U.S. judge orders Biogen , Berlex officials deposed .
Leslie Gevirtz
BOSTON 1996-08-28
In order to help him decide whether he should hear the case , a U.S. District Court judge Wednesday ordered the legal counsels of Biogen Inc and Berlex Laboratories , a subsidiary of Schering AG , deposed .
The tempest beyond the test tube involves allegations that the U.S. Food and Drug Administration violated the Orphan Drug law by allowing Biogen the right to sell its multiple sclerosis drug Avonex .
Berlex also charges that Avonex is so similar to its MS drug , Betaseron , that it is a patent infringement .
Both drugs are types of interferon .
One analyst said sales of Avonex had already cut into Betaseron market share .
BioVest Research , Inc 's analyst Eddie Hedaya said , " Berlex sales are losing share like mad ...
my understanding of the marketplace is that they 're below expectations . "
He added Chiron Corp reported its sales of inventory to Berlex was down .
Chiron makes Betaseron ; Berlex markets it , he said .
Biogen , in its Securities and Exchange Commission quarterly report for the period ending June 30 , said it had earned $ 6.1 million from Avonex sales during the drugs first six weeks on the market .
When it approved Avonex in May , the FDA said both Biogen 's product and Betaseron were developed under the incentives of the Ophran Drug Act which provides seven years of marketing exclusivity for products that treat rare diseases .
Avonex " has been allowed to enter the market because it differs from interferon beta-1b ( Betaseron ) ..
. "
the FDA said .
Now , U.S. District Judge Mark Wolf has ordered the chief counsel for Biogen , Michael Astrue , and Robert Chabora , his counterpart at Berlex be deposed about a May 21 meeting the two men attended to help him determine whether the lawsuit filed by Biogen against Berlex should be heard in Massachusetts .
Berlex filed a lawsuit against Biogen in U.S. District Court in Newark , N.J. in July , but Biogen had already filed a suit against Berlex in Massachusetts in May .
Wolf ordered the depositions to determine if he or U.S. District Judge John Bissell of Newark should preside over the case .