Date: 12/30/2008
By LINDA A. JOHNSON
AP Business Writer
TRENTON, N.J. (AP) — Pharmaceutical and chemical maker Bayer AG has filed a federal lawsuit alleging that drugmaker Abbott Laboratories’ best-selling drug, Humira, infringes on a decade-old Bayer patent.
The German company’s Bayer HealthCare LLC unit sued Abbott and two of its subsidiaries, claiming the popular biotech drug used to treat severe types of arthritis and other immune disorders infringes on the U.S. patent that Bayer was awarded in 1997.
Bayer’s lawsuit was filed six years after Humira was approved for U.S. sales — and in the plaintiff-friendly U.S. District Court for the Eastern District of Texas. The lawsuit seeks triple damages for past and future patent infringement, attorney fees and other relief, but does not seek to halt sales of Humira.
Humira, which is injected, is Abbott’s top revenue driver, with sales jumping 50 percent to $1.2 billion in the third quarter. In October, the company boosted its forecast for full-year sales to $4.4 billion.
Bayer does not have any products that compete with Humira, according to spokeswoman Marcy Funk.
North Chicago-based Abbott, which was sent a summons by the court on Tuesday, will “vigorously defend against this lawsuit,” spokesman Scott Stoffel said.
“Humira does not infringe Bayer’s patent and Abbott believes Bayer’s patent is invalid,” Stoffel said.
Humira is approved to treat several serious immune system disorders, including rheumatoid and other kinds of arthritis as well as Crohn’s disease. The drug carries the risk of serious, possibly fatal, infections, including tuberculosis.
The Bayer patent in question, No. 5,654,407, covers a genetically engineered antibody that binds to and blocks the action of a type of immune system cell called tumor necrosis factor, or TNF. TNF is one of the cytokines, the “messengers” of the immune system, and stimulates inflammation, a key problem in the conditions that Humira treats.
According to the lawsuit, filed on Dec. 24 in Tyler, Texas, Bayer chose to file in the Eastern District of Texas because Abbott and subsidiaries Abbott Bioresearch Center Inc. and Abbott Biotechnology Ltd. sell and advertise Humira there.
Bayer’s lead lawyer in the case, T. John Ward Jr., is the son of a federal judge in Marshall, Texas, who helped build the Eastern District into a patent lawsuit hotbed.
Humira competes with the drug Remicade, made by Johnson & Johnson’s Centocor unit. That company and New York University filed a patent infringement suit against Abbott in April 2007, also in the Eastern District of Texas. The case is ongoing, according to Stoffel.
Abbott has a number of patents that cover Humira, including a “composition of matter” patent that doesn’t expire until 2016, he said.
Bayer said its patent runs until August 2014.
Bayer’s top drugs include the erectile dysfunction treatment Levitra, the antibiotics Cipro and Avelox, contraceptives Mirena and Yasmin, and Glucobay for diabetes. The company also makes agricultural products, coatings and plastics.
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AP Business Writer David Koenig in Dallas contributed to this report.
Copyright 2008 The Associated Press.
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