Lipitor – Enantiomer Patents

Ranbaxy Australia Pty Ltd (ACN 110 781 826) v Warner-Lambert Company LLC [2008] FCAFC 82: http://www.austlii.edu.au/cgi-bin/sinodisp/au/cases/cth/FCAFC/2008/82.html?query=^ranbaxy

The Full Court today handed down the Australian decision relating to Lipitor – a pharmaceutical drug with the global sales of approximately 10 billion, annually.

In finding that Ranbaxy’s product infringed Warner-Lambert’s Broader Patent, the Full Court held the Enantiomer Patent invalid on false suggestion grounds. In light of this holding, a ‘final view’ was not given with respect to the grounds of utility and manner of manufacture.

With respect to false suggestion claims, the Full Court expressed the relevant principles at [82]-[83]:

[82] If a representation that was false or misleading materially contributed to the Commissioner’s decision to grant a patent, even if other circumstances or causes also played a part in the making of that decision, it may be said that the patent was obtained by a false suggestion or misrepresentation (or on a false suggestion or representation, to use the language of the 1952 Act). It is sufficient if the representation materially contributed to the Commissioner’s decision to grant the patent or was a material, inducing factor, which led to the grant. However, it is not necessary to establish that the representation was material in the sense that, without it, the patent would not have proceeded to grant (Pfizer Overseas Pharmaceuticals v Ely Lilly & Co (2005) 225 ALR 416 at 495). It is not necessary to show that, but for the suggestion or representation, no grant would have been made (Prestige Group (Australia) Pty Limited v Dart Industries Inc (1990) 95 ALR 533 at 537-538).

[83] …In the absence of explicit evidence that the Commissioner, or the Commissioner’s delegate, was in fact misled, it may nevertheless be inferred that a representation in fact contributed to the decision to grant a patent, if the representation was objectively likely to contribute to such a decision and the patent was in fact granted (see Synthetic Turf Development Pty Limited v Sports Technology International Pty Limited [2004] FCA 1179 at [2], and WM Wrigley Jr Co v Cadbury Schweppes Pty Limited (2005) 66 IPR 298 at 321).

At [140], the Full Court held:

[140] The Enantiomer Specification cites the Broader Patent as prior art…. The Enantiomer Specification asserts a surprising result. It asserts, by statement and by supporting data, that the enantiomer has an unexpected and surprising level of activity of more than twice that of the racemate. That was a false representation. When the examiner questioned the patentability of a claim to an enantiomer where the racemate had been prior published, the representation was repeated and affirmed. The statements in the patent attorneys’ letter were made in response to the examiner’s objection, which if not overcome, would have led to rejection of the patent application. The statements sought to overcome the objection. Warner-Lambert succeeded in overcoming the objection based on want of novelty and the Enantiomer Patent was granted. The inference is clearly open, and should be drawn, that the grant of the Enantiomer Patent was made because the examiner accepted the truth of the representation. It follows that the Enantiomer Patent was obtained by false suggestion or misrepresentation. That is the conclusion reached by the primary judge.

Reference to selection patent principles were also examined in the false suggestion analysis at [105].