The American Civil Liberties Union and Public Patent Foundation have led the case against Myriad Genetics, owner of patents on the crucial BRCA breast cancer genes. The landmark case could determine the future of gene patents in the U.S. After an initial ruling against Myriad's patents, a Federal Circuit court issued its ruling on Myriad's appeal on July 29.
Sandra Park, JD, is an attorney at the ACLU Women's Rights Project.
GeneWatch: What happened? What did the court say?
Sandra Park: The Federal Circuit decided three main legal issues in its opinion from July.
The first issue is whether the plaintiffs had standing to bring the case. The court found that there was standing, and they specifically found that our plaintiff, Dr. Harry Ostrer, had standing, so the case was allowed to move forward.
One of the other issues that all three judges agreed upon was the issue of whether the method claims that we had challenged were valid. The District Court had found that they were invalid because they covered abstract ideas and the Federal Circuit agreed as to all but one of the claims. They found that the method claims in effect were on the mental process of comparing two genetic sequences, and so were invalid as embodying abstract ideas.
The biggest issue where there was disagreement on the court had to do with the patentability of isolated DNA claims. There, two of the judges reversed the District Court and found that isolated DNA is patentable subject matter. The judges disagreed in terms of the reasoning for why they found that.
Judge Lourie found that isolated DNA is patentable because in his mind, the chemical structure of isolated DNA is different from naturally occurring DNA based on the breaking of covalent bonds. He was very much focused on the chemical structure of isolated DNA and what he perceived to be chemical structural differences.
Judge Moore took a very different approach. She looked at both structure and at function. She suggested that because full length genes-even if isolated and removed from the cell-would not have a markedly different function from naturally occurring genes, she would consider whether or not they are actually patentable.
She said: "If I were deciding this case on a blank canvas, I might conclude that an isolated DNA sequence that includes most or all of a gene is not patentable subject matter. Despite the literal chemical difference, the isolated full length gene does not clearly have a new utility and appears to simply serve the same ends devised by nature."
She recognized that the patent claims that we challenged cover full length isolated genes and that their function does not differ significantly from their function in nature. However, she then went on to find that the Patent Office had a longstanding practice of granting these patents and she was reluctant to disturb what the Patent Office had been doing.
The third judge, Judge Bryson, wrote a dissent where he talked about how both the structure and the function of isolated DNA are not markedly different from natural occurring DNA. One of his main arguments was that the majority's focus on the breaking of a covalent bond is not rooted in law. There is no precedent from either the Federal Circuit or Supreme Court that elevates the breaking of a chemical bond to the point that that alone can justify finding that something is not a product of nature. He also talks about his concern that these kinds of patents would preempt new technologies like whole genome sequencing.
GW: It sounds like one of the things that it came down to was a reluctance to be the one who changes the practice of the Patent Office.
SP: I think that that certainly motivated Judge Moore. She wrote at length about the Patent Office's practices here.
I think that Judge Bryson talks a lot about how in this situation-as in many situations-they should not defer to the Patent Office's judgment about what is patentable subject matter because the Patent Office lacks rule making authority. When a federal agency does have this authority, courts often will defer to these agencies; but the Federal Circuit has been consistent in finding that the Patent Office does not have substantial rule making authority. And Judge Bryson also talked about the utility guidelines that the Patent Office had issued that provided the basis on which they issued these gene patents. He concluded that the Patent Office's discussion of whether isolated DNA is patentable subject matter was perfunctory. It really wasn't an in depth discussion, which is the kind of analysis you look at in determining whether to defer to an agency.
He also noted that in Diamond v. Chakrabarty, the 1980 case, the Patent Office found that the microorganisms subject to the patent were not subject patentable matter, yet the Supreme Court didn't defer to their decision in any way and instead found that these microorganisms were subject patentable matter.
We've also pointed to statistics that once patents are challenged in court, courts have found them invalid about 40% of the time. That is an extremely high reversal rate.
GW: What's the significance of the part of the District Court's decision that was upheld, the method claims? For example, this doesn't mean that someone can start offering their own BRCA tests without running afoul of Myriad's patents?
SP: Exactly. You might have thought they could, so long as they are not isolating the BRCA DNA, because there are methods where you may not have to isolate the DNA as it has traditionally been done but you can still get the sequence. The problem is that the majority opinion is all about the breaking of covalent bonds, so even with these testing methods that do not rely solely on isolating DNA in the way that it's traditionally been done, there is still a breaking of covalent bonds that occurs, so that continues to be a barrier, even with the newer technologies. Myriad's patents still stand in the way of anyone who wants to do BRCA genetic testing.
GW: Is there anything in particular that surprised you about the decision?
SP: One thing we found surprising was the focus of the decision on the breaking of covalent bonds-an argument that Myriad never brought to the fore. It was something the court really generated itself, and it also generated its own scientific findings. This is one of the reasons we petitioned for a panel rehearing.
I think if you read Judge Lourie's opinion, he understands that geneticists do not think of DNA in the way that he's thinking about it, but that he is deciding to apply a chemistry approach nonetheless. That really departs from the language of the patent claims themselves, which talk about DNA as encoding for a protein. The definition of DNA in the patent claims relies on genetics, not chemistry.
The other troubling part is that we never really had a chance to brief the issue of breaking of covalent bonds, because Myriad had never relied on that argument in its own support. That's something that we raised in the petition for panel rehearing.
GW: Both sides asked for panel rehearing, and both were denied by the court. What reasoning did the court give?
SP: The court simply denied the petitions for panel rehearing, without explaining its reasoning. Courts usually do not give explanations for such denials.
GW: What's the next step? Are you preparing an appeal to the Supreme Court?
SP: We are considering our options. If we move forward, the next step would be to seek review from the Supreme Court, but a final decision has not yet been made.