Thursday, May 14, 2009

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.....

1 comment:

Anonymous said...

Not sure how "patents stifle research." I've actually never heard of a gene patent holder impeding or filing suit against a researcher or research institution on the grounds of gene patent infringement, unless that researcher/research institution had plans to use that research for their own profit. For example, a tremendous amount of research on BRCA1/2 mutations has been conducted over the past 10 years and hardly any of that genetic testing has been conducted or licensed by Myriad. I'm just not aware of gene patents ever really affecting research - they serve not to hinder scientific knowledge but as a competitive advantage and barrier to entry for a company in offering a service.

That being said, I do fully agree with you that Myriad made a very tactical mistake by 1) not lowering the price of their tests and 2) not allowing independent laboratory confirmation of their results when so requested.