One of our readers has a problem for which no information or case law could be found. The SPC Blog wonders whether any of our other readers might be able to offer some information -- or at least their opinions -- for which our reader would be most grateful. The problem runs like this:
"The basic patent concerned covers in claim 1 an oral formulation which releases the active ingredient in a specific amount, which may exist in specific embodiments (a) to (g). (a) is a matrix tablet not specifying the excipients, while (b) to (g) are other forms such as a coated tablet, a pulsatile dosage form etc.
The SPC is based on a matrix tablet. The title reads: "Pharmaceutical formulations comprising (the active ingredient) X"
As far as reported in textbooks and commentaries, the scope of protection of an SPC is that of the basic patent, but restricted to the specific authorized product. This means that, if the basic patent claims a generally defined formula, the SPC is restricted to the specific active ingredient which is present in the authorized product. If the patent claims a use, then the scope of the SPC is restricted to this use of the authorized product. If the patent claims a process for obtaining the active ingredient, the SPC is restricted to the process for obtaining the active ingredient present in the authorized product.
My questions now are:
1: Is the scope of protection of the SPC restricted to the embodiment (a), that is, to a matrix tablet, and are the other embodiments (b) to (g) not covered by the SPC any more?
Or, even more narrowly:
2. Is the scope of protection SPC even restricted to the specific excipients used in the authorized products, and can other excipients be used without infringing the SPC literally? (Equivalency would have to be considered separately)".
If you have any bright ideas or comments, do let us know!
4 comments:
Maybe you should simply wait for the outcome of the current cases at the ECJ: Medeva, Georgetown, Neurim, Yeda Research and so on :)
I have a question:
For what entity (product) the market authorisation was obtained?
As regards Question 1: The scope of protection would extend to (b) through (g) if those embodiments would receive marketing authorizations prior to SPC expiry (Art. 4 of Regulation 469/2009). Also, from the facts given it is not clear if embodiments (b) to (g) would infringe embodiment (a), or if (b) to (g) are independent embodiments. To the extent they would infringe (a), the SPC would cover these embodiments.
As regards Question 2: An SPC is not directed to excipients but to the active ingredient of embodiment (a). Can we assume that embodiment (a) when authorized for marketing would be the first EU authorization for this active ingredient? Otherwise, the SPC wouldn't be valid (see the ECJ's MIT and Yissum decisions). Under this assumption, I believe that different excipients would be covered by the SPC.
(Based on the limited information provided in the blog post)
In relation to Question 1:
The SPC is based on matrix tablet; therefore the protection is limited only to the matrix tablet in this case (presuming that the marketing authorisation has only been obtained for the embodiment (a)). The other embodiments (b) to (g) would be covered by the SPC if marketing authorisation in relation to them is obtained before the expiry of the certificate.
In relation to Question 2:
There could be two dimensions to this:
1) As excipients are non-active components of a medicinal drug, the scope of SPC protection would not be restricted to the specific excipients used in the authorised products. It is only the active ingredient (Articles 1(a), 1(b), 2, 3(b) and 4 and 3rd sentence of Recital 10 to the Preamble of the Regulation (EC) No. 469/2009 (‘SPC Regulation’)) that can form subject matter of the SPC protection. Though the excipients are known to influence the pharmaceutical performance of the active ingredients in relation to which it is used, Article 4 affords the protection only to the ‘product’ which, according to Article 1(b) of the SPC Regulation, is strictly confined to ‘active ingredient’ or ‘combination of active ingredients’.
2) (the other dimension of the whole scenario (put forth for discussion))
Article 4 of the SPC Regulation restricts the scope of the protection ‘only to the product covered by authorisation to place the corresponding medicinal product on the market’.
The marketing authorisation is for the medicinal product as such and not for an active ingredient in particular. Medicinal product has been referred to as a substance or combination of substance in the Article 1(2) of the Directive 2011/83/EC and Article 1(a) of the Regulation (EC) No. 469/2009. The term ‘substance’ has been defined by Article 1(3) of the Directive as ‘any matter irrespective of origin’. Therefore, it could be put forth that excipients are covered by the definition of the medicinal product in the context of the Directive.
----Article 8(3)(c) of the Directive 2011/83/EC requires that the application for seeking marketing authorisation should contain qualitative and quantitative particulars of all the constituents of the medicinal product. Excipients could also be considered the constituents of the medicinal products (though excipients are inactive).
----Article 8 (3)(l) of the Directive provides that the application that is made to the competent authority to obtain the marketing authorisation in relation to a medicinal product should contain particulars and documents pertaining to copies of the ‘summary of the product characteristics proposed by the applicant in accordance with Article 11 or approved by the competent authorities of the Member State in accordance with Article 21. It also provides that this information should be updated on a regular basis. According to Article 11(1)(6)(6.1) of the Directive, the summary of the product characteristics includes the list of the excipients. (Also see Article 11 (2) of the Directive)
----According to Article 21 (2) of the Directive, it is required to be ensured that ‘the information given in the summary is in conformity with that accepted when the marketing authorization is issued or subsequently’.
----Article 23 of the Directive requires the authrisation holder to supply to the competent atuhority any new information that might entail the amendment of the particulars or documents referred to in Article 8(3).
----Article 115 of the Directive provides that the marketing authorisation shall be ‘suspended, revoked, withdrawn or varied’ if the particulars provided under Article 8 are not amended in accordance with Article 23.
----variations are to be dealt with relevant regulations.
In view of the aforementioned it could be argued that if the marketing authorisation is jeopardised on account of not dealing with change in the excipients in accordance with relevant laws, the scope of protection under SPC could be debated.
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