Protecting patents

Dr Kfir Luzzatto, partner at Luzzatto & Luzzatto, speaks to World Pharmaceutical Frontiers about modernised court methods and trade issues regarding global patent rights.

One of the consequences of the heightened fears about international terrorism is the increasing incidence of expert evidence being given via video conferencing. ‘I have been involved in a couple of such cases,’ says Dr Kfir Luzzatto, partner at Israeli patent attorneys Luzzatto & Luzzatto. ‘Initially, judges were unwilling to accept video conferencing in patent cases and arguments were put forward that it might diminish the supreme authority of the law, but eventually the courts allowed it.’

As worries about the dangers of international travel continue, giving evidence via a video link will become increasingly common. In criminal cases it is already a widespread procedure. ‘The case law has not crystallised yet,’ Luzzatto explains, ‘but it is developing.’

Both sides have to have a lawyer in the remote room with the witness and the camera. ‘It is often more arduous for the witnesses, considering they might spend four or five hours talking to a camera while they are cross-examined,’ Luzzatto comments.

Israel’s generics industry boom

Changes are also occurring within the intellectual property rights sector. Luzzatto & Luzzatto is one of Israel’s leading firms of patent attorneys. It operates on behalf of big international companies that want to protect their intellectual property rights against Israel’s booming generics industry.

Dr Luzzatto confirms: ‘More than 90 per cent of our business in the pharmaceutical field is with foreign companies.’ The international expansion of the Israeli generics over the past few years - buying manufacturing capacity in Eastern Europe and North America - means that demand for Luzzatto & Luzzatto’s services is strong.

Israel’s main domestic market for pharmaceuticals lies with its sick funds, which account for 70 per cent of the pharmaceutical sale. These sick funds provide medical insurance and hospital services for Israelis. The development of the country’s generic pharmaceutical industry helps the sick funds to deliver healthcare at the cheapest possible cost.

As a result of the final round of the general agreements on tariffs and trade negotiations (GATT), in 1995, the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) came into force. TRIPS was largely based on the work of World Intellectual Property Organisation.

The Israeli Patent Office, like many other traditional government departments, is being modernised. For instance, it now accepts the electronic filing of trademark applications. ‘The new Registrar of Patents reflects this change,’ Luzzatto points out. ‘Like all the previous registrars, he is a lawyer, but he is also a chemist and therefore stronger on the scientific aspects.’

Ethical companies versus manufacturers

‘Another topical issue is data package exclusivity,’ Luzzatto reveals. The Office of the US Trade Representative is pushing for countries to follow the US practice by which ethical companies that discover and develop new pharmaceuticals retain the rights to the data. This means that in the cases where no data package exclusivity exists, the generics do not have to go through expensive and time-consuming clinical trials but can piggyback on the data of ethical manufacturer. The US Trade Representative wants countries to protect the exclusivity of the data package used to obtain regulatory approval.

Countries with strong generic pharmaceutical industries are discontented by the US Trade Representative’s diktats. They want generic manufacturers to start producing the pharmaceuticals immediately, once the regulators and the public know that it is safe. The USTR, however, argues that this is unfair, as the generic manufacturer should not be allowed to piggyback on the expensive development work carried out by the ethical company.

While the debate about global patent rights continues to rumble on, video conferencing is gradually facilitating patent litigation.

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