Call for comments for C-673/18 (Santen v INPI)

The UK IPO is seeking comments on CJEU case C-673/18 by 2 January 2019 with a view to lodging observations with the CJEU.  The case was previously reported on the SPC Blog here. If you would like to comment on this case, please email policy@ipo.gov.uk referencing the case number in the subject heading. 

As a refresher, the questions referred to the CJEU in this case is as follows:

“1 - Should the notion of different application within the meaning of the CJEU Neurim decision of 19 July 2012, C-130/11, be strictly understood, i.e.:

- be limited to the case of a human application following a veterinary application,
- or concern an indication in a new therapeutic field, in the sense of a new medical specialty, compared to the previous MA, or a drug in which the active principle exerts an action different from that which it exerts in the drug that was the subject of the first MA;
- or more generally, in the light of the objectives of Regulation (EC) No 469/2009 aiming at establishing a balanced system taking into account all the interests at stake, including those of public health, be assessed according to more stringent criteria than those used for the assessment of the patentability of the invention;

or, on the contrary, should it be understood in an extensive way, i.e. including not only different therapeutic indications and diseases, but also different formulations, dosages and/or modes of administration?

2 - Does the notion of application falling within the scope of protection conferred by the basic patent within the meaning of the CJEU Neurim decision of 19 July 2012, C-130/11, imply that the scope of the basic patent should be consistent with that of the MA invoked and, therefore, limit itself to the new medical use corresponding to the therapeutic indication of said MA?” 

An SPC Hat-trick: a THIRD referral under Article 3(a) heads to the CJEU

Many thanks to Nicholas Fischer and Andrew Hutchinson (Simmons & Simmons) for sharing their article (here) on the latest referral to the CJEU on SPCs from the UK Court, which will be published in Bio-Science Law Review.

In short summary, the UK Court of Appeal referred another question to the CJEU seeking clarity concerning the correct interpretation of Article 3(a) of the SPC Regulation. This makes it a hat-trick of referrals (England 2 – Germany 1) trying to understand what it means for a product to be ‘protected’ by a patent. This referral follows Sandoz’s appeal of Arnold J’s first instance decision, in which the outcome was held to be clear (in favour of SPC grant), even if the legal test was not. The UK Court of Appeal has overturned Arnold J’s decision, stayed the appeal and referred another question to the CJEU.

The question asked by the Court of Appeal is:

“Where the sole active ingredient the subject of a supplementary protection certificate issued under [the SPC Regulation] a member of a class of compounds which fall within a Markush definition in a claim of the patent, all of which class members embody the core inventive technical advance of the patent, is it sufficient for the purposes of Article 3(a) of the SPC Regulation that the compound would, upon examination of its structure, immediately be recognised as one which falls within the class (and therefore would be protected by the patent as a matter of national patent law) or must the specific substituents necessary to form the active ingredient be amongst those which the skilled person could derive, based on their common general knowledge, from a reading of the patent claims?”

Following the CJEU hearing the Teva v Gilead referral on Article 3(a) on 20 February (sitting as a Grand Chamber of 15 Judges) it will be interesting to see whether they deliver an overarching decision on Article 3(a) or approach this step-wise via the subsequent referrals from Germany and now the UK. We have heard that there will be an AG opinion in that case on or around 25 April so watch this space.

Swedish Appeal Court opens towards re-examination of Swedish SPC terms

Many thanks to Louise Jonshammar (Awapatent) for providing the following summary of recent decisions of the Swedish Patent and Market Appeal Court on SPC terms following the CJEU's Seattle Genetics case:

"On 4 October, 2017, the Swedish Patent and Market Appeal Court handed down eight decisions in appeal cases regarding re-examination of SPC term decisions. 

The background relates to the famous Seattle Genetics case (C-471/14) in which the CJEU gave a preliminary ruling on the interpretation of Article 13(1) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products. In the judgement, the CJEU held that the ‘date of the first authorisation to place the product on the market in the [European Union]’ within the meaning of Article 13(1) is the date on which notification of the decision granting marketing authorisation was given to the addressee of the decision. As many patent offices around the EU, if not most, calculated the SPC term on the date of grant of the marketing authorisation, the judgement started an avalanche of requests for changes to the already issued SPCs. The different EU countries have handled these requests differently, as re-examination is not provided for in the regulation. 

The Swedish Patent and Registration Office refused to change the term of already issued SPCs unless there was still time within the two months’ appeal limit to appeal the grant decisions – in which case the patentee was urged to file such appeal. The reason for refusal was mainly that new practice is not a basis for re-examination under the Swedish Administrative Law. 

The Patent and Market Court agreed with the patent office and did not change the decisions. Further, the court said that decisions to grant SPC effect not only the applicant but also an unknown number of other actors on the market, having contradictory interests. Therefore, decisions on grant of SPCs shall be considered similar to civil actions, despite the fact that third parties are not parties to these decisions. 

The Patent and Market Appeal Court decisions are long and include a lot of very useful reasoning for understanding the decision. The grand finale of the decisions is a reasoning on the balance of interest between the patentee and third parties. The Patent and Market Appeal Court finds that where the patent protection has ceased and the SPC has come into effect, companies marketing generic drugs may have customised their efforts on the market to fit the decision and prepared according to the final date of the SPC in the decision. If the SPC term has begun, the interest of foreseeability speaks against a change of the SPC term in such cases. Before the beginning of the SPC term, however, the patentees’ interest in a longer term shall prevail. Therefore, as a general rule, decisions on SPC term shall be changed in accordance with the principles set out in the Seattle Genetics judgement, provided that a request for changes has been filed before the beginning of the SPC term. 

The decisions then differ depending on when the patentee filed its request - in some cases the term is extended and the patent office is asked to put that decision into practice, in other cases the request for change of the term is denied because the SPC term has already begun. 

Also, as a point of interest, one may note that the Patent and Market Appeal Court disagrees with the Patent and Market Court with respect to SPC applications being considered similar to civil actions. The fact that a re-examination may have economic consequences for third parties is not a special circumstance which motivates a deviation from the general rule of administrative law. The third party interest shall therefore be considered within the re-examination, which is then what the Patent and Market Appeal Court does in its balancing of interests, as described above. 

Another interesting note is that the Patent and Market Appeal Court has allowed for the decisions to be appealed to the Supreme Court."

Call for comments for C-443/17 (Abraxis Bioscience)

The UK IPO is seeking comments on CJEU case C-443/17 (Abraxis Bioscience) with a view to advising the UK government as to whether it wishes to make representations in this reference.  Comments should be sent by email to policy@ipo.gov.uk by 6 September 2017.

As a refresher, the question referred to the CJEU in this case is as follows:

Is Article 3(d) of the SPC Regulation to be interpreted as permitting the grant of an SPC where the marketing authorisation referred to in Article 3(b) is the first authorisation within the scope of the basic patent to place the product on the market as a medicinal product and where the product is a new formulation of an old active ingredient?

UKIPO seeks comments on C-567/16

The UKIPO is seeking comments on CJEU case C-567/16 (Merck Sharp and Dohme Corporation) with a view to advising the UK government as to whether it wishes to make representations in this reference.  The deadline for filing submissions is coming up very soon - 6 January 2017.

The questions referred to the CJEU are:

1. Is an End of Procedure Notice issued by the reference member state under Article 28(4) of European Parliament and Council Directive 2001l83/EC of 6 November 2001 on the Community code relating to medicinal products for human use before expiry of the basic patent to be treated as equivalent to a granted marketing authorisation for the purposes of Article 3(b) of European Parliament and Council Regulation 469/2009/EC of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) (the “SPC Regulation”), such that an applicant for an SPC in the Member State in question is entitled to apply for and be granted an SPC on the basis of the End of Procedure Notice?
2. If the answer to question (1) is no; in the circumstances in question 1, is the absence of a granted marketing authorisation in the Member State in question at the date of the application for an SPC in that member state an irregularity that can be cured under Article 10(3) of the SPC Regulation once the marketing authorisation has been granted?

Many thanks to Andrew Hutchinson (Simmons & Simmons) for pointing this out!

Brexit: what does Boris Johnson have to say about SPCs?

Fortunately nothing at all,  but after the UK's exit from normality we've been asked what impact there will be on SPCs in the UK?

As SPCs are granted in the UK under an EU regulation, which will no longer apply after Brexit, in the future it will be necessary for the UK to enact legislation to create some form of equivalent protection. Presumably this will not be at the top of the list of priorities for our new PM, and possibly we will adopt the current EU legislation into UK law, but without appeal to the CJEU for obvious reasons.  The possibility remains that any new protection could be of a different scope, but this seems an unlikely outcome given that there will apparently be some other things to do as well.  After Brexit the UK courts will not be bound by the existing CJEU decisions, or be able to refer questions on SPCs to the CJEU, and we may have divergent opinions on similar legal issues between the UK and EU as we move forward.  Given the view of some of the UK judges on the opinions of the CJEU, this could be rather interesting.

There will also need to be a new mechanism for extending the SPC term after appropriate paediatric studies, assuming the UK looks to maintain equivalent protection with the rest of the EU.

SPCs already granted by the UKIPO should be unaffected, but could potentially have a different validity if the law that applies to them is interpreted differently by a court free from the constraints of CJEU decisions.

Finally, this will all have to be subject to any new or transitional approval regime, given that the EMA may cease to have any jurisdiction in the UK.

All in all, Brexit has placed the UK in a position that arguably is more complex than SPC case law….and that's saying something.

Rob and Catherine

The Court of Justice: who needs it? A new article

New has reached The SPC Blog of the latest publication by Mike Snodin of Park Grove IP (a copy of which can be viewed here). On this occasion, Mike’s article (“The CJEU – for supplementary protection certificates, who needs it?”) discusses the arguments for and against the use of Notification Date for “centralised” marketing authorisations (MAs) and explains why the arguments against, as typified by a decision of the Danish Patent Office, are fatally flawed.

Mike concludes that it is acte clair that the SPC legislation requires the use of the date of validity of a MA to calculate the duration of an SPC. How the date of validity is calculated will depend upon the type of MA involved – but for “centralised” MAs it will involve use of the Notification Date.

In the light of his analysis of the legislation, Mike concludes that it is not necessary for patent offices to refer this matter to the CJEU in order to accept arguments in favour of the use of the Notification Date.  Mike’s article was published too late to persuade the Oberlandesgericht Wien not to make a reference on this point. However, Mike hopes that his article will help the CJEU quickly grasp the key points of the matter. He also hopes that they will forgive the title that the publishers chose for his article!

Curia Fairies busy last night, posting reasoned orders

Luxembourg night-workers ...

Yesterday the SPC Blog posted that it had been asked by a correspondent if we had a text for another reasoned order of the Court of Justice of the European Union of 14 November, Case C-617/12 AstraZeneca AB v Comptroller-General of Patents. This reasoned order was not accessible via the Curia website.

Good news!  The reasoned order must have been uploaded by the Curia Fairies overnight, since it's now available online here. For the record, the CJEU ruled in that order as follows:

"In the context of the European Economic Area (EEA), Article 13(1) of Regulation ... 469/2009 [on SPCs] must be interpreted as meaning that an administrative authorisation issued for a medicinal product by the Swiss Institute for Medicinal Products (SwissMedic), which is automatically recognised in Liechtenstein, must be regarded as the first authorisation to place that medicinal product on the market within the meaning of that provision in the European Economic Area where that authorisation predates marketing authorisations issued for the same medicinal product, either by the European Medicines Agency (EMA), or by the competent authorities of European Union Member States in accordance with the requirements laid down in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, and with the requirements of the Republic of Iceland and the Kingdom of Norway. The fact that, on the basis of similar clinical data, the European Medicines Agency, unlike the Swiss authority, refused to grant a marketing authorisation for that medicinal product at the conclusion of its examination of those data, or the fact that the Swiss authorisation to place the product on the market was suspended by the Swiss Institute for Medicinal Products and subsequently reinstated by the latter only when the holder of the authorisation submitted additional data to it are irrelevant".

Further good news is that the reasoned order in Case C-210/13 Glaxosmithkline is now also miraculously available online. A big thank-you to the Curia Fairies for working their magic spells last night ...

The "Special Mechanism": some 'Merck-y' questions for the CJEU

In April The SPC Blog reported on Merck Canada Inc and another v Sigma Pharmaceuticals plc [2013] EWCA Civ 326, a Court of Appeal for England and Wales reference to the Court of Justice of the European Union (CJEU) for preliminary rulings on a number of questions -- not precisely articulated at that time -- on SPCs and the "special mechanism". Case C-539/13 Merck Canada and Merck Sharpe and Dohme.

The UK Intellectual Property Office (IPO) is now seeking your opinion as to how these questions should be answered. Writes the IPO:

"We have received notification of a new case referred to the Court of Justice: C-539/13. This is a request for a preliminary ruling in a case concerning the importation into the UK from Poland of a drug by the defendant. The claimant states that the importation of the drug in question was an infringement of the Claimant companies' rights covered by a Supplementary Protection Certificate.

The filing date of the application for the Patent was prior to the date when Poland introduced patent protection for pharmaceutical products under its laws, and the application date for the SPC was before the date when SPCs could be applied for under the laws of Poland.

The questions referred relate to the Specific Mechanism in Chapter 2 of Annex IV to the Act concerning the conditions of accession of (inter alia) the Republic of Poland".

The questions are somewhat cumbersome on account of their interrelationship:

Conditions for reliance upon the Specific Mechanism

1. May the holder, or his beneficiary, of a patent or supplementary protection certificate rely upon his rights under the first paragraph of the Specific Mechanism only if he has first demonstrated his intention to do so?

2. If the answer to Question 1 is yes:

(a) How must that intention be demonstrated?

(b) Is the holder, or his beneficiary, precluded from relying upon his rights with respect to any import or marketing of the pharmaceutical product in a Member State that occurred prior to the demonstration of his intention to rely upon those rights?

The notifier

3. Who must give the prior notification to the holder or beneficiary of a patent or supplementary protection certificate under the second paragraph of the Specific Mechanism? In particular:

(a) Must the prior notification be given by the person intending to import or market the pharmaceutical product?

or

(b) Where, as permitted by the national regulatory system, an application for regulatory approval is made by someone other than the intended importer, can prior notification given by the applicant for regulatory approval be effective if that person does not itself intend to import or market the pharmaceutical product but where the intended importation and marketing will be carried out under the applicant's regulatory approval?; and

(i) Does it make any difference if the prior notification identifies the person that will import or market the pharmaceutical product?

(ii) Does it make any difference if the prior notification is given and the application for regulatory approval is made by one legal person within a group of companies which form a single economic unit, and the acts of importation and marketing are to be carried out by another legal person within that group under licence from the first legal person, but where the prior notification does not identify the legal person that will import or market the pharmaceutical product?

Who should be notified? 

4. To whom must prior notification be given under the second paragraph of the Specific Mechanism? In particular:

(a) Is the beneficiary of a patent or supplementary protection certificate limited to persons who have a legal right under national law to bring proceedings to enforce that patent or supplementary protection certification?

or

(b) In a case where a group of companies forms a single economic unit comprising a number of legal entities, is it sufficient if the notification is addressed to a legal entity which is the operating subsidiary and marketing authorisation holder in the Member State of importation rather than the entity within the group that has a legal right under national law to bring proceedings to enforce that patent or supplementary protection certificate, on the basis either that such legal entity may be characterised as a beneficiary of the patent or SPC. or that it is to be expected that such notification in the ordinary course of events will to come to the attention of the persons who make decisions on behalf of the patent or SPC holder?

(c) If the answer to Question 4(b) is yes, is a notification which is otherwise compliant rendered non-compliant if it is addressed to the "the Manager, Regulatory Affairs" of a company when that company is not the entity within the group that has a legal right under national law to bring proceedings to enforce that patent or supplementary protection certificate but is the operating subsidiary or marketing authorisation holder in the Member State of importation and when that Regulatory Affairs department in practice regularly receives notifications from parallel importers regarding the Specific Mechanism and other matters?

Adds the IPO (if you're still reading after all this!):

"If you would like to comment on this case please email policy@ipo.gov.uk by 27 November 2013. 

We understand how difficult it is to provide detailed comments in the time available. The IPO has tight time limits in which to consider and provide advice to ministers on ECJ cases. In order to help us provide the right advice, we just need a short email by the deadline stating whether you think the UK should intervene and some general points about how you think we should answer the questions.  

You are welcome to follow this email up with more detailed comments after the deadline, which can be taken into consideration if we have chosen to submit observations or if we decide to attend a hearing".

CJEU rules on status of emergency MAs in SPC applications

Case C‑210/12, Sumitomo Chemical Co. Ltd v Deutsches Patent- und Markenamt, is a decision of the Court of Justice of the European Union on a reference for a preliminary ruling from the German Bundespatentgericht. What was this case about?

Sumitomo was the proprietor of European patent EP 0 376 279, DE 689 06 668, which covered Germany among other countries. The patent was for the active substance clothianidin, used for insecticide products. Back in February 2003 the United Kingdom authorities issued a marketing authorisation (‘MA’) to a company in the Bayer group, in accordance with Article 8(1) of Directive 91/414, for a product containing clothianidin. That ‘provisional’ MA was the first issued in the European Union for a product containing that active substance. In December of the same year the German authorities, on the basis of the national provisions transposing Article 8(4) of Directive 91/414, issued an emergency MA to a company in the Bayer group for a plant protection product containing the active substance clothianidin. That emergency MA was valid for 120 days, from 15 January to 13 May 2004.

On 14 May 2004, Sumitomo applied to the German patent office for a supplementary protection certificate for plant protection products. In its application Sumitomo referred to (i) the provisional MA granted in the UK in February 2003, this being the first MA granted in the European Union, and (ii) to the emergency MA issued in Germany in December 2003. In September 2004 the German authorities granted, on the basis of the national provisions transposing Article 8(1) of Directive 91/414, a provisional MA to a company in the Bayer group for a product based on clothianidin. The period of validity of that provisional MA was from 8 September 2004 until 7 September 2007. In November 2004 Sumitomo informed the German patent office of the existence of the provisional MA of 8 September 2004.

The German patent office eventually, in January 2006, dismissed Sumitomo's SPC application. Although the application had been lodged within the period set out in Article 7(1) of Regulation 1610/96, the German patent office considered that no SPC could be granted since the MA -- being an emergency MA which had expired -- was no longer valid within the meaning of Article 3(1)(b) of Regulation 1610/96. Sumitomo appealed to the Bundespatentgericht, which decided to refer to the CJEU the following questions for a preliminary ruling:

‘1. Is Article 3(1)(b) of [Regulation No 1610/96] 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]?

2. If Question 1 is answered in the affirmative:

Is it necessary under Article 3(1)(b) of [Regulation 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 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?’

Earlier this month the CJEU ruled as follows:

1. Article 3(1)(b) of Regulation ... 1610/96 ... concerning the creation of a supplementary protection certificate for plant protection products must be interpreted as precluding the issue of a supplementary protection certificate for a plant protection product in respect of which an emergency marketing authorisation has been issued under Article 8(4) of Directive 91/414 ... concerning the placing of plant protection products on the market, as amended....

2. Articles 3(1)(b) and 7(1) of Regulation No 1610/96 must be interpreted as precluding an application for a supplementary protection certificate being lodged before the date on which the plant protection product has obtained the marketing authorisation referred to in Article 3(1)(b) of that regulation.

Thanks go to Tony Breen (Syngenta) for drawing our attention to this decision.

Short Summary of the Medeva/Georgetown CJEU Hearing

Many thanks to Hugh Goodfellow (Carpmaels & Ransford) and Brian Cordery (Bristows) for submitting the report below on the Medeva/Georgetown hearing before the CJEU on 12 May 2011.

"On 12 May 2011, the Court of Justice of the European Union (CJEU) heard the joined cases of Medeva (Case C-322/10) and Georgetown (Case C-422/10) - both references from the UK Courts on the interpretation of certain provisions of Article 3 of the SPC Regulation (EC Regulation 469/2009).

For those readers who are not intimately familiar with the issues referred (and thus may have inadvertently stumbled across this blog), Article 3 of the SPC Regulation sets out certain conditions for an SPC to be obtained. Article 3(a) requires that at the time the SPC application is made, the product which is the subject of that SPC must be “protected by a basic patent in force”. Article 3(b) requires that “a valid authorisation to place the product on the market as a medicinal product” has been granted at the time that the application for the SPC is made.

Representatives for Medeva, Georgetown, the UK and Portuguese Governments, and the Commission gave oral submissions to a panel of five judges: (Jean-Claude Bonichot (France), Lars Bay Larsen (Denmark), Camelia Toader (Romania), Alexandra Prechal (The Netherlands), and Egidijus Jarašiunas (Lithuania)).

Medeva and the UK Government advocated applying a so-called “infringement test” when considering Article 3(a), such that a combination of A+B would be protected by a patent for A because the patent would be infringed by the combination. For the UK Government, this represents a complete shift in thinking from the position previously adopted by the UK IPO on this issue. From the oral submissions made to the Court at the hearing, it was unclear what approach the Commission would prefer.

On Article 3(b), Georgetown and the Commission both considered that this should be interpreted so that a marketing authorisation (MA) for A+B could be specified as a valid authorisation to obtain an SPC for A, if the MA for A+B represents the first approval for A. The UK Government was opposed to this idea.

At the hearing, reference was made to questions submitted by the Court to the parties and the other bodies represented at the hearing on Article 4 (Subject Matter of Protection) and the Biogen decision (C-181/95). Those questions and the answers submitted to the Court have not been made public. However the representative for the Commission stated that an analysis of Article 4 was not necessary in order to be able to interpret Article 3.

The opinion in these cases will be delivered on 13 July 2011 by Advocate-General Verica Trstenjak of Slovenia. The actual decision of the Court – which of course may follow the AG’s opinion or deviate from it - will follow several months later."