The recent Federal Court decision in ViiV Healthcare Company v Gilead Sciences Pty Limited  FCA 594 has provided greater clarity as to the function of position statements in patent litigation proceedings within Australia.
Case management in Australian patent litigation
Australia’s Federal Court is the primary venue for patent infringement and revocation proceedings in Australia. Patent litigation often gives rise to complex scientific or technical issues. The Court’s approach to patent litigation case management is to ensure proceedings are conducted efficiently and remain unobscured by;
- irrelevant or academic issues; and/or
- unnecessary evidence with respect to matters that are (or should be) agreed and which cannot be expected to influence the resolution of the real issues in dispute.
Section 6 of the Federal Court Intellectual Property Practice Note (IP-1) provides several mechanisms the Court can utilise to achieve these goals. This includes agreed primers, glossaries of key terms, and even the appointment of a Court expert or assessor.
Additionally, the Court may require parties alleging patent infringement, to provide a “Position Statement on Infringement”. A position statement outlines the facts and matters that are being relied upon by reference to the specific integers of the claims alleged to have been infringed. Similarly, defending parties are usually required to forward a statement in response. In this response, defending parties must articulate why it believes it does not infringe; it is typically not enough to merely assert that the applicant is ‘put to proof’.
Aside from helping identify key issues in the dispute, the exchange of position statements early in proceedings can also assist outlining the proposed construction of the integer(s) in the claims.
ViiV Healthcare brought infringement proceedings against Gilead Sciences concerning Gilead’s HIV combination product marketed as Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide). Justice Beach ordered ViiV Healthcare to file an amended position statement on infringement. Gilead subsequently filed an interlocutory application claiming that the amended position statement submitted by ViiV was inadequate. Justice Beach disagreed, finding that ViiV Healthcare’s amended position statement performed its intended function. Gilead’s application was subsequently dismissed - with costs. Before ruling, Justice Beach made a number of general observations about position statements on infringement, including the following (at -):
- There needs to be a clear identification of the precise features thereof which are said to correspond with one or more integers of the asserted claims(s) of the patent-in-suit.
- Diagrams or other pictorial representations should be used where possible.
- The foundational construction being used be the applicant concerning the relevant integer(s) and the asserted claim(s) must be clear from the position statement, whether expressed or necessarily implied. This does not mean however that the applicant must justify any such construction.
- To the extent possible, the respondent’s position statement in response should mirror the applicant’s format.
- If the allegedly infringing product, process or method has been incorrectly described by the applicant, this should be pointed out and it should be correctly and fully described by the respondent.
- The respondent should explain where it takes issue with the applicant’s identification of features which are said to correspond with one or more integers of the asserted claim(s).
- If the identification is erroneous because the product, process or method has been incorrectly described, the respondent should say so.
- If the identification is erroneous because the respondent is advancing a different construction of the relevant integer(s) or claim(s) to that advanced by the applicant, this should be stated and the different construction identified.
Justice Beach stated, among other things, that ViiV Healthcare was not required to define the outer parameters of a key claim integer, but only to make it clear as to the construction being relied on when alleging infringement by Gilead’s product.
Despite Gilead’s request for a detailed position on issues that would be addressed in the proceedings, Justice Beach’s decision makes clear that the position statement was not the appropriate place to do so.
Position statements are to be used in identifying the proceedings’ critical issues and, critically, which issues would likely not be in play. Details provided beyond this, were getting into the substance of the matter; a discussion which should be reserved for the trial itself.
For further information relevant to this case, please speak with your existing Griffith Hack relationship contact.