Tuesday, February 28, 2006

Patent Issues

Patent Issues

There’s an interesting article on UPI about patent and intellectual property issues related to stem cell research. You may recall that some of the issues with California Prop. 71 have to do with patent sharing, royalty rights, and so on—issues that are not medical or scientific per se but have to do with the capital of ideas. The UPI story is about a proposal by Merrill Goozner, of the Center for Science in the Public Interest, to place patents in an open source pool similar to that used in software development.

Industry is obviously opposed to this. However, Goozner told UPI, “If what they [industry] bring to the market can't be afforded by the healthcare system, then they're not going to have the blockbusters they want and people won't be able to afford them. That's a stupid business plan, not to mention immoral." A biotech representative responded that the current system would force biotech companies to change direction. (So?????)

The article goes on to give several examples of how patent issues might be delaying medical research and the ideas put forth by several other people regarding a patent pool and the need to consider different methods for dealing with patents in stem cell research. Here’s the idea:
If a company develops a product based on the use of a technology in the pool, they would then have to grant an unrestricted license on that new product or technology for use by other researchers. If the product eventually becomes a medical therapy, then a prize system would go into effect. Those whose technology contributed to the development of the product would be granted financial rewards based on how successful the product is, the significance of their contributions and other factors.

I approach intellectual property issues from a divided perspective. On the one hand, as a writer, I support copyright protection for artists. On the other hand, open source stuff is really cool and important for the advancement of knowledge. I guess—and I’m thinking through this now as I write—that a patent on a technology is somewhat different from a copyright on a book. A copyrighted book, painting, song, etc. is still publicly disseminated. The idea is that it can’t be reproduced or claimed by another, not that no one has access to it. A patent, on the other hand, restricts use.

I am involved in the development of an open-source software program, and one of the things the project leader has emphasized is how the openness of open-source allows other people to contribute and help the project grow. It becomes truly collaborative, in other words. Science needs this. Yes, the companies need to make enough money to keep going, invest in future research, and pay their employees decently, all of which can be hard to do with a start-up. But when a business model is applied to knowledge (or health care—imagine if your HMO weren’t profit-driven!) it can become a zero-sum game. We need collective, community knowledge in order to grow as a people.

More state news

More state news

Massachusetts: The state lieutenant governor, Kerry Healey, is making headlines because she is taking a stand on stem cell research that is different from Governor Mitt Romney’s. A short AP story on television channel WPRI reports that Healey believes a stem cell research bill that became law last year makes Massachusetts a leader. Romney vetoed the bill, but his veto was over-ridden.

In New Jersey, state Senator Richard Codey has introduced another stem cell research bill. The funding would come from bonds and not from the state operating budget, unlike a bill that failed. An AP story in Newsday reports that bill includes $200 million for two separate research facilities. The governor and the state Assembly speaker both spoke in favor of the bill.

The opponents of a ballot initiative that would allow embryonic stem cell research, including therapeutic cloning, in Missouri held a press conference today. The Kansas City Star reports that the opponents will be making an effort to convince the public that somatic cell nuclear transfer leads to a viable embryo.

Not exactly news, but there’s an opinion piece in the Wisconsin Technology Network arguing that the state legislature should not add additional regulation to stem cell research now that ethical standards are being established nationally and internationally. The proposed regulation would restrict embryonic stem cell research. The writer believes the researchers are already sufficiently limited by federal restrictions.

Prop 71 Trial

Prop 71 Trial

The big story today is the opening of the Prop 71 Initiative trial in Alameda County in California. I’ll fill in events from several sources. Recap—two lawsuit have been filed alleging conflict of interests by members of the board of the California Institute for Regenerative Medicine. They are being heard together. Plaintiffs include the People's Advocate and National Tax Limitation Foundation and the California Family Bioethics Council. Opening arguments took place yesterday. (Remember when I commented about jury selection? It’s a non-jury trial, so it will be up to the judge.)

First, from the San Francisco Chronicle: Plaintiffs’ lawyers argued that the CIRM is unconstitutional. Defense lawyers argued that the lawsuits were brought about by an opposition to embryonic stem cell research rather than by real concerns about financial issues. The lead attorney for the CIRM said that the trial was not an “opportunity to overturn” the ballot initiative vote which created the CIRM. The first witness called was Robert Klein, the person who got the measure on the ballot. Klein said that members of the CIRM board took an oath to represent the interests of the state and not whatever universities they are affiliated with.

From an AP story in many papers, I pulled it from the Seattle Times: Pretty much the same info, but it adds the detail that one attorney argued that the 5 members of the CIRM from the University of California system were among the ones with conflicts of interest.

UPI has a very short article, and the San Jose Mercury News has a longer one—you have to log in to read it, though, and there are REALLY annoying pop-ups with sound. It reports that the trial is likely to last at least a week, and whoever loses will probably file an appeal. The article also talks about some of the results of the delay in finding, such as scientists leaving for Singapore and logistics about where to store newly developed embryonic stem cell lines.

The court minutes report that Klein was the only witness called yesterday.

The Los Angeles Times ran an interesting article before the trial started, which quoted a law professor and chairman of the steering committee of the Stanford Center for Biomedical Ethics as saying it should be an “easy win” for the defendants. It also points out that many key decisions about the CIRM have now been made. An attorney for the CIRM said, “In some sense, this trial gives us a chance to prove what this agency has accomplished and how accountable it has been.”