A 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?