End of Gene Patents?

With the NY district court ruling in ACLU et.al. v USPTO/MYGN it appears clear that the bar for gene patents is super high and most will likely not reach it. Does this mean the end of gene patents or even just the BRCA1/2 patents?

No, but it is the beginning of slipshod sequencing and a whole host of labs testing for BRCA1/2 sequences. It is also the making of a SCOTUS case.

But here's why I think Myriad STILL is the gold standard.

A. They have the experience doing this testing
B. They have the infrastructure to handle national samples
C. They have the ability to analyze rare variants best. Why? They have the samples.....

That being said, could Quest or LabCorp begin BRCA testing? Yes and they would do a hell of a job.

One thing is for certain, Myriad will have a hard time justifying that 3120 USD price tag.

If you have MYGN maybe a short is in store?

The Sherpa Says: Myriad is how a genetics lab should be run, except for the outrageous price.

What a difference a year makes

It has been one year since I commented on 23andMe's foray into clinical medicine. I was frankly blown away that such a move would be so blatant without integration of health care practitioners.

I also was blown away that Myriad wouldn't sue the ever living bejesus out of 23andMe. A year later, no lawsuit. I am still surprised about this one. Don't you have to demonstrate protection of your patent to keep it?

Maybe Google/23andMe are paying a VIG to Myriad? I don't know, but it hasn't shown up on Myriad's SEC reports yet......

Why was I so surprised? Well, a few months after 23andMe launched the service AND Myriad did not sue, MYRIAD WAS SUED.

I began to wonder if not suing Google/23andMe was a sign of weakness. I was certain Myriad would then shut down the DTC Genomics BRCA testing.

To date, they have not.

This begs the question, does Myriad think they do not have a case and would lose against Google, thus strengthening the case against them by the ACLU? If that is truly the case and we will begin to see judicial activism in patent removal, well, then we could be in for an EXPLOSION of genetic testing labs out there, each doing their own thing, their own way.

An article in Nature Medicine by Brendan Borrell, does an excellent job of discussing the potential backlash and issues related to DTC Genomics and patent holders. They took the tech line. "Should we really be charged to look in the mirror?" Well, do you have to buy a mirror to look in it? FAIL

The question is: "Will other patent holders see themselves as vulnerable by allowing DTC Genomics companies to test for THEIR patented genetic markers?"

This could prompt a huge wave of lawsuits against these fledgling DTC Genomics companies. Normally, companies sue to shake down, scare away competition and make money or at least protect patents. What we could see is lawsuits designed to crush these young companies in an attempt to scare off the ACLU et.al.

By Myriad NOT suing 23andMe, we may have opened up a new wave of patent paranoia and fear. When that happens companies often turn to the courts to scare away competitors and people hell bent on their (patent) destruction......(ACLU)

It will be interesting to see what this year holds for the Gene Patent......

The Sherpa Says: I would love to hear Dan Vorhaus or Gary Marchant's or Barbara Evans' opinions on these things.........

The Wicked Witch? Or Not?

Ok, so everyone knows now that ACMG et.al. is suing Myriad for patents on BRCA1 and BRCA2 testing...........

Let me be the first to say that patents stifle research. At the same time patents don't stifle innovation. In fact they actually reward it. And they also give lawyers a job.....aside from Congress, these days this may actually be the only business lawyers can get steady work from......

Myriad has built quite a company out there in Utah in case you have missed it. The stock is trading at a decent 32 dollars a share, they have money in the bank and are most importantly delivering a very needed service.

In addition, they are helping patients discover risk and have some very useful sets of information and patient support. They also do philanthropy BTW.....

So I have to ask myself, should we punish someone who is doing good? The answer is a resounding yes. Laws exists and courts of law exist to hash out differences.....whether they are hairbrained or not.....

Trust me, I have seen hairbrained differences.........and accusations.......

What the ACMG is bringing is not exactly hairbrained......

That being said, if the monopoly on this test is removed, we will soon see the true and complete race to the bottom for ALL MOLECULAR TESTS......for those that think this will ONLY affect Myriad, think again.

My guess is that this move is designed to bring BRCA testing in house in a whole host of academic labs....where the send a bundle of these tests of each year. I know, I saw it first hand.......our Ashkenazi Mutations were sent off to Allen Bale's lab, NOT Myriad....

I am still trying to figure out how he saw all of those patients.....

Anyways, I digress......If the patent is removed, then this will be a deathblow to things like APOE testing and the like......Clinical DX and the 5000 USD familion panel will be destroyed AND more importantly, this may prove to be a huge disincentive to have a small boutique lab doing rare diagnosis.....i.e. GeneDx

What we would soon see is the huge shift of these labs into large academic centers and the roll up of these little labs into the big guys who can then deliver testing at a cheaper rate....not necessarily better, but cheaper.

The legal challenge here is whether gene patents are uncostitutional or not. It turns out that the USPTO is part of the lawsuit as well. Yes, correct. The very body which issues patents is being challenged......My initial gut says.....when you fight the government and the administration is pro-gov't.....you will likely lose. But in this case, we could see the opposite.

In addition to several individual women patients and researchers, plaintiffs in the case include: the Association for Molecular Pathology; the American College of Medical Genetics; the American Society for Clinical Pathology; the College of American Pathologists; Breast Cancer Action; and the Boston Women's Health Book Collective.

I would love to hear the opinion of my legal experts here....In fact I have sent out feelers to the best IP and Personalized Medicine attorneys in the land......I will let you know what they say shortly.

In addition to the illegal nature of patents, they are also arguing that it is against the First Amendment to patent scientific knowledge...

This case is landmark and likely will go to the Supreme Court (My Guess)

The Sherpa Says: Beware the hand that feeds you.......and in this case, Myriad probably should have dropped the price just like 23and- did when the economy turned south. In a recession AND a healthcare crisis it is NOT, I repeat NOT a good idea to screw with Medicare by charging 3000 USD for a molecular test.....Or Drew covered in pink in a picture from over a month ago.....