United States: One For All Or One For One More Than One Supplementary Protection Certificate For One Basic Patent?

Last Updated: December 31 2013
Article by Christian Fulda, Roland J. Graf and Christiane S. Schweizer

On December 12, the Court of Justice of the European Union ("CJEU") issued its decisions in cases C-443/12, Actavis, and C-484/12, Georgetown (referred to as "Georgetown II").

In these decisions, the CJEU outlined the circumstances under which a patent proprietor may obtain more than one supplementary protection certificate ("SPC") based on the same basic patent. The decisions will necessitate changes in SPC-granting practice in the majority of Member States, liberalizing the practice in some while raising new requirements in others.

Issue

Regulation (EC) No. 469/2009 of the European Parliament and of the Council of May 6, 2009 (the "SPC Regulation") defines the conditions for the grant of an SPC in Article 3. These conditions are: (i) the product (meaning the active pharmaceutical ingredient, "API") or a combination of APIs has to be protected by a basic patent, (ii) a valid marketing authorization for the API exists, (iii) no other SPC exists for said API, and (iv) the marketing authorization referred to in (ii) is the first authorization to place the API on the market as a medicinal product. The wording of the SPC Regulation does not provide for a restriction on the number of SPCs obtainable per basic patent.

In C-181/95, Biogen, the Court held that, with regard to a case involving a single product, only one SPC per patent could be obtained. This judgment had been widely interpreted as leaving open the possibility of more than one SPC being obtainable on the basis of the same patent, as long as they related to different products.

However, in 2011, the CJEU decision C-322/10, Medeva, cast doubts when the Court held that "[W]here a patent protects a product, in accordance with Article 3(c) of Regulation No 469/2009, only one certificate may be granted for that basic patent (see Biogen, paragraph 28)" (C-322/10, Rdnr. 41). This would have amounted to a "one SPC per basic patent" rule.

Divergent national practices evolved in the course of the past two years. While Dutch authorities turned to a literal interpretation of both the Medeva and Biogen judgments, which could be summarized by "one SPC per patent," UK authorities chose to read Medeva in line with the previous interpretation of Biogen, which could be summarized by "one SPC per patent, per product."

In the Actavis and Georgetown cases described below, UK and Dutch courts referred questions to the CJEU seeking clarification on the correct application of Article 3 (c) of the SPC Regulation.

Procedural History

In the Actavis case, Sanofi had first obtained an SPC for Irbesartan, and subsequently for Irbesartan and Hydrochlorothiazide (the "Sanofi Combination SPC"), based on the same patent. Actavis challenged the validity of the Sanofi Combination SPC, arguing, inter alia, that the Sanofi Combination SPC had been granted based on the same basic patent as the Irbesartan SPC, and thus contravening Article 3 (c) of the SPC Regulation as interpreted in the Medeva decision.

In the Georgetown II case, Georgetown had applied for the grant of several SPCs concerning either proteins of single HPV types as active ingredients or combinations of proteins from different HPV types. All of these applications were based on one basic patent and one marketing authorization for a combination of the viruslike particles ("VLP") of the recombinant L1 protein of HPV 6, 11, 16, and 18. One of these SPC-applications, directed to HPV 16 only, (the "HPV 16 SPC-application") has been refused (appeal pending); two SPCs have been granted (directed to the combination of HPV 16 and 18 and, respectively, the combination of HPV 6, 12, 16, and 18—the "Georgetown Combination SPCs"); and five further SPC applications are pending. The Octrooicentrum Nederland has opposed the grant of the currently refused HPV16 SPC-application based on the fact that the Georgetown Combination SPCs had already been granted based on the same basic patent, contravening Article 3 (c) of the SPC Regulation as interpreted in the Medeva decision.

Rulings of the CJEU

In answer to requests for preliminary rulings of the respective national courts, the CJEU has confirmed that it is possible to obtain more than one SPC per patent, but only under certain conditions. According to the Actavis decision, where a first SPC protected an API, whether used alone or in combination, it is not possible to obtain a further SPC for such API in conjunction with another API—such as the Sanofi Combination SPC, where the other API is "not protected as such by the basic patent but simply referred to in the wording of the claims of the patent in general terms, such as [...] 'beta-blocking compound', 'calcium antagonist', 'diuretic', 'non-steroidal anti-inflammatory' or 'tranquilizer' [...]." By contrast, in the Georgetown II case, the Court noted in explicit distinction from the Actavis case that the combination of four active ingredients (including HPV-16) as well as HPV-16 as an active ingredient individually are protected by the Georgetown patent. Accordingly, the Court held that the second SPC was available based on the same patent.

Assessment

Unfortunately, both decisions leave considerable room for interpretation. It is unclear when an API is "protected as such" by a basic patent. From the reasoning of both decisions, it appears that the Court applied the following logic: If a basic patent covers an API alone or in combination, an SPC based on a marketing authorization for such API also "exhausts" the use of such API in a fixed combination—unless the other API in turn is protected in isolation under the basic patent, for use as a sole ingredient or in a combination product. In that case, however, the SPC would actually be sought for that other ingredient, in combination with the first (for which an SPC had already been granted).

Practical Considerations

Owing to the open questions resulting from the Actavis and Georgetown II decisions, further referrals are to be expected. Still, Georgetown II-like cases should now be received in Member States that so far rejected a second SPC on the same basic patent per se. By contrast, applicants have to prepare to overcome objections in Sanofi-like cases.

With regard to drafting the claims of patents that potentially may serve as basic patents, once an API is being authorized, the litmus test may be whether an API referred to in the claims may also be claimed individually in an independent claim, i.e., as innovation, be it for sole use or in combination.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Authors
Christian Fulda
Christiane S. Schweizer
 
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