Aktiebolaget Hassle v Alphapharm Pty Ltd

The High Court of Australia heard an appeal from a decision of the Full Court of the Federal Court concerning the validity of a patent for an oral pharmaceutical preparation. The patent holder, Aktiebolaget Hassle (Astra), appealed a revocation order made by Lehane J and affirmed by the Full Court, which found the invention to be obvious and lacking an inventive step. Alphapharm Pty Ltd was the respondent.

The central legal issue before the High Court was whether the primary judge had erred in law in concluding that the patent was invalid for obviousness. This required the court to consider the principles of patentability, specifically the inventive step requirement, and how they applied to a pharmaceutical formulation arrived at after experimental research. The court also had to determine the relevance of publications discoverable by a routine literature search but not part of the common general knowledge in Australia at the priority date, and whether an invention is obvious if a skilled worker would have considered it "worthwhile to try" its constituent elements.

The High Court's reasoning focused on the primary judge's assessment of the evidence regarding the perceived incompatibility between the enteric coat and the acid-labile omeprazole. The primary judge had noted that no evidence was presented of prior encounters with such a problem, nor of any existing products where this issue had been addressed. Furthermore, evidence indicated that other acid-labile drugs had been successfully enteric coated, and that experts would have initially attempted a direct enteric coating. The court considered the significant experimental work undertaken by Astra, including extensive human trials over several years, and the fact that even an expert tasked with developing the formulation did not arrive at the claimed invention without considerable effort and multiple reports. This extensive research and the lack of prior art suggesting the problem or its solution were key factors in the court's assessment of obviousness.

The High Court allowed the appeal, setting aside the orders of the Full Court of the Federal Court. The matter was remitted to the Full Court for determination of any remaining grounds of appeal, and the revocation order was further stayed. Costs were to be in the discretion of the Full Court.