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« IPO Amicus Brief Argues for Patent Eligibility of Myriad's Isolated DNA Claims and Method Claim 20 | Main | Hatch-Waxman Watch »

July 10, 2012

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How do you think this decision will apply to stem cells, particularly Human Embryonic Stem Cells and the therapies developed from them considering the differentiation processes?
Wondering about the current case in patent interference 105734 and 105827Geron vs Viacyte?

So Kev, you told me that the claims at issue did not preempt on any of the judicial exceptions, why is the US gov telling me differently?

Easy, 6. The government is wrong (you're familiar with that, right?)

Well Kev, this right here:

"The U.S, argues, however, that "patents on isolated but otherwise unmodified DNA would significantly impair the public's ability to study and make use of genomic DNA.""

Is patent [redacted] speak for "patents on isolated but otherwise unmodified DNA would effectively preempt the genomic DNA however used.

But you think that they're wrong. I'm supposing that you think they're wrong because there are many other uses for genomic DNA that wouldn't be hampered by such claims.

One question though remains, would their ability to use and/or study the genomic DNA be significantly impaired? And be honest with me.

There have been more than 8,000 published scientific papers reported on the BRCA genes since the patents were granted. How inhibited can they be?

While I respect your lawlyerly ability to answer a question with nothing but another question and a statistic I'm afraid that I am going to have to say that such is not really a complete answer. However, I will take it from what you did say that you believe that their ability to study the genomic DNA is not significantly impaired because there is evidence of many articles. Ignoring for a moment that you don't bother to compare this against the number of articles published about a comparable gene which was never patented this still does not touch on whether the ability to use the genomic DNA is significantly impared.

The problem with the statistic you want is that it depends on the scientific interest in the gene, which is a confounding variable. I think 8,000 papers is a lot.

I gotta say that my favorite sentence in the US Gov't brief is, "To be sure, that guidance is indirect."

I have to think that Melissa Patterson or whomever wrote that sentence was smiling.

BCD

Well yes Kev, I agree about the stat, but that isn't so much what I want. What I would like to eventually get at is what I asked at the end, specifically whether the ability to use the genomic DNA is significantly impared.

Hows about it? Is the ability to use the genomic DNA significantly impared?

Sorry, 6, I have been traveling.

My answer is that in my opinion, based on many, many, many studies looking for a negative effect of patents on basic genetic research that have found no effect, is that these patents do not inhibit basic research on human genomic DNA.

Dear Bill:

Stem cells are next. Dan Ravicher has been trying to get the WARF patents invalidated for several years.

Your answer is to evade the question as a whole? I have specifically noted, thought I may not have been clear enough, that I am not talking solely about "basic genetic research" or even "research" in general.

I am asking, as a whole, not limiting ourselves to a discussion about basic genetic research or research at all, is the ability to use the genomic DNA significantly impared?

6:

Not sure what you need. Maybe I'll approach it another way. If you want to use an isolated genomic DNA molecule and charge people money fr it, then you may infringe. But that isn't what those who say DNA claims arm innovation are saying. They don't want to admit they think the rules don't apply to them.

"Not sure what you need. Maybe I'll approach it another way. If you want to use an isolated genomic DNA molecule and charge people money fr it, then you may infringe."

I'm trying to ask, in your way of phrasing this: if you want to use an UNisolated genomic DNA, do the claims to the isolated genomic DNA significantly impair your efforts? And this question is taking into consideration all uses, every last conceivable use, of the UNisolated genomic DNA including ones "for a charge of money" or not.

"But that isn't what those who say DNA claims arm innovation are saying. "

No, I think this is where you're talking past one another. They're (the gov) are telling you this, and you aren't listening.

And also, as an ASIDE, but not to freak you out, it is likely the reason that Myriad's claims are likely on the way to the chopping block.

Aha - now I understand. Simple answer: if the DNA is NOT isolated, you can do whatever you want to your heart's content. No worries, because the UNisolated DNA is like the leaf - not patentable without more.

I know what the government (or at least a part if it - the PTO seems to still be granting patents) is saying, and they are wrong.

"if the DNA is NOT isolated, you can do whatever you want to your heart's content. "

K I hear you, but you're saying you can do whatever you want to your heart's content except isolate it ... right? And isolating it is pretty much required to do something useful with just that little sequence of unisolated genomic dna isn't it?

Ah, no, actually. For example, you could amplify pieces of it to detect specific mutations associated with disease, and because you have not isolated ALL of it, you don't infringe.

Also, you forgot the part about charging people - if you are not charging people you are not making anything to sue over, and the public interest will impact whether there is an injunction granted against you. So it seems to me that these claims are not the problem (except that they make a great sound bite and are good for fundraising by groups who should have plenty of other opportunities to right wrongs, etc.).

Anything else?

"Ah, no, actually. For example, you could amplify pieces of it to detect specific mutations associated with disease, and because you have not isolated ALL of it, you don't infringe."

So... I could use pieces of it. That seems good. But not the whole thing. So if I wanted to say... oh, idk, use the whole UNisolated genomic DNA... then I infringe. K. Yeah. I'm seeing bit of a problem emerge here.

"Also, you forgot the part about charging people - if you are not charging people you are not making anything to sue over, and the public interest will impact whether there is an injunction granted against you."

No, I remember it. I'm not so much concerned about injunctions as I am $$$/royalties.

"if you are not charging people you are not making anything to sue over"

Hmmm, that's funny, because I'm not sure if Myriad shares your view on this. Somehow I doubt they'd appreciate some do gooders eating into their biz.


In any case, I understand your position Kev, and I thank you for the dance, I will trouble you no more. But, upon further inspection, I think we're going to see a bit of a problem emerge in this here case due to the government's reasoning (that just so happens to be my reasoning from like what? 2 years ago?).

Not to leave you with a false impression, if the genomic DNA isn't isolated you DON'T infringe. Let me give you one more hypothetical and be done. You have a cell that cannot make metabolite X, so it requires X on the media to grow. The deficiency is due to a mutation in gene Y.

You take DNA from a cell that CAN make metabolite X and introduce it into the cell that cannot make X. Now this part is important: isolating the cellular DNA (ALL of it) does not infringe a claim to isolated gene Y.

You then grow the cells into which you have introduced ALL the DNA from the cells that can grow without X in media without X. Most of the cells die, but the cells that grow now contain the Y gene.

Guess what - you don't infringe. Added bonus: this is how people did these experiments in the '80's and it works just fine.

Ok?

I applaud the U.S. brief for acknowledging (albeit indirectly) that the most significant issues regarding gene patents revolve around policy, rather than hard science. In my opinion, any decision as to whether to permit such patents can only be satisfactorily resolved by considering their effects on society at large.
http://www.generalpatent.com/blog

Yes Kev, I understand that I could use the "whole unisolated genomic DNA and not infringe". Thank you for fleshing it out further though. I apologize for not having used the correct wording in the previous post where I said " use the whole UNisolated genomic DNA". I was referring to what you would, using this new wording, call "the whole unisolated gene Y".

It is a difficult dance to even keep up with how you're using the terminology as you seem to be bobbing back and forth whenever I adopt my language to yours. Never the less, it appears that what I'm actually referring to, for example the BRAC1 gene, as it exists in the human body, practically cannot be used in its entirety and by its lonesome (note I'm not referring to your "isolation" although even if I were it wouldn't much matter) without infringing.

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