The University of Iowa Research Foundation (UIRF) in Iowa City has sued Abbott Laboratories for allegedly infringing a pair of UIRF-owned patents related to a cytomegalovirus (CMV) promoter used to manufacture a number of vaccines and therapeutics. The suit, filed in the U.S. District Court for the Southern District of Iowa, claims that Abbott has infringed one or more claims by manufacturing its blockbuster monoclonal antibody Humira, which is used to treat a variety of autoimmune diseases. UIRF, an independent non-profit corporation that handles technology transfer for the University of Iowa, is seeking enhanced monetary damages because it says Abbott “willfully and deliberately” infringed the patents. Interestingly, a similar lawsuit over Humira, brought by Johnson & Johnson’s Centocor and New York University, was decided last week. The jury verdict went in favor of J&J and NYU, to the tune of $1.67 billion in lost profits and reasonable royalty. The jury also found that Abbott had willfully infringed the Centocor-NYU patents.

The UIRF complaint alleges that Humira also infringes U.S. Patents 5,168,062 and 5,385,839, “Transfer vectors and microorganisms containing human cytomegalovirus immediate-early promoter-regulatory DNA sequence.” Both patents are based on the inventions of Mark Stinski, professor of microbial biology at the UI Carver College of Medicine. Because the ‘839 patent is a continuation of the ‘062 patent, which was awarded December 1, 1992, under U.S. patent law both patents would expire December 1 of this year. According to Timothy B. McBride, an associate specializing in biotech patent law with St. Louis, MO-based Senniger Powers, LLP, a patent holder “can only sue on a patent that still has term, or is still valid. Certainly [UIRF] would want to sue now while that is still an active patent.” UIRF’s suit claims the CMV promoter is “a fundamental tool used in the biotech industry to enhance the manufacture of vaccines and therapeutics.” UIRF said that it has granted 112 active licenses to the patents, including 16 linked to royalty-bearing products. According to the Institute’s 2008 annual report, the CMV patents accounted for nearly all royalties received by the school and for approximately three quarters of UIRF’s overall income of $28.6 million. UIRF said that it received approximately $21.5 million from royalties on product sales in 2008, or an average of approximately $1.3 million per royalty-bearing license for the patents. In its complaint, UIRF claims that Abbott Labs and subsidiaries Abbott Bioresearch Center and Abbott Biotechnology “illegally use or contribute to the use or induce the use of compositions covered by one or more claims of the Iowa patents to manufacture the pharmaceutical product Humira.” The complaint does not specify which claims of the patents are allegedly infringed in the manufacture of Humira, a fully recombinant mAb for treating autoimmune disorders in which tumor necrosis factor plays a role, including rheumatoid arthritis, chronic plaque psoriasis, Crohn’s disease, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis. Worldwide sales of Humira increased to $4.5 billion last year from $3 billion in 2007 and are projected to increase by more than 25% this year, according to Abbott. In a statement, Abbott said that it “believes that Humira does not infringe these patents, and that the patents are invalid.” The company will “vigorously defend against the allegations,” the statement said.

Like NYU, UIRF is seeking “enhanced damages” based on the claim that Abbott’s activities were willful. “It might be a little more difficult to calculate damages when the patent is something that is used along the way in manufacturing the product,” but it’s possible that damages would be awarded just as if the patents covered the core product itself, McBride says. The case is a “perfect example of a university doing wonderful research, creating a product that’s useful, and then obtaining patent rights and being able to exercise those rights to benefit the university,” he adds. The suit also “demonstrates that universities are forces to be reckoned with when it comes to technology and intellectual property. They understand what is at stake in this game, and they’re not afraid to play it.”

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Posted July 1st, 2009 under Tech Transfer

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