The patent was granted to Rudolf Jaenisch of Whitehead Institute, and his former post-doc Konrad Hochedlinger, now at the Massachusetts General Hospital for inventing the method for reprogramming cells to produce induced pluripotent stem cells (iPS cells). Biotech company Fate Therapeutics Inc. holds an exclusive licence from Massachusetts Institute of Technology and Jaenisch, one of its founders.
The US follows in the footsteps of the UK Intellectual Property Office, which recently awarded a similar patent to rival Californian firm iPierian for genetic programming technology to produce iPS cells. Fate Therapeutics' patent covers methods which involve introducing one or more reprogramming genes into an adult cell that has been genetically engineered to carry another pluripotency gene in its genome.
Although many consider Shinya Yamanaka of Kyoto University to be the inventor of this technology, the patent credits the work of Japanese researchers led by Kazuhiro Sakurada. The two parties Kyoto University and iPierian disagree on who filed the patent claim first.
Jaenisch has obtained the patent for creating the method in 2003, three years before Yamanaka. He reported making the first iPS cells using genetically-modified skin cells in mice in 2006, and achieved the same using human cells a year later. In 2009 he was awarded the Lasker prize for his achievements. In an interview Jaenisch said: '[Yamanaka] was the first one to do it, we had the idea first'.
Yamanaka's method has now become redundant, according to Nature blogs. Some believe the same may be true of Jaenisch's methods. David Resnick, a patent attorney with Nixon Peabody in Boston, told Nature Medicine: 'Yes, it's an induced pluripotent cell but, in my experience, I don't think anybody is making them this way'. Consequently, the patent will have limited impact on competitor companies and other researchers in the field, he says.
Paul Grayson, president and CEO of Fate Therapeutics, said: 'Dr. Jaenisch's prescient vision in 2003 for creating human iPS [cells], and how reprogrammed cells could be used to revolutionize drug discovery and enable cell-based therapies, is truly unparalleled'. He further said the patent will help reassure Fate's investors that it has freedom to operate without fear of infringing the intellectual property of other scientists.
James Thomson of the University of Wisconsin also developed a method for producing stem cells, and he and Yamanaka published papers the same day describing the creation of human iPS cells and both applied for patents.
Jeanne Loring, director of the Center for Regenerative Medicine at the Scripps Research Institute in La Jolla, California, believes that this may signal a start of a patent war. 'Historically, the owners of stem cell patents have interfered with the progress of medical research, and I have been dreading the inevitable onslaught of new patents' claiming the discovery of methods to develop stem cells, Loring said in an e-mail to BusinessWeek. 'With the allowance of Rudolf Jaenisch's patent on reprogramming cells, it appears that the deluge has begun'.
Loring joined a legal battle in 2006 to block patents issued to the University of Wisconsin for Thomson's work isolating embryonic stem cells, BusinessWeek reports. The ability of researchers to advance stem cell technology will depend partly on how broadly Jaenisch's patent is interpreted and what other patents are granted, she said.