Date: 8 February 2024
Court: Australian Patent Office
Judge: L. F. McCaffery
Date:
Court:
Judge:
8 February 2024
Australian Patent Office
L. F. McCaffery
Zoetis Services LLC opposed two Australian patent applications (one standard and one innovation patent application) in the name of Boehringer Ingelheim Vetmedica GmbH. The applications claim a method of treating heart failure due to asymptomatic myxomatous mitral valve disease (MMVD) in a patient (including a dog) by administering pimobendan (also known as Vetmedin®).
A key question for the delegate on inventive/innovative step was whether information contained in a press release reporting interim clinical trial results of the use of pimobendan to treat MMVD in dogs was common general knowledge (CGK) amongst veterinary cardiologists. The delegate found that, while the existence of the clinical trial itself may well have been widely known amongst veterinary cardiologists, key information in the press release reporting the interim clinical trial results (and other announcements) was not CGK amongst veterinary cardiologists at the priority date of the applications. Furthermore, evidence before the delegate showed that some earlier studies had suggested a potentially detrimental effect of the use of pimobendan in dogs at the early stages of MMVD, thus pointing away from the hypothesis being tested in the clinical trial.
The delegate held that, to constitute CGK, information must be generally assimilated and accepted without question by persons skilled in the art. In this case, the evidence indicated that, while the existence of the clinical trial (and even the hypothesis that was being tested) formed part of the public knowledge of veterinary cardiologists, the technical information relating to the clinical trial (for example at what stage pimobendan can be safely administered to dogs with MMVD) had been more contentious, and less well-accepted, in the art.
The delegate, however, did go on to find the claims of the standard application obvious in light of the CGK of veterinary cardiologists when combined with the information in the press release. By contrast, the claims of the innovation patent were found to contain an innovative step on the basis that reducing the size of an already pathologically enlarged heart clearly makes a substantial technical or functional contribution and is a significant aspect of the operation of the invention over the prior art disclosures.
Zoetis was unsuccessful on all other grounds of opposition to the standard application, including lack of novelty, prior use, support, clarity, sufficiency of the disclosure, utility and manner of manufacture. However, the delegate saw potentially patentable subject matter in the standard application and provided Boehringer with an opportunity to amend its claims.
The opposition to the innovation patent application failed on all grounds.
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