01 July 2010

As If Patent Litigation Were Not Already Expensive Enough...

CSL Limited v Novo Nordisk Pharmaceuticals Pty Ltd [2010] FCA 671 (28 June 2010)

Patents Act 1990 - Section 105 - application for direction to amend - Discovery - whether further discovery of documents relevant to s105 application should be granted.

This decision breaks no new ground, but appears to be an object lesson on the potential consequences of cutting corners in drafting and prosecution of a patent application.  On the face of it, it seems to us that the situation that has arisen here could have been avoided, or at least rendered less critical, by employing a different claim strategy.  Patent drafters and prosecutors take note!

Outline:
  1. Background
  2. Amendment procedures
  3. Amendment traps
  4. CSL's amendment application
  5. Motion for discovery
  6. Could all this have been avoided?
  7. Morals of the story

1. BACKGROUND

CSL and Monash University (the applicants) have brought proceedings against Novo Nordisk (the respondent) for alleged infringement of their Australian patent no. 716,747, which relates to a stabilised growth hormone and a method of preparation thereof.  As a preliminary matter, the applicants are seeking a direction from the court to amend the claims of the patent, under section 105 of the Patents Act 1990 (the Act).  Unfortunately for the applicants, the respondent is fighting the amendment application, which has sidetracked the substantive infringement and validity proceedings, and bogged both parties down in additional (and presumably costly) discovery.

This decision relates to the respondent's motion for discovery of documents relevant to the amendment application.

2. AMENDMENT PROCEDURES

Under the Act, a request to amend a granted patent may be made for any reason, and in general terms will be allowable subject to two conditions:
  1. the amendment must not result in a broadening of the patent scope; and
  2. the claims must remain clear, and adequately supported by the disclosure in the patent specification.
Notably, there is no examination of an amendment request against substantive patentability criteria, such as novelty, inventive step, or subject-matter eligibility.  Since the claims have already been examined and granted, and they cannot be broadened, this is not necessary.

A request for leave to amend may be made before the Patent Office, under section 104 of the Act.  However, once there are proceedings underway before a court, the Office will generally not process requests for amendment, because it is more appropriate and efficient for amendments to be dealt with in the course of the litigation.  Applications to the court for a direction to amend are made under section 105.

3. AMENDMENT TRAPS

Subject to satisfying the various requirements of the Act, and associated Regulations, the Patent Office has no discretion in whether or not to allow the patentee leave to amend.  An amendment request can be opposed by a third party, but only on the grounds that either of the two conditions outlined above are not satisfied.

A court, on the other hand, does have a discretion, and may refuse to give a direction to amend a patent if it does not consider it appropriate to do so.  It is well-established that the conduct of the party requesting amendment is relevant to exercise of the discretion.  In one recent case (Apotex Pty Ltd v Les Laboratoires Servier (No 2) [2009] FCA 1019), the patentee (Servier) sought to add narrower claims to its patent, which it argued (in effect) more precisely defined its invention (and which presumably it also considered to be infringed by Apotex), without also seeking to cancel existing broad claims that had been found hopelessly invalid in the course of corresponding litigation in the UK.

The court found Servier's conduct to be sufficient reason to exercise its discretion not to allow the amendments.

Clearly, in proceedings in which an application has been made for revocation of a patent, the refusal of an application to amend in order to preserve validity may be fatal to the patentee's case.

It appears likely that this is also the situation faced by CSL.

4. CSL'S AMENDMENT APPLICATION

Claim 1 of the applicant's patent is directed to a "method for the preparation of a stable, liquid formulation of growth hormone".  (The details are unimportant to the issues in the decision.)

Claim 7 is dependent upon claim 1, and recites that "the pH of the formulation is from 5.0 to 7.5, preferably 5.0 to 6.8, more preferably from 5.2 to 6.5, and most preferably from 5.4 to 5.8."

CSL wishes to amend claim 1 to include the limitation that "the pH of the formulation is from 5.0 to 6.8", and claim 7 to delete the ranges "5.0 to 7.5" and "5.0 to 6.8".

In opposition proceedings before the European Patent Office (EPO), relating to the corresponding European patent, the EPO issued a decision on 25 May 2009 finding the original independent claim to be invalid for lack of novelty, but that claims including the pH limitation of 5.0 to 6.8 to be novel.  The applicants claim that it was this decision that set in train the sequence of events that led to them filing the amendment application on 6 November 2009.  However, the Notice of Opposition was originally filed on 26 June 2007, and the proposed claim amendments first filed at the EPO (albeit as a "fall-back" position) on 11 April 2008.

5. MOTION FOR DISCOVERY

The issue being pursued by the respondent is that the applicants must have known earlier than 25 May 2009 that its broad claims were likely to be found invalid.  It is therefore seeking discovery of various documents relevant to advice that they may have received, and opinions that they may have formed, regarding the validity of the patent claims following filing of the European Notice of Opposition.

The respondent is presumably hoping to persuade the court to apply Apotex v Servier, and exercise its discretion to refuse the amendment application.

As a result of the discovery, the amendment application, which is preliminary to the main proceedings, is itself becoming protracted and expensive.  Worse still, for the applicants, if the amendment request is denied, it appears likely (unless the EPO Opposition Division is in error) that the patent will be found invalid.

6. COULD ALL THIS HAVE BEEN AVOIDED?

It appears to us that there should have been many opportunities over the years for the applicants to have avoided their present predicament.

The first problem is claim 7 itself.  Although it recites a main range of pH values, and then a number of increasingly "preferred" subranges, the preferable ranges are not limiting.  If the prior art discloses the main range (5.0 to 7.5), then the claim is invalid, notwithstanding the further specified ranges.

While there may be sound reasons for filing claims in this form in Europe, it seems hard to justify in Australia, particularly for a patent granted on 15 June 2000.  Since excess claims fees would not have been payable at the time, the cost of splitting the claim into four separate dependent claims, each covering a different range, would have been negligible.  If a claim limited to one of the narrower pH ranges is valid, then one or more of these separate independent claims would be valid, and the applicants would not now be dependent upon the discretion of the court to preserve the validity of their patent.

Furthermore, an application to amend the claims to split claim 7 in this manner could have been made at any time after the applicants became aware of the potential problem.  Indeed, this could have been done before the Patent Office long before the present litigation was initiated on 10 March 2009.

It may be that the applicants had good reason to await the decision in the European opposition.  For example, there may have been genuine doubts about the outcome.  However, the present amendment application, and associated discovery process, is no less distracting or costly if the application is ultimately allowed.

7. MORALS OF THE STORY

Do not "skimp" on claims when drafting and prosecuting applications.  Even if excess claim fees become payable (at acceptance, for all claims over 20, under the current regulations) they are likely to be much cheaper than subsequent litigation!

Do not include non-limiting features in claims.  Watch out for "preferably", "optionally", "advantageously", and their ilk.  These non-limitations are worthless.  If a limitation is worth claiming, give it its own claim!

Amend early, and amend often (if necessary)!  If you become aware of any validity problems with your granted claims, it is a false economy, and potentially fatal, to delay a saving amendment until court proceedings are underway.

We will have to wait to see how this turns out for CSL and Monash in the end...

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