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?” 

France - Court of Appeal of Paris refers questions to the CJEU

Thomas Bouvet and Laura Romestant (Jones Day) kindly report below on a recent decision (here, in French only) of the Court of Appeal of Paris to refer questions to the CJEU:

On 9 October 2018, the Court of Appeal of Paris issued a decision which refers two questions to the CJEU intended to clarify the terms “different application” and “falling within the scope of protection conferred by the basic patent” as addressed in the CJEU Neurim decision. 

Background
Santen is the holder of:

• European patent № 1 809 237, entitled “Ophthalmic oil-in-water type emulsion with stable positive zeta potential”, filed on 10 October 2005 and granted on 31 December 2008;
• a central marketing authorization № EU/1/15/990 valid in the entire European Union, granted on 19 March 2015 and notified on 23 March 2015, for the medicinal product with the proprietary name Ikervis, whose active ingredient is ciclosporin in the formulation, covered by EP 1 809 237, indicated for the treatment of severe keratitis in adult patients with dry eye disease, for which ciclosporin has not been approved before.

By a decision dated 6 October 2017, the Director General of the INPI dismissed the application to grant an SPC for ciclosporin eye drop emulsion, filed by Santen on 3 June 2015. 

The Director of the INPI considered that the marketing authorization, on which the application is based, would not be the first authorization to place the product on the market as a medicinal product:

• it considered that the sole active ingredient of the specialty object of MA № EU/1/15/990 for “ciclosporin for use in the treatment of keratitis” is ciclosporin which should be considered as the product object of the requested SPC, within the meaning of Article 1(b);
• it considered that the previous MA for ciclosporin had been granted on 23 December 1983 for the medicinal product Sandimmun;
• it considered that CJEU Neurim decision C-130/11 would not apply in the circumstances of the case because:

- the application for which Ikervis is authorized is not a different application from that of Sandimmun as both relate to inflammatory diseases of the eye;
- the basic patent does not protect a new application of ciclosporin, but a new formulation containing no specific use limitation.

Santen lodged an appeal against this decision by declaration of 3 November 2017.
In its written submissions filed before the Court of Appeal of Paris, Santen requested:

• as a main request, that the Court of Appeal hold the decision of the Director General of the INPI null, as it is contrary to the case law of the CJEU as set out in the Neurim judgment of 19 July 2012 as well as to the case law of the Court of appeal itself as it is set out in the Merck & Co decision of 15 February 2013;
• as an auxiliary request, that the Court of Appeal refer a question for a preliminary ruling to the CJEU, in the terms set out in its written submissions before the Court.

The decision of the Court of Appeal of Paris of 9 October 2018
The decision of the Court of Appeal (here) refers two questions to the CJEU, which read in working translation 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?” 

The Court of Appeal found it necessary to ask two questions resulting from the Neurim decision:

- the first one is intended to clarify the meaning of the term “different application” within the meaning of the CJEU Neurim decision of 19 July 2012, C-130/11;
- the second one intended to clarify to what extent the basic patent should cover said different application, in particular whether it should be limited to the new medical use.

Thomas Bouvet and Laura Romestant  represented Santen.

Austrian SPC decision on an SPC application based on a variation type II of an existing MA

Bianca-Lucia Vos and Klemens Stratmann of Hoffmann-Eitle have generously provided a copy of a recent decision of the Higher Regional Court of Vienna (here) regarding an SPC application based on a variation type II of an existing marketing authorisation.  An English translation of the decision can be obtained here.  Bianca-Lucia and Klemens comment:

On January 21, 2016 the Higher Regional Court of Vienna, Austria, issued a decision (34 R 104/15) on the interpretation of Art. 3(b) of Regulation 469/2009 in the light of the Neurim judgment of the CJEU (case C-130/11). In the case underlying the appeal to the Higher Regional Court of Vienna, the Austrian Patent Office had rejected an SPC application that was based on a second medical use patent (EP 0 758 900) and a Type II variation of an existing (national) marketing authorization for Botox due to which the indication protected by the selected basic patent, i.e. treatment of chronic migraine, was added to the already approved indications of Botox. The Examiner had calculated the 6-month time limit for filing the SPC application according to Art. 7(1) of Regulation 469/2009 from the date of the very first marketing authorization for Botox in Austria. In his view, the amendment by a Type II variation of a marketing authorization does not newly trigger the 6-month time limit for applying for an SPC.

However, following the considerations of the European Court of Justice in the Neurim decision C-130/11, the Higher Regional Court of Vienna ruled that a marketing authorization as amended by a Type II variation can be considered as a valid marketing authorization in the sense of Art. 3(b) of Regulation 469/2009. The Court also emphasized that patent protection and marketing authorization must harmonize in terms of content, and that earlier authorizations do not deprive the more recent authorization of a patented use from being the “first authorization” pursuant to Art. 3(d) of Regulation 469/2009, if the earlier authorization refers to areas not protected by the basic patent.

Accordingly, the Court also held that an earlier authorization granted for a use outside the scope of protection of the patent has no negative effect in so far as it does not trigger the 6-month time limit pursuant to Art. 7(1) of Regulation 469/2009.  Therefore, the contested decision had to be reversed, and the Patent Office ordered to render a decision on the merits as to whether the application had been filed in due time.

Applying the principles set forth by the CJEU in Neurim, the Higher Regional Court Vienna hence confirmed that an SPC application may be filed on the basis of a Type II variation of an existing marketing authorization as “valid authorization to place the product on the market” according Art. 3(b) and “first authorization” in the sense of Art. 3(d) of Regulation 469/2009.

Many thanks to Bianca-Lucia and Klemens for sharing this decision!

Neurim rapid response seminar this Thursday

The Olympic Sheep 5K run. Can you tell which sheep is on the melatonin? 

Wasting no time at all, the UK branch of the AIPPI (that's the Association Internationale pour la Protection de la Propriété Intellectuelle, the International Association for the Protection of Intellectual Property or Internationale Vereinigung für den Schutz des Geistigen Eigentums, depending on your preference) is holding a Neurim-themed rapid response seminar this coming Thursday, 2 August.

"On 19th July 2012, the Court of Justice of the European Union delivered its eagerly anticipated Neurim Pharmaceuticals judgment [see earlier posts on this weblog here and here]. Following the Advocate General's guidance, the Court has made it clear that Neurim should be granted its SPC for melatonin despite the existence of earlier authorisations relating to that active ingredient. However, the judgment is expressed in terms which are considerably broader than the facts at issue in the Neurim case.

Continuing AIPPI UK's quick response events on SPCs, Hugh Goodfellow returns to give his insightful views having acted for Neurim along with Ed Oates. Jürgen Dressel from Novartis will be speaking to give his views. They will together examine the extent to which the Neurim judgment has changed the SPC system".

This event kicks off at 5.30pm for 6pm and its official title is "The world of SPCs post-Neurim. So what has changed?"  Even though almost every corner of London is filled with Olympians contending for gold in sports as obscure as tiddlywinks, shove-ha'penny and hunt the slipper, the AIPPI UK has found an appropriate place to hold the seminar: Carpmaels & Ransford, One Southampton Row, London WC1B 5HA. Tickets are considerably cheaper for this event than for most Olympic ones: admission will set you back just £20 (AIPPI non-members) or indeed nothing at all if you belong to AIPPI.  Drinks are apparently free, whether you belong to AIPPI or not. Further details by email here or online here.

A more “fit for purpose” SPC Regulation?

Apart from the various comments posted at the foot of yesterday's blog item on Case C-130/11 Neurim Pharmaceuticals,  The SPC Blog has also received the following observations from Andrew Hutchinson (Associate Solicitor, Simmons & Simmons LLP)

A more “fit for purpose” SPC Regulation?

The CJEU’s judgment has allowed Neurim to obtain an SPC and so in that sense has followed the Court of Appeal (England and Wales) and the Opinion of Advocate General (AG) Trstenjak of 3 May 2012. However, while the CJEU has allowed Neurim’s application to proceed, as is now a common theme in SPC decisions, it seems to have struggled to formulate a legal test that can be applied generally and simply to all cases.

The CJEU has not applied the same test or gone into the detailed reasoning of the AG’s Opinion, which suggested that an earlier authorisation should be ignored if it did not fall within the scope of the protection of the later basic patent. This test required the assessment of the scope of protection of the basic patent in question and a determination of whether any earlier authorisations fell within it. The clear water between Neurim’s patent and the earlier authorisation was not in dispute. However, the CJEU may have been reluctant to apply this test given that finer distinctions may arise and an assessment of the scope of protection of a basic patent could overburden the SPC-granting authorities. The CJEU may have also been concerned about causing conflicts with its own earlier decisions, in particular Pharmacia (case C-31/03) and Yissum (case C-202/05), which the High Court for England and Wales had already assessed and considered, acte clair, to preclude Neurim’s SPC.

While the CJEU has held that the mere existence of an earlier authorisation can no longer be said to be automatically relevant to (and perhaps preclude) a later SPC application for the same product, the CJEU has provided hardly any test at all. As a result, it is not completely clear how similar to Neurim a subsequent case will need to be to benefit from this decision. In this sense, the decision provides for a specific exception to the stricter, literal interpretation of Articles 3(d) and 13(1), as opposed to applying a wider, more general teleological interpretation.

The requirements for benefiting from Neurim are split into two parts, which are closely connected: (1) is your SPC application for an old product with a “different application" and (2) do you have a “new patent” for that different application as your basic patent (paras 25-27). The central question is therefore: what is covered by "a different application"? A second medical use appears to qualify. There is no mention of the need for there to be a different species (as was the case in Neurim) but, as this is not addressed, it may be argued that this is a further limitation. This also leaves open the issues of any non-active components, new formulations, inventive excipients, etc.

Overall, some will seek to limit the scope of this decision while others will seek to extend it, so the circumstances of the case in question will be paramount. Another common theme in SPC decision continues: more referrals are likely.  It remains to be seen whether, as Jacob LJ commented when referring Neurim to the CJEU, cannot yet be ascertained whether allowing Neurim’s SPC will create a more “fit for purpose” SPC Regulation. It may only be a small step in that direction.

Neurim judgment liberalises SPC system

Today marked the publication of the eagerly-awaited decision of the Court of Justice of the European Union (CJEU) in Case C-130/11 Neurim Phamaceuticals, which the Court of Appeal for England and Wales sent for a preliminary ruling on the basis that it was up to the CJEU to determine whether the SPC Regulation was "fit for purpose" or not.

The full text of the judgment of the CJEU can be read here. Meanwhile, the following note has been kindly provided for The SPC Blog by Edward Oates (Carpmaels & Ransford). Edward writes:

Earlier this morning the CJEU, Europe’s highest court, issued its ruling in case C-130/11 Neurim Pharmaceuticals. The CJEU’s judgment has a liberalising effect on supplementary protection certificate (“SPC”) law and presents new opportunities for extending patents through SPC filings.

Prior to today, and based on a line of CJEU jurisprudence (C-31/03 Pharmacia, C-431/04 MIT, C-202/05 Yissum, C-195/09 Synthon and C-427/09 Generics), it was generally thought that an SPC was precluded (or its duration was truncated) if the active ingredient in question had been authorised in any earlier marketing authorisation within the EU, even if the earlier authorisation related to a different use in a different species. Today’s ruling clarifies that that is not the case and thereby provides an incentive for companies to engage in the research of new uses of previously authorised actives. The precise terms of the Court’s ruling are as follows.

1. Articles 3 and 4 of Regulation ... 469/2009 ... concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that, in a case such as that in the main proceedings, the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product does not preclude the grant of a supplementary protection certificate for a different application of the same product for which a marketing authorisation has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate.

2. Article 13(1) of Regulation ... 469/2009 must be interpreted as meaning that it refers to the marketing authorisation of a product which comes within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate.

In referring to “a case such as that in the main proceedings” and “an earlier marketing authorisation obtained for a veterinary medicinal product”, the above ruling at first sight avoids explicitly addressing the question of whether the CJEU would have reached the same conclusion had the earlier marketing authorisation related to human use. However, the CJEU’s reasoning makes it clear that the CJEU would indeed have reached the same conclusion had the earlier marketing authorisation related to human use (emphasis added):

“25 Therefore, if a patent protects a therapeutic application of a known active ingredient which has already been marketed as a medicinal product, for veterinary or human use, for other therapeutic indications, whether or not protected by an earlier patent, the placement on the market of a new medicinal product commercially exploiting the new therapeutic application of the same active ingredient, as protected by the new patent, may enable its proprietor to obtain an SPC, the scope of which, in any event, could cover, not the active ingredient, but only the new use of that product.

26 In such a situation, only the MA of the first medicinal product, comprising the product and authorised for a therapeutic use corresponding to that protected by the patent relied upon for the purposes of the application for the SPC, may be considered to be the first MA of ‘that product’ as a medicinal product exploiting that new use within the meaning of Article 3(d) of the SPC Regulation…

30 … Therefore, the MA referred to in Article 13(1) of the SPC Regulation is the authorisation of a product which is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC.”

As such, today’s judgment widens the possibility of obtaining SPC protection and will be enthusiastically received by holders of pharmaceutical and agrochemical patents.

Brave New World post-Neurim?

"A brave new world for supplementary protection certificates?” is the title of an article by Mike Snodin and Michael Pears (both of Potter Clarkson) that has been published in the most recent edition of Life Sciences IP Review.  The article discusses the opinion of Advocate General Verica Trstenjak in Neurim Pharmaceuticals (C-130/11), which it notes has the potential to greatly increase the number of medical innovations that will qualify for supplementary protection in Europe .

Mike and Michael acknowledge that, on the face of it, the opinion appears to be good news for the innovative pharmaceutical industry. However, their analysis of the opinion highlights some potentially serious side-effects that may throw the SPC system out of balance in a way that is detrimental to the long-term interests of the industry. In particular, they point to the fact that the solution proposed by the Advocate General would inadvertently sever an important link in the legislation (a link between a high regulatory hurdle and the award of an SPC) and lead to not only inconsistencies with certain statements of principle from the authors of the original legislation but also to a proliferation of SPCs based upon almost any kind of marketing authorisation (and therefore almost any degree of regulatory hurdle).

Mike and Michael therefore question whether, when reaching their judgment later this year, the Court of Justice of the EU may wish to consider alternative "cures" that have fewer side-effects but that still avoid the harsh result for Neurim that is reached through strict application of the prior case law of that court.

You can read Mike and Michael's article in full here.