|The Grand Chamber: a Kat's eye view|
|Mr Justice Birss -|
getting in on the
SPC reference game
(i) Actavis sportingly agreeing to give an interim undertaking not to launch its own product pending the resolution of the action and (ii) Boehringer, equally sportingly, agreeing to provide a corresponding cross-undertaking that it would compensate Actavis in the event that its SPC turned out to be invalid.
The referred Questions andthe judge's comments run like this:
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")?
(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?
(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?
"The system of amending patents is an integral part of the patent system. Part of that system includes the retrospective effect of amendments. Amendments are only permitted if they comply with the law. There is nothing untoward or unusual or "wrong" in a patentee amending a patent. It does not and should not matter where an amendment is made. If the amendment is a lawful amendment, then I can see no good reason why it matters from the point of view of the validity of an SPC when the amendment took place. Indeed in many cases it is necessary to amend a patent in order to cure an invalidity as a result of a trial and that may well happen years after the grant of an SPC."
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 active ingredient A and a further 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 ?
"If it is not a relevant factor, then not. I will not add to the already substantial volume of text and learning on these questions by expressing a preliminary view about Question 2."The judge said that this question in particular needed to be referred before any time or cost is spent on the issue as it is the only one which may lead to a substantial factual trial in this matter and because "it may well be that there will be no need to deal with the substantive issue at all".
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
(c) An authorisation to place Product X on the market as a medicinal product has been
(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?
"I would be surprised if there could be said to be any basis in the Regulation for giving an otherwise valid SPC a lesser term than it would otherwise be entitled to for this sort of reason."
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 2001/82/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 in
force was granted?
"I can see nothing wrong with what the IPO did in this case and I can see no good reason why
the procedure adopted by the IPO in this case should lead to any difficulty or any problem with the SPC which resulted."