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University of Iowa Sues Abbott Claiming Humira Manufacture Infringes CMV Promoter IP

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By Ben Butkus

The University of Iowa Research Foundation has sued Abbott Laboratories for allegedly infringing a pair of UIRF-owned patents related to a cytomegalovirus promoter used to manufacture a number of vaccines and therapeutics.

The suit, filed this week in the US District Court for the Southern District of Iowa, claims that Abbott has infringed one or more claims of the patents by manufacturing its billion-dollar 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 has "willfully and deliberately" infringed the patents.

In a statement, Abbott said that it "believes that Humira does not infringe these patents, and that the patents are invalid," and that it will "vigorously defend against the allegations."

In September 2008, UIRF sued Amgen over the same patents, claiming that the company infringed the patents by manufacturing biologic therapies such as Enbrel and Vectibix (see BTW, 9/10/08).

According to court documents, UIRF voluntarily dismissed that case in March of this year, although the reasons for the dismissal are unclear. UIRF referred questions about the suit to its outside legal counsel, which declined to comment on the suit.

Like the lawsuit against Amgen, the complaint against Abbott centers on US Patent Nos. 5,168,062 and 5,385,839, entitled "Transfer vectors and microorganisms containing human cytomegalovirus immediate-early promoter-regulatory DNA sequence." Both patents are based on the inventions of Mark Stinski, a professor of microbial biology at the UI Carver College of Medicine.

The '839 patent is a continuation of the '062 patent, which was awarded on Dec. 1, 1992. As such, under US patent law, both patents would expire on Dec. 1 of this year.

According to Timothy McBride, an associate specializing in biotechnology patent law with Senniger Powers, a patent holder "can only sue on a patent that still has term, or is still valid. Certainly [IURF] would want to sue now while that is still an active patent."

The suit claims that the CMV promoter is "a fundamental tool used in the biotech industry to enhance the manufacture of vaccines and therapeutics." IURF said that it has granted 112 active licenses to the patents, including 16 linked to royalty-bearing products.

Examples of marketed pharmaceutical products produced using the CMV promoter technique include Rituxan and Zevalin for treating non-Hodgkin's lymphoma; Synagis, for treating respiratory syncytial virus; ReFacto, for treating factor V deficiency in hemophilia; and Zenapax, for preventing acute organ rejection following transplant.

IURF said that it received approximately $21.5 million from royalties on product sales in 2008, which means that it averaged approximately $1.3 million per royalty-bearing license for the patents.

According to IURF's 2008 annual report, the CMV patents accounted for nearly all royalties received by the school, and accounted for approximately three quarters of IURF's overall income of $28.6 million.

In its complaint, UIRF claims that Abbott Labs and its subsidiaries Abbott Bioresearch Center and Abbott Biotechnology "do not have such a license, and … [Abbott] infringes the Iowa patents when … it and its affiliates use the inventions covered by the claims of the [patents] to manufacture pharmaceutical products including, without limitation, Humira."

Specifically, the suit claims that the defendants "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.

UIRF is seeking judgment from the court that Abbott has directly and indirectly infringed one or more claims of the '062 and '839 patents; that it is entitled to monetary damages as determined by a jury; and "enhanced damages" based on the claim that Abbott's activities were willful.

Humira is 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.

The biologic blocks the body's production of TNF, reducing the inflammation and some of the complications associated with the aforementioned diseases, according to Abbott. Worldwide sales of Humira increased to $4.5 billion last year from $3 billion in 2007 and $2 billion in 2006, and are forecasted to increase by more than 25 percent this year, Abbott said.

Humira is approved in 77 countries and currently treats approximately 340,000 patients worldwide. Abbott is also studying two additional indications for the biologic, it said.

It would appear that IURF believes it has a fairly large financial stake in the suit. Senniger Powers' McBride said that "damages can really fluctuate and you can use a number of different models to calculate them.

"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 is possible that damages would be awarded just as if the patents covered the core product itself, he added.

McBride also said that 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.

"A lot of times universities might overlook opportunities that a technology like this can bring them, and is a perfect example of why they should focus on the technology they have, obtain IP rights, and exercise those rights," he added.

"It demonstrates as well that universities are forces to be reckoned with when it comes to technology and intellectual property," McBride said. "They don't necessarily roll over easy. They understand what is at stake in this game, and they're not afraid to play it."

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