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Dana-Farber sues company started by one of own researchers over possible anti-cancer drug he helped invent
By adamg on Wed, 09/22/2010 - 7:09am
The Dana-Farber Cancer Institute says rights to the novel chemical invented by Dr. Nathanael Gray actually belong to pharmaceutical giant Novartis, in a lawsuit filed in U.S. District Court in Boston yesterday.
Novartis and Dana-Farber have a research-funding agreement in which Novartis gets first dibs on any potential anti-cancer agents developed by Dana-Farber researchers who have agreed to take Novartis money.
Although Gray took money from Novartis, he assured Dana-Farber last year none of it went to research WZ4002, which shows promise against lung cancer that has become resistant to other drugs, Dana-Farber says in its suit. Based on that, Dana-Farber says, it agreed to give Gatekeeper Pharmaceuticals, a company started by Gray, rights to the new drug. A Dana-Farber press release announcing the drug does not mention Novartis as among the organizations that had funded the research.
But when officials at Novartis saw a paper announcing WZ4002, they protested and demanded they be given exclusive rights to the chemical. Dana-Farber tried to mediate between the two companies, but when that failed, began a review of the agreement and its relation to the chemical:
In August, 2010, Dana-Farber completed this review and concluded that Novartis had a strong claim to the option under the Novartis [agreement] and therefore, that Dana-Farber did not have the capacity to grant the WZ4002 license requested by Gatekeeper ...
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Comments
I sure hope this doesn't slow the research down...
...but something tells me it will. Oh well, this is what we get when medical research is dominated by the need for more and more and yet more profit from huge corporations.
Sorry
I tried farting out magical compounds that cure cancer and they haven't tested well yet on my random human studies in the Red Line at rush hour.
There is a tremendous up-front cost to doing pharmaceutical research. Novartis fronted some money and said "for this money, we get first right of refusal on anything you do with it". Seems fair enough to me. If the researcher didn't want to agree to their demand, he didn't have to take the money and could have found other research to do.
The contingency is going to be whether Novartis' money paid for that specific research that led to this compound's discovery. Dana-Farber seems to think the evidence will lead to that being true. Time will tell.
But the idea that this is a greed motivated move by Novartis doesn't pan out here. Novartis is one of the pharma companies that puts out a lot of basic research money for start-ups and academics to try out wilder ideas that big pharma doesn't have the maneuverability for and their only greed comes if something comes from that research. That seems pretty reasonable to me given all the times they put money out there at risk and the science didn't pan out.
Kaz,
so sorry you don't know the difference between scientific research and your commute!
Novartis may be a better corporation than others, but it is still driven by the profit motive. What if governments funded research better and removed the profit motive altogether?
You may argue that for-profit companies would get the drugs out there more quickly, but we have seen that 'more quickly' isn't necessarily 'better for the patients' (just this week, for example, the FDA is considering recalling Meridia because it caused deaths from heart attacks and strokes).
You may have other arguments, but please make them stronger than your Red Line joke.
Novartis disoute
Anon;
"Novartis may be a better corporation than others, but it is still driven by the profit motive. What if governments funded research better and removed the profit motive altogether?"
1) What's wrong with profits???
2) Government funded research???
ARE YOU KIDDING ME??? Do you have any idea how much money is involved and necessary to keep a company like Novartis running? Do you know how many companies are depending on Novartis - not to mention the thousands of employees in the pharma industry!??
They call it Kapitalism and it works, for the most part, pretty darn good! You want to drink more Kool-Aid and hope for Socialism, be my guest, but you'd be better off in Europe!
Government wouldn't have the funds to support, let alone fund the pharma industry or it's research! They already screwed the tax payers with their "support" of the automobile industry everything else they stuck their big noses in. What else do you want them to mess up? At the rate they are going, you couldn't be safe buying Aspirin over the counter....
Keep government out of running anything, because history has shown that it just does not work! The FDA already has plenty of oversight and control!
Kaz, keep fartin'....
What if he didn't use their money?
Therein lies the Rub. Just because Novartis gives money to an institution doesn't necessarily mean that that everything developed by that institution or by researchers who work on funded projects belongs to Novartis. It belongs to Novartis if and only if Novartis funded the project that developed the chemical. If the researcher was working on an NIH grant or NCI grant at the same time and developed it on their dime, then Novartis has to go fish.
Gee, my institution has funded some research at Dana Farber ... I wonder if we can get a cut of this! See what I mean?
There's a paragraph for that
The damning bit for me is the fact that when Dana-Farber reviewed everything they knew about the situation and what Novartis was claiming to them, they basically said "oops, my bad, yo" to Dr. Gray and Gatekeeper Pharmaceuticals and now filed a lawsuit on Gatekeeper when the only response was "no backsies".
To keep in mind: even if
To keep in mind: even if Novartis's claim was weak, Dana-Farber probably has a more lucrative relationship with Novartis than it does with a single researcher.
True
But at the same time, DFCI may have sided with Novartis because they're the bigger player, and they stand to lose more from souring their relationship with them than with a smaller company started by an ex-researcher. But who knows, maybe their audit of the situation truly proved Novartis has some merit to their claim.
Unbelievable
And this BS will probably delay clinical trials and potential FDA clearance of the drug.
i certainly hope not...
... my mother has non-small cell lung cancer, which is currently being treated adequately with Tarceva. but we know that, eventually, Tarceva stops works. and for each person, that timeline is unique. no one knows how long it will last. currently, when the Tarceva stops being effective, we are medically at the end of the line. a new medicine like this is exactly what we are waiting for. and i hope we don't run out of time before these drugs becoming available.
while i understand the legal shenanigans that occur due to money and ownership of drugs, as a consumer it is extremely frustrating to watch.
Actually
If Novartis were to get their hands on this compound today, it'd probably move faster towards market than if it sits in the hand of some rinky-dink virtual startup that has no money (and there's hardly VC money out there for them to get these days), no employees, and no expertise in moving something to market from an optimized lead.
If Gatekeeper wants to run this ball in on their own, then they're probably at least 2 years from organizing to the point of running their own pre-clinical testing. If they want to partner with someone, they'd be behind the curve from what Novartis could start today if it took possession of the compound by option.
Of course, either way we're probably talking about 5 years minimum before this would get out of the clinic, although the fact that they have a genotypic target means they could customize their trial participants to maximize return on their data and speed up the process with the FDA.
Ah Kaz,
so now you know how far Gatekeeper has progressed, how much funding they have and what staff they have on board... or is this also something you blew out your butt?
Call it a hunch
I speak from experience having helped a company successfully go from academic research to private corporation. There are periods of startup and required filings and everything else that go along with it. They've generated a website in Mar'09...that's it. They have no announced board or scientific advisors. The guy still has his lab going at Dana-Farber. All of the signs point to the company being a holder for the I.P. of this one chemical and nobody has likely invested in them yet...so they'd have no money, no lab space, no setup... (unless Dr. Gray is independently wealthy) to do anything yet. It takes time and they just started all of this within the past year.
Meanwhile, Novartis just got the first oral Multiple Sclerosis pill approved by the FDA today. I'm pretty sure I'm not "blowing it out my butt" to say they'd have the jump on the research here if they had the molecule tomorrow.