Patentability of Diagnostic Inventions
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Transcript of Patentability of Diagnostic Inventions
PATENTABILITY OF DIAGNOSITC
INVENTIONS
Disclaimers
2
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
U.S. GOVERNMENT DISCLAIMER NOTICE. The views
expressed in this presentation are those of the author and do
not necessarily reflect the official policy or position of the
Department of the Army, Department of Defense, or the U.S.
Government. The information appearing on this presentation is
for general informational purposes only and is not intended to
provide legal advice to any individual or entity. Please consult
with your own legal advisor before taking any action based on
information appearing in this presentation or any sources to
which it may cite.
UNLESS OTHERWISE STATED
Who is this guy?
MARCUS A. STREIPS
Attorney-Advisor (Intellectual Property)
United States Army Medical Research & Materiel Command
Fort Detrick, MD
What inventions are patentable?
• An invention can be patented if:
– The invention is eligible for patenting (“patentable subject matter”), and
– 35 USC §101
– The invention meets other statutory conditions (e.g., “new” and
“unobvious” as measured against the prior art)
– 35 USC §§102, 103, 112
What Inventions are not Patentable?
• Abstract ideas
– Mental processes
• Physical phenomena
• Laws of nature
– Abstract mathematical formulas or pure algorithms
– Inventions that clearly do not work
• Perpetual motion machines
OBVIOUSLY NOT PATENTABLE
OR IS IT SO OBVIOUS?
A method and system for placing an order to purchase
an item via the Internet. The order is placed by a
purchaser at a client system and received by a server
system. The server system receives purchaser
information including identification of the purchaser,
payment information, and shipment information from the
client system. The server system then assigns a client
identifier to the client system and associates the
assigned client identifier with the received purchaser
information. The server system sends to the client
system the assigned client identifier and an HTML
document identifying the item and including an order
BUTTON. The client system receives and stores the
assigned client identifier and receives and displays the
HTML document. In response to the selection of the
order button, the client system sends to the server
system a request to purchase the identified item. The
server system receives the request and combines the
purchaser information associated with the client
identifier of the client system to generate an order to
purchase the item in accordance with the billing and
shipment information whereby the purchaser effects the
ordering of the product by selection of the order button.
What is this a patent for?
Amazon.com 1-Click
A portable communication device with
multi-touch input detects one or more
multi-touch contacts and motions and
performs one or more operations on an
object based on the one or more multi-
touch contacts and/or motions. The object
has a resolution that is less than a pre-
determined threshold when the operation is
performed on the object, and the object
has a resolution that is greater than the
pre-determined threshold at other times.
What is this a patent for?
Apple Pinch to Zoom
OK, but surely nothing that
violates the Laws of Physics? Right?
AND ITS NOT JUST PATENTS
What is “Patentable Subject Matter”?
• Whoever invents or discovers any new and useful
▫ process
▫ machine
▫ manufacture
▫ or composition of matter
or any new and useful improvement thereof, may obtain
a patent therefore, subject to the conditions and
requirements of this title.
Patent Act of 1952 (35 USC §101)
Along comes the Bilski Decision
• Decided June 28, 2010
• The opinion offers little clarity in determining whether a particular invention falls within the scope of Section 101.
“Today, the Court once again declines to impose limitations on the Patent Act that are inconsistent with the Act’s text. The patent application here can be rejected under our precedents on the unpatentability of abstract ideas. The Court, therefore, need not define further what constitutes a patentable “process,” beyond pointing to the definition of that term provided in §100(b) and looking to the guideposts in Benson, Flook, and Diehr.”
Practical Effect
Must take each case, one case at a time and compare with old cases.
Prometheus Rising
(some background)
Prometheus Rising Prometheus Rising is a book by Robert Anton Wilson first
published in 1983. It is a guide book of "how to get from here to there", an amalgam of
Timothy Leary's 8-circuit model of consciousness, Gurdjieff's self-observation
exercises, Alfred Korzybski's general semantics, Aleister Crowley's magical theorems,
Sociobiology, Yoga, relativity, and quantum mechanics amongst other approaches to
understanding the world around us. Source: http://en.wikipedia.org/wiki/Prometheus_Rising
Our “Prometheus Rising” is a lot
more complicated
At the time the patents were filed, scientists already understood
that the levels in a patient's blood of certain metabolites were
correlated with the likelihood that a particular dosage of a
thiopurine drug could cause harm or prove ineffective. But they
did not know the precise correlations between metabolite levels
and likely harm or ineffectiveness. The patent claims at issue here
set forth processes embodying researchers' findings that identified
these correlations with some precision.
Prometheus Rising
(some background)
Prometheus’ Patents
Prometheus’ Patents
• U.S. Patents 6,355,623 and 6,680,302
• methods for calibrating the proper dosage of thiopurine
drugs used for treating both gastrointestinal and non-
gastrointestina l autoimmune diseases (Crohn’s Disease).
Prometheus’ Patents
Claim 1 of the ‘623 patent:
“A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising” two steps
“(a) administering” one of a class of drugs (thiopurines) (“a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder;”) and
“(b) determining the level of” a specified metabolite (“6-thioguanine in said subject having said immune-mediated gastrointestinal disorder”),
“wherein” a level below a given threshold (“the level of 6-thioguanine less than about 230 pmol per 8 x 108 red blood cells”) “indicates a need to increase the amount of said drug subsequently administered to said subject and”
“wherein the level” above the threshold (“6-thioguanine greater than about 400 pmol per 8 x 108 red blood cells”) “indicates a need to decrease the amount of said drug subsequently administered to said subject.”
“A method of optimizing therapeutic efficacy, comprising:
“(a) administering a drug; and
“(b) determining the level of 6–T
“wherein the level of 6–thioguanine less than [X] indicates a need to increase the amount of said drug subsequently administered to said subject and
“wherein the level of 6–thioguanine greater than [Y] indicates a need to decrease the amount of said drug subsequently administered to said subject.”
Said another way . . .
Source: www.law.berkeley.edu/files/3_-_8-30-2012_-_101_Part_2.ppt, © Board of Regents – University of California
Supreme Court follow up to Bilski
• Mayo v. Prometheus Labs
– On June 29, 2010, the Supreme Court granted cert., vacated the
decision and remanded the case to the Federal Circuit
• The Federal Circuit was instructed to reconsider the case “in light
of Bilski v. Kappos, 561 U.S. ____ (2010).”
– On March 20, 2012, the Supreme Court issued the unanimous decision
that:
• No patents for claims that do not do “significantly more than simply
describe natural relations.” No 10-1150, 566 U.S. __ (2012).
[T]he claims inform a relevant audience about certain laws of nature; any
additional steps consist of well-understood, routine, conventional activity
already engaged in by the scientific community; and those steps, when viewed
as a whole, add nothing significant beyond the sum of their parts taken
separately. For these reasons we believe that the steps are not sufficient to
transform unpatentable natural correlations into patentable applications of
those regularities.
Prometheus Falling
(S.Ct. Mayo Decision)
– Monopolization of laws of nature, mental processes and abstract
intellectual concepts through the grant of a patent might tend to impede
innovation more than it would tend to promote it.
– An application of a law of nature or mathematical formula to a known
structure or process may be deserving of patent protection.
– However, to transform an unpatentable law of nature into a patent-eligible
application of such a law, one must do more than simply state the law of
nature while adding the words “apply it.”
Prometheus Falling
(S.Ct. Mayo Decision)
Relationship to Flook and Diehr
The claim before us presents a case for patentability that is weaker than
the (patent-eligible) claim in Diehr and no stronger than the
(unpatentable) claim in Flook. The claimed instructions add nothing
specific to the laws of nature other than what is well-understood,
routine, conventional activity, previously engaged in by those in the field
Parker v. Flook, 437 U.S. 584 (1978) “Method for Updating Alarm
Limits” (on catalytic converters).
Diamond v. Diehr, 450 U.S. 175 (1981) “[process] for molding raw,
uncured synthetic rubber into cured precision products."
See the similarity?
Court’s analysis based on Diehr & Flook
Diehr process – patentable
Method for molding raw, uncured rubber
into cured, molded products.
The process
(1) continuously monitoring the
temperature on the inside of the mold,
(2) feeding the resulting numbers into a
computer, which would use the
Arrhenius equation to continuously
recalculate the mold-opening time, and
(3) configuring the computer so that at
the appropriate moment it would signal a
“device” to open the press.
Flook process – not patentable
Method for improved system for adjusting
“alarm limits” in the catalytic conversion
of hydrocarbons.
The process
(1) measuring the current level of the
variable, e.g., the temperature;
(2) using an apparently novel
mathematical algorithm to calculate the
current alarm limits; and
(3) adjusting the system to reflect the
new alarm-limit values.
Source: www.law.berkeley.edu/files/3_-_8-30-2012_-_101_Part_2.ppt © Board of Regents – University of California
Court’s analysis based on Diehr & Flook
Diehr process – patentable
The combination of steps was NOT
obvious, already in use or purely
conventional.
The additional steps of the process
integrated the equation into the
process as a whole.
Flook process – not patentable
The steps of the method were well-
known to the point that, putting the
formula to the side, there was no
“inventive concept” in the claimed
application of the formula.
The process did not limit the claim to
a particular application.
Source: www.law.berkeley.edu/files/3_-_8-30-2012_-_101_Part_2.ppt © Board of Regents – University of California
“A method of optimizing therapeutic efficacy, comprising:
“(a) administering a drug; and
“(b) determining the level of 6–T
“wherein the level of 6–thioguanine less than [X] indicates a need to increase the amount of said drug subsequently administered to said subject and
“wherein the level of 6–thioguanine greater than [Y] indicates a need to decrease the amount of said drug subsequently administered to said subject.”
Back to this . . .
Source: www.law.berkeley.edu/files/3_-_8-30-2012_-_101_Part_2.ppt © Board of Regents – University of California
Court’s analysis of the claims
Analysis of the claims went through four steps:
• 1. the Court observed that the administering step just defines “the relevant
audience”—doctors who treat patients with thiopurine drugs.
• 2. “the ‘wherein’ clauses simply tell a doctor about the relevant natural
laws.”
• 3. the determining step does not specify any particular process, but merely
invites doctors “to engage in well understood, routine, conventional activity.’
• 4. “to consider the three steps as an ordered combination adds nothing to
the laws of nature that is not already present when the steps are considered
separately.”
Source: www.law.berkeley.edu/files/3_-_8-30-2012_-_101_Part_2.ppt © Board of Regents – University of California
Court’s Conclusion
• Concluded that these instructions add nothing specific to the laws of
nature other than what is well-understood, routine, conventional activity,
previously engaged in by those in the field; and
• the steps of the method, when viewed as a whole, add nothing significant
beyond the sum of their parts taken separately.
• The effect of the steps is simply to tell doctors to apply the law of nature
somehow when treating their patients.
Source: www.law.berkeley.edu/files/3_-_8-30-2012_-_101_Part_2.ppt © Board of Regents – University of California
Looking Ahead - Tips
• In process or method claims and in new applications include
– elements or combinations of elements which themselves comprise an
“inventive concept”
• not “well-understood, routine, and conventional activity already
engaged in by the scientific community”
– additional transformative step which include
• an assay component
• quantification techniques
• treatment protocols
Source: www.lowndes-law.com/site/.../jason_miller_ip_presentation_on_mayo.ppt © Lowndes, Drosdick, Doster,
Kantor & Reed, P.A.
Looking Ahead - Tips
• In process or method claims and in new applications include
– active steps which will be more difficult to identify as “laws of nature”
• novel determinative steps
• what is administered is novel
• the relationship between what is detected and a particular disease is
novel
– multiple, additional known steps must add something “significant” as a
whole, beyond the sum of their parts
Source: www.lowndes-law.com/site/.../jason_miller_ip_presentation_on_mayo.ppt © Lowndes, Drosdick, Doster,
Kantor & Reed, P.A.
Thank You!
Source:
http://en.wikipedia.org/wiki/File:PrometheusRisingCover.jpg