Why would people not get the cure? If you are suggesting they get it for free regardless of ability to pay or insurance coverage, then I guess they wouldn’t get the cure, but that isn’t any different than currently exists. Medical care, like all other scarce resources, are rationed.

-Gene

I will take a look to see if I missed a claim, but clearly the use of “isolated” in the claim provides the requisite human activity required by the Supreme Court. Unfortunately, Judge Sweet interpreted “isolated DNA” to mean “DNA” including DNA in it’s natural state. But isolated DNA does not occur naturally, and he is wrongvon the law and wrong on the facts. He will be reversed without doubt.

Not sure what you mean by straw man argument. I know the concept, but no straw man here. I just point out the lies of the ACLU. Facts and reality should matter.

-Gene

“An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2. ”

Unlike the claim you did cite, this one does not recite “altered”. From what I read in the press the judge decided that in the case of DNA, “isolated” and un-isolated are the same thing, unlike insulin I suppose. I do not know enough to have an opinion on the ruling but your readers should get to see the claim that does not have the limitation of “altered” .

I enjoyed your talk at NAPP in San Diego.

—George White

2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.

3. The isolated DNA of claim 1 which contains BRCA1 regulatory sequences.

4. The isolated DNA of claim 2 which contains BRCA1 regulatory sequences.

5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.

6. An isolated DNA having at least 15 nucleotides of the DNA of claim 2.

Yes, they have great claims. An isolated DNA, and a half dozen methods of detecting BRCA mutations.

They also have a plethora of mutations described:
(i) C and T at position 2201,
(ii) T and C at position 2430,
(iii) C and T at position 2731,
(iv) A and G at position 3232,
(v) A and G at position 3667,
(vi) T and C at position 4427, and
(vii) A and G at position 4956;

Isolated genes, i.e. not in a human body, are not found floating around in nature. Yes, they are isolated by the hand of man and fifteen years ago when the genes were isolated, it took a lot of work and investment to identify the genes that correlated to a specific disease. The claims expire in ~5 years and are available without restriction in the public domain.

Others were working on the same or similar problems. I have not reviewed the genes involved or DNA sequences used, but the DNA markers used for detection in “Screening of inherited breast cancer with DNA markers,” Lancet. 1993 May 29;341(8857):1422, may provide some prior art. You would have to do a detailed analysis of the sequences provided, complete alignment, and identify any mutations and/or amplified sequences that are available in the prior art (if Lalle, et al. had the right gene). I do not have a full day to devote to this analysis.

Myriad Genetics currently has 172 assigned patents and applications with the USPTO. I do not have time to review each and every claim of each and every application. IT is clear to me that if someone were to use the Lalle markers to sequence the BRCA gene, they should be in the prior art. It would take much more time and analysis to ensure DNA sequencing using the Lalle markers would be outside each and every one of the Myriad Genetics claims.

Arguing that the excact sequence, SEQ ID NO. 1, would spontaneously end up isolated in a microtube without the hand of man is not a logical argument. That is an emotional statement that you feel Myriad’s work is outside of patent scope because in your professional opinion they don’t deserve a patent. The question of whether or not Myriad deserves a patent is a legal question based on the state of the art at the time the patent was filed, the content of the patent application, and the discussion between the examiner and the patentee. Courts may review the examiner’s decision, especially in light of new prior art. Any sequence existing greater than 1 year prior to the filing of their first application is in the prior art and may be used without fear of infringement.

Claims 5 and 6 should be easy to invalidate because prior art DNA seqeunces of 15 nucleotides are fairly easy to find, if you have the time. Legally, they may already be invalid because they are broader than the claim from which they depend (that’s a “No! No!”). That would have to be flushed out in a legitimate court case.

All of this began through University of Utah and Cancer Institute research. They either are or at one point made money off of this invention and received financial support for their research. The may have some form of licensing agreement to continue research and there may have been US government funding allowing some institutions to research as well.

This is a very long and detailed case, with a lot of patents and pending applications. I cannot review each and every avenue out, but I have shown several paths (prior art, limits on the definition of BRCA gene, and possible licensing) to free up use of the BRCA gene. It would take money and time to clear a path through this patent thicket, a legal, legitimate, fact-based, non-infringing path.

Right now I would use a primer encoding a 20 aa tag sequence to amplify 90% of the BRCA coding region, that would be outside the literal scope of claims 1 – 4. Claims 5 & 6 may be much more difficult to enforce, and more easily invalidated.

Best regards and good luck with your design-around,

Mike

Claims 1, 2, 5, and 6 say nothing about detection… dowload the patent from my blog, or read here verbatim:

1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.

5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.

6. An isolated DNA having at least 15 nucleotides of the DNA of claim 2.”

which is why Myriad has enforced their patent against anyone daring to replicate the BRCA1 or 2 genes, no matter what the purpose.