Mayo v. Prometheus, 132 S. Ct. 1289 (2012)

advertisement
What is Happening to Patent Eligibility
and
What Can We Do About It?
June 24, 2014
Bruce D. Sunstein
Denise M. Kettelberger, Ph.D.
Sunstein Kann Murphy & Timbers LLP
The Phenomenon
A recent series of Supreme Court rulings has
made a wide range of patents and patent
applications ineligible for patent protection
These decisions significantly expand the
scope of claims ineligible for patenting
The rulings cover diagnostic methods, gene
sequences, and computer-related inventions
2
The root of the trend:
Mayo v. Prometheus, 132 S. Ct. 1289 (2012)
The Claims
administering a thiopurine drug to a subject
with a gastrointestinal disorder,
determining the level of a specific metabolite
of the thiopurine drug in the subject,
wherein a level below a first threshold
indicates a need to increase drug dosage, and
wherein a level above a second threshold
indicates a need to decrease drug dosage.
3
The root of the trend:
Mayo v. Prometheus, 132 S. Ct. 1289 (2012)
The Holding
The claimed subject matter is ineligible for
patenting as the claimed processes fail to
transform unpatentable natural laws into
patent-eligible applications of those laws.
Upholding the patents would disproportionately
risk tying up use of the underlying natural laws,
inhibiting their use in making further
discoveries
4
The root of the trend:
Mayo v. Prometheus, 132 S. Ct. 1289 (2012)
The Theory
“the ‘administering’ step simply refers to the
relevant audience, namely doctors who treat
patients with certain diseases with thiopurine drugs”
“the ‘wherein’ clauses simply tell a doctor about the
relevant natural laws”
the determining step “tells doctors to engage in
well-understood, routine, conventional activity
previously engaged in by scientists who work in the
field”.
5
The root of the trend:
Mayo v. Prometheus, 132 S. Ct. 1289 (2012)
The Analysis
1. Determine whether the claims are directed to
a patent-ineligible law of nature, natural
phenomenon, or abstract idea
2. If so, then search for an “inventive concept”—
i.e., an element or combination of elements
sufficient to “transform” the claimed abstract
idea into a patent-eligible application
6
The root of the trend:
Mayo v. Prometheus, 132 S. Ct. 1289 (2012)
Rationale
The Court has “a concern that patent law not
inhibit further discovery by improperly tying
up the future use of laws of nature”
The patent claims here “threaten to inhibit the
development of more refined treatment
recommendations (like that embodied in
Mayo's test), that combine Prometheus'
correlations with later discovered features of
metabolites, human physiology or individual
patient characteristics”
7
The next step:
Ass'n for Molecular Pathology v. Myriad, 133
S.Ct. 2107 (2013)
Holding: isolated segments of genomic DNA
are not eligible for patenting, because gDNA
is a natural phenomenon and “separating a
gene from its surrounding genetic material is
not an act of invention”
But preparation of complementary DNA is
patent eligible, because it is not a “product of
nature”
8
Draft Guidelines from the USPTO, March 2014,
in the wake of Prometheus and Myriad
Would render ineligible for patenting:
Diagnostic tests, isolated DNA segments,
many purified naturally occurring substances
and mixtures thereof
9
Alice Corp. v. CLS Bank, 6/19/14
Holding
The claims “are drawn to the abstract idea of
intermediated settlement” [“i.e., the use of a
third party to mitigate settlement risk”]
“[M]erely requiring generic computer
implementation fails to transform that abstract
idea into a patent-eligible invention”
The subject matter is ineligible for a patent, but
computer-related inventions not drawn to an
abstract idea may still be eligible.
10
Alice Corp. v. CLS Bank, 6/19/14
Analysis
“As stipulated, the claimed method requires the
use of a computer to create electronic records,
track multiple transactions, and issue
simultaneous instructions; in other words, ‘[t]he
computer is itself the intermediary.’”
The claims here do nothing more than “simply
instruct the practitioner to implement the abstract
idea of intermediated settlement on a generic
computer.”
11
Alice Corp. v. CLS Bank, 6/19/14
Rationale
“Laws of nature, natural phenomena, and
abstract ideas are the basic tools of scientific
and technological work.
“Monopolization of those tools through the
grant of a patent might tend to impede
innovation more than it would tend to
promote it, thereby thwarting the primary
object of the patent laws.” [citations and
interior quotes eliminated]
12
The Court Distrusts the Patent System
Ineligibility is linked to purported preemption of
scientific research and discovery by patent claims
that are said to be drawn to laws of nature, natural
phenomena, and abstract ideas
In determining eligibility, the specificity of the
claims is ignored by generalizing them into an
abstraction and then using the abstraction as a
core that is ignored in determining whether
“significantly more” than the abstraction is
present—a subjective exercise that eviscerates the
claims
13
Ironically, the Court rewards the
clever draftsman
“This Court has long warned against interpreting
§101 in ways that make patent eligibility depend
simply on the draftsman’s art.” Alice, quoting from
Prometheus [interior quotes, ellipses omitted]
Claims that are atomized into smaller parts, that
include more hardware, more non-natural parts, more
physical effects, and more detail are likely to be more
successful. See Ultramercial v. Hulu, 722 F.3d 1335
(Fed. Cir. 6/21/13)(example of patent claims found
not abstract, and in an opinion by J. Lourie, who is
hostile to eligibility)
14
What to do?—Pass a law to override Prometheus
Add a new sentence at the end of section 101 of
35 U.S.C.:
Claimed subject matter that provides a useful,
concrete, and tangible result shall not be denied
eligibility for a patent on the ground that it is
directed to a law of nature, natural
phenomenon, or abstract idea, and shall be
evaluated in accordance with the other
provisions of this title.
15
Thank you.
bsunstein@sunsteinlaw.com
dkettelberger@sunsteinlaw.com
www.sunsteinlaw.com
Download