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U of Iowa Settles Dispute with Amgen over Stinski Patents; Abbott Suit Still Ongoing

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This article was originally published on Aug. 14.

Amgen and the University of Iowa Research Foundation have settled a patent-infringement lawsuit filed last year by UIRF related to a pair of patents for a cytomegalovirus promoter used to manufacture a number of marketed vaccines and therapeutics, Amgen officials said this week.

The Iowa Press-Citizen reported this week that the settlement was reached in March and was for $19 million. However, it also reported that UI officials had yet to comment on the matter.

Earlier today, a spokesperson for the university wrote in an e-mail to BTW that a confidentiality agreement prevents the University of Iowa from commenting on the case.

David Polk, executive director of corporate communications for Amgen, confirmed in an e-mail to BTW that a settlement had been reached, but did not confirm the amount.

UIRF, the independent non-profit technology-transfer company for the University of Iowa, filed the suit last September in the US District Court for the Southern District of Iowa, claiming that Amgen infringed one or more claims of the patents by manufacturing its billion-dollar blockbuster anti-inflammatory Enbrel and moncoclonal antibody Vectibix (see BTW, 9/10/2008).

Specifically, UIRF claimed that Amgen infringed US Patent Nos. 5,168,062 and 5,385,839, both of which are based on inventions by Mark Stinski, a professor of microbial virology at IU’s Carver College of Medicine.

Both patents are directed to a human cytomegalovirus promoter-regulatory sequence that was obtained from purified HCMV DNA, according to the patents.

Enbrel is a tumor necrosis factor blocker used to treat rheumatoid arthritis, psoriasis, ankylosing spondylitis, psoriatic arthritis, and juvenile rheumatoid arthritis; while Vectibix is a human monoclonal antibody used to treat metastatic colorectal carcinoma following chemotherapy.

According to Amgen's 2008 financial report, worldwide product sales of Enbrel totaled $3.6 billion last year, up 11 percent from $3.2 billion in 2007. Amgen co-markets Enbrel in the US and Canada with Wyeth. The company did not break out sales figures for Vectibix.

"Amgen is pleased to have reached a settlement with [UI] and UIRF that ends the dispute," Polk said this week. "Amgen denies the allegations of the complaint and makes no admission regarding any validity or infringement of patents that were the subject of the dispute."

Court documents filed in March confirm that UIRF voluntarily dismissed that case, but didn't provide reasons for the dismissal.

The CMV promoter technology is used by several biotech companies to manufacture a variety of vaccines and therapeutics, including 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.

All told, UIRF has granted 112 active licenses to the patents, including 16 linked to royalty-bearing products. In 2008, IURF received approximately $21.5 million from royalties on product sales in 2008, accounting for nearly all royalties received by the school and about three quarters of IURF's 2008 total income of $28.6 million.

UIRF also filed a similar lawsuit in June against Abbott, claiming that the company's manufacture of billion-dollar blockbuster monoclonal antibody Humira, which is used to treat a variety of autoimmune disorders, infringed upon the same UIRF patents (see BTW, 6/24/2009). That suit is ongoing, and no new court documents have been filed since the original complaint.

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 forecast to increase by more than 25 percent this year, according to the company.

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