|European Case Law Identifier:||ECLI:EP:BA:2005:W001404.20050919|
|Date of decision:||19 September 2005|
|Case number:||W 0014/04|
|IPC class:||A61K 9/50|
|Language of proceedings:||EN|
|Download and more information:||
|Title of application:||Controlled Release Compositions and Methods for using same|
|Applicant name:||SOUTHWEST RESEARCH INSTITUTE|
|Relevant legal provisions:||
|Keywords:||Lack of reasoning|
Summary of Facts and Submissions
I. On 10 October 2003, the International Searching Authority (ISA) dispatched an invitation to the Applicant to pay three additional search fees on the grounds that the international application contained, inter alia, the following four inventions:
Claims 1, 3, 4, 6-8, 9-18 partially, 20 partially, 22-60 partially:
Microcapsules adapted to provide controlled release of an active agent, for mucosal delivery of antihistamines or anticholinergics comprising:
1.1 a shell comprising a release retardant(claim 1, 4, 8-18 partially, 20 partially, 22-60 partially) or
1.2 an absorption enhancer (claims 3,6,7,8-18 partially, 20 partially, 22-60 partially).
Claims 2,5,9-18 partially, 19,20 partially, 21,22-60 partially:
Microcapsules adapted to provide controlled release of an active agent, for mucosal delivery of antihistamines or anticholinergics comprising a single enantiomer of the active agent.
Method for alleviating motion stickness or allergy comprising administering a highest pharmacological activity enantiomer of a phenothiazine
method for resolving the (+) and (-) enantiomer of ethopropazine
It mentioned that all subject-matters mentioned under invention 1, although not necessarily linked by a common concept, could be searched without particular effort, so that it would not justify to ask for more than one search fee.
As to a link between invention 1, 2 and 3, the ISA considered in substance that, since document (1) (Pharmacological Research, vol. 38, July 1998, pages 35-39) already disclosed an anti-histamine (promethazine), microencapsulated in microspheres (page 36, left-hand column, paragraph 2; page 38, right-hand column, lines 13-18), no structural feature could be seen which could be considered as a special feature within the meaning of Rule 13.2 PCT.
Concerning invention 4, it expressed the view that is was clearly concerned with a different problem than the one in the groups 1 to 3.
II. The Applicant replied to the invitation in due time by paying under protest the three additional search fees on 24 November 2003.
In summary, it submitted that the ISA failed to demonstrate that the prior art disclosed microcapsules adapted to provide controlled release of an active agent, for mucosal delivery of antihistamines with minimal side effect similar to the ones claimed in its application.
III. In response to the applicant's payment of three additional fees under protest, on 29 March 2004 the Review Panel of the EPO communicated to the applicant the result of a prior review under Rule 40.2(e) PCT of the justification for the invitation to pay additional search fees.
It first observed that the applicant had only provided observations relevant to inventions 1 and 2.
It considered that the argumentation given by the applicant did not invalidate the ISA's reasoning leading to the non unity invention.
However, it ordered the refund of one additional search fee as, in its opinion, "the extra necessary search effort for invention 2 did not justify the levying of an additional search fee".
It further invited the Applicant to pay a protest fee for the examination of the protest (Rule 40.2(e) PCT).
IV. On 29 April 2004 the applicant paid the protest fee.
Reasons for the Decision
1. PCT Rule 40.2.(c) provides that: "Any applicant may pay the additional fee under protest, that is, accompanied by a reasoned statement to the effect that the international application complies with the requirement of unity of invention or that the amount of the required additional fee is excessive."
2. The purpose of the protest procedure under Rule 40.2(c) PCT is to enable the justification for the invitation to pay to be submitted to substantive review; however the Board's competence to examine is limited to the issue of whether or not, considering the reasons stated by the ISA and the submissions made in support of the protest, retaining additional search fees was justified. The Board cannot investigate ex officio whether an objection of lack of unity would have justified for other reasons.
3. In the present case, the search fee paid for invention 2 was reimbursed, so that only the fees relating to inventions 3 and 4 are still in dispute. However, the appellant did not make any submissions at all as to inventions 3 and 4. As a consequence, and because the reasons given by the ISA are not manifestly untenable, there is nothing the Board could examine as regards the fees paid for the search of inventions 3 and 4. As a consequence, in the Board's view, although the protest has to be dismissed the protest fee should be reimbursed.
For these reasons it is decided that:
1. The protest is dismissed.
2. The protest fee is to be reimbursed.