SPCs: Actavis v Boehringer, interpretation of Regulation (EC) no. 469/2009

SPCs: Actavis v Boehringer, interpretation of Regulation (EC) no. 469/2009

Submission by CIPA (January 2014) to the UK IPO in relation to the referral to the Court of Justice of The European Union of certain questions on the interpretation of Regulation (EC) no. 469/2009 (“the Regulation”) in Actavis v Boehringer [2013] EWHC 2927: C-577/13

Following the CJEU’s recent rulings in Georgetown II (C-484/12), Actavis (C-443/12) and Eli Lilly (C-493/12), the relevant law has developed since Justice Birss referred these questions to that court. A number of the questions have been resolved, as discussed below.

In particular, to the extent that the facts of this case mirror question 3 (below), it appears that Boehringer’s SPC would be invalid following the Actavis ruling. Accordingly, the CJEU may be tempted not to answer any of these questions. However, there is still an important issue concerning the possible impact of post-grant amendments on the validity of SPCs which CIPA considers should be clarified by the court. This is discussed below. 

In essence, the outstanding issue is whether or not, in circumstances where a basic patent does not meet the requirements of Article 3(a) of the Regulation but could be amended so as to meet these requirements, the patent so amended could serve as the basis of a valid SPC. CIPA fully supports the current practice of the UK IPO in this regard, namely that post-grant amendment of a patent should not preclude the grant of an SPC based on that patent. 

In Eli Lilly, the CJEU clarified that Article 3(a) does not require the precise structure of the active ingredient(s) to be identified in the claims. According to that ruling, Article 69 EPC and its Protocol should be used to determine whether the claims relate to the active ingredient(s) in question and, therefore, the requirements of Article 3(a) are met if active ingredients(s) are within the scope of the claims. However, CIPA’s view is that even if it were necessary to have recourse to a post-grant amendment, such an amendment should not preclude the grant of an SPC. 

The EPC provides a mechanism for amending the claims after grant by limitation (Article 105a). There are similar provisions in most Member States. Under this procedure, when the decision to limit a patent takes effect, the effects of the patent are cancelled ab initio to the extent that the patent has been limited. CIPA agrees with the referring judge that this procedure is entirely commonplace and transparent, and that there is no reason for a post-grant amendment to impact on the validity of an SPC, provided the amendment is itself lawful. The suggestion that allowing post-grant amendments would lead to legal uncertainty for third parties is misplaced, because the third parties are safeguarded by Article 123(3) EPC (and corresponding national provisions), which provides that the scope of protection of a patent cannot be extended after grant. Article 69 EPC and its Protocol are to be used for the purposes of assessing the scope of protection under Article 123(3) EPC (G 2/88 MOBIL OIL/Friction Reducing Additive OJEPO 4/90). Article 69 EPC itself, which applies across all Member States, further protects the interests of third parties. In particular, Article 69(2) EPC states inter alia that “the European patent as granted or as amended in opposition, limitation or revocation proceedings shall determine retroactively the protection conferred by the application, in so far as such protection is not thereby extended.”. A patentee cannot, therefore, make an amendment after grant which extends the scope of protection and so the scope of any resulting SPC cannot be broader than the claims of the patent as granted. 

In summary, CIPA considers that where a lawful amendment could be made after grant of a patent to ensure compliance with Article 3(a) of the Regulation, there is no reason why making such an amendment should preclude grant of an SPC. Any such preclusion would be contrary to the fundamental objective of the Regulation as set out in the second and third recitals, namely to ensure sufficient protection to encourage pharmaceutical research, and the fourth and fifth recitals which make it clear that the loss of time caused by the need for a marketing authorisation penalises pharmaceutical research. Further, legal certainty for third parties is ensured by Articles 69 and 123(3) EPC. 
For completeness, the questions asked by the referring court are outlined below, along with CIPA’s comments. 
The referring court asks in C-577/13:

1. (a) If a patent does not, upon grant, contain a claim that explicitly identifies two active ingredients in combination, but the patent could be amended so as to include such a claim could this patent, whether or not such an amendment is made, be relied upon as a "basic patent in force" for a product comprising those ingredients in combination pursuant to Article 3(a) of Regulation No 469/2006/EC ("the Regulation")?

To the extent this question still needs to be answered, it should be answered in the affirmative. CIPA’s reasons are given above.

(b) Can a patent that has been amended after the grant of the patent and either (i) before and / or (ii) after grant of the SPC be relied upon as the "basic patent in force" for the purposes of fulfilling the condition set out in Article 3(a) of the Regulation?

This question should be answered in the affirmative under both conditions (i) and (ii). CIPA’s reasons are given above.

(c) Where an applicant applies for an SPC for a product comprised of active ingredients A and B in circumstances where,

 (i) after the date of application for the SPC but before the grant of the SPC, the basic patent in force, being a European Patent (UK) (the "Patent") is amended so as to include a claim which explicitly identifies A and B;
 
 and
 (ii) the amendment is deemed, as a matter of national law, always to have had effect from the grant of the Patent;
 
 is the applicant for the SPC entitled to rely upon the Patent in its amended form for the purposes of fulfilling the Art 3(a) condition?

This question should be answered in the affirmative. CIPA’s reasons are given above. 

To summarise, CIPA fully supports the current approach of the UK IPO in allowing post-grant amendments in order to ensure compliance with Article 3(a) of the Regulation. Such amendments have an ab initio effect and cannot extend the scope of protection of the original patent. There is therefore no prejudicial impact on legal certainty. In view of the recent Eli Lilly ruling of the CJEU, however, it appears that such post-grant amendment will only be required under exceptional circumstances.

2. For the purposes of determining whether the conditions in Article 3 are made out at the date of the application for an SPC for a product comprised of the combination of active ingredients A and B where (i) the basic patent in force includes a claim to a product comprising the combination of active ingredients A and B and (ii) there is already an SPC for a product comprising active ingredient A ("Product X") is it necessary to consider whether the combination of active ingredients A and B is a distinct and separate invention from that of A alone?

To the extent this question still needs to be answered, it should be answered in the affirmative, but only when the specific criteria of the question are met. 

In Actavis the CJEU referred to the “core inventive advantage” of the basic patent which, in that case, was active ingredient A (i.e. Product X) rather than the combination of active ingredients A and B. The criteria outlined in question 2 mirror the facts of Actavis and so it appears that it is necessary, under these conditions and following that ruling, to consider whether the combination of active ingredients A and B is a distinct and separate invention from that of A alone. However, CIPA considers that the CJEU should clarify that it is only necessary to consider the inventive contribution of the combination of active ingredients in the situation set out in the question. A more general requirement to assess the inventive contribution of a combination product in order to determine the validity of an SPC to the combination product would be contradictory to the fundamental objective of the Regulation because it would discourage patentees from undertaking the necessary research to develop a combination product. For example, it should be possible to obtain an SPC for a formulation comprising a non-inventive combination of active ingredients. Moreover, in Georgetown II, which differs from the specific facts of this question (and Actavis), the inventive contribution of the combination product was not considered.

3. Where the basic patent in force "protects" pursuant to Article 3(a):

(a) A product comprising active ingredient A ("Product X"); and
(b) A product comprising a combination of active ingredient A and active ingredient B ("Product Y")
and where
(c) An authorisation to place Product X on the market as a medicinal product has been granted;
(d) An SPC has been granted in respect of Product X; and
(e) A separate authorisation to place Product Y on the market as a medicinal product has subsequently been granted,
does the Regulation, in particular Articles 3(c), 3(d) and/or 13(1) of the Regulation preclude the proprietor of the patent being issued with an SPC in respect of Product Y? Alternatively, if an SPC can be granted in respect of Product Y, should its duration be assessed by reference to the grant of the authorisation for Product X or the authorisation for Product Y?

To the extent this question still needs to be answered, it should be answered in the affirmative. 

The specific conditions outlined in this case mirror the facts of Actavis, in which the CJEU ruled that the SPC corresponding to Product Y was invalid.

4. If the answer to question 1(a) is in the negative and the answer to question 1(b)(i) is positive and the answer to question 1(b)(ii) is negative, then in circumstances where:

(i) in accordance with Art 7(1) Regulation, an application for an SPC for a product is lodged within six months of the date on which a valid authorisation to place that product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 200l/82/EC;
(ii) following the lodging of the application for the SPC, the competent industrial property office raises a potential objection to the grant of the SPC under Article 3(a) of the Regulation;
(iii) following and in order to meet the aforesaid potential objection by the competent industrial property office, an application to amend the basic patent in force relied upon by the SPC applicant is made and granted;
(iv) upon amendment of the basic patent in force, said amended patent complies with Article 3(a),
  does the SPC Regulation prevent the competent industrial property office from applying national procedural provisions to enable (a) suspension of the application for the SPC in order to allow the SPC applicant to apply to amend the basic patent, and (b) recommencement of said application at a later date once the amendment has been granted, the said date of recommencement being
– after six months from the date on which a valid authorisation to place that product on the market as a medicinal product was granted but
– within six months of the date on which the application to amend the basic patent?

If questions 1(a), 1(b)(i) and 1(b)(ii) are answered as outlined in the preamble to question 4, then CIPA agrees with the referring judge that there is no reason to object to the competent industrial property office from acting according to the remainder of question 4.