Can a company patent a gene? According to a new appeals court ruling, yes ó even when that gene is an isolated version of a gene that occurs in nature.
Salt Lake City-based Myriad Genetics sells a test to screen for dangerous variants of the BRCA1 and BRCA2 genes, which are associated with increased risks of breast and ovarian cancer. On Thursday, the U.S. Federal Court of Appeals in Washington, D.C., upheld the gene patent ó but held that some processes related to analyzing gene patents may not have protection.
Pete Corless is a Boston-based partner at Edwards Wildman Palmer, a law firm that represents patent holders ó including the National Institutes of Health, universities and biotech companies ó in intellectual property cases. He views the appeals courtís decision as a mixed result.
What did the court decide?
Myriad has patents on isolated DNA sequences that correspond in various respects to sequences you would find in the human body. It also has patents on manipulated forms of those sequences.
The court said all of those were patentable subject matter. Thatís a big thing.
But Myriad also had so-called method claims for analyzing these DNA sequences. The method claims were treated differently by the court.
What is a method claim?
Take a chair. You can have a patent claim to a chair per se, and then you could have a method claim of using the chair. Such a method claim may recite, for example, in a first step placing the chair on the floor, and in the next step placing the lower portion of your body in the chair.
In todayís decision, the federal circuit [court] said that Myriadís method claims, as drafted, were not patentable subject matter.
Iím troubled by that, because we donít want to see innovation of diagnostics restricted in any way. Nobody does. If you start taking away patent rights, thatís certainly a possible result. People would have less incentive to make the up-front investment to explore new diagnostics.
Whatís the rationale for why the DNA sequences are patentable?
An isolated DNA sequence doesnít exist in nature. Sophisticated work can be required to obtain an isolated DNA sequence for the first time.
A counter argument, as noted in the decision, what if you snap a leaf off of a tree? Itís an isolated leaf ó is that patentable subject matter? In my view, thatís taking the position to an extreme, and it was not the facts before the federal circuit in this case.
The ACLU and other litigants would say that if only Myriad can make this test, it harms patients because other outfits wonít try to do it as well, and perhaps come up with a better way.
That argument I donít buy. You needed Myriadís work initially to show how this would be done. If Myriad didnít have the potential reward that can be provided at least in part via patent rights, it would not have been reasonable for them to put forth the risk capital to develop the technology.
I donít think the argument is credible that restricting diagnostic patent rights spurs innovation, or better patient care.
Can you elaborate on the objection to the method claim?
In the claim, all they have is a single step: something like, analyzing or comparing two different DNA sequences. There is prior case law that says you have to have some kind of transformation going on. The argument is that Myriadís analysis, as defined, is merely a mental process.
Itís kind of strange that the company can patent a gene, but not an invented process.
If youíre saying the method claims merely provide for analyzing these sequences, that could be viewed as an over-simplification of those method claims.
But people are now wondering, do we need to go through formalistic hoops to protect these claims? Perhaps we need to include in a diagnostic patent claim one or more additional steps to distance the claim from the impact of the decision. For example, a claim might include steps to obtain a patient sample, then isolate and analyze the genetic product, to thereby provide a ďtransformationĒ that would elevate the claim to the realm of patentable subject matter. That may be how practice will evolve, but it also may be placing form over substance.
Say my mother had had breast cancer and Iím wondering if I need to get screened for these mutations. Does this decision make any change in what would happen to me?
I think as a patient it wouldnít make a difference to you. Right now, you would have had to go through Myriad, as I understand the marketplace for this diagnostic.
What happens next in the courts?
Is the Supreme Court going to consider an appeal of this case? I donít believe so.
The other card to play is, does Congress get involved here ó do they amend the patent laws? Thatís always an option, but again probably not likely.
From your perspective, is this a good outcome?
Itís a good outcome that the DNA claims are safe. As the court said in its main decision, what an upheaval it would have been if those claims had been held unpatentable!
Many patents would have become arguably invalid Ė would people stop paying royalty fees? It would take a huge amount of litigation to clear up the existing patents. Somebody would have to jump in ó Congress or the Supreme Court.
But I think it will be an unfortunate outcome if this case is subsequently applied to restrict patent rights for genetic-based diagnostic inventions to any significant extent.
Is this the last word on DNA patents?
[laughs] Iíd be hesitant to say that forever and ever there wonít be any issue with DNA patents. I would find that hard to believe.
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