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Legal Affairs : Jul 1, 2013 ( )
iPSCs: Analysis of U.S. Patent Landscape
Find Out Which Institutions Are Leading R&D in the Creation and Use of Induced Pluripotent Stem Cells!--h2>
Since their discovery in 2006, induced pluripotent stem cells (iPSCs) have promised to revolutionize regenerative medicine and therapies. Similar to embryonic stem cells, iPSCs possess pluripotency but avoid the associated ethical issues. They are re-engineered from various cell types, and several new techniques recently have been developed for their creation. This article reviews the iPSC patent landscape in the United States to the end of identifying the key technologies and institutions that are leading research and development in the creation and use of this promising new technology.
The search sought to identify methods to generate iPSCs, the resultant cells, compositions, and use of the cells. To that end, the U.S. Patent and Trademark-issued and published application databases were searched for claims having the following terms: “reprogramming and induce” and “pluripotent” or “stem cell.” The initial search identified approximately 230 pending and issued patents having these terms in the claims. To identify those documents that were principally focused on iPSCs and exclude ancillary technologies (such as methods to confirm pluripotency or identification of cell markers), the patent documents were manually reviewed by the Foley & Lardner LLP law firm, and in particular licensed U.S. patent attorneys with appropriate technical and legal expertise. 177 pending applications and issued patents were selected as relevant.
Trends in the development of the technology were further identified by categorization of the 177 patent literature documents as follows:
(a) type of claim, i.e., were the claims directed to a composition, a method of making, use/diagnostic use, therapy or a device?;
(b) types of cells and their use, i.e., in vitro versus in vivo use of iPS cells and the tissue of the originating cell type, e.g., fibroblast cell; and
(c) iPSC induction technology, i.e., whether the iPS cells were induced with the aid of cytokines, and/or the use of transformation genes or factors (e.g., OCT, Klf, Myc), and whether the method of making the iPSC-required integration of the transforming factor into the chromosome or extra-chromosomally (e.g., episomal expression).
Global patenting trends were identified by categorizing the documents by assignee and the global region based on address of the assignee as listed on the patent document.
iPSC patenting shows strong geographical clustering (see Table 1). 61% of all iPSC patenting activating is clustered around four geographical areas: Massachusetts (Boston), California, Japan (almost entirely from Kyoto), and Madison, Wisconsin. Boston alone is responsible for generating more iPSC patent filings (32) than all of Europe (16) and Asia outside of Japan (11). Given the early leadership of Shinya Yamanaka's team at Kyoto University, Japan, and James Thomson's team at the University of Wisconsin-Madison, it is not surprising that Japan and Madison are hotspots for iPSC patenting activity. It is also unsurprising that iPSC patenting activity is strong in areas with traditional strength in biomedical research.
Digging deeper into the data suggests that local business and academic culture has driven innovation and will be key to future growth and commercialization of iPSC technology. For example, Kyoto University is the single largest assignee of all iPSC patents and applications (21, 11%). However, Japan’s strength appears to be focused within one institution—Kyoto University. It has not fostered many domestic competitors or collaborators either in academia or industry. Indeed, Kyoto University is responsible for 61% of all iPSC patenting activity in Japan. By comparison, Madison’s success appears to draw from the twin strengths of the University of Wisconsin-Madison (WARF) and a private company, Cellular Dynamics. The most successful cluster—Boston—benefits from two elite universities and two private companies.
California, the second most successful cluster, appears to reflect the “start up” cultures of the Bay Area and San Diego with strong academic support within the local universities. California is distinguished from Japan in that it also has a good number of smaller players in industry and multiple academic institutions trying to establish a foothold in the area.
New Orleans and Rome have emerged as mini-clusters, but based only on the actions of a single group in each location. Within the rest of Europe, the strongest mini-cluster is found in Munich (not shown), with four iPSC patent filings spread across multiple assignees reflecting Munich’s role as a recognized biotech hub.
The percentage of patents and applications that claimed a method of therapy was highest outside the major clusters, e.g. in Rome, or at “Other” (Table 2). In vivo patent filings were also more common in “Other.” These results may reflect statistical aberrations caused by a relatively small pool of data or attempts by smaller research groups to develop an IP portfolio but avoid direct competition with the larger groups who have a commanding strength in the basic science.
Along with the growth in iPSC technology, there is an upward patenting trend as measured by the increase in the number of patent filings (Table 3).
To analyze trends in the technology and avoid the distortions caused by low numbers, data for all patent literature was grouped from 2006 to 2008 and 2012 to 2013.
As shown in Figure 1, there has not been a clear trend in claims directed to therapeutic use of iPSCs but there is a clear trend in moving away from technology criticized for being ill-suited for in vivo therapy. Specifically, since 2009, fewer patent documents mention or recite the use of the transforming factors OCT, Myc, or Klf (“any gene” in Figure 1) and there is a downward trend in the number that recite chromosomal integration. There has not been, however, a clear rise in iPSC generation methods that use only cytokines to the exclusion of OCT, Myc, or Klf. These data suggest an attempt to move away from genetic transformation but that a clear alternative has not fully replaced it.
The raw data supporting these findings will be made available by the California Institute of Regenerative Medicine (CIRM) on their internet site.
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