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Supreme Court Agrees to Hear so Called “Gene Patenting Case”: Myriad’s Stock Falls 9%

Supreme Court Agrees to Hear so Called “Gene Patenting Case”: Myriad’s Stock Falls 9%

The Supreme Court agreed to review the case Association for Molecular Pathology (AMP) and ACLU v. USPTO and Myriad Genetics (Fed. Cir. 2012).  Myriad holds a patent for identifying certain mutations in the BRCA genes that correlate with an increased risk of breast and ovarian cancer.  Myriad’s stock dropped nine percent on the news.  This is the market’s way of saying they don’t believe the Supreme Court will uphold Myriad’s property rights.  The Supreme Court has displayed a shocking lack of understand of patents and property rights.  For instance, their decision in Mayo Collaborative Services v. Prometheus Labs., Inc. (Supreme Court 2012)  if followed logical would hold that only magic is patentable.  If I were handicapping this I would say there is a 75% chance that the Court will hold all the claims do not meet the requirements on 35 USC 101 (Patentable subject matter).  This will be devastating to the biotech industry, probably wiping out billions of dollars of value in a single day.

This case revolves around the myth that you can patent a person’s genes.  A number of books have been published on this theme and I have explained why this is nonsense in my post Patenting Life.  The CAFC’s most recent decision discussed below also explains why this is not true.

The only issue involved in the Myriad case is whether the claims are patent eligible under 35 USC 101.  In the Mayo case the Supreme Court mixed the concepts of 35 USC 101 (patent eligibility) with novelty (35 USC 102) and nonobviousness (35 USC 103).  No doubt we will see more of this confused statutory interpretation by the Court in this case.  The only minor justification for this confusion is that 35 USC 101 states the invention must be NEW and useful.  However, 35 USC 102 clearly defines novelty (new) in detail and any invention that meets the requirement of 35 USC 102 should be considered NEW under 35 USC 101.  This is something that should have been fixed in the America Invents Act that was just passed in 2011, but the drafters were too busy passing out goodies to Wall Street, pharmaceutical companies and large companies generally to actually worry about improving the clarity of statute.


CAFC ruling under reviewed

The ruling in the 2012 version of this case was very similar to the ruling in 2011 that I discussed in my post Association of Molecular Pathology v. USPTO.  Below I provide what I think are the most interesting excerpts from the opinion.

Composition claims are all eligible under 35 USC 101.

They (The isolated strands of DNA) are obtained in the laboratory and are man-made, the product of human ingenuity.  While they are prepared from products of nature, so is every other composition of matter.  All new chemical or biological molecules, whether made by synthesis or decomposition, are made from natural materials.  For example, virtually every medicine utilized by today’s medical practitioners, and every manufactured plastic product, is either synthesized from natural materials (most often petroleum fractions) or derived from natural plant materials.  But, as such, they are different from natural materials, even if they are ultimately derived from them.  The same is true of isolated DNA molecules.  PP. 38-39

The highlight portion points out a general rule of patent law (actually nature) – all inventions are combinations of existing elements, these elements are formed from natural materials.  You cannot create something from nothing – it’s called conservation of matter and energy.  Unfortunately, this simple rule of physics is often ignored by the courts – probably because most of them do not have a scientific background and are therefore unfit to rule in patent cases.

A composition of matter is not a law of nature.  P. 51

The anti-patent crowd has been trying to expand laws of nature to include anything that occurs naturally.  A law of nature is something that explains a host of data and can be used to accurately predict how things will behave in nature, such as gravity.  Using a counterbalance in an elevator uses gravity – a law of nature, but it is not a law of nature.

It is undisputed that Myriad’s claimed isolated DNAs exist in a distinctive chemical form—as distinctive chemical molecules—from DNAs in the human body, i.e., native DNA. P. 44

The critics of patenting human genes miss this point.  The claims do not cover native DNA, they cover DNA that does not exist but for the intervention and ingenuity of humans.

Claims 1 of the ’999, ’001, and ’441 patents, as well as method claims 1 and 2 of the ’857 patent—all of which consist of analyzing and comparing certain DNA sequences—not to be patent-eligible subject matter on the ground that they claim only abstract mental processes.  P. 55

I strongly disagree with this statement.  Myriad clearly showed that the analyzing step requires machines that are clearly described in the specification.  Even if a doctor had the print out of the results of analysis and then he compared the results without a machine, then this is contributory infringement.  The only justification for the CAFC’s decision is hyper technical analysis of the claim that requires a recited machine in the claims.  This sort of overly formal interpretation does nothing to protect the property rights of inventors, but does advance the interests of entities that want to steal other people’s inventions.

We once again, even in light of Mayo, arrive at the same conclusion of patent-eligibility because at the heart of claim 20 is a transformed cell, which is made by man, in contrast to a natural material.

By definition, however, performing operations, even known types of steps, on, or to create, novel,  i.e., transformed subject matter is the stuff of which most process or method invention consists.  All chemical processes, for example, consist of hydrolyzing, hydrogenating, reacting, etc.  In situations where the objects or results of such steps are novel and nonobvious, they should be patent-eligible.  P. 61

The idiots at the Supreme Court have attempted to break claims down and determine if each step is new.  You can’t create something from nothing and a step which is completely new does not meet the requirements of 35 USC 112.  This form of interpretation of the claims was specifically rejected by the 1952 Patent Act under 35 USC 103.  But the anti-patent Justices on the Supreme Court are not interested in logic, the Constitution, or the law.  They are only interested in forcing their policy visions on the American public.

We hold that claim 20 of the ’282 patent recites patent-eligible subject matter under § 101.



The Supreme Court is incompetent to hear patent cases and their jurisdiction over them should be removed by Congress.

1 Comment

  1. Dale,

    On the issue of SCOTUS granting cert. we likely mostly agree.

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