Widgets Magazine

Unclear patent policies make future of stem cell research murky

Though patents are meant to encourage innovation, broad stem cell patent protection could slow research in the field, according to a recent report by the Hinxton Group, a body of scientists and public policy experts who study the ethical and legal challenges surrounding stem cell research.

The report argues that policies governing the sharing of intellectual property and scientific materials, while beneficial in bringing private investment into underfunded areas of research, may act as legal tripwires. These policies therefore have the potential to slow innovation.

While assigning patent rights for most inventions is relatively simple because of their discrete parts and manufacturing processes, the task is less clear-cut in stem cell research, where the debate continues over what technologies—entire lines, methods for deriving them or only clinical uses—should be patentable.

With its recent establishment of the Institute for Stem Cell Biology and Regenerative Medicine (ISCBRM), whose new building features prominently on the School of Medicine campus, the University has millions of research dollars at stake in this field.

Sharing research rights

Researchers must first make an agreement with patent holders when they use intellectual property not owned by their research institution. So far, few Stanford researchers have had difficulty acquiring permission to use such information, according to School of Medicine professor and ISCBRM Director Irving Weissman and bioengineering graduate student Blake Byers.

“Patent protection doesn’t really matter for academic research, since we’re in a nice bubble where we can do research here irrespective of where patents are,” Byers said.

Katharine Ku, director of the Office of Technology Licensing (OTL), confirmed that it’s typically easy to share intellectual property between institutions for research purposes.

“But when the technology is commercialized for clinical use, there can be a problem,” Ku said.

Though Weissman’s lab has not yet encountered any licensing trouble to his recollection, the potential for problems still exists, he said.

Because of the ambiguities in stem cell patenting policy, “you never know until you try to move it into the sphere where you’re going to make [the technology] useful clinically and therefore commercially viable,” Weissman said.

That’s when patent holders take interest and could sue if the new technology oversteps patent restrictions.

An ‘intellectual stranglehold’

Patent restrictions have been an issue in the field of stem cell research since its very beginning, when James Thompson, a University of Wisconsin professor, isolated the first human embryonic stem cell. Thompson was granted patents for three stem cell lines. Those patents included not only how to derive embryonic stem cells but also all embryonically derived pluripotent cells irrespective of the method, allowing the patent holder to essentially own all cells derived from that line.

“That means that anybody in possession of a stem cell line needs to take a license from the patent holder,” explained Christopher Scott, director of the Program on Stem Cells and Society at the Center for Biomedical Ethics, who is also a member of the Hinxton group.

Such a broad patent becomes a problem when the patent holder “vacuums up” all intellectual property that might pose a competition to their technology, a situation he describes as an “intellectual stranglehold”.

“When technology [and] intellectual property are held so tightly and not licensed broadly, it can hinder a field,” Scott said. “If you hinder competition, you may hinder progress to getting things to people who need them.”

Weissman calls the University of Wisconsin’s patents on embryonic stem cells “far more restrictive” than any other patent he knows, and says that those restrictions affect the field’s ability to move forward.

More ‘socially responsible’ policies

Although Ku said that few of Stanford’s stem cell patents are actually licensed, Scott noted that Stanford’s “socially responsible” licensing policies could be beneficial to research and development. In the case of early biotechnology research, Stanford followed policies that encouraged the use of technologies among a large group of inventors or scientists—a move that launched an entire industry, Scott said.

“Some argue that without that broad licensing the biotech industry wouldn’t exist,” he added.

With Thompson’s patents set to expire in the near future, competition within the field of stem cell research will begin to heat up. While Scott holds that greater competition is a good thing, Byers predicts a less sunny outcome, one that is already evident as the field expands into studying new types of stem cells. He speculates that because the field is so crowded and competition for patents is so high, researchers might stall the process of peer reviewing papers so they can first claim their own patents.

“It’s been almost exponentially more difficult to get a stem cell paper out in the last year and especially around differentiation of embryonic stem cells,” Byers said.

Clear and consistent policies for stem cell patentability have yet to be set. As the debate continues, Scott said, the tension lies between creating a competitive market within an intellectual framework versus having a monopoly on the technology.

“It’s a hard line to walk,” he added.

Bigger challenges take precedence

Despite the roadblocks patent-related restrictions could cause, researchers cited the historical lack of federal support as the greatest obstacle the stem cell field faces.

“Intellectual property pales in comparison to having the money to do the research,” Scott said. “If you don’t have the money, that, basically, is a show stopper.”

Under the Aug. 23 injunction issued by U.S. District Judge Royce Lamberth, which suspends federal funding for human embryonic stem cell research, the futures of many federally funded projects in the field are uncertain. While researchers in California have the support of the California Institute for Regenerative Medicine to supplement missing funding from the National Institute of Health, Scott stressed the need for federal backing.

“Though California has been an exception to the rule, the funds aren’t going to last forever,” he said.

“Since stem cells are so in vogue and everybody’s talking about them, they think they’re going to do everything, so there are a lot of research dollars available,” Byers said. “But Obama still hasn’t overturned a lot of the restrictions Bush has placed on embryonic stem cell research.”          The Bush restrictions have further stymied funding.

In his 25 years of studying biomedical ethics, Scott said no other field had such “a promising future for potential therapies and treatments” and “was so complicated with ethical, legal, regulatory, and funding issues.”

“Without federal policy that allows and encourages research on embryonic stem cells,” he concluded, “it’s going to be a really hard field to move forward quickly.”

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