Patent decision

BL number

O/019/22

Concerning rights in

SPC/GB11/051

Hearing Officer

Dr L Cullen

Decision date

11 January 2022

Person(s) or Company(s) involved

Chiesi Farmaceutici S.P.A.

Provisions discussed

Regulation (EC) 469/2009, Articles 8, 9, 10, 11, 13 Regulation (EC) 1901/2006, Articles 28, 36 Section 117B, 128B

Keywords

Extension for Paediatric Testing, Supplementary Protection Certificates

Related Decisions

None

Summary

An application for a paediatric extension to granted certificate SPC/GB/11/051 relating to a combination of active ingredients used for the treatment of asthma was filed. The view of the examiner was that the application did not meet the requirements of Article 8(1)(d)(ii) of Regulation (EC) 469/2009 as it did not provide proof of possession of authorisations to place the product on the market in all other EU member states before the unextended expiry date of the SPC. In line with the Court of Appeal decision inDuPont, the examiner had allowed the applicant the opportunity to provide the necessary proof up 13 July 2021, the unextended expiry date of the SPC. At this date, authorisation for two states were still outstanding. The applicant argued that the Office had the power to extend the time-period for filing the necessary documents until after the expiry date of the SPC and up to the end of the applied for six-month paediatric extension (13 January 2022). Third parties would not be adversely impacted because they would be aware (a) that a paediatric extension had been applied for, and (b) that if granted, it would extend the SPC to 12 January 2022.

The Hearing Officer (HO) considered the various materials provided by the applicant describing their efforts to gain the updated marketing authorisation and compliance statement under Art 36(3) of Regulation (EC) 1901/2006. The applicant was able to provide the necessary documents for the outstanding member states in November 2021, approximately four months after the expiry date of the SPC at issue. The HO was satisfied that these documents would, if accepted, correct the irregularity with the application identified by the examiner under Article 10(3). Having reviewed the arguments proposed by the applicant in relation to the discretion available to the Comptroller to extend the time periods for providing the relevant documents, and given the specific circumstances of this case, the HO found that discretion could be exercised under Section 117B(4) of the Act to extend the deadline for filing these documents until after the expiry date of the SPC. As these documents address the irregularity identified with the application under Article 10(3), the HO remitted this application for a paediatric extension to the examiner to compete the necessary steps for grant of the paediatric extension under Article 10(1).

Full decisionO/019/22  520Kb