T 1589/21 - Mentioned but not disclosed

Key points

•  This case reminds me of T 2842/18 where a verbatim statement was no valid basis for a claim amendment under Art. 123(2) EPC in a case about a second medical use claim.
• "One of the issues with respect to the amendments [under Article 123(2) EPC] was whether or not the application and the earlier application disclosed the purpose recited in the claim, i.e. protection against Lawsonia intracellularis, Mhyo and Porcine circo virus (PCV), in combination with the claimed vaccine and the administration route and scheme recited in the claim (intramuscular administration of the vaccine only once)."
• "Example 3 is the only passage in the application that discloses the administration of a composition of the three non-live antigens of the pathogens Lawsonia intracellularis, Mhyo and PCV as defined in the claim to subjects (pigs) intramuscularly and only once. However, as also disclosed in Example 3, after a single intramuscular injection, no Mhyo antibodies could be detected "
• "The information conveyed to the skilled person by Example 3 of the application is that the claimed vaccine does not confer protection against Mhyo when administered intramuscularly only once, yet the contrary is claimed, i.e. that it does confer such protection (see section I.). The claimed subject-matter hence relates to new technical information which is not directly and unambiguously derivable from the application."
  
• "The opposition division held that achieving the purpose recited in the claim was only a matter of sufficiency of disclosure, not of added subject-matter. In line with decision T 2593/11 (Reasons 3.4), it was sufficient that the inventors had "thought of" protection against Lawsonia intracellularis, Mhyo and PCV by intramuscular administration of the claimed vaccine only once. This was evident from the purpose of Example 3 described in lines 2 to 4 of page 14 of the application and from the vaccination experiment carried out for Group 2 of Example 3 "
• "the purpose of Example 3 was "to test" a combination vaccine comprising killed whole cells of Lawsonia intracellularis and antigens of Mhyo and PCV. However, a mere statement that a vaccine test experiment was conducted, without disclosing any results, does not amount to a disclosure of the tested vaccine for a specific therapeutic purpose"
• 
  
•  "The board considers that this conclusion is in line with the established case law on novelty of second medical use claims. By way of example, mere statements that a particular therapy is being explored do not amount to a novelty-destroying disclosure of a second medical use claim which includes the achievement of this therapy as a technical feature (T 1859/08, Reasons 13), and a document that describes the administration of a compound to diseased subjects but neither explicitly nor implicitly discloses an effective treatment of the disease by this compound does not directly and unambiguously disclose this treatment (T 239/16, Reasons 5.2 and 5.3). Although this case law is on novelty and not on added subject-matter, the concept of disclosure must be the same for the purposes of Articles 54 and 123 EPC (G 2/10, OJ EPO 2012, 376, Reasons 4.6, citing G 1/03, OJ EPO 2004, 413, Reasons 2.2.2)."
• "In line with this case law, the disclosure in the application that pigs were vaccinated with a combination vaccine comprising antigens of the three pathogens by intramuscular administration of the vaccine only once does not per se amount to a disclosure of protection against these three pathogens by this vaccine via this administration route and scheme. Moreover, as set out above (see point 9.), Example 3 in fact discloses that no protection against Mhyo could be obtained by an intramuscular administration of the combination vaccine only once. Therefore, Example 3 of the application does not directly and unambiguously disclose a vaccine comprising in combination non-live antigens of Lawsonia intracellularis, Mhyo and PCV for use in protection against Lawsonia intracellularis, Mhyo and PCV by intramuscular administration of the vaccine only once."
  
  
• As a comment, this approach appears to merge, in a way, the requirements of sufficiency of disclosure and basis under Art. 123(2) (as is, incidentally, the case with the USA written description/enablement/possession case law).

EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

https://www.epo.org/law-practice/case-law-appeals/recent/t211589eu1.html

Main request (patent as granted) - claim 1

Amendments (Article 100(c) EPC)

7. For the purpose of assessing whether or not the claim contained subject-matter that extended beyond the content of the application and the earlier application, reference is made only to the application since the relevant disclosures in the descriptions of the application and the earlier application are identical.

8. One of the issues with respect to the amendments was whether or not the application and the earlier application disclosed the purpose recited in the claim, i.e. protection against Lawsonia intracellularis, Mhyo and Porcine circo virus (PCV), in combination with the claimed vaccine and the administration route and scheme recited in the claim (intramuscular administration of the vaccine only once).

9. Example 3 is the only passage in the application that discloses the administration of a composition of the three non-live antigens of the pathogens Lawsonia intracellularis, Mhyo and PCV as defined in the claim to subjects (pigs) intramuscularly and only once. However, as also disclosed in Example 3, after a single intramuscular injection, no Mhyo antibodies could be detected (see page 16, lines 6 to 8 and Table 5 of the application). Mhyo antibodies were only detected when a second ("booster") vaccination was given (ibid.).

10. In the application, however, the suitability of the combination vaccine for protecting against the three pathogens is linked to achieving particular Mhyo and PCV antibody titres. This is evident from page 18, lines 1 to 6 of the application, which discloses that "given the fact that the combination vaccine provided titres for Mhyo and PCV antibodies to a level comparable with the levels obtainable with available single vaccines that are adequate to combat these micro-organisms, it has been demonstrated that a combination vaccine comprising non-live Lawsonia intracellularis antigens in combination with Mhyo and PCV antigens is suitable to combat [the three pathogens]". This passage thus links the effectiveness of the combination vaccine against Mhyo to Mhyo antibody titres comparable with those achieved with prior-art vaccines. As set out in point 9. above, however, such Mhyo antibody titres were only obtained when the vaccine was administered twice (see Table 5 of the application).

11. Thus, the information conveyed to the skilled person by Example 3 of the application is that the claimed vaccine does not confer protection against Mhyo when administered intramuscularly only once, yet the contrary is claimed, i.e. that it does confer such protection (see section I.). The claimed subject-matter hence relates to new technical information which is not directly and unambiguously derivable from the application.

12. The opposition division held that achieving the purpose recited in the claim was only a matter of sufficiency of disclosure, not of added subject-matter. In line with decision T 2593/11 (Reasons 3.4), it was sufficient that the inventors had "thought of" protection against Lawsonia intracellularis, Mhyo and PCV by intramuscular administration of the claimed vaccine only once. This was evident from the purpose of Example 3 described in lines 2 to 4 of page 14 of the application and from the vaccination experiment carried out for Group 2 of Example 3 (see the sentence bridging pages 14 and 15 of the application).

13. Line 2 of page 14 of the application discloses that the purpose of Example 3 was "to test" a combination vaccine comprising killed whole cells of Lawsonia intracellularis and antigens of Mhyo and PCV. However, a mere statement that a vaccine test experiment was conducted, without disclosing any results, does not amount to a disclosure of the tested vaccine for a specific therapeutic purpose. As such, lines 2 to 4 on page 14 of the application do not disclose protection against the three pathogens by the test vaccine. The same is true for the sentence that bridges pages 14 and 15 of the application. This sentence merely describes that "Group 2 was vaccinated intramuscularly once with 2 ml combi vaccine at 25 days of age" but does not disclose any results of the vaccination. Hence it also fails to provide a direct and unambiguous disclosure of effective protection against the three pathogens recited in the claim by the claimed vaccine.

14. The board considers that this conclusion is in line with the established case law on novelty of second medical use claims. By way of example, mere statements that a particular therapy is being explored do not amount to a novelty-destroying disclosure of a second medical use claim which includes the achievement of this therapy as a technical feature (T 1859/08, Reasons 13), and a document that describes the administration of a compound to diseased subjects but neither explicitly nor implicitly discloses an effective treatment of the disease by this compound does not directly and unambiguously disclose this treatment (T 239/16, Reasons 5.2 and 5.3). Although this case law is on novelty and not on added subject-matter, the concept of disclosure must be the same for the purposes of Articles 54 and 123 EPC (G 2/10, OJ EPO 2012, 376, Reasons 4.6, citing G 1/03, OJ EPO 2004, 413, Reasons 2.2.2).

15. In line with this case law, the disclosure in the application that pigs were vaccinated with a combination vaccine comprising antigens of the three pathogens by intramuscular administration of the vaccine only once does not per se amount to a disclosure of protection against these three pathogens by this vaccine via this administration route and scheme. Moreover, as set out above (see point 9.), Example 3 in fact discloses that no protection against Mhyo could be obtained by an intramuscular administration of the combination vaccine only once. Therefore, Example 3 of the application does not directly and unambiguously disclose a vaccine comprising in combination non-live antigens of Lawsonia intracellularis, Mhyo and PCV for use in protection against Lawsonia intracellularis, Mhyo and PCV by intramuscular administration of the vaccine only once.