Decision Nº O/506/12 from Intellectual Property Office - (Patent decisions), 19 December 2012
| Judge | Mrs C L Davies |
| Court | Intellectual Property Office (United Kingdom) |
| Patent Number | SPC/GB/08/046, SPC/GB/11/043 |
| Administrative Decision Number | O/506/12 |
| Date | 19 December 2012 |
| Parties | GlaxoSmithKline |
COUNCIL REGULATION (EC) 469/2009
CONCERNING THE CREATION OF A
SUPPLEMENTARY PROTECTION
CERTIFICATE FOR MEDICINAL
PRODUCTS
BL O/506/12
19 December 2012
APPLICANT
GlaxoSmithKline Biologicals S.A.
ISSUE
Whether SPC application numbers
SPC/GB/08/046 and SPC/GB/11/043
complies with Article 1(b) and may be
granted
HEARING OFFICER
C L Davies
DECISION
Introduction
1 This relates to two applications for a supplementary protection certificate (SPC) which
were filed by GlaxoSmithKline Biologicals S.A. (“the applicant”) and accorded the
numbers SPC/GB/08/046 and SPC/GB/11/043. The applicant seeks the grant of these
SPCs relating to novel adjuvant systems under the Regulation (EC) No 469/2009 (“the
Regulation”). Both applications rely on the marketing authorization (“MA”)
EU/1/08/453/001 dated 14 May 2008 for Prepandrix (RTM) but refer to separate basic
patents. Prepandrix (RTM) is a pre-pandemic influenza vaccine (split virion, inactivated,
adjuvanted). It consists of a split influenza virus inactivated, containing antigen
equivalent to A/Indonesia/05/2005 like strain used (PR8-IBCDC-RG2), adjuvanted by a
combination of substances collectively referred to as AS03.
2 The following table adapted from one provided by the applicant in their skeleton
argument filed on 1 October 2012, summarises the applications at issue:
SPC/filing date
Product
Basic patent
proprietor
SPC/GB08/046
10/10/08
An oil in water emulsion
comprising squalene, DL-
α-tocopherol and
polysorbate 80
EP (UK) 0868
918 B1
GlaxoSmithKline Biological S.A.
SPC/GB11/043
An adjuvanted influenza
vaccine comprising an
EP (UK)
GlaxoSmithKline Biological S.A.
Intellectual Property Office is an operating name of the Patent Office
18/8/2011
influenza virus
component which is an
influenza virus antigen
from an influenza virus
strain that is ass ociated
with a pandemic outbreak
or has the potential to be
associated with a
pandemic outbreak,
wherein the adjuvant is
an oil in water emulsion
comprising squalene, DL-
a-tocopherol and
polysorbate 80
1618889 B1
&
GlaxoSmithKline Biologicals
Niederlassung der SmithKline
Beecham Pharma GmbH & Co.
KG
The main claims of the basic patents read as follows:
EP (UK) 0868 918 B1 - An adjuvant composition comprising an oil in water emulsion of
the following composition: from 2 to 10% squalene, from 2 to 10% alpha tocopherol, and
from 0.3 to 3% TWEEN80TM.
EP (UK) 1618889 B1 - A monovalent influenza vaccine composition comprising an
influenza virus component which is a low dose of influenza virus antigen from an
influenza virus strain that is associated with a pandemic outbreak or has the potential to
be associated with a pandemic outbreak, in combination with a suitable adjuvant,
wherein said low antigen dose is less than 15ug of haemagglutinin per dose or no more
than 15ug per combined dose of vaccine, and wherein said adjuvant is an oil-in-water
emulsion carrier comprising squalene, alpha tocopherol and Tween 80.
3 The Examiner, Dr. Philip Mountjoy, raised two main objections in his pre-hearing report
dated 4 September 2012:
“(1) In my opinion the AS03 adjuvant (comprising squalene, D-L-α-tocopherol and
polysorbate 80) for which an SPC is sought is not an active ingredient for the purposes
of Article 1(b) of the Regulation. Adjuvants, whilst having a biological effect, cannot be
considered active ingredients for the purposes of Article 1(b) of the Regulation in light of
the CJEU’s judgment in MIT (C-431/04).
(2) … once the product definitions were amended to overcome the objections raised all
three applications would ultimately have to relate to the same product. Given that Article
3(2) of the Plant Protection Regulation (which is relevant to the Medicinal Regulation by
virtue of Recital (17) of the Plant Protection Regulation 1610/96) precludes the grant of
more than one certificate for the same product to a patent holder, I explained that it was
likely that you would have to decide which of the aforementioned applications you
wished to have granted and withdraw the others. “
Originally, a third application SPC/GB08/045 was due to be considered at the hearing
but in a letter dated 19 October 2012, the applicant withdrew it therefore I will consider it
no further.
4 The applicant requested a hearing in their letter dated 9 July 2012 and the matter came
before me on 16 October 2012. The applicant was represented by Ms Marjan Noor and
Mr Andrew Hutchinson of Simmons & Simmons. Also in attendance were Dr James
Robertson and Dr Marcus Dalton of GlaxoSmithKline. The hearing was also attended by
the Examiner, Dr Mountjoy and Dr Jason Bellia.
5 Prior to the hearing, the applicant submitted skeleton arguments dated 1 October 2012
which formed the basis of the hearing and hence the framework of my decision.
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