The Neurim CJEU decision of July 2012 has arguably caused an equal amount of excitement and controversy.  On the one hand, it seemed to open the door to supplementary protection certificates (SPCs) for second or further medical uses.  On the other, it seemed to go against a number of previous decisions.  On a strict literal interpretation of Article 3(d)[1] of the SPC Regulation[2], it should not be possible to obtain an SPC for new applications of old active ingredients that had already been the subject of a marketing authorisation.  In Neurim, based on a teleological interpretation to the SPC Regulation, the CJEU held that such an SPC could be validly granted.

A recent Opinion from Advocate General M. Giovanni Pitruzzella in the Santen SPC preliminary reference[3] urges the CJEU to expressly reject the Neurim decision, considering that the mere limitation of its application or marginalisation would not be a satisfactory option.

The facts in Santen

On 3 June 2015, Santen filed an SPC application relying on European Patent No. 057959306 as the basic patent in force (the “basic patent”) and on an EMA marketing authorisation granted on 19 March 2015 for the drug Ikervis (an eye drop emulsion containing the active ingredient ciclosporin used to treat severe keratisis).  The French National Institute of Industrial Property (“INPI”) rejected the application on the ground that a marketing authorisation had been previously issued for the same active ingredient for a medication called Sandimmun (an oral solution with several therapeutic indications including the eye disease uveitis, an inflammation of some or all of the uvea (the middle part of the eye)).

INPI held that the conditions in Neurim had not been satisfied for two reasons:

  • the basic patent was not limited to the severe keratisis indication – the claims included product only claims and claims to numerous other eye diseases; and
  • Santen had not demonstrated that the marketing authorisation constituted a ‘new therapeutic indication’ within the meaning of Neurim (for example, where the mode of action of the active ingredient differs or where the medical field differs).

Santen appealed the decision to the Paris Court of Appeal and it, in turn, decided to stay proceedings referring two preliminary questions to the CJEU.  The first question has asked the CJEU to consider how the concept of “different application” of an old active substance as understood in Neurim should be interpreted and the question provides a range of possible options from strict to broad interpretations.  The second question asks whether, in the context of determining whether the “[SPC application is] within the limits of the protection conferred by the basic patent” as understood in Neurim, the scope of the basic patent should be the same as the marking authorisation relied upon (i.e. it should be limited to the new medical use corresponding to the therapeutic indication of that marketing authorisation).

Less than six months after the preliminary reference was made by the Paris Court of Appeal, the CJEU had the opportunity to consider the scope and relevance of the Neurim decision in the Abraxis SPC case[4].  In that case the CJEU did not openly criticise the Neurim decision and, instead, limited its ramifications by referring to it as an “exception to the narrow interpretation of Article 3(d)” which “does not, in any event, refer to cases of new formulations of the product at issue”.


Continue Reading Santen SPC case: Advocate General Pitruzzella urges CJEU to reject Neurim

Opinion of the CJEU Advocate-General in Case C-581/18 RB v TÜV Rheinland LGA Products GmbH, Allianz IAED SA: application of the principle of non-discrimination on grounds of nationality in a medical device case.

Background

The effects of the Poly Implant Prothèse SA (PIP) defective breast implant scandal continue to be felt almost ten years since it first came to light that PIP had fraudulently used cheaper, industrial grade silicone in the implants that it manufactured. Due to PIP’s insolvency, those affected have attempted to obtain compensation from other sources, including the relevant notified body, TÜV Rheinland,[1] on the basis that this body had negligently certified PIP’s products and the French regulatory authorities.


Continue Reading Medical Devices and Compulsory Insurance in the EU

On 14 February 2019, the Court of Justice of the EU (CJEU) delivered its judgment in Case C-423/17 Netherlands v Warner-Lambert Company, finding in line with the opinion of Advocate General Kokott issued on 4 October 2018, that “carving-out” indications or dosage forms covered by the patent right of a third party, leading to a skinny label for the product, is a request to limit the marketing authorisation for the generic medicinal product. In practice, this prevents the competent authorities from publishing a complete SmPC, showing all indications associated with the innovator product, on their website.

Today’s judgment will be welcomed by innovative companies seeking to ensure the effectiveness of their second medical use patents.


Continue Reading CJEU decision on scope of skinny labels

Last week, the CJEU gave its decision in another procurement case in the healthcare area, Case C‑413/17 Roche Lietuva UAB. The case concerned the scope of technical specifications included as part of a tender by the Polyclinic for the Dainava District of Kaunas in Lithuania. The tender set out details of the medical diagnostic equipment and materials the authority wished to procure. Roche claimed that the specifications unreasonably restricted competition among suppliers due to their high specificity, and that in reality, the specifications corresponded to the products of certain manufacturers and excluded others.

The question referred to the Court concerned the limits to the margin of appreciation of a contracting authority to set out specifications in the tender, based on the quality of testing and the value of healthcare that it needs. The Court set out a useful summary of when technical specifications can be included in a tender and the principles for applying such specifications.


Continue Reading European Court clarifies use of technical specifications in healthcare tenders

Last week, the European Court of Justice gave its judgment on certain procurement questions relating to the supply of a radiopharmaceutical product, referred by the Italian Court in Case C-606/17, IBA Molecular Italy Srl. An Italian regional health authority and a public hospital were seeking to award a substantial contract to a private hospital, without conducting a public tender. They argued that as no direct consideration was provided to the hospital, and as the hospital was “classified” as part of the public healthcare system, any award constituted an agreement between public authorities to which EU law on public procurement does not apply. The European Court disagreed, and concluded that (i) public authorities cannot circumvent the EU procurement rules by awarding “funding” to an organisation in return for the provision of free products, and (ii) it was not possible to treat a “private” hospital as a public hospital in order to award contracts to them outside the EU procurement rules.

From the information available about the case, the answers to the questions referred seem straightforward and may be limited to the Italian system. However, it is nonetheless useful to have confirmation from the Court on the extent to which the provision of healthcare falls within the EU procurement regime.


Continue Reading European Court clarifies the application of procurement rules to healthcare

The next Future Pharma Forum will be on 27 September: Implications of Recent EU and UK Court Decisions in the Pharmaceutical Sector

Emily MacKenzie, Barrister at Brick Court Chambers, will join us to recap on how challenges to pharmaceutical decisions may be brought to the European and domestic courts. Emily will provide a summary

Yesterday, the UK Government finally published its White Paper setting out its position on the UK’s continued relationship with the EU post-Brexit. Theresa May has said it “delivers on the Brexit people voted for”, although others in Parliament disagree. While at a very early stage of the negotiations, and with no real indication of how the European Commission has received the White Paper, other than that it represents important progress for focusing the further discussions, we set out below the key points for the supply and manufacture of medicinal products and medical devices after Brexit.


Continue Reading UK Government’s Brexit White Paper

On 20 December 2017, the Court of Justice of the European Union (CJEU) confirmed that the term of a supplementary protection certificate (SPC) can be corrected to bring it into line with CJEU case law at any time before expiry of the SPC.

Following on from the decision in Seattle Genetics (C‑471/14) in 2015, which provided welcome clarity on which date should be used as the date of the first marketing authorisation (MA) for the purposes of calculating the duration of an SPC, this week’s decision should drive consistency in the application of Seattle Genetics by national patent offices across the EU. In Incyte (C‑492/16), the CJEU has ruled that an SPC holder can apply to rectify the duration of an SPC to bring it into line with Seattle Genetics at any time before expiry of the SPC, even if the period for appealing the decision under national legislation has passed.


Continue Reading CJEU confirms that SPC term calculated using “incorrect” MA date can be rectified at any time before expiry

In October, we reported that the oral hearing before the Court of Justice of the European Union (CJEU) took place in Case C-557/16 relating to the role of the Concerned Member States (CMS) in the Decentralised Procedure (DCP).

The Opinion of Advocate General Bobek has now been handed down. Although the AG takes no position on whether Ribomustin or Levact should have been used as the reference medicinal product, or when the applicable regulatory data protection (RDP) period started running, he opines that the CMS may raise issues as to RDP during the assessment phase and are co-responsible for the documents approved in that procedure. However, once agreement has been reached, CMSs cannot unilaterally revisit that decision. After authorisation, the courts of CMSs are competent to review the determination of the national competent authority.


Continue Reading AG opines that CMSs are co-responsible for MAs granted under the DCP