Both Medeva and Georgetown University had patents relating to individual vaccines.* In accordance with the current public policy by the time those vaccines were put on the market, they were authorised by the pharmaceutical regulatory authorities in combination with a number of other vaccines, to provide a single multi-vaccine injection, and were marketed as such.
Regulation (EC) No 469/2009 (the Supplementary Protection Certificate (SPC) Regulation) requires the product which is the subject of a SPC application ("product" being defined as an "active ingredient") to be both "protected by a basic patent" and the subject of a "marketing authorisation". SPC applications for both parties' products were refused on the basis that these two requirements were not satisfied. In both cases, the active ingredient "protected by the patents" was the single active, whereas the subject of the "marketing authorisation" was a multi-active medicine.
As most courts which have dealt with these cases (and cases like them) have commented, this outcome did not appear to achieve the stated objective of the SPC Regulation – namely to reward pharmaceutical innovation by providing additional monopoly time (the SPC) to make up for time lost in obtaining marketing approval for medicinal products. The English Courts referred these cases to the Court of Justice of the European Union (CJEU), posing questions addressing the meaning of aspects of articles 3(a) and 3(b) of the Regulation.
(* In fact, both patents related to more than one antigen, but for the purposes of this analysis it is easier to consider the patents being for single actives.)
The Advocate-General's opinion – 13 July 2011
Advocate-General Trstenjak had sought to address this anomaly in the SPC regime in her opinion in July this year. However, in doing so she appeared to have further confused several of the issues that were already the subject of referrals to the CJEU, and to have got other issues apparently wrong in her interpretation. In particular, she introduced at least two new tests for potential SPC applicants to have to deal with:
- that a patent only "protected a product" if that product fell within the "subject matter" of the patent; and
- that SPCs should only be sought for the "central active ingredient" of any patent.
What these new phrases meant was anyone's guess. While the courts of certain jurisdictions had some familiarity with the phrase "subject matter" (e.g. the German Courts), it is by no means a phrase which would immediately promote EU-wide harmony. The second phrase, "central active ingredient" appears to be a new concept in all jurisdictions.
She also expressed the opinion that an earlier CJEU judgment in Biogen, was authority for the principle that "only one SPC may be granted for each basic patent". As has been pointed out on many blogs and in many seminars since the Advocate-General gave her opinion, this principle does not appear to be in accordance with past and current practice in any EU jurisdiction. Many patents have been highlighted where several SPCs have been granted, for different actives, on the basis of the same patent.
We have waited – with bated breath – for today's final judgment of the European Court.
Today's judgment of the court
The six questions posed fell into two groups. The first addressed what "protected by a basic patent" in article 3(a) means. The second addressed whether the marketing authorisation (MA) referred to in article 3(b) could support a SPC for a single active if it only authorised that active in combination with other active ingredients.
Questions one to five – what is the meaning of "protected by a basic patent"?
The court reviewed the arguments at the hearing which fell into two camps, namely that a patent protects:
- only material falling within "the wording of the claims" (also referred to as the "disclosure test"), or
- everything that is "directly infringing the patent" (also referred to as the "infringement test").
The earlier ECJ authority on this point in C 392/97 Farmitalia , had stated that the answer "can be determined only in the light of the non-European Union rules governing patents" (i.e. under national law). However, the purpose of the SPC Regulation was:
"intended to establish a uniform solution at European Union level by creating a SPC which may be obtained by the holder of a national or European patent under the same conditions in each Member State."
The court then looked at the terms of the Regulation and noted that Article 5 provides that any SPC confers "the same rights as conferred by the basic patent". From this it said that:
"It follows that Article 3(a) of the regulation precludes the grant of a SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent."
"Similarly, if a patent claims that a product is composed of two active ingredients but does not make any claim in relation to one of those active ingredients individually, a SPC cannot be granted on the basis of such a patent for the one active ingredient considered in isolation."
The court therefore answered the first five questions (together) stating that Article 3(a) must be interpreted as "precluding" the granting of a SPC relating to "active ingredients which are not specified in the wording of the claims" of the basic patent.
Question six – what if the MA only authorises the patented active in combination with other actives?
The court then turned to the sixth question. It noted that the fundamental objective of the Regulation is to ensure "sufficient protection to encourage pharmaceutical research". It discussed the current public policy of the relevant health authorities that medicinal products placed on the market, in particular medicinal products for complex diseases (particularly vaccines), often consist of combinations of active ingredients for multiple therapeutic uses which can be administered to patients in a single preparation.
It noted that if a patentee for an innovative active ingredient were to be refused a SPC on the ground that the active ingredient coexists in the medicinal product alongside other active ingredients, the fundamental objective of the Regulation could be undermined. In particular, this would favour the development of monovalent medicinal products, in particular vaccines, which may not be in the interests of patients or national public health authorities.
The court then turned again to the terms of the Regulation and suggested that the requirement in article 3(b) that the 'product' must be authorised, "as a medicinal product" does not in itself rule out the possibility that the MA may cover other active ingredients contained in such a medicinal product.
Again referring to Article 5 of the Regulation, the court noted a SPC confers the same rights as were conferred by the basic patent in relation to the product. Accordingly, if the patent holder could oppose use of a medicinal product consisting of, or containing, his 'product', then the SPC granted in relation to that product would also confer on the holder the same rights.
However, the court clarified that:
"only the authorisation in respect of the first medicinal product placed on the EU market comprising, among its active ingredients, the active ingredient which is the subject of the application may be regarded as the first MA for that 'product' as a medicinal product within the meaning of Article 3(d) of Regulation." As discussed further below, potentially somewhat confusingly, the Court further stated that, "where a patent protects a product, in accordance with Article 3(c) of Regulation No 469/2009, only one certificate may be granted for that basic patent (see Biogen, paragraph 28)".
The court therefore answered question six saying that Article 3(b) does not preclude granting a SPC for an active ingredient(s) corresponding to that specified in the wording of the claims of the basic patent, where the medicinal product for which the MA is submitted in support of the SPC application also contains other active ingredients.
Discussion and consequences of today's decision
The court appears to have done a considerably better job than the Advocate-General in this case. It has provided a solution which appears to work to allow SPC's to be granted for new active ingredients despite them being authorised and placed on the market as part of a combination with other actives. The decision also provides a legal test comprising words which (like the word "wording") are familiar and can (hopefully) be interpreted in a uniform manner around the EU.
The basic proposition is this:
Any active (or combination of actives) that is "specified in the wording of the claims" of a patent may be the subject of an SPC, as long as that active has been authorised as a medicinal product, either on its own, or in combination with other actives.
However, once an active is the subject of an SPC, it may not be permissible to seek a further SPC for a different "product" comprising that active as part of a wider combination "product".
It is also worth noting, in passing, that in today's judgment, the court has also answered a question that has recently been referred to the CJEU in another case (Novartis v Actavis). That question (in summary) is: Is a SPC for product "A" infringed by the sale of a combination product "A+B"? In its discussion of Article 5 of the Regulation, the court has today confirmed (in paragraph 39 of the Medeva decision) that:
"if, during the period in which the patent was valid, the patent holder could oppose, on the basis of his patent, all use or certain uses of his product in the form of a medicinal product consisting of such a product or containing it, the SPC granted in relation to that product would confer on the holder the same rights for all uses of the product, as a medicinal product, which were authorised before the expiry of the certificate".
Patentees can therefore now be more confident that their SPCs for individual active ingredients will provide protection against sales of "infringing" products which contain that active as part of a larger combination product.
However, (and as usual with the ECJ!) all is not totally clear.
Firstly, it is unclear what the word "specified" means in the phrase "specified in the claims of the patent". Taking as examples the past UK authorities on this subject in Gilead and Astellas, the claims in issue in those cases were, respectively:
"a composition comprising [active ingredient "A"] in combination with another therapeutically active ingredient"
"a composition comprising [active ingredient "A"]"
Do either of these claims "specify", and therefore form the basis for a SPC for a combination product containing active ingredients A and B? Purists may think not – "specified" requires specificity (although no doubt there will be many arguments to the contrary). Therefore, if a particular combination can be envisaged at the time of patent applications, such specific combinations should perhaps be given their own subsidiary claims. At least specifying in its own claim, a class or classes of drugs which may be deemed to be appropriate to work in combination with the main active would be prudent.
Secondly, the court appears to have maintained one of the Attorney-General's points which caused the most consternation among commentators, namely that the Biogen ECJ judgment is authority for the principle that "only one certificate may be granted for that basic patent".
Looking at the Biogen judgment, although the Attorney-General's words are taken as a direct quote from that judgment, this quote has hitherto been interpreted to mean that only one SPC may be granted per product for each basic patent. In fact, the A-G's opinion in that case even specified (at paragraph 53) "It is nowhere stated that a patent can be the subject of only one [SPC]".
It is hoped that in the future, this comment of the ECJ will be interpreted (as the quote from Biogen has been) to be product specific, and that the current practice of allowing more than one SPC for different products under each basic patent, will continue. If not, we may be forced back onto the A-G's concept of picking the "central active ingredient" of each patent, and limiting any extended protection from a SPC to that product.