J&J Sues Boehringer Unit Over Doxil Production Pact

Johnson & Johnson sued a unit of Boehringer Ingelheim Gmbh over whether a dispute about an agreement to produce the cancer drug Doxil must be submitted to arbitration.

Lawyers for New Brunswick, New Jersey-based J&J, the world’s biggest seller of health-care products, contend executives of Boehringer’s U.S. unit violated a 2009 agreement to make Doxil, used to treat ovarian cancer, and left J&J scrambling to meet demand, according to court filings unsealed in Delaware Chancery Court in Wilmington.

“BI’s breach of the agreement cannot be seriously disputed,” J&J said in a redacted version of the complaint filed yesterday. The lawsuit was filed under seal this week.

Jennifer Forsyth, a U.S.-based spokeswoman for Boehringer, didn’t immediately respond to a phone call for comment on the unsealed suit.

Closely held Boehringer, based in Ingelheim, Germany, won U.S. approval in July for a lung-cancer therapy designed to work with a gene test that pinpoints which patients will best respond to the medication. Lung cancer is the leading cause of U.S. cancer deaths, according to the American Cancer Society.

J&J’s Alza Corp. unit hired Boehringer as its “sole-source manufacturer” of Doxil in 1995 because the drugmaker’s Ben Venue Laboratories unit had special expertise in producing the drug, according to the court filings.

Production Snags

Doxil production hit a snag in 2011 when a Boehringer manufacturing plant in Ohio was forced to halt after regulators questioned the quality of the products being made at the facility. J&J said publicly at the time that it planned to hire another company to make the medicine.

A 2011 FDA inspection of the Bedford, Ohio, plant found a lack of routine maintenance and failure to find the source of microbial contaminants, according to the Cleveland Plain Dealer newspaper.

Because of Doxil shortages tied to Boehringer’s production woes, the U.S. Food and Drug Administration gave approval to India’s Sun Pharmaceuticals Industries Ltd. to sell a generic form of the drug starting in February, according to the unsealed court filings.

Despite generic competition “there remains strong demand” for brand-name Doxil, J&J said in the filings. “Although sales of most brand drugs rapidly diminish when a generic version is introduced, utilization of Doxil has remained high.”

J&J officials are asking Delaware Chancery Judge Leo Strine to order Boehringer to honor its agreement to submit disputes over Doxil production to an arbitrator.

“J&J’s right to arbitration is clear,” the drugmaker’s attorneys said in the unsealed filings.

The Delaware case is Alza Corp. v. Boehringer Ingelheim USA Corp., 8877, Delaware Chancery Court (Wilmington).

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