Transcript Patent Law Prof. Merges

Patent Law
Prof. Merges
Section 101: Issues in the Life
Sciences
9.1.2011
Main Themes
• Living Subject matter
• Gene Patents
Historical progression
1. Chakrabarty – on the cusp of “classical
genetic engineering”
2. Rediscovering Parke-Davis – Learned Hand’s
1911 decision on the “adrenalin patent” – p.
164
3. Supreme Court “dodges” Metabolite: 2006
Today’s controversy
• Ass’n Molecular Pathology – the “Myriad”
gene patent case
• Fed Cir. Opinion 2011 – motion to rehear,
rehear en banc, then cert. petition?
Chakrabarty: Questions
• 1. Why are “discovered” things not
patentable?
• 2. Why are newly discovered laws of nature
not patentable?
Chakrabarty (cont’d)
• 3. Why isn’t Chakrabarty’s invention just a
newly discovered law of nature?
• 4. Why don’t the Plant Patent Act and the
PVPA show that Congress assumed living
things to be unpatentable?
Chakrabarty (cont’d)
5. Why is this decision so
important if
Chakrabarty could have
obtained process claims
anyway?
6. Would a cloned human be
patentable under this
decision? How broad is this
holding?
Page 72
“Congress thus recognized that
the relevant distinction was not
between living and inanimate
things, but between products of
nature, whether living or not,
and human-made inventions.”
Thesis/antithesis
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) . . .
-- casebook p. 70
This is not to suggest that § 101
has no limits or that it embraces
every discovery. The laws of
nature, physical phenomena,
and abstract ideas have been
held not patentable.
Thus, a new mineral discovered in the
earth or a new plant found in the wild is
not patentable subject matter. Likewise,
Einstein could not patent his celebrated
law that E = mc2; nor could Newton
have patented the law of gravity. Such
discoveries are “manifestations of . . .
nature, free to all men and reserved
exclusively to none.”
Natural substance patents
• “Purified and isolated” claims
–§ 101 Issues
–Practical advantages
Parke-Davis v. Mulford
• 1911 District Court case
• Centered on a patent for purified adrenalin
• Patented by Jokichi Takamine
Jokichi Takamine
Takamine: The Legend
Takamine’s patents
• ‘176 Product patent
–Why was this valuable?
–Why not a process patent (see
Chakrabarty)
• See p. 164
What is the value of a product
patent?
• Mulford used a different process to
precipitate out the final adrenaline product
• Might not have infringed a detailed
process patent if Takamine had
claimed narrowly
Judge Hand’s Decision
Hand’s decision
“While it is of course possible
logically to call this a purification of
the principle, it became for every
practical purpose a new thing
commercially and therapeutically.”
-- p. 168
Everyone, not already saturated with scholastic
distinctions, would recognize that Takamine’s
crystals were not merely the old dried glands
in a purer state, nor would his opinion
change if he learned that the crystals were
obtained from the glands by a process of
eliminating the inactive organic substances.
The line between different substances and
degrees of the same substance is to be drawn
rather from the common usages of men than
from nice considerations of dialectic.
-- P. 166
Lab Corp of America v. Metabolite
Labs, Inc.
• Supreme Court 2006
• No official opinion – cert dismissed
• Grant of cert., dissent from dismissal: signals
from the Court?
Metabolite v. Lab Corp. Am.
13. A method for detecting a deficiency of
cobalamin or folate in warmblooded
animals comprising the steps of:
assaying a body fluid for an elevated
level of total homocysteine; and
correlating an elevated level of total
homocysteine in said body fluid with a
deficiency of cobalamin or folate.
’658 patent, col. 11, ll. 58-65.
The ’658 patent claims methods for
detecting cobalamin or folate deficiency.
Cobalamin and folate are both B
vitamins, commonly known as B12 and
folic acid, respectively. A deficiency in
these vitamins can cause serious
illnesses in humans, including vascular
disease, cognitive dysfunction, birth
defects and cancer. If detected early
enough, however, vitamin supplements
readily treat the deficiency.
Because these B vitamins assist
in metabolizing the amino
acid homocysteine, scientists
directly or indirectly assay
homocysteine to screen for
cobalamin and folate
deficiency.
Supreme Court
Drafted its own cert question: “First,
measure the level of the relevant
amino acids using any device, whether
the device is, or is not, patented;
second, notice whether the amino acid
level is elevated and, if so, conclude
that a vitam in B deficiency exists. Is
the patent invalid because one cannot
patent “laws of nature, natural
phenomena, and abstract ideas”?
Official disposition
• Writ of certiorari
dismissed as
improvidently granted.
Breyer et al. dissent
• “laws of nature, natural phenomena, and
abstract ideas” excluded from § 101
• “[T]he reason for the exclusion is that
sometimes too much patent protection can
impede rather than “promote the Progress of
Science and useful Arts” . . . . Casebook p.
100
But one can reduce any process to a series of
steps. The question is what those steps
embody. And here, aside from the
unpatented test, they embody only the
correlation between homocysteine and
vitamin deficiency that the researchers
uncovered. In my view, that correlation is an
unpatentable “natural phenomenon,” and I
can find nothing in claim 13 that adds
anything more of significance. . . .
-- casebook p. 132
Myriad
• The gene
• The patent
• The controversy
BRCA-1
Gene Expression  Protein
Relying on a large set of DNA samples from families
with inherited breast and ovarian cancers, the
inventors correlated the occurrence of cancer in
individual family members with the inheritance
of certain marker DNA sequences. This allowed
the inventors to identify, or “map,” the physical
location of the BRCA genes within the human
genome and to isolate the BRCA genes and
determine their exact nucleotide sequences. This
in turn allowed Myriad to provide BRCA
diagnostic testing services to women. – p. 8
Myriad
• The isolated DNA sequence can
be used in genetic testing to
determine whether a person
carries certain alleles of the
BRCA 1 or 2 gene and is thus at
higher risk for breast or ovarian
cancer.
Claim 1 of U.S. Pat. No. 5,747,282
(issued 1998)
1. An isolated DNA coding for a
BRCA1 polypeptide, said
polypeptide having the amino
acid sequence set forth in SEQ ID
NO: 2.
Association for Molecular Pathology v. United
States PTO
(The “Myriad” Case)
2010 U.S. Dist. LEXIS 35418 (Apr. 5, 2010)
Myriad – district court
• Rejects Learned Hand analysis in
Parke-Davis
• Statement re: 101 was dicta
there
Holding
In light of DNA's unique qualities as a physical
embodiment of information, none of the structural
and functional differences cited by Myriad
between native BRCA1/2 DNA and the isolated
BRCA1/2 DNA claimed in the patents-in-suit render
the claimed DNA. "markedly different." This
conclusion is driven by the overriding importance
of DNA's nucleotide sequence to both its natural
biological function as well as the utility associated
with DNA in its “isolated” form.
. The
preservation of this defining
characteristic of DNA in its native
and isolated forms mandates the
conclusion that the challenged
composition claims are directed
to unpatentable products of
nature.
Am. Fruit Growers (1931)
Manufacture implies a change, but every
change is not manufacture, and yet every
change in an article is the result of treatment,
labor, and manipulation. But something more
is necessary . . . . There must be
transformation; a new and different article
must emerge having a distinctive name,
character, or use.
Myriad in the Federal Circuit
[A]lthough the parties and the
government appear to agree
that isolated DNAs are
compositions of matter, they
disagree on whether and to what
degree such molecules fall
within the exception for
products of nature. – p. 10
The distinction, therefore, between a
product of nature and a human-made
invention for purposes of § 101 turns
on a change in the claimed
composition’s identity compared with
what exists in nature. [Patentable:]….
compositions that human intervention
has given “markedly different,” or
“distinctive,” characteristics. – p. 11
Fed Cir Strategy
• Point out the significance of the isolation
• Chromosomes: 80 million – 110 million base
pairs
• Genes: 80,000 bp
• Coding region: 10,200 bp
Distinguishing Parke-Davis
Purified vs. merely isolated:
[I]n nature, isolated DNAs are covalently
bonded to such other materials. Thus, when
cleaved, an isolated DNA molecule is not a
purified form of a natural material, but a
distinct chemical entity. In fact, some forms
of isolated DNA require no purification at all,
because DNAs can be chemically synthesized
directly as isolated molecules.
Dissent: Judge Bryson
• No to long DNA sequences
P. 14
It is also important to dispute the dissent’s
analogy to snapping a leaf from a tree. With
respect, no one could contemplate that
snapping a leaf from a tree would be worthy
of a patent, whereas isolating genes to
provide useful diagnostic tools and medicines
is surely what the patent laws are intended
to encourage and protect. Snapping a leaf
from a tree is a physical separation, not one
creating a new chemical entity.