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Prometheus Patents Overturned

The US Supreme Court ruled that two dose calibration methods from biotech company Prometheus Laboratories cannot be patented.

By | March 20, 2012

WIKIMEDIA COMMONS, GALLO & SPERO LLP

Personalized medicine just got a little harder to patent. Today (March 20), the United States Supreme Court decided that two diagnostic methods developed by Prometheus Laboratories to calibrate drug dosages did not meet the standards for patent eligibility, reported Reuters.

Synthetic thiopurines are administered to treat certain auto-immune diseases, such as Crohn’s disease, but patients must be monitored to optimize dosing while minimizing side effects. Prometheus’s methods rely on monitoring the levels of various metabolites in red blood cells. In 2004, the Mayo Clinic devised its own diagnostic tests based on different levels of these metabolites. Prometheus Laboratories sued in District Court, alleging patent infringement, and Mayo claimed in return that Prometheus’s tests relied on unpatentable natural phenomena. The Federal District Court upheld Prometheus’s patents, because the methods added treatment steps and used the natural correlation between metabolite concentration and toxicity in a specific application, reported Genetic Engineering & Biotechnology News.

But the US Supreme Court disagreed with this assessment and overturned the Federal District Court’s ruling.

“To transform an unpatentable law of nature into a patent­ eligible application of such a law, a patent must do more than simply state the law of nature while adding the words 'apply it,'” the Supreme Court’s opinion, written by Justice Stephen Breyer, asserted. “We conclude that the patent claims at issue here effectively claim the underlying laws of nature themselves. The claims are consequently invalid."

Lisa Haile, a patent attorney and co-chair of the Global Life Sciences Sector at the firm DLA Piper, predicted that the US Supreme Court would overturn Prometheus’s patents, but suggests that the addition of more “active” steps could render the methods eligible for patenting. Examples of “active” steps, Haile explained to The Scientist in an email, include comparing a patient’s 6-thioguanine concentration to a reference level and determining whether it falls within the therapeutic range.

Prometheus’s patents aren’t the only ones under scrutiny. Several other cases will be decided soon, including Myriad Genetics’ patents on the BRAC1 and BRAC2 genes. The court’s ruling will help determine how patents will be applied to personalized medicine, Courtenay C. Brinckerhoff, vice-chair of the Chemical, Biotechnology & Pharmaceutical Practice at law firm Foley & Lardner LLP, wrote in a recent opinion piece for The Scientist. Whether patents stifle development of new therapeutics, encourage innovation, help or hurt patients, is still unclear, said Brinckerhoff, and the Supreme Court may be approaching these questions on a case-by-case basis.

Correction (March 21, 2012): The story has been updated to correct the name of Justice Stephen Breyer. The Scientist regrets the error.

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Comments

Avatar of: Darren Sledjeski

Darren Sledjeski

Posts: 1

March 21, 2012

Who is this "Justice Stephen Meyer" on the US Supreme court.  Maybe you meant Justice Stephen Breyer?

Avatar of: TheSciAdmin

TheSciAdmin

Posts: 56

March 21, 2012

 Thank you for pointing out the typo, Darren, it's been corrected.

March 21, 2012

This is a fantastic ruling. It woiuld be even better if one day we as the human race decided that Medicine and therapies shouldn't be patented, and should be freely available to all in need. I might change my moniker to AltruisticThoughtStreams....

Avatar of: RobertD

RobertD

Posts: 1457

March 21, 2012

AncientThoughtStreams, I second your enthusiasm for making therapies based on "laws of nature" unpatentable.  However, in a world where therapeutics are unpatentable, you better be satisfied with access only to the current state of the art, because you will effectively kill the incentive for private industry to innovate.  In that case, you'd better be willing to fund large government agencies to do it for the public good.

Avatar of: Sara Volk

Sara Volk

Posts: 5

March 21, 2012

Those genes should be BRCA1 and BRCA2 (for "breast cancer"), not BRAC1 and BRAC2 -- http://www.cancer.gov/cancerto...

Avatar of: TheSciAdmin

TheSciAdmin

Posts: 56

March 21, 2012

Thanks for pointing out the typo, Sara. It's been corrected.

~Jef Akst, editor, The Scientist

Avatar of:

Posts: 0

March 21, 2012

Who is this "Justice Stephen Meyer" on the US Supreme court.  Maybe you meant Justice Stephen Breyer?

Avatar of:

Posts: 0

March 21, 2012

 Thank you for pointing out the typo, Darren, it's been corrected.

Avatar of:

Posts: 0

March 21, 2012

This is a fantastic ruling. It woiuld be even better if one day we as the human race decided that Medicine and therapies shouldn't be patented, and should be freely available to all in need. I might change my moniker to AltruisticThoughtStreams....

Avatar of:

Posts: 0

March 21, 2012

AncientThoughtStreams, I second your enthusiasm for making therapies based on "laws of nature" unpatentable.  However, in a world where therapeutics are unpatentable, you better be satisfied with access only to the current state of the art, because you will effectively kill the incentive for private industry to innovate.  In that case, you'd better be willing to fund large government agencies to do it for the public good.

Avatar of:

Posts: 0

March 21, 2012

Those genes should be BRCA1 and BRCA2 (for "breast cancer"), not BRAC1 and BRAC2 -- http://www.cancer.gov/cancerto...

Avatar of:

Posts: 0

March 21, 2012

Thanks for pointing out the typo, Sara. It's been corrected.

~Jef Akst, editor, The Scientist

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