Myriad Genetics Appeals Ruling Invalidating Gene Patents
Just over two months ago, in a widely publicized decision we characterized as “a nearly complete victory for the plaintiffs and their supporters,” a district court judge in New York invalidated a number of Myriad Genetics’ patent claims, including the company’s patents on isolated DNA sequences in the BRCA1 and BRCA2 genes (i.e., “gene patents”).
Yesterday, to absolutely nobody’s surprise, the defendants in the case, including Myriad, filed a notice of appeal (pdf) with the district court. Next stop is the Court of Appeals for the Federal Circuit. It has been just over a year since the lawsuit was first filed with the district court, and a safe guess would be that it will take roughly the same amount of time for the Federal Circuit to reach a decision, which is itself likely to be followed by an appeal to the Supreme Court. More than anything else, this appeal should serve as a reminder that there is still a long way to go before this litigation is finally resolved.
First of all, thanks for keeping up the information about the Myriad litigation.
I have spoken to many people about this case and reading blogs etc. The overall opinions are that the Federal Circuit probably will overturn the ruling done by judge Sweet. If not, the Supreme Court may do so in the end.
Although, it is not expected, but I’d like to know what consequences there will be if this will actually happen? Can we expect major changes in the patent law following the ruling done by the Federal Circuit or Supreme Court? Will this scenario really affect the biotech industry then (theoretically in a couple years..)? Can we make assumptions at all?
@Chi: I think the Myriad litigation is a part of a broader reexamination of the role that patents play in biotechnology innovation. As for what will happen in this specific piece of litigation, while we can certainly prognosticate, I do not think we can do so with any confidence. While it’s true that a majority of commentators believe that the Federal Circuit is likely to overturn Judge Sweet’s ruling, at least in part, should the case proceed to the Supreme Court all bets are off.
The real question is whether changes to the biotechnology patent landscape, if and when they come, will be delivered by the courts, by Congress, or through some other channel (e.g., through cooperative industry action).
- Dan
Had Myriad or any other companies actually created the gene, then I could see that they would have an argument for a patent. But isolating a human gene, something that is found in Human DNA is just ridiculous. If every Tom, Dick and Harry genetics company isolates a disease causing gene, do you realize what the cost would be to test a person in future for any number of possible genetic problems? Science is suppose to help not hinder our lifespan. I do not understand how isolating the DNA of someone else (several someone elses’) makes it their gene.
CJ:
I wonder if you have any clue on how much it would cost a company to identify a “disease causing gene”, and how much it would cost a company to have their test approved by the FDA.
The patent system is designed to encourrage people to make investments in science (e.g. to pay for scientists’s salary and their equipments).
@ KM.
Although the patent system is designed as you say, Myriad Genetics scientist did not isolate either BRCA1 or BRCA2 gene sequence – in BRCA1 6 NHI scientists are listed on the patent as “inventors” (or discoverers if you prefer as i do) who Myriad Genetics acknowledge a) constructed two fragments and 2) the total genetic sequence. From 1994 when they contributed this information, until 2005 (11 years) Myriad genetics had made zero, nada, niclsh royalty payments to those inventors/discoverers – in 2008 Myriad made $229Million from the diagnostics (87% from this specific area).
My point is this. Although the system is designed a certain way, it relies on patent holders (i agree with Sweet D.J.) to “pay the scientists salaries” & Myriad Genetics did not do so.
@ Everyone else. The s. 101 molecule/chemical only argument for subject matter patentability, was rejected as DNA does more than exist as a mere molecule, it expresses for proteins and is the carrier of genetic information. Just because some BS is offered to ignore 2 of the 3 characteristics of DNA to get a patent – is wrong and i for one thank Sweet D.J. for pointing out these other 2 characteristics deserve legal recognition, not just the molecular chemical sequence of a particular gene sequence.
@ Myriad Genetics, “You don’t control the DNA of sick people who need diagnostic help, no you don’t – may you fail on appeal and then step aside and let the biotechnology industry flourish and help people”
@TSP:
And were those inventors employed by Myriad at the time they did the research, and were they under contract to assign their inventions to Myriad? Did they perform their research at the direction of the company?
From the way you write it, it sounds like Myriad leapt out from behind a bush, clobbered a bunch of researchers over their heads, rifled their pockets, and stole their work. Somehow, I don’t think that’s how it went down. :-/
Myriad isn’t “control[ling] the DNA of sick people”; the tests in question, as I understand the situation, are risk assessments, not diagnostic tools. In other words, the sort of vanity testing that tells people they are at elevated risk for a certain form of cancer and so should eat their broccoli and take out life insurance. The tests, as I understand them, are explicitly NOT the sort of “use chemo drug X instead of chemo drug Y to treat this cancer because it is genetically susceptible to X but not to Y” test that would be a “diagnostic help” tool.
I welcome any corrections.