Following its reference to the Court of Justice of the EU (CJEU) in Medeva on the meaning of Art 3 of the SPC Regulation, the Court of Appeal has applied the CJEU's judgment to the facts of the case (Medeva BV v . Comptroller General of Patents [2012] EWCA 523).  The Court of Appeal's decision (which was handed down yesterday) is of interest as it discusses the CJEU's judgment and highlights the remaining areas of uncertainty.  It appears increasingly likely that another reference to the CJEU will be required to further clarify the application of Art 3(a) of the SPC Regulation.

Key points

  • Art 3(a) of SPC Regulation 469/2009 (the "SPC Regulation"), states that an SPC may only be granted in respect of a product if it is protected by a basic patent in force.
  • In determining whether Art 3(a) was satisfied, the Court of Appeal noted that the CJEU had impliedly rejected the 'infringement test' and in order to satisfy Art 3(a) the active ingredients of a product must be specified in the claims of the basic patent.
  • The Court of Appeal noted the ambiguity in the CJEU judgment as to the ambit of 'specified', which may range from express naming, through description, necessary implication to reasonable interpretation.  The Court of Appeal recognised that where on that scale the dividing line should be drawn, will necessitate further references to the CJEU. 
  • In this case, however, the Court of Appeal was not required to determine the meaning of the term 'specified' as it was clear that some of the active ingredients that were the subject of the SPC application were excluded from the claims of the basic patent in this case.  It was not enough to satisfy Art 3(a) that the claims were directed to a method of producing a vaccine comprising a subset of active ingredients subject to the SPC application, as there was no wording in the claims to indicate that the other active ingredients were included.

Art 3(a) of SPC Regulation 469/2009, states that an SPC may only be granted in respect of a product if it is protected by a basic patent in force. When referrals were made to the CJEU by the High Court in order to determine what was meant by the phrase 'protected by a patent in force', it was clear that the decisions of the CJEU would have a major impact on the scope of intellectual-property protection for combination drugs. In particular, the referral was intended to clarify the situation where only one of the active ingredients in the combination was explicitly claimed in the patent on which the SPC was granted.

In this case, Medeva had a patent directed to a vaccine which contained two active ingredients, namely pertactin and filamentous haemagglutinin. Medeva filed five SPC applications based on its patent, each of which was refused. Four of the five applications listed all of the active ingredients in the marketed product. The Patent Office decided that these fell foul of Art 3(a) because not all of these active ingredients were specifically claimed by the basic patent. The fifth application on the other hand listed the products that were protected by the patent but omitted some of the active ingredients in the marketed product. Although this application satisfied Art 3(a), it was found not to be compliant with Art 3(b) because it did not contain the same active ingredients as the product on the market. Therefore, Medeva found itself in the impossible position of being unable to comply with both Art 3(a) and 3(b) (similar issues were encountered in the Georgetown University case) and various questions were subsequently forwarded to the CJEU as to the interpretation of these Articles.

Upon answering the questions referred to it, the CJEU decided to construe Art 3(a) strictly and held that the product (active ingredient) must be specified in the wording of the claims of the basic patent. Therefore, where the subject matter of a patent is A, then an SPC for A + B cannot be obtained due to Art 3(a). This is so even if the combination of A + B will have infringed, under national law, the basic patent due to the presence of A. Conversely, if a patent claims a combination of two products (A + B), an SPC cannot be granted on the basis of this patent for either A or B individually (please see here for a previous newsflash on the decision of the CJEU).

Court of Appeal decision

In yesterday's decision, the Court of Appeal held that the result of the CJEU decision was that the IPO and High Court had correctly applied the provisions of Art 3(a) to the facts of Medeva, for the following reasons:

  • It was clear from the rival arguments before the CJEU there was a choice between the 'infringement' test and the 'scope of protection' test, and that the Advocate General and the CJEU in Medeva had impliedly rejected the infringement test in its decision by rejecting the notion that the protective effect of a patent had any relevance to the issue before the Court.
  • The issue for the national Court was therefore to determine which active ingredients were specified in the claims of the basic patent.  It noted that the ambit of 'specified' might range from express naming, through to description, necessary implication and reasonable interpretation and that where on that scale the dividing line is to be drawn will likely necessitate further references to the CJEU in due course. The problem for Medeva was that no matter where the dividing line was to be drawn ,the only ground for suggesting the other active ingredients might be included was the convention used in drafting patent specifications to the effect that the word 'comprising' does not exclude other elements. This was held to be insufficient as the ruling of the CJEU clearly required the other elements or active ingredients to be specified in the wording of the claims i.e. there must be some wording indicating that they are included in the claims. If it were otherwise, the Court would be applying the infringement test which had been excluded by the CJEU.

In this case there was no wording in the claims of the basic patent indicating that the active ingredients of the vaccine against diphtheria, tetanus, meningitis and polio were included and the earlier decisions of the IPO and High Court were correct.

While the CJEU's decision was sufficient to allow the Court of Appeal to determine the matter in this particular case, it is very likely that further referrals to the CJEU will be required in the future in order to provide some much needed clarity as to the meaning of the term 'specified' within the 'scope of protection' test under Art 3(a).