J&J: Abbott owes $2.1 billion in Humira royalties
Johnson & Johnson's Centocor told a U.S. jury today it was entitled to a $2.1 billion slice of the revenue Abbott Laboratories gets from selling the arthritis drug Humira.
Centocor claims Humira is made using technology developed by New York University and exclusively licensed to the J&J unit. The NYU property related to antibodies against tumor necrosis factor, or TNF, which is linked to inflammation. Humira works by blocking the action of the TNF protein.
"Centocor is not seeking to take Humira off the market; we just want to compete fair and square," Centocor lawyer Dianne Elderkin of Woodcock Washburn in Philadelphia told the federal jury in Marshall, Texas. "The bottom line is, if someone uses someone else's product, they should pay for it."
Humira, the biggest seller for Abbott Park-based Abbott, generated $4.5 billion in global sales last year, or about 15 percent of Abbott's total revenue. The company has projected global sales growth of Humira of 15 percent to 20 percent this year.
Humira sales rose 17 percent in the first quarter to $1.02 billion. The drug costs about $19,000 a year.
"We're seeking $2.1 billion to Centocor in damages," Elderkin said. "Even if you award $2.1 billion to Centocor, Abbott will still be left with more than that in profit."
Abbott countered that it hasn't infringed Centocor's property and the patents are invalid.
'Grossly Inflated'
"In any event, Johnson & Johnson's damage request is grossly inflated and not supported by either the facts or the law," said company spokesman Scott Stoffel.
Abbott contends the patent doesn't cover the human antibodies that are used in Humira, and they are invalid because scientists couldn't make fully human antibodies against TNF in a laboratory in 1994, the date set by the court as the time of the invention.
"Centocor's fully human antibody has only been on the market for one month," Abbott lawyer Ali Hassan Shah told the court. "Abbott has been on the market since 2002. The products are completely different."
The trial before U.S. District Judge T. John Ward is scheduled to be completed by June 30.
J&J makes the competing medicine Remicade, which generated $3.75 billion in sales for the New Brunswick, New Jersey-based company, mostly in the U.S. Global sales of Remicade by J&J and marketing partners were $6.2 billion, according to data compiled by Bloomberg.
Autoimmune Treatments
The patent is licensed to J&J for use in Remicade, which is made with a combination of mouse and human antibodies. J&J and NYU claim the patent covers both the combination and fully human antibodies against TNF.
Both Humira and Remicade are autoimmune treatments based on inhibiting the germ-fighting protein TNF. When the body produces too much TNF, it can cause the immune system to attack healthy tissue and leads to inflammation.
Humira is approved for six indications, including the skin disease psoriasis and Crohn's Disease, an inflammation of the bowel. The largest number of prescriptions is for rheumatoid arthritis, which can cause long-term joint damage, resulting in chronic pain and loss of movement.
Rheumatoid Arthritis
About 1.3 million people in the U.S. have rheumatoid arthritis, according to the Arthritis Society, an Atlanta-based nonprofit.
The University of Iowa and its research foundation that licenses the school's intellectual property sued Abbott today, also seeking royalties on Humira. The school said it owns two patents related to tools to "promote the expression of genes and production of proteins that are important in the production of many life saving protein-based drugs now on the market."
Iowa University said it has granted 112 licenses and received "millions of dollars" from the patents. It wants a court to order Abbott to pay an unspecified amount for use of the patented technology, according to the complaint filed in federal court in Davenport, Iowa.
In response to that suit, Stoffel said "Abbott believes that Humira does not infringe these patents and that these patents are invalid" and Abbott "will vigorously defend against the allegations."
New Medicine
Abbott has a separate lawsuit against J&J over a new medicine called Simponi. The drug, whose chemical name is golimumab, is infringing a patent issued to Abbott in 2007, Abbott claims in a complaint filed last month in Worcester, Massachusetts. Simponi, like Humira, is made with just human antibodies and not the combination of mouse and human.
Bayer AG's HealthCare unit also is trying to collect royalties on Humira. Abbott is challenging the Bayer patent in court. Both the Simponi and Bayer lawsuits are pending in Massachusetts.
The cases are Centocor Inc. v. Abbott Laboratories, 07cv139, U.S. District Court for the Eastern District of Texas (Marshall) and University of Iowa v. Abbott Laboratories, 09-99, U.S. District Court for the Southern District of Iowa (Davenport).