One More Piece in the SPC Puzzle - Medical Devices with Ancillary Substances Authorised under Article 1(4) of the Medical Devices Directive Do Not Qualify for an SPC

30/10/2018

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Gregory Bacon and Eleanor Denny

On 25 October 2018 the CJEU published their latest judgment[1] on the application of the SPC Regulation (Regulation (EC) No 469/2009). The question concerned the interpretation of Article 2 and whether it would permit the grant of an SPC on the basis of a medical device authorised under Article 1(4) of Directive 93/42/EEC (the MDD) rather than a marketing authorisation (MA) under Directive 2001/83/EC.  Article 1(4) of the MDD concerns devices that incorporate a substance, which if used separately may be considered a medicinal product but whose action is ancillary to that of the device.  This article summarises the key facts of the case and the judgment.

Background

Boston Scientific held a patent that was filed in 1994 (the ’94 Patent) and related to the use of medical substances, including paclitaxel (the principle active ingredient marketed as Taxol), in the treatment of certain cancers. Claim eight of the ’94 Patent stated “Use of taxol for the preparation of a medicament to maintain an expanded vessel luminal area”.

In 2003 Boston Scientific obtained a CE certificate of conformity for their medical device TAXUS, which was a paclitaxel-coated stent. It was authorised under the MDD on the basis of Article 1(4)[2] of the MDD and so Paclitaxel was subject to assessment under the first and second paragraphs of section 7.4, Annex I MDD[3].

In 2011 Boston Scientific applied for an SPC with the German Patent Office on the basis of the ’94 Patent and the CE conformity certificate for TAXUS; however, the application was rejected in February 2016 due to the lack of an MA for the purposes of the SPC Regulation.

The German Court

Boston Scientific brought an appeal against the decision of the German Patent Office arguing that paclitaxel met the requirement of Article 2 of the SPC Regulation, which states “Any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure as laid down in Directive [2001/83] … may, under the terms and conditions provided for in this Regulation, be the subject of a certificate”, and so should be entitled to an SPC. They argued that the mandatory certification procedure should be regarded as an authorisation procedure equivalent to the MA procedure in Directive 2001/83/EC.

The referring court agreed with Boston Scientific concluding that paclitaxel was “mandatorily subject, in the obligatory certification procedure for the medical device, to an equivalent evaluation, from the point of view of the material criteria for its assessment, to that which is laid down in Directive 2001/83 for the evaluation of medicinal products”. The court therefore thought products authorised under Article 1(4) of the MDD, along with the MA procedure, “should therefore both be regarded as administrative authorisation procedures within the meaning of Article 2 of Regulation No 469/2009” and that this was in line with the spirit and purpose of the regulation to reward holders of patents for time spent obtaining authorisation for products and incentivise R&D.

However, due to the differing views of the Patent Office and Court the court referred the following question to the CJEU:

Must Article 2 of Regulation [No 469/2009] be interpreted as meaning that, for the purposes of that regulation, an authorisation under Directive [93/42] for a combined medical device and medicinal product within the meaning of Article 1(4) of [that directive] is to be treated as a valid [MA] under Directive [2001/83], where, as part of the authorisation procedure laid down in Annex I, Section 7.4, first paragraph, to Directive [93/42], the quality, safety and usefulness of the medicinal product component has been verified by the medicinal products authority of a Member State in accordance with Directive [2001/83]?

Court of Justice Judgment

The CJEU did not agree with Boston Scientific and the referring court in their judgment. They set out their reasoning clearly as to why the Article 1(4) authorisation was not sufficient for the purpose of Article 2 and this is summarised below.

Firstly, the CJEU noted Article 2 of the SPC Regulation (as set out above) defines the scope of the Regulation and the Court stated “It is thus clear from the actual wording of that Article 2 that a product may be the subject of an SPC only if it has been subject, as a medicinal product, to an MA procedure as laid down in Directive 2001/83” (emphasis added). The CJEU discussed the definitions of “medicinal product” and “medical device” under the relevant legislation and noted these terms were “mutually exclusive” and explained a substance that performs an action ancillary to that of a medical device to which it is incorporated does not meet the definition of a medicinal product[4] and cannot be classified independently of the device.  The CJEU concluded that as a substance incorporated into a device within the meaning of Article 1(4) of the MDD cannot be classified as a medicinal product it cannot fall within the scope of the SPC Regulation.

Secondly, the CJEU did not agree that substances authorised under Article 1(4) of the MDD undergo an administrative procedure equivalent or comparable to the procedure provided for in Directive 2001/83. The CJEU explained that assessments carried out of substances in accordance with section 7.4, Annex I of the MDD are not in the context of the substance as a medicinal product (as would be the case under Directive 2001/83/EC) but instead take the intended purpose of the medical device in which the substance is incorporated into account.  This is even though the notified body is required under Article 1(4) to seek a scientific opinion on the quality and safety of the substance from either one of the competent authorities designed by the Member States or the EMA under Directive 2001/83/EC or the EMA[5].

The CJEU stated that this interpretation is borne out by both the context of the Article (noting both Articles 3(b) and 4 require the relevant product to have a valid MA granted under 2001/83/EC and to be authorised as a medicinal product) and the objective of the Regulation (noting recitals 3, 4, 8 and 10 that reserve the granting of SPCs to medicinal products alone). Finally, the Court did not think the judgments the referring court referred to[6] inferred a link of functional equivalence between the criteria for assessing a substance under section 7.4, Annex I of the MDD and the criteria for assessing medicinal products under Directive 2001/83/EC (and in addition they both related to SPCs for plant protection products).

Implications

While the judgment is only a small stanza in the epic saga of cases regarding the application of the SPC Regulation, this case does provide applicants with some additional clarity on what products can benefit from an SPC.  Even though the judgment is primarily restrictive in scope, it should also mean that patentees can be sure that if a substance has been used in a medical device, which has obtained a CE mark in accordance with Article 1(4) of the MDD this will not block the patentee from gaining an SPC (or limit the term of such an SPC) if an MA for this substance is subsequently obtained under Directive 2001/83/EC.



[1] Case C-527/17

[2] Article 1(4) of the MDD “Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive [2001/83] and which is liable to act upon the body with action ancillary to that of the device, that device shall be assessed and authorized in accordance with this Directive

[3] Paragraph 1 of Section 7.4, Annex I of the MDD “Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive [2001/83] and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive [2001/83].”

[4] Article 1(2) of Directive 2001/83/EC “Medicinal product: (a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or (b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.”

[5] See Paragraph 2 of Section 7.4, Annex I of the MDD

[6] Judgments of 11 November 2010, Hogan Lovells International (C‑229/09, EU:C:2010:673), and of 17 October 2013, Sumitomo Chemical (C‑210/12, EU:C:2013:665)

On 25 October 2018 the CJEU published their latest judgment on the application of the SPC Regulation (Regulation (EC) No 469/2009). The question concerned the interpretation of Article 2 and whether it would permit the grant of an SPC on the basis of a medical device authorised under Article 1(4) of Directive 93/42/EEC (the MDD) rather than a marketing authorisation (MA) under Directive 2001/83/EC. 
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