Transcript 08_Issac Patent Eligibility Presentation Mid Winter Orlando

American Intellectual Property Law Association
More Fun with §101 – A Prosecution Perspective
for Biotechnology Derived Innovation
Roy P. Issac, Ph.D., J.D.
IP Practice in Japan – Pre-Meeting at AIPLA Mid-Winter Institute
Orlando, Florida
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January 27, 2015
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Disclaimer
This presentation is intended for educational
purposes only. It is not intended to convey legal
advice pertaining to any particular situation and is
not a substitute for legal advice.
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USPTO Guidance: A Streamlined Approach
• Product claims– Apply the markedly different
characteristics test (Chakrabarty test)
– If the claims do not meet the Chakrabarty test, apply the
significantly more test from Myriad.
• Process/Method claims–Apply the Mayo/ Alice test
Well-understood
Routine
Conventional
Inventive concept
Significantly more
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Myriad v. Ambry Uses the Same Bifurcated Approach
• Soon after the PTO Guidance was published, the Federal
Circuit’s opinion in Myriad v. Ambry was issued.
• Case involved product claims directed to primers and
method claims directed to screening for BRCA1 mutation
by comparing a patient’s gene sequence with a germline
BRCA sequence.
• Both sets of claims were held patent ineligible.
• The Court applied the Chakrabarty approach for primers
and the Mayo/Alice approach for the method claims.
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PTO Guidance: Focus on pre-emption
• Determine whether an element in the claim
directed to a law of nature, natural phenomenon or
abstract idea will tie-up the subject matter and preempt others from using the judicial exception.
• Argue how the additional elements in the claim
limit the law of nature, natural phenomenon or
abstract idea such that not all uses are preempted.
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PTO Guidance: For products, apply the markedly
different characteristics test
• Dissection Analysis: The markedly different characteristics test
is applied to the nature-based product limitations, not for the
claim as a whole.
• However, care should be taken not to overly extend the
markedly different characteristics analysis to products that when
viewed as a whole are not nature-based.
• Changes that are incidental to isolation is not enough.
• E.g. A claim directed to an artificial hip prosthesis coated with a
naturally occurring mineral is not an attempt to tie up the mineral.
Here, the claim is analyzed as a whole and determined that the
prosthesis when viewed as a whole is not nature-based.
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PTO Guidance: Markedly Different Characteristics
• Difference in structure, function and/or other properties
• Even a small change can result in markedly different
characteristics.
• Purified or isolated products will be eligible when there is a
resultant change in characteristics sufficient to show a marked
difference.
• Biological/ pharmaceutical function or activities
• Chemical or physical properties
• Phenotype including functional and structural characteristics
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Examples of Nature-Based Products That Will Likely Meet
the Markedly Different Characteristics Test
• Genetically modified organisms (Diamond v. Chakrabarty)
– Organisms that have been modified to be genetically different from
any natural organism such as e.g. insertion of vectors encoding and
expressing one or more exogenous genes.
– Organisms that have been modified to be biologically or
phenotypically different from any natural organism in the absence of
genetic engineering e.g. organisms subjected to different growth
conditions resulting in some phenotypic difference or cloned
animals having a phenotypic difference such as altered telomeres.
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Examples of Nature-Based Products That Will Likely Meet
the Markedly Different Characteristics Test
• cDNA (AMP v. Myriad Sup. Ct. 2013)
– Nucleic Acids
• Non-naturally occurring nucleic acid sequences of a native
sequence wherein one or more nucleotides have been modified
(e.g. tagged nucleic acids, modified bases), deleted, inserted,
substituted) such that there is no naturally occurring counterpart.
• Codon optimized nucleic acid sequences of native nucleic acid
sequences so long as the codon optimized sequence is not
identical to any native sequence.
• Nucleic acids having modified internucleotide linkages (e.g.
phosphorothioate internucleotide linkages).
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Vectors
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Examples of Nature-Based Products That Will Likely Meet
the Markedly Different Characteristics Test
– Proteins
• Non-naturally occurring crystal structures of natural proteins
• Non-naturally occurring glycosylation of natural proteins
• Unglycosylated forms of natural proteins (such as a eukaryotic protein
produced in a prokaryotic cell).
• Non-naturally occurring amino acid sequences of natural proteins
resulting from e.g. amino acid substitution, insertion deletion, or
presence of a non-naturally occurring or chemical modified amino acid.
• Non-naturally occurring fusion proteins (e.g. recombinantly produced
fusion proteins of two different genes not otherwise found fused
together in nature).
• Circularly permuted proteins (e.g. wherein the amino acid structure of a
proteins
altered to provide a new N- and C-terminus).
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Examples of Nature-Based Products That Will Likely Meet
the Markedly Different Characteristics Test
– Cells
• Cells that are genotypically different from any naturally occurring
cell
• Cells that are phenotypically different from any naturally occurring
cell
• Combinations of naturally occurring cells and unnaturally
occurring cells resulting in different biological properties of the
combination.
• Hybrid plants (J. E. M. Ag Supply v. Pioneer Hi-Bred Sup. Ct. 2001)
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PTO Guidance: Significantly More
• If the markedly different characteristics test cannot be met
for the claim element directed to nature-based product,
apply the significantly more test from Myriad.
• Do additional elements add significantly more?
• Is there an element or a combination of elements sufficient
to ensure that the claims amount to significantly more than
the judicial exception?
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PTO Guidance: Significantly More
• What types of additional elements will be considered
sufficient to meet the significantly more test is not clear.
• It is also not clear whether conventional elements can meet
the significantly more standard.
– For instance, will buffers or carriers in a pharmaceutical formulation
be considered sufficient to meet the significantly more standard for
a formulation containing a nature-based product.
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PTO Guidance: Method Claims
• Does any element, or combination of elements, in the claim
is sufficient to ensure that the claim amounts to significantly
more than the judicial exception.
– Here the claim elements are analyzed by dissecting the judicial
exception out of the claim and determining if the additional elements
add sufficiently more.
• Inventive concept: Does the claim as a whole amount to
significantly more than the exception itself?
– Claim is analyzed as a whole.
– “It is important to consider the claim as a whole. Individual
elements viewed on their own may not appear to add significantly
more to the claim, but when combined may amount to significantly
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the exception.”
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Back to the Myriad v. Ambry Decision
• The Court held that claims directed to short single stranded
DNA primers were not patent eligible since they were
“structurally identical to the ends of DNA strands found in
nature.”
• In case of screening method claims, the Court determined
that the additional elements apart from the DNA sequence
itself were directed to “well-understood, routine and
conventional activity.”
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Myriad v. Ambry: Primers
• Primers are not distinguishable from the isolated DNA
found patent-ineligible in Myriad.
• Structurally identical to the ends of DNA strands found in
nature.
• No weight given to the fact that the sequences are
synthetically replicated.
• Separating DNA from its surrounding genetic material is not
an act of invention.
• Myriad argued that primers have fundamentally different
function than when the sequence is part of the DNA strand.
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Myriad v. Ambry: Primers
• However, the Court found that the naturally occurring
sequences do not perform a significantly new function.
• “A DNA structure with a function similar to that found in
nature can only be patent eligible as a composition of
matter if it has a unique structure, different from anything
found in nature.”
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Myriad v. Ambry: Screening Method Claims
Claim 7: A method for screening germline of a human subject for an alteration of a BRCA1 gene which
comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from
said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences
of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the
sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an
alteration in the BRCA1 gene in said subject[,]
wherein a germline nucleic acid sequence is compared by hybridizing a BRCA1 gene probe which
specifically hybridizes to a BRCA1 allele to genomic DNA isolated from said sample and detecting the
presence of a hybridization product wherein a presence of said product indicates the presence of said
allele in the subject.
“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 natural laws?”
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Myriad v. Ambry: Screening Method Claims
• Are “the remaining elements, either in isolation or
combination with the other non-patent-ineligible elements,
sufficient to “transform the nature of the claim” into a
patent-eligible application.”
• Abstract mental steps are not enough.
– Compare
– Analyze
– Determine
• The first paragraph of the claim is directed to patent
ineligible abstract idea of comparing BRCA sequences and
determining
the existence of alterations.
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Myriad v. Ambry: Screening Method Claims
• Methods directed to identification of alterations of the gene,
require merely comparing the patient’s gene with the wildtype and identifying any differences.
• The number of covered comparisons is unlimited.
• The covered comparisons are not restricted by the purpose
of the comparison or the alteration detected.
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Myriad v. Ambry: Screening Method Claims
• The second paragraph of the claim adding particular
mechanisms of comparison are analyzed to see if they
transform the claim into a patent-eligible application.
• Additional elements
– Hybridizing a BRCA gene probe
– Detecting the presence of a hybridization product
– Amplification of BRCA1 gene
– Sequencing amplified nucleic acids
• Additional elements “do not add enough to make the claims
as a whole patent-eligible.”
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Myriad v. Ambry: Screening Method Claims
• Additional elements are not enough because, they “set
forth well-understood, routine and conventional activity
engaged in by scientists at the time of Myriad’s
applications.”
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Back to PTO Guidance: Examples of Nature-Based
Products That Meet Patent Eligibility Requirements
• Combinations of nature-based products that exhibit new
functionality or characteristics
– Gunpowder where new functional characteristics of explosiveness
is not present in individual ingredients.
• Combinations of nature-based product with additional
agents that provide additional characteristics
– E.g. Pomelo juice with added preservatives.
• Formulations with nature-based product
– E.g., Amazonic acid with solubilizing agent
• Method of treating cancer with nature-based product
– E.g., Treating cancer with amazonic acid.
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Back to PTO Guidance: Examples of Nature-Based
Products That Meet Patent Eligibility Requirements
• Purified proteins
– Purified antibiotics
– Proteins expressed in recombinant yeast
– Proteins with point mutations
• Genetically modified bacterium
• Bacterial mixtures
– If the combination provides a mixture with additional
functional properties.
• Nucleic acids
– At least one substitution or modification compared to that
exists in nature.
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Back to PTO Guidance: Examples of Nature-Based
Products That Meet Patent Eligibility Requirements
• Antibodies
– E.g. Human antibodies to bacterial protein.
• Cells
– E.g. Isolated human pacemaker cell expressing marker Z
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Take Home Points
• Product claims are largely governed by the “markedly different
characteristics” test.
• Determine when to analyze the claim as a whole and when to
focus on the nature-based product element.
• Have a series of narrow claims that add additional claim
elements that specify methods of characterizing, comparing etc.
• Determine if the changes to a nature-based product is “merely
incidental to isolation.”
• AMP v. Myriad may be limited to cases where the changes for a
nature-based product are those “merely incidental to isolation.”
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Acknowledgements
Carolyn Elmore, Esq.
Darlene Vanstone, Esq.
Mahreen Hoda, Esq.
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Questions?
Roy P. Issac, Ph.D., J.D.
Elmore Patent Law Group, P.C.
484 Groton Rd.
Westford, MA 01886
978.251.3501
[email protected]
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