The UK Patents
Court recently issued a judgement which referred four questions to the CJEU in
the case Actavis Group v Boehringer
Ingelheim that aim to clarify how the SPC Regulation ought to be
interpreted in respect of products having combinations of active ingredients.

This referral
follows three earlier referrals to the CJEU concerning the interpretation of
the SPC Regulation in the cases of Actavis
v Sanofi, Lilly v Human Genome Sciences and Georgetown University.  These referrals were heard by the CJEU on 12 September 2013 and we are awaiting
the CJEU's guidance to be issued.  It is suspected that the guidance on the
three earlier referrals will provide a good indication as to how the CJEU will
deal with the present referral.

Background and facts

Boehringer's European patent, EP (UK) 0502314, has a claim to
a compound called telmisartan.  This
compound is used in the treatment of hypertension and is marketed under the
brand name Micardis.  The corresponding SPC is due to expire on 10
December 2013.

Boehringer also sells MicardisPlus,
a product comprising telmisartan and hydrochlorothiazide.  In 2003 Boehringer
applied to the UK IPO for an SPC to the combination of telmisartan and
hydrocholothiazide.  EP (UK) 0502314 as
granted did not have a claim specifically directed to this combination.  Boehringer
therefore applied to amend the patent to insert a claim specifically directed
to the combination.  Whilst the
application to amend was pending the UKIPO agreed to suspend the SPC
application for four months.  The
amendment was granted and Claim 12, directed to the combination of telmisartan
and hydrocholothiazide, was included in the amended patent.  The SPC for the combination was granted and
is due to expire on 30 January 2017.

Actavis Group sought to invalidate the combination SPC in order
to clear a path to launch its own product comprising telmisartan and
hydrocholothiaziode.  In considering the
invalidation action the UK Patents Court referred the four questions to the
CJEU in order to seek clarification on the interpretation of the SPC Regulation
in respect of combination products.

Questions referred

1.    (a) If a patent does not, upon grant, contain a claim that
explicitly identifies two active ingredients in combination, but the patent
could be amended so as to include such a claim could this patent, whether or
not such an amendment is made, be relied upon as a "basic patent in force"
for a product comprising those ingredients in combination pursuant to Article
3(a) of Regulation No 469/2006/EC ("the Regulation")?

(b)  Can a patent that has been
amended after the grant of the patent and either (i) before and / or (ii) after
grant of the SPC be relied upon as the "basic patent in force" for
the purposes of fulfilling the condition set out in Article 3(a) of the
Regulation?

(c)  Where an applicant applies for
an SPC for a product comprised of active ingredients A and B in circumstances
where,

(i)  after the date of application for the SPC but before the
grant of the SPC, the basic patent in force, being a European Patent (UK) (the "Patent")
is amended so as to include a claim which explicitly identifies A and B;

and

(ii)  the amendment is deemed, as a
matter of national law, always to have had effect from the grant of the Patent;

is the applicant for the SPC
entitled to rely upon the Patent in its amended form for the purposes of
fulfilling the Art 3(a) condition?

The SPC regulation
requires the basic patent which protects the active ingredient covered by the
SPC to be in force.  In the present case,
the patent as granted did not have a claim specifically to the combination of
telmisartan and hydrocholothiazide when the SPC application for the combination
was filed. Instead, a claim to the combination was added to the patent after
the SPC application was filed.  The
questions therefore arises as to whether the patent qualifies as "a basic
patent in force" as per the requirement specified in the SPC regulation.

The UK judge's
preliminary view was that given that amendments to UK patents have
retrospective effect to the date of patent grant, if the amendment is allowable
then when the amendment occurred ought to not affect the validity of the SPC.

2.    For the purposes of determining
whether the conditions in Article 3 are made out at the date of the application
for an SPC for a product comprised of the combination of active ingredients A
and B, where (i) the basic patent in force includes a claim to a product
comprising active ingredient A and a further claim to a product comprising the
combination of active ingredients A and B and (ii) there is already an SPC for
a product comprising active ingredient A ("Product X") is it
necessary to consider whether the combination of active ingredients A and B is
a distinct and separate invention from that of A alone ?

This question
essentially asks whether, in order for an SPC to be granted to a combination of
active ingredients, is it necessary to consider whether the combination has to
be an "inventive advance" over either one of the active ingredients
alone.

The issue of
whether a combination of active ingredients amounts to an "inventive
advance" over either one of the active ingredients is the subject of the
referral by the UK Court to the CJEU in the case of Actavis v Sanofi.  The UK judge in the present case did not give his
opinion as to what he thought the answer to this question ought to be, but
preferred to wait for the CJEU's guidance in Actavis v Sanofi which is expected in the coming months.  However,
the UK judge indicated that if the "inventive advance" question is of
relevance in the case of telmisartan and hydrocholothiazide, then a further
trial on this point will need to be held at a later date.

3.    Where the basic patent in force "protects" pursuant
to Article 3(a):

(a) A product comprising active
ingredient A ("Product X"); and

(b) A product comprising a
combination of active ingredient A and active ingredient B ("Product Y").

And where:

(c) An authorisation to place
Product X on the market as a medicinal product has been granted;

(d) An SPC has been granted in
respect of Product X; and

(e) A separate authorisation to
place Product Y on the market as a medicinal product has subsequently been
granted.

Does the Regulation, in particular
Articles 3(c), 3(d) and/or 13(1) of the Regulation preclude the proprietor of
the patent being issued with an SPC in respect of Product Y? Alternatively, if
an SPC can be granted in respect of Product Y, should its duration be assessed
by reference to the grant of the authorisation for Product X or the
authorisation for Product Y?

This question
essentially asks whether the prior existence of the telmisartan SPC precludes
the possibility of obtaining an SPC for the combination of telmisartan and
hydrocholothiazide.  If the answer to this question is "no," then the
question goes on to ask whether the term of the combination SPC ought to be
limited to the term of the telmisartan SPC.

The UK judge
indicated that he thought the telmisartan SPC should have no bearing on the
grant of the combination SPC and that he would be surprised if the telmisartan
SPC affected the term of the combination SPC.

4.    If the answer to question 1(a) is in the negative and the
answer to question 1(b)(i) is positive and the answer to question 1(b)(ii) is
negative, then in circumstances where:

i) in accordance with Art 7(1)
Regulation, an application for an SPC for a product is lodged within six months
of the date on which a valid authorisation to place that product on the market
as a medicinal product has been granted in accordance with Directive 2001/83/EC
or Directive 2001/82/EC;

ii)  following the lodging of the
application for the SPC, the competent industrial property office raises a
potential objection to the grant of the SPC under Article 3(a) of the
Regulation;

iii)  following and in order to
meet the aforesaid potential objection by the competent industrial property
office, an application to amend the basic patent in force relied upon by the
SPC applicant is made and granted;

iv)  upon amendment of the basic
patent in force, said amended patent complies with Article 3(a);

does the SPC Regulation prevent the competent industrial
property office from applying national procedural provisions to enable (a)
suspension of the application for the SPC in order to allow the SPC applicant
to apply to amend the basic patent, and (b) recommencement of said application
at a later date once the amendment has been granted, the said date of
recommencement being

•    after six months
from the date on which a valid authorisation to place that product on the
market as a medicinal product was granted but

•    within six months of the date on which the application to amend the
basic patent in force was granted?

Question 4 is
related to question 1 and asks whether the procedure adopted by the UKIPO to
suspend the application for the combination SPC, whilst the application to
amend the patent was heard, was the correct approach.  In his preliminary view,
the UK judge could see no good reason why this approach could be
challenged.

We await the CJEU's guidance on the referrals in the Actavis v Sanofi, Lilly v Human Genome
Sciences and Georgetown University cases which is expected in the next few
months.  This ought to give an indication
of how it will deal with the four questions that have been referred in the
present case.

This
report comes from European Patent Attorneys at WP Thompson & Co., 55 Drury Lane,
London UK.  Further details and commentary can be obtained from Gill Smaggasgale,
a partner at the firm.