England and Wales Court of Appeal (Civil Division) Decisions

IN THE COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE CHANCERY DIVISION
John Baldwin QC (sitting as a Deputy Judge of the
Chancery Division)
CH 2009 APP 0210

		Royal Courts of Justice Strand, London, WC2A 2LL
		17/09/2009

Lord Justice Jacob:

1. This case is about an application by du Pont for a so-called "paediatric extension" to the term of its Supplementary Protection Certificate (SPC) for a medicine called losartan.  This is sold by its licensee, Merck, under the trade mark Cozaar.
2. Du Pont originally patented losartan by a patent applied for on 9^th July 1987.   This expired 20 years later, on 9^th July 2007.   To sell a medicine in the EU you need a marketing authorisation (MA).  This is by virtue of the provisions of Directive 2001/83/EC which superseded Directive 65/65EEC to like effect.  The first MA to place losartan on the market within the EU was Danish, granted on 26^th September 1994.   So some seven years of marketing under patent protection was lost.
3. The SPC system was devised for cases of lost time such as that of losartan.   The general scheme, provided for by the SPC Regulation EEC/1768/92 as amended (now replaced by a codified version EC/469/2009) is to provide protection equivalent to patent protection for a medicine when there has been lost time caused by the MA process.  The period of extra protection is calculated according to a formula set out in the Regulation.    Under the SPC scheme an SPC has to be applied for in each Member State where it is wanted – there is no central scheme.  Quite why, I do not know.  In this country the application is made to the Patent Office (which now goes by the trendy but pointless "operating name" of "UK Intellectual Property Office").
4. Du Pont applied in 13 Member States for an SPC.   An SPC was granted in all cases.  They were due to expire on 1^st September 2009.  
5. Provision has been made for a possible extension for 6 months of an SPC by the Paediatric Regulation EC/1901/2006.   This amended the SPC Regulation as well as containing its own specific provisions. 
6. The Paediatric Regulation was to encourage specific research – and dissemination of knowledge about its results - into already known medicines as to their applicability for children.  Prior to the Regulation there was no specific incentive for such research.  If you discovered a new medicine you could patent it.  You could then get an SPC if there was delay in getting an MA.   And that was that.  There was no particular requirement or incentive for going on to investigate whether the medicine was suitable (or unsuitable) for children or had particular application for children.   The Paediatric Regulation provides an incentive – an extra six months of protection - for having conducted such research.  
7. Broadly the scheme is this.  The SPC holder agrees a research programme into the treatment of children with the medicine.  The agreement is with a scientific body called the Paediatric Committee, part of the European Medicines Agency.  The programme is called a "paediatric investigation plan" (PIP).   If you carried that out properly (and the Committee agrees you did), and take proper steps to publish the results including getting an appropriate modification of your MAs (of which more anon) you are entitled to a 6 month extension.  
8. By an application of 18^th February this year du Pont sought such an extension in the UK and 12 other Member States.   We are told that it has been granted in 8 out of the 13 and refused in none, save in this country.   Without going into the detail it seems that the basis of grant in various countries differs.  
9. In the UK the Hearing Officer, Dr Cullen (with du Pont's consent, given to speed things up, working on the papers alone) by a decision of 9^th April held that the application did not comply with the rules in the SPC Regulation as amended by the Paediatric Regulation. He set a deadline of 6^th July for the defects to be rectified.   But it is the Comptroller of Patents' contention that in fact that is not possible – because the defects were such that could not be rectified and there is no power to put things right.  
10. In fact all the defects (if defects they are) have now been put right.  But, says the Comptroller, that is too late even though the basic SPC has not yet expired.   The Comptroller fairly and properly, however, accepts that if it is possible to grant the extension on the basis that things have been put right now, then such an extension should be granted.  For that purpose he would be willing to extend a time period for putting things right.
11.  On appeal, the Deputy Judge, John Baldwin QC, upheld Dr Cullen's decision.  The matter comes to us in vacation as an expedited appeal with the permission of the Deputy Judge.  I granted expedition because without it the appeal even if successful might be pointless.  It is not clear whether an SPC can be extended after it has expired.  And in any event third parties would be in a position to enter the market when the SPC expired.   Generic companies, quite understandably and quite lawfully, endeavour to enter a market as soon as protection expires.
12. As I have said, the SPC Regulation was amended by the Paediatric Regulation.  I shall use the text as amended. 
13. Article 7(3) of the SPC Regulation provides rules about the timing of an application for an SPC and for an application for an extension.  It says:

Article 7 Application for a certificate

3. The application for an extension of the duration may be made when lodging the application for a certificate or when the application for the certificate is pending and the appropriate requirements of Article 8(1)(d) or Article 8(2), respectively, are fulfilled.

4. The application for an extension of the duration of a certificate already granted shall be lodged not later than two years before the expiry of the certificate.

5. Notwithstanding paragraph 4, for five years following the entry into force of Regulation (EC) No 1901/2006, the application for an extension of the duration of a certificate already granted shall be lodged not later than six months before the expiry of the certificate.

14. So after the transitional period, if you want an extension, you will have to lodge your application for it not later than two years before expiry of the main SPC.  But the period is only six months before expiry for the transitional period of five years following entry into force of the Paediatric Regulation.  
15. This case of course falls within the transitional period.  Because the SPC for losartan would expire on 1^st September, the application for an extension had to be in before 1^st March.   We were told that Merck had proceeded as fast as they could.  They made their application for an extension on 18^th February putting in all the materials they could at that time.   The Patent Office position is that those materials were deficient and that the position cannot be remedied.
16. What then are the materials which an application must contain?   These are set out in Article 8 of the SPC Regulation as amended.   The Article provides both for what an application for a basic SPC and for an extension must contain.  I set it out in full:

Article 8 Content of the application for a certificate

1. The application for a certificate shall contain:

(a) a request for the grant of a certificate, stating in particular:

(i) the name and address of the applicant;

(ii) if he has appointed a representative, the name and address of the representative;

(iii) the number of the basic patent and the title of the invention;

(iv) the number and date of the first authorisation to place the product on the market, as referred to in Article 3(b) and, if this authorisation is not the first authorisation for placing the product on the market in the Community, the number and date of that authorisation;

(b) a copy of the authorisation to place the product on the market, as referred to in Article 3(b), in which the product is identified, containing in particular the number and date of the authorisation and the summary of the product characteristics listed in Article 11 of Directive 2001/83/EC or Article 14 of Directive 2001/82/EC;

(c) if the authorisation referred to in point (b) is not the first authorisation for placing the product on the market as a medicinal product in the Community, information regarding the identity of the product thus authorised and the legal provision under which the authorisation procedure took place, together with a copy of the notice publishing the authorisation in the appropriate official publication;

(d) where the application for a certificate includes a request for an extension of the duration:

(i) a copy of the statement indicating compliance with an agreed completed paediatric investigation plan as referred to in Article 36(1) of Regulation (EC) No 1901/2006;

(ii) where necessary, in addition to the copy of the authorisation to place the product on the market as referred to in point (b), proof of possession of authorisations to place the product on the market of all other Member States, as referred to in Article 36(3) of Regulation (EC) No 1901/2006.

17. Art. 8(1)(d)(i) of the SPC Regulation cross refers to Art. 36(1) of the Paediatric Regulation.  Although only the first sub-section is referred to, it is necessary to set out subsections 2 and 3 which are germane to the argument. 

Article 36

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 supplementary protection certificate shall be entitled to a six-month extension of the period referred to in Articles 13(1) and 13(2) of Regulation (EEC) 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.

2. The inclusion in a marketing authorisation of the statement referred to in Article 28(3) shall be used for the purposes of applying paragraph 1 of this Article.

3. Where the procedures laid down in Directive 2001/83/EC have been used, the six-month extension of the period referred to in paragraph 1 shall be granted only if the product is authorised in all Member States.

18. This in turn cross-refers to Articles 7 and 8 and 28(3) (of the Paediatric Regulation), Art 28(3) and the "procedures laid down in Directive 2001/83" – the Directive dealing with the Marketing Authorisation system.   All this cross-referring and sub- and sub-sub- cross-referencing begins to make the mind boggle.  But the interested reader is urged to persevere – I shall be able to identify the points in dispute ere long.
19. First then Articles 7 and 8 (of the Paediatric Regulation).   I have to set out both because although it is Art 8 which applies to this case, Article 8 cross-refers to Article 7.

Article 7

An application for marketing authorisation under Article 6 of Directive 2001/83/EC in respect of a medicinal product for       human use which is not authorised in the Community at the time of entry into force of this Regulation shall be regarded as valid only if it includes, in addition to the particulars and documents referred to in Article 8(3) of Directive 2001/83/EC, one of the following:

      (a) the results of all studies performed and details of all information collected in compliance with an agreed paediatric investigation plan;

      (b) a decision of the Agency granting a product-specific waiver;

      (c) a decision of the Agency granting a class waiver pursuant to Article 11;

      (d) a decision of the Agency granting a deferral.

For the purposes of point (a), the decision of the Agency agreeing the paediatric investigation plan concerned shall also be included in the application.

      2. The documents submitted pursuant to paragraph 1 shall, cumulatively, cover all subsets of the paediatric population.

 Article 8

In the case of authorised medicinal products which are       protected either by a supplementary protection certificate under       Regulation (EEC) No 1768/92, or by a patent which qualifies for the granting of the supplementary protection certificate, Article 7 of this Regulation shall apply to applications for authorisation of new indications, including paediatric indications, new pharmaceutical forms and new routes of administration.

      For the purposes of the first subparagraph, the documents referred to in Article 7(1) shall cover both the existing and the new indications, pharmaceutical forms and routes of administration.

20. Next Art 28(3) of the Paediatric Regulation:

3. If the application complies with all the measures contained in the agreed completed paediatric investigation plan and if the summary of product characteristics reflects the results of studies conducted in compliance with that agreed paediatric investigation plan, the competent authority shall include within the marketing authorisation a statement indicating compliance of the application with the agreed completed paediatric investigation plan.  …..

21. I should also set out the second point of Art. 28(1):

Where authorisation is granted, the results of all those studies shall be included in the summary of product characteristics and, if appropriate, in the package leaflet of the medicinal product, provided that the competent authority deems the information to be of use to patients, whether or not all the paediatric indications concerned were approved by the competent       authority.

22. The last thing I need to do before getting to the points in issue is to say something about how marketing authorisations may be obtained.   Two basic routes are possible (actually there is a third, a sort of hybrid of the others), a central, Community, procedure via the European Medicines Agency and a Mutual Recognition procedure.   The latter system involves an application for authorisation to the relevant authority of a particular Member State – called the "reference Member State."    If that authority grants authorisation for that Member State, then the corresponding authorities of all the other Member States must grant corresponding authorisations.  They are supposed to do so within 30 days of receipt of a report from the reference Member State of the relevant information.
23. At last I can turn back to this case.  What du Pont filed with the Patent Office with its application is said to be deficient in two respects:

(a)    It did not contain an MA containing a statement referred to in Article 28(3);

(b)     The product was not authorised in all Member States as required by Article 36(3).

24. Mr Peter Prescott QC and Mr Iain Purvis QC for du Pont dispute that these are indeed deficiencies.    Further, they submit, even if they are, they can be cured pursuant to the provisions of Article 10(3) of the SPC Regulation (which I have not yet set out).  They indicated that if we were minded to allow the appeal on the Article 10(3) point we need not consider the first two points.
25. Miss Charlotte May, on behalf of the Comptroller, whilst accepting that was so, indicated that the Comptroller would very much like as much guidance from this Court in administering the paediatric extension system as we could give.   Ultimately, in theory, questions about the SPC system as modified would be for the ECJ.  In reality there will often be insufficient time for a reference to reach and be decided by that court.  So the national court must perforce decide, probably in practice as the ultimate arbiter.   For that reason, and because we heard full argument on the point, we decided to go as far as we legitimately can in providing the guidance sought.  

Must an application for an extension contain a marketing authorisation including an Art 28(3) statement? (Article 8(1)(d)(i))

26. Du Pont could not include such an authorisation when they made their application on 18^th February, for none existed until it was issued by the Dutch reference authority on 9^th April.  But on 13^th February the Dutch reference authority had issued an email sent to du Pont and the relevant authorities of all other member states which said that:

The MAH [i.e. du Pont, the marketing authorisation holder] has received a positive PDCO opinion on February 6, 2009 which certified that the development of this product has complied with all measures in the agreed PIP …

In reference to Art 24 of the Regulation the Reference Member state has not concluded during the scientific assessment of this application for variation that the studies are not inconformity with the agreed PIP   [This reflects the clumsy wording of Art.24]

Hence the product shall be eligible for the rewards and incentives provided for in Arts. 36, 37 and 38.

The email had attached to it the statement from the Paediatric Committee indicating that the PIP had been complied with.

27. Du Pont says this means that it had been finally and fully accepted that it had carried out the agreed PIP.   So "the results of all studies conducted in compliance with an agreed PIP" was included with its application.  That is all that is called for by Article 36(1).
28. Miss May says not so for two reasons.  First because the email can only contain a provisional view – nothing is finally determined until the varied MA (which will include the key information resulting from the PIP) is issued.   Second, and much more importantly the e-mail is not good enough.  The only way Article 36(1) of the Paediatric Regulation can be satisfied is by a MA containing an Art 28(3) statement.
29. I am very doubtful about the first point.  The relevant body, the Paediatric Committee, has clearly decided that the PIP has been complied with.  It has no further involvement.  Comments from the Member States are over.  That seems to be an end of it.   We had very little argument about how final things are at this stage.  Certainly the Dutch, as the reference Member State, assumed it was all over ("shall be eligible").   However it is not necessary to decide the point – even for the purposes of guidance for the Comptroller, for I think Miss May is clearly right about the second point.  I thought otherwise before she addressed us.
30. The key provision is Article 36(2) of the Paediatric Regulation.  It says the inclusion of an Article 28(3) statement in a MA "shall be used".   Miss May says that means that is the only way of proving compliance with Article 36(1).   And for a range of convincing reasons.
31. First because the system is meant to be practical, open and transparent.  All a Patent Office has to do is to look at the MA to see whether the PIP has been complied with.  If one could prove the results of and compliance with the PIP in some other way, that would not necessarily be so.  Potentially, for instance, if du Pont's wide meaning were adopted, the non-expert authority in the Member State could be faced with an applicant who tried to prove before it that it had complied with the PIP.  That would mean going into the requirements of the PIP and examining what had been done in purported compliance with it.  The national authority would have to consider the same issues as the Paediatric Committee.   That cannot be right.
32. It might be suggested (though du Pont did not do so) that there is a halfway house:  that it is good enough for the applicant to show that the Paediatric Committee agrees the PIP has been complied with, but not good enough to  demonstrate compliance by reference to the underlying materials   The trouble with such a suggestion is that there is no room for it on the language of Art 36(1).   Either you have to go by the MA or you don't.  If you don't, the language is incapable of limiting the means of proof only to showing that the Committee has agreed.
33. Miss May's next point is based on the language of Article 36(2) itself – "shall be used".  She says that it is mandatory language – you have got to use the MA.   Mr Purvis submitted not so – taking us to some of the other language versions of Art.36(2).   These were French: "est utilisée"; German: "dient";  Italian: è utilizzato";  Portuguese:  "serva" and Spanish: "servirá."    The suggestion was that at least some of these versions, the Portuguese and Spanish particularly, which mean "will serve" did not convey the mandatory flavour of the English "shall be".  
34. There might have been something in this, but for the recitals to the Paediatric Regulation.   Miss May took us to a number of them,  For present purposes it will suffice to set out the following:

(4) This Regulation aims to facilitate the development and accessibility of medicinal products for use in the paediatric population, to ensure that medicinal products used to treat the paediatric population are subject to ethical research of high quality and are appropriately authorised for use in the paediatric population, and to improve the information available on the use of medicinal products in the various paediatric populations. These objectives should be achieved without subjecting the paediatric population to unnecessary clinical trials and without delaying the authorisation of medicinal products for other age populations.

(17) To provide healthcare professionals and patients with information on the safe and effective use of medicinal products in the paediatric population and as a transparency measure, information on the results of studies in the paediatric population, as well as on the status of the paediatric investigation plans, waivers and deferrals, should be included in product information. When all the measures in the paediatric investigation plan have been complied with, that fact should be recorded in the marketing authorisation, and should then be the basis upon which companies can obtain the rewards for compliance.

(21) This Regulation should include measures to maximise access by the Community population to new medicinal products tested and adapted for paediatric use, and to minimise the chance of Community-wide rewards and incentives being granted without sections of the Community paediatric population benefiting from the availability of a newly authorised medicine. An application for a marketing authorisation, including an application for a Paediatric Use Marketing Authorisation, which contains the results of studies conducted in compliance with an agreed paediatric investigation plan should be eligible for the Community centralised procedure set out in Articles 5 to 15 of Regulation (EC) No 726/2004.

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 supplementary protection certificate created by Council Regulation (EEC) No 1768/92 [6]. Any decisions by Member States' authorities as regards the setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes have no bearing on the granting of this reward.

35. Of most direct relevance to this point is recital 17 – saying as it does that when the measures in the PIP have been recorded in the MA, that should then be the basis for the rewards for compliance.   There is simply no getting around that.  Mr Purvis tried:  suggesting that the "then" referred only to the fact of PIP compliance.  But that will not do – it is simply pretending that the "then" is not there.
36. But Miss May had even more to her argument.  She submitted that there was a reason for the rule that you only get your reward once you have not only complied with your PIP but also got your MA which reflects the information gained.  It is that the Paediatric Regulation is concerned not only with creation of that information but its Community-wide dissemination and availability.   Only when the MAs for each Member State have been brought into line with the PIP information– so that the packaging and information leaflets carry it as well - can you have your reward.   She pointed out (it is not necessary to set them all out here) that both the travaux préparatoires  and the Explanatory Memorandum to the Regulation are unambiguous about that.
37. She summarised her submissions thus.  First that the aims and objectives of the Regulation are three-fold – as set out in the key recital (4).  They are:

i) To facilitate the development and accessibility of medicinal products for use in the paediatric population.

ii) To ensure that medicinal products that are used to treat the paediatric population are subject to ethical research of high quality and are appropriately authorised for use in the paediatric population.

iii) To improve the information available on the use of medicinal products in the various paediatric populations.

And these objectives are to be achieved by the following substantive requirements:

1. All the measures in the agreed PIP must have been compiled with [Recitals 9-11, 17, 26; Articles 7-8, 28(3), 36(1); Explanatory Memorandum].

2. The authorised product information must include relevant information on the results of the studies [Recitals 17, 26, 28; Articles 28(3), 36; Explanatory Memorandum].

3. The product must be authorised in all Member States [Recitals 17, 21, 26; Article 36(3); all travaux].

38. I accept those submissions.   I think they are inescapable.  Mr Purvis tried to answer the need for dissemination of information point by showing us other provisions for dissemination of information.  But in the end it is what is on and in the packet which counts.  And that is not determined finally until the MA is settled.

What is meant by "authorisations to place the product on the Market of all other Member States"? (Article 8(1)(d)(ii))

39. Du Pont says it has got authorisations to place losartan on the market everywhere.   It not only has the original authorisations, but it even has an authorisation to market a syrup form specifically for paediatric use, an authorisation obtained on 22^nd January this year via the central procedure.  Proof of both these facts was contained in the application.  So the application did contain the necessary proof.
40. Miss May says not so.   It is not good enough to prove that there are EU wide authorisations for formulations containing the active ingredient.   In context "the product" means formulations presented in accordance with the requirements of the modified MA. The presentation must include the information resulting from carrying out the agreed PIP. And it was only on 9^th August 2009 that the last Member State, a little belatedly, fell into line and granted an MA requiring the inclusion of the statement of compliance called for by Article 28(3).
41. Mr Purvis submitted that the Office position was both absurd and inconsistent with the drafting of the SPC Regulation.  As to absurdity he asked two forensic questions.  Why should the reward be dependent on the bureaucratic competencies of the Member State?  Why should an applicant lose his reward just because even one Member State is late in doing what it is bound to do within 90 days of approval by the reference Member State?
42. As to drafting he pointed out that Art 1 of the SPC Regulation contains definitions of both "medicinal product" and "product".

(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;

So, he submitted, "product" in Article 8(1)(d)(ii) not only naturally means the medicine itself, but the very Regulation so defines it.  

43. I do not accept either submission.  The absurdity point falls away, if, as I think, the problem of a laggard Member State can, save in an improbably extreme case, be cured (see below).  And the definition point must give way to the entire purpose of the Paediatric Regulation and the clear intention that you are not to get your reward unless products carrying the information generated by carrying out the agreed PIP are authorised EU wide.   There is no sense in saying that an MA which does not include this information will suffice to get you your reward.
44. Further, the drafting point loses its force if one considers other language versions of the Paediatric Regulation.  As Miss May pointed out some of them (e.g. German, Spanish and Portuguese) use the same word as that used for "medicinal product" in the definition of Art. 1.   So Mr Purvis's definition point is at best ambiguous – the ambiguity being resolved by the very purpose of the Paediatric Regulation.

Can the deficiencies be cured?  Article 10(3)

45. Art 10 of the SPC Regulation includes the following provisions:

3. Where the application for a certificate does not meet the conditions laid down in Article 8, the authority referred to in Article 9(1) shall ask the applicant to rectify the irregularity, or to settle the fee, within a stated time.

4. If the irregularity is not rectified or the fee is not settled under paragraph 3 within the stated time, the authority shall reject the application.

6. Paragraphs 1 to 4 shall apply mutatis mutandis to the application for an extension of the duration.

46. Thus far I have deliberately used the word "deficiency" to cover the defects in the original application by du Pont, namely the lack of an Article 28(3) statement and the lack of proof of MAs in all Member Sates updated to include the PIP information.   Do these deficiencies amount to an "irregularity"?  If so they can be cured by rectification by the applicant.  As I have said the deficiencies have in fact now been cured and the Office, quite properly as one would expect, has indicated that it will extend the appropriate time for rectification accordingly, if it has power to do that.
47. It will be seen that Article 10(3) is mandatory – the Office "shall ask the applicant to rectify."   The Hearing Officer's decision took a faintly absurd position.   It accepted that Article 10(3) required it to state a time for du Pont to cure the irregularity and set a date of 6^th July.  At the same time it held that the irregularity cannot be cured at all.   So the date set was pointless.
48. With respect that cannot be right on any view.   Time only has to be given to cure "an irregularity."   If the deficiencies cannot be so regarded then there is no obligation to give any time   The real question therefore is how widely the word "irregularity" is to be read.  Does it cover anything required by Art. 8(1) of the SPC Regulation which is missing or incomplete, or does it have some more limited meaning?
49. Miss May contends for the latter.   She suggested "irregularity" means only something missing from the application which could have been contained within it at the time.   Or, if not that, something which could have been produced by the last moment an application could be made.   Something missing which could not have been produced by at least then was not an "irregularity" – it was a fundamental incurable defect.   So in this case, the Article 28(3) statement and the necessary MAs from all Member States had not come into existence by either the date of application or the last possible date for an application.   So although du Pont have now got "all their ducks in a row" and have done so before the basic SPC has expired it is too late to cure the position.
50. Further, she submits, there is no point in providing for the time limits of Article 7 (2 years save for the transitional period when it is 6 months) if the applicant can supplement its application with post-application material.
51. I see no reason for giving "irregularity" such a restrictive meaning – and every reason to give it a wide enough meaning to encompass cases such as the present where the defect is cured after the date of application.
52. Firstly and most tellingly, all the Recitals and the Explanatory Memorandum which Miss May deployed so effectively in persuading me on the first two points turn against her argument on this point   For they are all about the reward of an extension being made available if the applicant complies with its PIP and gets the necessary MAs.   The reward is for that, not for doing all that before the application is made.  
53. Most tellingly there is no Recital or other material indicating everything must be in the application or capable of being in the application by the date it must be made.  
54. Moreover if she were right, then the problem of the laggard Member State would be significant – and it would be unrealistic to think that the Community legislator was so innocent as to think that all Member States would be certain to get it right within the 90 days provided for.   There is no indication of any intention that the reward should be contingent upon all Member States doing the right thing in time.   And no indication that the legislator intended to draw a distinction between what might be called a "mere irregularity" and something more fundamental.
55. Nor do I think her point about the last dates for an application particularly telling.  She sought to ally it with a point about certainty for third parties, submitting that competitors should be in a position to know where they stand at an early date.  But there is nothing about that in either Regulation.   The nearest Miss May could point to was the first sentence of ninth Recital of the SPC Regulation – 10^th of the codified version):

All the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector should nevertheless be taken into account.

That is far from saying that everything must be complete by the date of the application.

56. The "third party certainty" point is further undermined by the fact that there is no requirement that third parties shall be entitled to see sufficient of the details of the application to form a view as to whether it will succeed.  Or any of the details of an application for an MA or a variation of an MA.  Nor is there any requirement that a national authority must come up with a decision by a particular time after the application.    So third parties must wait for an indeterminate time – which on any view may include an Art 10(3) time extension – before knowing the result of the application for an extension.
57. Besides, on any rational view, the importance of research into paediatric uses of medicines stands ahead of the purely commercial interests of third parties.  The importance of that research being conducted and the results disseminated is the whole point of the Paediatric Regulation.   A narrow construction of "irregularity" is inimical to that fundamental purpose.
58. Miss May indicated that, for future guidance, it would be helpful for the Comptroller to know just how late an applicant can be in supplementing its application with missing material.    As at present advised (and of course this is strictly a question not before us) I would only say this:  that in setting the Article 10(3) period the Comptroller can and should take into account all relevant factors.  These will include the reasons for the failure to include all the Article 8(1) materials in the application, the extent to which the applicant is guilty of unreasonable conduct or delay, and how close to the date of expiry of the SPC full compliance with Article 8(1) is expected.  The guiding principle is the purpose of the Regulation.   The upshot is that unless the applicant has behaved unreasonably, time should be extended so that it gets its reward.

Conclusion

59. We indicated at the conclusion of the oral hearing that the appeal would be allowed.   This was necessary in order that the Patent Office could extend the SPC before it expired.  These are my reasons for that decision.   They are largely the same (though I fear expressed at much greater length) as those of the Dutch Patent office which, by its letter of 2^nd June, extended the corresponding Dutch SPC.

Lord Justice Stanley Burnton:

60. I entirely agree with my Lord's clear and cogent judgment. I add a few words of my own out of deference to the arguments before us.
61. The crucial issue before us concerns Article 10(3), and the meaning of "irregularity". There are a number of reasons for giving the word a wide meaning. First, its context. It takes its meaning from the first part of the sentence. The natural meaning of "irregularity" is a respect in which the application for the certificate does not meet the conditions laid down in Article 8. There is no contextual indication of any different meaning, and no basis in the wording or Article 10 or, as Lord Justice Jacob has shown, in the Recitals to the Regulation to limit its meaning. More particularly, nothing in the Recitals or the substantive provisions of the Regulation suggests the distinction contended for by Miss May.
62. Secondly, the requirements of Article 8 are documentary. If an applicant produces the right documents, he is entitled to his extension. An irregularity is a failure of the application to contain the requisite documents. An irregularity can be rectified under Article 10, by submitting the missing documents. There is nothing to indicate that rectification requires anything else, and in particular that the relevant authority must not only consider whether the documents are genuine and fulfil the requirements of the Regulation but also whether they came into existence or could have come into existence before the latest date for the submission of the application.
63. Lastly, but by no means least important, there are the reasons given by Lord Justice Jacob in paragraphs 52 to 54 of his judgment for giving "irregularity" the natural meaning derived from its context.

Lord Justice Ward:

64. I agree with both judgments.