Articles
Lexicon Genetics Patents Creation Of Knockout Mice 12/04/03
Thu, 12/04/2024 - 11:08am
Lexicon Genetics Incorporated obtained a patent this weak entitled "High Efficiency Gene Targeting in Mouse Embryonic Stem Cells" that covers methods of producing genetically engineered knockout mice by gene targeting. US Patent No. 6,653,113 (the "113 patent") provides Lexicon the exclusive rights to methods widely used in the pharmaceutical and biotechnology industries for drug discovery.
"The patent covers the most efficient and commonly used technique for making a gene knockout," says Arthur Sands, MD, PhD, president and CEO of Lexicon. "The technology has a direct role in commercial drug discovery research."
Several pharmaceutical and biotechnology companies, have sublicenses to the technology covered by the patent for internal research including Pfizer Inc., GlaxoSmithKline Plc., Merck & Co. Inc., Aventis Pharmaceuticals Inc., Amgen Inc., Genentech Inc., Biogen Idec Inc., and Millennium Pharmaceuticals Inc.
Lexicon scientists use gene knockout technology to study the physiological functions of genes in mice and identify the genes that encode potential targets. "Most drugs act by blocking their target," says Sands. "The gene knockout technology provides the most efficient way to genetically block any target in an animal model. The model behaves as if it's on the ideal drug and we can observe the effects to predict the physiological effect of a drug in humans. It's the most direct way to see the potential of a drug before its invention," he says.
Researchers at Lexicon recently used mouse knockouts to identify a novel gene target for controlling hypertension. Mice with reduced levels of a gene called WNK1 reacted with lower blood pressure. "The mice knockout directly demonstrates the effectiveness of a drug that blocks that target," says Sands.
The 113 patent, according to the company, covers the use of vectors in gene targeting possessing specified degrees of DNA sequence identity with the vector's intended target in the chromosome of a mouse embryonic stem cell.
"This patent does give me pause," says Richard Lebovitz, PhD, a biotech patent attorney with Millen, White, Zelano, & Branigan, in Arlington, Va. "It covers a technique of making transgenic mice using a method called homologous recombination that is widely used in the industry."
There are a couple of ambiguities about the patent, says Lebovitz, that make it hard to determine precisely what it covers. "It requires the use of DNA from one strain to be introduced back into the same mouse strain. This step is widely used to make knock-out mice."
"The big question is whether this introduced sequence has to be 100% from the same mouse, or whether it can contain sequences from other strains of mice," says Lebovitz. "If it's the latter, then the company has a pretty broad patent on their hands. If it's the former, then there are ways around the patent, such as using a DNA sequence from an unrelated mouse strain."
As for the patent's effect on academic research, "that's a difficult question," says Lance Ishimoto, vice president of intellectual property. "The line between academic and commercial research is blurring. For pure academic research, there is no issue. It's exempt from patent infringement. But things become more complicated when commercial funding is involved, or when the researchers try to commercialize their research. We are always willing to talk with researchers on these issues."
"The patent covers the most efficient and commonly used technique for making a gene knockout," says Arthur Sands, MD, PhD, president and CEO of Lexicon. "The technology has a direct role in commercial drug discovery research."
Several pharmaceutical and biotechnology companies, have sublicenses to the technology covered by the patent for internal research including Pfizer Inc., GlaxoSmithKline Plc., Merck & Co. Inc., Aventis Pharmaceuticals Inc., Amgen Inc., Genentech Inc., Biogen Idec Inc., and Millennium Pharmaceuticals Inc.
Lexicon scientists use gene knockout technology to study the physiological functions of genes in mice and identify the genes that encode potential targets. "Most drugs act by blocking their target," says Sands. "The gene knockout technology provides the most efficient way to genetically block any target in an animal model. The model behaves as if it's on the ideal drug and we can observe the effects to predict the physiological effect of a drug in humans. It's the most direct way to see the potential of a drug before its invention," he says.
Researchers at Lexicon recently used mouse knockouts to identify a novel gene target for controlling hypertension. Mice with reduced levels of a gene called WNK1 reacted with lower blood pressure. "The mice knockout directly demonstrates the effectiveness of a drug that blocks that target," says Sands.
The 113 patent, according to the company, covers the use of vectors in gene targeting possessing specified degrees of DNA sequence identity with the vector's intended target in the chromosome of a mouse embryonic stem cell.
"This patent does give me pause," says Richard Lebovitz, PhD, a biotech patent attorney with Millen, White, Zelano, & Branigan, in Arlington, Va. "It covers a technique of making transgenic mice using a method called homologous recombination that is widely used in the industry."
There are a couple of ambiguities about the patent, says Lebovitz, that make it hard to determine precisely what it covers. "It requires the use of DNA from one strain to be introduced back into the same mouse strain. This step is widely used to make knock-out mice."
"The big question is whether this introduced sequence has to be 100% from the same mouse, or whether it can contain sequences from other strains of mice," says Lebovitz. "If it's the latter, then the company has a pretty broad patent on their hands. If it's the former, then there are ways around the patent, such as using a DNA sequence from an unrelated mouse strain."
As for the patent's effect on academic research, "that's a difficult question," says Lance Ishimoto, vice president of intellectual property. "The line between academic and commercial research is blurring. For pure academic research, there is no issue. It's exempt from patent infringement. But things become more complicated when commercial funding is involved, or when the researchers try to commercialize their research. We are always willing to talk with researchers on these issues."
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