Amgen Sued by Its Marketing Partner
Amgen Inc., a Thousand Oaks biotechnology company already embroiled in patent lawsuits over its new anti-anemia drug, has been hit with another suit from its own marketing partner, consumer products giant Johnson & Johnson.
Ortho Pharmaceutical, a Johnson & Johnson unit, asked a federal court in Delaware to block Amgen’s effort to get federal approval for the drug and to begin marketing it.
Amgen is awaiting approval from the Food and Drug Administration to start selling the drug, which is generally known as EPO but also carries the brand name Epogen. It helps curb anemia by boosting production of red blood cells.
A Johnson & Johnson spokesman told Reuters news service that the company wants Amgen to comply with the obligations of a contract that the two companies signed in 1985. The deal gives Ortho the drug’s U.S. distribution rights for uses other than treatment of anemia in kidney dialysis patients, the spokesman said. Such uses might include treating anemia caused by cancer therapies as well as by AZT, the only federally approved anti-AIDS drug.
Johnson & Johnson claims that the contract compelled Amgen to list Ortho as a distributor of the drug in its application to the FDA. Amgen did not do this and did not submit Ortho’s tests of the drug on non-dialysis patients, the spokesman said. Ortho wants the court to prohibit Amgen from selling the drug until it files a product license application on Ortho’s behalf.
Called ‘Unjustified’
Otherwise, Ortho is apparently worried that its marketing of the product could be delayed in the United States.
But Amgen issued a statement terming Ortho’s request “highly unusual and completely unjustified.” The company said Johnson & Johnson “should suffer the commercial consequences of its inability” to file its own application “on a timely basis and should not be allowed to interfere with Amgen’s approval and sale” of EPO.
A federal judge has agreed to schedule a hearing on the case in the first week of March, the Johnson & Johnson spokesman said.
The clash between the partners unsettled investors. Amgen’s common stock closed at $37.25 a share, down 75 cents, in over-the-counter trading.
“The stock is off because it is a bad sign that partners have to resolve their differences in court,” said Peter Drake of Vector Securities. “This came as a shock to a lot of people.”
Other Legal Problems
The Johnson & Johnson spokesman said the suit was not “an attempt to delay the FDA review of the drug” but was instead “a last resort we took after months of negotiations to try to sort out our differences.”
The lawsuit adds to Amgen’s list of legal tangles. The company is locked in several patent-infringement suits with its chief rival, Genetics Institute, a biotech company in Cambridge, Mass., which, with Chugai Pharmaceutical in Japan, is racing to get its own version of EPO approved for sale in the United States.
On Thursday, a federal judge in Boston dissolved a temporary restraining order that had prevented Genetics Institute from making and selling its version of EPO, and urged a speedy trial in the matter.
