State of Innovation

Patents and Innovation Economics

Supreme Court’s Myriad Decision a Mixed Bag

The Supreme Court issued its opinion in the ASSOCIATION FOR MOLECULAR PATHOLOGY ET AL. v. MYRIAD GENETICS, INC., ET AL today.  While I disagree with the court’s opinion, it is perhaps the most clearly written patent decision by the Supreme Court in over a decade.  Basically, the court stated those claims directed to cDNA are patent eligible under 35 USC 101.  While those patents directed to isolated DNA segments are not patent eligible.

A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring.  P. 2

This is a better written and reasoned opinion than we have any hope to expect from the Supreme Court and its likely impact to the biotech community will be minimal.  The decision is clear and easy for inventors and patent attorneys to follow.

Below I want to point out some issues in the opinion that I found significant.  For instance, the court suggests patents are balancing acts.

The rule against patents on naturally occurring things has limits, however.  Patent protection strikes a delicate balance between creating “incentives that lead to creation, invention, and discovery” and “imped[ing] the flow of information that might permit, indeed spur, invention.”  P. 2 & 11

As I stated in my post, Nation of Laws?  Balancing tests are just a way to enhance the power of the judicial branch and create a nation of men – specifically judges.  The word invention has a definition.  Either something is an invention or it is not.  If you are the inventor and file within certain timeframes and your claims properly delineate your invention,  you are entitled to a patent.  No balancing tests are needed.

The court goes on to state.

Before Myriad’s discovery of the BRCA1 and BRCA2 genes, scientists knew that heredity played a role in establishing a woman’s risk of developing breast and ovarian cancer, but they did not know which genes were associated  with those cancers.  P. 4

Knowledge of the location of the BRCA1 and BRCA2 genes allowed Myriad to determine their typical nucleotide sequence.  That information, in turn, enabled Myriad to develop medical tests that are useful for detecting mutations in a patient’s BRCA1 and BRCA2 genes and thereby assessing whether the patient has an increased risk of cancer.  P. 4-5

Those tests included isolating a specific set of genes, which no one had ever done.  Just because people could isolate genes, did not tell them which genes were important to isolate.  Isolated genes do not exist in nature and are not an attempt to patent a person’s genes.

Finally, the court had this caveat.

First, there are no method claims before this Court. Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent. But the processes used by Myriad to isolate DNA were well understood by geneticists at the time of Myriad’s patents “were well understood, widely used, and fairly uniform insofar as any scientist engaged in the search for a gene would likely have utilized a similar approach,” 702 F. Supp. 2d, at 202–203, and are not at issue in this case.  P. 17

The court is wrong.  There were no known genetic tests for breast cancer.  Every invention is a combination of known/existing elements – you can’t create something from nothing, it’s called conservation of matter and energy.  It is axiomatic that just stating the individual parts of an invention are known ,tells you nothing about the novelty of the invention.

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June 13, 2013 - Posted by | -Law, News, Patents | , , , ,

2 Comments »

  1. Dale,

    I am going to compile here 2 simple comments I left at IP Watch Dog:

    Travis,

    For you edification, here is what the written law actually says:

    35 U.S.C. § 101 35 U.S.C. 101 Inventions patentable.

    Whoever
    invents or discovers
    ANY new and useful
    process,
    machine,
    manufacture,
    or composition of matter,
    or any … improvement thereof,
    may obtain a patent therefor,
    subject to the conditions and requirements of this title.

    p.s.

    Note how the Supreme Court Myraid decision conveniently ignores the words “discovers” and “composition of matter”.

    Comment by step back | June 14, 2013 | Reply

  2. True and the judicial exceptions for laws of nature natural phenomenon, or abstract idea are completely redundant.

    Comment by dbhalling | June 14, 2013 | Reply


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