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[MYK]

In case anyone has been living for the last few days in a cave, on Mars, with their fingers stuck in their ears, a district court judge just decided to legislate from the bench and invalidate seven patents owned by Myriad Genetics:

http://www.genomicslawreport.com/index.php/2010/03/30/pigs-fly-federal-court-invalidates-myriads-patent-claims/

The patents were on a human DNA sequence and tests for it.  The sequence is tied to an increase in risk for certain cancers.

The ruling was a summary judgment in favor of the ACLU and some other hangers-on who felt that patents on human DNA sequences were horrible.  The judge made his decision based on his belief of what public policy should be.

Anyone want to discuss?  I assume this will get appealed, and I'm willing to bet that it will be reversed.

[Robert K S]

Reversed, unceremoniously, and may heaven help the SCOTUS if they are so improvident as to grant cert.

Maybe there are real issues here, but they aren't being covered in the opinion, or by either side, or by the commentators in the media.  Instead, what we have is a travesty, and a silly one at that.

[bartmans]

I agree with Robert's opinion that this decision is totaaly ignoring any precedent set by SCOTUS or the CAFC.
If you want to see a lively discussion on the matter, you should consult the Patently-O blog on this item: http://www.patentlyo.com/patent/2010/03/court-essentially-all-gene-patents-are-invalid.html.

One remarkable comment of Kevin Noonan (author of the Patent Docs weblog) there: an advise for Myriad not to file appeal. Then this decision will only affect the parties (and patents) involved, it will not form precedent and it will take away the possibility for ACLU and its co-plaintiffs to do more damage, because they will not be able to appeal from the current decision.

[JimIvey]

I heard about that on NPR.  I even heard a patent professional admit that human genes are patented.  How can that be?  I've had all my human genes in public use in the US years before the first applications on any human genes.  102(b).  Done.

I imagine they don't claim "a human gene ... for making blue eyes."  I imagine they claim methods for treating certain conditions by testing for expressions of a certain gene and then applying a particular treatment upon detection of the expression.  That's not patenting a gene but rather patenting reference to the gene for treatment.

I like what one of the patent professionals on NPR said.  (paraphrasing...)  "Nobody has problems with patents on iphones, ipads, cars, HDTVs, and you wouldn't have many of those products without patents on them.  We also wouldn't have gene therapies without patents on them."

Regards.

[bartmans]

JimIvey,

just to update you: they do claim genes as product claims. However, the magic word in the claim is the word 'isolated', which means that there is a human intervention which makes the discovery of the gene in its natural environment turn into an invention: one has made the compound (gene) fit for human practice.

It is this 'axioma' that basically is misunderstood. However, this is true for all chemical compounds that occur in nature (and genes basically are nothing more than chemical compounds). Taxol (now a wide-spread anti-cancer drug), for instance, was originally found in plants, but the isolation of this chemical compound from the plant has made it patentable. I have to admit, however, that use of the word 'isolated' to indicate that it is no longer in its natural environment, is only felt necessary when claiming gene sequences.

[JimIvey]

Thanks, Bartmans (I always thing of Bart Man, as in Bart Simpson, when I see your userid).

So, to dumb it down for my feeble mind (in the context of life sciences), a claim would recite a human gene identifier "in isolation" and the identified gene would be the one responsible for blue eyes (in my simple example).

First, once you can isolate any gene, wouldn't isolating any other gene be obvious?  I assume there's a machine (or a well-understood process) for isolating a gene in a human chromosome that starts at position x and ends at position y -- well, probably wasn't well-known not-too-long ago, but would be when the first gene was isolated.

Second, how useful is an isolated gene?  What does one do with that?

I guess maybe diagnostic tests can be performed on a tissue/fluid sample in which all the other DNA has been removed.  You don't take a pill (or other delivery) of the isolated gene, do you?

I feel like a complete newbie in this area of patents -- so far removed from my experience.

Regards.

[klaviernista]

"So, to dumb it down for my feeble mind (in the context of life sciences), a claim would recite a human gene identifier "in isolation" and the identified gene would be the one responsible for blue eyes (in my simple example).'

That's about right. 

"First, once you can isolate any gene, wouldn't isolating any other gene be obvious?  I assume there's a machine (or a well-understood process) for isolating a gene in a human chromosome that starts at position x and ends at position y -- well, probably wasn't well-known not-too-long ago, but would be when the first gene was isolated."

Not necessarily.  There are myriad ways to isolate genes, e.g., restriction enzymes, gene cloning, etc.  A major problem is simply identifying the gene itself.  How does one isolate a gene until one knows what base pairs make up the gene?

"Second, how useful is an isolated gene?  What does one do with that?"

Research is a major use of isolated genes.  Gene therapy is becoming more and more mainstram too.  You could also develop tests for genetic defects that depend on isolated the gene as well.

The following link points to a good article re: gene patenting and the end use of isolated genes.  http://www.ornl.gov/sci/techresources/Human_Genome/elsi/patents.shtml

[JimIvey]

Thanks.

[Yet another examiner]

First, once you can isolate any gene, wouldn't isolating any other gene be obvious? 

There's a case to be made for that, but my understanding is that this case only dealt with 101 issues and not 103.

[bartmans]

Klaviernista is right: the invention is not in the step of isolating but in determining what should be isolated. Further, one can not claim a gene (or any stretch of DNA) without having a utility for it. So basically, the inventive part is determining which DNA is responsible for which function.

Human genes or DNA (there is a difference, not all stretches of DNA are genes) are indeed mostly used in diagnostics, e.g. for diagnosis of breast cancer as in the Myriad case. Then the focus lies on detection of specific mutations in the DNA that have been found to have a relationship with a disease. Another area of use is in laboratory tests: provide a test cell with the gene and use it to test compounds having an effect on the gene or the gene product. In such a case e.g. new anti-cancer drugs can be tested.

Outside the field of human genetics there are other uses of DNA. In the plant field many inventions lie in providing plants with DNA coding for new traits (Monsanto's glyphosate resistant soy plants are one example). Also transgenic animals (Harvard's oncomouse) can be made in this way.


With regard to patentability, DNA just should be regarded as a chemical compound (which basically it is). For that matter, it is no more different than proteins or other chemical substances (like insulin, enzymes, taxol, caffein, cannabis and many others) that are found in nature. The only 'extra' that DNA adds is that it is able to convey information: the genetic information.

[MYK]

Thanks, folks.  Sorry for missing out on the discussion;  it's been a bad few weeks here, and it's going to get worse before it gets better.  Sigh.

Bartmans, I think I saw that suggestion (not to appeal) also on another site, not sure if from Mr. Noonan or whom;  the problem is that while that would limit the damage to everyone else, it would leave Myriad significantly harmed, so I doubt that's going to happen.

Since the judge has already ruled the patents invalid, does this mean that everyone in the world can now claim interim rights, or will that part of the ruling be stayed while Myriad appeals?  Will interim rights issues be in play even if/when the district court gets reversed?

Jim, one thing to keep in mind is that the claims were directed toward specific variants of the gene which Myriad had found were linked to an increased risk of certain cancers, primarily in certain population groups.  Note also that these were tests for FUTURE RISK, not for detecting actual growing cancers, nor even about effectiveness of a given treatment.  So, Myriad sampled a population that appeared to be at a high risk for certain cancers, figured out which genes triggered the cancers, and figured out which specific defective versions of the gene were the versions responsible for the increased risk.  The patents weren't on "hey, you have a BRKA1 gene, pay up!" (which is how the media seemed to be playing it).

BTW, I sincerely hope you aren't using (dare I say infringing) these high-risk genes.

[JimIvey]

Okay, let's see if the dunce in the back of the class gets this.....

Take this long bit of rope (a chromosome) and start with the left end, follow along to the right until you find the pattern, GATTACA.  Then, go 27 more segments to the right and cut.  Then go 35 more segments to the right and cut again.  I call that the BKRA1 gene.

My argument for novelty is that the BRKA1 gene does not occur in isolation like that in nature.  My argument for non-obviousness is that no one would have known that snipping out that segment of the chromosome would have any particular utility and therefore would have no motivation to snip chromosomes in the particular manner to isolate that particular segment of the chromosome.

Now, by claiming that as a gene in isolation, I can prevent others from taking that gene and replicating it many times over in a lab to conduct tests and/or experiments -- i.e., cover direct replication of the gene in isolation rather than only the elaborate process of snipping it out of chromosomes.

Hmmm....  I wonder what happens if it's later determined that some genes occur in isolation in nature -- as in splintering during some odd replication malfunction within a natural cell.

Interesting.  Thanks, all, for educating the dunce.

[JustAnotherExaminer]

Klaviernista is right: the invention is not in the step of isolating but in determining what should be isolated. Further, one can not claim a gene (or any stretch of DNA) without having a utility for it. So basically, the inventive part is determining which DNA is responsible for which function.

The technique for isolating isn't part of claim?

Is KSR's finite possible combinations obviousness test applicable?  Assuming there's a max possible DNA thingie length and finite selection group.

[klaviernista]

I think bartmans was over generalizing.  Typically, the means of isolation is not novel.  Restriction enzymes, etc. have been known for 20+ years now.  But sure, the technique of isolating could be the subject of a patent claim, in the right circumstances.