What is an ‘active ingredient’ for an SPC?—the UK IPO rules out excipients but on what basis? (Halozyme v The Comptroller-General of Patents)
Life Sciences analysis: The Patents Court has confirmed the UK IPO Hearing Officer’s decision to refuse to grant two SPCs for combination products in circumstances where both products in each combination are not ‘active ingredients’ within the meaning of Article 1(b) of the SPC Regulation. The products were combinations of Trastuzumab with recombinant human hyaluronidase, and Rituximab with recombinant human hyaluronidase. The judge agreed with the lower tribunal that recombinant human hyaluronidase was not an active ingredient within the SPC Regulation, which requires that ‘a pharmacological, immunological or metabolic action of its own which is covered by the therapeutic indications of the marketing authorisation’. The judge held that the UK IPO Hearing Officer was entitled to make the findings he did about recombinant human hyaluronidase and that, therefore, it can be appropriate to refer primarily to the regulatory documentation that accompanies a drug (the SmPC and EPAR). Particularly, in situations where additional documentation adds nothing. He would, however, not be drawn into finding that those should be the only documents referred to (as the UK IPO was urging for simplicity). Of interest is that this judgment was made while the same question was pending before the Court of Justice from a referral by the Czech Supreme Administrative Court, which the judge indicated could be persuasive. Written by Daniel Byrne, partner at Venner Shipley LLP.
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