A few firms directly in the firing line are having to spend still more time and money defending themselves. Lundbeck is being
quizzed for questionable practices to defend Citalopram. Servier is under investigation not only for potentially dodgy deals
to protect Perindopril, but also for allegedly supplying the Commission with misleading information during the inquiry. Sanofi-Aventis,
Novartis/Sandoz, Teva, Ratiopharm, and a scattering of small generics firms have also come under scrutiny. The Commission
doesn't say they are guilty—but doesn't say when it might pronounce them innocent, either. And the companies themselves are
keeping their heads well down.
The Commission's guns-blazing intervention has left every patent holder—even those who have emerged without so much as a flesh
wound so far—with an uncomfortable sense of insecurity, since, as the Commission repeatedly makes clear, the whole thing could
start up again any time. That explains in part the reluctance of even the most outspoken industry executives to go public
on what they think about it all; to say too much might be to precipitate a new visitation.
The generics industry claims that the Commission inquiry vindicated its own longstanding complaints about obstructionism from
patent holders, and confirmed the existence of inefficiencies in the European patent system. This, in turn, says the European
Generic Medicines Association, put pressure on the European Patent Organization to tighten up its controls. But there is still
no evidence of faster generic market access—and generics companies continue to complain.
For its part, the European Patent Organization (which is quite separate from the European Commission, and actually issues
patents) self-righteously maintains that long before the Commission inquiry started, it was in any case reforming its procedures
to limit the opportunities for patent holders to extend protection through filing dubious patent extension claims. Some additional
controls will take effect this month, but the EPO resists the suggestion that its procedures have been seriously inadequate
until now. Its officials privately murmur that the Commission didn't focus its inquiry very accurately—and consequently came
up with only the most limited findings that didn't generate any real change.
The Commission, meanwhile, is still trying to save its honor after more or less admitting that it was wrong in its initial
suggestions that patent holders were the key villains in holding up generic launches. It finally had to acknowledge what patent
holders argued throughout the inquiry—that the obstacles arising from regulation cannot be ignored in exploring barriers to
generics getting onto the market—or indeed to innovation. As a small gesture of appeasement, the Commission is now reviewing
its legislation on how national drug pricing systems function, in the hope that this could help cut through some of the red
tape, for generics and even for new drugs.
The inquiry was, of course, only one of many factors and forces influencing the European environment for pharmaceuticals—and
for relations between patent holders and generic firms. In recent months, a final judgment has emerged from the European Court
of Justice on a much older case, confirming that AstraZeneca misused regulatory procedures and made misleading representations
to patent offices in a bid to protect Losec. There is a ceaseless series of national actions, in court or with national regulators,
on the limits to patent protection. And big changes have taken place at the top level within the European Commission too.
The abrasive Kroes has been replaced as competition commissioner by the more phlegmatic Joaquín Almunia—who feels less compulsion
to pursue Big Pharma, especially since the focus of the Commission as a whole in the fiscal post-crisis world is on boosting
recovery through innovation. Overall, therefore, even the most aggressive generics lobbies are not certain when or how more
cases will be launched—and nor are the most optimistic patent holders confident that none will ensue.
It is, as one industry executive wryly commented, a typical European result. Lots of talk, lots of time wasted, and not much
to show for it.
Reflector is Pharm Exec Europe's anonymous columnist, a commentator so close to the action in Europe that his identity must remain secret.