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You are here: BAILII >> Databases >> England and Wales High Court (Patents Court) Decisions >> Master Data Center, Inc v The Comptroller General Of Patents [2020] EWHC 572 (Pat) (11 March 2020) URL: https://www.bailii.org/ew/cases/EWHC/Patents/2020/572.html Cite as: [2020] EWHC 572 (Pat) |
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2020] EWHC 572 ( Pat) | ||
BUSINESS AND PROPERTY COURTS
OF ENGLAND AND WALES
INTELLECTUAL PROPERTY LIST (ChD)
PATENTS
COURT
7 Rolls Buildings Fetter Lane London EC4A 1NL |
||
2020 |
B e f o r e :
(Sitting as a Judge of the
Patents
Court)
____________________
Claim Number: CH- 2020-000062 | ||
| MASTER DATA CENTER, INC. |
Appellant |
|
| - and - |
||
THE COMPTROLLER GENERAL OF PATENTS | Respondent |
|
and Between: |
||
Claim Number: CH- 2020-000065 | ||
| GENENTECH INC. |
Appellant |
|
| - and - |
||
THE COMPTROLLER GENERAL OF PATENTS | Respondent |
____________________
MR. ANDREW LYKIARDOPOULOS QC (instructed by Marks & Clerk Law LLP) appeared for GENENTECH, INC.
MR. MICHAEL SILVERLEAF QC (instructed by Government Legal Department) appeared for The Comptroller General of
Patents.
Hearing date: 4 March
2020
____________________
Crown Copyright ©
Mr Recorder Douglas Campbell QC:
Introduction
2020
Mr Ben Micklewright, on behalf of the Comptroller, held that this SPC will lapse on 2 April
2020
on the grounds that Genentech's
patent
administration company, Master Data Center Inc. ("Master Data") only requested and paid for a 2-year term on the relevant form, rather than a 4-year term.
Patents
Rules 2007 (as amended) which relates to the correction of irregularities generally. Similarly Genentech relies on s. 117 of the
Patents
Act 1977, which provides for correction of errors and mistakes in certain documents, and upon one further ground of appeal.
Legal context
Article 8(4)
Content of the application for a certificate
… Member States may provide that a fee is payable upon application for a certificate and upon application for the extension of the duration of a certificate.
Article 12
Annual fees
Member states may require that the certificate be subject to the payment of annual fees.
1. The certificate shall take effect at the end of the lawful term of the basicpatent
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 certificate 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 Regulation (EC) No. 1901/2006 applies. In that case, the duration of the period laid down in paragraph 1 of this Article may be extended only once.
Article 14
Expiry of the certificate
The certificate shall lapse:
(a) at the end of the period provided for in Article 13;
(b) if the certificate holder surrenders it;
(c) if the annual fee laid down in accordance with Article 12 is not paid in time;
(d) …
Article 19
Procedure
1. In the absence of procedural provisions in this Regulation, the procedural provisions applicable under national law to the corresponding basicpatent
shall apply to the certificate, unless the national law lays down special procedural provisions for certificates…
Patents
Act 1977, the
Patents
Rules 2007 (as amended) and the
Patents
(Fees) Rules 2007 (as amended).
Fees
5. A supplementary protection certificate does not take effect unless –
(a) the prescribed fee is paid before the end of the prescribed period, or
(b) the prescribed fee and any prescribed additional fee are paid before the end of the period of six months beginning immediately after the prescribed period.
Patents
Rules 2007 (as amended) provides as follows, so far as presently relevant:
Supplementary protection certificates
116. …
(2) The period prescribed for the purposes of paragraph 5(a) of Schedule 4A to the Act is—
(a) three months ending with the start date; or
(b) where the certificate is granted after the beginning of that period, three months beginning immediately after the date the supplementary protection certificate is granted.
(3) The comptroller must send a notice to the applicant for the certificate—
(a) before the beginning of the period of two months immediately preceding the start date; or
(b) where the certificate is granted as mentioned in paragraph (2)(b), on the date the certificate is granted.
(4) The notice must notify the applicant for the certificate of—
(a) the fact that payment is required for the certificate to take effect;
(b) the prescribed fee due;
(c) the date before which payment must be made; and
(d) the start date.
(5) The prescribed fee must be accompanied by
Patents
Form SP2; and once the certificate has taken effect no further fee may be paid to extend the term of the certificate unless an application for an extension of the duration of the certificate is made under the Medicinal Products Regulation.
(6) Where the prescribed fee is not paid before the end of the period prescribed for the purposes of paragraph 5(a) of Schedule 4A to the Act, the comptroller shall, before the end of the period of six weeks beginning immediately after the end of that prescribed period, and if the fee remains unpaid, send a notice to the applicant for the certificate.
(7) The notice shall remind the applicant for the certificate—
(a) that payment is overdue; and
(b) of the consequences of non-payment.
…
Patents
(Fees) Rules 2007 (as amended) at rule 6:
Supplementary protection certificates
6.—(1) The prescribed fee payable for a supplementary protection certificate to take effect is set in accordance with paragraph (2).
(2) Where the certificate expires during the period of one year beginning with—
(a) the start date, the fee is £600;
(b) the first anniversary of the start date, the fee is £1,300;
(c) the second anniversary of the start date, the fee is £2,100;
(d) the third anniversary of the start date, the fee is £3,000; or
(e) the fourth anniversary of the start date, the fee is £4,000.
(3) The period in paragraph (2) shall be calculated without reference to any extension of the duration of a supplementary protection certificate under Article 13(3) of the Medicinal Products Regulation(a).
(4) The additional fee prescribed for the purposes of paragraph 5(b) of Schedule 4A to the Act (supplementary protection certificates) shall be half the prescribed fee.
(5) In this rule "start date" is the first day following the day on which the basic
patent
expires.
Patents
Rules 2007 (as amended) provides as follows:
Correction of Irregularities
107.—(1) Subject to paragraph (3), the comptroller may, if he thinks fit, authorise the rectification of any irregularity of procedure connected with any proceeding or other matter before the comptroller, an examiner or the
Patent
Office.
(2) …
(3) A period of time specified in the Act or listed in Parts 1 to 3 of Schedule 4 (whether it has already expired or not) may be extended under paragraph (1) if, and only if –
(a) the irregularity or prospective irregularity is attributable, wholly or in part, to a default, omission or other error by the comptroller, an examiner or thePatent
Office; and
(b) it appears to the comptroller that the irregularity should be rectified.
a) From the European perspective, Member States can decide whether or not they want to require application fees and/or annual fees for SPCs, and if so in what amount: see the SPC Regulation at Articles 8(4), 12, 19. The duration of the certificate is determined by Article 13. The certificate shall lapse in any of the situations set out in Article 14.
b) From the UK perspective, the SPC does not take effect unless the relevant fees are paid in time. "In time" means either in the 3 months ending with the start date (if the certificate is granted before that 3-month period, which it usually will be) or in the 3 months beginning when the certificate is granted (if the certificate is granted later): see paragraph 5(a) of Schedule 4A and rule 116(2). Paragraph 5(b) can be disregarded for present purposes.
c) For payments made in time, the relevant payment is the "prescribed fee".
d) The prescribed fee is determined by rule 6(2). It will be seen that the amount of the fee depends on when the certificate expires relative to the start date. I will return to this below. For the moment it should be noted that the prescribed fee is paid once, not every year.
e) The comptroller has to send a notice to the applicant containing the information required by rule 116(4). This must be sent at least 2 months before the start date for normal certificates or on the date of grant for later certificates: see rule 116(3).
f) If the fee is not paid when it should be, the comptroller has to send a reminder within 6 weeks of the end of the relevant period: see rule 116(6).
The facts
The SPC certificate
"In accordance with Article 10(1) of the [SPC] Regulation, Supplementary Protection Certificate No SPC/GB07/12 is hereby granted to Genentech Inc. in respect of the product 'ranibizumab' protected by basic
patent
No EP0973804 entitled 'Anti-VEGF Antibodies.
"This certificate will take effect (subject to the payment of the prescribed fees) at the end of the lawful term of the basic
patent
and its maximum period of duration in accordance with Article 13 will expire on 23 January 2022 subject to the provisions of Articles 14 and 15."
The UKIPO letter
patent
agents on 5 January 2018, which is Annex 1 to this judgment. Master Data accept that this letter complies with rule 116(4)(a), (c), and (d) but do not accept that it complies with 116(4(b), ie as regards the prescribed fee. In particular Master Data complain of the following paragraph:
"The maximum period of duration of the certificate in accordance with Article 13 will expire on 23 January 2022, therefore the period is made up of 4 effective years as defined by Fees Rule 6(2), for which the prescribed fees are:
- for first year or part thereof £600
- for second year or part thereof £700
- for third year or part thereof £800
- for fourth year or part thereof £900
- for fifth year or part thereof £1000"
Genentech's instructions to Master Data
Patent
Operations and employed at F.Hoffman-La Roche AG ("Roche"). She explained that Master Data were contracted to make annuity payments on behalf of Roche's group of companies, including Genentech. Her evidence showed that Master Data had standing instructions to pay the full annuity fees for all relevant rights which had payments due, and that although there were some exceptions to these instructions none of these exceptions applied to this SPC. Thus Genentech's instructions to Master Data were that the annual fee should be paid for the maximum available term of the SPC. Master Data were also specifically instructed that the expiry date of the SPC was 23 January 2022.
Master Data's acts
patents
form SP2 in relation to the SPC on 26 March 2018. Despite Genentech's instructions, this form stated in handwriting that the applicant wanted the period to be effective for "2 years" and that the amount of annual fee was "£1300".
Patent
Data Specialists (who are responsible for resolution of
patent
payment data errors) and one showing the procedure for Payment Coordinators (who instruct the payments for
patent
annuities to
patent
offices and agents). Ms Nalepka stated that the listing of a two-year term on the form was an "error". However she did not claim to have done this listing herself nor did she set out details of any investigations among Payment Coordinators. The only reason she gave for her belief that this was an error was that "it had been the intention", presumably meaning Genentech's intention, to seek the maximum term of protection.
SPC payments in other jurisdictions
The Hearing Officer's decision
3 In relation to Genentech's case, the following questions arise:
a. Does rule 116(5) of thePatents
Rules 2007 allow further annual fees to be paid if an application for a paediatric extension is made, thereby extending the SPC to its maximum term?
b. Can a paediatric extension be allowed for an SPC in circumstances where the SPC is not in force for the full maximum term?
c. Should I allow a request to correct the forms used to pay the prescribed fee for the SPC to take effect, so as to extend the duration of the certificate, under sections 117 and/or 32(2)(d) of thePatents
Act 1977?
4 In relation to MDC's case, the following question arises:
d. Has there been an irregularity in procedure, a mistake or an error attributable at least in part to the Office and, if there has, should the irregularity be rectified under rule 107?
Master Data's appeal
Patents
Act 1977 envisages that a single fee must be paid before the certificate comes into effect.
Master Data submitted that these errors gave rise to 3 procedural irregularities which could properly be corrected under rule 107: see its skeleton argument at [30]-[32].
"47. I believe the starting point for a consideration of these submissions must be Article 12 itself and I would make two general points at the outset. First, the provision is permissive; there has never been a requirement that Member States must implement an annual fee regime. Second, save that any fees must be "annual", no restriction or limitation has ever been imposed upon Member States as to the level of the fees or when or how they must be paid. All of these matters have been left to Member States to decide for themselves and Article 18 of the 1992 Regulation (now Article 19 of the 2009 Regulation) permitted them to lay down special procedural provisions to give effect to those decisions.
48. That brings me to paragraph 5 of Schedule 4A, rule 116 of the
Patents
Rules and rule 6 of the
Patents
(Fees) Rules. These all relate to matters arising under the provisions of the 1992 Regulation and, as such, plainly fall within the scope of s.2(2) of the European Communities Act 1972, subject to the overriding requirement that they must of course impose a regime for the payment of annual fees.
49. In considering the crucial issue whether they impose a regime for the payment of annual fees, I think it important to have in mind that, for the reasons I have explained, an SPC may be granted some time before it is due to take effect. Further, the maximum term of each SPC will vary from certificate to certificate and depend upon the date on which the application for the basic
patent
was filed and the date of the first authorisation to place the product on the market in the EU, subject to the requirement that the duration of the certificate may not exceed five years from the date on which it takes effect.
50. Turning now to the fee structure set out in rule 6 of the
Patents
(Fees) Rules, it can be seen that as the number of years for which the certificate is to have effect increases, so also does the fee. Further and importantly, an applicant is not required to take a certificate for the whole period permitted by the Regulation. He may elect to take the certificate for a shorter period and, if he does so, he will only pay a fee in respect of those years for which he has elected. Thus far, as it seems to me, the prescribed fee may properly be described as an annual fee. It is calculated by reference to the number of years for which a certificate is to have effect.
51. I come then to consider the impact on this analysis of the requirement imposed by rule 116 of the
Patents
Rules that the fee must be paid before the SPC takes effect. Here I believe that Mr Johnson's submissions confuse the nature of the fee and the date upon which the liability to pay it arises. I do not believe that the fee ceases to be an annual fee because the rules impose an obligation to pay it in advance. Nor does the fee cease to be an annual fee because the rules impose an obligation to pay it all at once. Further, I do not consider that these rules are in conflict with Article 13. Provided the fee is paid within the prescribed period, the certificate will automatically take effect on the day after expiry of the basic
patent."
patentee
to elect to pay only for the period he desires. Provided the relevant fee is paid, the certificate shall take effect on the date determined by Article 13. At the end of the period for which the relevant fee has been paid, the certificate shall expire in accordance with Article 14(c). Thus when Article 13 says that the certificate "shall take effect", this is merely a reference to when the certificate starts. It does not override Article 14(c).
Genentech's appeal
Does rule 116(5) of the
Patents
Rules 2007 allow further annual fees to be paid if an application for a paediatric extension is made?
patent.
Patents
(Fees) Rules to be £200. Indeed the entitlement to a paediatric extension may only became clear after the SPC has come into effect. The dispute is as to whether the applicant is also allowed to pay for more annual fees than he or she originally paid for when filing form SP2.
Patents
Rules 2007 can be relied on to interpret rule 116(5); and (5) the teaching of Tulane. He did not place a great deal of weight on the fourth factor, but I agree with Genentech that he should have not considered this at all. It is not a statutory source, merely the UKIPO's non-binding view of the 2007 Rules.
patentees
who allow their
patents
to lapse for non-payment of annual fees are not entitled to an SPC. This is merely the same logic being applied to paediatric extensions.
patent
but I cannot see that this makes any difference to the legal principles. The policy is to incentivise paediatric work, not late work.
Can the form be corrected under s. 117 of the
Patents
Act?
Legal context
patents
and applications". In fact its scope is wider than that since it provides as follows, my emphasis:
"(1) The Comptroller may, subject to any provision of rules, correct any error of translation or transcription, clerical error or mistake in any specification of a
patent
or application for a
patent
or any document filed in connection with a
patent
or such an application."
patent
or application, and other requests. It provides as follows
"(3) Where the request is to correct a specification of a
patent
or application, the request shall not be granted unless the correction is obvious (meaning that it is immediately evident that nothing else could have been intended in the original specification)."
This is a far stricter requirement. It does not apply in this case, as the Hearing Officer accepted at paragraph [55] of his decision.
[57] … It is however a well-established principle that the general powers of section 117 cannot be used to circumvent the clear mandatory specific provisions of the Act. See for example Antiphon AB.'s Application [1984] RPC 1 and Payne's Application [1985] RPC 193, both specifically relating to section 117, and E's Applications [1983] RPC 231, relating to an earlier version of rule 107 (which was at that time rule 100) which relates to procedural irregularities. In E's Applications Lord Diplock said:
"An irregularity in procedure is simply a failure to observe procedural rules, whatever the cause of the failure may be. Where there is a discretion to rectify the failure, the reason for it may be of the utmost relevance to the way in which that discretion should be exercised; but if rule 100 confers upon the comptroller jurisdiction to excuse failure to observe a time limit which is made inextensible by rule 110(1) and (2), on the ground that it is an irregularity in procedure, that jurisdiction must extend to all such failures whatever the reason for them may be, with the result of rendering the express prohibition of extensions of specified time limits by rule 110(1) and (2) wholly nugatory. So to construe rule 100 in relation to rule 110 would be to turn on its head the well-established canon of construction generalia specialibus non derogant."
[58] In Payne's Application, Falconer J said, quoting his own judgment in Antiphon:
What I said in the Antiphon case, and perhaps I may be forgiven if I read it again and then make some comments about it, was this:
"Section 117(1), which I have already read, is, of course, expressed in general terms, but to allow, under its provisions and those of rule 91 (which is the rule made pursuant thereto), correction of an error or mistake such as that sought to be corrected in this case"—that is the Antiphon case—"so as to allow the application to proceed as if the drawings filed later were part of the documents initially filed, would be to allow the provisions of section 117(1) and rule 91 to be used to circumvent the clear mandatory provisions of section 15(2). Section 15(2) is a particular enactment in the statute and, although section 117(1) is an enactment in general terms in the statute, it seems to me that it can have no application to a case which falls within the terms of section 15(2) and must be taken to affect only the other parts of the statute to which it may properly apply: see Halsbury's Laws of England, 3rd Edition, Volume 36, paragraph 597 at page 397."
I concluded:
"In my judgment, under the provisions of section 117(1) and rule 91, a correction may not be allowed if the effect of it would be to allow an applicant to circumvent the clear mandatory requirements of section 15(2)."
[59] These cases therefore demonstrate the applicability of the principle that a general provision cannot be used to circumvent a specific mandatory legislative provision."
Potential effect on third parties
Discretion to allow the correction
Can a paediatric extension be allowed for an SPC in circumstances where the SPC is not in force for the full maximum term?
Conclusion
5 January 2018
Dear Sirs
Council Regulations (EC) No 469/2009 (Medicinal Products)
Patents
Act 1977:
Patents
Rules 2007:
Patents
Fees Rules 2007.
SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB07/012
NOTIFICATION CONCERNING PAYMENT OF REQUISITE FEES (PLEASE NOTE WARNING AT THE END OF THIS LETTER)
The start date on which the certificate, subject to the requirement to pay the prescribed fees as set out in paragraph 5 of Schedule 4A to the
Patents
Act 1977, will take effect at the end of the lawful term of basic
patent
No EP0973804 is 03 April 2018.
Pursuant to Rule 116(5) and Fees Rule 6(5) this start date is also the due date for the payment of fees. These fees should therefore be paid not later than this date.
The maximum period of duration of the certificate in accordance with Article 13 will expire on 23 January 2022, therefore the period is made up of 4 effective years as defined by Fees Rule 6(2), for which the prescribed fees are:
- for first year or part thereof £600
- for second year or part thereof £700
- for third year or part thereof £800
- for fourth year or part thereof £900
- for fifth year or part thereof £1000
As set out in Rule 116(5)the desired effective period of the certificate, which may be less than the maximum period allowable, should be specified on Form SP2 (blank copy enclosed) which, together with the fee sheet FS.1, should accompany the fees due for that period.
Pursuant to Rule 116(5), where the effective period chosen by the applicant is less than the maximum allowable period of the certificate it cannot subsequently be extended unless an application for an extension of the duration of the certificate is made under the Regulation on medicinal products for paediatric use, Regulation (EC) No 1901/2006 .
If the fees have not been paid by the due date, or (together with the additional late payment fee) within the further period of six months prescribed by paragraph 5(b) of Schedule 4A to the
Patents
Act 1977 , the certificate will lapse in accordance with Article 14(c) of the Regulation.
WARNING: IT IS NOT POSSIBLE FOR THE APPLICANT TO OPT TO PAY RENEWAL FEES ANNUALLY ON SUPPLEMENTARY PROTECTION CERTIFICATES IN THE UNITED KINGDOM. THIS IS A REQUEST FOR A ONE-OFF PAYMENT OF FEES TO COVER THE EFFECTIVE PERIOD CHOSEN BY THE APPLICANT FOR WHICH HE REQUIRES PROTECTION AND CANNOT BE EXTENDED. SPC PRACTICE IS THEREFORE DIFFERENT FROM THAT ON
PATENT
RENEWALS DURING THE FIRST 20 YEARS OF LIFE OF THE
PATENT AND SPC ANNUAL RENEWAL PRACTICE IN OTHER EC STATES SUCH AS FRANCE.
Yours faithfully
Formalities Examiner