Sunday, 21 February 2010

Glaxo gets asthma patent relief by claiming Cipla abuse

Afro Leo has been alerted by Tim Ball to the judgment of Prinsloo J, as Commissioner of Patents, handed down on Wednesday in the matter of Glaxo Group Ltd v Cipla Medpro (Pty) Ltd – Patent 90/7136. Tim has also kindly contributed the following summary and comment:

"The patent in issue is Glaxo’s patent on its SERETIDE asthma product, containing a combination of salmeterol and fluticasone propionate. Glaxo’s equivalent patents have been revoked in the UK and Ireland (ed: see an Irish case here).

At grave risk of oversimplifying the facts (described in the proceedings as a “procedural quagmire”), Glaxo sought to have Cipla’s application for revocation of patent 90/7136 struck out on the basis that Cipla had abused the court’s process. Cipla had earlier filed a similar application for revocation of the patent, but, in the face of a procedural challenge, had elected to withdraw the earlier revocation application and start again with a fresh application. Glaxo sought to have the new revocation application struck out, and to force Cipla to continue with the procedurally-challenged earlier revocation application. In this regard, the court said:

“[36] In lighter vein, I proposed to counsel during the proceedings before me that this was akin to a situation where the helpers of a battered boxer throw the towel into the ring, signaling the surrender of their charge, only to have the towel thrown back at them with the referee insisting that the battered boxer is not allowed to surrender, but has to soldier on so that he can be properly knocked out. To me this seems to be legally untenable. The respondent's deponent, in the opposing affidavit to the abuse application, puts it as follows:‘I respectfully submit that it is manifest that it is Glaxo that is perpetrating the abuse. What Glaxo is attempting to achieve is a delay of CIPLA's access to Court. Nothing less. Why it wishes to reinstate it to have it struck [out] has never been explained. It cannot be explained. There is no question of "due process" not being followed as a result of CIPLA withdrawing the allegedly procedurally flawed 2006 revocation application. Faced with the allegations of procedural irregularities, CIPLA withdrew the 2006 revocation application. There is no reason why this court should be burdened with hearing an uncontested dispute on procedural flaws.’ With these sentiments I agree.”

Central to the matter was the issue of whether Glaxo’s success in a rule 30A application would have brought the dispute to an end, if Cipla had not withdrawn the earlier application of its own accord. In this regard, the court stated:

“It was argued on behalf of the respondent that the applicant's submission that the effect of success in the rule 30A application would bring an end to all revocation proceedings between the respondent and the applicant, effectively meaning that the respondent would be unable to challenge the registrability of a patent of dubious validity, has no merit: it was submitted on behalf of the respondent, correctly in my view, that rule 30A is clearly aimed at procedural irregularities and striking a claim for non-compliance with a procedural requirement does not mean that a litigant is non suited from bringing the identical action for the identical relief in instances where none of the procedural irregularities are present. It was submitted on behalf of the respondent that the logical conclusion of the stance adopted by the applicant is that the issue of the validity of the patent is res judicata between the parties and that the respondent can never challenge the validity of the patent again. This is untenable.”

The court dismissed the abuse application. Nevertheless, the exercise gained Glaxo gained over a year, and it is now unlikely that the revocation could be finalised before the expiry of the patent."

Readers may recall that Tim represents Cipla whose frustration (no doubt shared by asthma sufferers) is evident. Afro Leo is not offended by Glaxo's litigation techniques. The case seems to illustrate the disadvantages of having a deposit system for patents (perhaps compounded by inevitable litigation delays in revocation proceedings). However, it also seems that Cipla themselves delayed in attempting to revoke the apparently invalid patent.

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