Lundbeck decision sounds alarm for South African patentees
21/01/2009

The latest decision on the patent matter between pharmaceutical manufacturers Lundbeck and Cipla Medpro has again gone against Lundbeck. The case highlights the importance of amending the claims of a South African patent as soon as possible so that they conform to the amended claims of a corresponding patent that has been examined in another jurisdiction or that has been amended as a result of litigation.

It also appears from the decision that a third party is entitled to assume a patent is invalid for interdictory purposes if its claims appear to be clearly invalid. The third party can then make, sell and import the invention in South Africa. This finding creates enormous difficulties for patentees in South Africa, which is a non-examining jurisdiction.

On 20 June 2008, Lundbeck’s application for an interim interdict against Cipla Medpro (Pty) Ltd, together with an application for correction or amendment, was turned down by Southwood J, sitting as Commissioner of Patents. The court did not accept Lundbeck’s explanation for its failure to amend its patent.

Lundbeck then approached the Court of the Commissioner of Patents for the same relief. This time, the amendment was aimed at deleting the offending claims and Hartzenberg J, sitting as Commissioner of Patents, was just as unforgiving as Southwood J, denying the amendment.

Hartzenberg J found that although Lundbeck’s patent No. 89/4476 was registered it was invalid, for interdictory purposes, at all relevant times. The court said Lundbeck was at least negligent in not amending its claims in 1993 (when it became aware of the issues with them in the corresponding US application) and especially in 2003 when it launched its product in South Africa. The court added that an inventor who wishes to exploit his invention to the exclusion of competitors must have the patent properly registered. In the case of Lundbeck, the invention had not been properly patented.

In considering whether there was any basis to dispense with the ordinary procedure to be followed in the amendment of a patent, and more particularly whether there was any basis to dispense with the advertisement of the amendment to allow interested parties to oppose it, Cipla argued that persons purchasing its product at a lower price than the competing product of Lundbeck should be given the chance to oppose the amendment.

The court rejected Lundbeck’s argument that the mere deletion of the claims could not cause prejudice since it was not broadening the scope of the invention and held that there would indeed be prejudice as the amendments sought to validate a previously invalid patent. Cipla would be prejudiced by an amendment since it had been selling its generic product legitimately since Judge Southwood’s judgement and it would then have to withdraw its product.

The market would also include other competitors, said the court, and it would be wrong to deny an interested party the opportunity to oppose the amendment. It therefore held that it could not grant the application for the amendment of the patent.

The court took matters a step further and stated that even if the above approach was overly simplistic, Lundbeck had not shown that it had a clear right to the relief it sought because it appeared from the evidence that claim 1 of the patent was invalid for lack of clarity. In seeking interim relief the patentee must generally show that it has a prima facie right to the relief sought. However, the court held that, due to the expiry of the patent in suit being 13 June 2009, the effect of the relief sought would be final in nature because a trial which would dispose of the issue would not occur before expiry. Accordingly, Lundbeck had to demonstrate that it had a clear right, not just a prima facie right under the patent, meaning that there had to be no dispute left on the evidence as to the infringement and validity of the patent. Lundbeck had not done so. Its application for an interim interdict was therefore dismissed.

It is hoped that issues raised by the decision will be clarified by our higher courts.

Alexis Apostolidis
Partner
Alexis-A@adamsadams.co.za