Atripla - a combination of issues

Mr Justice Arnold gave his ruling earlier this week in Teva UK Limited & Ors v Merck Sharp & Dohme Corporation [2017] EWHC 539 (Pat).

In brief, Merck Sharp & Dohme (MSD) was granted an SPC for a combination product of  efavirenz, emtricitabine and tenofovir disoproxil fumarate based on EP (UK) 0 582 455 (the product is marketed as Atripla by Bristol-Myers Squibb Co. and Gilead Sciences Inc).  At trial, MSD relied on claim 16 as protecting the product.  Claim 16 reads:

“A combination of the compound of claim 12 or a pharmaceutically acceptable salt thereof with a nucleoside analog having biological activity against HIV reverse transcriptase.”

MSD also previously obtained an SPC for efavirenz based on the same patent.  Teva, Accord and Mylan challenged the validity of the SPC.

Mr Justice Arnold found that the SPC was invalid because it did not comply with either Article 3(a) or Article 3(c) of the SPC Regulation.  More specifically, he found that the scope of protection of claim 16 extended to a combination of efavirenz and tenofovir or a combination of efavirenz and emtricitabine, but not to a combination of all three actives.  He also found that the SPC does not comply with Article 3(c) because claim 16 does not represent a distinct invention from the invention protected by the claims for efavirenz.

Actavis CJEU reference: your chance to comment

Case C-577/13 Actavis Group & Actavis is now well on its way to the Court of Justice of the European Union following a reference of several questions by Mr Justice Birss of the Patents Court, England and Wales (briefly noted on this blog here).  The questions referred look like this:

1. (a) If a patent does not, upon grant, contain a claim that explicitly identifies two active ingredients in combination, but the patent could be amended so as to include such a claim could this patent, whether or not such an amendment is made, be relied upon as a "basic patent in force" for a product comprising those ingredients in combination pursuant to Article 3(a) of Regulation No 469/2006/EC ("the Regulation")?

(b) Can a patent that has been amended after the grant of the patent and either (i) before and / or (ii) after grant of the SPC be relied upon as the "basic patent in force" for the purposes of fulfilling the condition set out in Article 3(a) of the Regulation?

(c) Where an applicant applies for an SPC for a product comprised of active ingredients A and B in circumstances where,

(i) after the date of application for the SPC but before the grant of the SPC, the basic patent in force, being a European Patent (UK) (the "Patent") is amended so as to include a claim which explicitly identifies A and B;

and

(ii) the amendment is deemed, as a matter of national law, always to have had effect from the grant of the Patent; is the applicant for the SPC entitled to rely upon the Patent in its amended form for the purposes of fulfilling the Art 3(a) condition?

2. For the purposes of determining whether the conditions in Article 3 are made out at the date of the application for an SPC for a product comprised of the combination of active ingredients A and B where (i) the basic patent in force includes a claim to a product comprising the combination of active ingredients A and B and (ii) there is already an SPC for a product comprising active ingredient A ("Product X") is it necessary to consider whether the combination of active ingredients A and B is a distinct and separate invention from that of A alone?

3. Where the basic patent in force "protects" pursuant to Article 3(a):

(a) A product comprising active ingredient A ("Product X"); and

(b) A product comprising a combination of active ingredient A and active ingredient B ("Product Y")

and where

(c) An authorisation to place Product X on the market as a medicinal product has been granted;

(d) An SPC has been granted in respect of Product X; and

(e) A separate authorisation to place Product Y on the market as a medicinal product has subsequently been granted,

does the Regulation, in particular Articles 3(c), 3(d) and/or 13(1) of the Regulation preclude the proprietor of the patent being issued with an SPC in respect of Product Y? Alternatively, if an SPC can be granted in respect of Product Y, should its duration be assessed by reference to the grant of the authorisation for Product X or the authorisation for Product Y?

4. If the answer to question 1(a) is in the negative and the answer to question 1(b)(i) is positive and the answer to question 1(b)(ii) is negative, then in circumstances where:

(i) in accordance with Art 7(1) Regulation, an application for an SPC for a product is lodged within six months of the date on which a valid authorisation to place that product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 200l/82/EC;

(ii) following the lodging of the application for the SPC, the competent industrial property office raises a potential objection to the grant of the SPC under Article 3(a) of the Regulation;

(iii) following and in order to meet the aforesaid potential objection by the competent industrial property office, an application to amend the basic patent in force relied upon by the SPC applicant is made and granted;

(iv) upon amendment of the basic patent in force, said amended patent complies with Article 3(a),

does the SPC Regulation prevent the competent industrial property office from applying national procedural provisions to enable (a) suspension of the application for the SPC in order to allow the SPC applicant to apply to amend the basic patent, and (b) recommencement of said application at a later date once the amendment has been granted, the said date of recommencement being

- after six months from the date on which a valid authorisation to place that product on the market as a medicinal product was granted but

- within six months of the date on which the application to amend the basic pate?

If you would like to comment on this case, and thus guide the UK government in its decisions as to whether and how to make representations to the CJEU, please email policy@ipo.gov.uk by the agreeably generous date of 10 January 2014.

Actavis v Boehringer: more questions for the CJEU

There's a double blog-post on the IPKat (here and here) on Actavis v Boehringer [2013] EWHC 2927, a Patents Court, England and Wales, decision from the recently-promoted Mr Justice Birss which was handed down last month but which is still not available in the BAILII databank. The first post gives a brief background and deals with the four further questions that have been referred to the Court of Justice of the European Union for preliminary rulings, while the second deals with an important practical issue: the scope of a cross-undertaking where the alleged infringer has agreed to keep a product covered by the disputed SPC off market pending the full trial.

The IPKat is hosting the full text of this decision for your convenience: you can read it here.

Court of Justice sprints to reasoned order in Case C-422/11

A Court of Justice judge models
his new uniform ...

 The SPC Blog has received today a note from Brian Cordery (Bristows) concerning the Reasoned Order of the Court of Justice of the European Union in Case C-442/11Novartis v Actavis, this being a reference from the Patents Court, England and Wales (Floyd J), noted on this blog here. The Reasoned Order is dated 9 February but was only released to the parties' lawyers at the end of last week.

Brian observes that the operative part of the ruling [which is not yet available on Curia but you can read it in full, here] is as follows:

"Articles 4 and 5 of Regulation ... 469/2009 ...  concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that, where a 'product' consisting of an active ingredient was protected by a basic patent and the holder of that patent was able to rely on the protection conferred by that patent for that 'product' in order to oppose the marketing of a medicinal product containing that active ingredient in combination with one or more other active ingredients, a supplementary protection certificate granted for that 'product' enables its holder, after the basic patent has expired, to oppose the marketing by a third party of a medicinal product containing that product for a use of the 'product', as a medicinal product, which was authorised before that certificate expired."

He adds, and this blogger agrees, that most SPC devotees will not be surprised by this ruling: it appears to be the logical consequence of the recent Court of Justice rulings in Medeva and Georgetown.

One point of interest is how (relatively) speedily the Court of Justice dealt with this reference. Admittedly, it didn't require detailed knowledge of the field of technology and the reference was on an issue on which it has been focusing a good deal in recent times, but the time between the referring court's decision to refer and the Court of Justice's order was little over eight months.

Thanks, Brian, for letting us know!

Court of Justice rulings and combination products: an article

Volume 12, Issue 2 of Lawtext Publishing's Bio-Science Law Review contains an article from Mike Snodin, John Miles and Michael Pears (all of Potter Clarkson’s SPC & Regulatory Group) entitled “Supplementary protection certificates: The CJEU issues its decision in two seminal cases”. This article discusses the Medeva (C-322/10) and Georgetown et al. (C-422/10) decisions, as well as the three further cases decided by reasoned order (Yeda, Daiichi and Queensland). In the article, Mike, John and Michael conclude that likely consequences of the Medeva and Georgetown et al. decisions in the short to medium term will include:

“• National courts will invalidate SPCs to combination products that have been granted on the basis of the ‘infringement test’ but where the active ingredient(s) are not specified in the wording of the claims of the basic patent. 

• More SPC applications will be filed in which the product is defined as one or more (but not all) of the active ingredients present in the authorised medicinal product. 

• Subject to confirmation in Case C-442/11 of the Court of Justice’s comments on point (C) above, national courts will enforce SPCs to single active ingredients against the manufacturers of generic versions of combination products containing a protected active. 

• Generic manufacturers will delay launch of combination products until SPCs to the individual actives have expired (or have been invalidated). 

Further, although it is a point of view that may not be shared by all practitioners, the authors believe that the decisions may not lead to any changes in established practices with regard to the numbers of SPCs granted for basic patents that protect more than one product.”

In relation to the latter issue, the article points to the similarity in wording between the Biogen decision and the Medeva and Georgetown et al. decisions in respect of comments on the number of SPCs that may be granted for each basic patent, and questions whether any change to the status quo was really intended by the Court of Justice on this issue.

The article also discusses possible longer term implications of the decisions, and suggests that further judicial interpretation will be required in order to clarify what is meant by “specified (or identified) in the wording of the claims” - particularly in connection with patent applications that can be argued to “specify” both a novel active ingredient (A) and the combination of that active with another, specific active ingredient (i.e. A+B).

Mike, John and Michael conclude the article by saying:

“Putting aside the issues where there is a need for further clarification, the Medeva and Georgetown et al. decisions should be welcomed by the pharmaceutical and agrochemical industries as representing a carefully balanced approach that rewards genuine innovation with an appropriate degree of protection.”

The points mentioned above are all explained in more detail in the article.

Dawn of a new era? The AG's Opinion in Georgetown and Medeva

"Supplementary Protection Certificates: is a new era beckoning for combination drugs in the EU?" is the title of an article by Michael Pears and Mike Snodin (both of Potter Clarkson) which has recently been published in Scrip Regulatory Affairs. This article, which considers the effects of Advocate General Trstenjak's Opinion in Joined Cases C-422/10 Georgetown University and C-322/10 Medeva,  concludes with the following observations.

"Although the Advocate General seems to be ruling out an infringement test to establish whether a product is protected by a basic patent under Article 3(a), the precise test to be used remains unclear. At least some form of disclosure of each active ingredient of a product appears to be necessary, but how specific this must be is not known.

What is clear from the opinion, however, is the proposal for SPCs to be obtained for a patented part of authorised products containing a combination of active ingredients. In reaching this conclusion, the advocate general has obviously recognised the importance of providing SPC protection for active ingredients which are first authorised in combination with other active ingredients.

If the CJEU follows the opinion, the narrow interpretation of what is “protected” by a basic patent may mean that some granted SPCs are invalid. On the other hand, the more permissive interpretation of what represents a valid authorisation could provide new opportunities for obtaining useful (and very broad) SPC protection.

Overall, the above-mentioned aspects of the A-G’s opinion provide what seems to be a workable approach for obtaining SPC protection for combination products.

While the facts of the Medeva and Georgetown et al cases relate to combination vaccines, the issues apply equally to other areas of human and veterinary medicine and also in agriculture. Indeed, an increasing trend to authorise medicines and plant protection products in combination suggests that the Court’s decision may have far-reaching consequences. The final judgement will therefore be eagerly anticipated".

You can read this article in full here.

Losartan and HCTZ: now it's the turn of the French Cour d'appel

The Cour d'appel de Paris

The SPC Blog is grateful to Laëtitia Bénard (Partner, Allen & Overy LLP, Paris) for sending The SPC Blog some information concerning recent litigation before the Cour d'appel de Paris on 15 March 2011 in which that court ruled on Mylan's appeal against the order of the Tribunal de Grande Instance de Paris of 12 February 2010.  That earlier order had previously prohibited Mylan from launching a generic product containing Losartan and HCTZ on the basis of EI Du Pont de Nemours' SPC for Losartan (the first instance decision has previously been noted on The SPC Blog). For full disclosure, Laëtitia reminds readers that her firm acted as counsel to E.I. Du Pont de Nemours and Merck in this case.

The case, in short, is summarised as follows:

Du Pont - Merck v Mylan: the Paris Court of Appeals confirms that combination products infringe mono-SPCs and sets a precedent on the requirements for obtaining a paediatric extension 

Mylan and Qualimed had lodged an appeal against the preliminary injunction rendered on 12 February 2010, enjoining them, on the basis of Du Pont's SPC granted for Losartan as extended by a paediatric extension, from marketing a generic drug comprising Losartan and HCTZ. The appeal essentially rested on two grounds: 

(i) the appellants alleged that the owner of an SPC must file, along with his initial application for a paediatric extension, all "paediatric" (varied) marketing authorisations for each of the 27 Member States of the European Union, without a possibility to supplement the file at a later stage and
(ii) the appellants argued that a combination product does not infringe the SPC granted for one of the active ingredients of the combination. 

The Court of Appeals dismissed both arguments, and confirmed the first instance injunction. 

1. As far as the validity of the SPC is concerned, the Court first noted (in line with an earlier decision of the Dutch Patent Office of 2 June 2009) that it would place an undue burden on owners of SPCs to require them to provide all 27 "paediatric" marketing authorisations along with the application for paediatric extension: 

"This provision [Article 36 of the SPC Regulation], which only mentions the fact that the product must be authorised, does not specify that, at the date of the filing of the application, all the paediatric MAs must have been granted. Indeed, requiring the filing of the 27 paediatric MAs on the day of the filing of the application is in practice not possible in the absence of a centralised registration procedure and due to the variable speediness of the different agencies in charge of granting these authorisations." 

The Court went on to decide, in conformity with the practice of the French patent office, that the applicant for a paediatric extension must only prove that the product has been authorised in all 27 Member States, i.e. provide the initial ("non-paediatric") marketing authorisations: 

"The provision can only refer to the requirement to provide the initial MAs, while the paediatric MAs can be provided during the course of the granting procedure of the extension. It should be mentioned in this respect that this position has eventually been adopted by the INPI, as confirmed by the circular letter of the pharmaceutical industry trade union dated 7 January 2011. 

Du Pont filed its application for an extension on 27 February 2009 and the copies of the MAs for all other Member States were enclosed. Consequently, the procedure is lawful and the extension granted further to this application is not to be nullified."

2. The Court further confirmed, as also recently ruled by the President of the Paris First Instance Court in Novartis v Actavis (Valsartan), that an SPC covering a compound (Losartan in the present case) obviously prohibits the marketing of pharmaceutical products containing Losartan alone or in combination with another active ingredient. 

In this respect, the Court first referred to the basic principles of patent law: 

"It should be remembered that, under French law, infringement is assessed according to resemblances and not differences only, such that the inclusion of additional features to those claimed in a patent does not put an end to the infringement." 

It also analysed the purpose of SPCs: 

"An SPC, which aims at supporting innovation in the field of health, grants a protection to a product as a medicament under all the forms that fall within the protection of the basic patent." 

The Court concluded from this that: 

"Consequently, in the case at hand, the certificate which has been extended grants the same rights as those of the basic patent covering losartan, and the protection granted by this certificate concerns the product covered by the MA for any use of this product as a medicament that has been authorised prior to the expiry of the certificate. Consequently, the protection encompasses any use of losartan as a medicament." 

The Court also specifically addressed the appellants' argument based on the fact that the claimants had also been the owners of a (then-expired) SPC specifically covering the combination product (Losartan and HCTZ°). In this regard, the Court followed a classical intellectual property reasoning, and held that

"The existence of another SPC whose protection is expired is irrelevant in the case at hand." 

A further appeal to the Supreme Court is still possible".

The authentic French version of the decision can be read here.  The English translation can be read here.

The Daiichi questions -- now on Curia

Another of the references for a preliminary ruling by the Patents Court (England and Wales) is now on the Curia website. This is Case C-6/11 Daiichi Sankyo Company v Comptroller-General of Patents (there's some background here and here on The SPC Blog).  The questions referred for rulings by the Court of Justice of the European Union are as follows:

1. Regulation 469/2009 (the Regulation) 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 absence of Community harmonisation of patent law, what is meant in Article 3(a) of the Regulation 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 Art 3(a) of the Regulation and, if so, what are those further or different criteria? 

In order for a combination of active ingredients cited in an authorisation for placing a medicinal product on the market to be the subject of an SPC, and having regard to the wording to Article 4 of the Regulation, is the condition that the product be "protected by a basic patent" within the meaning of Articles 1 and 3 of the Regulation satisfied if the product infringes the basic patent under national law? 

In order for a combination of active ingredients cited in an authorisation for placing a medicinal product on the market to be the subject of an SPC, and having regard to the wording to Article 4 of the Regulation, does satisfaction of the condition that the product be "protected by a basic patent" within the meaning of Articles 1 and 3 of the Regulation depend upon whether the basic patent contains one (or more) claims which specifically mention a combination of (1) a class of compounds which includes one of the active ingredients in the said product and (2) a class of further active ingredients which may be unspecified but which includes the other active ingredient in the said product; or is it sufficient that the basic patent contains one (or more) claims which (1) claim a class of compounds which includes one of the active ingredients in the said product and (2) use specific language which as a matter of national law extends the scope of protection to include the presence of further other unspecified active ingredients including the other active ingredient in the said product?

The SPC Blog once again thanks the eagle-eyed Michèle Lavé (Cabinet Michèle Lavé) for letting us know.

The missing Daiichi judgment, now available

The SPC Blog's trained trackers will do their
best to hunt down missing decisions!

An email from Cabinet Michèle Lavé sparked off a bit of borrowing around this weekend from The SPC Blog team.  Michèle wrote:

"I read your post [here] dated Monday, 6 December 2010 relating to the decision EWHC 2898 (Pat) of 5 November 2010. Now, when reading the full text of this decision I noticed the following sentence "This is an application by Novartis AG to be joined as a party into the appeal brought by Daiichi and in respect of which I have given a judgment earlier this afternoon". The 6 December 2010 post says among other things "While Daiichi's SPC application was turned down as being non-compliant with Article 3(a), the court proposed to refer questions to the Court of Justice for a preliminary ruling on the interpretation of that article." I was unable to find this decision on the BAILII website.

Do you know where and how I can catch the decision dealing with the appeal by Daiichi?"

A little bit of digging has revealed the decision, which is still not on BAILII -- but we've uploaded it here.  Thanks, Michèle, for spotting that we still hadn't picked it up!

What's Brown, Curley and writes about Pandora's Box?

"Reflections on the Erbitux® decision: Combination Products, Combination Therapies and SPCs" is the title of a Case Comment published today in Lawtext's bimonthly Bio-Science Law Review (volume 11, issue 2, at p.54).  The authors are Chartered Patent Attorney and European Patent Attorney Andrew Brown together with Duncan Curley (Solicitor and Director, Innovate Legal).  The BioSLR has kindly allowed The SPC Blog to make this note available to its readers here.  More details of the journal can be found here.

The authors conclude as follows:

"The preamble to the SPC Regulation contains the following recital (10), which states that:

All the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector should … be taken into account. For this purpose, the certificate cannot be granted for a period exceeding five years. The protection granted should furthermore be strictly confined to the product which obtained authorisation to be placed on the market as a medicinal product.

The SPC Regulation thus seems to envisage a narrow scope of protection for SPCs, once they have been granted. But in his Erbitux® judgment, Lewison J seems to have used this reference in the preamble to justify a restrictive interpretation of the SPC Regulation when assessing eligibility, rather than the scope of protection. This is consistent with other judgments by the English courts, which have to date required correspondence between the product claimed in a basic patent as an active ingredient and the same product as an authorised medicinal product, before granting an SPC. Yet some active ingredients (such as cetuximab) are only ever authorised for use in combination therapies. In the field of biological medicines and in particular mAbs, by the time that an SPC can be applied for, there may no longer be a patent directly claiming the product itself, given the long development times of these products. A restrictive interpretation of the SPC Regulation (as seen in the Erbitux® decision) may exclude such valuable medicines from the possibility of supplementary protection in the future. Should then SPCs based upon the way in which a product is used be allowed (assuming that the granted patent protects, directly or indirectly, such use)? Whilst it is still possible for the ‘infringement’ test to prevail (given the Medeva reference), the answer to this question remains an open one. However, if a further development in the law was to allow SPCs to be granted on this basis, it will open up some further difficult questions, such as what happens when the use of the product

is changed after the initial marketing authorisation is granted, and how the issue of infringement of a certificate is to be resolved for any generic/biosimilar version of a product (given that the argument will be entirely about the question of indirect infringement). The SPC Regulation was drafted and introduced in the early 1990s, at a time when vertically integrated pharmaceutical companies relied upon novel chemistry, small molecule blockbuster products and patents to earn their revenues.

Will the ECJ open the box?

Today, the industry landscape has changed with the advent of biologics. Whilst it is interesting to observe that the English Court of Appeal has referred to the Court of Justice what is essentially a question of policy underlying the SPC Regulation (namely, whether there should be a stand-alone test for multi-diseases vaccines, in order to determine whether a product is protected by a basic patent in Article 3(a) of the SPC Regulation), we doubt whether the European Court will want to open Pandora’s box, by carving out exceptions to the SPC Regulation for novel products and treatments such as vaccines, combination therapies and even chemically-modified small molecules with improved pharmaceutical properties.8 For radical change of this kind, we suggest that there will need to be a more fundamental reform of the patent extension legislation for medicinal products in the EU.

See also The SPC Blog here.

"No, no, Novartis", says court, you can't join in!

Daiichi Sankyo Co Ltd v Comptroller General of Patents [2010] EWHC 2898 (Pat) is a decision of Mr Justice Floyd (Patents Court, England and Wales) almost exactly a month ago, on 5 November. Perhaps because it is a small decision and was not made available on BAILII, it slipped past The SPC Blog, which thanks Mr Justice Arnold for pointing out that the decision has remained unnoticed on the blogosphere.

Under Article 3(a) of Regulation 469/2009

"A certificate shall be granted if, ...

(a) the product is protected by a basic patent in force".

This was an application by Novartis, under the Civil Procedure Rules (CPR) r.19.2(2)(a), for an order that it be joined as a party to proceedings in which questions were to be referred to the Court of Justice of the Euroepan Union on the interpretation of Article 3(a) of Regulation 469/2009. Under r.19

""The court may order a person to be added as a new party if -
"(a) it is desirable to add the new party so that the court can resolve all the matters in dispute in the proceedings; or
"(b) there is an issue involving the new party and an existing party which is connected to the matters in dispute in the proceedings, and it is desirable to add the new party so that the court can resolve that issue".

What had happened here is that Daiichi had appealed against the Comptroller's decision to refuse to grant an SPC in relation to a combination of olmesartan medoxomil and hydrochlorothiazide (olmesartan medoxomil being one of a range of compounds disclosed in one of Daiichi's European patents, while the diuretic hydrochlorothiazide was used as an anti-hypertensive agent but was not one of the claimed agents).  While Daiichi's SPC application was turned down as being non-compliant with Article 3(a), the court proposed to refer questions to the Court of Justice for a preliminary ruling on the interpretation of that article.

What, then, was Novartis's interest? Teva was suing Novartis in Italy, Belgium and the Netherlands, alleging that Novarrtis's SPC for a combination of Valsartan and hydrochlorothiazide was invalid since the product in question was not protected by the basic patent -- thus also raising a question under Article 3(a). There were also proceedings in Belgium in which it was argued that a generic combination product could not infringe the SPC for Valsartan alone.  According to Novartis, therefore, that any judgment on the reference which was to be made in Daiichi's case would be of direct relevance at least to some of the proceedings which it faced, and joining Novartis would bring "a new perspective" to these proceedings.

Mr Justice Floyd rejected the application, having concluded that it was not appropriate to join Novartis as a party since the requirements of CPR.19.2(2)(a) were not satisfied. It could not be said that, with the presence of the existing parties, the matters in dispute in the present proceedings could not be adequately and properly resolved and Novartis had failed to show that its involvement was needed in order to assist either the Patents Court or the Court of Justice to reach a conclusion.

The judge added that Novartis's interest was solely in the outcome of a question of law, on which submissions would be made both by Daiichi and by the Comptroller.  Adding extra parties would not have any beneficial effect.

AB Hässle combination product case: informal translation available

Niklas Mattsson (European Patent Attorney and Swedish Authorized IP Attorney, Awapatent AB) has kindly written to The SPC Blog as follows:

"Listed on your Resources website is a pretty interesting Swedish case, AB Hässle, which is cited in the UK Takeda case and provides the same reasoning with regard to the question of whether a combination product is covered by a basic patent relating to only one of the components. The question of course is highly interesting in light of the Medeva ECJ referral.

In connection with some casework relating to the same issue some years ago, I had occasion to prepare an informal, translation of the Swedish decision into English. If you would like to post it to the Resources web site, you’re more than welcome to use it, in the interest of “promoting the dissemination of legal information".

The SPC Blog thanks Niklas very much for his thoughtfulness and hopes that other readers, when the opportunity arises, will be able to promote knowledge and understanding in our field of interest in the same way.

The translation can be read here and will soon be posted on the Resources site too.

French say "non" to olmesartan medoxomil and hydrochlorothiazide combination

Thank you, Alice de Pastors, for supplying The SPC Blog with a copy of the decision of the Cour d’appel de Paris, pôle 5, 2e ch., 6 novembre 2009 (here) in which that court dismissed the appeal of Daiichi Sankyo against the decision of the Director-General of the French Patent Office (INPI) on 13 February 2009 to reject French SPC 06C0019.

Daiichi Sankyo's 06C0019 SPC application was for an olmesartan medoxomil and hydrochlorothiazide combination, referring to EP0503785 patent and to the MA CIS 66838901 of 6 February 2006 relating to this combination and marketed as Colmetec®.
The Cour d'appel de Paris dismissed Daiichi Sankyo's appeal because it was not possible to get an SPC for the Olmesartan Medoxomil and Hydrochlorothiazide combination, as this combination was not protected by the patent.

The Cour d’appel de Paris added that the EP0503785 patent covered only Olmesartan Medoxomil and not the combination; SPC 03C0037 for Olmesartan Medoxomil was granted on 11 February 2005, referring to this patent and to MA NL No. 28,292, issued on 6 August 2003.

Astellas appeal dismissed, with no reference to ECJ

Mr Justice Arnold has just given his ruling this morning in Astellas Pharma Inc v Comptroller-General of Patents [2009] EWHC 1916 (Pat), an appeal against the decision of the Intellectual Property Office, United Kingdom. At the time of writing this post, the decision has not yet been added to the decisions freely available on the BAILII website, but you can read it in full here.

Arnold J dismissed the appeal, considering the hearing officer's decision to be correct. He did not feel that this was a matter that was appropriate to refer to the Court of Justice of the European Communities for a preliminary ruling:

31. ... Astellas contends that Takeda was wrongly decided and that the correct test to apply under Article 3(a) of the Regulation is the infringement test.

32. Counsel for Astellas supported the five reasons given by Kitchin J in Gilead [see SPC Blog here] for questioning the correctness of Takeda. In particular, he submitted that Takeda is inconsistent with the ECJ’s ruling on the second question in Farmitalia that to determine whether a product is protected by a basic patent reference must be made to the national law governing the patent. He argued that this must mean determining whether the product falls within the scope of protection of the patent in accordance with section 125 of the Patents Act 1977 and Article 69, and the Protocol on the Interpretation of Article 69, of the European Patents Convention. He also submitted that, in the light of Kitchin J’s judgment, it could not be said that it was acte clair that the infringement test was wrong and that this question should be referred to the ECJ.

33. Counsel for the Comptroller submitted that none of the five points identified by Kitchin J justified the conclusion that the infringement test was the right test. In particular, she submitted that there is a distinction between the scope of protection of a patent and infringement: the scope of protection is limited to that specified in the relevant claim properly construed, whereas infringement is not so limited. A product which includes all the elements of the claim infringes, but so does a product which also includes additional elements which are not specified in the claim at all. Accordingly, she argued, it is the scope of protection which matters, not whether a product infringes. She also submitted that consideration of the Opinion of Advocate General Fennelly in Farmitalia leads to the conclusion that the ECJ rejected the infringement test in that case. Finally, she submitted that the matter remained acte clair. She acknowledged, however, that it is the Comptroller’s understanding that at least one Member State of the Community, namely Norway, applies the infringement test.

34. I am not convinced that Takeda is wrong. To my mind, Jacob J’s reasoning remains persuasive. Furthermore, I agree that there is a distinction between the scope of protection and the question of infringement. As to Farmitalia, it is not clear to me that the ECJ either endorsed or rejected the infringement test in that case. Nevertheless, I agree with Kitchin J that there are arguments in favour of the infringement test which do not appear to have been considered in Takeda and which merit consideration by a higher court and perhaps the ECJ.

35. I have considered whether it is appropriate to refer this question to the ECJ. If I were confident that the Court of Appeal would refer it, I would avoid delay by making a reference now. I am not confident that the Court of Appeal will refer it, however. I conclude that the decision whether to refer should be left to that Court.

On the same basis, Arnold J decided not to to refer a question about the correct treatment of applications for SPCs for combination products to the ECJ.

The SPC Blog's note on the original decision can be read here.

Profender SPC (UK)

Astellas Pharma Inc's application, another decision on an SPC application on a combination product was handed down by the UK's IPO recently, where the Takeda decision was followed.

In the case in question, a combination of active ingredients emodepside and praziquantel, marketed under the trade mark Profender, was the subject of supplementary protection certificate (SPC) application number SPC/GB/06/002. The marketing authorisation on which this application was based was for the combination product emodepside and praziquantel. However, the patent on which the application was based clearly disclosed the active ingredient emodepside but provided no indication, specific or generic, of the other active ingredient praziquantel.

The Examiner refused the application on the grounds that the product, Profender, was not covered by the basic patent. Moreover, the Examiner had issues with the applicant's request to change the product definition to read "a product comprising Emodepside." Particularly, a product defined with reference to Emodepside alone would require a corresponding authorisation for Emodepside alone to satisfy Article 3(b).

In his decision, Lawrence Cullen, acting for the Comptroller, considered the case law on the interpretation of Art. 3(a) to determine what is "protected" and felt obliged to follow the decision in Takeda Chemical Industries Ltd's SPC Applications (No 3) [2004] RPC 3, and distinguished Gilead's SPC application [2008] EWHC 1902 (Pat) because in that case the patent included a claim for the patented compound in a carrier and "optionally other therapeutic ingredients". In this case there was no equivalent broad composition claim. The product, Profender was not protected by the designated basic patent for the purposes of satisfying Art. 3(a) of EC Regulation 1768/92.

In addition, the request by the applicant to change the product definition to read “A product comprising Emodepside” was found to be contrary to Article 3(b) of the Regulation. Article 1(b) of the Regulation dictates that the authorised combination of emodepside and praziquantel is a different product from emodepside alone. Therefore, the proposed product was not authorised and Article 3(b) was not complied with.

An appeal may be lodged by the applicant within 28 days of the decision, and we understand that it is likely that this will happen.