The recent Australia Patent Office decision of Zoetis Services LLC v Boehringer Ingelheim Vetmedica GmbH [2024] APO 4 dated 8th February 2024 has (on one aspect) highlighted the challenge for clinical researchers and innovators when reporting interim clinical trial results by way of press releases.
The Australian Patent Office held that the press release reporting the interim clinical trial results known as the EPIC Press Release, (“EPIC” being an acronym for Evaluation of Pimobendan In dogs with Cardiomegaly caused by preclinical mitral valve disease) dated 13th March 2015, whilst not novelty destroying, was relevant prior art for the purposes of inventive step. The EPIC Press Release when combined with the common general knowledge before the priority date of the claims (6th April 2016), invalidated claim 1 for being obvious.
Claim 1 of the ‘601 Application (AU2017245601) recites the following:
A method for treating a patient with asymptomatic (occult, preclinical) myxomatous mitral valve disease (MMVD), the method comprising administering to the patient an effective amount of a pharmaceutical composition comprising pimobendan so as to effect a reduction of the heart size of an already pathologically enlarged heart of the patient in combination with delaying the onset of clinical symptoms of heart failure in the patient.
It was noted that there was no teaching by the EPIC Press Release of the specific dosage regime of the pimobendan (although not required by claim 1, was required in order to enable the invention). Further, there was no teaching by the EPIC Press Release of the recited feature in claim 1 being the “reduction of the heart size of an already pathologically enlarged heart”.
Evidence showed that, before the priority date, pimobendan was prescribed in defined doses for the treatment of Stage C MMVD, but there was doubt whether that dose would be suitable for Stage B2 MMVD covered by the scope of claim 1.
The Australian Patent Office held that the skilled person would be led to try the invention with a reasonable expectation of success, as it would have been a matter of routine to determine the specific dosage regime of pimobendan required by claim 1.
Further, whilst the EPIC Press Release did not teach the recited feature of the “reduction of the heart size of an already pathologically enlarged heart”, this bonus effect would have been inevitable based upon the evidence, when the skilled person would have administered the specific dosage regime of pimobendan as a matter of routine. Therefore, such recited feature was obvious, thereby lacking an inventive step.
The take-home message for innovators and clinical researchers is that press releases from interim clinical trials, whilst not novelty-destroying, can be problematic prior art for inventive step.