FEDERAL COURT OF AUSTRALIA
Bayer Pharma Aktiengesellschaft v Generic Health Pty Ltd [2017] FCA 250
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- Case
- [2017] FCA 250
- Decision Date
CaseChat Overview and Summary
In its judgment, the court found that Bayer had sufficiently demonstrated that its original patent specification met the statutory requirements of good faith and reasonable skill and knowledge. The court also held that each sale of Generic Health’s product was a lost sale of Bayer’s product, justifying the calculation of damages based on this premise. Furthermore, the court rejected Generic Health’s argument that Bayer’s standard costings should be discounted for risk, affirming that Bayer’s approach to calculating lost profits was appropriate. The court concluded that Bayer was entitled to damages of $25,751,336 plus interest, as calculated by Bayer.
In light of the findings, the court ordered the parties to confer and submit agreed short minutes of order within 14 days, including any directions for the issue of costs.
Orders
Orders of the court
1. The parties confer and submit agreed short minutes of order reflecting these reasons for judgment within 14 days, including directions if the issue of costs is not agreed.
Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.
Background
Background to the litigation
Full text does not contain this section.
Evidence
Evidence Before The Court
Decision
Reasons for decision
Ratio Decidendi
Legal Principle Established
Documents relating to the preparation of the PCT application: Dr Broesamle explained that in late 1998 the then Head of Patents at Schering AG directed him and Dr Ulrich to engage P&V to obtain patent protection for the Yasmin formulation of DRSP and EE. Dr Broesamle believed that P&V had particular expertise in the preparation of pharmaceutical formulation patents and he had confidence in the quality and soundness of P&V’s work, his experience always having been that P&V complete their work with a high level of skill and care and in accordance with his instructions. The PCT application (on which the Australian patent was based) was based on two priority documents, being US and European patent applications which were filed on 31 August 1999. To prepare those priority documents, Dr Broesamle instructed P&V, but others from Schering AG were also involved in the process including Dr Ulrich and three of the named inventors, Mr Hilmann, Dr Heil, and Dr Lipp. The PCT application based on the priority documents was filed on 31 August 2000. In accordance with its instructions P&V then instructed Australian patent attorneys (FB Rice & Co initially and then Davies Collison Cave) to obtain patent protection in Australia. The Australian application was filed on 14 March 2002 and granted on 30 June 2005 and was based on the PCT application, subject to an amendment made in 2004, before the grant of the patent, to ensure consistency with the European Patent application then also being prosecuted based on the PCT application. The amendment is relevant to the dissolution test issue which is dealt with separately below. The first document which I infer is of direct relevance to the preparation of the priority documents and thus the PCT application is dated August 1998. It is a table identifying five reports in respect of different formulations of DRSP and EE including 0.5, 1, 2, and 3mg of DRSP. From the fact that the table identifies the status and availability of each report, I infer that Schering AG was collating information it considered of obvious relevance to the patents for DRSP for which it subsequently applied. I infer that Schering AG was at least aware of all of the information in these five reports when it gave instructions to P&V for the framing of the specifications for the priority documents and PCT application. Another document headed “Open questions for patent application regarding DRSP” contains the following:1)DRSP: EE (ratio) contraceptive[Dr Hethecker]DRSP: EE (ratio) hormonal disorders[Dr Schurmann]- therapeutic effect (optimal)- side effects (minimal) From this I infer that Schering AG was considering the ratio of, relevantly, DRSP to EE to achieve the optimal therapeutic effect and minimal side effects for contraceptive purposes (and separately for hormonal disorders). I infer that they were doing so for the purposes of seeking patent protection for the Yasmin formulation given the timing and the content of the document. There is a typed document dated 13 November 1998 which appears to have been prepared by Mr Hilmann and Dr Heil, two of the three named inventors. It refers to an active ingredient of drospirenone in the range of 0.5 to 7.0mg, with a handwritten note beside this stating “lower limit 2mg for ovulation inh” which must mean 2mg as the lower limit for ovulation inhibition (a figure to be expected once the reports, discussed below, are considered). I infer from this that Schering AG was considering the dosage range and held the view that 2mg was the lower limit for ovulation inhibition.