Opinion of the Advocate General — ECLI:EU:C:2026:348
Date: 2026-04-23
Language of the case: Czech

Summary C-456/24 – 1 
Case C-456/24 
Summary of a request for a preliminary ruling pursuant to Article 98(1) of 
the Rules of Procedure of the Court of Justice 
Date lodged: 
27 June 2024 
Referring court: 
Nejvyšší správní soud (Czech Republic) 
Date of the decision to refer: 
18 June 2024 
Appellant: 
Halozyme, Inc. 
Respondent: 
Úřad průmyslového vlastnictví 
  
Subject matter of the main proceedings 
The referring court is hearing an appeal in cassation brought by Halozyme, Inc. 
(‘the appellant’) against the judgment of the Městský soud v Praze (Prague City 
Court), dismissing the appellant’s action challenging the decision of the President 
of the Úřad pro průmyslové vlastnictví (Industrial Property Office), which upheld 
the Office’s decision to reject the appellant’s application for a supplementary 
protection certificate (‘SPC’) in respect of patent CZ/EP 2163643 for the product 
Herceptin SC, which was placed on the market as a medicinal product. 
Subject matter and legal basis of the request  
The referring court entertains doubts as to the interpretation of Regulation 
No 469/2009 in relation to the question of whether Herceptin SC constitutes a 
combination of two active ingredients and whether that combination of active 
ingredients is protected under patent CZ/EP 2163643. In that regard, the referring 
court submits six questions. 
EN 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-456/24 
 
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Questions referred 
(1) Is Article 1(b) of Regulation (EC) No 469/2009 of the European Parliament 
and of the Council concerning the supplementary protection certificate for 
medicinal products to be interpreted as meaning that a substance expressly 
designated as an excipient, in the authorisation for a medicinal product, cannot be 
regarded as an active ingredient? 
(2) If the answer to question 1 is in the negative, is Article 1(b) of Regulation 
No 469/2009 to be interpreted, in the light of Article 8(1) and Article 10(1) to (3) 
of that regulation, as meaning that a substance must be deemed to constitute an 
active ingredient if it has a therapeutic effect of its own which is included in the 
therapeutic indications of the marketing authorisation and which is also 
demonstrably identifiable from the basic patent and the documents mandatorily 
presented with the application for a certificate? 
(3) If the answers to questions 1 and 2 are negative, is Article 1(b) of Regulation 
No 469/2009 to be interpreted as meaning that a substance must be deemed to 
constitute an active ingredient if it has a therapeutic effect of its own which is 
included in the therapeutic indications of the marketing authorisation and that a 
person skilled in the art would identify as documented as of the date of the basic 
patent application or the date of priority of that patent? 
(4) Is Article 1(b) of Regulation No 469/2009 to be interpreted as meaning that, 
inter alia, an excipient must be deemed to constitute an active ingredient with a 
therapeutic effect of its own which is included in the therapeutic indications in the 
authorisation of a medicinal product for treating breast cancer, if it breaks down 
another substance that occurs naturally in the human body, thereby facilitating the 
effects of the product’s main active ingredient on cancerous cells in breast cancer, 
if, according to certain studies and scientific articles, that excipient or a substance 
related thereto has resulted, in and of itself, in vitro or in animal models, in 
arresting the growth of tumours of the same as well as another type, or to the 
shrinkage thereof, and if other scientific articles confirm its potentially similar 
effect in humans? 
(5) Is Article 3(a) of Regulation No 469/2009, in conjunction with Article 1(b) 
thereof, to be interpreted as meaning that a product protected by a basic patent 
must also be deemed to include a combination of two active ingredients, if the 
subject of the invention to which the basic patent applies is only one of the two 
ingredients and the patent claims include its potential combination with other 
alternatively specified categories of active ingredients, one of which may include 
the other active ingredient, according to the opinion of a person skilled in the art 
based on the state of knowledge as at the date of the basic patent application or the 
priority date of that same patent? 
(6) If the answer to question five is negative, is Article 3(a) of Regulation 
No 469/2009, in conjunction with Article 1(b) of that regulation, to be interpreted 
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as meaning that a product protected by the basic patent may be considered as 
including a combination of two active ingredients, if the subject of the invention 
to which the basic patent applies is only one of the two substances and the patent 
claims include its potential combination with other alternatively specified 
categories of active ingredients, one of which included the only active ingredient 
that was the subject of the authorisation for the medicinal product, regardless of 
whether there were, as at that date, other substances falling into that same 
category? 
Applicable provisions of EU and international law 
Regulation (EC) No 469/2009 of the European Parliament and of the Council of 
6 May 2009 concerning the supplementary protection certificate for medicinal 
products (Codified version): Article 1(b) [the referring court cites sub-paragraphs 
(a) to (d)], Article 3(a) [the referring court quotes sub-paragraphs (a) to (d)], 
Article 8(1), and Article 10(1) to (3). 
Directive 2001/83/EC of the European Parliament and of the Council of 
6 November 2001 on the Community code relating to medicinal products for 
human use, as amended by Directive (EU) 2022/642 of the European Parliament 
and of the Council of 12 April 2022 amending Directives 2001/20/EC and 
2001/83/EC as regards derogations from certain obligations concerning certain 
medicinal products for human use made available in the United Kingdom in 
respect of Northern Ireland and in Cyprus, Ireland and Malta: Article 1. 
Convention on the Grant of European Patents of 5 October 1973, as amended by 
subsequent Revision Acts (‘European Patent Convention’: Article 69(1). 
Protocol on the Interpretation of Article 69 of the Convention. 
Summary of the facts of the case and original proceedings 
1 On 21 July 2015, the appellant lodged an application with the Industrial Property 
Office for an SPC in respect of patent CZ/EP 2163643 titled Soluble 
hyaluronidase glycoprotein (sHASEGP), the method of its preparation, use, and 
the pharmaceutical composition that contains it, for a product that was placed on 
the market as the medicinal product HERCEPTIN PRO SUBKUTÁNNÍ 
POUŽITÍ (HERCEPTIN FOR SUBCUTANEOUS USE; ‘Herceptin SC’). The 
appellant claims that Herceptin SC is a combination of two active ingredients – 
trastuzumab and recombinant human hyaluronidase (‘rHuPH20’). Trastuzumab 
falls into the category of monoclonal antibodies for use in the treatment of breast 
cancer. The substance rHuPH20, its preparation, and its medicinal usage in 
combination with various categories of active ingredients, identified by type and 
function, was the subject of the invention to which patent CZ/EP 2163643 applies. 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-456/24 
 
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2 The Industrial Property Office (‘the respondent’) rejected the applicant’s 
application for the SPC concerned, on 11 January 2019, and the President of the 
Office upheld that decision on 6 November 2020. Both found that the application 
did not meet the requirements of Article 3(a), (b), and [as the case may be, (d)] of 
Regulation 469/2009, as trastuzumab is not listed in the patent claims of patent 
CZ/EP 2163643 (nor does it appear from its description), while in the marketing 
authorisation for Herceptin SC, the substance rHuPH20 is listed as an excipient 
and the possibility of rHuPH20 having an anti-cancer effect of its own has not 
been documented. The appellant challenged the decision of the respondent’s 
president with an action lodged with the City Court in Prague, which dismissed it 
by judgment of 13 June 2022, primarily on the grounds that rHuPH20 is not an 
active ingredient as it did not clearly appear from the evidence that rHuPH20 in 
combination with trastuzumab had its own particular pharmacological, 
immunological or metabolic action in the treatment of breast cancer. The appellant 
has filed an appeal in cassation with the referring court against that judgment. 
Succinct presentation of the reasoning in the request for a preliminary ruling 
3 According to the referring court, there is no dispute in the present case that 
trastuzumab is an active ingredient. It was not, however, the subject of the 
invention to which patent CZ/EP 2163643 applies does not in itself fall under its 
protection. In order for an SPC to be issued in respect of the patent, rHuPH20 
would also have to constitute an active ingredient and the product would, 
therefore, have to constitute a combination of two active ingredients. In such a 
case, an SPC could be issued for the product only if the combination in question 
fell under the protection of the patent concerned. 
4 The first three questions seek in essence to ascertain whether the inclusion of a 
substance in the category of excipients in the marketing authorisation for a 
medicinal product excludes the possibility of that substance constituting an active 
ingredient under Article 1(b) of Regulation No 469/2009, or is it necessary to 
examine, even in such a case, whether that substance has a pharmacological, 
immunological, or metabolic action of its own, and if so, on the basis of what 
background documents and as at what point in time. 
5 According to the referring court, the Court of Justice has repeatedly held that an 
‘active ingredient’ within the meaning of Article 1(b) of Regulation No 469/2009 
must have a ‘therapeutic effect’ of its own, 1 whereas in the context of 
Article 1(3a) of Directive 2001/83, it has applied the criterion of 
‘pharmacological, immunological, or metabolic actions’. 2 In the questions 
 
1 Judgment of 21 March 2019, Abraxis Bioscience, C-443/17, EU:C:2019:238, paragraph 27; of 
4 May 2006, Massachusetts Institute of Technology, C-431/04, EU:C:2006:291, paragraph 25 et 
seq.; ‘MIT’; order of 14 November 2013, Glaxosmithkline Biologicals and Glaxosmithkline 
Biologicals, Niederlassung der Smithkline Beecham Pharma, C-210/13, EU:C:2013:762, 
paragraph 29; ‘Glaxosmithkline Biologicals’). 
2 Judgment of 15 January 2015, Forsgren (C-631/13, EU:C:2015:13). 
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referred, the referring court uses the term therapeutic effects, but it maintains that 
the two categories overlap and, for the purposes of Article 1(b) of Regulation 
No 469/2009, it is appropriate to rely on the definition in Article 1(3a) of 
Directive 2001/83. At the same time, the Court of Justice has stated that the 
therapeutic effect of its own of an active ingredient must be included among the 
therapeutic indications of the authorisation for the medicinal product. 3 
6 The referring court maintains that if a particular substance has been explicitly 
classified as an ‘excipient’ in the authorisation for a medicinal product, there is no 
room in the SPC application proceedings to revisit the nature of that substance. 
The accuracy of that conclusion is the subject of the first question. If a substance 
is designated in the authorisation decision as an ‘adjuvant’, which, according to 
Annex I to Directive 2001/83 is classified in the category of excipients, it cannot 
at the same time be an active ingredient as the two terms are clearly distinct in the 
context of that directive and that must also be the case in the context of Regulation 
No 469/2009. 4 According to the referring court, that conclusion may be applied 
generally to all of the excipients listed in a decision on the authorisation of a 
medicinal product. 
7 The referring court maintains that that conclusion is not altered by the judgments 
in Bayer CropScience 5 and Forsgren, contrary to the views of the applicant, as 
well as those of the Spanish court and the Polish patent office, which evaluated 
identical applications by the applicant for an SPC in Spain and Poland. The 
judgment in Bayer CropScience concerns the term active substance under 
Article 1(3) of Regulation (EC) No 1610/96 of the European Parliament and of the 
Council of 23 July 1996 concerning the creation of a supplementary protection 
certificate for plant protection products. Even though, in interpreting the term 
‘active substance’, the Court of Justice was repeatedly inspired by its own case-
law concerning Article 1(b) of Regulation No 469/2009 and vice-versa, 6 the 
referring court maintains that the conclusions in Bayer CropScience concerned the 
very specific case of safeners in plant protection products, which cannot be 
directly compared to active ingredients or excipients in medicinal products. 
Hence, only the basic argument (subsequently confirmed by the judgment in 
Forsgren) can be transferred to medicinal products, that is, that the failure to list a 
substance among the active ingredients does not preclude the possibility that it is 
indeed an active ingredient. It is precisely to that limited extent that, according to 
the referring court, it is also necessary to view the judgment in Forsgren, which 
concerned the assessment of a substance that is generally considered to be an 
adjuvant but which was not explicitly designated as such in the marketing 
 
3 Judgments in MIT, paragraph 31; and Forsgren, paragraph 55; or order in Glaxosmithkline 
Biologicals, paragraph 34. 
4 Order in Glaxosmithkline Biologicals, paragraphs 36 to 38. 
5 Judgment of 19 June 2014, C-11/13, EU:C:2014:2010. 
6 Judgments in MIT, paragraph 22; Bayer CropScience, paragraph 34; or Forsgren, paragraph 50. 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-456/24 
 
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authorisation (or, more precisely, classified as an excipient). In that situation, it 
seemed logical to leave it for the national court to ascertain whether the substance 
concerned has a pharmacological, immunological or metabolic action of its own, 
which is covered by the therapeutic indications listed in the marketing 
authorisation, whereas in a case when that possibility had already been effectively 
examined within the framework of registration and the substance had been 
explicitly classified as an excipient, the referring court maintains that the 
conclusions reached in Glaxosmithkline Biologicals 7 should be applied. 
8 According to the referring court, the proceedings concerning an SPC application 
should be, in the light of Article 8(1) and Article 10(1) to (3) of Regulation 
No 469/2009, a rather formal procedure resulting de facto solely in the extension 
of the basic patent, in view of the specific nature of the invention. The only thing 
required in those proceedings should be a confirmation of that specific nature – 
namely, of the fact that it applies to a product that was the subject of an 
authorisation as a medicinal product. Whereas, pursuant to the provisions referred 
to above, any shortcomings in the SPC can be remedied, shortcomings concerning 
the product cannot. 8 According to the referring court, the abovementioned 
proceedings should not result de facto in revisiting the registration process of a 
medicinal product on the basis of an extensive examination of evidence. 
9 The referring court holds that, for those reasons, the answer to the first question 
should be in the affirmative. Even though it derives that conclusion primarily from 
the order in Glaxosmithkline Biologicals, it does not consider the matter to be an 
acte éclairé, in view of the fact that different patent offices and courts in the 
European Union have made different assessments of compliance with the 
conditions for issuing an SPC in respect of this same European patent on the basis 
of the same regulation. 9 
10 The referring court maintains that, in the event of a negative answer to the first 
question, the second question should be answered in the affirmative. Any 
substantive assessment of the therapeutic effects of a substance should be limited 
to the contents of the documents mandatorily submitted with the application and 
the basic patent, which is the necessary basis for the decision. According to the 
referring court, there is no room in the proceedings concerning an SPC for a 
complex examination of the nature of the substances contained in the medical 
product that would be comparable to the patent or authorisation proceedings. 
11 Should the Court of Justice answer the first two questions in the negative, the 
referring court suggests that it answer the third question in the affirmative. In that 
 
7 In support of this conclusion, see also judgment in Forsgren, paragraphs 42 and 43. 
8 In this context, see judgment of 7 December 2017, Merck Sharp, C-567/16, EU:C:2017:948, 
paragraphs 50 to 53. 
9 For example, High Court in Madrid (judgment of 28 December 2020, No 696/2020) and Polish 
Patent Office (Order of 16 December 2022, No DB.SPC.0357.315.2017.41.mkoz). 
HALOZYME 
 
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context, it addresses the question of whether a therapeutic effect of its own 
covered by the therapeutic indications listed in the authorisation is an objective 
fact, for the establishment of which it is irrelevant when such an effect was 
demonstrably proven. In particular, in relation to rHuPH20, certain scientific 
documents examined its effects before the priority date arising from the patent, 
some in the period between that date and the date on which the medicinal product 
received marketing authorisation, and others afterwards. 
12 The referring court maintains that if the therapeutic effects of an active ingredient 
are to be deemed to constitute an objective fact, the time when they were 
demonstrably established should not play a role. That argument, however, 
ultimately results in the SPC not fulfilling the purpose intended by Regulation 
No 469/2009 (covering the investment put into the research of the medicinal 
product) 10 and will not take into account all the interests at stake, including those 
of public health, which was also one of the objectives of that regulation. 11 In a 
situation when the subject of the research was the use of a certain substance as an 
excipient, but subsequent research revealed that it had a therapeutic effect of its 
own, it cannot be said that the SPC compensates for the research into those 
therapeutic effects. Pointing to paragraph 37 of the judgment in Abraxis 
Bioscience, the referring court holds that it would be contrary to the purpose and 
meaning of Regulation No 469/2009 if research were to be taken into account, in 
the assessment of an active ingredient’s therapeutic effects of its own, that only 
took place after the basic patent application or after the priority date thereof. One 
exception could perhaps be the case of a specific finding of an active ingredient 
having its own therapeutic effects made within the framework of the authorisation 
proceedings concerning that medicinal product (in particular during clinical 
studies) as in that instance it would also be possible to speak of pharmaceutical 
research into a new active ingredient by the applicant. 
13 The fourth question referred concerns the interpretation of the concept 
‘therapeutic effect of its own’ (or, as the case may be, ‘a pharmacological, 
immunological or metabolic action of its own’) that is covered by the therapeutic 
indications of the marketing authorisation, as used by the Court of Justice for the 
purpose of defining the term ‘active ingredient’ within the meaning of Article 1(b) 
of Regulation No 469/2009. The answer to question 4 is essential, particularly if 
the Court of Justice answers the first three questions in the negative. 
14 The referring court questions whether that definition specifies the legal concept of 
‘active ingredient’ so precisely that relating specific findings of facts to that 
definition is a question of fact for a person skilled in the art or whether it is a 
question of a legal classification that is reserved to the administrative authorities 
and the courts. According to the referring court, the case-law of the Court of 
Justice does not set out sufficiently clear criteria in this situation for determining 
 
10 Recitals 3 and 4 of Regulation No 469/2009. 
11 Recital 10 of the regulation. 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-456/24 
 
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the therapeutic effects of its own that are covered by the therapeutic indication of 
the authorisation, which results in different assessments of the same situation by 
different industrial property authorities, 12 despite the Court of Justice considering 
that it has provided answers in its case-law to the questions at issue that admit of 
no reasonable doubt. 13 The referring court maintains that the inconsistent 
interpretation of Regulation No 469/2009 and the case-law of the Court of Justice 
is also shown by the fact that the patent offices in Albania, Belgium, Bulgaria, 
Cyprus, Italy, Luxembourg, Poland, Northern Macedonia, Slovenia, Spain, and 
Switzerland in particular decided in favour of the appellant, whereas the patent 
offices in France, 14 the Netherlands, and Sweden, in particular, decided against 
it. 15 
15 If the assessment of the therapeutic effects of its own that are included in the 
therapeutic indication specified in the authorisation decision is a legal question 
that depends on specific criteria, the fourth question is intended in essence to 
ascertain those criteria and to determine a standard of evidence for establishing the 
effects of the substance on humans. At the present time, it appears likely on a 
preliminary basis that the substance rHuPH20 has proven to have certain 
metabolic effects (it is an enzyme that degrades hyaluronan, which is naturally 
found in the human body and which reduces the effect of trastuzumab when 
administered subcutaneously); nevertheless, it is not clear whether those effects 
can be deemed to be therapeutic effects that are covered by the therapeutic 
indication specified in the marketing authorisation for Herceptin SC. One reason 
is that existing studies and scientific articles have researched the effect of the 
substance on its own (or substances related to it) in vitro or in animal models and 
have found that the substance under investigation has resulted in arresting the 
growth of a tumour of the same or other type, or to its shrinkage. Other scientific 
documents confirm its potentially similar effect in humans. 
16 The fifth and sixth questions concern the interpretation of Article 3(a) of 
Regulation No 469/2009, which sets out the condition that the product must be 
protected by a basic patent. If in the present case the substance rHuPH20 were to 
be assessed as an active ingredient, the question arises, according to the referring 
court, whether its combination with trastuzumab falls under the protection of 
patent CZ/EP 2163643. That combination may be classified under patent claim 21 
(in conjunction with patent claims 12, 18, 19, and 20), where one of the 
pharmaceutical compositions listed is a composition containing, in addition to 
rHuPH20, a monoclonal antibody for use in the treatment of breast cancer. 
 
12 Order in Glaxosmithkline Biologicals, paragraph 21. 
13 Order in Glaxosmithkline Biologicals, paragraph 23. 
14 The decision was confirmed by the judgment of the Court of Cassation of 1 February 2023, 
No 101 FP-B, ECLI:FR:CCASS:2023:C00101. 
15 The decision was confirmed by a decision of the Supreme Court in Stockholm of 29 March 
2023, No Ö 6725-22. 
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17 Specifically, the patent claims are worded as follows: 
‘12. A pharmaceutical composition, comprising the substantially 
purified hyaluronidase polypeptide of any of claims 1-4. 
… 
18. The pharmaceutical composition of claim 12 for use in treating a 
tumour, wherein the composition further comprises an anti-cancer 
agent selected from among a chemotherapeutic, an antibody, a peptide, 
a gene therapy vector, a virus or a DNA molecule. 
19. The pharmaceutical composition of claim 18 for use in treating a 
tumour wherein the anti-cancer agent is an antibody. 
20. The pharmaceutical composition of claim 19 for use in treating a 
tumour, wherein the antibody is a monoclonal antibody. 
21. The pharmaceutical composition of any of claims 19 or 20 for 
use in treating a tumour, wherein the tumour is a cancer of the breast.’ 
18 In regard to the question as to when an active ingredient or a combination of 
active ingredients is protected by the basic patent, the referring court points to the 
case-law of the Court of Justice. 16 As the regulation of patent protection has not 
been harmonised at EU level, the extent of the protection granted by a basic patent 
may be determined only on the basis of the rules regulating such a patent. 17 As 
regards the European patent, the referring court adds, with reference to Article 69 
of the European Patent Convention and Article 1 of the Protocol on the 
Interpretation of that article of the Convention, that patent claims cannot be used 
exclusively as a guide nor be interpreted to the effect that the extent of the 
protection conferred by a patent should be understood as being defined by a strict 
and literal interpretation of the wording used in patent claims. 
19 Hence, according to the referring court, the Court of Justice has stated that it is not 
necessary for an active ingredient to be identified in the claims of the patent by a 
structural formula, and it suffices if it is possible to reach the conclusion, on the 
basis of the patent claims interpreted, inter alia, in the light of the description of 
the invention, that the claims relate, implicitly but necessarily and specifically, to 
the active ingredient in question. 18 As for a combination of active ingredients, 
then it must (1) necessarily fall, in the light of the description and drawings of the 
patent, under the invention covered by the patent, and (2) it must be possible to 
 
16 Judgments of 12 December 2013, Eli Lilly and Company, C-493/12, EU:C:2013:835; of 25 July 
2018, Teva UK and Others, C-121/17, ECLI:EU:C:2018:585; and of 30 April 2020, Royalty 
Pharma Collection Trust, C-650/17, EU:C:2020:327. 
17 Judgments in Eli Lilly and Company, paragraph 32; and Teva UK and Others, paragraph 32. 
18 Judgment in Eli Lilly and Company, paragraphs 39 and 44. 
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specifically identify each active ingredient in the light of all of the information 
disclosed by the patent. 19 
20 The above phrases ‘necessarily and specifically’ and ‘specifically identify’ could 
indicate that each active ingredient included in the product should be listed in the 
patent in a manner that is not interchangeable with another substance, even if it be, 
for example, by means of a functional definition. According to the referring court, 
that interpretation is apparently advanced by the parties to the proceedings in this 
case, as they are de facto arguing as to whether a person skilled in the art would 
consider trastuzumab, at the priority date of patent CZ/EP 2163643, to be a 
synonym for monoclonal antibody for use in the treatment of cancer. 
21 With regard to the judgments in Eli Lilly and Company and Royalty Pharma 
Collection Trust, the referring court notes that they concerned products comprised 
of a single active ingredient. The aim of the requirement for patent claims to 
concern ‘necessarily and specifically’ that active ingredient is to prevent the 
patent holder from claiming more rights than would arise from the basic patent 
and for the SPC to indeed constitute compensation for the costs of the patent 
holder’s own research. In another words, an SPC may be issued only for an active 
ingredient that was the subject of the invention to which the patent applies. 
22 The judgment in Teva UK and Others is more instructive for the present case, 
according to the referring court. The difference from the present case is that in 
Teva UK and Others, the combination of active ingredients was included under a 
more generally worded patent claim. 20 Accordingly, the case concerned a 
combination of a substance that was the subject of the invention with another 
therapeutic ingredient. The present case concerns a combination of a substance 
that is the subject of the invention with a monoclonal antibody for use in the 
treatment of cancer of the breast. 
23 The referring court does not view the judgment in Teva UK and Others as an 
extension of the rule set out in Eli Lilly and Company – according to which patent 
claims must necessarily and specifically concern active ingredients – to each of 
the active ingredients which in combination constitute the product in question. 
The Court of Justice specified therein the rule expressed in the Eli Lilly and 
Company judgment in relation to a combination of active ingredients and 
embodied it in the first condition. It thus created an amended rule according to 
which a combination of active ingredients must necessarily, in the light of the 
description and drawings of the basic patent, fall under the invention covered by 
that patent. It applies to the product as a whole, that is, for the combination of 
 
19 Judgment in Teva UK and Others. See also judgment in Royalty Pharma Collection Trust 
applicable to cases when a product consists of a single active ingredient. 
20 ‘A pharmaceutical composition comprising a compound according to any one of claims 1 to 25 
together with a pharmaceutically acceptable carrier, and optionally other therapeutic 
substances.’ 
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active ingredients itself. 21 The purpose was to confirm that the product must be 
the result of the patent holder’s own research (which is why the condition says 
that the combination of substances should be based on the invention rather than 
the patent claims). 
24 The second condition set out in the judgment in Teva UK and Others likewise 
cannot be deemed to constitute an extension of the requirement of the judgment in 
Eli Lilly and Company to each active ingredient, in the case of a product that 
consists of a combination thereof. The purpose of that condition is not to ensure 
that a product is the outcome of the patent holder’s own development. The 
condition requires ‘only’ the identification of each of the active ingredients from 
the information disclosed by a patent. According to the referring court, it is 
therefore necessary for a person skilled in the art to clearly identify, on the basis 
of the prior art as at the filing date (or the priority date), which substances fall 
under which patent claim (and whether the combination in question therefore falls 
under them), but it is not necessary for individual patent claims to pertain only to a 
single substance (or to a combination of entirely specific substances). 
25 With reference to point 77 of the Opinion in Joined Cases Royalty Pharma 
Collection Trust and Sandoz and Hexal, 22 the referring court notes that, in the 
case of the combination of the active ingredients currently under consideration, it 
is sufficient for the ingredient that is not the subject of the invention to be 
classified, by a person skilled in the art, as of the filing or priority date for that 
patent, under a relatively specific category included in the patent claims, even 
though it includes several active ingredients. 
26 In the present case, that would mean that it is not important whether, as at the 
application for patent CZ/EP 2163643, there were several monoclonal antibodies 
for use in treating cancer of the breast, but rather, whether a person skilled in the 
art could specifically identify, as at the given date, that trastuzumab is a 
monoclonal antibody for use in treating cancer of the breast. That would meet the 
second condition of the judgment in Teva UK and Others. What would be vital for 
meeting the first condition is whether it follows from the patent, according to a 
person skilled in the art, that the invention did not consist merely in the discovery 
of rHuPH20 or the process for obtaining it, but also in the discovery of a method 
for its use together with monoclonal antibodies for use in treating cancer of the 
breast. 
27 For the sake of completeness, the referring court states that the conclusions 
described above cannot result in multiple SPCs being issued for the combination 
of rHuPH20 with a number of other monoclonal antibodies for use in the 
treatment of breast cancer or any other active ingredients that can be classified 
 
21 Judgement in Teva UK and Others, paragraphs 52 to 55. 
22 Opinion of Advocate General Hogan delivered on 11 September 2019, C-650/17 and C-114/18, 
EU:C:2019:704. 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-456/24 
 
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under other patent claims according to patent CZ/EP 2163643. Inasmuch as those 
would be different products, the conclusions set out in the judgment in Actavis 
Group PTC and Actavis UK 23 would apply to them. Multiple SPCs for various 
combinations of active ingredients or independent active ingredients may be 
issued only if each of the active ingredients as such is protected by a basic 
patent. 24 That should mean that the condition for the issuance of multiple SPCs is 
for each active ingredient to be the subject of an invention. It follows from the 
judgment in Actavis Group PTC and Actavis UK 25 that only one SPC can be 
obtained for medicinal products containing various combinations of an active 
ingredient that is protected as such by a basic patent and which constitutes the 
subject of an invention, with other substances that are not the subject of the 
invention. 
28 In view of that consequence, it is not necessary, according to the referring court, 
in the case of a product consisting of several active ingredients, to place high 
standards on those substances that do not constitute the subject of the invention, in 
terms of their being fully individualised in patent claims (whether by name, 
formula, or functional definition that rules out placing other ingredients under 
such a definition). If the subject of an invention is a single active ingredient and its 
combination with other types of previously invented substances, the patent holder 
will be unable to obtain several SPCs for products consisting in a combination of 
that ‘new’ substance with other substances. At the same time, it will never be able 
to derive from an SPC more rights (broader protection) than it derived from the 
basic patent. 26 
29 For the reasons given above, the referring court proposes that the Court of Justice 
answer the fifth question in the affirmative. 
30 Should the Court of Justice conclude that, for the purpose of Article 3(a) of 
Regulation No 469/2009, it is necessary, in the case of a product comprised of a 
combination of two active ingredients, for each active ingredient to be specified in 
the patent claims in an individual and non-interchangeable manner, question six 
seeks to ascertain what aspects must be taken into account when considering 
compliance with that requirement. Does it suffice for an active ingredient to be 
specified in patent claims as a substance of a certain type, if, as of the date of the 
basic patent application or the priority date thereof, the only active ingredient that 
was the subject of the authorisation for the medicinal product fell into that same 
 
23 Judgment of 12 March 2015, Actavis Group PTC and Actavis UK, C-577/13, 
EU:C:2015:165C-577/13, EU:C:2015:165. 
24 Judgment of 12 December 2013, Georgetown University, C-484/12, EU:C:2013:828, 
paragraph 30; and judgment in Actavis Group PTC a Actavis UK, paragraph 33. 
25 In particular, paragraphs 36 to 38. 
26 Judgment in Georgetown University, paragraph 39; judgments of 19 July 2012, Neurim 
Pharmaceuticals (1991), C-130/11, EU:C:2012:489, paragraphs 24 and 25; and of 24 November 
2011, Medeva, C-322/10, EU:C:2011:773, paragraph 39. 
HALOZYME 
 
13 
category? That circumstance could lead a person skilled in the art, as of a 
particular date, to automatically link the given category of substances with that 
active ingredient. Similarly, however, a person skilled in the art should be familiar 
with the existence of other substances of the same type that have been developed 
but cannot be yet used in treatment. Question six therefore seeks in essence to 
ascertain whether or not such substances should be taken into account in the 
application of Article 3(a) of Regulation No 469/2009.