SPCs, actives and medical devices

Recently, we posted a German Federal Patent Court decision which overruled a decision of the German Patent and Trademark Office, and granted an SPC to an implantable medicinal device (see link - Yttrium-90 Glass Microspheres). In light of questions we have received on this issue the SPC Blog asks whether any of its readers is aware of further decisions on SPCs involving medicinal devices.

By way of background, the issue is as follows.

Article 2 of SPC Regulation EC 469/2009 stipulates that:

"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/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use or Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products may, under the terms and conditions provided for in this Regulation, be the subject of a certificate."

[A product according to Article 1 of the SPC regulation is any active ingredient or combination of active ingredients of a medicinal product].

What does the underlined text mean? Does it mean that only a product specifically approved under Directive 2001/83/EC or 2001/82/EC may be subject of an SPC, or does it allow for an SPC to be granted for an active approved under some other EC legislation, and where the active component has undergone the same level of scrutiny as required by in Directive 2001/83/EC or 2001/82/EC.

The latter situation may arise in the medicinal devices Directives 93/42/EC (for Medicinal Devices) and 90/385/EEC (for implantable medicinal devices).

For example, Article 1(3) of Directive 93/42/EC indicates that medical devices containing actives are generally covered by the medicinal device directive and would not be authorised under Directive 2001/83/EC or 2001/82/EC. [The exception is where the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, in which case Directives 2001/83/EC or 2001/82/EC apply].

Directive 93/42/EC specifies, in paragraph 7.4 of Annex 1,that:
"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 65/65/EEC and which is liable to act upon the body with action ancillary to that of the device, the safety, quality and usefulness of the substance must be verified, taking account of the intended purpose of the device, by analogy with the appropriate methods specified in Directive 75/318/EEC [now Directive 2001/83/EC]. Similar language is found in Article 1(3) and paragraph 10 of Annex 1 of Directive 93/385/EEC.

Thus it would appear that an active component of a medicinal product whose approval is governed by the medicinal devices Directives should to be assessed at the same level of rigour as an active agent covered by Directives 2001/83/EC or 2001/82/EC. The need for equally stringent testing of active ingredients approved under different directives makes perfect sense, but does that fact alone open the door to SPC protection for the product?

Arguably it should. It appears to be unfair that SPC protection would only be available to actives that have been approved under Directives 2001/82/EC or 2001/83/EC, and that a new active specifically delivered by a device but approved under the medicinal devices Directive 93/42/EC (for example), could not take advantage of the SPC provisions.

The German Federal Patent Court in the Yttrium-90 Glass Microspheres case considered the level of testing required by the medicinal devices Directives allowed the product to conform to the administrative authorisation requirement of Article 2 of SPC Regulation EC 469/2009.

A similar conclusion was arrived at by the Court of The Hague in 2004 in Genzyme Biosurgery v. BIE (if anyone has an English translation of this decision we'd love to see it).

However, a court might consider that it was not able to interpret Article 2 of the SPC regulation more broadly than approval under Directives 2001/82/EC and 2001/83/EC per se. It might also be argued – at a stretch - that assessment of safety "by analogy" with Directive 2001/83/EC is not necessarily assessment at the same standard as under by Directive 2001/83/EC.

If you have other examples in the device area we would be interested to find out.

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