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American Intellectual Property Law Association
Myriad Guidance for Biotechnology and Chemical Practice
Joerg-Uwe SziplGriffin and Szipl, P.C.
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AIPLA IP Practice in Japan Committee Premeeting
AIPLA Annual Meeting
Washington, DC, October 21, 2014
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Myriad and Mayo Guidance
• USPTO issued Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena & Natural Products (Guidance) on March 4, 2014.
• A forum was held on May 9, 2014 at which members of the public were invited to give comments on the guidance.
• Comments on the Guidance were almost universally critical.• This talk attempts to summarize the major criticisms of the
Guidance, and indicate where the Guidance departs from existing law in significant ways.
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American Intellectual Property Law Association Guidance treatment of Mayo and Myriad decisions
• Much criticism focused on the fact that Mayo and Myriad should be applied narrowly according the the language of the cases themselves.
• Mayo:– The question before Mayo was “whether the claims do
significantly more than simply describe [the] natural relations” or “do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply the natural laws.”
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American Intellectual Property Law AssociationGuidance treatment of
Mayo and Myriad decisions
• Mayo:– In Prometheus the claims at issue state that the claimed methods
are for “optimizing therapeutic efficacy for treatment” however, the claims contain no step that requires one to apply to the natural correlation to achieve a practical result.
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American Intellectual Property Law AssociationGuidance treatment of
Mayo and Myriad decisions
• Mayo:– The Guidance implies that claims must contain at least one step
that is not “well understood, routine or conventional activity.” That is not what Mayo requires.
– Mayo requires a practical application of the law of nature, not merely a referral to the law of nature with instructions to “apply it.”
– Mayo should only require at least one process step that results in a practical application of the law of nature.
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American Intellectual Property Law Association Guidance treatment of Mayo and Myriad
• Myriad:– The Supreme Court in Myriad went through great lengths to
state what is was not deciding and to limit its holding to the case before it.
– The holding in Myriad relied on two factual findings• The patentee had not created or altered the genetic
information in the BRCA1 and BRCA 2 mutations, nor did the patentee create or alter the structure of the claimed DNA; and
• The claims were written in such a way that they relied solely on the genetic information in the isolated polynucleotide.
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American Intellectual Property Law Association Guidance treatment of Mayo and Myriad • Myriad (cont.)
– “Myriad’s claims are simply not expressed in terms of chemical composition, nor did they rely in any way on the chemical changes that result from the isolation of a particular section of DNA.”
– The Court noted that Myriad’s claims are “concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition.”
– Myriad simply does not support the USPTO’s interpretation that all compounds and compositions isolated or purified from nature are patent ineligible unless markedly different in structure
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American Intellectual Property Law AssociationGuidance treatment of
Mayo and Myriad
• Myriad simply does not support the USPTO’s conclusion that all compounds and compositions isolated or purified from nature are patent ineligible unless markedly different in structure.
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• Chakrabarty – Congress plainly contemplated that the patent laws be given
wide scope– Chakrabarty recites with approval Louis Pasteur’s patent on
“yeast, free from organic germs of disease, as an article of manufacture.”
– Is the invention “a nonnaturally occurring manufacture or composition of matter” having “markedly different characteristics from any found in nature and one having the potential for significant utility.”
– The USPTO test of “markedly different structure” is not found in Chakrabarty.
USPTO Guidance departs from Chakrabarty
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USPTO Guidance departs from Chakrabarty
• In re Bergy– CCPA in a companion case not considered by the Supreme Court
found pure culture of Streptomyces Vellosus to be patentable subject matter.
– The CCPA decision in Bergy is binding precedent on USPTO.
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USPTO Guidance departs from Chakrabarty
• USPTO Guidance departs from many decades of USPTO practice in granting patents on purified and isolated microorganisms, and chemical compounds found in nature.– USPTO has issued patents on numerous isolated and purified
microorganisms, and isolated chemical compounds of which aspirin and adrenalin are some of the most famous examples.
• The USPTO justification for the guidelines appears to be: “we were wrong and now we’re correcting our error” in spite of the fact that no such error was identified by the Supreme Court.
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Guidance Examples
• Example A– A stable energy-generating plasmid, which provides hydrocarbon
degradative pathway.– USPTO concludes this is not patentable if the plasmid has the
same structure as found in the natural bacterium– If the plasmid is isolated and purified, claimed in terms of chemical
structure,and has a characteristic markedly (such as a new utility) different from what is found in nature (i.e., the bacterium), and it should be patentable.
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Guidance Examples
• Example B– Purified Amazonic Acid– USPTO concludes that this is not patentable because the structure
is identical to what is found in the leaves of an amazonian plant. This means that patents for numerous discovered drugs would be invalid.
– If the isolated and purified compound is new, and has markedly different characteristics from what is found in nature (i.e., the tree leaves), then it should be patentable.
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Guidance Examples
• Example C– Assumes that gunpowder is a naturally occurring substance.– Gunpowder is a mixture of saltpeter, sulfur, and charcoal.– Rewrites chemistry, physics and history, did the ancient Chinese
mine gunpowder?
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Guidance Examples
• Example D– Follows the facts of Funk Bros., 333 U.S. 127 (1948)– A combination of bacteria not patentable subject matter where each
of the bacteria “serves the ends nature originally provided and act independently of any effort of the patentee.”
– This is distinguishable from the isolated and purified bacteria cases where the isolate has a unique utility compared with what is found in nature.
– Distinguished by Chakrabarty
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Guidance Examples
• Example E (Primers)– Primer examples have structure of Seq. ID NO. 1 and Seq.
ID NO. 2.– USPTO concludes are not patentable if the portions of the
two sequences are found in a natural chromosome.– This conclusion exceeds the scope of the Myriad decision
where the claims did not recite any chemical structure.– If the primers have a markedly different characteristics and
the exact sequences are not found in nature, they should be patentable.
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Guidance Examples
• Example F– Diagnostic claim utilizing a new antibody and a specific assay
technique concluded to be patentable subject matter.– Not controversial
• Example G– Claim to exposing a patient to sunlight to effect mood just an
appropriation of a natural principle
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Conclusion
• The USPTO’s guidance goes far beyond the holdings of Myriad and Mayo
• Without support in the case law the USPTO has concluded that all substances derived from nature (even if not found in isolated and purified form) would not be patentable subject matter unless they have have a significantly different structure (even if the isolated compound has significant utility not present in what is found in nature).
• USPTO is largely inconsistent with decades of practice in the pharmaceutical field.
