Source: EURLEX
Language: en
Format: md

OPINION OF ADVOCATE GENERAL

BOT

delivered on 9 June 2011 ([1](#Footnote1))

**Case C‑125/10**

**Merck Sharp & Dohme Corp.,** formerly Merck & Co.,

**v**

**Deutsches Patent- und Markenamt**

(Reference for a preliminary ruling from the Bundespatentgericht (Germany))

(Intellectual and industrial property – Patents – Regulation (EEC) No 1768/92 – Article 13(1) – Supplementary protection certificate for medicinal products – Conditions of grant – Regulation (EC) No 1901/2006 – Article 36 – Extending the duration of the supplementary protection certificate – Possibility of granting that certificate where the period that elapses between the filing of an application for a basic patent
and the date of the first authorisation to place the product on the market in the Community is less than five years)

  
  
  
  

1.        In the present preliminary ruling proceedings, the Court is asked to specify what consequences the adoption of Regulation
(EC) No 1901/2006 of the European Parliament and of the Council ([2](#Footnote2)) has on the conditions for granting a supplementary protection certificate (‘SPC’) intended to extend the exclusive right
to exploit a medicinal product conferred by a patent.

2.        The development of a medicinal product requires long and costly research. In order to enable pharmaceutical laboratories to
make a return on the investment needed for such research and, therefore, to promote that research, the Member States provided,
in their domestic law or, by way of agreement, at European level, ([3](#Footnote3)) that medicinal products could be granted a patent intended to guarantee for the patent holder an exclusive right to exploit
those products for a specific period. ([4](#Footnote4))

3.        However, the marketing of a medicinal product in a Member State is subject to the prior grant of a marketing authorisation
(‘MA’) issued either by the competent authority of that State ([5](#Footnote5)) or, since the entry into force of Council Regulation (EEC) No 2309/93, ([6](#Footnote6)) by the European Community. ([7](#Footnote7))

4.        The period that elapses between the filing of a patent application and the grant of an MA can be relatively long. Whereas a patent for a medicinal product must be applied for very early in order to avoid any risk
of disclosure or the completion of parallel research, the grant of an MA may take several years on account of the research
that has to be carried out to verify the effectiveness, safety and quality of the product. ([8](#Footnote8))

5.        This therefore reduces by the same period the effective duration of the monopoly on exploitation conferred by the patent.

6.        In order to mitigate that disadvantage in a uniform manner in the Member States, the Community legislature, in Council Regulation
(EEC) No 1768/92, ([9](#Footnote9)) made it possible for pharmaceutical laboratories to obtain an SPC which, on the expiry of the basic patent, confers on its
holder the same rights as those attached to the patent for a period intended to offset the duration of the procedure for obtaining
the MA where this exceeds the normal estimated period of five years.

7.        Thus, Article 13 of Regulation No 1768/92 provides that the SPC is to take effect at the end of the lawful term of the patent
for a period equal to the period which elapsed between the date on which the patent application was lodged and the date of
the first MA in the Community reduced by a period of five years, but may not last longer than five years from the date on
which it takes effect.

8.        The Paediatric Regulation, for its part, was prompted by the finding that many medicinal products were being placed on the
market without having undergone proper studies into their paediatric effects, which meant that they could not be used as an
effective and safe treatment for children.

9.        The Community legislature therefore provided in that regulation that, unless it had been granted a waiver, a medicinal product
could not obtain an MA until it after had undergone studies to determine whether and how it could be used in the paediatric
population.

10.      In return for the completion of those additional studies, the Community legislature provided in the Paediatric Regulation
that the duration of the SPC was to be extended by six months.

11.      In this case, the Court is asked whether and to what extent an economic operator is eligible for that six-month extension
where less than five years have elapsed between the application for a patent and the date on which the MA was granted.

12.      The question, in other words, is whether an SPC may be granted with a negative or zero duration so as to make the six-month
extension run either from the starting point of the negative duration, that is to say before the date on which the basic patent
expires, or, if such a negative duration is to be rounded up to zero, from the date on which the basic patent expires.

13.      In this Opinion, I shall say that there is no clear answer to the question referred in the content and scheme of Regulation
No 1768/92 and the Paediatric Regulation and that the answer must therefore be inferred from the objectives which they pursue.

14.      I shall explain that the purpose of Regulation No 1768/92 is to guarantee for the patent holder a period of exclusive exploitation
of no more than 15 years from the grant of the MA and that the aim of the Paediatric Regulation is to extend by six months
the SPC granted for that purpose. I shall submit that, taken together, those two regulations have the effect of guaranteeing
for the patent holder a period of exclusive exploitation of 15 years and 6 months from the grant of the MA.

15.      Consequently, I shall propose that the Court should find that a patent holder is eligible for the six-month extension established
by the Paediatric Regulation where less than five years have elapsed between the application for a patent and the date on
which the MA was granted, and that that extension must begin to run from the date determined by applying the negative value of the SPC
to the date of expiry of the patent.

I –  **Legal context**

16.      In its order for reference, the Bundespatentgericht (Germany) refers to Regulation (EC) No 469/2009 of the European Parliament
and of the Council, ([10](#Footnote10)) which reproduces the content of Regulation No 1768/92 without amending its substance. However, Regulation No 469/2009 did
not enter into force until 6 July 2009, in other words after the adoption of the decision under appeal in the main case. The
applicable regulation is therefore Regulation No 1768/92.

A –    *Regulation No 1768/92*

17.      The third to fifth recitals to Regulation No 1768/92 state that the period that elapses between the filing of an application
for a patent for a new medicinal product and the authorisation to place the medicinal product on the market makes the period
of effective protection under the patent insufficient to cover the investment put into the research, which penalises that
research and creates the risk of research centres relocating outside the Member States.

18.      The eight and ninth recitals to Regulation No 1768/92 state:

‘Whereas the duration of the protection granted by the [SPC] should be such as to provide adequate effective protection; whereas,
for this purpose, the holder of both a patent and an [SPC] should be able to enjoy an overall maximum of fifteen years of
exclusivity from the time the medicinal product in question first obtains authorisation to be placed on the market in the
Community;

Whereas all the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical
sector must nevertheless be taken into account; whereas, for this purpose, the [SPC] cannot be granted for a period exceeding
five years; whereas the protection granted should furthermore be strictly confined to the product which obtained authorisation
to be placed on the market as a medicinal product’.

19.      Article 3 of Regulation No 1768/92 is entitled ‘Conditions for obtaining a[n SPC]’. It reads as follows:

‘A[n SPC] 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)      the product is protected by a basic patent in force;

(b)      a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive
65/65 … or Directive 81/851/CEE, [([11](#Footnote11))] as appropriate;

(c)      the product has not already been the subject of a[n SPC];

(d)      the authorisation referred to in (b) is the first authorisation to place the product on the market as a medicinal product.’

20.      Under Articles 4 and 5 of Regulation No 1768/92, the protection conferred by the SPC applies only to the product covered by
the MA for the corresponding medicinal product and includes the same rights as those conferred by the basic patent.

21.      Article 7(1) of Regulation No 1768/92 provides that the application for an SPC is to be lodged within six months of the date
on which the authorisation to place the product on the market as a medicinal product was granted. Paragraph 3 of the same
article provides that the application for an extension of the duration may be made when lodging the application for an SPC
or when the application for the SPC is pending and the appropriate requirements of Article 8(1) of Regulation No 1768/92 are
fulfilled. According to Article 7(4) of the same regulation, the application for an extension of the duration of an SPC already
granted is to be lodged not later than two years before the expiry of the SPC.

22.      Article 8 of Regulation No 1768/92 sets out the information which the application for an SPC must contain. It provides, in
particular, that, where the application for an SPC includes a request for an extension of the duration, it must include a
copy of the statement indicating compliance with a paediatric investigation plan as referred to in Article 36(1) of the Paediatric
Regulation.

23.      Article 10 of Regulation No 1768/92, entitled ‘Grant of the certificate or rejection of the application’, states:

‘1. Where the application for an [SPC] and the product to which it relates meet the conditions laid down in this Regulation,
the [competent] authority shall grant the [SPC].

2. The [competent] authority … shall, subject to paragraph 3, reject the application for an [SPC] if the application or the
product to which it relates does not meet the conditions laid down in this Regulation.

…’

24.      Article 13 of Regulation No 1768/92, entitled ‘Duration of the [SPC]’, provides:

‘1. The [SPC] shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed
between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the
product on the market in the Community reduced by a period of five years.

2. Notwithstanding paragraph 1, the duration of the [SPC] may not exceed five years from the date on which it takes effect.

3. The periods laid down in paragraphs 1 and 2 shall be extended by six months in the case where Article 36 of the [Paediatric]
Regulation applies. In that case, the duration of the period laid down in paragraph 1 of this Article may be extended only
once.’

25.      Article 14(a) of Regulation No 1768/92 states that the SPC is to lapse ‘at the end of the period provided for in Article 13
[of that regulation]’.

B –    *The Paediatric Regulation*

26.      Recitals 26 to 28 to the Paediatric Regulation state:

‘(26) For products falling within the scope of the requirement to submit paediatric data, if all the measures included in the agreed
paediatric investigation plan are complied with, if the product is authorised in all Member States and if relevant information
on the results of studies is included in product information, a reward should be granted in the form of a 6-month extension
of the [SPC] created by … Regulation … No 1768/92.

(27)      An application for an extension of the duration of the [SPC] pursuant to this Regulation should only be admissible where an
[SPC] is granted pursuant to Regulation … No 1768/92.

(28)      Because the reward is for conducting studies in the paediatric population and not for demonstrating that a product is safe
and effective in the paediatric population, the reward should be granted even when a paediatric indication is not authorised.
However, to improve the information available on the use of medicinal products in the paediatric population, relevant information
on use in paediatric populations should be included in authorised product information.’

27.      Article 36 of the Paediatric Regulation is worded as follows:

‘1.      Where an application under Article 7 or 8 includes the results of all studies conducted in compliance with an agreed paediatric
investigation plan, the holder of the patent or [SPC] shall be entitled to a six-month extension of the period referred to
in Articles 13(1) and 13(2) of Regulation … No 1768/92.

The first subparagraph shall also apply where completion of the agreed paediatric investigation plan fails to lead to the
authorisation of a paediatric indication, but the results of the studies conducted are reflected in the summary of product
characteristics and, if appropriate, in the package leaflet of the medicinal product concerned.

…

4.      Paragraphs 1, 2 and 3 shall apply to products that are protected by an [SPC] under Regulation … No 1768/92, or under a patent
which qualifies for the granting of the [SPC]. …

…’

II –  **The dispute in the main proceedings and the question referred for a preliminary ruling**

28.      Merck Sharp & Dohme Corp., formerly Merck & Co. (‘Merck’), is the owner of a European patent covering dipeptidylpeptidase
inhibitors for the treatment or prevention of diabetes. That patent was applied for on 5 July 2002.

29.      On 14 September 2007, Merck applied to the Deutsches Patent- und Markenamt (German Patent and Trade Mark Office) for the grant
of an SPC for the pharmaceutical substance sitagliptin covered by that patent, where appropriate in the form of a pharmaceutically
acceptable salt, in particular for sitagliptin phosphate monohydrate. It gave as the date of the first MA in the European
Union and the Federal Republic of Germany 21 March 2007, the date on which European authorisation was issued for the medicinal
product under the brand name Januvia, which contains the active ingredient sitagliptin phosphate monohydrate.

30.      That application was rejected by decision of 1 July 2008 on the ground that a period of only four years, eight months and
sixteen days had elapsed between the date of the filing of the basic patent and the date of issue of the first MA, so that
calculating the length of the SPC would have given a negative duration of three months and fourteen days.

31.      Merck brought an action against that decision before the Bundespatentgericht.

32.      It submits that duration is not one of the conditions governing the grant of an SPC, that the SPC must be granted to it because
it fulfils all the conditions required for that purpose and that the grant of the SPC is necessary to enable it subsequently
to apply for an extension of that SPC.

33.      Merck points out that a paediatric investigation plan was authorised by the competent authority on 27 March 2009 and that
the studies prescribed in that plan must be completed by 2017.

34.      It argues that it should be granted an SPC with a negative or zero duration so as to make the six-month extension provided
for by the Paediatric Regulation run either from 21 March 2022 or from the date of expiry of the basic patent, 5 July 2022.

35.      The referring court states that, until the Paediatric Regulation was adopted, it was accepted that an SPC could be granted
only where a period of five years had elapsed between the application for a patent and the grant of the first MA for the medicinal
product in question. It raises the question whether, following the entry into force of that regulation, a different interpretation
should be adopted and SPCs with a negative or zero duration should be granted.

36.      The referring court states, first, that neither the Paediatric Regulation nor Regulation No 469/2009 expressly provided for
the possibility of granting such SPCs and that that solution would run counter to the normal meaning of the word ‘duration’
in Article 13 of Regulation No 469/2009.

37.      It states, secondly, that Article 13 does not form part of the conditions for granting an SPC and that granting an SPC with
a negative or zero duration would be consistent with the objective pursued by the Paediatric Regulation. It points out that,
if that interpretation were to prevail, it would also be necessary to clarify the starting point of the extension of the SPC.
There would thus be a need to ascertain whether the six-month period must begin to run before the date of expiry of the patent,
on the date established by assigning a negative value to the SPC, or whether that value must be rounded up to zero and the
six-month period made to run from the date of expiry of the patent.

38.      The referring court points out in this regard that the situation of the appellant in the main proceedings has revealed the
existence of different practices in the Member States. Thus, it states, the competent authorities of the Republic of Bulgaria,
the Kingdom of the Netherlands and the United Kingdom of Great Britain and Northern Ireland granted the appellant an SPC with
a negative duration, while the competent authorities of the Hellenic Republic granted it one with a zero duration. Similarly,
in Estonia and Latvia, the decisions refusing to grant an SPC were annulled by the boards of appeal.

39.      The referring court states that, in the light of those considerations, it considered it necessary to ask the Court for an
interpretation of Article 13(1) of Regulation No 469/2009. The Bundespatentgericht refers the following question for a preliminary
ruling:

‘Can an [SPC] for medicinal products be granted if the period of time between the filing of the application for the basic
patent and the date of first authorisation [MA] in the Community is shorter than five years?’

III –  **My analysis**

40.      The referring court has set out very clearly the matter at issue in these preliminary ruling proceedings. It must determine
whether the appellant in the main proceedings is entitled to obtain an SPC for the product in question when only four years,
eight months and sixteen days, that is to say, less than five years, elapsed between the date of filing of the basic patent
and the date of issue of the first MA.

41.      That question arises because the Paediatric Regulation makes the grant of the six-month extension of the SPC dependent on
the grant of that SPC and because, under Regulation No 1768/92, the duration of that SPC is equal to the period that elapsed
between the date on which the application for a patent was lodged and the date of the first MA, reduced by five years. The
question, therefore, is whether the grant of the extension provided for by the Paediatric Regulation must be made subject
to the condition that the patent holder should be able to obtain an SPC with a positive duration.

42.      If that question is answered in the affirmative, the appellant will not therefore be eligible for any extension of the exclusive
rights conferred on it by its patent. If, on the other hand, the answer to that question is in the negative, it is also necessary
to clarify the starting point of the six-month period.

43.      It must after all be made clear whether the six-month period would have to run from the date determined on the basis of the
negative value of the SPC or, by rounding up that value to zero, from the date of expiry of the patent, that is to say, in
the present case, 5 July 2022.

44.      In the former case, the six-month period would have to run from 21 March 2022, ([12](#Footnote12)) so that the exclusive rights conferred on the appellant in the main proceedings by the basic patent would be extended by
two months and sixteen days after the date on which the patent would ordinarily have expired, that is to say until 21 September
2022.

45.      If that solution were adopted, this would mean that the basic patent holder would be eligible for the six-month extension
provided for by the Paediatric Regulation only if the period that elapsed between the date of the patent application and the
date on which the first MA was granted exceeds four years and six months.

46.      In the latter case, the exclusive rights enjoyed by the appellant in the main proceedings would be extended until 5 January
2023. If that solution were adopted, this would mean that the patent holder would always be eligible for the extension provided
for by the Paediatric Regulation for the full six-month period, irrespective of the period which had elapsed between the date
of the patent application and the date when the first MA was granted.

47.      In order to be able to answer those questions, the referring court is asking, in essence, whether and to what extent Regulation
No 1768/92, read in the light of the Paediatric Regulation, must be interpreted as meaning that medicinal products can be
granted an SPC where the period that elapsed between the filing of the application for a basic patent and the date of the
first MA in the Community is less than five years.

48.      The parties intervening before the Court have adopted opposing positions.

49.      Thus, the Hungarian and United Kingdom Governments, like the appellant in the main proceedings, have asked the Court to answer
the question referred in the affirmative and have also stated that the six-month period should begin to run from the ‘negative’
expiry date of the SPC.

50.      The French, Lithuanian and Portuguese Governments and the European Commission, on the other hand, have submitted that the
question under examination should be answered in the negative, on a number of grounds based on the wording of the relevant
provisions, the scheme of which they form part and the objectives which they pursue.

51.      As regards, first of all, the wording of the relevant provisions, the Commission points out that, under Article 13(1) of Regulation
No 1768/92, the SPC ‘shall take effect at the end of the lawful term of the basic patent’ and that, under Article 13(2) of
that regulation, the duration of such an SPC may not exceed five years from the date on which it takes effect, so that the
SPC must necessarily have a positive duration. The French Government also considers that an SPC with a zero or negative duration
is incapable of producing such an effect and is therefore devoid of any purpose.

52.      To the same effect, the Portuguese Government argues that Article 13(3) of Regulation No 1768/92 provides for the six-month
extension of the SPC under Article 36 of the Paediatric Regulation, which implies that the SPC has a period of validity that
can be extended.

53.      For its part, the Lithuanian Government maintains, with respect to the conditions for granting the SPC, that those laid down
in Articles 3, 7 and 8 of Regulation No 1768/92 are not exclusive and that there is no obligation to grant that SPC if those
conditions are met. Moreover, it submits, Article 11 of that regulation imposes an obligation to state the duration of the
SPC, which means that its duration must be calculated before it is granted.

54.      Furthermore, the Commission points out that none of the amendments made to Regulation No 1768/92 by the Paediatric Regulation
supports the view that the condition relating to the five-year period has been removed. On the other hand, recital 27 to the
Paediatric Regulation shows that the reward in the form of a six-month extension forms part of the existing SPC system and
can be granted only if an SPC has been granted under Regulation No 1768/92. That reward is therefore ancillary in nature.

55.      With regard, next, to the scheme of which the relevant provisions form part, the French Government and the Commission take
the view that a schematic interpretation of Regulation No 1768/92 cannot call in question the assessment that an SPC must
have a positive duration in so far as that regulation contains no indication that an SPC might have a negative duration.

56.      What is more, the Lithuanian and Portuguese Governments do not consider it possible to draw a convincing argument from the
position of Articles 10, 11 and 13 of that regulation or to infer from it that the application for an SPC must be assessed
in several stages.

57.      With regard, finally, to the objectives of Regulation No 1768/92, the French and Lithuanian Governments and the Commission
submit that the aim of that regulation is to offset not the entire duration of the procedure for granting an MA but only that
part of the procedure that exceeds five years, in order to ensure a balance between the interests at stake.

58.      Consequently, in the view of the French and Lithuanian Governments, if the duration of the period between the patent application
and the first MA authorisation were less than five years, the SPC, if granted, would never enter into force. Similarly, if
that were the case, it would be possible to receive income from the sale of the medicinal product for more than 15 years after
the date of filing of the patent application and therefore to cover the investment put into the research.

59.      The Lithuanian Government states in this regard that the converse solution would give create a distortion of competition inasmuch
as the patent holder would be accorded a long period of protection.

60.      I am not persuaded by those arguments. On the contrary, an analysis of the scheme of Regulation No 1768/92 and the Paediatric
Regulation and in particular of their objectives inclines me towards the proposition put forward by the appellant in the main
proceedings and the Hungarian and United Kingdom Governments to the effect that it must be possible to grant an SPC where
less than five years have elapsed between the patent application and the date on which the first MA was granted. I too consider,
like those governments, that the six-month extension must begin to run not from the date on which the patent expires but from
the date on which the SPC takes effect, as determined by applying the negative value of the duration of the SPC to the date
of expiry.

61.      My position is based on the following considerations.

62.      The first point to be made is that there is quite clearly no ready answer to the question under examination in the provisions
of Regulation No 1768/92 and the Paediatric Regulation. None of the provisions of those regulations states explicitly whether
or not the grant of an SPC with a positive duration is a necessary condition for granting the six-month extension provided
for in the Paediatric Regulation. In accordance with the case-law, the answer to that question must therefore be inferred
from the scheme established by those regulations and from the objectives which they pursue. ([13](#Footnote13))

63.      Significantly, in my opinion, an examination of the scheme of Regulation No 1768/92 and the Medicines Regulation shows that
the duration of the SPC is not one of the conditions for granting the six-month extension established by the Paediatric Regulation
which are set out in Articles 7 and 8 of that regulation. The duration of the SPC is mentioned only in Article 36 of that
regulation, which, it will be recalled, provides merely that, where an application under Article 7 or 8 of the Paediatric
Regulation includes the results of the studies conducted in compliance with an agreed paediatric investigation plan, the holder
of a patent or an SPC is to be entitled to a six-month extension of the period referred to in Article 13 of Regulation No
1768/92.

64.      Similarly, an examination of the scheme of Regulation No 1768/92 shows that duration is not one of the substantive conditions,
listed in Article 3 of that regulation, or formal conditions, laid down in Articles 7 to 9 of that regulation, governing the
grant of the SPC. The rules relating to the duration of the SPC, set out in Article 13 of Regulation No 1768/92, also appear
after the provisions of that regulation relating to the grant or rejection of [the application for] the SPC, contained in
Article 10.

65.      Consequently, the positive duration of the SPC cannot be regarded as a condition for granting the SPC that is explicitly required
by Regulation No 1768/92. It follows that recital 27 to the Paediatric Regulation does not serve as a decisive lesson for
the purposes of this case to the effect that an application for extension must be admissible only where an SPC has been granted
within the meaning of Regulation No 1768/92.

66.      Although, as the referring court pointed out, the grant of an SPC with a zero or negative duration was not conceivable before
the entry into force of the Paediatric Regulation, the grant of such an SPC was precluded, in my view, not by any actual legal
prohibition but by reasons of common sense relating to the fact that such an SPC was devoid of any purpose.

67.      After all, up until that regulation was adopted, the only purpose of an SPC was to extend the exclusive rights conferred by
the basic patent on its holder, which meant, self-evidently, that the SPC must have a positive duration and, therefore, taking
into account the detailed calculation rules laid down in Article 13(1) of Regulation No 1768/92, that more than five years
must have elapsed between the patent application and the date on which the first MA was granted.

68.      Since the entry into force of the Paediatric Regulation, however, that has no longer been the case because the grant of the
SPC is also a condition of eligibility for an additional six-month extension, and because – the matter at issue in this case
– that extension may be applicable and cause the exclusive rights of the patent holder to continue in being for a given time,
even though the duration of the SPC is zero or negative.

69.      Previous practice cannot therefore be relied on for the purpose of answering the question referred and, at this stage of the
analysis, it must be assumed, in my opinion, that the scheme of Regulation No 1768/92 and the Paediatric Regulation does not
preclude an SPC from being granted where less than five years have elapsed between the patent application and the date on
which the first MA was granted.

70.      Since an examination of the scheme of those regulations leaves the question under examination open, the answer must be found
in the objectives pursued by those regulations. I shall now argue that, in my view, those objectives provide clear justification
for an affirmative answer to the question referred.

71.      As I have already stated, the purpose of Regulation No 1768/92 is to compensate for the loss of entitlement to exclusive exploitation
rights during the period required for the grant of the first MA where that period exceeds five years. It also serves to protect
the interests of the consumers and health systems of the Member States by ensuring that the monopoly on exploitation so guaranteed
does not exceed what appeared to be necessary to cover the investment and does not unduly delay the moment when the product
in question comes into the public domain.

72.      To that end, the Community legislature provided that the patent holder could be granted an SPC of a duration equivalent to
the period that elapsed between the patent application and the date on which the first MA was granted, reduced by five years,
although the duration of the SPC itself could not exceed five years.

73.      As the eighth recital to Regulation No 1768/92 states, the Community legislature intended that regulation to have the effect
of guaranteeing for the patent holder a monopoly on exploitation of no more than 15 years from the time when the first MA
is granted for the medicinal product in question.

74.      As for the Paediatric Regulation, its aim, as stated in recital 26 to that regulation, is to grant a reward in the form of
a six-month extension of the SPC to laboratories which have conducted all the research recommended in the paediatric investigation
plan established for the product in question.

75.      That regulation is therefore intended to offset by means of a six-month period of additional exclusivity the cost and constraints
resulting from the obligation to subject medicinal products to additional studies to assess their paediatric effects.

76.      An examination of the objectives pursued by the two regulations taken together shows that the Community legislature intended
the holder of a basic patent to be able to exercise a monopoly on exploitation for a total period of 15 years and 6 months,
not just 15 years, as maintained by the Commission. Thus, where more than 5 years have elapsed between the patent application
and the grant of the first MA, the cumulative effect of Regulation No 1768/92 and the Paediatric Regulation is to grant the
patent holder a monopoly of 15 years and 6 months.

77.      To accept the proposition, as the French, Lithuanian and Portuguese Governments and the Commission do, that the extension
provided for by the Paediatric Regulation is not applicable where less than five years have elapsed between the patent application
and date on which the first MA was granted, on the ground that, in those circumstances, the person concerned enjoyed a 15-year
monopoly on exploitation, is therefore to deprive that regulation of much of its effectiveness.

78.      That argument is also questionable, in my view, because it produces disproportionate results. After all, the difference between
obtaining its MA five years and one day after its application for a basic patent and obtaining it exactly five years thereafter
would determine whether the patent holder qualified for an extension of its exclusive rights by a period of six months or
for no extension at all.

79.      Such a disparity in treatment because of a difference of a mere 24 hours is, in my opinion, genuinely excessive. Nor is it
in conformity with the SPC system established by Regulation No 1768/92, under which the five-year period referred to in Article
13(2) of that regulation is not an irreducible period but a limit designed to ensure that the patent holder will be able to
exercise a monopoly on exploitation for no more than 15 years from the first MA.

80.      Implementation of the extension provided for by the Paediatric Regulation must therefore, as I see it, obey the same logic
and mean that the combined application of Regulation No 1768/92 and the Paediatric Regulation has the effect of guaranteeing
for the patent holder a monopoly on exploitation of 15 years and 6 months.

81.      Moreover, the argument put forward by the French, Lithuanian and Portuguese Governments and the Commission has a further disadvantage.
The importance of the economic consequences that might result, if that argument were upheld, from a mere 24-hour difference
in the date when an MA is granted might prompt pharmaceutical laboratories to delay the date on which the MA is obtained,
which would be at odds with the protection of public health. After all, as recital 4 to the Paediatric Regulation points out,
that general interest requires that a medicinal product be put on the market so that it can be used to treat patients as soon
as possible.

82.      The objectives of Regulation No 1768/92 and the Paediatric Regulation call, in my opinion, for an affirmative answer to the
question referred. They also allow the following clarifications to be made as regards the starting point for the six-month
extension where less than five years have elapsed between the patent application and the date on which the first MA was granted.

83.      For the reasons that I have just outlined, the duration of the SPC, where less than five years elapsed between the patent
application and the date on which the first MA was granted, cannot be ‘rounded up to zero’ to make the six-month period run
systematically from the date of expiry of the patent. The purpose of the Paediatric Regulation, read in conjunction with that
of Regulation No 1768/92, is, as I have stated, to guarantee for the basic patent holder a monopoly on exploitation starting
on the date of the first MA and lasting for a maximum total duration of 15 years and 6 months. Its aim is not to extend the
expiry date of all patents by a period of six months.

84.      Such a systematic extension would jeopardise the balance, sought by the Community legislature, between covering the costs
of the research necessary to develop medicinal products, on the one hand, and the economic interests of consumers and national
social security systems, on the other, since it might lead to monopolies on exploitation being conferred for longer than the
limit of 15 years and 6 months.

85.      It might also lead to the unequal treatment of economic operators, since the combined application of Regulation No 1768/92
and the Paediatric Regulation would no longer have the effect of making the monopoly on exploitation exercised by basic patent
holders subject to the same maximum duration.

86.      I therefore propose that the Court’s answer to the question referred should be that Regulation No 1768/92, read in the light
of the Paediatric Regulation, must be interpreted as meaning that medicinal products can be granted an SPC where the period
that elapses between the filing of the application for the basic patent and the date of the first authorisation to place the
product on the market in the Community is less than five years. In that event, the six-month period provided for by the Paediatric
Regulation begins to run from the date determined by deducting from the date of expiry the difference between five years and
the duration of the period that elapsed between the filing of the patent application and the grant of the first MA.

IV –  **Conclusion**

87.      In light of the foregoing considerations, I propose that the question referred by the Bundespatentgericht should be answered
as follows:

Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for
medicinal products, as amended by Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December
2006 and read in the light of Regulation No 1901/2006, must be interpreted as meaning that medicinal products can be granted
a supplementary protection certificate where the period that elapses between the filing of the application for the basic patent
and the date of the first authorisation to place the product on the market in the European Community is less than five years.

In that event, the six-month period provided for by Regulation No 1901/2006 begins to run from the date determined by deducting
from the date of expiry the difference between five years and the duration of the period that elapsed between the filing of
the patent application and the grant of the first marketing authorisation.

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[1](#Footref1) – Original language: French.

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[2](#Footref2) – Regulation of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directives
2001/20/EC and 2001/83/EC and Regulation (EC) No 726/2004 (OJ 2006 L 378, p. 1) (‘the Paediatric Regulation’).

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[3](#Footref3) – The Convention on the Grant of European Patents was signed in Munich on 5 October 1973 and it entered into force on 7 October
1977.

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[4](#Footref4) – Pursuant to Article 63 of that convention, the term of the European patent is 20 years as from the date of filing of the
application.

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[5](#Footref5) – See Article 3 of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation
or administrative action relating to proprietary medicinal products (OJ, English Special Edition 1965-1966, p. 20) and Article
6 of 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 (OJ 2001 L 311, p. 67).

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[6](#Footref6) – Regulation of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products
for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (OJ 1993 L 214, p.
1).

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[7](#Footref7) – See Article 3 of Regulation No 2309/93.

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[8](#Footref8) –      See Chemtob-Concé, M.-C., ‘Le certificat complémentaire de protection: un instrument devenu insuffisant pour assurer la rentabilité
de l’innovation pharmaceutique’, *Gazette du Palais,* October 2008, No 283, p. 42.

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[9](#Footref9) – Regulation of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products (OJ
1992 L 182, p. 1), as amended by the Paediatric Regulation (‘Regulation No 1768/92’).

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[10](#Footref10) – Regulation of 6 May 2009 concerning the supplementary protection certificate for medicinal products (OJ 2009 L 152, p. 1).

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[11](#Footref11) –      Council Directive of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal
products (OJ 1981 L 317, p. 1).

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[12](#Footref12) – In other words, the date on which the patent would ordinarily have expired, 5 July 2022, reduced by three months and fourteen
days, that is to say the length of the period that elapsed between the patent application on 5 July 2002 and the date of the
first MA on 21 March 2007, reduced by five years.

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[13](#Footref13) – For an example of an interpretation of a provision of the initial version of Regulation No 1768/92 arrived at by viewing
it within its context and by reference to its spirit and purpose, see Case C‑127/00 *Hässle* [2003] ECR I‑14781, paragraph 55.

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