Wednesday, 9 August 2017

T 2369/12 - Everything you submit can and will be used against you?


The Examining Division held a particular auxiliary request not to be disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art (Article 83 EPC).

In the appeal, the applicant now appellant submits a post-published document (Exhibit A) with the title "Efficacy of Enterisol® Ileitis administered to Lawsonia-positive pigs 1 to 6 days of age" and argues that there was no evidence on file that there were serious doubts substantiated by verifiable facts that the application lacked sufficient disclosure, and indeed, that the post-published data contained in "Exhibit A" made it plausible that vaccination with the L. intracellularis vaccine in the face of maternal immunity in young pigs would be effective.

The present case shows the Board scrutinizing Exhibit A and - probably to the dismay of the appellant - concluding that it is in fact Exhibit A which as a whole raises serious doubts on the suitability of the claimed bacteria for vaccination. "Everything you submit can and will be used against you"?

Reasons for the Decision
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Auxiliary request I - Claim 1

Disclosure of the invention - Article 83 EPC

3. Article 83 EPC requires that the European patent application discloses the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art. In the case of a therapeutic use, the application must disclose the suitability of the product to be manufactured for the claimed therapeutic application (see Case Law of the Boards of Appeal of the European Patent Office, 8th edition, II.C.6.2).

4. For the therapeutic use of claim 1, the application must disclose the suitability of the attenuated L. intracellularis bacteria for the vaccination (i.e. for inducing immunity) of 1 to 9 day old pigs against L. intracellularis infections, when administered by oral drench.

5. The appellant argued that the application disclosed the suitability of attenuated L. intracellularis bacteria for the vaccination of 1 to 9 day old pigs against L. intracellularis infections. In particular, Examples 2 and 3, taken alone, demonstrated the suitability of attenuated L. intracellularis bacteria for the vaccination of 1 to 9 day old pigs against L. intracellularis infections.

6. The board does not consider these arguments as persuasive in the face of the evidence of Exhibit A, submitted by the appellant with the statement of grounds of appeal (see points 7 to 8.5, below). The results contained in the application were either from in vitro or tissue culture assays (Examples 1 and 2) or, if they were generated through animal studies, relate to maternal antibody-negative piglets or piglets of 3 weeks of age (Examples 3 and 4, respectively). On the other hand, the evidence in Exhibit A derives from a clinical study representing an embodiment of the claimed subject-matter, i.e. it provides direct evidence of the suitability of attenuated L. intra-cellularis for the purpose claimed and is therefore given more weight than the results contained in the application.

7. The Exhibit provides the results of a study "conducted to evaluate Enterisol® Ileitis vaccine efficacy in suckling piglets derived from Lawsonia intracellularis exposed (group A) and negative sows (group B) and to determine if there was any maternal interference with vaccine efficacy against a virulent, pure culture L. intracellularis challenge" (see Exhibit A, page 1).

8. Piglets in groups A and B were further divided into subgroups 1 to 6 (see Tables 1 and 2 of the Exhibit). Piglets in subgroups 1 and 4 were vaccinated with a single dose of attenuated modified live

L. intracellularis (Enterisol® Ileitis) at 1 week of age. Piglets in groups 2, 3, 5 and 6 received a placebo. At 6 to 7 weeks of age, piglet groups 1, 2, 4 and 5 received a virulent, pure culture of L. intracellularis challenge, while groups 3 and 6 did not.

8.1 All piglet groups were humanely euthanised and evaluated for macroscopic (gross) and Lawsonia-specific microscopic lesion development at 3 weeks post challenge administration (9 to 10 weeks of age; supra).

8.2 Table 2 provides a summary of average gross lesion scores for the small and large intestines, with group 1 being the trial group (piglets from L. intracellularis exposed sows, vaccinated) and group 2 being the control group (piglets from L. intracellularis exposed sows, unvaccinated). It can be seen from the table that the trial group has significantly larger intestinal lesions than the control group.

8.3 Table 3 provides a summary of average microscopic lesion scores for the small, large and whole intestines, with group 1 being the trial (vaccinated) group and group 2 being the control (unvaccinated) group. Here too, the trial group has significantly larger intestinal lesions than the control group.

8.4 The appellant argued that, although Tables 2 and 3 of the study report showed that group 1 piglets (from Lawsonia positive sows, vaccinated and challenged) had greater gross average lesion scores than the unvaccinated challenge control (group 2), the data in Table 4 confirmed that the same group, had better daily clinical scores than the unvaccinated control group.

8.5 Table 4 does indeed show that group 1 piglets had fewer clinical symptoms of infection than those in the challenge control (group 2). However, given the significance of intestinal lesions as a symptom of infection and of the fact that two out of three measures of infection were significantly worsened in piglets from sows exposed to L. intracellularis bacteria in comparison to the non-vaccinated piglets from the same sows, the board must conclude that Exhibit A as a whole raises serious doubts as to the suitability of attenuated L. intracellularis bacteria for the vaccination of 1 to 9 day old pigs against L. intracellularis infections when administered by oral drench, which cannot be overcome by the results in the application, given their indirect nature (see point 6 above).

9. In view of the above, the board holds that the application does not disclose the invention of claim 1 in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.

(...)

11. In view of the above considerations, none of the pending claim requests relates to an invention for which the application meets the requirements Article 83 EPC.

Order

For these reasons it is decided that:

The appeal is dismissed.

This decision T 2369/12 (pdf) has European Case Law Identifier:  ECLI:EP:BA:2017:T236912.20170317. The file wrapper can be found here. Photo "Miranda Warning" by Mike Licht obtained via Flickr under CC BY 2.0 license (no changes made).

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