Euroceltique v Sandoz – A Historical Footnote

Euroceltique v Sandoz – A Historical Footnote

AU61963/94 was an Australian patent application dealing with controlled release preparations of Tramadol, an opioid analgesic for treatment of moderate to severe pain. The application had an earliest priority date of 10 May 1993, and was filed on 9 May 1994 (claiming priority to several earlier applications). It was allowed to lapse, but not before a divisional application was filed. A few divisionals later saw AU2003200863 (D3) and AU2004229058 (D4) prosecuted to acceptance. A further divisional, AU2009243527 (D5), was also filed, but more of that anon.

Both the D3 and D4 applications were opposed by Sandoz (the initial opposition to D3 by Hexal Australia was transferred to Sandoz part way through the opposition proceedings).

In the D3 opposition, many of the claims were found by the Delegate to be patentable, although the opposition was upheld in respect of a few of the claims. Both parties appealed the decision to the Federal Court. The Applicant also filed claim amendments, however these amendments did not completely bring the claims in line with the requirements of the Delegate. These amendments were then opposed by Sandoz, as well as by Spirit Pharmaceuticals.

The oppositions to the amendments were extended for a lengthy period, due to numerous requests for extension of time to file evidence. This continued to the point where it became apparent to the Applicant that the 20 year term of any patent granted on the applications might expire before grant of the patents. A strategic reassessment therefore came up with the following actions:

1)    The opposed amendments to D3 were withdrawn, and a new amendment request was lodged to bring the claims strictly in line with the claims found patentable in the s.59 opposition decision; and

2)    The D5 application, which had been filed as a safety precaution, was amended in such a way that, it was hoped, would not encompass Sandoz’s products and would therefore be less likely to be opposed.

Unfortunately for the Applicant, the Raising the Bar Act came into force during implementation of this strategy. Accordingly, the withdrawal of earlier amendments was accepted, bringing the oppositions to the earlier proposed amendments to a close, but the new proposed amendments were not allowed since Federal Court proceedings were underway (new s.112A prevents amendments other than those directed by the Court if Federal Court appeals are pending).

With respect to the D4 application, the decision of the Delegate was favourable to the Applicant: it was found that the opposition failed on all grounds. This decision was promptly appealed to the Federal Court by Sandoz.

Unfortunately also for the Applicant, once the D5 application was accepted by the Patent Office, it too was opposed by Sandoz under s.59.

It is of interest that the Opponent in the D5 opposition matter requested an extension of time to file evidence in support, citing progressing negotiations and attendant public interest in having the matter resolved by negotiation as reasons for the extension. In keeping with the post-Raising the Bar regime, this was refused. The matter went to a hearing at which, unusually, the patent Applicant supported the request. Despite this, the Delegate still refused the extension.

At this stage it had become clear to the Applicant that without the cooperation of the Opponent, none of the three pending applications would be granted before the 20 year expiry date, since the pending Federal Court appeals in respect of the D3 and D4 applications and the opposition to the D5 application had no prospect of being concluded before that date. This raised two important questions for the Applicant:

1)    Could a patent grant after its 20 year term and, if it did, could the patentee of the expired patent sue for past infringement?

2)    Could an extension of term be requested for a pharmaceutical patent which expired before it was granted?

In respect of question 1, it appeared contrary to natural justice that an infringer could avoid penalties for infringement by using delaying tactics to postpone grant of a patent to after its 20 year term.

In the event, the negotiations between the parties were concluded shortly before the 20 year term expired on 9 May 2014 and all three pending applications were granted. Extension of term applications were promptly filed and were allowed by the Patent Office.

Whereas this was an excellent result for the Applicant, it leaves open the two questions above.

With respect to question 1, opinions were requested from both the Patent Office and from counsel. Both of these expressed the opinion that it was likely that, even if a patent were to be granted after expiry of the 20 year term, action could be taken in respect of alleged infringements which occurred before the 20 year term. In view of the steps instituted in the Raising the Bar Act to speed up prosecution and opposition proceedings, the chances of this being tested in future are much reduced, although it is still theoretically possible for prosecution of an application to continue beyond its 20 year term. This appears to be a significant benefit of the Raising the Bar Act.

With respect to question 2,it is of note that s.71(2) of the Patents Act states that “[a]n application for an extension of term of a standard patent must be made during the term of the patent …”. It is hard to see when such an application could be validly filed if the patent expires before it is granted, since there would then be no time that is “during the term of the patent” at which the application could be made.

As we discussed in our recent report on the case of Alphapharm Pty Ltd v Lundbeck A/S [2014] HC 42, the High Court has confirmed that it is not possible to obtain an extension of time under s.223 in order to file an application within the term of the patent, although it is possible to use s.223 to obtain an extension in respect of the requirement that the application be made “within 6 months after the latest of the following dates: (a) the date the patent was granted;(b) the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, any of the pharmaceutical substances referred to in subsection 70(3);(c) the date of commencement of this section.” Since there does not appear any time that would be both within 6 months of the specified dates and within the term of the patent, it seems unlikely that an extension of term would have been obtainable had the patent not granted before the expiry of the 20 year term since there would be no valid time at which to file the application for extension of term.

As it now turns out, the extensions of term of all three Euroceltique applications have now been opposed. Those actions are still on-going.

Spruson