Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft

In the case of Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft, the primary dispute concerned the patentability of certain pharmaceutical formulations. The Federal Court was tasked with determining whether the alleged invention lacked an inventive step and if it would have been obvious to a hypothetical skilled addressee at the priority date. Additionally, the court considered the admissibility of experimental proof of facts under Federal Court Rules 2011 (Cth) r 34.50, particularly whether the manufacture of tablets for dissolution testing experiments constituted part of the experimental proof of fact. The case also involved an application for leave to appeal against an interlocutory decision on the admissibility of evidence, raising issues regarding the timeliness of the application and the connection between the interlocutory decision and the final orders.

The court addressed several legal issues, including whether the hypothetical skilled addressee of the patent would have undertaken the steps in the patent as a matter of routine, and if so, whether they would have expected to successfully produce the invention or some other useful result. The court also considered whether the expectation of the hypothetical skilled addressee was a necessary element of the obviousness test and whether the test was of universal application. Furthermore, the court examined whether the manufacture of tablets for dissolution testing experiments was akin to the manufacture of standard products used in the course of an experiment, and thus subject to the directions under r 34.50. Lastly, the court deliberated on the timeliness of the application for leave to appeal against the interlocutory decision, considering whether it was made out of time and if the interlocutory decision was sufficiently connected with the final orders.

The court found that the hypothetical skilled addressee would not have undertaken the steps in the patent as a matter of routine, and thus the invention was not obvious. The court concluded that the expectation of the hypothetical skilled addressee was not a necessary element of the obviousness test and that the test was not of universal application. Regarding the admissibility of experimental proof of facts, the court determined that the manufacture of tablets for dissolution testing experiments was not part of the experimental proof of fact, as it did not constitute the manufacture of standard products used in the course of an experiment. The court also found that the application for leave to appeal was made out of time and that the interlocutory decision was not sufficiently connected with the final orders. Consequently, the appeal was dismissed.

The final orders of the court granted leave to appeal in terms of the Amended Draft Notice of Appeal dated "2013", dismissed the appeal, and ordered the appellants to pay the respondents’ costs of the application for leave to appeal and of the appeal. The court also dismissed the Application for an extension of time and leave to appeal dated 4 June 2013 and 7 June 2013, with no order as to costs. Entry of orders was dealt with in Rule 39.32 of the Federal Court Rules 2011.