The AG has opined on two references from the UK on the application of the SPC Regulations (Regulation 469/2009) to combination products (Medeva BV v Comptroller-General of Patents, Designs and Trade Marks (Case C-322/10) and Georgetown University, University of Rochester, Loyola University of Chicago v Comptroller-General of Patents, Designs and Trade Marks (Case C-422/10).
The AG's opinion provides a comprehensive review of the SPC Regulations within the context of medicinal products containing several active ingredients. According to the AG:
- Where the subject matter of a basic patent is an active ingredient ("A"), an SPC may be granted for A on the basis of a marketing authorisation for A in combination with other active ingredients (eg, A+B+C…).
- The corollary of this is that an SPC for A would be infringed by a medicinal product comprising A in conjunction with other active ingredients.
- Once an applicant obtains an SPC for A, it is precluded from seeking a further SPC using the same patent for A in conjunction with other active ingredients.
- The AG opines that only one SPC can be obtained per patent on the basis of the ECJ decision in Biogen (Case C-181/95). There is likely to be significant debate on whether this interpretation of Biogen is correct.
The AG's opinion is not binding, and may therefore not be followed by the ECJ when it gives its judgment in these cases. The AG's opinion goes further than the referred questions (eg, in relation to infringement of an SPC), meaning that the ECJ may not rule on these points.
Each of these cases concerned:
- medicinal products authorised to be marketed in Europe which contain multiple active ingredients (eg, A+B+C+D); but
- in which the patent on which the SPC application was based covers only one active ingredient (eg, A or B or C or D), or a subset of combinations of active ingredients (eg, A+B, A+C, A+D….).
Interpretation of the SPC Regulations
The AG recognised that the referred questions raise an important question of principle: 'whether and, if so, how and under what conditions supplementary protection certificates may be applied for and granted in respect of [such] medicinal products…' The importance of this question of principle is reflected in the number of observations submitted by the European Commission and Member States1 , and the number of pending references to the ECJ on similar issues2.
The AG recognised ambiguities in the SPC Regulations and having considered the relevant articles concluded that a literal interpretation was not tenable and inconsistent with the objectives of the SPC Regulations (which are to compensate a patent holder for the loss of exclusivity caused by the requirement to obtain marketing authorisations, whilst balancing this against the interests of generics companies, patients and Member States to ensure that innovative new products would be developed but that cheaper medicines were not precluded from the market for an unfair period of time). A literal interpretation of the SPC Regulations implies that no SPCs could ever be granted for medicinal products in which there is a combination of active ingredients and in which some, but not all, these active ingredients are the subject-matter of a patent. This was particularly well evidenced in the vaccine field where manufactures are either legally or practically obliged to manufacture such medicinal products (eg, by national purchasing policies requiring large combination vaccines).
The AG opined that the definition of 'product' should be widened by replacing any reference to 'the' active ingredient or combination of ingredients with 'a' active ingredient or combination of ingredients. Therefore, a medicinal product containing a combination of active ingredients (A+B+C+D) includes several distinct products (eg, A, B, A+B, A+C, A+B+C, A+B+C+D…).
In addition, Article 3(b) (that there is 'a valid authorisation to place the product on the market as a medicinal product' ) is fulfilled where the authorised medicinal product contains not only the patented active ingredient or ingredients but also further unpatented active ingredients. A marketing authorisation for A+B+C+D is a valid authorisation when considering SPC applications based on patents in which the subject matter is A alone, or A+B, or A+C, or A+B+C, etc.
To prevent the teleological approach resulting in an abuse of the SPC system, the AG sought to fetter it by ensuring that:
- a consistent meaning of 'product' is applied for both the definition of a 'basic patent' in Article 1(c) and in the meaning of 'the product is protected by a basic patent in force' contained in Article 3(a). The 'product' is determined by reference to the subject matter of the patent and not by reference to whether the medicinal product subject to the marketing authorisation would infringe the patent. If the basic patent claims product A alone and the medicinal product contains A+B+C+D, then the product is A and not A+B+C+D. The AG then states that, once this determination has been made as a matter of national law 'the further condition laid down by Article 3(a), namely that that product must be protected by a basic patent in force, is, as a rule, satisfied by that fact alone. That is because…it must be assumed that a product which, according to the rules governing the basic patent, is the subject‑matter of the basic patent, will also be protected by the latter' (our emphasis added).
- Article 3(c) prevents any given applicant obtaining a series of SPCs for further combinations containing the same active ingredient based on the same patent. If the basic patent claims product A alone and an SPC is obtained on the basis of a marketing authorisation for a medicinal product containing A alone, a subsequent SPC cannot be obtained on the basis of that patent and an authorisation of a medicinal product containing A+B+C+D (in both cases, the product is A and such further SPC is prohibited).
The AG also opined that only one SPC can be obtained per patent on the basis of the ECJ decision in Biogen (Case C-181/95). There is likely to be significant debate on whether this interpretation of Biogen is correct. It seems that this conclusion may encourage patentees to file divisional applications to avoid this restriction.
- In circumstances where a patent has been granted, Articles 3(d) and 7 require an SPC application to be filed within six months of the grant of the first marketing authorisation in that Member State for the first medicinal product which contains the patented active ingredient.
- The duration of an SPC, as calculated by the formula in Article 13, ties the SPC's duration to the first marketing authorisation in the Community for the first medicinal product which contains the patented active ingredient.
When considering Articles 3(d), 7 and 13 (as in 3 and 4 above), as the AG's opinion permits several products to be authorised by a single combination product (eg, an authorisation for the medicinal product A+B+C+D, contains the products A, B, A+B, C, A+C…), there may be circumstances outside of the vaccine field where such an interpretation could result in unfairness on an applicant by preventing an SPC or reducing its duration to zero.
Infringement of an SPC under Articles 4 and 5 of the SPC Regulations
The AG opined that a medicinal product which is authorised following the grant of an SPC but which contains the 'product' on which that SPC is based will infringe that SPC. This statement suggests that:
- even if the medicinal product is authorised for a new use, so long as that use is within the scope of the basic patent, an existing SPC would be infringed; and
- a combination product would infringe an SPC for single active ingredient (or a subset of the combination) contained in that combination.
However, the AG's opinion does not address the situation of whether an SPC for a specific combination (eg, A+B+C+D) would be infringed if one or more of the active ingredients contained within that combination were removed. Would a medicinal product containing A+C+D infringe and SPC for A+B+C+D?
It will be interesting to see if the ECJ provides any ruling on the infringement of SPCs.