On Sep 18, 2018, UK high court revoked SPC for Gilead’s Truvada®
challenged by generic filers.
In these proceedings the Claimants (Teva, Accord, Lupin
& Mylan) challenged the validity of the Defendant's (Gilead') supplementary
protection certificate SPC/GB05/041 for a product described in the SPC
as "Composition containing both Tenofovir disoproxil, optionally in the
form of a pharmaceutically acceptable salt, hydrate, tautomer or solvate,
together with Emtricitabine". The SPC covers a product which is marketed
by Gilead under the trade mark Truvada®.
It is a combination product consisting of two active ingredients, namely (i)
245 mg tenofovir disoproxil ("TD") in the form of 300 mg of the
fumarate ("TDF") and (ii) 200 mg emtricitabine (also known as FTC) in
a single, fixed dose tablet. Mr. Justice Arnold in his judgment dated 13
January 2017 referred the question to Court of Justice of the European Union
(CJEU) in this matter & asked the question, “what are the criteria for
deciding whether 'the product is protected by a basic patent in force' in
Article 3(a) of the SPC Regulation?"
On 25 July 2018 the Grand Chamber of the CJEU handed down
its judgment in Case C-121/17. It ruled as follows:
"Article 3(a) of [the SPC Regulation] must be
interpreted as meaning that a product composed of several active ingredients
with a combined effect is 'protected by a basic patent in force' within the
meaning of that provision where, even if the combination of active ingredients
of which that product is composed is not expressly mentioned in the claims of
the basic patent, those claims relate necessarily and specifically to that
combination. For that purpose, from the point of view of a person skilled
in the art and on the basis of the prior art at the filing date or priority
date of the basic patent:
–
the combination of those active ingredients must
necessarily, in the light of the description and drawings of that patent, fall
under the invention covered by that patent, and
–
each of those active ingredients must be specifically
identifiable, in the light of all the information disclosed by that
patent."
Applying CJEU judgment Justice Arnold said that if the
product is not expressly mentioned in the claims of the Patent, the
claims must relate to the product necessarily and specifically. For the
purposes of the application of Article 3(a) of that regulation, the claims of the basic patent must be construed in the light of the limits
of that invention, as it appears from the description and the drawings of that
patent. The issue here is whether a claim such as claim 27 of the basic
patent (EP 0915894) in fact covers a combination such as the
TD/emtricitabine combination which is the subject of the SPC at issue. In the
present case it is apparent, first, from the information in the order for
reference that the description of the basic patent at issue contains no
information as to the possibility that the invention covered by that patent
could relate specifically to a combined effect of TD and emtricitabine for the
purposes of the treatment of HIV. Consequently, it does not seem possible
that a person skilled in the art, on the basis of the prior art at the filing
date or priority date of that patent, would be able to understand how
emtricitabine, in combination with TD, necessarily falls under the invention
covered by that patent. There is no dispute that TD is specifically
identifiable. Also it is clear that emtricitabine is not specifically
identifiable. Once again, it is not mentioned in the Patent. It is not even a
member of a specific class of compounds mentioned in the Patent, whether by
reference to their structure or activity, as being suitable for combination
with the compounds of the invention. Furthermore, although emtricitabine was
known at the priority date, there is no evidence that it was known that
emtricitabine was an effective agent for the treatment of HIV in humans, still
less that this was common general knowledge to the person skilled in the art to
whom the Patent is addressed.
Accordingly the SPC does not comply with Article 3(a) and
must be revoked.
No comments:
Post a Comment