Jennifer Washburn’s article on stem cells in the April 12, 2006 issue of the Los Angeles Times mentioned Jeanne Loring, an embryologist at the Burnham Institute in La Jolla: In 1999, Loring tried to launch a stem cell company, but the company quickly collapsed when he couldn’t raise the $100,000 in initial fees from the Wisconsin foundation. [WARF] loaded.
Washburn’s article did not mention an earlier article by Loring and co-author Cathryn Campbell, titled “Intellectual Property and Human Embryonic Stem Cell Research,” which appeared in 311 Science 1716 on March 24, 2006. There, Loring and Campbell mentioned the changing royalties fees charged by WARF in response to a “memorandum of understanding” (MOU) with the federal funding agency. Loring/Campbell mentioned the “SBIR paradox” regarding small business funding, which may be an issue, but not associated with patent law.
Both the Washburn and Loring/Campbell articles suggested that the WARF/Thomson patents would pose a long-term threat to stem cell science. Washburn highlighted the position of the Santa Monica-based Foundation for Consumer and Taxpayer Rights, which is urging the California stem cell agency to challenge Wisconsin patents. In greater detail, the Santa Monica group stated: Stem cell institute faces threat from University of Wisconsin-associated foundation [WARF], which claims that it is owed licensing rights because it holds patents on all human embryonic stem cells in the United States. John M. Simpson stated: “This is an outrageous raid on California’s treasury based on far-reaching patents. No other nation in the world recognizes them. They are blocking vital research in the United States. I call on the Stem Cell Institute challenge the validity of patents”.
Neither the Washburn nor the Loring/Campbell articles discuss the potential investigative safe harbor created in the Hatch-Waxman Act and codified at 35 USC 271(e)(1). The breadth of this safe harbor was recently affirmed in the Supreme Court decision Merck v. Integra. Neither the Washburn nor the Loring/Campbell articles dispute that patent infringement lawsuits against states and state agencies (such as California’s CIRM) are likely to be heard in state court, not federal court, depending on the decision of the Supreme Court in Florida Prepaid Postsecondary.
Although there may be a knee-jerk reaction to lash out at patents perceived as too broad, the warning in NTP v. RIM suggests that sometimes negotiation is the best path for infringement advocates. Additionally, Loring/Campbell mention the possibility of interference with Plurion, although this will most likely only change the identity of the owner of the controlling patents. On the other hand, it is recalled that Thomson’s patents refer to the creation of stem cells from blastocysts; It’s not about “cloning” [SCNT] technology. To date, traditional methods for the separation of stem cells from blastocysts have failed involving SCNTs. There may be a question of clearance regarding Thomson’s patents for SCNT-related cases, which is where the holy grail of patient-specific stem cell lines resides.
As a general proposition, state taxpayers who support efforts like Proposition 71 have an expectation that the money will be used for research, not to litigate the patent positions of previous researchers. Extrapolating further, state funding to achieve patent positions could lead to a balkanization of research, with entities from individual states (such as California, New Jersey, Maryland, Illinois, Connecticut) fighting each other, rather than collaborating.