F. Hoffman-La Roche AG v New England Biolabs Inc

Judgment (8 paragraphs)

[1]

REASONS FOR JUDGMENT 1 F. Hoffmann-La Roche AG ("Hoffman-La Roche") is the assignee of an application for a patent which has been assigned acceptance number 632857. New England Biolabs Inc ("NEB") opposes the grant of a patent on that application. I have before me proceedings involving appeals relating to the rejection of certain claims and the acceptance of other claims in the specification contained in the application. The matter is fixed for hearing before me for eight weeks beginning on 20 March 2000. 2 NEB has applied for several orders by notice of motion. Two of the orders are, at present, contentious. The third is to be deferred for the time being. INDEPENDENT ASSESSOR UNDER SECTION 217 3 The first contentious order is in the following terms: "An assessor be appointed under section 217 of the Patents Act 1990 to assist the Court in the hearing and trial or determination of these proceedings." 4 Section 217 of the Patents Act 1990 (Cth) ("the Act") is in the following terms: "A prescribed court may, if it thinks fit, call in the aid of an assessor to assist it in the hearing and trial or determination of any proceedings under this Act." The Federal Court is a "prescribed court" within the meaning of section 217. 5 The specification describes the invention as relating to "Purified thermostable enzyme". Claims 1 and 75 are in the following terms: "1. A purified thermostable DNA polymerase isolated from a Thermus species which catalyzes combination of nucleoside triphosphates to form a nucleic acid strand complementary to a nucleic acid template strand, said polymerase having a molecular weight of 86,000 to 95,000 daltons as compared to phosphorylase B by SDS-PAGE. 75. A method for purifying a thermostable polymerase which comprises treating an aqueous mixture containing said thermostable polymerase with a hydrophobic interaction support under conditions which promote hydrophobic interactions and eluting said thermostable polymerase from said support with a solvent which attenuates hydrophobic interactions." 6 I confess that, at the present time, I do not understand much of that material. However, it is expected that, by the end of the hearing, I will have some understanding of the subject matter of the patent application. NEB contends that it would be desirable, having regard to the technical nature of that subject matter, that the court appoint an assessor pursuant to section 217. I am not certain that section 217 contemplates a formal appointment, although that is a step which has been taken in the past - see Genetic Institute Inc v Kirin-Amgen Inc (No.2) (1997) 78 FCR 368 and Genetics Institute Inc v Kirin-Amgen Inc (No.3) (1998) 156 ALR 30 at 50-51. 7 Appointment is opposed by Hoffmann-La Roche, at least at this stage. My present view is that I do not know enough about the case or the issues to know whether I will, in fact, desire to call in the aid of an assessor to assist in the hearing and trial. Nevertheless, it seems to be common ground that, unless some arrangements are put in place reasonably quickly, it may be that there would be no suitable person available for the trial if I were to consider that it was desirable to exercise the discretion conferred by section 217. 8 An assessor for that purpose would not necessarily require the qualifications or standing that may be desirable for an expert witness who is to give evidence in the proceedings. An apt description of an assessor might be that he or she is a "human primer" whose function is to assist the court in understanding the complex scientific material that is likely to be before the court in connection with the hearing. 9 In order to preserve my option under section 217, therefore, I consider that it is appropriate that a process be put in train to ensure that, if I do feel the need to call in the aid of an assessor, there will be an assessor available who would meet with no objection from either party. Since NEB is the moving party, the appropriate course is for me to direct NEB to furnish to Hoffmann-La Roche within 14 days a list of independent persons suggested as being qualified to act as an assessor pursuant to section 217. 10 Within 14 days after receipt of the list, Hoffmann-La Roche should indicate whether any of those persons named is acceptable and, if not, to furnish an alternative list. If agreement cannot be reached as to the identity of persons who might be approached, then the parties would have leave to have the matter restored. My intention is that the parties would agree on a list of persons who should be approached. The approach should come from the Court and the parties will therefore be required to furnish to my associate, within 21 days, the proposed form of letter to be addressed to the prospective assessors:

The precise content of the letter is a matter for the parties to settle between themselves in consultation with my associate. These comments are merely intended to serve as guidelines as to what may be appropriate for inclusion in that letter. 11 Senior counsel for Hoffman-La Roche raised some concern that opportunities to contact and retain expert witnesses, which her client is still in the process of doing, may be curtailed by making approaches to persons qualified to act as independent assessors. As I have said, it may be that persons who would be best qualified to act as independent assessors would not necessarily be those who would fit into the category of expert witnesses. Nevertheless, to avoid any conflict, I propose to direct the parties to notify each other if any person on the list has been or will be approached in connection with these proceedings. I propose to fix the matter for directions later in the year by which time it may be that responses to the proposed letters will have been received. STATEMENT OF INVENTION 12 The second contentious matter raised by the notice of motion is a prayer in the following terms: "5. F. Hoffmann-La Roche AG inform or disclose to this Honourable Court on a date to be fixed, the invention(s) that it contends is/are described and claimed in the complete specification Australian Patent Application No. 632857." 13 The basis upon which such an order is sought is that it is said that the specification is of such length and complexity that it is not clear precisely what invention is claimed by Hoffmann-La Roche. Specifically, the specification contains the following: "The present invention relates to a purified thermostable enzyme. In one embodiment the enzyme is DNA polymerase purified from Thermus aquaticus, and has a molecular weight of about 86,000-95,000. In another embodiment the enzyme is produced by recombinant DNA means. The present invention also relates to a process for amplifying existing nucleic acid sequences if they are present in a test sample, and optionally detecting them if present by using a probe." 14 Under the heading "Disclosure of Invention", the specification says as follows: Accordingly, the present invention provides a purified thermostable DNA polymerase, which catalyses combination of nucleoside triphosphates to form a nucleic acid strand complementary to a nucleic acid template strand, the polymerase having a molecular weight of about 86,000-95,000 daltons, as compared to phosphorylase B by SDS-PAGE." 15 At the end of the descriptive part of the specification, a summary appears as follows: "In summary, the present invention is seen to provide a process for amplifying one or more specific nucleic acid sequences using a temperature-cycled chain reaction and a thermostable enzyme, in which reaction primer extension products are produced that and subsequently act as templates for further primer extension reactions." 16 The first claim in the specification is in the terms that I have already set out. The claim appears to be a product. On the other hand, parts of the material I have just referred to from the body of the specification suggest that the invention is a process. 17 Under section 40(1), a provisional specification must describe the invention, and under section 40(2), a complete specification must describe the invention fully, including the best method known to the applicant of performing the invention. Section 40(3), requires that the claims must be clear and succinct and be fairly based on the matter described in the specification. It may be that the conclusion to be drawn from the apparent conflict is that section 40 of the Act has not been satisfied. 18 If the criticism directed at the specification by senior counsel for NEB is justified, that may well be a reason why the objection based on section 40 will succeed. Of course, I have formed no view about that at this stage. That is a matter, no doubt, which will be raised at the hearing and decided after full argument from both parties. It is not appropriate for me to attempt to form any view at this stage. 19 Senior counsel for NEB indicated that the concern that prompted the prayer for relief with which I am now dealing, was that there may be a significant waste of resources by reason of some misapprehension on the part of NEB as to the nature of the invention. Senior counsel for Hoffmann-La Roche, on the other hand, has indicated that it is not appropriate at this stage for Hoffmann-La Roche to be required to rely on a statement of the invention other than is contained in the specification itself. 20 If there is some doubt in the minds of NEB, and those advising it, one course that would be open would be for NEB to indicate to Hoffmann-La Roche its understanding of the invention, indicating that that is the basis upon which preparation for the trial will proceed. It would then be a matter for Hoffmann-La Roche to indicate, if it chose to, whether that understanding was misconceived. If it was misconceived, and Hoffmann-La Roche chose to lie quiet about the matter, there may well be a penalty for costs at the end of the day. 21 I do not consider that it is appropriate to accede to the request made by NEB at this stage. However, given the apparent complexity of the subject matter of the patent application, I do consider that it is appropriate that Hoffmann-La Roche be required to open in some detail the nature of the invention and some of the technology involved in the patent. That should occur some little time before the commencement of the trial. It would also be desirable, if possible within the timetable that has been fixed, for NEB's opposition to be opened. Whether that is feasible will depend upon the progress of preparation. 22 I have in mind fixing the matter for directions on 10 December 1999. On that day, I will fix a date in February 2000 for the opening by Hoffmann-La Roche, to which I have just referred. I will stand over the motion part-heard to that date. If there is any further contentious matter to be dealt with in relation to the motion, either party may approach my associate with a view to having the matter fixed for hearing at a time convenient for both parties. I certify that the preceding twenty-two (22) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Emmett.

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