CLINICAL TRIAL DATA
“ONCE INFORMATION WITHIN THE MA APPLICATION HAS BEEN DISCLOSED, IT BECOMES PRIOR ART AND CANNOT THEN SERVE AS THE BASIS FOR AN INVENTION AND PATENT APPLICATION.”
MA application in the EU. If they find that the most profitable option is to apply for an MA outside the EU first, it could delay the progress of medicines in the EU market as well as EU patients’ access to new drugs, Heimhalt warns.
Stephanie Pilkington, a partner at Potter
Clarkson in the UK, agrees that timing is key and recommends that drug companies review their strategies for managing their patent portfolios in light of the changes.
“Prudent innovators certainly should consider how changes to the EMA’s policy might affect their plans for portfolio management and securing the strongest position from the research and development they undertake,” she says.
“Careful coordination between regulatory and IP functions should allow innovators to continue to be able to secure useful protection, but thorough and timely analysis of material submitted to the EMA will be more important than ever to make sure that protection has been sought before material potentially enters the public domain.”
What’s next?
Te EMA’s policy, due to come into effect on January 1, 2015, will apply to any new MA applications made aſter that date.
However, uncertainties remain. Heimhalt says there are some concerns about how the policy might affect bilateral agreements, which protect partnerships and oſten contain confidentiality clauses.
Tere is also the question of whether there will be any copyright in the data submitted, she adds: “At the moment it is unclear whether or not copyright applies due to jurisdictional differences.”
Intellectual Property… It’s in our DNA
Pilkington says that innovator drug companies may feel uncertain, as the EMA could make further changes to the policy in the coming months.
“Uncertainty about what the EMA will do is likely to be drug companies’ biggest concern, which has an unsettling effect, and the possibility that EMA changes in policy might have retroactive effects.”
Tere also remains the spectre of the CJEU’s
pending opinion in InterMune v EMA, which could prompt amendments to the policy.
However, Pilkington says, continued discussion will give the EMA a better understanding of what
information is commercially valuable,
and the CJEU’s opinion may further clarify this understanding.
As the major challenges in healthcare evolve, so will strategies for tackling them. Such a dramatic shiſt in thinking from confidentiality to transparency was never going to please all parties, but if this approach proves to have a positive effect on companies’ drug pipelines, it is likely that transparency will become the way forward.
Powell Gilbert is a London-based intellectual property all around
than we do… and we have the
www.lifesciencesipreview.com Life Sciences Intellectual Property Review Volume 2, Issue 1 13
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