Pfizer successful in enforcing ARIPO patent in Kenya
13/11/2008

How often have you considered patenting in Africa when considering your Intellectual Property strategy and decided that it would not be worthwhile because it would be difficult, if not impossible, to enforce your rights there ?

Well, the recent success of Pfizer, in respect of Pfizer Inc v Cosmos Limited (Case No. 49 of 2006), is a strong indication that you may have been wrong and that you should give filing your patents in Africa serious thought.

Pfizer Inc (Pfizer) alleged that Cosmos Limited (Cosmos) had infringed its ARIPO Patent No. 44 (the Patent), the Patent providing protection for a medicinal product known as azithromycin dehydrate and the process for its manufacture. ARIPO patents provide protection in all member states of ARIPO which are designated when the application is filed. It is for this reason that Pfizer was able to enforce its Patent against the unauthorized manufacture, sale and stock piling of an allegedly infringing product sold by Cosmos under the trade name Zithrox in Kenya, a member state of ARIPO and which was designated in the ARIPO application.

Cosmos denied infringement of the Patent on the basis that the Patent was not valid during the period 2003 to 2006 in that the Patent had not been renewed and that in any event it was allowed to deal with the product without authorization in terms of, inter alia, the Trade Related Aspects of Intellectual Property (TRIPS) and the “Peace Clause” made by the United States during the World Trade Organization General Council meeting.

The Tribunal considered the evidence concerning the payment of renewal fees from which it appeared that in some cases the renewal fees may have been paid beyond the six month grace period within which a renewal fee may be paid. The Tribunal recognized however that ARIPO has the authority to accept late payment even after the grace period. From the evidence it appeared that ARIPO did not attempt to remove the Patent from the register. The Tribunal found it unnecessary to traverse the question of restoration of the Patent and the effect thereof in Kenya.

Following an analysis of the administrative interaction between ARIPO and the Kenyan Patent Office it was concluded that the Kenyan Patent Office would not have the authority to remove the Patent from its register unless instructed to do so by ARIPO and that, in any event, no action had been taken by the Kenyan Patent Office to do so. The Tribunal therefore concluded, despite the fact that the file integrity of the patent file left much to be desired, that the Patent was in force at all material times and dismissed Cosmos’ defence.

The Tribunal then turned to the issue of patent infringement and the defences raised by Cosmos. The first defence, that the corresponding American patent had lapsed, was quickly set aside on the basis that patent protection was territorial in nature and the fact that there was not an American patent could not mean that the product had been put into the public domain as alleged.

Next the Tribunal turned to consider the defence based on TRIPS and the Peace Clause. With respect to TRIPS the Tribunal considered the Industrial Property Act (the Act) and stated that the exceptions and flexibilities envisioned by TRIPS were contained in the Act, more particularly in respect of those sections dealing with voluntary licenses and compulsory licenses. The Tribunal stated that Cosmos had not requested any of these during the material time in which the alleged infringement took place and only applied for a voluntary licence following a cease and desist letter and did not deal further with the issue.

The Tribunal then considered the sections of the Act which relate to parallel importation and stated that the sections could not be read so as to mean that they provide “blanket protection for anyone to deal with patented products without the patent holder’s authority” as this would defeat the very intention of the Act in the first place – to encourage innovation and facilitate acquisition of such technology and provide protection for rights holders. The Tribunal therefore rejected Cosmos defence that its actions were legitimized on the basis of the parallel importation sections of the Act.

Insofar as the defence concerning the “Peace Clause” is concerned, the Tribunal noted that Cosmos had not provided it with the text of the clause but that in terms of the Tribunal’s research the clause expired in December 2003 and related to Article 13 of the Agreement on Agriculture which protected countries using subsidies that complied with the Agreement from being challenged under other WTO agreements relating to Subsidies and Countervailing Measures Agreements. Due to the expiry of the Peace Clause, the Tribunal did not deal with this defence any further.

As a matter of public interest the Tribunal also addressed the defence of Cosmos that it was entitled to import and manufacture the product because the product is used for the treatment of opportunistic infections in patients with HIV/AIDS. The Tribunal stated that on its own research the product was not used as a first line of treatment for HIV/AIDS patients and that even if it were a first line of treatment Cosmos had not followed the conditions for the exploitation of the Patent in the case of a national emergency, HIV/AIDS having been declared as such by the government.

In summary the fact that Cosmos did not have a licence (compulsory or voluntary) and was not authorized by the government to import or exploit the Patent as a result of HIV/AIDS having been declared a national emergency, the Tribunal concluded that Cosmos had indeed infringed the Patent. The Tribunal went further to state that even though Cosmos had stopped selling the Product, except for fulfilling its contractual obligations to the government, and had no intention of infringing the Patent it would grant the injunctive relief sought in that intention is not an ingredient in determining whether an infringement has or has not taken place. The Tribunal went even further and stated that it had no doubt that if Cosmos was left unchecked it would continue to exploit the Patent.
The above case is an important one in that it shows that the courts and tribunals are quite capable of applying the law and enforcing patent rights, analyzing the effect of international agreements on the application of local law and importantly that they are able to present succinct and competent judgments which provide a useful aid to the interpretation of the relevant laws for both patentees and member states.

Our Africa Filings Department which deals with the filing and prosecution of patent and design applications throughout Africa (excluding South Africa), the Surrounding Islands and the Middle East is headed up by Nicky Garnett. Before joining Adams & Adams in January this year, Nicky practised as an attorney in Zimbabwe where she was responsible for the filing and prosecution of patent and design applications at the Zimbabwean patent Office and also at ARIPO (the Headquarters of which is based in Harare).

Please do not hesitate to contact Nicky (nickyg@adamsadams.co.za) should you require any information regarding the filing of applications in any countries throughout Africa.

Nicky GARNETT
Consultant
Nickyg@adamsadams.co.za
Alexis APOSTOLIDIS
Partner
Alexis-A@adamsadams.co.za