Sumitomo CJEU reference: some further information

The EU Law Radar weblog carries a helpful note on Case C-210/12 Sumitomo Chermical, which has recently been referred to the Court of Justice of the European Union.  An extract of this note is reproduced here, with permission.

Case C-210/12, Sumitomo Chemical – insecticide and an SPC application 

Posted on 21 June 2012 

Can a supplementary protection certificate for a plant protection product be issued to a company when the application is made after an earlier marketing authorisation has expired?

Facts
In this case involving Sumitomo Chemical, the claimant holds patents for an insecticide with Clothianidine as an active substance (European Patent EP 0 376 279 covering Guanidine derivatives, their production and insecticides; and German patent DE 689 06 668). The claimant had applied for its European Patent on 27 December 1989 so the claimant was now seeking to gain a supplementary protection certificate for the plant protection products known as ‘Poncho Pro’, which contains Clothianidine.

The dispute relates to the fact that on 14 May 2004 the claimant’s legal predecessor sought a plant protection product certificate from the German Patent and Trade Mark Office. The application was supported by reference to a decision of Germany’s Federal Office of Consumer Protection and Food Safety. The authority had issued an authorisation in December 2003 to Bayer CropScience for the latter’s product ‘Poncho Pro’, that contains Clothianidine as an active substance.

Whilst the German Patent and Trade Mark Office was reaching its decision in respect of the claimant’s application, other events were taking place. On 8 September 2004, Germany’s Federal Office of Consumer Protection and Food Safety granted Bayer a provisional authorisation valid for the active substance of Clothianidine – its decision being based on Article 8(1) of Directive 91/414. This provisional authorisation was valid for 3 years until 7 September 2007, an authorisation which later became definitive by dint of a decision taken in June 2007.

Learning of the initial provisional authorisation granted in 2004, the claimant’s legal predecessor informed the German Patent and Trade Mark Office of this development. Time passed. In January 2006, a year and a half after the claimant’s legal predecessor had applied for a plant protection product certificate, the German Patent and Trade Mark Office decided to turn down the application. The reason given for the refusal was that the authorisation which enabled Poncho Pro to be put on the German market had been rather a special one. It had been an emergency authorisation granted in accordance with Article 8(4) of Directive 91/414. The Directive’s provision allows for a limited use of a plant protection substance where this appears necessary because of an unforeseeable danger that cannot be contained by other means. As such, the authorisation had run for only 120 days covering the period from 15 January 2004 until 13 May 2004. Since the claimant’s application had been made on the 14 May 2004, the day after the expiry, a plant protection product certificate could not be granted because the phytosanitary certificate could not be considered to be ‘in force’ for the purposes of Article 3(1)(b) of EC Regulation 1610/96.

The claimant’s legal predecessor launched an appeal against the decision of the German Patent and Trade Mark Office. And it sought to revoke the Office’s decision to grant an emergency certificate to Bayer. In turn, Bayer launched two appeals against the German Patent and Trade Mark Office’s decisions which refused to grant subsequent certificates – even though the company had been granted both provisional and definitive authorisations from Germany’s Federal Office of Consumer Protection and Food Safety.

Questions Referred 

According to the UK IPO website, the German Federal Patent Court asked: 

1. Is Article 3(1)(b) of Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products to be interpreted as not precluding the grant of a supplementary protection certificate for a plant protection product if a valid marketing authorisation was granted in accordance with Article 8(4) of Directive 91/414/EEC? 

2. If Question 1 is answered in the affirmative: is it necessary under Article 3(1)(b) of Regulation (EC) No 1610/96 for the marketing authorisation to be still in force at the time of application for the Certificate? 

3. If the answer to Question 1 is in the negative: is Article 7(1) of Regulation (EC) No 1610/96 to be interpreted as meaning that an application can be lodged even before the period mentioned in that provision starts to run?

UK asks: should IPO Opinions service cover SPCs?

Last week the UK's Intellectual Property Office announced a consultation on plans to expand its excellent and badly under-used (and non-binding) Patent Opinions service. Surprisingly, this consultation was aimed at the SPC community too.  The proposals are rolled in together with proposals for the SME-directed Mediation Service, which is a little confusing, not least because only half as much time has been allocated for consultation on mediations.  Anyway, according to the information available:

"The Intellectual Property Office (IPO) ... set out proposals to expand its Patent Opinions Service and is seeking views from business on how to improve its Mediation Service.

The Government is committed to providing SMEs with the economic environment and framework they need to grow. The Hargreaves Review identified a number of barriers facing SMEs trying to making the most of their Intellectual Property. One of these was the cost of managing IP, in particular resolving disputes surrounding the enforcement of their own IP rights and defending themselves against allegations of infringement made by others.

...  The IPO’s Patent Opinions Service allows individuals or companies to request an opinion on the validity or infringement of a patent and is well used. A review of this service demonstrated a high desire from users for expansion of the service to aid resolution of further patent disputes. Government is now consulting on the following proposal:

• expanding the questions relating to patent validity that can be the subject of an opinion; 

• expanding the service to offer opinions as to whether a Supplementary Protection Certificate ('SPC') is valid or is infringed; 

• giving the IPO the power to consider revoking a patent following issue of an opinion which concludes it is invalid.

The IPO provides a Mediation Service to any parties involved in an IP dispute who wish to resolve matters without resorting to the Courts. However, uptake of this service is low and the IPO is therefore seeking comments and supporting evidence from key stakeholders and IP right holders on the reasons for this. This will be used to determine what service, if any, the IPO should be offering to support speedier and lower cost dispute resolution".

The Patent Opinions Service consultation will run for 12 weeks and concludes on 4 September 2012. Please send your comments here.

Thank you, John Miles (Potter Clarkson), for the link.

Telmisartan combination: the Cour d'appel de Paris rules

SPC Blog reader Edouard Kling and his colleague François Pochart (august & debouzy avocats , Paris) have let us have sight of another "sartan" ruling, this one being particularly significant in that it is the first post-Medeva decision in France to decide on SPC for combination products. They write:

"In its ruling dated Friday 8 June, the Court of Appeal of Paris confirmed the rejection of the SPC application 02C0028 directed to the combination product Telmisartan + HCTZ. The basic European patent EP 502 314 did not claim the combination product but the specification disclosed a list of additional compounds to be used in combination with Telmisartan.

Of note, Boehringer had applied for a limitation of the French part of the basic patent to enter HCTZ into the claims and comply with Medeva. However, the limitation was rejected only a few days before the hearings. As a matter of procedural law, the court disregarded the request for the stay of the proceedings, pending the appeal proceedings against the limitation and ruled:

“It is common ground, as the Director of the INPI (French National Intellectual Property Institute) points out, that the Court, ruling on the appeal, is required to evaluate the facts on the date the decision is handed down, so that proceedings that are brought subsequently to the issuance of the disputed decision have no impact on the dispute for which the court was seized.

Moreover, the outcome of the late patent limitation request will not influence the resolution of the dispute, in so far as Boehringer requests, as the Director of the INPI points out, that the Court “attributes to claim 9 (as granted) the appropriate scope, namely that in light of the description of the basic patent, the term medicament indeed protects a combination of active ingredients Telmisartan – Hydrochlorothiazide” (paragraphs 56 et seq. of its submissions); 

No ground derived from the proper administration of justice requires, consequently, that the examination of this appeal be postponed further;”

This issue of limitation may be related to a previous decision dated 7 September 2011 where the court considered that a combination product was concerned with a different subject matter than the mono product and could not be construed as a mere limitation. The decision is attached.

Therefore, the Court turned to the claims as granted and logically rejected the SPC. Nevertheless, the judge did provide some elements that may be used in view of Medeva and remaining issues of clarity.

“Whereas, however, it is in vain that the claimant supports that the terms of claim 9 of the basic patent prevail;

Indeed, said patent is concerned with Benzomidazoles, being the subject matter of claims 1 to 7 referred to in claim 9: that, contrary to Hydrochlorothiazide, only Telmisartan is protected by the patent claims, the Director of the INPI specifying, without being challenged, that Benzomidazoles works on the contraction of blood vessels whereas Hydrochlorothiazide has diuretic effects; even if claim 9 mentions the use of a compound for the preparation of a medicament, it does not refer in any way to a combination with an active ingredient such as Hydrochlorothiazide;

Moreover, the interpretation that it contemplates for the condition laid out in paragraph a) for it to be ruled that the scope of the basic patent must be determined by taking into account not only the actual claims but also the description of the patent could not be based on Article 69 paragraph 1 of the European Patent Convention which only attributes to the description of the patent the function of interpreting the claims; …

If the description of the patent considers, in hypothetical terms, a combination with active ingredients such as Hydrochlorothiazide, the protection of the combination of those two ingredients which is not the subject matter of a claim, would not allow the reasonable degree of legal certainty to be provided to third parties, within the meaning of this text;

Lastly, despite the positions that were adopted by the authors or despite previous decisions, the Court of Justice of the European Union, which intends to harmonize Member States’ rights and refers to different European texts that corroborate this approach (point 27), ruled, in a decision issued on 24 November 2011 (Medeva BV v Controller General of Patents, Designs and Trade Marks):

-that “it should be recalled that Article 5 of Regulation No 469/2009 provides that any SPC confers the same rights as conferred by the basic patent and is subject to the same limitations and the same obligations. It follows that Article 3(a) of the regulation precludes the grant of a SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent” (point 25),

-and, in response to the preliminary ruling that were put forward to the Court, “Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the SPC for medicinal products 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”. 

Whereas, regarding the difference in treatment also mentioned by Boehringer, the content of the preliminary ruling put to the CJEU in the previously mentioned decision by the High Court of Justice (England & Wales), Chancery Division (Patent Court) (point 17) as well as the grounds for this decision (point 20 et seq.), all noting that there are dissenting positions in the States and a will towards harmonization, contradict the claimant assertions according to which the INPI would have rendered a decision which is contrary to the unanimity of the European Offices and that INPI could not rely upon different conditions of Examination according to the Offices; 

It follows that none of the arguments invoked by Boehringer to support the appeal are valid and that therefore such claim should be dismissed”.

The text of the judgment has been kindly provided and can be read here. Edouard and François hope to be able to provide us with a full translation in due course.

Daiichi in the CJEU: a note on the hearing

Constantinos Kilimiris (Patrinos & Kilimiris, Athens) has written to draw attention to our previous post here on the SPC blog and here on the IPKat blog regarding the Court of Justice of the European Union (CJEU) Case C-414/11 Daiichi Sankyo Co. Ltd, which his firm is handling on behalf of Daiichi.

Constantinos has kindly provided us with this short report of the CJEU's hearing of this case, which his firm attended together with Herbert Smith, on behalf of Daiichi. He reminds us that this the first case regarding the interpretative jurisdiction of the CJEU on the provisions of TRIPS after the Lisbon Treaty. Present at the hearing were representatives of no fewer than eight Member States and the European Commission. The Advocate General's Opinion is pencilled in for 15 November 2012 and the CJEU's decision is expected some time in 2013.

Sumitomo plant protection reference: it's all a question of timing

Case C-210/12 Sumitomo Chemical is a reference for a preliminary ruling from the Court of Justice of the European Union. The referring court is the German Bundespatentgericht, which wishes to obtain the guidance of the CJEU on the following questions relating to SPCs for plant protection products:

"1. Is Article 3(1)(b) of Regulation (EC) No 1610/96 ... concerning the creation of a supplementary protection certificate for plant protection products to be interpreted as not precluding the grant of a supplementary protection certificate for a plant protection product if a valid marketing authorisation was granted in accordance with Article 8(4) of Directive 91/414/EEC?

2. If Question 1 is answered in the affirmative:

Is it necessary under Article 3(1)(b) of Regulation (EC) No 1610/96 for the marketing authorisation to be still in force at the time of application for the Certificate?

3. If the answer to Question 1 is in the negative:

Is Article 7(1) of Regulation (EC) No 1610/96 to be interpreted as meaning that an application can be lodged even before the period mentioned in that provision starts to run?"

If you have any comments on this reference which you would like to share with the British government, you are invited to email policy@ipo.gsi.gov.uk before 22 June 2012 -- that's this Friday.

If you have any interesting background information concerning this reference, do feel free to share it with us!

The SPC blog Seminar 2012 - the slides and video

The 2012 SPC blog seminar held at the end of May was the usual heady mixture of clarity and uncertainty, as the 85 attendees and 5 speakers reviewed a wide range of current and future issues across Europe and, unusually, the position on patent term extension overseas.

As Chairman I suggested that, in light of Medeva and the AG's opinion in Neurim, all outstanding issues in this field were now resolved and there was no need for the blog or any future seminar. But I could be wrong….

First, Dolores Cassidy from the Irish Patents Office gave her view on the fall out from Medeva. Whilst the issue around the meaning of the phrase "specified" or "identified " in the claim is still to be decided, Dolores pointed out that a Markush formula in the claims could cover a small or vast range of compounds, so even for this type of claim format the answer may be case specific.  We'll see what the CJEU decides in due course…

Micaela Modiano from Modiano and Partners reviewed the development of SPC law in Italy, reflecting on the complications of the "old" Italian SPCs and the laws that govern when generic companies may apply for marketing approval. I was personally relieved only to have to advise on the issues under UK law after hearing the saga unfold.

Hugh Goodfellow from Carpmaels and Ransford, reprising his role from last year, discussed the ramifications of the AG's opinion in Neurim. In response to some detailed questions, Hugh pointed out that the EPO and national patent offices, as gatekeepers for granting patents, play a key role in ensuring that obvious developments could not be the subject of life cycle management SPC strategies.

Jean-Frederick Gaultier from Clifford Chance (although now recently moved to Olswang LLP) explained the references to SPC protection in the proposal for the centralized European patent court. Issues remain: it appears that SPCs granted on national patents will be handled by national courts and SPCs granted on European and community patents will be handled by the proposed community court.  How will that work in reality?

Finally, the inaugural patent term extension quiz was unveiled. I am aware of at least one score of 9 out 10 (multiple choice), but the real win was the access to materials on PTE from multiple countries, for which this blog expresses thanks to all who helped us: Griffith Hack (Australia), Gorodissky (Russia); Luzzatto and Luzzatto (Israel); Kim and Chang (S. Korea); Saint Island Patent and Law (Taiwan); LeClair Ryan (US); Cantab IP (Singapore); Shiga International (Japan).  This blog may try, over time and where possible, to compare the various PTE provisions across the world to see how the European SPC matches up!

Please click here for the slides, below for links to the videos of the day and here for some supporting materials from outside the EU on patent term extension.

Video Links:

Introduction
Delores
Michaela
Hugh
Jean-Frederick
PTE Quiz
Questions

Latest News on Medicinal Product SPCs: Alice de Pastors' report

With The SPC Blog's seminar almost upon us, here's a link to "Latest News on Medicinal Product SPCs in Europe", this being the 26th issue of Alice de Pastors' SPC News. It contains nine pages of fascinating data, enriched with colourful tables.

Thanks, Alice, for sharing all your hard work with us!

Pharma summer school covers SPCs, extensions

"Pharmaceutical Law and Policy -- Hot Topics shaping the Future of the European Pharmaceutical Industry" is the title of a five-day course, from 13 to 17 August, in the University of Copenhagen's 'Copenhagen Summer University'.  

What are the most significant current issues shaking and shaping today's pharmaceutical industry? The business environment and legal framework pertaining to the pharmaceutical industry continue to change rapidly as they are constantly challenged by competition, politics and new technological possibilities. Considering the highly lucrative and competitive nature of the industry, it is more important than ever for professionals working with legal and regulatory aspects of drug development to stay abreast of the most recent developments. 

This course provides a broad and practical understanding of the "hot topics", and will present and analyse these topics from a scientific, legal and policy perspectives. The hot topics are:

• Scientific trends - Scientific breakthroughs that impact the pharmaceutical industry and create new business opportunities

• Biosimilars & Antibodies - New approval pathways, guidelines & regulatory requirements

• Data & market exclusivities - Legislation and political debates

• Individualized medicine - Threats, challenges and opportunities

• New markets - How to deal with the emerging Asian markets?

• Clinical trials - New challenges posed by increasing international competition

• Patents & competition law - Recent pharma-related case law

• Paediatric extensions & SPCs - New developments & case law

• Public Private Partnerships (PPPs) - An increasingly important model of co-operation

• Counterfeit Medicines - Buying and selling pharmaceuticals in cyberspace beyond established quality control systems?

Full details of the programme and registration are available here. The deadline for registration is 29 May.

Medeva: the final chapter in the UK

First, thanks to all those kind readers who sent copies of the final judgment of Medeva to us yesterday; we now have the link, too: it's here and the citation is Medeva BV v Comptroller General of Patents [2012] EWCA Civ 523. In this ruling the Court of Appeal for England and Wales (the Chancellor -- Sir Andrew Morritt, Lords Justices Etherton and Elias) applied the now-familiar preliminary ruling of the Court of Justice of the European Union (CJEU) in Case C-322/10 Medeva and dismissed the appeal.

To recap for new readers of The SPC Blog, Medeva had filed five SPC applications. Three related to vaccines against five diseases (diphtheria, tetanus, meningitis, polio and whooping cough), while the other two omitted the vaccine against meningitis (Hib). The UK IPO's hearing officer rejected all five applications. In the case of four of them, the active ingredients included some which were not protected by Medeva's patent (ie the vaccines against diseases other than whooping cough); as to the fifth, while the active ingredients were limited to those protected by Medeva's patent, the market authorisation covered a combination vaccine which included vaccines against the other four diseases. Thus in all five there was a mismatch between the active ingredients protected by the patent and the active ingredients in the vaccine or medicinal product for which the relevant market authorisations had been given.

Medeva appealed unsuccessfully to the Patents Court and then again to the Court of Appeal, which stayed the proceedings and referred a number of questions concerning art.3(a) of the SPC Regulation to the CJEU for a preliminary ruling. In its ruling, the CJEU held that art.3(a) had to be interpreted as precluding the competent industrial property office of a Member State from granting an SPC relating to active ingredients which were not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate.

Medeva put quite a positive spin on this ruling.  The way they saw it, the CJEU's explanation of the law still entitled them to the grant of SPCs on the first four of their applications --  or, if this was not so, that the EU's senior court had insufficiently answered the questions referred , so that another reference was needed.

The Court of Appeal dismissed Medeva's further arguments and, with it, the appeal. It held that, since both the Advocate General and the CJEU had rejected any test based on infringement or on the protective effect of the basic patent, all that was left for the national court to do was to determine which active ingredients were specified in the wording of the patent's claims. In this context, "specified" is an interesting word: it could mean anything between expressly naming, actually describing, effectively implying something, or this could be the result of a reasonable construction of the claims. Medeva's problem was that, wherever the dividing line was to be drawn, the active ingredients relating to vaccines against diphtheria, tetanus, meningitis and polio were excluded, while the CJEU's ruling required that the other elements or active ingredients be specified in the wording of the claims. Here was no such wording to indicate that the active ingredients of the vaccines against diphtheria, tetanus, meningitis and polio were included.

Neurim and "first authorisation": the Advocate General speaks

The Advocate General rendered his Opinion this morning in Case C-130/11 Neurim Pharmaceuticals, a reference from the United Kingdom in which the facts were as follows. In December 2009 a hearing officer at the UK's Intellectual Property Office refused Neurim's application for a supplementary protection certificate for the use of melatonin to correct a distortion or deficiency in the plasma melatonin profile of a human subject. The basis of the refusal was the fact that the cited marketing authorisation was not the first authorisation to place melatonin on the market as a medicinal product: there was an earlier authorisation to another company for a composition comprising melatonin for use in sheep to initiate an early breeding season -- an authorisation that had nothing whatever to do with Neurim's research or its resulting patent.

The questions referred for a preliminary ruling are these:

"1. In interpreting Article 3 of Regulation EEC No. 1768/92 [now Regulation (EC) No. 469/2009] (“the SPC Regulation”), when a marketing authorisation (A) has been granted for a medicinal product comprising an active ingredient, is Article 3(d) to be construed as precluding the grant of an SPC based on a later marketing authorisation (B) which is for a different medicinal product comprising the same active ingredient where the limits of the protection conferred by the basic patent do not extend to placing the product the subject of the earlier MA on the market within the meaning of Article 4? 

2. If the grant of the SPC is not precluded, does it follow that in interpreting Article 13(1) of the SPC Regulation, “the first authorisation to place the product on the market in the Community” needs to be an authorisation to place a medicinal product on the market within the limits of the protection conferred by the basic patent within the meaning of Article 4? 

3. Are the answers to the above questions different if the earlier marketing authorisation has been granted for a veterinary medicinal product for a particular indication and the later marketing authorisation has been granted for a medicinal product for human use for a different indication? 

4. Are the answers to the above questions different if the later marketing authorisation required a full application for marketing approval in accordance with Article 8(3) of Directive 2001/83/EC (formerly a full application under Article 4 of Directive 65/65/EEC)? 

5. Are the answers to the above questions different if the product covered by authorisation (A) to place the corresponding medicinal product on the market is within the scope of protection of a different patent which belongs to a different registered proprietor from the SPC applicant?".

Said Advocate General Verica Trstenjak, the questions should be answered as follows:

"(1) Under Article 3(d) of Council Regulation (EEC) No 1768/92 of 18 June 1992 ..., a supplementary protection certificate for a product which is protected by a basic patent in force may be granted only on the basis of the first authorisation which permits that product to be placed on the market as a medicinal product which is within the scope of protection conferred by the basic patent in the Member State for which the application is made. The fact that the same product has previously been authorised as a medicinal product for human use or a veterinary medicinal product in the Member State for which the application is made does not preclude the grant of a supplementary protection certificate based on a later authorisation to place that product on the market as a new medicinal product, provided the first-authorised medicinal product is not within the scope of protection conferred by the patent designated by the applicant as the basic patent. 

(2) The first authorisation to place the product on the market in the European Union to which Article 13(1) of Regulation No 1768/92 refers must also be understood as the first authorisation to place a product on the market in the European Union as a medicinal product which is within the scope of protection conferred by the basic patent designated by the applicant. 

(3) The answers to the above questions are no different if 

– in the Member State for which the application is made, a first authorisation has been granted to place a product on the market as veterinary medicinal product for a particular indication and a second authorisation has been granted to place that product on the market as a medicinal product for human use for a different indication;
– there are two authorisations to place a product on the market as a medicinal product and the later authorisation required a full application under Article 4 of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products;
– the product covered by an earlier authorisation to place the medicinal product on the market is within the scope of protection of a patent which belongs to a different registered proprietor from the person who applied for a supplementary protection certificate on the basis of a later authorisation to place that product on the market as a new medicinal product and on the basis of a different patent".

The SPC Blog's Rob Stephen hopes to post a comment soon but, in the meantime, readers who wish to post their own thoughts in this advice are, as usual, both welcome and encouraged to do so.