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« Court Report | Main | EPO Prepares to Roll out New Prior Art Search Disclosure Rules »

October 31, 2010

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Thanks for the analysis, Kevin. Yet again, the Obama administration proves that, for a group of ostensibly smart people, its forte is devising boneheaded policies. Not only are biotech-derived medicines already here, but they're just going to increase in medical and economic importance in the future - unless Obama & Co. manage to push through this ill-conceived change in policy. Fortunately, as you (and Hal Wegner) note, if the CAFC boots this case for lack of standing, the question of the patentability of DNA molecules will be set aside, at least for now - Supreme Court review, if granted, would be restricted to the question of standing.

the DOJ is well aware that this is a change in policy. The PTO was overruled by other agencies, including NIH.

Great analysis. As a biotech patent attorney, I am shocked by the DOJs brief.

um, can you post the brief? Isn't that what bloggers do?

Even scarier - If the administration stacks the PTO with management that believe in the position. The first denial of sequences based on 101 will probably be borne on a startup, who probably won't have the resources to take on a CAFC appeal from BPAI.

The brief could be interpreted very narrowly. It seems to say only sequences that are isolated directly from the genome are unpatentable. This would not include, for example, PCRd sequences, which are synthesized using the gene as a template. If you think about most assay applications of biotech, the gene in the person's cell is not physically removed, it is used as a template for PCR. Myriad's assay works this way. If claims to PCR probes, the product of PCR, and genes in vectors are OK, there is really very little else that is needed.

Why is the Department of Justice rather than the Department of Commerce submitting a brief?

Dear Grimace:

Agreed. Which raises the question of why the administration weighed into this fight in such an ineffective way.

Thanks for the comment.

"in such an ineffective way."

Not to be contrarian Kevin, bu I think the brief is extremely effective for an audiance of laymen. Therein lies the danger.

In its much simplififed way, the point is much more accessible to all those who do not have the in depth knowledge and (dangerously) humanizes the Judge Sweet position.

In a sense, it paints the picture that the greedy patentee is trying to make money on something already out there which already does the same thing. The "something already out there" may not be "isolated", but the argument strongly conveys (rightly or wrongly) that the act of isolation is relatively meaningless.

Is there any utility for an "isolated gene" that would justify getting a patent on it in the first place? The products actually used in commerce are totally synthetic primers and probes. I'm beginning to wonder if the whole "gene patent" controversy has much real-world relevance.

Golly. years ago I isolated a receptor and characterized it, and my techniques were required to study the gene that was cloned some years later. Why didn't I think of patenting my "invention"? Of course, the reason was that it was a discovery (knowledge), NOT an invention. The gene is the same. New drugs targeting the receptor, novel ways of affecting gene function, etc., these are inventions. Contrary to earlier posts, this DoJ filing is a whiff of fresh air.

Dear Old:

Probably because you didn't isolate the gene. Sorry.

Grimace/Kevin: I disagree that the brief can be interpreted narrowly. It directly addresses "an ordinary BRCA gene isolated from a tissue sample taken from a woman in a hospital" which would be the template for PCR-based assays. I think the argument is that the gene is unpatentable, preventing any one individual from owning the gene and all assays related to it. Individuals would be free to develop and patent assays related to it, but could not prevent others from developing and patenting other assays related to the same gene.


As an aside, the distinction disallowing patents on genes but allowing them on cDNAs seems ludicrous, considering the ease with which one can isolate cDNAs from "an ordinary BRCA gene isolated from a tissue sample taken from a woman in a hospital" or any other biological material.

I find your slippery slope (that the decision will in the end mean the unpatentability of a variety of naturally occurring protein products) much more thrilling than you seem to.

Dear Material:

You, like Judge Dyk, must think these drugs grow on trees. They don't.

Thanks for the comment.

Confusus
The way I read it, the gene sitting in the tissue sample would not be "isolated", and nobody is trying to claim that. In the Myriad assay, the DNA is extracted from the sample. The gene is still not isolated, it is still in context. Then the sample is subjected to PCR, I am not sure if there is a digestion step prior, Myriads tech specs do not say there is. Either way, still not isolated. The result of the amplification is a newly synthesized DNA, it is not isolated from the subject, it did not exist until the PCR step. I guess the point is that Myriad never needed claims that read on the gene isolated directly from the subject, and "losing" that subject matter is not a loss. Unless you are saying the brief is also excluding from patentability the products of PCR amplification. I don't agree, but at this point your reading of it is as good as mine.

Your libertarianism is showing:

"While not relevant to the '502 patent (which long ago expired), what will be the effect on the economics of producing vaccines for the next pathogenic outbreak if the DNA comprising the vaccine cannot be protected?"

Does everything have to be done for a profit? Aren't there issues important enough (especially public health issues such as vaccination) that we can take a short break from worshiping The Market? When it comes to vaccines I think we need a little less Ayn Rand and a little more Jonas Salk: "The people own the patent on this vaccine. There is no patent. Could you patent the sun?"

Also, the idea that the current administration (or any conceivable future administration, save some extreme campaign finance reform) will do anything but diligently serve PhRMA is absurd. PhRMA got everything they could dream up in the so-called health care "reform" bill.

Corey:

Your citation of Jonas Salk's response to Edward Murrow in 1955 regarding the polio vaccine tells only half the story. Gene patent opponents often overlook that Dr. Salk also started a company (The Immune Response Corporation) in the 1980's to develop an HIV vaccine, and secured seven patents on which he was a named inventor and which were assigned to his company. Clearly, Dr. Salk's views changed between 1955 and the 1980's.

Don

Dear Corey:

And speaking of Dr. Salk, remember that the good doctor developed his vaccine by experimenting with retarded children at the local institution with precious little oversight (parental or governmental). The Thalidomide tragedy and the changes in FDA rules were years in the future, and the costs of developing vaccines and drugs substantially less.

It isn't libertarianism, it is reality - this is a capitalist society. If we want to make sure everyone gets care/vaccines/drugs, that is a political and economic decision. We have the means but not the political will. Changing the patent system to provide disincentives for commercialization and (what's worse) disclosure is just not the answer. And the DOJ brief does nothing to hurt Myriad or help patients/plaintiffs. A fig leaf, and a malignant fig leaf at that.

Thanks for the comment. I admire Dr. Salk, but 1) he wasn't a saint and 2) Sabin's vaccine was better.

"the government's brief confuses a claim to a method for detecting the existence of a natural phenomenon with a claim to the phenomenon itself. "

Lulz, does your claim to a method for detecting the existence of a natural phenomenon cover pretty much all uses of the phenomenon itself?

If yes, you know you're done son. Otherwise alright, maybe that claim is ok.

O and we all read the takings post and shared a chuckle awhile ago Kev, you don't have to trot out the same old jokes time and again.

"You, like Judge Dyk, must think these drugs grow on trees."

Do they grow IN trees? Or do they just grow in plants other than trees? Maybe in animals? Where do they grow?

Don his views probably changed because he talked to too many patent lawlyers.

6:

Or maybe Dr. Salk understood what nine non-patent attorneys were saying in Diamond v. Chakrabarty.

Don

6:

The two of us have had more substantive discussions on the scope of these method patents than is contained in the DOJ's brief. The only thing the DOJ seems to care about is the artificial distinction between "natural" genomic DNA and "synthetic" cDNA.

And, once again, a claim to a machine, manufacture or composition of matter pre-empts all uses thereof (by which I mean, prevents unauthorized use, not prevent independent patenting of new ways to use them).

Thanks for the comment.

Kevin,

Excellent expose of the illogic in this DOJ brief. This brief is replete with utter sophistry and rhetorical nonsense. The fact remains that "isolated" nucleotides as claimed by Myriad don't exist in nature, plain and simple.

"6:

Or maybe Dr. Salk understood what nine non-patent attorneys were saying in Diamond v. Chakrabarty.

Don"

Lulz, I'm sure he did. Or at least I'm quite sure he could understand that they were prepared to draft a new patent law in lieu of the congress doing it themselves, even if he never bothered to actually find out about the decision. It's plain as day for all to see so I'm sure he could understand it as well as you or I could.

But even so, I doubt that would change his perspective at all.

It would be interesting to see what he did patent though. Maybe new methods etc? New machines?

"And, once again, a claim to a machine, manufacture or composition of matter pre-empts all uses thereof (by which I mean, prevents unauthorized use, not prevent independent patenting of new ways to use them)."

Correct, and when the claim ALSO preempts all uses thereof of a naturally occuring "something" then... the claim is invalid? Yep. So far as I know.

"The only thing the DOJ seems to care about is the artificial distinction between "natural" genomic DNA and "synthetic" cDNA."

I didn't really get that from the brief but if you say so.

"The fact remains that "isolated" nucleotides as claimed by Myriad don't exist in nature, plain and simple."

Does the fact that claims to "isolated" nucleotides as claimed by Myriad happen to also substantially preempt nucleotides that exist in nature also remain? Is that not also plain and simple?

Dear 6:

The isolated nucleotides do not preempt the nucleotides as they exist in nature. So you can sleep soundly - no one has any claims on your genes.

And regarding Dr. Salk, it is sad that I have to tell you about the PTO patent database, but here are some samples of the claims Dr. Salk obtained:

1. An immunogen comprising a non-infectious intact HIV virus devoid of outer envelope proteins. (USP # 5,256,767)

1. A method of stimulating the immune system of a human to produce antibodies, reduce viral burden or maintain CD4+ levels, comprising administering an immunogen comprising non-infectious intact HIV devoid of outer envelope proteins. (USP # 5,853,725)

4. Purified and isolated anti-retroviral antibodies obtained by the method of claim 3. (USP # 5,885,578)

4. An immunogen comprising whole inactivated retroviral particles in a physiologically acceptable solution. (USP # 5,895,650)

7. Monoclonal antibodies produced by the cell lines of claim 6. (USP # 5,916,806)

Thanks for the comment.

"The isolated nucleotides do not preempt the nucleotides as they exist in nature"

Ok Kev, lets just say for a moment that you're right. Mind making a small list of things I can do with the unisolated DNA at issue without infringing the patent? Just like 3 or 4 things.

We still might have a problem with the information being preempt like the DC says, but at least you might not be invalidated by preempting the uses of the natural DNA strand.

I think those claims you listed pass 101 fairly well even under my criteria except maybe claim 1 as there seems like there is a good chance that "non-infectious HIV virus" is something that occurs in nature (if I'm wrong about that actually being something that occurs in nature then the claim can pass) and all he did here was strip the outer envelope proteins. Stripping an irradiated tree of its bark doesn't make the inside of the tree patentable.

6,

How much "stripping" is needed to evidence the hand of man?

"6,

How much "stripping" is needed to evidence the hand of man?
"

Any stripping is adequate to "evidence the hand of man". Unfortunately for where you're trying to take this, that fact is wholly irrelevant.

So about that small list? Come on, just copy paste and fill in the blanks.

1.

2.

3.

4.

6,

Where is it that you think that I am taking this such that you confidently state the irrelevancy of the hand of man?

You're about to take this down the road where you say that the hand of woman doesn't count, but so long as the hand of man is necessarily present in the construction of the item (likely even in the performance of the method) at issue then you're all good to go to get past the 101 threshold.

But the truth is that the hand of man or woman being necessarily present is irrelevant to the 101 inquiry.

Now about that list.

MM just confidently stated over at PO that wild DNA has no use. Which I found kind of odd because he should know, but it seems like he might be mistaken at least in so far as wild DNA is turned into isolated DNA right?

Ok, 6, you can grow a cell that uses the unisolated DNA to make a protein (I.e., "the old-fashioned way").

You can transfect total chromosomal DNA into a cell to select for a phenotype.

You can detect restriction fragment length polymophisms by gel electrophoresis.

You can assay the gene for binding specific factors.

You can produce a sequence (provided that you never isolate the DNA),

Is that enough for you?

Thanks for giving me the opportunity to use those neurons.

6:

Bonus question: name the movie, the actor who says this, and the actor it is said to:

"Tell me, just when was it that you started thinking you were smarter than me?"

Kev even the internetz doesn't know that trivia.

I suppose that's long enough of a list for me. Although I don't really understand what those things are, and you could be bamboozling me. Some of them seem kind of suspect. But I'll take your word for it.

6:
I would never bamboozle you. Where's the fun in that?

Thanks for the dialog.

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