Supplementary Protection Certificates – Halozyme v The Comptroller

This was an appeal against Dr Lawrence Cullen’s decision in Halozyme, Inc. v The Comptroller General of Patents, Designs and Trade Marks BL O/0257/24 of 27 Mar 2024 in which he refused Halozyme Inc.’s applications for supplementary protection certificates for  Trastuzumab and recombinant human hyaluronidase and Rituximab and recombinant human hyaluronidase.

In my article Supplementary Protection Certificates I described a supplementary protection certificate (“SPC”) as 

“an intellectual property right (“IPR”) that protects the active ingredients in pharmaceutical or plant protection products.”  

I explained that:

“The right comes into force upon the expiry of a patent for such a product. The rationale for SPCs is that new pharmaceutical and plant protection products cannot be marketed unless and until they are found to be safe by the relevant national or European authorities. Evaluating the safety of a new drug or plant protection product can take time. As the maximum term of a patent is 20 years, the time waiting for such evaluation reduces the effective term of the monopoly. The purpose of an SPC, as Lord Justice Floyd explained in Teva UK Ltd and others v Gilead Sciences, Inc [2019] EWCA Civ 2272 (19 Dec 2019), is, therefore, to compensate the patentee for such lost time by protecting the active ingredient of the pharmaceutical or plant protection patent for up to 5 years (or in the case of a product used for treating children a further 6 months) after the expiry of the patent.”

The applicable legislation is Regulation (EC) No 469/2009 of the European Parliament and of the Council as amended. The legislative history of that amended regulation is set out in my article 

The application for Trastuzumab and recombinant human hyaluronidase was numbered SPC/GB15/047 and derived from EP (UK) 2163643 B1.  The application for Rituximab and recombinant human hyaluronidase was numbered SPC/GB16/039 and derived from EP2405015 B1.   The applications were rejected by the examiner on the ground that human recombinant hyaluronidase could not be regarded as an active ingredient in its own right.

Halozyme sought a hearing before a hearing officer appointed by the Comptroller.  The case came before Dr Cullen.  It was common ground that two conditions had to be fulfilled:

• The ingredient in question has an effect on the human body, that is to say, a metabolic effect, and
• the presence and effect of the ingredient is reflected in the technical information submitted as part of the marketing authotization and contributed to the delay in obtaining authorization.

Halozyme appealed to the Patents Court against Dr Cullen’s decision under s.97 of the Patents Act 1977. The appeal came on before Mr Justice Meade on 14 Nov 2024.  His lordship handed down judgment on 16 Dec 2024 (see Halozyme Inc v The Comptroller-General of Patents, Designs and Trade Marks [2024] EWHC 3202 ).

The learned judge identified two categories of issues in the appeal in paras [26] and [27] of his judgment:

• Whether it is legitimate to consider materials other than the summary or product characteristics and European Public Assessment Report in determining whether recombinant human hyaluronidase is an active ingredient, and
• What should be the factual finding as to whether recombinant human hyaluronidase is an active ingredient based on the materials that it is legitimate to consider?

Although the hearing officer had held that the summary of product characteristics and the European Public Assessment Report were the correct approach, he also made factual findings that even taking into account the basic patent and the literature on top of the product characteristics and the European Public Assessment Report.  He did not find that there was a basis for thinking that recombinant human hyaluronidase has a treatment effect for the particular indications approved by the MAs.  It followed that even if Halozyme was right about the materials to be considered, it would still lose on the facts.  The judge concluded that unless Halozyme could persuade him that Dr Cullen had been wrong about the facts, the question of what materials it was legitimate to consider simply did not arise and did not need to be decided.

Mr Justice Meade directed himself that as Dr Cullen was an expert tribunal with a high degree of competence in deciding technical/scientific matters, he should conduct a review rather than a rehearing of the hearing officer’s decision.  He was not required to ask himself whether he would have reached the same decision, but rather whether the decision was one that was reasonably open to the hearing officer.  He had to be particularly alert to the danger of “island hopping”.

The judge considered all the materials, including those relied upon by Halozyme, but could find no basis for overturning the hearing officer’s decision.  The appeal was dismissed.

Anyone wishing to discuss this case may call me on 020 7404 5252 during normal office hours or send me a message through my contact page.