Federal Circuit strikes down Apotex patent for inequitable conduct

The US Court of Appeals for the Federal Circuit has affirmed a lower court’s ruling that an Apotex patent covering a method of making a drug is unenforceable due to inequitable conduct by the company’s founder and chairman Bernard Sherman.

Apotex, Canada’s largest manufacturer of generic drugs, appealed against the decision from the US District Court for the Southern District of Florida.

In its ruling last Friday (August 15), the Federal Circuit agreed with the district court, finding that it did not “abuse its discretion in finding inequitable conduct”.

The patent at suit, 6,767,556, covers a process for manufacturing moexipril tablets, which are used to treat hypertension and congestive heart failure. Sherman wrote the patent application and is listed as its main inventor.

Apotex sued drug company UCB in 2012, accusing it of infringing the ‘556 patent by manufacturing and selling its moexipril products Univasc and Uniretic, as well as generic versions of those drugs.

The appeals court found, however, that these products were made in accordance with a method listed in another patent that UCB licenses from Warner-Lambert.

“Specifically, the district court found that Dr Sherman was aware that Univasc was made according to his claimed process, concealed this knowledge from the USPTO, and misrepresented the nature of Univasc and the prior art through his counsel’s arguments,” it said in the appeals court’s decision.

The district court also found that Sherman had withheld prior art and submitted results of experiments that he never conducted to support his patent application.

The appeals court approved the district court’s ruling in favour of UCB.

According to Forbes, Sherman has a net worth of $3.9 billion.