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UK – Master Data Center, Inc v. The Comptroller General Of Patents

15 May 2020

Master Data Center, Inc v The Comptroller General Of Patents [2020] EWHC 572 (Pat), 11 March 2020

In this judgment Douglas Campbell QC dismissed both appeals from Master Data Center Inc (“Master Data”) and Genentech Inc (“Genentech”). The parties were appealing the decision of the Hearing Officer, who held that when a supplementary protection certificate (“SPC”) for a pharmaceutical patent only requested and paid the fees for a two-year term, this could not be subsequently extended.

Genentech is the proprietor of a patent and an SPC protecting its product ranibizumab (marketed as Lucentis). The SPC was granted to Genentech on 17 July 2007. Genentech’s instructions to Master Data (a patent administration company) 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 to be 23 January 2022.

Master Data filed the relevant patent forms 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”.

The Law
Article 13 of Regulation (EC) No. 469/2009 (“the SPC Regulation”), regulates the duration of an SPC. This states that the SPC will take effect at the end of the basic patent for the period which elapsed between the application and the authorisation, reduced by five years. The SPC cannot exceed five years, unless the SPC is extended by six months in the case of a paediatric extension.

Rule 116 (5) of the Patents Rules 2007 (as amended) provides that “…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.

Section 117 of the Patents Act 1977 concerns the correction of errors in patents and applications, including correction of any document filed in connection with a patent or an application.

Paragraph 5 of Schedule 4A of the Patents Act 1977 states that “a SPC 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.

The Hearing Officer’s Decision
The Hearing Officer held that the SPC will lapse on 2 April 2020, on the grounds that Master Data only requested and paid for a 2-year term on the relevant form rather than a 4-year term.

In particular he held:

• rule 116(5) of the Patents Rules 2007, did not allow further annual fees to be paid if an application for a paediatric extension was made;

• the paediatric extension was not allowed for an SPC in circumstances where the SPC was not in force for the full maximum term;

• a request to correct the relevant forms used to pay the prescribed fee for the SPC, so as to extend the duration of the certificate, under sections 117 and/or 32(2)(d) of the Patents Act 1977 was not allowed; and

• there was no irregularity in procedure and no mistake or error attributable, at least in part, to the UKIPO.
Both Master Data and Genentech appealed the decision.

The Appeals

Master Data
Master Data had three grounds of appeal based on the Hearing Officer having fallen into error:

• by interpreting the SPC Regulation as allowing an applicant for an SPC to choose a duration of their certificate for a period that is shorter than that defined in Article 13 of the SPC Regulation;

• by holding that the Court of Appeal in Tulane had confirmed that the UK rules and practice did not conflict with the SPC Regulation; and

• by holding that paragraph 5 of Schedule 4A of the Patents Act 1977 envisages that a single fee must be paid before the certificate comes into effect.

Douglas Campbell QC held that the first two points were essentially the same and dismissed these grounds:

It is and was properly open to the UKIPO to give applicants the option of taking a certificate for a shorter period than that set by Article 13, such that applicants can thereby only pay a fee in respect of those years for which they have elected.” (para 39)

On the third ground of appeal he held that:

The third ground of appeal is not the same argument, but nothing turned on it since it was accepted by the UKIPO that a payment can be made after the date when the certificate takes effect, contrary to what was held by the Hearing Officer…” (para 28)

Genentech also appealed the conclusions of the Hearing Officer set out above. Douglas Campbell QC dismissed their first argument that rule 116(5) of the Patents Rules 2007 allows further annual fees to be paid if an application for a paediatric extension is made, finding that:

it seems to me… that the natural and ordinary interpretation of rule 116(5) in this context is that when an application for extension is made, the applicant is permitted, and only permitted, to pay for the paediatric extension itself. As noted above the applicant may not know at the time of the original payment whether he is entitled to an extension, so there is no reason to require him or her to pay for the extension at that stage and every reason to allow later payment. However the same logic does not apply to the annual fees, which have nothing to do with the paediatric extension.” (para 49)

Genentech’s second ground of appeal was that the form could be corrected under s. 117 of the Act (Genentech did not rely on s. 32(2)(d)). This argument was also dismissed, with Douglas Campbell QC confirming the Hearing Officer’s analysis of the case law, namely that “a general provision cannot be used to circumvent a specific mandatory legislative provision”, was correct.

Genentech’s third ground of appeal, that the paediatric extension could still extend the existing term of the SPC by 6 months, was also dismissed:

“… it is impossible to reconcile with the wording of Article 13(3). That wording makes it clear that the only possible paediatric extension is one which extends the period set out in Articles 13(1) and 13(2) (the full period), not some other period.” (para 73)

The UKIPO does have the discretion to allow any fees to be paid later. The UKIPO submitted three reasons as to why they had refused to exercise this discretion. Douglas Campbell QC did not accept that the first two reasons. However, he was convinced by the third:

“…this was the third time Master Data had made the same mistake. In particular Master Data kept on making the same mistake despite the UKIPO “going the extra mile” to point out the mistake the first two times.

The High Court upheld the decision of the Hearing Officer and the appeals by both Master Data and Genentech were dismissed.

A copy of the judgment can be found here.

Headnote: Luke Norton and Amy Crouch, Simmons & Simmons LLP