This is an attempt to present the facts leading to the outcome of the appeal request concerning Supplementary Protection Certificates (SPCs) in the case of Halozyme Inc. vs the UK Intellectual Property Office (IPO).
The parties concerned
Halozyme Inc.
vs
UK Intellectual Property Office
Medicinal products concerned
The following products that are pertinent to this case:
- a combination of rituximab and recombinant human hyaluronidase (rHuPH20) in the product MabThera solution for subcutaneous injection
- a combination of trastuzumab and recombinant human hyaluronidase (rHuPH20) in the product Herceptin solution for injection.
What is a supplementary protection Certificate?
An SPC is a sui generis intellectual property right that can extend by up to five years, the protection conferred by a patent (“the basic patent”), but only with respect to the medicinal product that is covered by the related marketing authorisation2.
A six-month additional extension is available in accordance with Regulation (EC) No 1901/2006 if the SPC relates to a medicinal product for children for which data has been submitted according to a Paediatric Investigation Plan (PIP).
You can read more about Supplementary Protection Certificates (SPCs) in this blog post and about the latest regulatory developments concerning SPCs in this post.
What is the function of Supplementary Protection Certificates (SPCs)?
SPCs aim to offset the loss of patent protection for pharmaceutical products that occurs due to the compulsory lengthy testing and clinical trials that these products require prior to obtaining regulatory marketing approval.
You can read more about Supplementary Protection Certificates in this blog post.
The relevant Articles from Regulation (EC) No 469/2009 (the Medicines SPC Regulation)
Article 1
For the purposes of this Regulation, the following definitions shall apply:
(a) “medicinal product” means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;
(b) “product” means the active ingredient or combination of active ingredients of a medicinal product;
(c) …
(d)…..
(e)…..
The term ‘active ingredient’ is not defined further in the Medicines SPC Regulation.
Article 3
A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:
(a) …
(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate
(c) the product has not already been the subject of a certificate;
(d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.
Article 10
Grant of the certificate or rejection of the application for a certificate
1….
2. The authority referred to in Article 9(1) shall, subject to paragraph 3, reject the application for a certificate if the application or the product to which it relates does not meet the conditions laid down in this Regulation.
3…
4….
5….
Background to the case
Halozyme Inc. filed the following two supplementary protection certificate (“SPC”) applications with the UK IPO:
(i) SPC/GB15/047 for the product “Trastuzumab and recombinant human hyaluronidase” – This was filed on 20 July 2015 and relies on the basic patent EP(UK) 2163643 B1 and the centralised European marketing authorisation EU/1/00/145/002, for the medicinal product “HERCEPTIN”.
The marketing authorisation (MA) for Herceptin was granted following Commission Implementing of 26 August 2013. Decision C(2013) 5603 granted a so-called line extension to the MA, granted originally under Decision C(2000) 2539, as provided for under Commission Regulation (EC) No. 1234/2008.
(ii) SPC/GB16/039 for the product “Rituximab and recombinant human hyaluronidase” – This was filed on 6 July 2016 and relies on the basic patent EP(UK) 2405015 B1 and the centralised European marketing authorisation EU/1/98/067/003 for the medicinal product “MABTHERA”.
The marketing authorisation (MA) for MabThera was granted following Commission Implementing Decision C(2014) 2048 of 21 March 2014. Decision C(2014) 2408 granted an extension to the marketing authorisation, granted originally under Decision C(1998) 1464 as provided for under Commission Regulation (EC) No. 1234/2008.
- The applicant (Halozyme Inc.) considered that both of these MAs concern products that are a combination of active ingredients and the examiner did not.
- This disagreement centred on the role of the human recombinant hyaluronidase component in the medicinal product and whether it can be regarded as an active ingredient or not.
- Following several rounds of correspondence, the applicant failed to persuade the examiner on this point and the matter came before an oral hearing on 13 July 2023.
- The issue to be decided in this case was whether, as required by Article 3(d) of Regulation (EC) No 469/2009, the Medicines SPC Regulation, the marketing authorisation cited in support of application SPC/GB15/047 to the combination of trastuzumab and human recombinant hyaluronidase is the first authorisation for this combination.
- The same issue arose in relation to the marketing authorisation cited in support of application SPC/GB16/039 to the combination of rituximab and human recombinant hyaluronidase.
- The answer to this question for each application depended on whether human recombinant hyaluronidase can be considered to be an active ingredient in its own right under Article 1(b) of the Medicines SPC Regulation. If it can, then the two applications at issue in this case relate to applications for combinations of active ingredients and could proceed as such.
- However, if human recombinant hyaluronidase is not an active ingredient as defined under article 1(b) of the Medicines SPC Regulation, then the two applications at issue in the this case would, in effect, each relate to a single active ingredient i.e. trastuzumab in the case of application SPC/GB15/047, and rituximab in the case of application SPC/GB16/039.
Conclusions of the hearing officer Mr L Cullen1
SPC/GB15/047 – “Trastuzumab and recombinant human hyaluronidase”
- Taking everything into account, the hearing officer considered that the marketing authorisation EU/1/00/145/002 for the medicinal product Herceptin, cited in support of SPC application SPC/GB15/047 for the product “Trastuzumab and recombinant human hyaluronidase”, is not the first authorisation to place this product on the market in the UK as a medicinal product and so does not meet the requirements of Article 3(d) of the Medicines SPC regulation.
- He considered that the Commission Implementing Decision, the SmPC, and the EPAR for the medicinal product Herceptin identify recombinant human hyaluronidase as an excipient only.
- The Commission Implementing Decision, the SmPC, and the EPAR for the medicinal product Herceptin do not show that recombinant human hyaluronidase has a metabolic, pharmacological, or immunological effect with respect to HER2 breast cancer, the therapeutic indication covered by this marketing authorisation. As such, recombinant human hyaluronidase cannot be considered to be an active ingredient under Article 1(b) of the SPC regulation.
- As a consequence, SPC application SPC/GB15/047 cannot be considered as an application for a combination of two active ingredients, i.e., trastuzumab and recombinant human hyaluronidase. Rather, it has to be considered as an application for a single active ingredient (trastuzumab).
- This SPC application also did not comply with Article 3(c) of the Medicines SPC Regulation given the existence of an earlier granted SPC for trastuzumab.
- SPC Application SPC/GB15/047 application was thus rejected under Article 10(2) of the Medicines SPC Regulation for failure to meet the conditions laid down in the Regulation.
SPC/GB16/039 – “Rituximab and recombinant human hyaluronidase”
- Taking everything into account, the hearing officer considered that the marketing authorisation EU/1/98/067/003 for the medicinal product MabThera cited in support of SPC application SPC/GB16/039 for the product “Rituximab and recombinant human hyaluronidase” does not meet the requirements of Article 3(d) of the SPC regulation.
- He considered that the Commission Implementing Decision, the SmPC, and the EPAR for the medicinal product MabThera, identify recombinant human hyaluronidase as an excipient only.
- The Commission Implementing Decision, the SmPC, and the EPAR do not show that, recombinant human hyaluronidase has a metabolic, pharmacological, or immunological effect with respect to non-Hodgkin’s lymphoma, the therapeutic indication covered by this marketing authorisation. As such, recombinant human hyaluronidase cannot be considered to be an active ingredient under Article 1(b) of the SPC regulation.
- As a consequence, application SPC/GB16/039 cannot be considered as an application for a combination of two active ingredients, i.e., rituximab and recombinant human hyaluronidase. Rather, it has to be considered as an application for a single active ingredient (rituximab).
- As this application did not meet the requirement of Article 3(d) of the Medicines SPC Regulation, it was rejected under Article 10(2) of this Regulation.
- SPC Application SPC/GB16/039 application was thus rejected under Article 10(2) of the Medicines SPC Regulation for failure to meet the conditions laid down in the Regulation.
In “the Decision” BL O/0257/24, the Hearing Officer refused two the SPC applications for reasons stated above.
The appeal
The appeal arose following the decision of 27 March 2024, BL O/0257/24 of the Hearing Officer, Dr Lawrence Cullen (“the Decision”) of the IPO.
The central issue in the appeal was, as described in paragraph 6 of the Decision (BL O/0257/24), namely that that both of these MAs relate to a product that is a combination of active ingredients and the examiner did not. This disagreement centred on the role of the human recombinant hyaluronidase component in the medicinal product and whether it can be regarded as an active ingredient or not.
The Judgement
On 16 December 2024, the High Court handed down its judgment in the case of Halozyme, Inc. v The Comptroller-General of Patents, Designs and Trade Marks.2
Justice Meade dismissed Halozyme’s appeal, upholding the decision of the UK Intellectual Property Office (UKIPO) to refuse two Supplementary Protection Certificate (SPC) applications related to human recombinant hyaluronidase (rHuPH20) in combination with the therapeutic antibodies trastuzumab (Herceptin®) or rituximab (MabThera®), respectively.2
In order to understand the appeal and its outcome, it is important to read the judgement as well as the Reference and articles below in the section Further Reading.
Reference
- Decision” BL O/0257/24 of 27 March 2024 concerning SPC applications SPC/GB15/047 and SPC/GB16/039
- High Court upholds UKIPO decision: Halozyme’s SPC appeal dismissed, Potter Clarkson.
Further reading
- Biotech’s UK SPCs application fails over nature of ‘active ingredients’, Catherine Drew et al, 16 January 2025, Pinsent Masons.
- High Court weighs in on the application of Forsgren to Halozyme’s Herceptin Hylecta® and MabThera® GB SPCs, Fergus Tyrrell et al, Carpmaels & Randford.