Arrow Pharmaceuticals Limited v Merck & Co Inc.

'7. The old claims include various "subsets" of different types of claims including "method of treatment" claims, "kit" claims, and claims of the "when used" format. In the proposed amended claims ("the new claims") some of these "subsets" have been deleted in their entirety as indicated below: (a) Old claims 1 to 44 directed to a "method of inhibiting bone resorption"; (b) All old claims of the "when used" format (e.g. old claim 2); and (c) All kit claims and "use of a kit" claims, old claims 129 to 220; 8. The pharmaceutical composition/oral pharmaceutical composition claims which originally numbered from old claim 221 to and including old claim 346 (i.e. 125 claims) have been reduced to new claims 27 to 63 (i.e. 26 claims). 9. Old claims 45 to 86 were directed to a "method for treating osteoporosis" (including claims to the use of a bisphosphonate for the manufacture of a unit dose for treating osteoporosis). Old claims 87 to 128 were directed to "a method for preventing osteoporosis" (including claims to the use of a bisphosphonate for the manufacture of a unit dose for treating or preventing osteoporosis). These old claims have been combined into a single group of claims (new claims 1 to 26) directed to a "method of treating or preventing osteoporosis" (including claims to the use of a bisphosphonate for the manufacture of a unit dose for treating or preventing osteoporosis). This group of claims is limited to treating or preventing osteoporosis by administering a bisphosphonate. The combination of a bisphosphonate with a histamine (H2) receptor blocker or a proton pump inhibitor, which was present in the old claims, has also been deleted from the new claims. 10. As a consequence of the foregoing, I inserted new claims 5, 15, 16, 18, 19, 30, 44 and 45.' 7 I agree with both counsel and Ms Irani that the requirements of s 102 are met. However, this is not conclusive in favour of the application, since the court retains a general discretion to refuse an amendment, even though it is allowable under s 102: Wimmera at 39,789. There, Sundberg J cited a passage from the reasons for judgment of Aldous J in Smith Kline & French Laboratories Ltd v Evans Medical Ltd [1989] FSR 561 at 569, which listed a number of principles relevant to the exercise of judicial discretion: 'First, the onus to establish that amendment should be allowed is upon the patentee and full disclosure must be made of all relevant matters. If there is a failure to disclose all the relevant matters, amendment will be refused. Secondly, amendment will be allowed provided the amendments are permitted under the Act and no circumstances arise which would lead the court to refuse the amendment. Thirdly, it is in the public interest that amendment is sought promptly. Thus in cases where a patentee delays for an unreasonable period before seeking amendment, it will not be allowed unless the patentee shows reasonable grounds for his delay. Such includes cases where a patentee believed that amendment was not necessary and had reasonable grounds for that belief. Fourthly, a patentee who seeks to obtain an unfair advantage from a patent, which he knows or should have known should be amended, will not be allowed to amend. Such a case is where a patentee threatens an infringer with his unamended patent after he knows or should have known of the need to amend. Fifthly, the court is concerned with the conduct of the patentee and not with the merit of the invention.' 8 Justice Sundberg in Wimmera observed that the above passage was cited with approval by the Court of Appeal in England in Hsiung's Patent [1992] RPC 497 at 522, and subsequently by Gummow J in Rescare Ltd v Anaesthetic Supplies Pty Ltd (Federal Court of Australia, 4 March 1993, unreported). 9 Counsel for the respondent submitted moreover that where the amendment sought involves the deletion of claims, the amendment should only be refused in exceptional circumstances. As was stated by Heerey J in Eli Lilly and Company v Pfizer Research and Development Company NV/SA [2003] FCA 988 at [20]: 'One obvious reason for this approach is that there is a public interest in the validity of a patent, extending beyond the patentee and those currently seeking revocation. The existence of patent claims which are in truth invalid, and which the patentee does not seek to propound, may inhibit persons from engaging in lawful and productive economic activity, with resultant disadvantage to the public by loss of competition and innovation.' 10 I do not consider that the circumstances of this case warrant any withholding of a favourable exercise of the judicial discretion. As was submitted by counsel for Merck, this is perhaps the only application to amend Letters Patent which has been unopposed by any of the Commissioner, or another party to proceedings on foot, or an interested member of the public. There are no exceptional circumstances, or disadvantage to the public, here involved by any loss of competition and innovation that would justify refusing the amendments sought. The application to amend was promptly made after the particulars of invalidity were amended by Arrow for a second time on 25 July 2003, and before any evidence was filed in these proceedings. Further, I agree that the amendments will reduce the number and scope of some of Merck's claims, and tend to render these already complex proceedings more manageable for both parties and the Court, and thus more readily susceptible to resolution.

11 The relief sought by Merck by its notice of motion of 12 November 2003 should be granted. I certify that the preceding eleven (11) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Conti.