T 0421/14 - Post hoc inventive

 Key points

• Claim 1 is directed to "a sustained release aminopyridine composition for increasing the walking speed of a patient with multiple sclerosis, said composition to be administered as a stable dose treatment twice daily in a therapeutic dose of 10 milligrams of aminopyridine."
• This claim is considered to be insufficiently disclosed, but the claim restricted to  4-aminopyridine is considered to be sufficiently disclosed.
• The Board does not hold some documents filed with the SoG inadmissible under "Article 12(4), first clause, RPBA [2007]". As a comment, is it hence safe to say that the RPBA provisions have ‘clauses’.
  
  
• There is a question of whether some conference papers were public or not. The Board finds that the stricter standard of proof "beyond all reasonable doubt" does not apply because "C30 and C31 alleged to be public prior disclosures are the patent proprietor's (respondent's) own documents."
  
  
• About inventive step  based on post-hoc statistical analysis in the medical field
  “C27 reports on the [patentee's] MS-F201 trial, which was designed as a preliminary study with 36 subjects to explore the safety and efficacy of escalating doses of sustained-release 4-aminopyridine from 10 mg bid to 40 mg bid. C27 […] reports that the 4-amino-pyridine-treated group as a whole showed improvement in walking speed, including statistically significant improvement in the lower dosage range from 10 mg bid to 25 mg bid; however, no separate individual analysis is provided as to how each dose of drug affected walking speed from baseline compared with placebo.
• "the board is satisfied that the technical effect of applying the 10 mg bid dosage regime is acceptable efficacy combined with a favourable safety profile"
• The  Board: “The board considers that, on the basis of the information presented in C27, it would have appeared realistic to the skilled person to investigate the dosages of 10, 15 and 20 mg bid, with the primary endpoint being an improvement in average walking speed, since this was known to have been recommended by a panel of expert MS neurologists and by a relevant regulatory authority (FDA) and these dosages had been found to be of interest in a preliminary study”
• " it actually turned out to be exceptionally difficult in this case to provide the required proof of efficacy - as shown in Example 5 of the patent which presents data obtained in the MS-F202 study"
• "Failure of a phase 2 trial such as MS-F202 would not have caused the person skilled in the art to simply set up, in spite of this result, a larger-scale trial with the same outcome variables, and nor is this suggested in C27. "
• "Only by developing, post hoc, a new statistical technique […] was the [patentee] able to prove that the 10 mg bid dosage regime is effective at increasing walking speed."
• This is basically the reason why the Board acknowledges inventive step.
  
  
• Regarding novelty of 2nd medical use claims: Since the therapeutic efficacy of sustained-release 4-aminopyridine administered at 10 mg bid is a functional technical feature of claims 1 and 5 of the main request (see point 3.3 above), this feature must be taken into account in the assessment of novelty and inventive step. This means that a prior-art disclosure can only be novelty-destroying if it discloses this therapeutic efficacy. It is not sufficient in this case that 4-aminopyridine may have been known to have a therapeutic benefit for improving walking speed and that a prior-art document discloses its administration as a sustained-release dosage form at 10 mg bid in a clinical study. The issue is rather whether the therapeutic efficacy of the 10 mg bid dosage is specifically disclosed in the prior art.

EPO T 0421/14 -  https://www.epo.org/law-practice/case-law-appeals/recent/t140421eu1.html

Decision text omitted.

Related case T 0799/16