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SPC revoked, PI lifted, but no damages awarded

In the Sanofi v. Teva ruling of 10 July 2014, the Court of Milan clarified the test for abuse of process, and denied an award of damages allegedly caused by the issue of a preliminary injunction which was later lifted due to the revocation of the enforced SPC.

The case concerned the Italian part of the irbesartan saga, in which Sanofi was engaged in several countries in the enforcement of its CoAprovel SPCs, covering irbesartan + hydrochlorothiazide. In the aftermath of the Medeva/Georgetown decisions, Sanofi obtained preliminary injunctions against generic CoAprovel in several jurisdictions, on the assumption that the combination irbesartan + hydrochlorothiazide was “specified in the wo [...]

Spanish Court clarifies that “restitutio in integrum” applies to SPCs

The legendary deficient regulation of supplementary protection certificates (“SPCs”) has caused the Spanish Patent and Trademark Office (the “SPTO”) and Spanish Courts to struggle as to whether or not the “restitutio in integrum” procedure available to patents is also applicable to SPCs. The High Court of Justice of Madrid, in a recent Judgment of 22 April 2015, has reached an affirmative conclusion, thus revoking a decision of the SPTO that had rejected the applicability of “restitutio in integrum” to SPCs. The facts of the case may be summarised as follows.

A U.S. company filed an application for an SPC before the SPTO after the deadline established in Article 7 of Regulation 2009/469/EC ( [...]

Switzerland’s SPC granting practice drawn into a future mess?

In the aftermath of the CJEU decisions Eli Lilly/Medeva and Actavis/Georgetown II, the Swiss Federal Institute of Intellectual Property proposes changes in its SPC granting practice.

One hot topic in connection with the granting of SPCs concerns the question on how to define whether a product is protected by a basic patent (Art. 3 (a) SPC Regulation (EC) No. 469/2009). This discussion became particularly relevant with respect to combination products with multiple active ingredients. The national courts in the EU member states basically have applied two different approaches: the so called “infringement test” and the “disclosure test”.

In Switzerland SPCs for combination products have [...]

SPC cases are back and there are more to come: will the CJEU definitively heal the Medeva wounds on 12 march, or will it rub salt into them?

The Supplementary Protection Certificate (“SPC”) seas have been relatively calm after the turmoil caused by “Super Thursday” (i.e. 12 December 2013), when shortly before packing for Christmas the Court of Justice of the European Union (“CJEU”) published three judgments on SPCs in a row. However, over the last few months there have been recent developments, some of which we would like to pick-up on in this blog.

The first development relates to what the relevant date is for calculating the term of the SPC: the date when the marketing authorization was “granted” or the date when the applicant was notified of the decision granting the authorization. So far, patent offices in the United Kingdom [...]

15 years are enough! ECJ decided on the maximum period of exclusivity of a patent and SPC

by Miriam Büttner

In a recent decision the European Court of Justice (ECJ) ruled on the maximum period of exclusivity of a patent and a supplementary protection certificate (SPC) (Order of the Court dated 13 February 2014 – case no C-555/13, Merck Canada Inc. vs. Accord Healthcare Ltd and others).

Background:

Merck Canada Inc. (Merck) lodged an application for a patent for the active ingredient “montelukast sodium” in Portugal on 11 October 1991, which was granted on 2 Octo-ber 1998. The first marketing authorization (MA) for a medicinal product containing that active ingredient within the European Union was obtained in Finland on 25 Au-gust 1997. Merck applied for a SPC with the Port [...]

Eli Lilly v HGS – Declaration Denied

It is perhaps a poor reflection on the CJEU that it regularly issues rulings that, when the case is restored before the referring court, lead both parties to an action to claim victory. However this happened yet again when Warren J was given the unenviable task of implementing one of the trio of references decided by the CJEU last December in the world of SPCs.

Most readers will already be familiar with the facts of the Eli Lilly v HGS case. HGS has a patent directed to Neutrokine-alpha which includes a claim to antibodies which bind to this protein. This claim is drawn at a fairly broad level – anything that binds specifically to the full length Neutrokine-alpha polypeptide or the extrace [...]

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