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74

Legal Focus

JUNE 2012

Pharmaceutical Patents Malta

The Pharmaceutical industry is evolving constantly. With new drugs and technology being developed all the time, patents are an integral aspect of this sector. However, a recent report by the intellectual property specialists Withers & Rogers has found that the number of patents filed by major pharmaceutical companies has dropped dramatically in recent years, creating concern for the industry’s ability to bolster its new product lines in coming years. To find out more, Lawyer Monthly speaks to Dr. Antoine Camilleri (B.A., LL.D., M. Juris), Partner at Mamo TCV Advocates and head of the Intellectual Property law and Anti-Counterfeiting Department.

Please introduce yourself, your role and your firm.

Mamo TCV Advocates evolved from the merger in 2000 of two leading Maltese law firms - Tonna Camilleri Vassallo & Co., and John Mamo & Associates. Today, the firm is one of the largest legal practices in Malta. Operating from offices in the capital Valletta, the practice offers an impressive depth and breadth of expertise which enables the firm to handle a variety of different legal areas, and provide, in essence a 'one-stop' service to clients.

What is the situation regarding pharmaceutical patents in Malta? did accession to the European Union have any effect in this regard?

Up till 1 May 2004 when Malta joined the EU and became part of a larger and more unified economic market, Malta was rarely chosen by the large foreign pharmaceutical companies as a country in which to register their pharmaceutical patents. Until then, the Maltese Patents Register contained a few thousand patents, a sizeable number of which had already expired by the said date. Between the period 1 May 2004 and 1 March 2007, Malta experienced an increase in national patent filings, the filings generally covering all the sectors of industry (engineering, manufacturing and pharmaceutical sector patents) whereby the Patents Register increased several thousand more patent registrations.

did Malta experience any different trends following its accession to the EPc and the Pct?

Following Malta’s accession to the EPC and the

PCT, national patent applications have virtually come to a standstill with only a few direct national filings observed every year. However, since mid-2009 the Industrial Property Registrations Directorate (IPRD) of Malta started to regularly receive a substantial number of EP validation requests and the outlook for these is that they will continue to increase over time.

can you briefly discuss the applicable legal regime in Malta dealing with pharmaceutical patents? What is your firm’s experience in this regard?

The Malta Patents and Designs Act (Chapter 417 of the Laws of Malta) includes certain exceptions to the patent owner’s exclusive rights which are highly relevant. The said exclusive rights and exceptions are found in Section 27 of the said Act and the relevant provisions include the ‘experimental’ and ‘scientific research’ exception, together with a ‘Roche Bolar’ exception. Therefore, the proprietor of a patent is incapable of preventing third parties from performing acts consisting in the making or using of a product for purely experimental purposes or for scientific research, and in situations when the act in question is done for purposes which can reasonably be related to the development and presentation of information required by the law of Malta or any other country that regulates the production, use or sale of medicinal or phytopharmaceutical products.

Is there anything else you would like to add?

Mamo TCV boasts a litigation department that has a wealth of experience in this field and can act for client in respect of any of the above- mentioned matters. The Intellectual Property

and Anti-Counterfeiting Department handles all matters relating to trademarks, patents, designs, copyright and cross-border measures even when such matters relate exclusively to pharmaceuticals. In fact, Mamo TCV acts for a number of major pharmaceutical companies and assists them in all their legal needs arising in Malta. LM

contact details

antoine camilleri Partner – IP department Mamo tcV advocates Palazzo Pietro Stiges 103, Strait Street Valletta VLt 1436 Malta

tel: (+356) 21232271 / 21231345 Fax: (+356) 21244291 / 21231298 Email: antoine.camilleri@mamotcv.com Website: www.mamotcv.com

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