Patent Law

From the European Public Health Alliance (EPHA):

European antitrust investigators are expanding the scope of a major inquiry into the ?484 billion pharmaceutical market in a bid to determine whether companies are blocking generics makers from getting less-expensive medicines to market quickly.

Neelie Kroes, the European Union competition commissioner, is trying to determine whether drug companies? efforts to block competitors by extending patents were also distracting them from developing new medicines, which have been slow in coming to market in recent years.

Investigators, who questioned approximately 100 companies earlier this year, including Pfizer, GlaxoSmithKline and Sanofi-Aventis, are now turning to other organisations, including associations of doctors, patients and pharmacists, as well as government agencies that set the prices of prescription drugs in Europe. That could make it the broadest antitrust investigation ever in the EU.

If Kroes determines that companies who make and sell medicines are using unfair practices, she could impose large fines - as has already happened once to AstraZeneca - and recommend changes to the operation of the industry.

EPHA urges the EU to adopt changes in the current legislation so as to make it easier for generics companies to place less-expensive drugs on the market as soon as patents expire - on "Day 1" rather than months afterwards - and discourage large pharmaceutical companies from suing makers of generics drugs for suspected patent violations that later turn out to be unfounded.

Yet EU investigators also appear to be turning their investigation on generics companies, too, asking whether they have accepted payments from brand-name drug makers as part of patent litigation, perhaps in exchange for launching a medicine later than originally intended. In the United States, the Federal Trade Commission has said these so-called reverse payments violate antitrust law by dividing up the market.

Read the full article here.