after the expiry of the valartan SPC-- but not after the expiry of the valsartan and hydrochlorothiazide SPC). It then endorsed the application of the infringement test as to Art. 3(a) of the SPC Regulation and clarified that Art. 3(c) was not breached if the products in question (in this case the product valsartan and the combination product valsartan and hydrochlorothiazide) are different, and therefore found that there had been infringement of a valid SPC.

The injunction is also noteworthy as it includes a prohibition that Mylan make pre-marketing activity (such as the collection of orders and pre-orders) before the expiry of the SPC, an order of recall of the products that have already been delivered to Mylan’s customers, and an order to notify the Italian Drugs Regulatory Authority with a view to preventing the inclusion of the generic in the substitution list of equivalent drugs.

The preliminary injunction is now subject to appeal and, in any event, to confirmation at the outcome of the merits proceedings".

You can read the court's order in the original Italian here, and in English translation here

JIPLP note on Medeva, Georgetown Opinion available online

2011-11-06T15:52:00.000Z

"Supplementary Protection Certificates for combination products" is the title of a Current Intelligence note by Tim Powell and Rebecca Lawrence (Powell Gilbert LLP) on the Advocate General's Opinion of 13 July 2011 in Joined Cases C322/10 Medeva and C422/10 Georgetown University.

The Fourth Chamber of the Court of Justice of the European Union will -- as regular readers of this weblog know -- be giving judgment on Thursday 24 November. It may be a few weeks till the printed version of Tim and Rebecca's note is published in the Journal of Intellectual Property Law & Practice (JIPLP). Meanwhile, you can read it in full on the jiplp weblog here.

Valsartan: French court upholds ex parte preliminary injunction

2011-11-04T11:19:00.002Z

The SPC Blog has received further information on the French Valsartan litigation from Laëtitia Benard (Allen & Overy, Paris). This relates to the very recent decision of the Paris First Instance Court on 31 October 2011, ruling on an attempt by Sanofi to remove the preliminary injunction which had previously been granted ex parte Laëtitia (whose firm acted for Novartis in these proceedings) takes up the story from here:

Further to a preliminary injunction rendered on an ex-parte basis against Sanofi on 27 October 2011, which ruled that Sanofi's generic medicines containing a combination of Valsartan and HCTZ infringed the SPC of Novartis for Valsartan and ordered the prohibition of the manufacturing, the importation, the offer for sale, the holding, the storing and the marketing of the infringing medicines as well as the recall of these medicines from all the distribution channels, Sanofi sought the withdrawal of this ex-parte order on the ground that the infringement was challengeable.

Ruling on Sanofi's recourse, the President of the Paris First Instance Court rendered an inter-partes decision on 31 October 2011, confirming the ex-parte preliminary injunction previously issued as well as the measures ordered. This ruling is in accordance with the previous decisions of the Paris First Instance Court and of the Losartan decision from the Paris Court of Appeals.

The main findings of the President of the Paris First Instance Court are as follows:

"Article 5 of EC Regulation No. 469/2009 provides that subject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations.

Thus, since the basic patent covering the active ingredient at stake, Valsartan, protects the owner of the patent against any non-allowed manufacture or marketing of pharmaceutical products containing this active ingredient, an SPC protects its owner against any non-allowed manufacture or marketing of any further pharmaceutical products containing this active ingredient and whose marketing would have been allowed before the expiry of the certificate.
Infringement is characterised when the claims of the patent are reproduced in the litigious product.

The protection conferred by SPC No. 97C0050 covers the active ingredient that is the subject-matter of EP No. 0 443 983, i.e. Valsartan, which has been the subject-matter of an MA for the treatment of hypertension, cardiac insufficiency and myocardial post-infarction.

In the present case, it is not challenged that the Valsartan Hydrochlorothiazide Zentiva product is a generic product of Valsartan and that it reproduces the claims of the patent relating to the Valsartan active ingredient. It does not matter that another active ingredient is present in the pharmaceutical product, because this is a mere addition that does not change the features of the claimed active ingredient. Therefore, since the claims of the patent are reproduced, the infringement is sufficiently likely for the measures of Article L. 615-3 to be implemented.

The preliminary injunction measures as well as the measures of recall of the products already marketed must therefore be maintained".
You can read the French decision here and the English translation here.
An appeal can still be lodged against this decision.