Albany Molecular Research Inc v Arrow Pharmaceuticals Pty Ltd

IN THE FEDERAL COURT OF AUSTRALIA VICTORIA DISTRICT REGISTRY GENERAL DIVISION VID 883 of 2007

AND: ARROW PHARMACEUTICALS PTY LTD (ACN 003 144 170)

SIGMA PHARMACEUTICALS (AUSTRALIA) PTY LTD (ACN 004 118 594)

JUDGE: JESSUP J DATE: 23 MARCH 2011 PLACE: MELBOURNE

REASONS FOR JUDGMENT 1 On 18 February 2011, I gave judgment in this proceeding: Albany Molecular Research Inc v Alphapharm Pty Ltd [2011] FCA 120. The parties have since filed written submissions with respect to the orders that should be made to give effect to my reasons published on that day. The parties have requested that I make final orders in the proceeding, save as to costs, and that they then have a final opportunity to advance submissions as to costs in the light of those orders. 2 The parties are agreed that the application be dismissed, that claims 1, 6, 7, 8, 9 and 10 of the patent in suit be declared invalid and revoked, and that the cross claim otherwise be dismissed. They are agreed that, subject to AMR offering certain undertakings, there should be a stay of the order revoking those claims for 28 days to give AMR the opportunity to file an appeal, should that be its preferred course. 3 The respondents press for a declaration of invalidity to be made in relation to all claims in the patent in suit, and for all claims to be revoked. They seek this wider form of relief on their cross claim by reason of their success on the false suggestion point under s 138(3)(d) of the Patents Act 1990 (Cth), which is the point which I reserved for further consideration in para 223 of my reasons of 18 February 2011. AMR resists that wider form of relief, submitting that my reasons dealt only with the claims which were otherwise controversial in the proceeding, and that no finding under s 138(3)(d) was made, or was possible, in relation to the other claims. The respondents submitted that the Examiner's letter of 20 February 1997, to which I referred in para 208 of my reasons, was concerned with all of the claims which ultimately found their way into the patent as granted, and that it was across that wide front that the then applicant's letter of 20 June 1997 satisfied the Examiner's concerns, and, inferentially, led to the grant of the patent. 4 In my view, AMR has the better of the argument on this point. In his letter of 20 February 1997, the Examiner cited Carr 129. That prior art disclosed a range of compounds in which a hydroxyl group was substituted on the first carbon attached at the para position of the dimethylated benzene ring. In claims 2, 4 and 5 of the patent in suit, a ketone is substituted at the para position. The evidence of Prof Wild, and the work of Mr Gugger, on which I relied to conclude that it was possible to achieve effective 100% para-substituted purity after the completion of Example 3 in Carr 129, were not, at least to the extent dealt with in my reasons of 18 February 2011, concerned with this ketone. Indeed, counsel for the respondents assured me that they were not contesting the ketone form of the compound which corresponds to fexofenadine. It is true that that assurance may have been intended to relate to so much of the respondents' case as related to novelty and inventive step, but similarly there was nothing in counsel's submissions otherwise which made it clear that their clients' case under s 138(3)(d) was intended to extend to claims in the patent in suit which could not define fexofenadine. 5 That leaves Claim 3 of the patent in suit, which involves a hydroxyl group on the para-substituted carbon. It does not cover fexofenadine because R1 is hydrogen. As Prof Wild's evidence makes clear, R1 is a hydroxyl group at the end of Example 5B in Carr 129 and subsequently. The steps which Mr Gugger took to proceed from 96.39% para-substituted purity at the end of Example 5B to 100% purity at the end of Example 3 do not, therefore, relate to a compound in the form given by Claim 3 of the patent in suit. That may be a distinction without a difference, of course, but so to conclude would involve my overreaching the scientific evidence given in the case. That evidence was important to my conclusion that the suggestion in the letter of 20 June 1997 was false. I do not think that I am in any position to find that that suggestion was indeed false save with respect to compounds that had the specific characteristics revealed in Prof Wild's evidence. 6 For the reasons given above I shall confine my orders under s 138(3)(d) to claims 1, 6, 7, 8, 9 and 10 of the patent in suit. I certify that the preceding six (6) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Jessup.