The Trade and Cooperation Agreement and its impact on IP, Pharma and Medical Devices

The final Brexit agreement, the Trade and Cooperation Agreement (the “TCA”) was agreed between the UK and the EU on 24 December 2020. Within this agreement are provisions that set out the standards expected to be recognised (mutually) between the EU and the UK in relation to intellectual property (including SPCs and trade secrets). There are some provisions concerning pharmaceutical regulation and product standards, but overall there is a lack of mutual recognition, with the consequence that, for both pharmaceuticals and medical devices, there are now effectively two separate regimes for the EU and the UK.

Intellectual Property

The provisions on IP match or exceed those for IP set out in the various treaties to which the UK and EU have acceded (such as WIPO, WTO and TRIPS agreements).  These IP standards are to be maintained as a minimum. The cited objectives and scope in relation to intellectual property (see Title V) indicate the aims behind these provisions which are to:

(a) facilitate the production, provision and commercialisation of innovative and creative products and services between [the UK and the EU] by reducing distortions and impediments to such trade, thereby contributing to a more sustainable and inclusive economy; and

(b) ensure an adequate and effective level of protection and enforcement of intellectual property rights.

The provisions are intended to “complement and further specify the rights and obligations of each [of the UK and the EU] under the TRIPS Agreement and other international treaties in the field of intellectual property to which they are parties” and do not “preclude either [the UK or the EU] from introducing more extensive protection and enforcement of intellectual property rights than required under [this section of the TCA] provided that such protection and enforcement does not contravene [those provisions]”. However, there are aspects of current UK and EU IP law, such as the dilution provisions in trade mark law, to which the agreement does not refer, instead referring to the Paris Convention provisions on the protection of well known marks. Whether this will be a point of future divergence remains to be seen.

Both the UK and the EU also have the ability to develop their own exhaustion regimes. The provisions on geographical indications (“GIs”) indicate that a mutual future scheme has not be agreed although a review clause on GIs has, which provides that the UK and EU may (if both parties agree it is in their interests) use reasonable endeavours to agree rules for the protection and domestic enforcement of their GIs.

The UK Government’s Summary document that accompanies the TCA (see here) states that the agreement “includes mechanisms for cooperation and exchange of information on IP issues of mutual interest” and “retains regulatory flexibility for each [of the UK and the EU], enabling the UK to develop an IP system in line with [its] domestic priorities“, thus enabling the UK to diverge where it so requires.

We have already commented on the changes to the UK IP regime in the firm’s guide to Brexit here (see the IP section).

The Regulation of Medical Devices and Medicinal Products

Medical devices: The TCA has a chapter (4) (under Trade – Title I) on eliminating unnecessary technical barriers to trade which deals with conformity of standards. However, this only provides for an approach under which each party can agree that its standards bodies (including those relating to medical devices) will conform with international standards and will work together to influence those and to “foster bilateral cooperation with the standardising bodies of the other Party“.

For medical devices, it had been hoped that there would be at least mutual recognition of conformity assessment under which each of the EU and the UK would recognise the other’s certification bodies. However, as things stand, although Great Britain will continue to accept CE marked medical devices until 30 June 2023 those devices certified by the UK and marked as UKCA (standing for UK Conformity Assessed, as discussed in more detail in our post here), will not mutually recognised by the EU.

Medicinal Products: For medicinal products there is a dedicated annex in the TCA, Annex TBT-2 – Medicinal Products (the “Medicinal Products Annex”), which applies to all medicinal products listed in its Annex C, namely:

  • marketed medicinal products for human or veterinary use, including marketed biological and immunological products for human and veterinary use,
  • advanced therapy medicinal products,
  • active pharmaceutical ingredients for human or veterinary use,
  • investigational medicinal products,

with this list being subject to amended by the UK-EU Partnership Council (the main governing body for the agreement and supplementing agreements).

The aim of the Medicinal Product Annex is to “facilitate availability of medicines, promote public health and protect high levels of consumer and environmental protection in respect of medicinal products”.  To help achieve this aim, the Annex provides for:

  • the mutual recognition of Good Manufacturing Practice (“GMP”) inspections and certificates, meaning that manufacturing facilities do not need to undergo separate UK and EU inspections;
  • the individual inspection, on notice, by the EU or UK of each other’s facilities); and
  • for the suspension of the mutual recognition arrangements.

Further, the TCA also states that the EU and the UK should work together to implement agreed international guidelines and that any changes to either the UK or the EU’s regulation regime should be on 60 days’ notice and be subject to discussion by a Working Group on Medicinal Products, which will be established to enable mutual consultation. This Working Group on Medicinal Products will be under supervision of the Trade Specialised Committee on Technical Barriers to Trade, and will monitor and review implementation and ensure the proper functioning of the Medicinal Products Annex. It is noteworthy that the Medicinal Products Annex is specifically excluded from the TCA’s disputes mechanism, however, through its role in facilitating discussions and functioning as an appropriate forum for issues relating to Medicinal Products, it is hoped that it will be a sufficient mechanism to deal with any concerns.

When considering the confidentiality of information supporting applications for marketing authorisations (“MAs”), regulatory protection of pharmaceutical products, and Supplementary Protection Certificates (“SPC”) it is noteworthy that this is not included in the Medicinal Products Annex, but is included in the IP section (Title V) of the TCA.

  • In relation to regulatory data protection generally, the TCA requires that both the UK and the EU ensure that commercially confidential information submitted to obtain an MA is protected against disclosure to third parties, unless there is an overriding public interest or steps are taken to ensure the data is protected from unfair commercial use.
  • For the regulatory protections of data and market exclusivity, the TCA provides that, subject to any international agreement to which both the EU and the UK are party, and without prejudice to any additional periods of protection which either party may wish to provide for in its domestic law, these regulatory protections will be “for a limited period of time to be determined by domestic law”. This allows each of the UK and the EU to determine the length of such regulatory exclusivities under their own regulatory regimes.
  • For SPCs, the TCA records the agreement of both the UK and the EU to provide for further patent protection to compensate for the impact of regulatory administrative procedures but, again, the length of time is not stipulated.

The effect of these provisions is that they provide some comfort that these valuable forms of protection for medicinal products will be maintained by both the UK and the EU.

For detailed commentary on the new regulatory position for Pharma in the UK, and the impact on IP rights generally, see our series of posts on the HSF Intellectual Property Notes blog here.

Other provisions relevant to the pharmaceutical and medical device industry

The TCA also has provisions relating to the UK’s continued participation in EU programmes and on UK / EU cooperation on “serious cross-border threat[s] to health that are relevant for the pharmaceutical industry.

  • Subject to the UK making financial contributions, Part 5 of the TCA includes agreement on the UK’s continued participation in EU programmes, including the EU’s research and innovation funding programme, Horizon Europe.
  • UK / EU cooperation on serious cross-border threat[s] to health is covered by the TCA including agreement between the UK and the EU on emergency relief in relation to importation requirements, tax and road transport exemptions, and agreement to cooperate in relation to international health security systems.

Future developments

Although tariff free and quota-free trade has been agreed, there is little mutual recognition of regulatory provisions. This may not be the end of negotiations, with automatic reviews every 5 years written into the TCA and termination possible on 12 months’ notice.  See the HSF Brexit blog for further information, and our initial comments here.

Key contacts and authors

Jonathan Turnbull

Jonathan Turnbull
Partner, London
+44 20 7466 2174

Rachel Montagnon

Rachel Montagnon
Professional Support Consultant, London
+44 20 7466 2217

George McCubbin

George McCubbin
Senior Associate, London
+44 20 7466 2764

Priyanka Madan

Priyanka Madan
Associate - London
+44 20 7466 2986

As the Bundestag passes the legislation to ratify the UPC Agreement, the UPC may finally open its doors in 2022

The Unified Patent Court (UPC) took another step closer to coming into being on November 26 with a Bundestag vote passing the legislation necessary for Germany to ratify the UPC Agreement and the Protocol on Provisional Application with (more than) the two thirds majority found to be required by the German Federal Constitutional Court in its decision rejecting the initial vote on these measures as unconstitutional for lack of sufficient majority (decision dated 13 February 2020, announced 20 March 2020).

German ratification – next steps and any further challenges?

Germany is the last required ratifier of the UPC Agreement (UPCA).  Ratification by at least 13 contracting states is required for the UPCA to enter into force, additionally this must include the “three States in which the highest number of European patents was in force in the year preceding the year in which the signature of the Agreement takes place”. With UK having withdrawn, those three countries are France, Germany and Italy. So far 15 contracting Member States have ratified, including France and Italy (see the ratification table here) so Germany’s ratification is the last piece of the jigsaw for the UPCA to come into force.

The legislation will now be submitted to the German upper house (Bundesrat) where approval is expected to take place on December 18. The next steps after that are a countersignature by the Federal Government (a formality) and the signature of the Federal President (so-called “Ausfertigung” or legalization). This is followed by the publication in the Federal Law Gazette, by which the law enters into force, allowing the Federal Government to deposit the ratification of the UPCA and sign the Protocol.

In the first German ratification attempt the Federal President did not sign because a constitutional challenge had been filed after the Bundesrat vote and the Constitutional Court asked the Federal President to delay his signature to await the outcome of the challenge, which in the end was successful based on the majority vote issue.

A “Foundation for a Free Information Infrastructure” (FFII) has following the Bundestag vote started a crowd-funding campaign for a new constitutional challenge. However, unless the FFII or others started preparation a while ago it seems highly unlikely that such a challenge could be filed before the law enters into force. Further, it seems unlikely that the Constitutional Court will once again ask the Federal President to delay his signature.

In addition, even though the Constitutional Court referred in its decision to a number of issues as relevant but either not substantiated enough in the constitutional challenge or not necessary to decide due to the successful majority challenge, it appears unlikely that any further challenge would succeed.

Once the German ratification is deposited, the UPC will commence on the 1st day of the fourth month after the month of the deposit of instrument of ratification. Germany is expected to delay the deposit of its ratification of the UPCA until the UPC has become fully operational during a period of provisional application as explained further below.

The UPC “Provisional Application” phase

The Protocol on Provisional Application (PPA) provides for a provisional application of the UPCA before the UPCA actually enters into force. As well as ratifying the UPCA, participating states need to sign the PPA, so that the provisional application stage can start.

By signing the PPA, the signatory states agree to apply the institutional, organisational and financial sections of the UPCA provisionally. Once the Protocol enters into force, the UPC organisation (as such) will be created and acquire legal personality. The Administrative Committee, the Budget Committee and the Advisory Committee will be established at the start of provisional application stage and will then take over the responsibility of the preparations from the UPC Preparatory Committee.

The provisional application stage allows the final preparations to be made for the commencement of the UPC in the certain knowledge that it will actually commence. This allows the employment of judges for example, and the finalisation of court preparations. The UPC rules of procedure also need to be finalised during this period.

There is no prescribed time-frame for the provisional application period, however, it is currently expected that it may take approximately 12 months.

In order for the PPA to enter into force, in addition to Germany, two other UPCA contracting Member States still need to sign the Protocol. It is currently envisaged that this could happen by February 2021.

Thus, assuming that the provisional application starts in February 2021 and that Germany deposits the ratification of the UPCA by February 2022, thereby triggering the prescribed period running up to the commencement of the UPC, the UPC could then open its doors on June 1, 2022.

Support for the UPC from the Commission and the EPO

The day before the Budnestag vote, the Commission released its EU IP action plan: Making the most of the EU’s innovative potential – An intellectual property action plan to support the EU’s recovery and resilience (25 November 2020) – see our blog post here. The Commission considers the unitary patent (UP) and the UPC as key to ensure that innovators have access to “fast, effective and affordable protection tools“. The Commission states that once the ratification process is completed, the Commission will work with the EPO and Member States to make the UPC/unitary patent system operational across the contracting EU Member States and will encourage the Member States that have not done so to join the system (Spain, Poland and Croatia).

The EPO President António Campinos responded to the Bundestag vote saying that, the so-called “the Unitary Patent package” (ie the UPC/unitary patent system) “will make Europe even more attractive for innovation and investors – and help with economic recovery in light of the COVID-19 crisis.” He declared that the EPO stands ready to register the first UPs, once the UPCA comes into force. The UPC is the only court in which UPs can be litigated. Campinos expects the UPC to start its work in 2022.

For more on the UPC and unitary patent system see our dedicated hub here.

Authors 

Sophie Rich

Sophie Rich
Partner, Global Head of IP, London
+44 20 7466 2294

Ina vom Feld

Ina vom Feld
Partner, IP, Dusseldorf
+49 211 975 59091

Sebastian Moore

Sebastian Moore
Partner, IP, Milan and London
+39 02 3602 1398

Rachel Montagnon

Rachel Montagnon
Professional Support Consultant, IP, London
+44 20 7466 2217

The CJEU’s decision in Santen confirms a restrictive interpretation of ‘product’ under article 1(b) and 3(d) of the SPC Regulation, and rejects the possibility of an SPC based on a Marketing Authorisation for a new use of a previously authorised product

On 9 July 2020, the Grand Chamber of the Court of Justice of the European Union (“CJEU”) handed down its decision in Santen SAS v Directeur général de l’Institut national de la propriété industrielle (C-673/18), a reference from the Paris Court of Appeal concerning the interpretation of Articles 1(b) and 3(d) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate (“SPC”) for medicinal products (“SPC Regulation“).

The CJEU considered whether the definition of ‘product’ in Article 1(b) of the SPC Regulation is tied to the therapeutic application of the active ingredient, and in particular if a new therapeutic application of a previously authorised active ingredient can be considered a distinct ‘product’, such that a further marketing authorisation (“MA”) covering that new therapeutic application would constitute the “first authorisation” under Article 3(d) of the SPC Regulation.

The CJEU held that an MA cannot be considered as the first MA within the meaning of Article 3(d) when it concerns a new therapeutic application of a known active ingredient (or combination of active ingredients) which has already been the subject matter of an MA for another therapeutic application.

This decision severely limits the availability of SPCs for second medical uses of known products and removes the ability to obtain an SPC based on a later MA for a subsequent therapeutic use of a known and previously authorised medicinal product. It will no doubt be disappointing to R&D based pharmaceutical companies that are investigating such new uses and which would wish to rely on the additional protection afforded by an SPC based on that later MA to compensate them for the loss of exclusivity caused due to regulatory delays in getting a product authorised for that new therapeutic use to the market.

Legal Background

Article 3(d) of the SPC Regulation provides that an SPC cannot be granted if there has been an earlier MA for the same ‘product’ (ie, the active ingredient or active ingredients of the medicinal product under Article 1(b) of the SPC Regulation). Despite the seemingly straightforward wording of this Article of the SPC Regulation, the issue of what constitutes a ‘product’ for the purposes of Article 3(d) has been the subject of significant debate in recent years.

The CJEU traditionally afforded a narrow interpretation to ‘product’ under Articles 3(d) and 1(b) of the SPC Regulation. In Yissum (C-202/05), which concerned a patent for a composition containing the compound ‘calcitrol’ for use in topical treatment of skin disorders, the CJEU interpreted Article 1(b) of the SPC Regulation as meaning that in a case where a basic patent protects a second medical use of an active ingredient, that use does not form an integral part of the definition of the ‘product’. As a consequence of which an SPC could not be granted on the basis of the MA for the new use if the same active ingredient had been subject to a previous MA authorised for a different use.

Similarly, in Pharmacia Italia (C-31/03), which concerned a patent covering the compound ‘cabergoline’, the CJEU held that the grant of an SPC based on an authorisation of a medicinal product for human use was precluded by a prior MA for that same product as a veterinary medicinal product. In that case, the later human medicinal product, DOSTINEX® containing the active ingredient ‘cabergoline’ was authorised in Germany, after an earlier veterinary medicinal product with that active ingredient, GALASTOP®, had been authorised in Italy.

However, in its decision in Neurim (C‑130/11), the CJEU departed from its previous case law, and instead indicated that SPCs would be available for second medical uses of known active ingredients. The Neurim case concerned a patent covering a formulation of melatonin, which was subsequently authorised and marketed as CIRCADIN® by Neurim. Neurim applied for an SPC on the basis of the CIRCADIN® MA despite there being an earlier authorisation for a veterinary product, REGULIN®, which used melatonin in regulating the seasonal breeding activity of sheep.

In considering this reference from the UK Court of Appeal, the CJEU held that the mere existence of an earlier MA obtained for a veterinary medicinal product does not preclude the grant of an SPC for a different application of the same product for which an MA has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the SPC. (the “Neurim exception”). In short, the Neurim exception permits the grant of an SPC on the basis of a subsequent MA for a new therapeutic use of a known active ingredient, where the earlier MA covering the known active ingredient falls outside the scope of protection of the basic patent relied upon for that SPC.

In reaching this conclusion the Grand Chamber noted that the fundamental objective of the SPC Regulation is to ensure sufficient protection to encourage pharmaceutical research. Therefore, if a patent protects a new therapeutic application of a known active ingredient, this should enable its proprietor to obtain an SPC for the new use of that active ingredient, even if it has already been marketed as a medicinal product (for veterinary or human use) for other therapeutic indications previously.

This Neurim exception was also subsequently suggested to cover a patent relating to any new therapeutic application of a previously known active ingredient, notably in paragraph 27 of the CJEU’s decision in Actavis v. Sanofi (C-443/12), and was seen as an encouraging development for the pharmaceutical industry as it incentivised investment in researching and developing new indications for known products that improve treatments and save lives.

However, in  Abraxis Bioscience LLC v the Comptroller General of Patents (C-443/17), the CJEU returned to its old strict approach, and confirmed that SPCs cannot be obtained on the basis of MAs for new formulations of previously authorised active ingredients (see our summary here). This case concerned “nab-paclitaxel” (ABRAXANE®) which contains the previously authorised active ingredient paclitaxel, but formulated as albumin bound nanoparticles. When considering this reference form the UK High Court, the CJEU held that Article 1(b) of the SPC Regulation must be interpreted narrowly, and that adjuvants (such as albumin) are excluded from the meaning of ‘product’ even if they allow the active ingredient with which they are associated to exercise its therapeutic effect more effectively. Having made its finding that Article 1(b) must be interpreted narrowly, the CJEU recognised that the objective of the SPC Regulation would not be fulfilled by allowing an SPC based on an MA for a new formulation of a previously authorised product. The CJEU therefore expressly rejected an extension of the Neurim exception to SPCs based on MAs for new formulations of a previously authorised product, but in doing so it did not provide any further clarity on the scope of this Neurim exception insofar as it related to new therapeutic uses.

In the above context, it was hoped that such scope would finally be clarified by the CJEU when it considered the current reference in Santen.

Factual background to Santen (C-673/18)

A reference was made to the CJEU by the Paris Court of Appeal concerning Santen’s French SPC application based on European Patent No. 1 809 237 (entitled ‘Ophthalmic oil-in-water type emulsion with stable positive zeta potential’), and a centralised MA for the medicinal product IKERVIS®, containing as its active ingredient 1 mg/ml cyclosporine in the form of an emulsion, administered as an eye drop for the treatment of severe keratitis in adult patients.

Prior to the grant of the centralised MA for IKERVIS®, an MA had been granted for the medicinal product SANDIMMUN®, which contained as its active ingredient 100 mg/ml of cyclosporine in the form of an oral solution for the prevention of rejection of solid organ and bone marrow grafts, and for the treatment of endogenous uveitis (an inflammation of some or all of the uvea, which is the middle layer of the eye).

In light of the earlier authorisation for SANDIMMUN®, the French Parent office rejected Santen’s SPC application, and this rejection was appealed to the Paris Court of Appeal, which in turn referred the two questions below to the CJEU on the scope of the Neurim exception (the full procedural background to the case is available here in our previous update). The two questions referred to the CJEU were:

“Must the concept of a ‘different application’ within the meaning of the judgment of 19 July 2012, Neurim (C-130/11, EU:C:2012:489), be interpreted strictly, that is to say:

–    as limited only to the situation where an application for human use follows a veterinary application;

–    or as relating to an indication within a new therapeutic scope, in the sense of a new proprietary medical product, compared with the earlier marketing authorisation, or a medicinal product in which the active ingredient acts differently from how it acts in the medicinal product to which the first marketing authorisation related;

–    or more generally, in the light of the objectives of Regulation (EC) No 469/2009 of establishing a balanced system taking into account all the interests at stake, including those of public health, must the concept of a “new therapeutic use” be assessed according to stricter criteria than those for assessing the patentability of the invention;

–    or must it on the other hand be interpreted broadly, that is to say, as including not only different therapeutic indications and diseases, but also different formulations, posologies and/or means of administration?

Does the expression “[application] within the limits of the protection conferred by the basic patent” within the meaning of the judgment [of the Court of Justice] of 19 July 2012, Neurim (C-130/11, [EU:C:2012:489]), mean that the scope of the basic patent must be the same as that of the marketing authorisation relied upon and, therefore, be limited to the new medical use corresponding to the therapeutic indication of that marketing authorisation?” 

AG’s opinion in Santen

On 23 January 2020, AG Giovanni Pitruzzella provided his Opinion on the referred questions. A full analysis of this Opinion is available here in our previous post.

Briefly, AG Pitruzzella made two proposals to the CJEU. His favoured proposal was for the CJEU to reverse its decision in Neurim and strictly interpret the meaning of ‘product’ under Article 1(b).

His alternative proposal permits SPCs for second medical uses of known and previously authorised products in some instances by interpreting the Neurim exception as allowing an SPC if the new MA “covers a new therapeutic indication of said active ingredient or relates to a use of it in which this active ingredient exerts a new pharmacological, immunological or metabolic action of its own”.

Analysis of the Santen decision of the Grand Chamber of the CJEU

In its decision, the Grand Chamber states that in order to respond to the Paris Court of Appeal in a useful way, the question that needs to be addressed is whether Article 3(d) can be interpreted as meaning that an MA can be the first MA within the meaning of this article if it concerns a new therapeutic application of a known active ingredient (or combination of active ingredients), which has already been the subject of an MA for another therapeutic application.

In responding to this question, the Grand Chamber notes that the MA in Article 3(d) is for a given ‘product’ as defined in Article 1(b), and that the first issue was whether a ‘product’ is dependent on or tied to a therapeutic application, in particular if a new therapeutic application of a known active ingredient can be considered as a product distinct from another therapeutic application of the same active ingredient.

In this respect, the Grand Chamber concludes that, as a result of a joint reading of Article 1(b) and 4 of the SPC Regulation, ‘product’ means the active ingredient or combination of active ingredients of a medicinal product, and it is not limited to any particular therapeutic application. This is supported by the Explanatory Memorandum for the SPC Regulation, which states that the term ‘product’ is to be understood strictly as the active ingredient, and that minor changes (such as a new dosage, the use of a different salt or ester or even the form of the pharmaceutical product), are not likely to give rise to a new SPC. Consequently, the fact that an active ingredient or a combination of active ingredients can be used for a new therapeutic indication does not make it a distinct ‘product’ because of this new therapeutic use.

The second issue considered by the Grand Chamber is whether an MA granted for a new therapeutic application of a known active ingredient or combination of active ingredients can be considered as the ‘first’ MA within the meaning of Article 3(d), where this MA is the first one to fall within the scope of protection of the basic patent relied upon in the SPC application.

The Grand Chamber notes that Article 3(d) does not refer to the scope of protection of the basic patent. In this respect, the Grand Chamber restates its decision in Abraxis that the first MA for a medicinal product is simply the one incorporating the active ingredient or the combination of active ingredients, whatever the therapeutic application for this active ingredient or combination of active ingredients might be. If one were to consider the scope of protection of the basic patent in assessing Article 3(d), then this would go against this definition of ‘product’ in Article 1(b), and it would then become possible for an SPC to be granted for a new therapeutic application of a known active ingredient, when the same active ingredient is already covered by a previous MA for another therapeutic use. The Grand Chamber then stresses that the Neurim decision, which allows for this possibility, is inconsistent with the SPC Regulation in this regard, as the scope of protection of the basic patent is irrelevant when assessing Article 3(d).

The Grand Chamber goes on to state that, on the basis of its ruling in Abraxis and the Explanatory memorandum to the SPC Regulation, the SPC regulation is not intended to reward any and all research, but is rather aimed at only rewarding research leading to the first placing on the market of an active ingredient or combination of active ingredients as a medicinal product. This objective would not be achieved if Article 3(d) were interpreted as meaning that the ‘first’ MA to fall under the scope of protection of the basic patent would entitle the proprietor to an SPC based on the later authorisation. Difficulties would also result from a different interpretation of Article 3(d) that relied on concepts such as a new “therapeutic indication”. As mentioned in the Opinion of Advocate General Pitruzzella, the notion of “therapeutic indication” is not even defined by the SPC Regulation and this might lead to National Patent Offices adopting inconsistent interpretations of such an Article 3(d) test.

The decision of the Grand Chamber therefore only leaves a (small) door open for SPCs for new therapeutic uses for “known” products, namely where the “known” product has not been previously authorised.

The ruling of the Grand Chamber of the CJEU is thus as follows:

60. […] The premiss on which the referring court relies, mentioned in paragraph 34 above, must be disregarded and that an MA for a therapeutic application of a product cannot be regarded as the first MA for that product as a medicinal product, for the purpose of Article 3(d) of Regulation No 469/2009, where another MA was granted previously for a different therapeutic application of the same product. The fact that the most recent MA is the first MA to fall within the limits of the protection of the basic patent relied on in support of the SPC application cannot call that interpretation into question.

61.[…] An MA cannot be considered to be the first MA, for the purpose of [Article 3(d)], where it covers a new therapeutic application of an active ingredient, or of a combination of active ingredients, and that active ingredient or combination has already been the subject of an MA for a different therapeutic application.”

The Grand Chamber considers this to be a balanced approach between, on the one hand, ensuring that the objective of the SPC Regulation to incentivise research and compensate for the insufficient protection offered by the basic patent is met, and on the other hand taking into account all interests at stake.

This is as close to a “reversal” of the Neurim decision as we are likely to get from the CJEU. It is clear from the language adopted by the Grand Chamber, ie, that the Neurim decision is “contrary” to the SPC Regulation (paragraph 53), and that the premise arising from the Neurim decision “must be rejected” (paragraphs 34 and 60), that there is likely to be little scope to argue for the grant of an SPC based on an subsequent MA for a new therapeutic use of known and previously authorised active ingredient.

Key contacts and Authors

Frederic Chevallier

Frederic Chevallier
Partner - Paris
+33 1 53 57 13 60

Jonathan Turnbull

Jonathan Turnbull
Partner - London
+44 20 7466 2174

Priyanka Madan

Priyanka Madan
Associate - London
+44 20 7466 2986

Patent and Pharma Update, February 2020

Key recent developments in the United Kingdom and Europe relating to patents and the pharmaceutical sector

In this issue we report on the Supreme Court decision of Shanks v Unilever on employee inventor compensation. We update on two CJEU decisions relation to public access to documents submitted to the EMA and a key competition decision on “pay-for-delay” agreements. We cover a string of patent-related UK Court of Appeal cases, including Ablynx v VHSquared on jurisdiction, Anan Kasei v Neo on insufficiency and joint tortfeasorship and L’Oreal v Liqwd on claim amendments and admission of late evidence. We provide brief updates from the EPO on the recent CRISPR priority decision, as well as its AI inventorship decision. We have bumper SPC and FRAND updates covering key Court of Appeal and CJEU decisions in respect of SPCs and a string of interesting interim decisions in the UK in the case of FRAND. We round off the issue with a link to our new IP podcast series and updates on Brexit and the UPC. Continue reading

CJEU AG’s Opinion in Santen referral proposes to abandon Neurim

CJEU’s AG in Santen referral (C-673/18) invites the Court to make a clear choice between reversing Neurim (main proposal) or extending the interpretation of the concept of ‘product’ in order to achieve the result sought in Neurim (alternative proposal)

On 23 January 2020, AG Giovanni Pitruzzella provided his Opinion on the interpretation of Article 3(d) 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 (“SPC Regulation“).

In doing so, AG Pitruzzella makes two proposals to the CJEU.

His favoured proposal would significantly curtail the availability of SPCs for second medical uses of known and previously authorised compounds, as it strictly interprets the meaning of ‘product’ under Article 1(b) and precludes an interpretation of Neurim according to which a marketing authorisation (“MA”) for a “different and new application of an old active ingredient” could be considered as the first MA of a previously authorised active ingredient.

His alternative proposal permit SPCs in a wider set of circumstances by interpreting Neurim as allowing an SPC to be granted if the new MA “covers a new therapeutic indication of said active ingredient or relates to a use of it in which this active ingredient exerts a new pharmacological, immunological or metabolic action of its own”.

Business impact

Article 3(d) of the SPC Regulation provides that an SPC cannot be granted if there has been an earlier MA for the same ‘product’ (ie, the active ingredient or active ingredients of the medicinal product under Article 1(b) of the SPC Regulation). However, the CJEU in Neurim (Case C-130/11) held that Article 3(d) did not preclude an SPC from being granted for a different application for human use of a product that had been previously authorised for a veterinary use, provided that the SPC application is based on a patent for which that second medical use falls within the limits of its protection.

The CJEU’s decision in Neurim was seen as a departure from its earlier case law (Yissum (Case C-202/05) and Pharmacia Italia (Case C-31/03)), as it did not strictly interpret Article 3(d) and indicated that SPCs were available for second medical uses of known active ingredients. This interpretation in Neurim was subsequently resumed notably in paragraph 27 of the CJEU’s decision in Actavis v. Sanofi (C-443/12). This was an encouraging development for the pharmaceutical industry and was an incentive to invest significantly in researching and developing new indications for known products that improve the treatment of patients and save lives.

However, in March of last year, the CJEU held in Abraxis (Case C-443/17) that an SPC could not be obtained for new formulations of previously approved active ingredients, with this following the Opinion of AG Saugmandsgaard Øe that suggested that the “Neurim exception” was limited to the “particular, and probably exceptional, kind of situations at issue in Neurim“ (see our update here). As a consequence, there is uncertainty as to the circumstances in which an SPC can be obtained for a second medical use of a known active ingredient and guidance is needed from the CJEU.

If the Grand Chamber of the CJEU follows the AG Giovanni Pitruzzella preferred proposal then this will severely limit the application of the “Neurim exception” and the availability of SPCs for second medical uses of known and previously authorised products and be a disappointing result for R&D based pharmaceutical companies.

Background

A reference was made to the CJEU by the Paris Court of Appeal following its decision of 9 October 2018. That case related to Santen’s French SPC application (No. 15C0040), which is based on the European Patent, EP 1 809 237 (entitled ‘Ophthalmic oil-in-water type emulsion with stable positive zeta potential’) and a centralised MA for the medicinal product, IKERVIS®. IKERVIS® contains as its active ingredient 1 mg/ml cyclosporine in the form of an emulsion, which is administered as an eye drop for the treatment of severe keratitis in adult patients. Originally the SPC application was for ‘cyclosporine eye drops, emulsion’, but following observations from the French Patent Office this was amended to ‘cyclosporine for use in the treatment of keratitis’.

Prior to the grant of the centralised MA for IKERVIS®, an MA had been granted for the medicinal product SANDIMMUN®, which contained as its active ingredient 100 mg/ml of cyclosporine in the form of an oral solution for the prevention of rejection of solid organ and bone marrow grafts, and for the treatment of endogenous uveitis (an inflammation of some or all of the uvea, which is the middle layer of the eye).

In light of the earlier authorisation for SANDIMMUN®, the French Patent Office rejected Santen’s SPC Application in its decision of 6 October 2017 and held that the requirements in Neurim were not satisfied as: (i) EP 1 809 237 protected not only a new use of cyclosporine (claims 23 to 24) but also types of ophthalmic emulsions of cyclosporine (claims 1 to 21 and 25 to 26); and (ii) the medical use of IKERVIS® was not a new therapeutic use of cyclosporine within the meaning of Neurim, as the therapeutic use of SANDIMMUM® was also for the treatment of ophthalmic inflammations.

The French Patent Office argued that the grant of an SPC is designed to be an exceptional reward for innovative medicinal products, such that several conditions must be satisfied and that Neurim must be narrowly applied. Despite arguing for a narrow application of Neurim, the French Patent Office did not want to limit its application to its specific facts (ie, where a human use follows a veterinary use). The French Patent Office therefore held that an SPC can be obtained if it relates to medicinal product that has a new therapeutic scope. The new therapeutic scope arising from either a medicinal product containing a new active ingredient, or from a medicinal product containing a known active ingredient utilising a different mode of therapeutic action when compared to the earlier authorisation.

On appeal, the Paris Court of Appeal noted the disagreement between Santen and the French Patent Office on the correct interpretation of the CJEU’s decision in Neurim. It also noted that “both medicinal products [in suit] relate to the treatment of inflammation of parts of the eye in humans, using the same anti-inflammatory mechanism of cyclosporine” and that both IKERVIS® and SANDIMMUM® “differ in their therapeutic indications and in their formulation, dosage and posology“, and that “it is not disputed that the [indications of both medicinal products relate to] different diseases, affecting different parts of the eye“. Given the uncertainty over the application of Neurim and when an SPC is available for a different application of a known active ingredient, the Paris Court of Appeal referred the following questions to the CJEU:

Must the concept of a ‘different application’ within the meaning of the judgment of 19 July 2012, Neurim (C-130/11, EU:C:2012:489), be interpreted strictly, that is to say:

–    as limited only to the situation where an application for human use follows a veterinary application;

–    or as relating to an indication within a new therapeutic scope, in the sense of a new proprietary medical product, compared with the earlier marketing authorisation, or a medicinal product in which the active ingredient acts differently from how it acts in the medicinal product to which the first marketing authorisation related;

–    or more generally, in the light of the objectives of Regulation (EC) No 469/2009 of establishing a balanced system taking into account all the interests at stake, including those of public health, must the concept of a “new therapeutic use” be assessed according to stricter criteria than those for assessing the patentability of the invention;

–    or must it on the other hand be interpreted broadly, that is to say, as including not only different therapeutic indications and diseases, but also different formulations, posologies and/or means of administration?

Does the expression “[application] within the limits of the protection conferred by the basic patent” within the meaning of the judgment [of the Court of Justice] of 19 July 2012, Neurim (C-130/11, [EU:C:2012:489]), mean that the scope of the basic patent must be the same as that of the marketing authorisation relied upon and, therefore, be limited to the new medical use corresponding to the therapeutic indication of that marketing authorisation?” 

Analysis

In his Opinion for the Grand Chamber of the CJEU, AG Giovanni Pitruzzella highlights that the CJEU’s decision in Neurim was out of line with its earlier case-law on the meaning of ‘product’ in Article 1(b) of the SPC Regulation. He emphasises that the use in Neurim of the undefined expressions “new therapeutic application”, “new use”, “different application” or “other therapeutic indication” rises several possible interpretations of this decision.

In light of this, AG Giovanni Pitruzzella considers the implications of the conclusions of Neurim, its departure from the CJEU’s earlier case-law and the subsequent case-law of the CJEU.

Considering the earlier case law, AG Giovanni Pitruzzella highlights the CJEU’s decision in Yissum where the CJEU held that “the concept of ‘product’ cannot include the therapeutic use of an active ingredient protected by a basic patent”. In his view, the CJEU’s decision in Neurim “dissociated” the concept of a ‘first MA’ from the concept of a ‘product’ under Article 1(b) of the SPC Regulation in order for it to be linked to the concept of ‘basic patent’ under Article 1(c) of the SPC Regulation. The cases following Neurim, then reaffirmed a strict definition of ‘product’, whilst at the same time acknowledging that Neurim permitted SPCs for new therapeutic indications of an old active ingredient (see GSK (Case C-210/13) and Georgetown (Case C-484/12)). This was the position until the recent decision of the CJEU in Abraxis, which in AG Giovanni Pitruzzella’s view, upheld a “different and inconstant interpretation of Article 3(d)” compared to Neurim, whilst not reversing that earlier decision. To resolve this position, AG Giovanni Pitruzzella’s recommendation to the CJEU is that it should not limit Neurim to a narrow exception on its facts, but that it should make a clear and definitive choice between either reversing Neurim or departing from a strict definition of the meaning of ‘product’ under Article1(b) of the SPC Regulation.

AG Giovanni Pitruzzella’s preference is for the CJEU to maintain a strict definition of ‘product’ and for the CJEU to reverse its decision in Neurim, as electing any criterion other than a chronological one for determining the first MA would be contrary to the clear drafting of Article 3(d). In the alternative, to permit SPCs for second medical uses of previously authorised products under Article 3(d) would require that the CJEU adopt a broader, less strict interpretation of ’product’ under Article 1(b).

Over several pages of his Opinion, AG Giovanni Pitruzzella considers the need for the CJEU to define “which type of research is encouraged” by the SPC Regulation and the current ambiguity that exists on this topic. In his Opinion, the reward of an SPC was not created for any kind of research, but he recognises the inconsistencies of the CJEU’s statements in Neurim and Abraxis. In doing so, he quotes and appears to endorse the CJEU’s statement in Abraxis that “the legislature intended, in establishing the SPC regime, to protect not all pharmaceutical research giving rise to the grant of a patent and the marketing of a new medicinal product, but to protect research leading to the first placing on the market of an active ingredient or a combination of active ingredients as a medicinal product”. AG Giovanni Pitruzzella therefore concludes that the SPC system should be consistent, easy and transparent, such that it achieves the correct balance of interests between the various stakeholders, and that this was not achieved in Neurim which “altered this balance in favour of pharmaceutical companies”. This, in his view, supports his preferred recommendation to the CJEU to reverse the decision in Neurim and maintain a strict definition of ‘product’.

Should the CJEU not agree with this conclusion, in the alternative, AG Giovanni Pitruzzella proposes that the correct balance needs to be found between strictly limiting the availability of SPCs to situations where a human use would follow a veterinary use and permitting SPCs for any subsequently authorised products that included the same active ingredient, such as new formulations, posologies or modes of administration. In his view, the correct balance is found if the MA on which the SPC is based “covers a new therapeutic indication of said active ingredient or relates to a use of it in which this active ingredient exerts a new pharmacological, immunological or metabolic action of its own.

A translation of the conclusion of AG Giovanni Pitruzzella’s Opinion, which is not currently available in English, is:

In light of all of the foregoing considerations, I suggest that the Court, mainly, respond to the Paris Court of Appeal (France) as follows:

Article 3(d) […] read in conjunction with Article 1(b) […] must be interpreted as meaning that the marketing authorization referred to in Article 3(b) of that regulation, relied upon in a supplementary protection certificate application relating to a different and new application of an old active ingredient, cannot be considered to be the first marketing authorization for the product in suit as a medicinal product when this active ingredient has already been the subject of such an authorization per se.

In the alternative, in the event that the Court decides to proceed to the interpretation of the Neurim decision, I propose that the Court answer the questions referred by the Paris Court of Appeal as follows:

1) Article 3 […] must be interpreted as meaning that the grant of a supplementary protection certificate for a different application of an active ingredient for which a previous marketing authorization has been granted in the Member State concerned, within the meaning of the decision of 19 July 2012, Neurim Pharmaceuticals (1991), (C-130/11, EU: C2012: 489), requires that the marketing authorization relied upon to apply for a supplementary protection certificate covers a new therapeutic indication of said active ingredient or relates to a use of it in which this active ingredient exerts a new pharmacological, immunological or metabolic action of its own.

2) Article 4 […] must be interpreted as meaning that, in the case where the supplementary protection certificate relates to a different application of an old active ingredient, the concept of ‘product’, in the meaning of this provision, designates only said application and does not extend to the active ingredient as such or to other applications thereof.

Frederic Chevallier

Frederic Chevallier
Partner, Paris
+33 1 53 57 13 60

CJEU refuses UK High Court’s request for preliminary ruling on SPC applications based on third-party MAs, on account of referred question being “hypothetical” (C-239/19 Eli Lilly v Genentech)

On 5 September 2019, the Ninth Chamber of the CJEU refused a request for referral in relation to the interpretation of Article 3(b) 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 (‘SPC Regulation‘).

Business impact

In its order, the CJEU held that this request for a preliminary ruling was manifestly inadmissible a under Article 52(3) of the Rules of Procedure of the Court of Justice, as the question referred was hypothetical for the purposes of the dispute in the main proceedings.

The referral request was made by High Court of Justice (England and Wales) in proceedings [2019] EWHC 388 (Pat) between Eli Lilly and Genentech. The referral was concerned with whether the SPC regulation should preclude SPC applications based on third-party marketing authorisations (‘MAs‘), which is where a patent holder seeks to obtain an SPC for a product without the consent of the unrelated third party that has developed that product and obtained the necessary a MA for it.

This issue is not a new one, and was previously referred to in Eli Lilly v HGS (C-493/12). Although it was not being pursued as a standalone ground, the CJEU decision observed in this case that if an SPC were granted to the patent holder, even though he was not the holder of the MA granted for the medicinal product developed from the specifications of the patent, and had therefore not made any investment in research relating to that aspect of his original invention, that would undermine the objective of the SPC Regulation. In a similar vein, in Gilead v Teva (C-121/17; a case that did not concern grant of SPCs based on third-party MAs) the CJEU held in paragraph 50 of its decision that when applying Article 3(a) of the SPC Regulation no account should be taken of research which took place after the filing date or priority date of the basic patent, as this would enable the SPC holder to unduly to enjoy protection for those unknown results.

The refusal of the reference means that disappointingly, the rather important question of SPC applications based on third-party MAs remains unanswered. Nevertheless, it is likely that there will be a further reference on this issue in the future, perhaps from one of the other national courts where the dispute between Eli Lilly and Genentech remains live, or from the Court of Appeal in the UK (should this happen before Brexit).

Background

The referral request was made by the UK High Court in proceedings which related to Genentech’s patent EP (UK) 1 641 822, entitled ‘IL 17A/F heterologous peptides and therapeutic uses thereof’ (the ‘Basic Patent’) and Eli Lilly’s MA for their product ‘ixekizumab’ marketed under the brand name ‘Taltz’.

Genentech contended that the formulation for ixekizumab fell within the scope of the Basic Patent, and applied for an SPC on the basis of the Basic Patent and Eli Lilly’s MA for ixekizumab.

Eli Lilly in turn contended that two grounds precluded the grant of the SPC: 1) the SPC application at issue did not comply with Article 3(a) of the SPC regulation, since the formulation for ixekizumab was not protected by the Basic Patent; and 2) the application did not comply with either Article 2 or Article 3(b) and (d) of the SPC Regulation, because the MA for ixekizumab is not a relevant MA, since it is owned by a third party and was relied upon without that party’s consent.

By the time the referring decision as handed down, the Basic Patent had already been held to be invalid in parallel proceedings. Nevertheless, Mr Justice Arnold considered it necessary to make a referral to the CJEU on whether the SPC Regulation should preclude SPC applications based on third-party MAs. Various factors played a role in making the referral:

  1. Even though the Basic Patent had been held to be invalid in parallel proceedings, it may be maintained on appeal;
  2. Because of Brexit, it is highly probable that the Court of Appeal will cease to have jurisdiction to refer a question for a preliminary ruling to the Court of Justice, so it was considered necessary that the High Court refer such a question now;
  3. As of the date of the reference decision, Eli Lilly and Genentech were in dispute on this issue not only in the United Kingdom but also in other Member States;
  4. This issue had arisen in other previous cases.

Keeping the above in mind, Mr Justice Arnold referred the following question to the CJEU:

Does [the SPC Regulation] preclude the grant of an SPC to the proprietor of a basic patent in respect of a product which is the subject of a marketing authorisation held by a third party without that party’s consent? 

Analysis

The CJEU’s order clarifies that the role of the CJEU is to aid with interpretation of such EU law as is necessary for national courts to give judgment in cases upon which they are called to adjudicate. A reference for a preliminary ruling made by a national court is to be rejected where it is obvious that the interpretation of EU law that is sought is unrelated to the actual facts of the main action or its object, or where the problem is hypothetical.

In considering whether the clarification or interpretation of EU law sought in the referral is necessary, the CJEU held that it is not sufficient to say that there may be an appeal down the line which may render the hypothetical scenario true. Neither is it of relevance that the same issue exists in proceedings in other jurisdictions, or may have been raised in previous proceedings – the existence of disputes in other Member States of the European Union or of previous disputes does not support the conclusion that the interpretation of EU law that is sought is necessary for the resolution of the dispute which the referring court is called upon to resolve.

The CJEU also clarified that the referring court could not pre-emptively request a reference pending Brexit, on the basis that the appeal court might subsequently lose its jurisdiction to refer the same question because of withdrawal from the European Union pursuant to Article 50 of the TFEU, and while EU law continues in full force in the UK.

Conclusion

Although the refusal of the CJEU to decide on the referral is disappointing, it is hoped that the question of SPC applications based on third-party MAs will not remained unanswered much longer, and that there will be a decision that clarifies this issue in the foreseeable future. Meanwhile, the CJEU’s order sheds light on some important issues like the CJEU’s approach to references in light of Brexit, which will no doubt inform litigation strategy in the coming months.

Sebastian Moore

Sebastian Moore
Partner
+44 20 7466 2801

Martina Maffei

Martina Maffei
Associate
+39 02 0068 1353

Priyanka Madan

Priyanka Madan
Associate
+44 20 7466 2986

 

Preparations for the UPC continue despite an “unpredictable environment”

The UPC Preparatory Committee has issued a “Status of the Unified Patent Court Project” statement and review of 2018, confirming that there are now 16 states which have ratified the UPC, and that German ratification is still awaited (dependent on the outcome of the complaint pending before the Constitutional Court in Germany) before the project can move into provisional application phase. This latter phase is allows the courts to be prepared and judges to be appointed.

 

Despite the current, somewhat unpredictable environment, the technical and operational preparations are continuing allowing for the project to move at pace in the event of a positive outcome from the German Constitutional Court“.

The press release says nothing more than was already known, but it does confirm that the status of the project is constantly being reviewed, stating that the Chairman of the UPC Preparatory Committee “continues to meet with the Executive Group and the operational team on a monthly basis” and noting that those that have applied for judicial positions in the Unified Patent Court are being contacted separately.

Author

Rachel Montagnon

Rachel Montagnon
Professional Support Consultant, London
+44 20 7466 2217

Advocate General proposes literal interpretation of Article 3(d) SPC Regulation in Abraxis (C-443/17)

The Advocate General of the CJEU proposed a narrow interpretation of Article    3(d) in the Opinion given yesterday in Abraxis Bioscience LLC v Comptroller General of Patents 13 December 2018, one that would marginalise the effect of the CJEU’s decision in Neurim (C-130/11). If followed by the CJEU, this position would be met with disappointment by the pharmaceutical industry, which continues to make significant investments in researching and developing formulations that improve efficacy and new uses of known products.

Continue reading

Patent and Pharma Update – December 2018

Key recent developments in the United Kingdom and Europe relating to patents and the pharmaceutical sector

This issue reports on several ground-breaking decisions from the UK courts on second medical use patents and skinny labels, infringement by equivalents and the possibility of global FRAND licences for standard essential patents (SEPs).  We also look at some significant decisions from the CJEU on SPCs and reimbursements in relation to medicinal products and a few developments at the European Patent Office. Finally, we provide our usual round-up of the latest UPC developments (this time from Italy) and Brexit-related developments relevant to the pharma sector. Continue reading

French court upholds validity of MSD’s SPC protecting ezetimibe and simvastatin in combination

A French Court has upheld the validity of a Supplementary Protection Certificate (“SPC“) protecting the ezetimibe+simvastatin combination under Article 3(a) of the SPC Regulation.

Merck Sharp & Dohme (“MSD“) is the owner of a basic patent covering the compound ezetimibe. The basic patent also covers ezetimibe’s combinations with statin compounds, such as simvastatin, in its dependent claim, and simvastatin was already known as at the priority date. On the basis of this basic patent, MSD was granted an SPC for ezetimibe that expired on 17 April 2018, and an SPC for the combination ezetimibe+simvastatin expiring on 2 April 2019. Facing generic entry for the combination product when the ezetimibe SPC expired, MSD initiated preliminary injunction proceedings against a generic company, and a main revocation action was initiated by another generic company against the combination SPC.

In the PI case, the President of the Paris First Instance Court and the Paris Court of Appeal refused to grant the injunction on 5 April 2018 and 26 June 2018 respectively, relying primarily on the CJEU referrals in Georgetown and Sanofi to rule that since ezetimibe is the only “core of the invention” in the basic patent, the combination SPC could not be granted for ezetimibe+simvastatin.

Nevertheless, on the merits, the Paris First Instance Court upheld the validity of the combination SPC in a decision issued on 25 October 2018. The Court ruled on the basis of Georgetown and Sanofi as well as the decision in Gilead on 25 July 2018, that for the purposes of Article 3(a) of the SPC Regulation, “if the product, which is a combination of active ingredients according to Article 1 of EC Regulation No. 469/2009, necessarily belongs to the invention covered by the patent and if each active ingredient is specially identifiable, the grant of an SPC for the combination of active ingredients is possible“, as in the present case. Although the SmPC of the ezetimibe product mentioned the possibility of combining ezetimibe with statin compounds even before the combination was authorised as a medicinal product, the Court disagreed with the generic and also ruled that the marketing authorisation for the ezetimibe product could not be considered the first marketing authorisation in respect of the combination product for the purposes of Article 3(d) of the SPC Regulation.

In addition to the SPC argument, the decision rules on other issues, such as the statute of limitation of a revocation action (not time barred in the present case), and the sufficiency of disclosure of the combination ezetimibe+simvastatin in the basic patent (upheld on the basis of the test set in the finasteride decision of the French Supreme Court).

Please see here for the court’s decision in French.

Contacts

Frederic Chevallier

Frederic Chevallier
Partner
+33 15 357 1360

Krishna Kakkaiyadi

Krishna Kakkaiyadi
Associate
+44 20 7466 2979