T 1214/18 - Disclosure of a pharmaceutical compound

Key points

• Claim 1 is directed to a compound and is based on claim 26 of the application as filed.
• The opponent argues, under Article 123(2), that "formula I in claim 1 as filed comprised an uncountable number of compounds. By contrast, with respect to this formula I, claims 1 and 2 of the main request were limited to the single specific compound cobicistat. "
• According to the opponent:  "This put the respondent [patentee] in the unforeseeable position of arguing that cobicistat had a technical effect over the other compounds disclosed in the application as filed which were in accordance with formula I. However, it was not disclosed that this technical effect was better with cobicistat than with other compounds. This gave the respondent [patentee] an unwarranted advantage."
• The Board:  "This [argument] is not convincing. For claimed subject-matter to meet the requirements of Article 123(2) EPC, it is crucial whether or not it is directly and unambiguously disclosed in the application as filed ("gold standard"). This is the case, see above. Only if subject-matter which is not directly and unambiguously disclosed were to be considered allowable could this lead to an unwarranted advantage for the respondent. Nothing other was decided in decision T 948/02 (point 2.4.1 of the Reasons), on which appellant 2 relied in support of its argument."
• The claim meets Art. 123(2) EPC.
• The Board, under inventive step: "Effects linked to the distinguishing features ... In contrast to [the prior art compound] ritonavir, cobicistat [the claimed compound] has no HIV-1 protease inhibitory activity (D6: table 1; D22: point 2.3.7 on page 24 and paragraph "Antiviral activity" on page 43; patent: paragraph [0511])." D6 and D22 seem post-filed evidence. 
• Plausibility is not discussed in the decision. 

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/t181214eu1.html

2. Amendments (Article 123(2) EPC)

2.1 Claim 1 of the main request is based on claim 26 of the application as filed.

Claim 2 of the main request is based e.g. on the combination of claims 1 and 51 as filed. Claim 51 as filed discloses a pharmaceutical composition comprising a compound of claim 1 as filed, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier or excipient. Claim 1 as filed, to which claim 51 as filed refers, discloses a compound of a broadly defined formula I. In the example section of the application as filed, example S, i.e. cobicistat, is mentioned as one of several compounds in accordance with this formula I. Thus, with regard to the combination of claims 1 and 51 as filed, the subject-matter of claim 2 of the main request is the result of a single selection of cobicistat from the application as filed. Such a single selection does not generate new subject-matter.

2.2 According to appellant 2, formula I in claim 1 as filed comprised an uncountable number of compounds. By contrast, with respect to this formula I, claims 1 and 2 of the main request were limited to the single specific compound cobicistat. This put the respondent in the unforeseeable position of arguing that cobicistat had a technical effect over the other compounds disclosed in the application as filed which were in accordance with formula I. However, it was not disclosed that this technical effect was better with cobicistat than with other compounds. This gave the respondent an unwarranted advantage.

This is not convincing. For claimed subject-matter to meet the requirements of Article 123(2) EPC, it is crucial whether or not it is directly and unambiguously disclosed in the application as filed ("gold standard"). This is the case, see above. Only if subject-matter which is not directly and unambiguously disclosed were to be considered allowable could this lead to an unwarranted advantage for the respondent. Nothing other was decided in decision T 948/02 (point 2.4.1 of the Reasons), on which appellant 2 relied in support of its argument.

2.3 Thus claims 1 and 2 of the main request meet the requirements of Article 123(2) EPC.