Forsgren: a new case note

The Bio-Science Law Review (Bio-SLR), published by Lawtext Publishing, carries a note on SPCs on vol.14 issue 4: it's "CJEU rules on the requirements for protecting carrier proteins using Supplementary Protection Certificates (SPCs)" and the author is Jennifer O'Farrell (Boult Wade Tennant, London). According to the abstract:

"Supplementary Protection Certificates (SPCs) extend the duration of protection conferred by a European patent for a medicinal product requiring marketing authorisation. The Court of Justice of the European Union (CJEU) has recently handed down the latest in a series of judgments (C-631/13 [a.k.a. Forsgren, noted briefly on The SPC Blog here]) which seeks to clarify what can, and cannot, be protected under EC Regulation No 469/2009 (the SPC Regulation). Here the CJEU has decided that an SPC may be granted for an active ingredient covalently bound to another substance only if the active ingredient for which supplementary protection is sought has a therapeutic effect covered by the wording of the marketing authorisation".

MAs and APIs: the Austrian Supreme Court applies Forsgren ruling

Last week our friend Rainer Schultes (Geistwert) posted on his blog this note, which we are happy to reproduce below with his permission, on the Austrian Supreme Court's application of the provisions of the SPC Regulation in the light of a recent ruling of the Court of Justice of the European Union (CJEU) in response to the Austrian court's reference in the Synflorix case.  For the benefit of any first-time readers, API stands for "active pharmaceutical ingredient" and an MA is not a higher degree but a marketing authorisation:

The API of an SPC need not be mentioned in the MA

In Case C-631/13 Forsgren [noted briefly here on The SPC Blog], the CJEU already ruled: Article 3(b) of Regulation 469/2009 must be interpreted as precluding the grant of a supplementary protection certificate for an active ingredient whose effect does not fall within the therapeutic indications covered by the wording of the marketing authorisation.

Article 1(b) of Regulation 469/2009 must be interpreted as meaning that a carrier protein conjugated with a polysaccharide antigen by means of a covalent binding may be categorised as an ‘active ingredient’ within the meaning of that provision only if it is established that it produces a pharmacological, immunological or metabolic action of its own which is covered by the therapeutic indications of the marketing authorisation.

GEISTWERT has blogged already (link).

Now, the Austrian Supreme Court shed further light on the SPC Regulation when applying the CJEU's judgment (Austrian Supreme Court, 4Ob20/15t).

In the matter at stake an SPC was requested for a protein D, which is a carrier protein covalently bonded to other active ingredients. Covalent binding does not exclude an SPC.

The Supreme Court analysed the context between the order for reference, the statement of the European Commission and the CJEU’s judgment: The Supreme Patent- and Trademark Senate, which referred the question to the CJEU had individualized the protein D as a carrier for which no pharmaceutical effect was mentioned in the Marketing Authorisation (MA). With regard to that, the Commission meant that the protein’s activity had to be mentioned in the MA, otherwise the request for SPC was not justified. The CJEU did not follow that but referred to the facts, thus to the effectiveness of the protein within Synflorix.

Upon this analysis, the Supreme Court now held that an own pharmacological, immunological or metabolic action of the protein D within the indications covered by the MA has to be established but it is not necessary that the protein D is explicitly mentioned in the Marketing Authorisation.

To verify that, the matter was referred back to the first instance.

Thanks so much, Rainer, for keeping us informed!