AstraZeneca, Europe' second largest drug maker, is being investigated by the European Commission for possible abuse of the patent system.
The EU executive said it believed the Anglo-Swedish group may have post-dated marketing authorisation for its Losec drug in order to extend its period of exclusivity in certain countries - thereby preventing rival groups from entering the market with cheaper versions of the drug.
Losec is used for treating stomach ulcers and other acid-related diseases. By the end of the 1990s, it was the world's best-selling prescription medicine, but has since suffered against generic competition.
AstraZeneca said it "vigorously denied any wrongdoing" and described the charges as "novel".
Damaging evidence
EU Competition Commissioner Mario Monti insisted the case was not seeking to weaken patent rights, which they said were "indispensable" for the pharmaceutical industry.
"This.....is about suspected misuses of governmental systems and procedures which have the effect of blocking or delaying entry to the market of cheaper medicines," said Mr Monti.
The Commission began its probe after receiving complaints from two rival manufacturers in 1999.
They raided AstraZeneca offices in London and in Sweden in February 2000, and it is evidence from these raids that the Commission is now using to accuse the firm.
It says AstraZeneca concealed from the national patent offices the date when it received the first marketing authorisation for Losec when it applied for an extension of patent protection.
"In the commission's view, the company could not have obtained the extra protection in the absence of its misrepresentations," said the EU.
The drug firm said it would defend itself against the claims.
"The allegations made by the commission should be rejected as groundless," said the group.