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Tuesday, November 13, 2007 3:00am — PHARMA, BIOTECH & CHEM IP STRATEGY Patent Uncertainty and Patent AcademyA guest post by Leighton Howard GenericsWeb held it’s second Generic Pharmaceutical Patent Academy in London last week, where attendees from many parts of the world learned from a range of patent attorneys, lawyers and other experts specialising in the field of generics, and discussed patents in the context of the industry. Of notable importance is the way in which EU legislation is interpreted in different member states. Whilst an ECJ decision will often clarify a situation, this takes a great deal of time and is often specific to a particular point of law. Meanwhile new regulations are interpreted in a variety of ways ensure that trading in the European Union is seemingly never going to be on a level playing field. Some examples include the way in which SPCs are often based on different EU authorisation dates in different member states, granting of multiple SPCs on single products in certain member states, and the question over the scope of protection of an SPC granted on a process patent (where product patents were not allowable in those countries at the time of the ‘basic’ patent application). Whilst we can form an opinion on how the legislation has been interpreted and how likely the prospects of a successful challenge are, the ultimate decision is often never known until the final court has ruled. Attendees were also made aware of loose interpretation of The IP Enforcement Directive 2004/48/EC (implemented in UK, NL, BE, IT & ES) applied by the Dutch courts when granting ex-parte an innovator pharmaceutical company the right to conduct a pre-judgement search of a major generic company’s offices and servers, based on an ‘imminent risk’ that they would be infringing IP rights (based on a belief that the Generic had filed for marketing authorisations). Although a court later determined that the seizure was unlawful because there was no proof of intent to infringe the patents before they had expired, we learned that this decision is not binding on any other member state. Such threats and uncertainty of litigation based on differing interpretation of EU Regulations clearly hampers the generic pharmaceutical industry in entering European markets as many smaller players are not prepared to take the litigation risk. It also means that the EU is far from being a single, borderless market in terms of when and how generic pharmaceuticals can be developed, authorised and sold. What do you think? Can this be fixed or is this kind of uncertainty inherent in the EU system? Should all generic players be expected to take risks to get on the market in Europe? Post a Comment | Permalink | + del.icio.us 0 Comments0 Trackbackstrackback url: http://duncanbucknell.com/trackback.php?id=178 |
 
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