CSL Limited v Novo Nordisk Pharmaceuticals Pty Ltd  FCA 671 (28 June 2010)
Zetco Pty Ltd v Austworld Commodities Pty Ltd  FCA 235 (17 March 2010)
Apotex Pty Ltd v Les Laboratoires Servier (No 2)  FCA 1019 (11 September 2009)
There are two mechanisms by which a patentee may amend a granted patent in Australia. The first is to file an application for leave to amend at the Australian Patent Office. The second is to apply to the court.
Each approach has its advantages and disadvantages, depending upon the circumstances in which the patentee finds themselves. Ideally, the patentee has a choice, but in some cases they may find this has been taken away.
All four of these cases - the most recent having issued just last week - relate to amendment applications filed in the Federal Court of Australia. In each case the patentee's reasons for applying to the court, rather than through the Patent Office, were different. In all four cases the amendments were technically allowable, but in one case the court nonetheless denied the application.
We think that it is interesting, and instructive, to compare these four cases. They illustrate why an application to the court may be necessary or desirable, and how things can go horribly wrong!
If you wish to jump directly to the discussion of each of the four cases, use these links:
- Bristol-Myers Squibb Company v Apotex Pty Ltd
- CSL Limited v Novo Nordisk Pharmaceuticals Pty Ltd
- Zetco Pty Ltd v Austworld Commodities Pty Ltd
- Apotex Pty Ltd v Les Laboratoires Servier (No 2)
Section 104 of the Australian Patents Act 1990 provides for an applicant or a patentee to ask the Commissioner of Patents for leave to amend a patent specification. Section 105 provides for a court, in the course of proceedings in relation to a patent and upon application by the patentee, to direct the Commissioner to amend a patent specification. In either case, section 102 provides that certain amendments are not allowable.
The types of amendments to a granted patent that are impermissible under s102 may be summarised as follows:
- any amendment that would broaden the scope of the patent is not allowable;
- any amendment that would add and claim subject matter no present in the specification as originally filed is not allowable;
- any amendment that would result in some new defect of the description or claims (under section 40) being introduced into the specification is not allowable.
Amendment Before the Patent Office
The significant advantages of requesting amendment through the Patent Office are firstly the relatively low cost, and secondly the fact that if the amendment is allowable under s102, and made in accordance with the regulations, the Commissioner must allow the request.
The disadvantage is that any decision by the Commissioner to allow an amendment request must be advertised, and is open to opposition by third parties. Grounds of opposition are limited to those relating to the allowability of the amendment (ie further issues of novelty, inventive step, and other grounds of invalidity of the patent as amended cannot be raised). Nonetheless, like any other opposition proceeding, the process can become protracted, involving evidentiary rounds leading to a hearing and decision.
And there is one further potential pitfall to amending before the Patent Office: the Commissioner will not allow an amendment if there are "relevant proceedings" pending in relation to the patent. Relevant proceedings include court actions relating to infringement or invalidity of the patent. In such cases, the patentee must ask the court to direct the Commissioner to make the amendment.
Amendment Before the Court
Once relevant proceedings have commenced in relation to a patent, it is necessary for the patentee to apply to the court for an order directing the Commissioner to make any desired amendments to the patent. A patentee wishing to commence proceedings against an alleged infringer, and believing that amendment is necessary, may therefore find it more convenient and efficient to make an application to amend through the court in a preliminary phase of the proceedings.
There is no mandatory opposition period for court-ordered amendments, although interested parties (including the respondent in the main proceedings) may appear before the court. Even so, there is a much lower likelihood that proceedings before the court will become as protracted as opposition proceedings before the Patent Office.
A major potential drawback of applying to the court for an amendment order is that the court has a discretion to refuse an amendment that is otherwise allowable under s102. Exercise of this discretion is guided by equitable considerations, and the guidelines that have been developed by the courts may be summarised as follows:
- the court is not hostile or antipathetic to amendment, but the onus lies with the patentee to satisfy the court that the requested amendments should be allowed;
- it is the conduct of the patentee that is at issue, not the merit of the invention;
- the patentee has an obligation to disclose to the court all relevant matters relating to the requested amendments;
- the patentee should not have sought to obtain unfair advantage from the unamended patent;
- there should not have been unreasonable delay by the patentee in seeking the amendments;
- nonetheless "mere" delay in itself does not warrant refusal, if there is a reasonable explanation;
- a patentee aware that its claims are of undue breadth must act promptly to amend them;
- the court should consider any other circumstances that may arise that may lead it to refuse the amendment; and
- none of the above principles are fixed rules, and they must be accommodated to the facts of each case.
A TALE OF FOUR AMENDMENT REQUESTS(See Smith Kline & French Laboratories ltd v Evans Medical Ltd (1989) 1 FSR 561 at 569; Wimmera Industrial Minerals Pty Ltd v RGC Mineral Sands Ltd (1997) 40 IPR 110 at 114; Wimmera Industrial Minerals Pty Ltd v RGC Mineral Sands Ltd (No. 3) (1997) AIPC ¶91-366 at 39,789; Apotex Pty Ltd v Les Laboratoires Servier (No 2)  FCA 1019 at .)
The four cases under consideration here serve to illustrate the above practices and principles.
Apotex Pty Ltd v Les Laboratoires Servier (No 2)
The patentee (Servier) sought to add narrower claims to its granted patent, and gave its reasons as being (in effect) to more precisely define its invention. Specifically, Servier's solicitor swore an affidavit in which he stated that he had "reviewed the .. Patent and formed the view that the specifications disclosed matter which could be the basis of additional claims" (at ).
Despite opposition by Apotex, the court found the requested amendments to be allowable under s102.
However, Servier failed initially to disclose to the court the outcome of proceedings in the UK, in which all of the original claims had been found hopelessly invalid by Lord Justice Jacob in the Court of Appeal (Les Laboratoires Servier v Apotex Inc  EWCA Civ 445). Servier resisted discovery of documents which showed that the UK proceedings had significantly influenced Servier's decision to amend its Australian patent.
The court exercised its discretion to refuse Servier's application to amend, finding (at ) that:
Servier was entitled to seek to amend the Australian patent to strengthen it but was then obliged to inform the Court of that reason. To the contrary, Servier put forward other reasons or permitted other reasons to be advanced. ... Servier failed voluntarily to disclose all relevant matters until they were exposed by Apotex. That failure to disclose was not of some minor, though strictly relevant, matter. It was a failure to disclose Servier’s reason for the amendments.CSL Limited v Novo Nordisk Pharmaceuticals Pty Ltd
We have reviewed this case in some detail in a previous article. It is not a final decision on an amendment application (by CSL), which would itself be preliminary to the main infringement proceedings, but on the further side issue of discovery in relation to CSL's reasons and timing in applying to amend. The focus on discovery is no doubt a product of Apotex' success against Servier.
Even in the absence of the additional discovery ordered by the court, it seems reasonable to conclude that CSL's reasons for amending are related to adverse decision in an opposition at the European Patent Office issued in May 2009, in view of which the delay until November 2009 before applying to amend the Australian patent does not seem excessive.
In this case, therefore, we are inclined to predict that CSL will ultimately be granted its order to amend. However, as we pointed out in our earlier article, this does appear to be a case in which the situation could have been avoided altogether if it were not for the false economy of combining distinct limitations in a single claim.
Zetco Pty Ltd v Austworld Commodities Pty Ltd
This is a rather unusual case, in that Zetco initially requested amendment before the Patent Office under s104, in order to overcome objections raised by an examiner in a re-examination that had been requested by Austworld. Having successfully overcome the objections, and with its patent attorneys being informed by the examiner (via telephone) that this was the case, Zetco commenced infringement proceedings against Austworld without waiting for the amendments to be formally allowed. The Commissioner subsequently asked the patentee to confirm that no relevant proceedings were pending. Of course, Zetco could not comply! (Zetco v Austworld at .)
As a result, Zetco had no choice but to apply to the court for an order under s105 directing the Commissioner to make the amendments. Zetco provided the court with copies of correspondence with its patent attorneys, so as to account for the events leading to the application. The court found that it was appropriate to exercise its discretion, stating (at ):
Zetco has waived its privilege in its communications with [its patent attorney] in order to provide an account of the circumstances for the proposed amendments. The reasons for seeking the amendments have been explained in detail. The circumstances of the incomplete s 104 application, the commencement of proceedings and subsequent s 105 application are explained by the history of communications with the Patent Office as to the grant of leave to amend. There is no unreasonable or unexplained delay in the amendment application apparent. There is no suggestion that Zetco has sought to obtain an unfair advantage in respect of the Patent prior to amendment.Bristol-Myers Squibb Company v Apotex Pty Ltd
Bristol-Myers Squibb ("BMS") is the exclusive licensee of a patent owned by Otsuka Pharmaceutical Co Ltd relating to the antipsychotic agent aripiprazole. BMS and Otsuka contend that Apotex infinges the patent. Apotex denies infringement, and has also cross-claimed for invalidity of various grounds.
As in Zetco, this is a case in which a request to amend before the Patent Office was prompted by a re-examination request made on behalf of the respondent (Apotex). In this case, however, BMS and Otsuka did not "jump the gun", but took no action during the period followiong advertisement of the requested amendments for opposition purposes. Instead, Apotex opposed the amendments (right at the end of the opposition period, see at ).
BMS immediately commenced proceedings against Apotex, as a result of which the Commissioner no longer has power to deal with the amendment application. This effectively halted the opposition proceedings, and Otsuka subsequently applied to the court for an order directing the amendments be made. Apotex has not opposed the amendments before the court, which strongly suggests that its opposition before the Patent Office was a strategic attempt to delay the proceedings (see at ).
Otsuka's requested amendments, which bring the Australian claims into conformity with corresponding European claims, could have been made earlier. However, the court was satisfied, on the evidence, that while conformity with the European claims might have been desirable, it was neither a "pressing nor necessary objective" (at ). The court applied the principle that mere delay, in itself, is insufficient reason to exercise the discretion to refuse an amendment request, stating (at ):
Delay generally needs to be coupled with improper conduct or resulting detriment to a particular person or the public more generally, such as where the patentee knows or has reason to suspect on good grounds that the claims are defective in some substantial way but nevertheless seeks, by delay, to take advantage of a wider monopoly than that to which the patentee is truly entitled.There being no indication of any improper conduct (on Otsuka's part), or other relevant factors in this case, the court proposes to allow the amendments (at ).
A few lessons may be drawn from the four cases considered here:
- it is recommended that patentees seek to amend their patents as soon as practicable following discovery of some reason or need to do so;
- it is preferable to make amendments before the Patent Office, if possible, prior to any need to enforce the patent arising;
- however, consideration must be given to the requirement for an amendment request before the Office to be advertised for opposition purposes; and
- a patentee seeking amendment before the court must come with "clean hands", and be prepared to make a full and frank disclosure of all of the reasons and circumstances relating to the amendments, including an explanation of any delay.