If private firms fund research at universities, who do you think will control access to the knowledge?

Just one more follow up on the matter of how research universities will make do as federal funds for research dry up. Some have suggested that the answer will come from more collaboration between university labs and researchers in private industry.

Perhaps it will. But, a recent article in the Boston Globe about conflicts within the Broad Institute is suggestive of the kinds of clashes of philosophy that might make university-industry collaborations challenging. From the article:

Just over a year ago, Cambridge's prestigious Broad Institute started an idealistic medical-research project, fueled by millions of dollars from drug companies, to create powerful new molecules and make them cheaply available to lab researchers around the world.

Called the RNAi Consortium , the program runs on donations from Novartis AG , Bristol-Myers Squibb Co. , and Eli Lilly & Co. , among others. It has designed a huge collection of molecules to block the workings of each human gene -- a new and increasingly important technique for scientists and drug makers. The project embodies the ambitious goals of the three-year-old Broad Institute, which united the czars of top science labs at Harvard University and the Massachusetts Institute of Technology to turn genetic research into real treatments for diseases.

But now the altruistic RNAi project has run into the shoals of commerce. The Broad relies on two for-profit companies to produce and distribute the new molecules to researchers, and one of those companies is suing the other to stop it from sending them out.

Sigma-Aldrich Corp. , a global lab supply company based in St. Louis, filed suit against Open Biosystems Inc. of Alabama, a private firm specializing in supplying genetic material, charging that it infringes two key scientific patents.

Although the Broad Institute invents the RNAi molecules, it can't produce them in the volume needed for research experiments. So it has licensed the two suppliers to keep a ready stock of Broad-invented material in their warehouse freezers to sell to customers. The companies make a profit, but because the Broad Institute absorbs the high cost of the original research, they can keep prices down for their customers.

If the lawsuit succeeds in shutting down Open Biosystems, it would give Sigma an effective monopoly, leading scientists to worry that a resource built with philanthropic money and intended for public access would become unaffordable.

"Our goal is easy access to the world research community," said David Root , the Broad Institute scientist who manages the RNAi Consortium. "We went to two distributors with the idea of trying to make sure it's widely available."

(Bold emphasis added.)

On the one hand, we have the researchers from Harvard and MIT who seem to want to make new knowledge (including made-to-order RNAi molecules) and allow that knowledge to be distributed widely, since that will help other scientists build more knowledge. (Also, since we're talking about biomedical stuff, sick people might get helped by this knowledge.) University and philanthropic resources were directed at achieving these aims.

On the other hand, one of the private companies in the collaboration is vigorously defending its patent rights (as one must if they are to be enforced at all). A private company may make knowledge, but it must also try to turn a profit.

The case might be made that the Broad Institute, not Sigma, invented the RNAi and "absorbs the high cost of the original research", so Sigma might not have so much to recover here by way of R&D costs. Still, companies are in business to make money.

Sometimes what helps make money gets in the way of what makes the knowledge widely available.

More from the article:

[The lawsuit] pits two very different companies against each other. With offices around the world, Sigma-Aldrich is one of the largest suppliers of laboratory research chemicals, with 7,000 employees and $1.7 billion in annual sales. It has a growing business in so-called biotechnology reagents, highly specialized chemicals that let laboratories use the new tools of genomics to test potential drugs. It was also one of the original $3.6 million donors to the Broad Institute's RNAi project.

Open Biosystems, with 55 employees, is a four-year-old private company that sells only human genes and related chemical tools. Its 36-year-old cofounder describes the company as the "iTunes of the genomics world," with a website that allows users to pick and choose individual genes and other chemicals, which are shipped overnight in dry ice via FedEx. The website, www.openbiosystems.com, trumpets the company's "open source business philosophy" of "democratizing access to materials." The company does not release annual sales figures.

The legal fight is being waged over short hairpin RNAi molecules, tiny strands of genetic material that can essentially switch a single gene to the "off" position and shut down its function in a cell. First identified in 1998, RNAi gave medical researchers a new and powerful tool to study and potentially devise treatments for a wide range of genetically linked health problems -- a discovery so important that RNAi was named the "breakthrough of the year" by Science Magazine.

As RNAi has developed into a critical tool of medical research, it has also become a legal battleground. Companies hoping to make RNAi-based drugs, including Alnylam Pharmaceuticals Inc. of Cambridge, have been racing to lock up the legal rights to use the molecules as therapy. Sigma-Aldrich has moved to become the most important supplier of RNAi as a research tool, spending more than $10 million to buy and license patents connected to its use.

Two of those patents, licensed last year from the British company Oxford BioMedica PLC , are the basis of the suit. The patents cover a "lentivirus," a disabled version of the HIV virus that works like a microscopic needle to inject RNAi into cells. Although Open Biosystems does not sell RNAi packaged inside the lentivirus, as Sigma-Aldrich does, the suit claims that Open Biosystems' use and testing of the RNAi includes techniques and gene sequences that violate its patents.

Troy Moore , chief technology officer and cofounder of Open Biosystems, said the company has its own patents and does not violate those named in the lawsuit.

Moore suggested that the suit contradicts the basic idea behind the RNAi Consortium. If RNAi "only ends up in one group's hands, that's kind of a monopoly situation, and that's not healthy for anyone," he said in an interview.

Keith Jolliff , strategic marketing director for Sigma-Aldrich's biotechnology business, said the company supports the public mission of the Broad Institute but filed the lawsuit to protect its heavy investment in becoming a leading RNAi supplier.

"There's no point in having patents if you're not going to enforce them," he said.

The legal case is still in its early stages. Sigma-Aldrich's complaint, filed in US District Court in the Eastern District of Missouri, asks the judge to block Open Biosystems from using or selling any RNAi that violates its patents. It also requests damage payments for money lost to the violation. Open Biosystems has until July 28 to file a formal response to the suit.

The Broad Institute, meanwhile, is left in the delicate position of having one of its key donors trying to shut down a member of the group whose goals are, on the surface, closely aligned with its own.

Part of what makes this conflict interesting is that it involves a clash of interests -- and seemingly of philosophies as well -- between two private sector players involved in the Broad Institute's work. It doesn't, to my eye, look like a fight over who will get a bigger share of the profit. Rather, Open Biosystems is positioning itself as a company that want knowledge to flow forth and be in many hands, rather than having it concentrated in one set of hands. (As a newish company in a field with big players like Sigma, perhaps its not surprising that Open Biosystems would have this kind of philosophy -- it's hard to want there to be a monopoly when the other guy will be the one who has it.)

Meanwhile, the academic scientists had been hoping to cooperate with both these private companies to make new knowledge and get it out there. They don't really want to get dragged into a clash of corporate cultures. Heck, they probably want to steer as clear of corporate culture as they possibly can. It used to be possible, back at the Ivory Tower, to view knowledge as an end in itself. I don't think academic scientists are really ready to view producing knowledge as if it were producing widgets. I think they need to explain that to their private-sector partners. It's not that the private partners will necessarily stop thinking of knowledge as a product with which profit will be made. But at least each partner will better understand the aims of the other, and that will put everyone in the collaboration in a better position to achieve at least some of what he or she wants to achieve.

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Sometimes what helps make money gets in the way of what makes the knowledge widely available.


Particuarly in the case of drugs -- I personally think that pharmaceutical patents are evil. It puts, for instance, USA diplomats in the position of having to argue that people in Africa need to die in order to protect the intellectual property of American companies. Is this an argument we really want to be making?

Of course, if companies can't sell drugs for exorbatant prices and maintain a 20-year monopoly on any new drugs, then they won't make as much money. While there is a lot of bullshit spending among drug companies, they do fund some of the research and testing that goes into these drugs. (What I'd be curious to know is what fraction of the research money really comes from the companies, and what fraction comes from government grants already? In other words, how often are taxpayers paying twice for highly expensive new drugs?)

If we removed the evil that is pharmaceutical patents, a lot of pharmaceutical companies that make their profits by denying drugs to the needy via patents might (happily) die, which would leave us with the need to find another way to fund and support the researchers that do the research and approval testing of new drugs.... Ideally, that would be via public funding the way much basic science is funded. Indeed, I suspect that the additional real costs to the government might not be as high as you'd think, since of course the government right now has to pay huge costs for patented drugs to anybody getting drugs through medicare, never mind the rest of us taxpayers. And, of course, any proposal that requires additional direct (i.e. visible) government funding, even if the impact isn't as big as it might look, is unrealistic, so we're stuck with the evil that is pharmaceutical patents. Worse, if federal funding is drying up, we may just be hosed.

But, damn, is it evil the way things work right now. Perhaps a necessary evil, but evil nonetheless.


This sort of misbehavior really ought to make Sigma a pariah with respect to future public interest collaborations, and maybe even get them disinvited from the Broad Institute itself.

By David Harmon (not verified) on 08 Jul 2006 #permalink

This right here is part of the problem of having sigma be nearly the only lab chemical supplier around.