Q: Old patents claim using a specific methylated (CH3) DNA as diagnostic. New method measures overall CH3 (no seq). FTO?
The old methods isolated unique sequences and showed that CH3 status of the sequence was important. The new method looks at all CH3 at once without any regard to sequence. It can be argued all patents looking at CH3 of specific sequences teach away. The new method does not identify any sequences. It does not use any specific probes (at present). In looking at all DNA it likely catches, without intending to, many previously claimed sequences. We don't even know which. Do we have to license them to use the new invention? If we make a "kitchen sink" probe to all things the new method isolates, again not knowing what they are, can that be used without licensing the 1,000-10,000 sequences that might be in it?
Each of the individual claimed sequences (theoritically) could be deleted from the assay with no effect. In reality this is not possible since the method is sequence agnostic.
Thanks for any thoughts about FTO!
A:
From your brief description, it sounds like you are OK. But it really depends on what the claims recite. If it calls for isolation of unique sequence, and you do not perform that step, then you are not infringing. But if the claims are simply directed to measuring methylation of a specific gene and you are measuring methylation of many genes which may include the specific gene, then you may be infringing.
You really should talk with a patent attorney who specializes in biotech.
A:
It's hard to say if you have FTO in this circumstance or not. However, I won't leave you with such an empty answer.
For infringement, you rely on the claims which were granted in the patent in question. If a system or method claim from the patent calls for elements A, B, C, and D, and you perform elements A, B, C, D, E, and F, then you still infringe the claim. The fact that you also perform elements E and F won't protect you from infringement. Now, if you don't use one of the elements of the claim, for example, you only perform elements A, B, and C, then, without further details, you would not be infringing. So, based on your statement that your procedure may catch many claimed sequences, it sounds like you would be infringing (hard to know at this point without further discussion and search).
However, since you're talking about DNA methylation, you are likely talking about probing for genomic sequences. Assuming all of that holds true, the validity of such patents may be affected by the Myriad Genetics ruling. I'm well versed in the biosciences (geneticist and pharmacologist) and I'd be happy to help you make a determination, if you need further assistance.
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