Indiana consortium targeting patent infringers

The Indiana Proteomics Consortium (Inproteo), formed last year by Eli Lilly, Indiana University, and Purdue University, plans to aggressively pursue users of Lilly's pioneering His-tag protein separation technology 17 years after the patent was issued. Inproteo will be seeking lump sum payments and license fees from hundreds of companies and research universities that have commercialized products or have patented their own discoveries based on the technique. "If you use this technology to purify proteins, polypeptides, lipids, whatever, then you'll be infringing the patent," said Inproteo President John G.R. Hurrell. Lilly's so-called Smith patent, named after researcher Michele C. Smith, was awarded in February 1986. The technology described a process for separating and purifying polypeptides and proteins by using immobilized metal ion chelating peptides containing histidine. Many commonly used protein separation techniques and reagents are derived from His-tag technology, but only a handful of companies and research universities have licensed it. This is largely because Eli Lilly did not actively seek to license its discovery. The company "wasn't worried" about others using its invention, Hurrell said. "Lilly was not in the business of licensing technology; they were in the business of making drugs." Since 1986, only about a dozen companies, including Roche, obtained licenses, he said. But because the patent expires next year, Lilly tasked Inproteo to track down suspected infringers and negotiate license fees for up to 6 years of past usage, the maximum allowed by the patent law. "Some people in Lilly felt there was a significant opportunity out there because people have ignored the patent," Hurrell said. Inproteo has identified 500 to 600 companies and universities worldwide that it believes are infringing the patent. These include pharmaceutical and biotech companies as well as research universities. "Our objective is not to stop people from using it. But if they have created a commercial enterprise, we believe Lilly, and now we, have a right to a portion of it," Hurrell said. In addition to a lump sum payment, users will be required to pay a license fee and a fee per patent. Hurrell said these fees would not be "onerous." He declined to name any of the companies or universities. "We are not interested in trying to squeeze money from research universities," Hurrell added. But if those universities have obtained or filed their own patents citing Lilly's patent, it indicates their intent to commercialize a discovery, he said. "We're going to be very aggressive in contacting them." Lilly will get a portion of any license revenues, and Inproteo plans to use the balance to fund additional biotech research and development in Indiana. Inproteo employs about 20 academic-appointed scientists who seek to develop novel proteomics instrumentation and analytical methods of interest to Lilly's drug discovery efforts. But because Lilly waited so many years before going after potential patent infringers, Inproteo may have a problem collecting license fees, said Richard Lebovitz, a biotech patent attorney with Millen, White, Zelano, & Branigan in Arlington, Va. Under the legal doctrine called "laches," patent owners may not be able to collect damages or royalties if they didn't actively pursue past infringements. "A patent owner cannot just sleep on his rights, do nothing for many years, and then suddenly decide to collect royalties on his patent," Lebovitz said. "If the patent owner knew, or should have known, that his patent was being infringed, and he has done nothing about it, he may have forfeited his right to collect," said Lebovitz, who holds a doctorate in biology from Princeton University and teaches bioethics at George Mason University. But Hurrell denied that Lilly abandoned its patent. "Lilly has been writing licenses since the early 1980s. They had just never aggressively gone out and written letters to people who have used the technology. That was not their primary business," he said. Lilly's licensing action is the latest involving pioneering patents. Five large biotech and pharmaceutical companies recently sued Columbia University, accusing it of having illegally extended the life of key patents to maintain highly lucrative licensing revenues. Columbia's Axel patents, named for researcher Richard Axel, cover the cotransformation process, a method for the recombinant DNA synthesis of complex proteins in mammalian cells. The process, which has been used to make new pharmaceuticals, has brought the university $300 to $400 million since 1983. Because all the companies and universities Inproteo plans to pursue have applied for or received their own patents, "they obviously expect the legal system to protect their patents," Hurrell said. "And we expect the legal system to protect our patents." _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Letter to the Editor, September 25, 2003: 6xHis peptides are state-of-the art technology tags for the purification of recombinant proteins and have significantly facilitated downstream applications like protein interaction assays, protein activity assay, and large-scale synthesis of recombinant proteins and antibodies. Therefore, your article on September 3, 2003 (above), has created a stir in the scientific community. Inproteo has said that they will sue infringers of Eli Lilly's His-tag patent. Because many of these researchers are working with products supplied by Qiagen, the question of whether researchers have to acquire a license from Inproteo arose. The technology describing the process of separating and purifying polypeptides and proteins by using immobilized metal ion chelating peptides containing polyhistidines was granted to Lilly in 1986 (US patent 4,569,974 and its foreign equivalents) and also by F. Hoffmann-La Roche Ltd. in 1989 and 1994 (US patents 4,877,830 and 5,284,933 and their foreign equivalents). Hilden, Germany-based Qiagen, has received an exclusive license from La Roche to market their 6xHis technology and to produce and sell nitrilotriacetic (NTA) resin and 6xHis coding vectors. In 1990, Roche and Lilly entered into an agreement to grant each other rights under their patents for protein purification, including the right for Roche to grant sublicenses under the Lilly patent, with Qiagen as a sublicensee approved by Lilly. That means that Qiagen is a sublicensee under both the Lilly patent and Roche patents, which allows Qiagen's customers the use of the 6xHis-tag technology for research purposes. Included in the costs of Qiagen's products, such as the pQE series of 6xHis expression vectors, the Ni-NTA purification matrices, and the EasyXpress system for in vitro protein expression, are the license fees under both Roche's and Lilly's patent rights. Therefore, no further license from Elli Lilly or Inproteo is necessary for customers who are buying and using Qiagen's products for cloning, isolation, and purification of recombinant His-tagged proteins. However, researchers need licenses from Roche if they wish to use the 6xHis-tag technology in diagnostics or for contract manufacturing. If companies or universities are buying His-tag technology–based products from suppliers that do not have licenses like ours, they may get into trouble with Inproteo and the Lilly patent, which expires in the United States on December 4th, 2004. Dr. Martin Potgeter (martin.potgeter@qiagen.com) Business Development Associate Director, Qiagen _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Indiana consortium targeting patent infringers

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