Diagnostic Patents Suffer Another Setback In US As Supreme Court Refuses To Hear Sequenom Appeal

from the outbreak-of-good-sense dept

Tue, Jul 5th 2016 11:23pm — Glyn Moody

In recent years, there have been a couple of really important US Supreme Court decisions in the biotech field. One is the 2013 judgment striking down gene patents. The other is a ruling from 2012 that rejected the patenting of basic medical diagnostics, in a case involving Mayo Collaborative Services and Prometheus Labs. The resultant loss for biotech companies in terms of devalued patent portfolios, and their reduced ability to control the market using intellectual monopolies, has been so serious that it is no surprise that there are periodic attempts to get these decisions mitigated through subsequent court rulings.

For this reason, the industry has been watching with great interest a case involving Sequenom, and its patent on a non-invasive pre-natal diagnosis test using the fact that fetal DNA is present in the blood plasma of expectant mothers. A lower court invalidated that patent on the basis of the Mayo decision, and Sequenom appealed to the Supreme Court to review the ruling. But a statement from the company has now dashed the biotech industry's hopes:

The Supreme Court of the United States denied [Sequenom's] petition to review decisions by lower Federal courts that the claims of Sequenom's U.S. Patent No. 6,258,540 ("'540 Patent") are not patent eligible under the patent eligibility criteria established by the Supreme Court's Mayo Collaborative Services v. Prometheus Laboratories decision. In the petition, Sequenom urged the Court to hear the case because the Court is uniquely suited to reconcile and interpret the patent eligibility criteria established in its Mayo decision. Sequenom will pursue no further appeal opportunities for review of the '540 Patent.

Although the industry will doubtless whine about how there is no incentive to produce new diagnostic tests, there's no evidence that research and development in this area has ground to a halt in the US since the Supreme Court ruling on Mayo. All that has happened is that obvious applications of natural biological phenomena have been removed from patentability. Given the inherent reasonableness of that, we can probably hope that further challenges to Mayo will also fail.

Follow me @glynmoody on Twitter or identi.ca, and +glynmoody on Google+

Thank you for reading this Techdirt post. With so many things competing for everyone’s attention these days, we really appreciate you giving us your time. We work hard every day to put quality content out there for our community.

Techdirt is one of the few remaining truly independent media outlets. We do not have a giant corporation behind us, and we rely heavily on our community to support us, in an age when advertisers are increasingly uninterested in sponsoring small, independent sites — especially a site like ours that is unwilling to pull punches in its reporting and analysis.

While other websites have resorted to paywalls, registration requirements, and increasingly annoying/intrusive advertising, we have always kept Techdirt open and available to anyone. But in order to continue doing so, we need your support. We offer a variety of ways for our readers to support us, from direct donations to special subscriptions and cool merchandise — and every little bit helps. Thank you.

–The Techdirt Team

Filed Under: biotech, gene patents, patents
Companies: sequenom

11 Comments

If you liked this post, you may also be interested in...

Reader Comments

Subscribe: RSS

View by: Time | Thread

Ninja (profile), 6 Jul 2016 @ 3:25am

I find it disturbing that some people (read pharma industries in this case) will do everything in their power to maximize profits even if it costs lives and they would still profit nicely if they actually sold medicine for lower prices. The greed is disturbing.
[ link to this | view in chronology ]
- Mason Wheeler (profile), 6 Jul 2016 @ 4:00am
  
  Re:
  It's the Big Pharma credo: "Your money or your life!"
  [ link to this | view in chronology ]
- Anonymous Coward, 6 Jul 2016 @ 7:02am
  
  Re:
  But... if they sold medicine for lower prices, who would pay for the advertising to get those new (ie still in patent) medicines prescribed? Who would pay to bury the marginal or contradictory studies on effectiveness?
  
  Think of the stockholders!
  [ link to this | view in chronology ]
- JEDIDIAH, 6 Jul 2016 @ 8:43am
  
  Throwing the baby out with the bathwater...
  That kind of thinking only works for Viagra and other mass market products. For the more sophisticated drugs for diseases none of your doctors have heard of, this kind of kindergarten thinking won't work. Someone has to pay the piper. You don't work for free, so why should you expect anyone else to?
  
  While there are some obvious abuses, seeking to destroy all economic incentives is shortsighted.
  
  This isn't just some meaningless entertainment product.
  [ link to this | view in chronology ]
  - Ninja (profile), 6 Jul 2016 @ 11:57am
    
    Re: Throwing the baby out with the bathwater...
    Remember Daraprim? Turing Pharmaceuticals?
    
    I agree with you and that's why I think the Government should support its citizens and bear the price of these uncommon, insanely expensive drugs IF their price is really justified. We both know this is not always the case.
    
    I know some chemicals are insanely complex to produce, being a chemical engineer I see your reasoning and understand it but I don't think it's quite right to profit 10.000% over something that cost pennies to manufacture like it happens many times. You do have R&D costs involved but again we also know that the companies often inflate these costs a lot.
    
    Remember Brazil simply broke the patents because the pharmas were abusing their control over certain HIV meds and we managed to bring it under some control quite quickly. The meds still cost thousands and the Government still needs to shoulder the financial burden but it's way more sensible than it was before.
    [ link to this | view in chronology ]
    - Wendy Cockcroft, 8 Jul 2016 @ 5:39am
      
      Re: Re: Throwing the baby out with the bathwater...
      I'm with Ninja here. Drug research is one of those things I would gladly see my taxes used to fund.
      [ link to this | view in chronology ]
Anonymous Coward, 6 Jul 2016 @ 6:36am

Are mandatory meds just around the corner or simply a big pharma pipe dream.
[ link to this | view in chronology ]
- Wendy Cockcroft, 8 Jul 2016 @ 5:40am
  
  Re:
  It's here; they put ads on the telly in which you are told to tell your doctor to prescribe these things.
  [ link to this | view in chronology ]
kallethen, 6 Jul 2016 @ 7:04am

For once I'm glad I misread the title.
Seriously, I accidentally read "patents" as "patients" when I first saw this. Glad I was in error.
[ link to this | view in chronology ]
- Zorg 2.0, 6 Jul 2016 @ 4:28pm
  
  Re: For once I'm glad I misread the title.
  me too!
  [ link to this | view in chronology ]
Capt ICE Enforcer, 6 Jul 2016 @ 8:02am

Trash
Well. Now that it can't be under a patent the company will surely throw out the plan to use that procedure. After all, there is no money in treating people unless you take 3 months pay from a family.
[ link to this | view in chronology ]