The FORUM February Seminar: a report

On 29 February a seminar on SPCs was held in London under the auspices of FORUM Institut für Management GmbH (as noted by The SPC Blog here). The two speakers were the German authors/practitioners Christopher Brückner and Peter von Czettritz, whose book on SPCs was published last year by Carl Heymanns. Following this event we are fortunate to have received this report on it:

"The seminar was divided into four parts directed to the issues (the numbers cited in brackets refer to the speakers' book):. 

I. The Concept of the Product, 

II. Material and Formal Requirements for an application, 

III. Paediatric Extension of Duration and finally 

IV. Scope and Effect of an SPC. 

I. The Concept of the Product 

The product is the pivotal element of the SPC system. It is important to note that definitions and restrictions which are directed to the product as such are product-related (Article 1, §68). The following example illustrates this point: 

According to Article 7(1) of Regulation 469/2009 (article of this SPC Regulation for Medicinal Products are cited below as ArtM), the application for a certificate shall be lodged within six months of the date on which the authorisation to place a product on the market was granted. This means that after the first Marketing Authorisation within the member state of the application has been filed, the deadline starts to run. If two competitors try to get a Marketing Authorisation for the same product, and both competitors want to file an SPC, the deadline for both applications are triggered by the earlier Marketing Authorisation. 

The same has to be said regarding requirements of ArtM 3d. If an application for an SPC is filed, the Marketing Authorisation on which this application is based must be the first Marketing Authorisation within the member state. Once again, if two competitors get two Marketing Authorisations for the same product and both competitors file an application for an SPC, both applications must be based on the earlier of the two Marketing Authorisations. 

Another issue was the possibility to get an SPC for a derivative of the product (Article 1,  §§ 87 to 98). If an SPC has been granted for a product and the applicant wants to get an SPC for a derivative of the product, the first requirement according to recital 14 of the Regulation 1610/96 is that the derivative is subject-matter of a separate patent protection. However, according to the Decision Triptorelin ( 14 W (pat) 9/06) of the Federal Patent Court (Article 1, §100) an SPC for this derivative can only be granted if the derivative is a product different from the product for which the SPC has been granted. To prove this difference, the applicant should present arguments that the derivative has pharmacological properties different from the pharmacological properties of the product. 

II. Material and Formal Requirements for an Application 

As a consequence of the CJEU decision in Case C-322/10 Medeva, for the first time it is possible to file an application for an SPC for a product which is different from the product for which the underlying Marketing Authorisation has been granted. The court decided there that an SPC can be granted for a combination of two compounds, if a Marketing Authorisation is presented which has been granted for more than two compounds. Subsequently Case C 422/10 Georgetown University clarified that an SPC can be granted even for one single compound if a Marketing Authorisation is presented which is directed to more than one compound. 

The term “specified” used in this decision caused further discussion regarding the questions, how the product of an SPC has to be defined in the basic patent. However, it is very likely that this issue will be the subject matter of a further Referral to the CJEU. 

Moreover, the special case of passive certificates, i.e. certificates based on third parties Marketing Authorisations, was discussed (Article 6, §§ 57 to 69). In Novartis v Medimmune [2012] EWHC 181 (Pat) of the High Court, this issue was discussed for the first time by a Court (§61). Perhaps, this question will be the subject-matter of a further Referral to the CJEU. 

III. Paediatric Extension of Duration 

The objective of the Paediatric Regulation is to ease the development and accessibility of medicinal products for use with the paediatric population. This objective is achieved by a system of obligations, rewards and incentives, where multiple incentives are ought to be excluded. An extension of duration is a reward with respect to ArtPd. 36. 

The general preconditions for an application for extension of duration were shown with regard to the respective form sheets of the German Patent and Trademark Office and the Intellectual Property Office, UK (Form SP4). Also it was shown for application deadlines to vary with respect to status of the application procedure. On the other hand, in the case of waiver, class waiver or deferral according to ArtPd. 7(1(b) to (d) an extension of duration is not possible. 

In the case of a new field of application of significant clinical benefit against existing therapy it may also be applied for a one year extension of data exclusivity (Art. 10(1) 2001/83). Here the company has to choose exclusively between one more year of data protection or a 6 month extension of duration. If market exclusivity was granted to orphan drugs according to Art. 8(1) 141/2000, there is no extension of duration (ArtPd. 26(4)). 

A controversial question in the field is whether studies which were conducted accordingly to the agreed paediatric investigation plan, must have been conducted by the holder of the patent or protection certificate or if the results of third party studies can be used instead. Although considering the intention of the Paediatric Regulation, the consequence of admissibility of use of third party studies and a missing analogy to the decision Biogen/ SmithKline, the question is yet not decided. 

IV. Scope and Effect of an SPC. 

Incidentally, on the same day the CJEU answered the Referral in Case C-442/11, directed to the question of the effects of a mono SPC against combination products, this issue was intensively discussed during the seminar. 

Principally, an SPC has the same effects as the underlying patent. The restriction to the product, introduced by the reference to ArtM 4 of the Regulation, only has an effect if the subject-matter of the patent and the SPC are different. In other words: If a basic patent simply protects one product, and an SPC has been granted for this one product, the subject-matter of the basic patent and the SPC are the same. Due to ArtM 5, in that case, the effects, i.e. the protection against a mono-product or a combination product are the same. As a consequence, an SPC directed to a mono-compound also protects against the use of this compound in combination with other compounds. The effect of the reference of ArtM 5 to 4 is the exclusion of non-pharmaceutical use and non-authorised use (Article 4, §§32 to 54). 

Finally, the protective effects of pending protection certificates were discussed (Article 5,  §§ 152 to 179). This question so far has not been the subject-matter of a court decision. However, it has to be assumed that the fact that an SPC was not granted for an admissible application should not be used against the applicant. 

Finally, a very interesting question was asked by the audience. We forward this question to the SPC blog as the Question of the Day: 

The question is the following: according to ArtM 5 an SPC should confer the same rights as conferred by the basic patent. As a consequence, the effects of an SPC must not be broader than the effect of the respective basic patent. For example, an SPC for a compound A cannot be granted if the basic patent claims only A plus B. If such an SPC was granted, the SPC, in addition to the effects of the basic patent, would also protect against A, A plus C and so forth. So far, this is more or less undisputed. 

However, if a basic patent claims A and A plus B, and an SPC has been granted for A plus B, does this SPC protect also against A? 

We are very keen to receive the answers of the members of the SPC blog on this question.

We have learned that two further SPC seminars are being offered by the FORUM Institute. One seminar, in English, will be held on 4 and 5 October 2012 in Amsterdam.  A second seminar, in German, will be held on 23 and 24 October 2012 in Frankfurt. Further details will be provided once they are available.