The International Trade Commission is a hot forum for patent disputes, but it's almost never used by pharmaceutical companies, whose IP cases typically involve specialized fights between brand name and generic drug makers.
That may be changing. In a novel strategy to beat back generic competition to its blockbuster cancer drug Gemzar, Eli Lilly and Co. has turned to the ITC.
The company got a green light today to bring a patent case seeking to block importation of the generic version Gemzar, known as gemcitabine.
Lilly claims that Hospira Inc. of Lake Forest, Ill., contracted with Jiangsu Hansoh Pharmaceutical Co. Ltd. of China, Intas Pharmaceuticals Ltd. of India, and ChemWerth Inc. of Woodbridge, Conn., to make gemcitabine using a manufacturing process that infringes its patent.
Hospira received approval from the Food and Drug Administration to make generic gemcitabine in November. The injectible drug is used to treat lung, breast, pancreatic and ovarian cancer and generated $750 million in sales in the United States for Lilly in 2009.
Lilly, represented by Finnegan, Henderson, Farrabow, Garett & Dunner, says its patent covers a way to make the drug that involves fewer steps, higher yields and lower costs. Lilly claims the process disclosed by the respondents is not commercially viable and alleges that they’re illegally using Lilly’s method instead.
Lilly wants the ITC to issue an exclusion order blocking importation of the generic drug.
Winston & Strawn partner James Hurst, who represents Hospira, vigorously disputes the charges. “Looking below the surface of Lilly’s accusations shows that they have no basis, and Lilly has failed repeatedly to prop them up with anything more than inconsistencies, contradictions, and speculation,” he wrote in a March 15 letter to the ITC.
He also noted that Lilly puts the “burden on Hospira to disprove infringement” in the manufacturing process, and that there is “no support for Lilly’s statement that Hospira’s process is not commercially viable.”
Intas counsel Daniel Yonan of Sterne, Kessler, Goldstein & Fox is equally indignant, writing on Feb. 2 that Lilly’s assertions are “unsupported and ignore readily accessible public information, as well as Lilly’s prior, gratuitous litigation.”
Indeed, related litigation spans the country and the globe. Lilly has sued Hospira and others in Indianapolis federal court and Hospira sued Lilly in the Northern District of Illinois. Disputes over the patent have also been filed in Canada, Singapore, Denmark, the United Kingdom, Australia and China.
Oblon, Spivak, McClelland, Maier & Neustadt partner Eric Schweibenz, who is not involved in the case, said it’s common for companies to use ITC cases as “a strategic counter-strike to other litigation.”
But he’s doubtful that the Lilly case marks the rush of big pharma to embrace the ITC, noting that many disputes may not satisfy the forum’s requirement that a product (at least in part) be made abroad. Nor is the ITC’s speed in resolving patent cases necessarily appealing to brand-name drug makers looking to extend the life of their patents.