Transcript Current Topics in Biotechnology Patents in the U.S.

Patent Law Changes and
Rulings: Impact on UNC
Patent Applications
December 6, 2012
Steven J. Sarussi
Who’s involved
 Supreme Court
 Ownership of federally funded inventions under the BayhDole Act
 Court of Appeals for the Federal Circuit
 Induced infringement by joint actors
 Inventorship
 Standard for inequitable conduct
 Both Supreme Court and Federal Circuit
 Patent eligible subject matter under 35 U.S.C. § 101
 Congress
 America Invents Act
 First to file provisions
•2
Big Changes??
YES/NO?
•3
Quiz
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.
 Patentable subject matter?
•4
Quiz
An isolated DNA coding for a BRCA1
polypeptide, said polypeptide having the
amino acid sequence set forth in SEQ ID
NO:2.
 Patentable subject matter?
•5
Quiz
A method for detecting a germline alteration in a BRCA1
gene, said alteration selected from the group consisting of
the alterations set forth in Tables 12A, 14, 18 or 19 in a
human which comprises analyzing a sequence of a BRCA1
gene or BRCA1 RNA from a human sample or analyzing a
sequence of BRCA1 cDNA made from mRNA from said
human sample with the proviso that said germline alteration
is not a deletion of 4 nucleotides corresponding to base
numbers 4184-4187 of SEQ ID NO:1.
 Patentable subject matter?
•6
Quiz
A method for screening potential cancer therapeutics which
comprises: growing a trans-formed eukaryotic host cell
containing an altered BRCA1 gene causing cancer in the
presence of a compound suspected of being a cancer
therapeu-tic, growing said transformed eukaryotic host cell
in the absence of said compound, determining the
 Patentable subject matter?
•7
Quiz
 Researcher signs agreement agreeing to assign
rights in his inventions to University
 Researcher later assigns his rights in Invention
X to Company
 Who owns the patents covering Invention X?
 University? Company?
 Does it matter if work resulting in Invention X was
federally funded research under Bayh-Dole?
 University? Company?
•8
Quiz
 Is Bill’s invention patentable?
Amy makes a
sale in Korea
Bill files
 Under old law?
 Under new law?
•9
Quiz
 Who gets the patent?
Amy
conceives
Amy reduces to
practice
Bill conceives
Amy files
Bill RTP
Bill Files
 Under old law?
 Under new law?
•10
Quiz
 Is the public use prior art?
Amy uses
invention
publicly in Italy
March 19,
2013
Amy files
March 18,
2014
•11
Quiz
 Is the disclosure by Bill prior art to Amy?
Amy
discloses X
March 17,
2013
Bill sees and
discloses X
April 21,
2013
Amy files
June 17,
2013
•12
Quiz
 Is Amy’s publication prior art under new law against Bill’s
application?
 Is Bill’s application prior art against Amy under new law?
less than one year
Amy
publishes
Bill files Application #1
(independent from Amy)
Amy files
Application #2
Application #1 publilshes
•13
Patent eligible subject matter
under 35 U.S.C. § 101
Mayo Collaborative Services v.
Prometheus Labs., Inc. (S.Ct., 2012)
 Supreme Court
 Method of administering drugs to a patient and
determining the proper dosage is not patent
eligible subject matter under § 101
 Prometheus’s patents “involve well-understood,
routine, conventional activity previously
engaged in by researchers in the field.”
 Patents cover laws of nature
•15
Mayo Collaborative Services v.
Prometheus Labs., Inc. (S.Ct., 2012)
 All steps considered together do not transform the
claims to something other than laws of nature
1. Administering step: refers to doctors who treat
patients with the drug
2. Wherein clause: alerts doctors to the laws of
nature to consider during treatment
3. Determining step: doctors may use any laboratory
process, even well-known methods, for assessing
metabolite level in blood
•16
Association for Molecular Pathology
v. USPTO (“Myriad”, Fed. Cir. 2012)
 Patent eligibility of isolated human DNA (BRCA)
and diagnostic tests for mutations under § 101 in
light of Prometheus
 Disputed claims:
 Composition claims for isolated DNA sequences
(BRCA1 and BRCA2 genes)
 Method claims for comparing and analyzing
sequences
 Method claim for screening cancer therapeutics
with transformed cells
•17
Association for Molecular Pathology
v. USPTO (“Myriad”, Fed. Cir. 2012)
 Eligibility of claims for human gene sequences:
 Chakrabarty controls, not Prometheus
 “isolated DNA molecules are not found in nature” and
“the product of human ingenuity”
 Plaintiffs argued that isolated and natural DNA share
the same sequence, and are not “markedly different”
 CAFC reasoned that although isolated DNA are
functionally similar to natural DNA, isolated DNA are
structurally distinct
•18
Association for Molecular Pathology
v. USPTO (“Myriad”, Fed. Cir. 2012)
 Eligibility of method claims:
 method claims for analyzing/comparing DNA
sequences ineligible because it is an “abstract
mental process” [Prometheus controls]
 method of screening potential cancer
therapeutics using transformed cells are eligible
subject matter because they “arose from human
effort” [Chakrabarty controls]
•19
Association for Molecular Pathology
v. USPTO (“Myriad”, Fed. Cir. 2012)
 Congress should determine policy questions
surrounding patenting biological molecules
 PTO has issued 2,645 patents on “isolated
DNA” over past 29 years
 Addressed preemption issue of others
experimenting with BRCA by noting that
“patents are rarely enforced against
scientific research, even during their terms”
•20
PerkinElmer Inc. v. Intema Ltd.
(Fed. Cir. 2012)
 1. A method of determining whether a pregnant
woman is at an increased risk of having a fetus
with Down's syndrome… comprising…:
 measuring the level of at least one screening marker from a
first trimester of pregnancy…
 measuring the level of at least one second screening marker
from a second trimester of pregnancy; and
 determining the risk of Down's syndrome by comparing the
measured levels of both the … first screening marker … and
the …second screening marker … with observed relative
frequency distributions of marker levels in Down's syndrome
pregnancies and in unaffected pregnancies.
•21
PerkinElmer Inc. v. Intema Ltd.
(Fed. Cir. 2012)
 District Court
 Denied PerkinElmer's motion for summary
judgment of patent ineligibility under § 101
 Concluded that the claims were directed to a
data-gathering method comprising measuring
steps that satisfied the machine-ortransformation test
 “the process of gathering data by taking
blood samples and measuring ultrasounds is
manifestly statutory subject matter. . . .”
•22
PerkinElmer Inc. v. Intema Ltd.
(Fed. Cir. 2012)
 Federal Circuit Reverses
 “Laws of nature, natural phenomena, and
abstract ideas are not patentable.”
 These exceptions make mental processes ineligible
for patenting
 But, all inventions at some level embody, use,
reflect, rest upon, or apply laws of nature,
natural phenomena, or abstract ideas.”
•23
PerkinElmer Inc. v. Intema Ltd.
(Fed. Cir. 2012)
 Federal Circuit Reverses
 "The key distinction … is between claims that
recite ineligible subject matter, and no more, and
claims to specific inventive applications of that
subject matter."
 Patentable process claims “must contain other
elements or a combination of elements,
sometimes referred to as an ‘inventive concept,’
sufficient to ensure that the patent in practice
amounts to significantly more than a patent upon
the natural law itself.”
•24
PerkinElmer Inc. v. Intema Ltd.
(Fed. Cir. 2012)
 Federal Circuit’s analysis
 Claims recite a mental process of comparing
data to determine a risk level
 Data are gathered in the first trimester of pregnancy
 Data are gathered in the second trimester of
pregnancy
 Those data are compared to known statistical
information.
 No action beyond the comparison is required.
•25
PerkinElmer Inc. v. Intema Ltd.
(Fed. Cir. 2012)
 Federal Circuit’s analysis
 That an increased risk of fetal Down’s syndrome
produces certain analytical results is a natural
process
 “an eternal truth that ‘exists in principle apart from
any human action.’ ”
 Thus, claims recite mental processes and
natural laws
 So, do they add enough to the ineligible subject
matter to direct the claims to applications of those
concepts” We think not.
•26
PerkinElmer Inc. v. Intema Ltd.
(Fed. Cir. 2012)
 Federal Circuit’s analysis
 Because the claims recite mental processes
and natural laws:
 Do they add enough to the ineligible subject
matter to direct the claims to applications of
those concepts?
 Do they possess or require an inventive
concept?
 Court: “No”
•27
PerkinElmer Inc. v. Intema Ltd.
(Fed. Cir. 2012)
 Inventive concept?
 Measuring steps: No
 Merely tell the users of the process to measure
the screening markers through whatever known
method they wish.
 “The individual measurements are obtained through
known methods”
 “Tell the user to engage in well understood, routine,
conventional activity previously engaged in by
scientists who work in the field.”
•28
PerkinElmer Inc. v. Intema Ltd.
(Fed. Cir. 2012)
 Inventive concept?
 Determining step: No
 Requires ineligible mental step of “comparing”
 Statistical information mentioned in the
determining step?
 “Well-understood, conventional information.
 “[T]he necessary statistical distribution parameters …
are known, being derivable from observed
distributions …”.
 Statistical calculation: also known and conventional
•29
PerkinElmer Inc. v. Intema Ltd.
(Fed. Cir. 2012)
 “Inventive concept”
 A hint?
 “It is the ‘two data points are better than one’
concept which is the focus of the claims; that
concept simply does not depend on the method
by which the data points are obtained.”
•30
Diagnostic method claims
 Recommendations
 Identify “natural laws” and “products of nature”
 Need more than “measuring” and “correlating”
 Claim strategies
 Narrow, specific, encompassing particular assay and
detection steps
 Add some (any) patentable feature other than the
naturally occurring correlation between a marker and
disease
 Novel transformative step, machine, composition, etc.
 Isolated DNA molecules
•31
Back to the Supremes
Myriad questions presented to Supremes
1. Are human genes patentable?
2. Did the court of appeals err in upholding a method
claim by Myriad that is irreconcilable with this Court's
ruling in Mayo Collaborative Servs. v. Prometheus
Labs?
3. Did the court of appeals err in adopting an inflexible
rule that parties who have been deterred by Myriad's
"active enforcement" of its patent rights nonetheless
lack standing to challenge those patents absent
evidence that they have been personally threatened
with a lawsuit?
•32
Ownership of federally funded
inventions under the
Bayh-Dole Act
Board of Trustees of the Leland Stanford Junior
University v. Roche Molecular Systems, Inc. (2011)
 Employee of Stanford University developed a method for
quantifying amounts of HIV in blood in collaboration with
Cetus, a research company
 Researcher “agreed to assign” the rights to his inventions
to Stanford University, but also assigned his rights to Cetus
 Roche acquired Cetus’s rights
 Stanford sued Roche, claiming Stanford had superior rights
under the Bayh-Dole Act because the research was
federally funded
 Roche claimed co-ownership of the HIV kit based on the
assignment to Cetus
•34
Board of Trustees of the Leland Stanford Junior
University v. Roche Molecular Systems, Inc. (2011)
 Universities do not automatically own the rights to
inventions conceived with federal funds
 Rights do not “vest” with government contractor under BayhDole
 Reasoning: Bayh-Dole Act § 201(a) permits
government contractors to “elect to retain title to any
subject invention.”
 Does not state that inventors are “deprived of their
interest in federally funded inventions”
 The Act “simply assures contractors that they may
keep title to whatever it is they already have’”
•35
Board of Trustees of the Leland Stanford Junior
University v. Roche Molecular Systems, Inc. (2011)
 Federal Circuit interpretation of the licensing
agreement language:
 Stanford agreement: used the words “agree to
assign”
 promise to assign rights in the future
 Cetus agreement: used the words “do hereby
assign”
 automatic transfer of rights once the invention was
created
•36
Board of Trustees of the Leland Stanford Junior
University v. Roche Molecular Systems, Inc. (2011)
 Recommendations
 Technology transfer department
 Aware of all communications between inventors and
third parties
 Develop/approve collaborations
 Review/approve agreements
 Assignments or other conveyances!
 Assignment of (potential) inventions: early
 Record
•37
Induced infringement by joint
actors
Akamai Tech., Inc. v. Limelight Networks and
McKesson Tech., Inc. v. Limelight Networks
(Fed. Cir. 2012)
 The court addressed the issue of joint
infringement of method patents under 35
U.S.C. § 271(b)
 Induced infringement § 271(b): “when a single
actor induces another actor to commit all the
elements of infringement, the first actor is liable”
 Direct infringement § 271(a): “when a single
actor commits all the elements of infringement
•39
Akamai Tech., Inc. v. Limelight Networks and
McKesson Tech., Inc. v. Limelight Networks
(Fed. Cir. 2012)
 Akamai
 Method patent for efficient delivery of web
content, including:
 Placing some content on servers, and
 Modifying content provider’s web pages
 Limelight directly performed step 1, but
instructed its customers to perform step 2
 Limelight found not liable by D.Ct. for induced
infringement because customers performed one
of the steps
•40
Akamai Tech., Inc. v. Limelight Networks and
McKesson Tech., Inc. v. Limelight Networks
(Fed. Cir. 2012)
 McKesson
 Method patent covering electronic
communication between healthcare providers
and patients
 Epic licensed software to healthcare companies
 The steps of the patent were performed in part
by patients and in part by healthcare providers –
none of the steps were performed by Epic
 Found not liable by D.Ct. for induced
infringement
•41
Akamai Tech., Inc. v. Limelight Networks and
McKesson Tech., Inc. v. Limelight Networks
(Fed. Cir. 2012)
 Problem: induced infringement liability arises only
if the “inducement give[s] rise to direct
infringement” and “direct infringement must be
committed by a single actor” BMC Resources, Inc.
v. Paymentech, L.P. (Fed. Cir. 2007)
 Requirement of direction and/or control by inducer
•42
Akamai Tech., Inc. v. Limelight Networks and
McKesson Tech., Inc. v. Limelight Networks
(Fed. Cir. 2012)
 Issue: whether a person may be liable for induced
infringement if:
1. The person performed some steps of a claimed
method and induced other parties to commit the
remaining steps (Akamai); or
2. The person induced others to jointly perform all the
steps of the claimed method, but no single person
performed all of the steps (Mckesson)
 Finding: Yes
•43
Akamai Tech., Inc. v. Limelight Networks and
McKesson Tech., Inc. v. Limelight Networks
(Fed. Cir. 2012)
 To prove
 Knowledge of patent
 Actions that induce performance of claimed method steps
 Steps were performed
 All steps need not be performed by same parties
•44
Akamai Tech., Inc. v. Limelight Networks and
McKesson Tech., Inc. v. Limelight Networks
(Fed. Cir. 2012)
 Recommendations
 Although easier to prove induced infringement,
still important to consider claim drafting
strategies for method claims
 How invention is to be used
 Who will use it
 What is sold
 What is used
 Where will it be used
 What activities will infringe (or which will not)
•45
Inventorship
Falana v. Kent State University
(Fed. Cir. 2012)
 Falana, a post-doc at Kent State University, developed the
synthesis protocol to produce a previously unknown
compound (Compound 7)
 Collaborators synthesized Compound 9, a more desirable
chemical of the same genus as Compound 7, using
Falana’s protocol
 Collaborators filed a patent claiming Compound 9, and
disclosed Falana’s protocol and Compound 7 in the
specification
 Falana was not listed as an inventor and filed a § 256
action to correct the inventorship of the patent
•47
Falana v. Kent State University
(Fed. Cir. 2012)
 Joint inventorship is a question of who conceived the
subject matter of the disputed claims
 Conception of chemical compounds: requires 1) knowledge
of structure; and 2) synthesis method
 Falana’s contribution was more than an exercise of
ordinary skill, and deserved inventorship
 Holding: “a putative inventor who envisioned the structure
of a novel genus of chemical compounds and contributes
the method of making that genus contributes to the
conception of that genus.”
•48
Falana v. Kent State University
(Fed. Cir. 2012)
 Recommendations
 Inventorship determination
 Consider co-authors listed on publications
•49
Standard for inequitable
conduct
Therasense, Inc. v. Becton, Dickinson and
Co. (Fed. Cir. 2011)
 Infringement lawsuit for patent on
disposable blood glucose strips
 District court found one of Abbott’s patents
unenforceable for inequitable conduct
 Abbott failed to disclose to the PTO
contradictory arguments it made to the EPO
during prosecution of the European
counterpart
•51
Therasense, Inc. v. Becton, Dickinson and
Co. (Fed. Cir. 2011)
 Heightened standard for Inequitable Conduct:
1. Intent: Accused infringer must prove by clear
and convincing evidence that the patentee had
specific intent to deceive the PTO
 Applicant knew of the reference;
 Applicant knew the reference was material;
and
 Made a deliberate decision to withhold it
•52
Therasense, Inc. v. Becton, Dickinson and
Co. (Fed. Cir. 2011)
2. “But for” materiality: “[w]hen an applicant fails to
disclose prior art to the PTO, the prior art is butfor material if the PTO would not have allowed a
claim had it been aware of the undisclosed prior
art.”
 No sliding-scale: weak showing of intent + strong
showing of materiality ≠ inequitable conduct
 Intent and materiality analysis must be done
separately
•53
Therasense, Inc. v. Becton, Dickinson and
Co. (Fed. Cir. 2011)
 Recommendations
 Disclose if question of materiality
 Record reason for not disclosing
 Advise against “smoking gun” communications
•54
The Leahy-Smith
America Invents Act
Patent Law “Reform” Statutes
 On Congress’ menu for years
 Numerous (fizzled) efforts to date:
 Berman/Boucher H.R. 5299 in 2004
 Evolving versions of H.R. 2795 in 2005
 Hatch and Leahy S. 3818, the “Patent Reform
Act of 2006”
 “Patent Reform Act of 2007 (S. 1145 and H.R.
1908)
 “Patent Reform Act of 2009 (S. 515 and H.R.
1260)
•56
Why success in 2011?
 Patent Law Reform was high on
Congressional agenda
 A desire to legislate
 Bipartisan
 Patent law reform is linked with job creation
 Harmonization with foreign patent laws
•57
Leahy-Smith
America Invents Act
 IP QUOTES
 “Through patent reform, we can cut the red tape
that stops too many inventors and
entrepreneurs from quickly turning new ideas
into thriving businesses—which holds our whole
economy back.” (President Barack Obama,
August 2, 2011, as quoted by the National
Journal)
•58
Leahy-Smith
America Invents Act
 IP QUOTES
 “Patent reform is about jobs…”
 “This bill will ensure that newly-issued patents
will be strong, high-quality patents that have
gone through rigorous review”
 “Reform will go a long way toward eliminating
lawsuit abuse” (U.S. Congressman Mike
Pence, (R) Indiana, Congressional Record,
June 23, 2011)
•59
Leahy-Smith
America Invents Act
 IP QUOTES
 "There will be heightened uncertainty for the
rest of the decade," said Paul Michel, a
retired judge of the U.S. Court of Appeals for
the Federal Circuit, in evaluating the
provisions of the new legislation. "The bill
makes fundamental changes, and many
sections are poorly written and ambiguous."
•60
Leahy-Smith
America Invents Act
 The Act in many people’s eyes
•61
Leahy-Smith
America Invents Act
 37 Sections
 General Topics







PTO Fees & Funding
Substantive Patent Law
PTO Practice & Operations
Post-Grant PTO Proceedings
Litigation
Special Interest Legislation
Studies
•62
Leahy-Smith
America Invents Act
Substantive Patent Law
 Change from a first to invent system to a
first inventor to file system
 Prior art exceptions
 A broadened scope of patent-defeating
prior art
 Broadened Prior User Rights provisions
•63
Leahy-Smith
America Invents Act
 March 16, 2013 (18 months from
enactment)
 “First inventor to file” replaces “First
to invent” system
 Priority based on application filing
dates
•64
Leahy-Smith
America Invents Act
 The First Inventor to File System
 The Act omits interference and prior art
provisions of current law, relating to an
invention previously made by another
inventor
 Patent interferences abolished, with
transition provisions
 Derivation proceedings available before
the renamed Patent Trial and Appeal
Board
•65
Leahy-Smith
America Invents Act
 The First Inventor to File System
 Race to the Patent Office
 Two paths
 File first (assuming nobody makes a public
disclosure of the invention before you file the
application)
 Be first to publicly disclose the invention and
then file within one year (assuming nobody files
an application on the invention before your
public disclosure
 CAREFUL, CAREFUL, CAREFUL!!!
•66
Leahy-Smith
America Invents Act
 Whoever files a patent application first will be
entitled to a patent over another inventor who
later files an application on the same invention,
regardless of who was first to make the
invention.
 This applies to the situation where multiple inventors
independently invent the same invention.
 Eliminates patent interferences and court
determinations
 Less uncertainty
•67
Leahy-Smith
America Invents Act
 No concerns with conception, diligence,
reduction to practice, abandonment,
suppression, and concealment
 But: also eliminates the ability of an inventor to
swear his invention behind a prior art reference
with an effective date no more than one year
earlier
 The invention date simply has no significance under
the AIA
•68
Leahy-Smith
America Invents Act
 Old §102
 A person shall be entitled to a patent unless—
 (a) the invention was known or used by others in
this country, or patented or described in a printed
publication in this or a foreign country, before the
invention thereof by the applicant for patent, or
 (b) the invention was patented or described in a
printed publication in this or a foreign country or in
public use or on sale in this country, more than one
year prior to the date of the application for patent in
the United States, or
•69
Leahy-Smith
America Invents Act
 Old §102
 A person shall be entitled to a patent unless—
 (c) he has abandoned the invention, or
 (d) the invention was first patented or caused to be
patented, or was the subject of an inventor‘s
certificate, by the applicant or his legal
representatives or assigns in a foreign country
prior to the date of the application for patent in this
country on an application for patent or inventor‘s
certificate filed more than twelve months before
filing of the application in the United States,
•70
Leahy-Smith
America Invents Act
 Old §102
 A person shall be entitled to a patent unless—
 (e) the invention was described in — (1) an application for
patent, published under section 122(b), by another filed in
the United States before the invention by the applicant for
patent or (2) a patent granted on an application for patent
by another filed in the United States before the invention
by the applicant for patent, except that an international
application filed under the treaty defined in section 351(a)
shall have the effects for the purposes of this subsection
of an application filed in the United States only if the
international application designated the United States and
was published under Article 21(2) of such treaty in the
English language; or
•71
Leahy-Smith
America Invents Act
 Old §102
 A person shall be entitled to a patent unless—
 (f) he did not himself invent the subject matter sought to be
patented, or
 (g)(1) during the course of an interference conducted under
section 135 or section 291, another inventor …establishes,
…, that before such person’s invention thereof the invention
was made by such other inventor …, or (2) before such
person’s invention thereof, the invention was made in this
country by another inventor who had not abandoned,
suppressed, or concealed it. In determining priority of
invention under this subsection, there shall be considered not
only the respective dates of conception and reduction to
practice of the invention, but also the reasonable diligence
of….
•72
Leahy-Smith
America Invents Act
 New §102
(a) What is prior art
 public disclosures
 patent filing disclosures
(b) Exceptions
(c) Joint Research Agreement situations
(d) Effective prior art date for patents and
published applications
•73
Leahy-Smith
America Invents Act
 35 U.S.C. §102 Conditions for patentability;
novelty
(a) A person shall be entitled to a patent unless –
(1)The claimed invention was patented, described in a
printed publication, or in public use, on sale, or otherwise
available to the public before the effective filing date of
the claimed invention, or
(2)The claimed invention was described in a patent
issued under section 151, or in an application for patent
published or deemed published under section 122(b), in
which the patent or application, as the case may be,
names another inventor and was effectively filed before
the effective filing date of the claimed invention.
•74
Leahy-Smith
America Invents Act
 New 102(a) compared to current §102(b)
35 U.S.C. 102 Conditions for patentability; novelty
(a) A person shall be entitled to a patent unless –
(1) the claimed invention was patented, or
described in a printed publication, in this or a
foreign country or in public use, or on sale in this
country, or otherwise available to the public more
than one year prior to the date of the application for
patent in the United States before the effective filing
date of the claimed invention, or
•75
Leahy-Smith
America Invents Act
Current Law Compared to New
Subject
Current (Old) Law
AIA (New) Law
Prior Art
Public Use
In this country
(§102 (a & b))
Anywhere
(§102(a)(1))
One Sale
In this country
(§102(b))
Anywhere
(§102(a)(1))
Patented or
Published
Patented or published
more than one year
prior to U.S. filing date
(§102(b))
Patented or published before the effective
filing date (§102(a)(1))
Other
Or otherwise available to the public before
the effective filing date (§102(a)(1))
•76
Leahy-Smith
America Invents Act
 Prior Art
 Prior use and on sale activities:
 No longer would be limited to “in this country”; and
 “On sale” would still include offers for commercial
sale (literally broader than many other countries’
prior art laws), and
 Will applicants’ and third party offers, sales and
uses, which do not reveal the claimed invention, be
considered prior art?
 Unclear
•77
Leahy-Smith
America Invents Act
 Prior Art
 The basic novelty provision: Section 102(a)(1)
 “A person shall be entitled to a patent unless-(1) the claimed invention was patented,
described in a printed publication, or in public
use, on sale, or otherwise available to the
public before the effective filing date of the
claimed invention”
•78
Leahy-Smith
America Invents Act
 Prior Art
 “otherwise available…”
 ???
 Legislative history suggests the AIA was
intended to overrule Metallizing Engineering
 Apparently meant to
 clarify the broad scope of relevant prior art
 emphasize the fact that it must be publicly
accessible
•79
Leahy-Smith
America Invents Act
 Prior Art
 “otherwise available…”
 Places a public availability standard on the
definition of all prior standard.
 Example
 Q uses secret process X to make product Y (cannot
reverse engineer)
 Sells Y for 15 years
 Files patent application on process X.
•80
Leahy-Smith
America Invents Act
 35 U.S.C. 102 Conditions for patentability;
novelty
(a) A person shall be entitled to a patent unless…
(2) The claimed invention was described in a
patent issued under section 151, or in an
application for patent published or deemed
published under section 122(b), in which the
patent or application, as the case may be,
names another inventor and was effectively
filed before the effective filing date of the
claimed invention.
•81
Leahy-Smith
America Invents Act
§102(d) PATENTS AND PUBLISHED APPLICATIONS
EFFECTIVE AS PRIOR ART. –For purposes of determining
whether a [U.S.] patent or application . . . Is prior art to a claimed
invention under subsection (a)(2), such patent or application shall
be considered to have been effectively filed, with respect to any
subject matter described in the patent or application –
–(1) if . . . (2) does not apply, as of the actual filing date of the
patent or the application . . .; or
–(2) if the patent or application for patent is entitled to claim a
right of priority. . . or the benefit of an earlier filing date . . .,
based upon 1 or more prior filed applications for patent, as of
the filing date of the earliest such application that describes
the subject matter.
•82
Leahy-Smith
America Invents Act
 What?
 Expanded scope of prior art
 U.S. patents and published patent applications of
other persons “effectively filed before the effective
filing date of the claimed invention” will be included in
the prior art.
 “Effectively filed” includes foreign priority dates
 The priority date will be the effective date for both
novelty and obviousness
 More broad than in many other countries
•83
Leahy-Smith
America Invents Act
 Deemed published means
 §374. Publication of International Application
 The publication under the treaty defined in
section 351(a) of this title, of an international
application designating the United States shall
be deemed a publication under section 122(b),
except as provided in sections 102(e) and 154(d)
of this title.
•84
Leahy-Smith
America Invents Act
 What is the prior art date
•85
Leahy-Smith
America Invents Act
 What is the prior art date
•86
Leahy-Smith
America Invents Act
 Impact of new §102(d)
 Some claims patentable in EPO not possible in
United States
 Claims may be obvious in US that are not in EPO
 More translations necessary
 Granted patents subject to validity attack in
court on issues not discoverable by USPTO
(e.g. prior use or sale in foreign country)
•87
Leahy-Smith
America Invents Act
 Exceptions for Applicants
 Personal Grace Period
 Exceptions from Prior Art
 Applicant’s own “disclosures” within 1 year
before the “effective filing date” (first priority
date) of a U.S. application
 Includes Applicants’ own publications
 Grace period extends to cases claiming foreign
priority
•88
Leahy-Smith
America Invents Act
35 U.S.C.§102(b)(1)
(b) EXCEPTIONS. –
(1) DISCLOSURES MADE 1 YEAR OR LESS
BEFORE THE EFFECTIVE FILING DATE OF
THE CLAIMED INVENTION. –A disclosure made
1 year or less before the effective filing date of a
claimed invention shall not be prior art to the
claimed invention under subsection (a)(1) if –
•89
Leahy-Smith
America Invents Act
§102(b)(1) (cont’d) –two exceptions
(A) the
disclosure
was made by
the inventorthe
or joint
The
public disclosure
represents
inventor or by another
whoown
obtained
inventors
work.the subject matter
disclosed directly
or indirectly
from the inventor or a
--a personal
exception-joint inventor (disclosure is inventor‘s own work); or
(the existing U.S. grace period)
(B) the subject matter disclosed had, before such
disclosure, been publicly disclosed by the inventor or
subsequent
anyone
is
aAjoint
inventor or disclosure
another who by
obtained
theelse
subject
not prior
art with
respect
to subject
matter
matter
disclosed
directly
or indirectly
from the
inventor
or in
a joint
inventor (“first
to publish”
provision).
an inventor’s
earlier
public disclosure.
This is the “first to publish” system.
•90
Leahy-Smith
America Invents Act
 35 U.S.C. §102(b)(1)
 Essentially defines what is not prior art under
§102(a)(1).
 Inventor has one year grace period for inventor‘s
own disclosures (or disclosures obtained from the
inventor).
 §102(b)(1)(B) allows inventor to avoid independent
3rd party disclosures by disclosing the invention with
an earlier date.
 BUT, inventor‘s benefit is limited to identical
disclosure
 So that independent 3rd party could damage
inventor with obvious variation.
•91
Leahy-Smith
America Invents Act
 102(b)(1)
 Obvious variation disclosed by third party
 A discloses X
 B reads A’s disclosure of X and discloses
expanded X + Y
 A then files patent application claiming X
 If X is obvious in view of X + Y, then A‘s
patent application is not patentable
•92
Leahy-Smith
America Invents Act
 102(b)(1)
 Personal Grace Period
 Is a public use or “on sale” activity a
“disclosure” for grace period purposes?
 Act is not clear
•93
Leahy-Smith
America Invents Act
35 U.S.C. §102(b)(2)
(2) DISCLOSURES APPEARING IN
APPLICATIONS AND PATENTS – A
disclosure
shall
not
be
prior
art
to
a
claimed
Defines three exceptions to
invention
under in
subsection
(a)(2) if –
disclosure
a patent disclosure
being prior art
•94
Leahy-Smith
America Invents Act
 three exceptions
 (A) the subject
matter disclosed
The inventors
own work was
obtained directly or indirectly from the
inventor or joint
inventor
(§102(b)(2)(A))
•95
Leahy-Smith
America Invents Act
 three exceptions
 (B) The subject matter disclosed had,
before
such
subject
matter
was
Earlier patent filings of others to the
effectively
filed
under
subsection
extent of inventors public disclosures
(a)(2),
publicly
disclosed
by the
thatbeen
precede
those
patent filings
inventor or a joint inventor or another
who obtained the
subject matter
(§102(b)(2)(B))
disclosed directly or indirectly from the
inventor or a joint inventor (―first to
publish‖ provision);
•96
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America Invents Act
 three exceptions
 (C) The subject matter disclosed and
the claimed
invention,
not
later
than
The inventor’s co-workers and
the effective
date
of
the
claimed
research collaborators patent
invention, were owned
filings by the same
person or subject to an obligation of
assignment to (§102(b)(2)(C))
the same person
(common ownership).
•97
Leahy-Smith
America Invents Act
 AIA did not create a “first to publish” system
 Rely on Grace Period to your peril!
 Best strategy is to obtain an early filing date
(and not rely on grace period).
 Grace period protection is only available for the
identical scope of the inventor‘s early public
disclosure
 3rd party can disclose obvious variants that might
defeat later patent application filing by inventor.
 And patent rights around the world are lost by
publishing prior to filing.
•98
Leahy-Smith
America Invents Act
Strategy/Actions
 More important to get earliest filing date to avoid
expanded prior art
 Speed up in-house invention disclosure and
preparation process
 Serial filing of provisionals to secure early
dates for subject matter.
 Prior art/validity searches will must consider
new areas of potential prior art.
 Need to consider “new” prior art for in-licensed
technology (university technology in particular)
•99
Leahy-Smith
America Invents Act
 Joint Research Agreements/New §102(c)
 §102(c) defines common ownership to
qualify for prior art exception under
102(b)(2)(C)
 3 requirements
 Claimed invention resulted from JRA activities.
 Patent application amended to name JRA
parties.
 JRA in effect on or before effective filing date
•100
Leahy-Smith
America Invents Act
 Joint Research Agreements
 Company A invents M
 Company B (having some collaboration with
Company A) invents broader genus LMN.
 Company B and Company A sign JRA
before filing patent application claiming LMN
 Company A invention M is not prior art.
•101
AIA: Section 3(n)(1)
 …(n) EFFECTIVE DATE.—
 (1) IN GENERAL.—Except as otherwise provided in this section,
the amendments made by this section shall take effect upon the
expiration of the 18-month period beginning on the date of the
enactment of this Act, and shall apply to any application for
patent, and to any patent issuing thereon, that contains or
contained at any time—
 (A) a claim to a claimed invention that has an effective filing date
as defined in section 100(i) of title 35, USC, that is on or after the
effective date described in this paragraph; or
 (B) a specific reference under section 120, 121, or 365(c) of title
35, United States Code, to any patent or application that contains
or contained at any time such a claim.
•102
AIA: Section 3(n)(1)
 Effective Date Complexity and Confusion (§
3(n)(1))
These provisions will apply to any application or patent
issuing thereon that contains or contained at any time:
a) a claim to a claimed invention that has an effective filing
date that is on or after March 16, 2013, or
b) a specific reference under §§ 120, 121, or 365(c)
(continuation, divisional, international, or national stage)
to any patent or application that contains or contained at
any time such a claim
•103
AIA: Section 3(n)(1)
 Effective Date Complexity and Confusion (§
3(n)(1))
 Once under new law, no swearing behind etc.
 Raises transition issues
•104
AIA: Section 3(n)(1)
 Which Law for Your Application?
 Depends on the effective filing date and support for the
claims in the application
 New law will apply to any application “that contains or
contained at any time” a claim with an “effective filing date”
after March 16, 2013
March 16, 2013
File Provisional
Application
File Non-provisional
Application adding
disclosure,
examples, and
claims
•105
AIA: Section 3(n)(1)
 Applications forever infected by claim with post
March 16, 2013 effective date
New subject matter/claim situation
CIP US Application
#2 filed; #1
US application
abandoned (new law)
#1 filed
March 1,
2012
March 18,
2013
May 15,
2014
Adds Claim 2 directed
to Embodiment #2 (no
priority in Application #1)
Claim 2 is cancelled,
Claim 1 remains
•106
AIA: Section 3(n)(1)
 That “contains or contained at any time”
US Provisional
Application
August 10,
2012
US Nonprovisional
Application
(new law)
August 6,
2013
Office Action with
rejection of claims
under Section 112
Claims amended to
overcome Section 112
rejection
No new matter added in non-provisional
•107
AIA: Section 3(n)(1)
Transition Issues
 Avoid mixing pre-AIA and post-AIA
(Mar. 16th 2013 priority) claims in one
application!
 “Mixing” brings in prior art from both pre-AIA and
post-AIA
 Subject to pre-AIA §102(g) prior inventions and
cannot prove earlier date of invention to remove
prior art under pre-AIA §102(a) or §102(e)
 Subject to all post-AIA prior art (expanded)
•108
AIA: Section 3(n)(1)
Transition Issues
 If pre-AIA and post-AIA claims are
necessary, keep the claims in separate
applications
 File first US application with only pre-AIA
claims
 Then file separate application with only postAIA claims
•109
AIA: Section 3(n)(1)
Transition Issues
 Preserving First to Invent
 File non-provisional applications early –
before March 16, 2013
 New disclosure, examples, and claims
•110
AIA: Section 3(n)(1)
Transition Issues
 Preserving First to Invent
 Add new matter (disclosure, examples,
claims) in CIP applications
 File continuations before 16-March-2013 for
pending important applications
 Avoid mixing claims having different priority
dates during the transition time
•111
AIA: Section 3(n)(1)
Transition Issues
 Preserving First to Invent
March 16, 2013
File Provisional
Application
File CIP
File Nonprovisional
Application (no
new disclosure)
•112
AIA: Section 3(n)(1)
Transition Issues
 Preserving First to Invent
 Advance prosecution to obtain allowable
subject matter in most important cases
 Use Patent Prosecution Highway
 Use Prioritized Examination ($4,800 Fee)
 Secure narrower claims now
 File continuations
•113
Leahy-Smith
America Invents Act
Impact
 May put pressure on those with limited
patent budgets
 Little or no change to large company
strategies
 Already had international focus
 Need to consider the timing of their patent
filings
 Heightened diligence to analyze priority
rights when in-licensing
•114
Leahy-Smith
America Invents Act
 Derivation Proceedings (§ 135)
 Someone derives invention from first-todisclose inventor and files first
 Must prove derivation
 Timing
 Cost
 Complexity
•115
Leahy-Smith
America Invents Act
 Other changes





Prior User Rights
Prioritized Examination
Opinions of Counsel
Special Interest Provisions
New Post Grant Proceedings
•116
Leahy-Smith
America Invents Act
 Prior User Rights
 The prior user defense would be expanded
to cover commercial use of the subject matter
of a patent in the United States
 But: this defense will not apply where the subject
matter of the patent was developed pursuant to a
federal government funding agreement, or by a
nonprofit institution of higher education or an
affiliated technology transfer organization that did
not receive private funding in support of that
development.
•117
Leahy-Smith
America Invents Act
 Prior User Rights
 Provides trade secret owners and other alleged
infringers with the “prior user defense” against
patent infringement claims for all inventions if the
trade secret owner or other accused infringer can
demonstrate internal commercial use (or other
commercial uses) of the subject matter at issue in
the patent infringement claim at least one year
prior to the effective filing date of the claimed
invention.
•118
Leahy-Smith
America Invents Act
 Prior User Rights
 AIA establishes prior user rights as a defense
 Right is personal, transferred only as part of good faith
assignment of entire business
 Commercial use one year prior to patent filing or public
disclosure that is exception to 102(b)
 Includes internal commercial use
 Clear and convincing evidence standard
•119
Leahy-Smith
America Invents Act
 Prior User Rights
 Company A invents “X” decides not to seek
patent protection for “X” and instead elects to
protect the invention as a trade secret.
 Independently, Company B invents “X” but
Company B elects to file and prosecute a
patent application resulting in a patent for “X.”
 Consider trade secret protection
•120
Leahy-Smith
America Invents Act
Prioritized examination:
 Covers all patent applications and technologies
 Requirements:
 $4,800 fee for filing request for prioritized examination of nonprovisional application
 Does not include filing, search, examination fees, excess claims and pages
fees, processing and publication fees
 Fee reduced 50% for small entities
 Application limited to 4 independent claims or 30 total claims
 Limited to 10,000 requests per fiscal year
•121
Leahy-Smith
America Invents Act
 Lack of opinion of counsel cannot be used as
evidence of willfulness or inducement
 Stronger than existing case law (i.e., no adverse
inference)
 Extends to inducement as well
•122
Leahy-Smith
America Invents Act
 Special Interest Provisions
 Priority examination for technologies important
to the national economy or competitiveness
 Pro bono program to assist financially underresourced independent inventors and small
businesses
 Transitional program for covered business
method patents
 Certain tax strategies within the prior art
•123
Leahy-Smith
America Invents Act
 Post Grant Proceedings
 Bottom Line
 PTO and courts have more bullets to
refuse/invalidate patents
 More options to contest patents
 Not clear whether public use falls within grace
period
 New category of prior art “otherwise available
to the public” undefined
 New challenge provisions are costly
•124
Leahy-Smith
America Invents Act
 Bottom Line
 Impact on
 Quality
 Trolls
 Easier to challenge
 Large damage awards
 Business methods patents
 PTO speed/efficiency
•125
Leahy-Smith
America Invents Act
 Take-aways
 Be much more aware of competitor activities
 Commercialization
 Patent
 Early filing more important
 Plan as early as possible
 (Multiple) provisional applications
 First-to-file may have little impact on
companies that have taken a global approach
to patenting
•126
Leahy-Smith
America Invents Act
 Take-aways
 Pay attention to disclosures, public use, and
offers for sale
 Universities must watch publications more
closely
 Consider trade secrets
 Consider “Pro bono” program
•127
Leahy-Smith
America Invents Act
 Notebooks




Continue to be relevant
Valuable history of work and activities
Potential evidence in derivation proceedings
Potential evidence in prior commercial use
defense
 Corroboration (co-signature) not necessarily
needed, but strengthens evidentiary proof
•128
Answers
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
Nosubject.
subsequently administered to said
 Patentable subject matter?
•129
Answers
An isolated DNA coding for a BRCA1
polypeptide, said polypeptide having the
amino acid sequence set forth in SEQ ID
NO:2.
Yes
 Patentable subject matter?
But Stay Tuned
•130
Answers
A method for detecting a germline alteration in a BRCA1
gene, said alteration selected from the group consisting of
the alterations set forth in Tables 12A, 14, 18 or 19 in a
human which comprises analyzing a sequence of a BRCA1
gene or BRCA1 RNA from a human sample or analyzing a
sequence of BRCA1 cDNA made from mRNA from said
human sample with the proviso that said germline alteration
is not a deletion of 4 nucleotides corresponding to base
numbers 4184-4187 of SEQ ID NO:1.
No
 Patentable subject matter?
•131
Answers
A method for screening potential cancer therapeutics which
comprises: growing a transformed eukaryotic host cell
containing an altered BRCA1 gene causing cancer in the
presence of a compound suspected of being a cancer
therapeutic, growing said transformed eukaryotic host cell in
the absence of said compound, determining the rate of growth
of said host cell in the presence of said compound and the
rate of growth of said host cell in the absence of said
compound and comparing the growth rate of said host cells,
wherein a slower rate of growth of said host cell in the
Yes
presence of said compound is indicative of a cancer
therapeutic.
 Patentable subject matter?
•132
Answers
 Researcher signs agreement agreeing to assign
rights in his inventions to University
 Researcher later assigns his rights in Invention
Company owns invention
X to Company
 Who owns the patents covering Invention X?
 University? Company?
Federal funding does not change
 Does it matter if work resulting in Invention X was
answer
federally funded research under Bayh-Dole?
•133
Answers
 Is Bill’s invention patentable?
Amy makes a
sale in Korea
Bill files
Amy’s sale is not prior art
 Under old law?
because not in U.S.
 Under new law? Amy’s sale is now prior art
•134
Answers
 Who gets the patent?
Amy
conceives
Amy reduces to
practice
Bill conceives
 Under old law?
 Under new law?
Amy files
Bill RTP
Bill Files
First to invent: Amy can win
First inventor to file: Bill wins
•135
Answers
 Is the public use prior art?
Amy uses
invention
publicly in Italy
March 19,
2013
Amy files
March 18,
2014
No, because public use was
less than one year from filing
•136
Answers
 Is the disclosure by Bill prior art to Amy?
Amy
discloses X
March 17,
2013
Bill sees and
discloses X
Amy files
April 21,
2013
June 17,
2013
No. §102(b)(1)(B)
Provided Bill’s disclosure is identical
•137
Answers
 Is Amy’s publication prior art under new law against Bill’s
Yes, under § 102(a)(1)
application?
 Is Bill’s application prior art against Amy under new law?
No, not if identical to Amy’s disclosure (§ 102(b)(1)(B))
less than one year
Amy
publishes
Bill files Application #1
(independent from Amy)
Amy files
Application #2
Application #1 publilshes
•138
The End
Thank you
Steven J. Sarussi
(312) 913-2136
[email protected]
•139