State of Innovation

Patents and Innovation Economics

Gene Patent Case: Case Study in Judicial Activism

Judge Sweet’s opinion in ACLU v. Myriad is a mind numbing 156 pages.  The opinion seems to be an attempt win an argument by boring the opposition to death.  The opinion is inconsistent, wrong on the law, but most importantly a case study in judicial activism.  Judge Sweet’s decision in this case is ultimate based on his opinion that “the overriding importance of DNA’s nucleotide sequence” means thatMyriad should not receive patent protection for genes that are an indicator of breast cancer.

The only legitimate question before the court was whether Myraid’s patents on isolated forms of genes are patentable subject matter under 35 USC 101.  However, the opinion rambles on for pages listing so called “facts” that have nothing to do with the only legitimate issue.  For instance, the opinion discusses how a clinic in Ontario is able to provide the same tests as Myriad for less money by “ignoring” – stealing would be the correct word, Myriad’s technology.  There is a lot of typical liberal hand wringing over the cost of the tests, but of course the cost and effort of the research are ignored.  The opinion in the “facts section” questions whether patents encourage innovation.  These facts are irrelevant to the case, since they have nothing to do with whether the genes in question are patentable subject matter.  The fact that the court cites these irrelevant “facts” or actually hypothesis shows that the court has no interest in law.  It is a typical case of Judicial Activism where the judge sets themselves up as the philosopher king ready and willing to refashion the whole country according to their dictates.  But, this is not the job of the court and the court does not have this authority.

The patent and trademark clause is the only place in the Constitution where a “right” is mentioned.  The courts and even Congress have no authority to eliminate the patent system.  Under the Constitution it is job of Congress to define the patent laws.  The only job of the courts is to apply the patent laws.  If there is some ambiguity in the laws the Courts may provide insight within the bounds of the statute, but it has no authority to rewrite the patent statue.  As a result, all of Opinion’s examining of the value of patents and how they affect innovation is irrelevant at best and unconstitutional at worst.

Judge Sweet’s legal basis  for his opinion that Myriad patents are not statutory matter under 35 USC 101 relies on Diamond v. Chakrabarty, 447 U.S. 303 (1980).  This case is widely cited for the proposition that “anything under the sun that is made by man” is patentable subject matter.  Isolated versions of human genes (i.e., BRCA1 and BRCA2 genes) do not exist in nature.  While it is possible that they are naturally isolated from the rest of the chromosome at some point in time, they are never naturally isolated outside of a human cell.  It is clear that isolated versions of the BRCA1 and BRCA2 genes are a product of man.  So how did Judge Sweet reach his ruling that Myriad’s patents were directed to non-statutory matter?  First, he quotes a dissenting opinion in Diamond v. Chakrabarty.  Dissenting opinions are not the law and generally citing a dissenting opinion in a case directly on point is a sign you are wrong.  Second, he states that the Supreme Court was wrong in their ruling in Diamond v. Chakrabarty.  He points to the legislative history of 35 USC 101:

Section 101 sets forth the subject matter that can be patented, ”subject to the conditions and requirements of this title.” The conditions under which a patent may be obtained follow, and section 102 covers the conditions relating to novelty.  A person may have ”invented” a machine or a manufacture, which may include anything under the sun that is made by man, but it is not necessarily patentable under section 101 unless the conditions of the title are fulfilled.

The opinion specifically points to the underlined section for the proposition that there are some other conditions necessary to meet the requirements of 35 USC 101.  This interpretation is clearly flawed.  The underlined section above means that a person has to not only meet the requirements under 35 USC 101, but also the requirements of Novelty, Non-Obviousness, Enablement, Written Description, etc.  I would like to believe that this clear error is an honest mistake, but it was apparent from the beginning of the opinion that Judge Sweet has no respect for Constitution or the law when it comes to patents.

Using this dishonest slight of hand, Judge Sweet then proceeds to state that just purifying a naturally occurring substance is not patentable subject matter under 35 USC 101.  There are many cases on point that the Judge conveniently ignores.  For instance, Merck & Co., Inc. V.Olin Mathieson Chemical Corporation, 253 F.2d 156 (1958), found that Merck had claimed an isolated and purified form of vitamin B12.  Isolated vitamin B12 is not found in nature.  Merck’s isolated vitamin B12 was better than the form found in nature since patients were spared having to consume a pound of liver in order to derive the same benefits.  The discovery of isolated vitamin B12 by George Whipple, George Minot, and William Murphy resulted in them winning the 1934 Nobel Prize in Medicine.

The philosophical basis for Judge Sweet’s opinion is based on the flawed reasoning that an invention that includes a naturally occurring substance is not patentable.  This reasoning is similar to the flawed reasoning that an invention based on a “combination of known elements” is not patentable or at least it is highly suspicious that such an invention should receive a patent.  All inventions are combination of known elements, these elements are always made at some level of naturally occurring substances.  This is a clear result of the conservation of matter and energy.  These elements always behave in a predictable way in that they never violate the laws of physics.  If Judge Sweet’s ideas on patents were applied consistently to all patents then only black magic would be patentable.

The sad fact is that both liberal, conservative, and strict constitutionalist judges have become activist judges with respect to patent law.  (See Judge Scalia’s statements in the Bilski oral arguments)  None of these judges has even a rudimentary understanding of the how the laws of physics apply to patent law.  If these judges would stick to there job of applying the law instead of acting as philosopher kings ready and willing to refashion the whole country according to their dictates, then their errors would not be so damaging to patent law, the country, and our economy.

April 16, 2010 - Posted by | Patents, Uncategorized | , , , , , , ,


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