1. A sealed vial or cartridge containing a storage stable pharmaceutical
composition in the form of a sterile solution ready for parenteral
administration in an human patient, which solution comprises PTH(1-34), a
buffer to maintain a pH from 3 to 7 and a polyol stabilizing agent, and
which solution has not been reconstituted from a lyophilisate."Teriparatide Acetate powder
"19. A process for preparing a pharmaceutical composition in the form of
a sterile solution ready for parenteral administration, said process
comprising: mixing human PTH(1-34), a buffering agent and an excipient
to form an aqueous solution containing PTH in a concentration range from
25myg/mL to 1000myg/mL, which is then sterile-filtered and filled into a
vial or cartridge for use, wherein the excipient comprises a polyol
stabilising agent".
"30. A pharmaceutical composition in the form of a stabilized solution
comprising: (a) a therapeutically effective amount of human PTH(1-34);
(b) an effective amount of a polyol stabilizing agent; (c) a buffering
agent in an amount sufficient to maintain the pH of the composition
within a range of about 3-7; (d) a parenterally acceptable preservative;
and (e) the balance bing water."
II. Four oppositions were filed against the granted patent under Article
100(a), (b) and (c) EPC on the grounds that its subject-matter lacked
novelty and inventive step, the patent was not sufficiently disclosed,
and its subject-matter extended beyond the content of the application as
filed.
III. The appeal by the opponents OP1, OP2 and OP3 (hereinafter
appellants 01, 02 and 03) lies from the decision of the opposition
division that the patent in amended form based on auxiliary request 19
filed during oral proceedings met the requirements of the EPC.
V. According to the decision under appeal, the main request comprised
subject-matter extending beyond the content of the original and parent
applications contrary to Articles 123(2) EPC and 76(1) EPC. Auxiliary
requests 1-7 did not comply with the requirements of Article 123(3) EPC.
Auxiliary requests 8-17 did not meet the requirements of Articles 76(1)
and 123(2) EPC. Auxiliary request 18 was not admitted into the
opposition proceedings under Rule 80 EPC.
In auxiliary request 19, claims 1-18 and 31 had been deleted, and the
requirements of Articles 123(3), Art. 84, A76(1) and 123(2) EPC and Rule
80 EPC were met by this request.
Process claim 1 corresponded to claim 19 as granted with the further
feature "and wherein said composition further comprises a parenterally
acceptable preservative". Product claim 11 was identical to claim 30 as
granted.
The subject-matte of the claims of auxiliary request 19 was considered to be new inter alia over D1.
As regards inventive step, D21 was considered to represent the closest
prior art; it related to the problem of stabilizing PTH, and PTH(1-34)
was mentioned. The formulations according to D21 contained PTH with a
basic amino acid such as arginine, in particular for injection or
infusion with a pH of 4-8.
D1 and D2 could not be considered as an appropriate starting point,
since these documents did not specifically relate to human PTH(1-34).
D12 related to human PTH(1-34) but did not refer to a buffer or
preservative and did not recognize any particular stability of the
disclosed formulations. Neither did D39 and D41 recognized any
particular stability associated with the disclosed compositions.
The difference between D21 and the claimed subject-matter concerned the
presence of a buffer in combination with a polyol and the addition of a
parenterally acceptable preservative as defined in the contested claims.
The problem to be solved in the light of D21 was the provision of an
alternative stable liquid formulation of human PTH(1-34), which was
ready for administration and suitable for use as a multi-dose
formulation. The claimed subject-matter was not considered obvious to
the skilled person from D21.
VI. With its statement of the grounds of appeal dated 2 November 2016, appellant 03 requested an accelerated appeal proceedings.
VII. With a letter dated 28 March 2017, the patent proprietor (hereafter
the respondent) filed a main request (corresponding to auxiliary
request 19 maintained by the opposition division) and auxiliary requests
1-20.
The subject-matter of claim 1 of the main request corresponded to claim
19 as granted with the further specification "and wherein said
composition further comprises a parenterally acceptable preservative".
The product claim 11 was identical to claim 30 as granted.
VIII. A communication from the Board was sent to the parties. The Board
mentioned in particular that documents D41 and D2 appeared to be as
closer on a technical point of view to the claimed invention than D1 or
D21, and that these documents could be the closest prior art for
assessing inventive step.
