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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline

« Animal Studies: Are Too Many Never Published At All? | Main | The Ariad Decision and Written Description »

March 30, 2010

Myriad's BRCA Gene Case: Wait For It

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Posted by Derek

I haven't commented so far on the decision yesterday in the Myriad Genetics case involving their breast cancer assay gene patents. This is surely going to be appealed, and we're not going to really know what's up here until the CAFC has a say. And who knows? This is the sort of case that might go even further than that.

That's what the folks at Patently Obvious think, at any rate. They note that this decision is rather far out of the usual range of case law on patentability, and will likely be reversed on appeal. And then?

Comments (10) + TrackBacks (0) | Category: Patents and IP


COMMENTS

1. PharmaWiz on March 30, 2010 3:09 PM writes...

It likely will be appealed, but it's hard to say if the verdict will be overturned. There are some fundamental precepts here, essentially dealing with the issue of what can be patented. If the notion of a gene from a person is not patentable, then someone like Amgen has little protection for isolating the genes coding for erythropoiten, say. In the aggregate, is that beneficial to society? Is that what Congress meant in passing the patent laws? I'm not a lawyer, but those appear to be the key issues. As I understand it, that's a decision that a district court deals with, and the appeal has to find fault with the manner in which the district court handled the case (handling of evidence, instructions to a jury, or reading of the law). Only the latter, though, looks like it may be in play, and looking at the opinion, I'm not so sure it can be overturned so easily.

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2. Indy on March 30, 2010 3:42 PM writes...

Patents are to be issued to protect inventions; consequently, discovering anything (in this case a gene) should have not merit issuing a patent in the first place.

Unless a gene was engineered and/or modified THEN the new construct certainly should be patentable.

My 2 cents. Indy.

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3. Mrten on March 30, 2010 4:45 PM writes...

Techdirt has another take on the news, decidedly positive, but expects an appeal as well.

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4. Bogart on March 30, 2010 4:58 PM writes...

CAFC will reverse - 100% probability.

Goes to supremo land where that degenerate body will likely affirm lower court- 99% probable.

1% overturn probability derived from the possibility Scalia will keel over from a heart attack. The court is so pro big business/ anti- individual that expect this new challenge to fizzle.

But then again it depends on what specific claims are at issue. Some may be overturned while others remain whole. I assume they challenged the claim for the chemical structure of the gene, not the assay.

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5. Jonathan on March 31, 2010 9:12 AM writes...

Judge Sweet's reasoning in the judgment is actually very logical and compelling. He cites case law going back to the 1800s that quite effectively eviscerates Myriad's claims that their patent isn't on a product of nature.

Some choice quotes:

"Were the isolated BRCA1/2 sequences different in any significant way, the entire point of their use - the production of BRCA1/2 proteins - would be undermined"

"The identification of the BRCA1 and BRCA2 gene sequences is unquestionably a valuable scientific achievement for which Myriad deserves recognition, but that is not the same as concluding that it is something for which they are entitled to a patent."

And my personal favorite:

"This claimed "process" is, in fact, the scientific method itself, and claim 20 seeks to patent a basic scientific principle: that a slower rate of cell growth in the presence of a compound indicates that the compound may be a cancer therapeutic. The recited transformative steps, as in Grams, represent nothing more than preparatory, data-gathering steps to obtain growth rate information and do not render the claimed mental process patentable under ยง101."

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6. g on March 31, 2010 12:28 PM writes...

One of the judge's main points is that the DNA itself is not important, but rather, it is the information encoded in the DNA that is important.

In identifying the DNA, they use a complementary sequence which they made and is different from the native DNA. But the encoded, useful information is EXACTLY the same as the native DNA.

This is a pretty solid argument. I don't expect this to be overturned.

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7. Philip on April 1, 2010 4:57 AM writes...

There's a fascinating take on this at the Skeptic's Health Journal, sort of provides some of the background to the debate, if interested you can read on it here, http://healthjournalclub.blogspot.com/

Permalink to Comment

8. Will on April 1, 2010 8:31 AM writes...

A large portion of the decision seems to be that there was no "invention" as the ability to sequence/isolate the gene was routine to molecular biologists - in which case I think it'd be a lot easier to say the claims were obvious without wading into a debate about what naturally occuring compounds are or are not patentable - taxol anyone? Even if it was obvious to isolate a compound, one could argue unexpected results in the case of an actually useful isolated product.

As to the method claims - the Sup. Ct is right now deciding whether the act of gathering data and making a decision from it is patentable subject matter (In re Bilski, business method) How that case falls out will impact the Myriad method claims

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9. John on April 1, 2010 11:25 AM writes...

A lot of patent folks made knee jerk statements after the decision came out that it would definitely be reversed. I suspect none of these people actually read the opinion. I agree with Jonathan- the opinion is (surprisingly) well-reasoned. Myriad will need much better arguments on appeal.

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10. Will on April 1, 2010 2:54 PM writes...

@John

I suppose by reference to "patent folks" you are not, and instead a scientist/researcher. Very few attorneys would find this case "well-reasoned."

Sweet relies on Sup. Ct. cases almost exclusively from 50-100 years+ ago, at a time when DNA could not be isolated or even conceived (and when the statutes governing patentable subject matter 101, 102 and 103 were written differently). Sweet's opinion does not address much more recent appellate court rulings on this very subject - that by itself almost compels reversal - that is perhaps the so-called "knee jerk" reaction you are talking about. Furthermore, Sweet's dubious distinction of DNA as being "information" as opposed to other compounds which are not might meet argument from a chemical biologist. This is as much a "legal trick" to find DNA non-patentable as what Sweet decries in the beginning of his opinion.

Sweet finds that isolated DNA is not "markedly different" than native DNA (121-124) right after acknowledging that other compounds isolated from natural sources are candidates for patent protection. Sweet finds that DNA "serves as a physical embodiment of the laws of nature - those that define the construction of the human body." To me, this is a statement more suited to philosophy class than legal decisions or biology textbooks. Note that Sweet himself admits to a limited understanding of the science (114, n.46)

Sweet's finding of a physical embodiment of a law of natures is the most suceptible to attack - at the end of the day, everything that exists is a physical embodiment of the laws of nature

I'm no fan of gene/DNA patents, I'd rather they be invalidated as obvious or lacking enablement/description though.

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