This esteemed panel of leading patent experts, included members of the European Patent Office, addressed U.S. and European perspectives on patenting stem cells, genes, and medical uses, as well as other ethical and legal issues.

1. © 2014 Vedder Price P.C.
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Thomas J. Kowalski, Esq, Shareholder
TKowalski@VedderPrice.com
Vedder Price PC, 1633 Broadway, 47th Floor, NY NY 10019
Tel +1 212 407 7700
2014 BROAD INSTITUTE
Innovation & Intellectual Property Symposium
DISCLAIMERS: This presentation is NOT individualized legal advice, and does NOT contain legal advice.
The authors, their organizations, including Vedder Price PC, and clients thereof are NOT bound by this
presentation. This presentation does NOT establish any form of attorney-client relationship . NO
author or author’s organization is liable for any errors or omissions in this presentation.
Hot Topics in European Bio-Patent Law
A US PERSPECTIVE
35 USC 101 PATENT ELIGIBILITY
Humans, Diagnostics, “Natural Products”
Pre-AIA, AIA, Myriad, Mayo & The USPTO’s Guidelines
The Petrie-Flom Center for Health Law Policy, Biotechnology
and Bioethics
Harvard Law School - 2 April 2014

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Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101
Topics:
 Introduction; Including Pre-AIA & Under the AIA
 The Myriad and Mayo Decisions
 The USPTO’s Guidelines - Extrapolation to Other Naturally
Occurring Biological Products
 Q&A

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Introduction:
 Pre-AIA
 13th Amendment
 Patenting of Humans - Appropriations Act
 “Isolated”
 Under the AIA Section 33
 “No Patent May Issue On a Claim Directed to Or
Encompassing a Human Organism”
 See 157 Cong. Rec. E1177-04 (testimony Representative Dave Weldon previously
presented re Consolidated Appropriations Act, 2004, Pub. L. 108-199, ' 634, 118 Stat. 3,
101, and resubmitted re AIA; see 149 Cong. Rec. E2417-01).
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101

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Introduction:
 Prior to Myriad there was In re Bergstrom, In re Bergy and
Diamond v. Chakrabarty
 In re Bergstrom: pure prostaglandin substance is not naturally
occurring
 In re Bergy: biologically pure culture of the Streptomyces not a
product of nature
 Diamond v. Chakrabarty, regarding 35 USC 101: “The
Committee Reports accompanying the 1952 Act inform us that
Congress intended statutory subject matter to ‘include
anything under the sun that is made by man.’ S Rep. No 1979,
82d Cong., 2d Sess., 5 (1952); H.R.Rep. No. 1979, 82d Cong., 2d
Sess., 6 (1952)”
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101

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Myriad:
 The Myriad Decision: DNA, even if isolated, is a product of
nature and NOT patent eligible; however, synthetically created
complementary DNA (cDNA) is patentable
 At Issue: Claims 1, 2, 5, 6, and 7 of US Patent 5,747,282 (the
’282 patent), claim 1 of US Patent 5,693,473 (the ’473 patent),
and claims 1, 6, and 7 of US Patent 5,837,492 (the ’492 patent)
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101

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Myriad:
 ’282 patent Claim 1: “[a]n isolated DNA coding for a BRCA1
polypeptide,” which has “the amino acid sequence set forth in
SEQ ID NO:2”
 “SEQ ID NO:2 sets forth a list of 1,863 amino acids that the
typical BRCA1 gene encodes … Put differently, claim 1 asserts a
patent claim on the DNA code that tells a cell to produce the
string of BRCA1 amino acids listed in SEQ ID NO:2”
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101

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Myriad:
 ’282 patent Claim 2: “[t]he isolated DNA of claim 1, wherein
said DNA has the nucleotide sequence set forth in SEQ ID NO:1”
 “Importantly, SEQ ID NO:1 lists only the cDNA exons in the
BRCA1 gene, rather than a full DNA sequence containing both
exons and introns”
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101

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Myriad:
 ’282 patent claim 5: “[a]n isolated DNA having at least 15
nucleotides of the DNA of claim 1”
 “The practical effect of claim 5 is to assert a patent on any
series of 15 nucleotides that exist in the typical BRCA1 gene”
 “Because the BRCA1 gene is thousands of nucleotides long,
even BRCA1 genes with substantial mutations are likely to
contain at least one segment of 15 nucleotides that correspond
to the typical BRCA1 gene”
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101

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Myriad:
 ’282 patent claim 6: “[a]n isolated DNA having at least 15
nucleotides of the DNA of claim 2”
 “This claim operates similarly to claim 5, except that it
references the cDNA-based claim 2”
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101

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Myriad:
 Two sets of ‘DNA’ claims recognized by the US Supreme Court:
 “Myriad’s patents would, if valid, give it the exclusive
right to isolate an individual’s BRCA1 and BRCA2 genes
(or any strand of 15 or more nucleotides within the
genes) by breaking the covalent bonds that connect the
DNA to the rest of the individual’s genome”
 “The patents would also give Myriad the exclusive right
to synthetically create BRCA cDNA”
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101

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Myriad:
 Myriad Holding:
 “Isolated DNA” claims, i.e., claims that give the exclusive
right to isolate a gene (or any strand of nucleotides within
the gene) by breaking the covalent bonds that connect
the DNA to the rest of the genome and not limited to
cDNA ARE NOT PATENT ELIGIBLE UNDER 35 USC § 101
and are HENCE INVALID
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101

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Myriad:
 Myriad Holding
 Claims that only give exclusive right to synthetically
create non-naturally occurring DNA or cDNA ARE PATENT
ELIGIBLE UNDER 35 USC § 101
 Supreme Court explicitly declined to opine on validity of
cDNA claims under 35 USC §§ 102, 103, 112
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101

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Patent-eligible claims involving genetic material:
 Under Myriad: Claims that only give the exclusive right to
synthetically create non-naturally occurring DNA or cDNA are
patent eligible under 35 USC § 101
 Supreme Court explicitly declined to opine on validity of
cDNA claims under 35 USC §§ 102, 103, 112
 BUT consider evolution of case law under Sections 103, 112
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101

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Patent-eligible claims involving genetic material:
 “It is important to note what is not implicated by this decision”
 “First, there are no method claims before this Court,” i.e., novel
methods to isolate DNA are not within this Decision (but see
USPTO June 13, 2013 Memorandum, “Supreme Court Decision
in Association for Molecular Pathology v. Myriad Genetics, Inc.”
available at http://patentdocs.typepad.com/files/uspto-myriad-
memorandum.pdf) (“USPTO June 13, 2013 Memorandum”)
 “Similarly, this case does not involve patents on new
applications of knowledge about the … genes”
 “Many … unchallenged claims are limited to such
applications”
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101

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Patent-eligible claims involving genetic material:
 “It is important to note what is not implicated by this decision”
 “Nor do we consider the patentability of DNA in which the
order of the naturally occurring nucleotides has been altered”
 “Scientific alteration of the genetic code presents a different
inquiry, and we express no opinion about the application of
§101 to such endeavors”
 “We merely hold that genes and the information they encode
are not patent eligible under §101 simply because they have
been isolated from the surrounding genetic material”
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101

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Patent-eligible claims involving genetic material:
 Outside of Myriad, for consideration in portfolio management:
 cDNA claims*
 Claims to “DNA in which the order of the naturally occurring
nucleotides has been altered”*
___________________________
*NB: Evolution of Obviousness and Section 112 case law
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101

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Mayo:
 Mayo Claim
 Claim 1 of US Patent 6,355,623 considered exemplary
“A method of optimizing therapeutic efficacy for treatment of an immune-
mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said
immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said
immune-mediated gastrointestinal disorder
wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red
blood cells indicates a need to increase the amount of said drug subsequently
administered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8x108
red blood cells indicates a need to decrease the amount of said drug
subsequently administered to said subject.”
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101

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Mayo:
 Mayo Holding:
 Correlation between the naturally–produced metabolites and
therapeutic efficacy and toxicity is an unpatentable “natural
law”
 First two steps of exemplary claim are not “genuine
applications of those laws[, but] rather ... drafting efforts
designed to monopolize the correlations”
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101

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Mayo:
 Mayo Holding:
 “Because methods for making such determinations were well
known in the art, this step simply tells doctors to engage in
well-understood, routine, conventional activity previously
engaged in by scientists in the field”
 “Such activity is normally not sufficient to transform an
unpatentable law of nature into a patent–eligible application
of such a law”
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101

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Mayo:
 Mayo Holding:
 A newly discovered law of nature is not patentable
 Application of a newly discovered law is not patentable if the
application merely relies upon elements already known in the
art
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101

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Mayo:
 Mayo Holding:
 “In consequence, we must hesitate before departing from
established general legal rules lest a new protective rule that
seems to suit the needs of one field produce unforeseen
results in another. And we must recognize the role of Congress
in crafting more finely tailored rules where necessary ... We
need not determine here whether, from a policy perspective,
increased protection for discoveries of diagnostic laws of
nature is desirable”
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101

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Dovetailing Myriad with Mayo:
 Myriad + Mayo:
 “Isolated DNA” IS NOT PATENT ELIGIBLE UNDER 35 USC § 101
as it is a PRODUCT OF NATURE
 A newly discovered law of nature or product of nature
(isolated DNA) is not patentable
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101

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Dovetailing Myriad with Mayo:
 Myriad + Mayo:
 Application of a newly discovered law of nature is not
patentable if application merely relies upon elements already
known in the art, and hence uses of a natural product (isolated
DNA) that rely on elements already known in the art may not
be patentable
 See Bowman v. Monsanto Co. (patent monopoly as to self-
reproducing biological material that contains and expresses
exogenous DNA; case decided before Myriad and not held for
Myriad Decision and remand in view thereof)
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101

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USPTO GUIDELINES:
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101

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USPTO GUIDELINES:
 Claim 1. Purified amazonic acid.
 -- NOT PATENT ELIGIBLE
 Claim 2. Purified 5-methyl amazonic acid.
 -- PATENT ELIGIBLE METHYL DERIVATIVE
 Claim 3. A method of treating colon cancer, comprising:
administering a daily dose of purified amazonic acid to a
patient suffering from colon cancer for a period of time from 10
days to 20 days, wherein said daily dose comprises about 0.75
to about 1.25 teaspoons of amazonic acid.
 -- PATENT ELIGIBLE METHOD
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101

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USPTO GUIDELINES:
 Analysis of Claim 1: The answers to Questions 1-2 in the above
analysis are both “yes”, because the claim is to a composition of
matter, and because the claim recites a judicial exception, i.e.,
amazonic acid is a naturally occurring chemical found in the
leaves of Amazonian cherry trees. The answer to Question 3 is
“no”, because the claim as a whole does not recite something
significantly different than the natural product, e.g., the claim
does not include elements in addition to the judicial exception
that add significantly more to the judicial exceptions, and also
does not include features that demonstrate that the recited
product is markedly different from what exists in nature.
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101

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POSSIBLE TOPICS ON THE HORIZON:
 What is the meaning of “Human Organism” or “Directed to Or
Encompassing a Human Organism” in AIA Section 33?
 Myriad, Complaint filed May 12, 2009:
 “All of the challenged patent claims represent patents on abstract
ideas or basic human knowledge and/or thought and as such are
unconstitutional under the First and Fourteenth Amendments to the
United States Constitution”
 “Myriad maintains the largest data base of BRCA1 and BRCA2 data. It
does not share the information in that database …”
 Myriad’s monopoly has resulted in a disparity in the amount of
information about genetic mutations … in ethnic groups other than
Caucasians”
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101

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QUESTIONS? — COMMENTS?
THANK YOU FOR YOUR ATTENTION!
Thomas J. Kowalski, Esq, Shareholder
TKowalski@VedderPrice.com
Vedder Price PC, 1633 Broadway, 47th Floor, NY NY 10019
Tel +1 212 407 7700
Hot Topics in European Bio-Patent Law -
A US Perspective: 35 USC 101