america invents act - Research at Carolina

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AMERICA INVENTS ACT: PATENT REFORM
AND INVENTORSHIP STANDARDS
Carolina Innovations Seminar
December 1, 2011
Mitchell S. Bigel
Myers Bigel Sibley & Sajovec, P.A.
Patent Lawyers
919-854-1400
[email protected]
www.myersbigel.com
ALSO KNOWN AS:
PATENT LAW IS HOT
PATENT LAW IS HOT
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Nortel Auctioned Patent Portfolio - $4.5B
Motorola Acquired by Google - $12.5B
Google Acquired Patents from IBM - $1B?
HP Acquired Palm - $1.2B
Kodak selling imaging patents to rescue itself
Pfizer facing massive losses as Lipitor patent set to
expire
• America Invents Act – First Major Patent Reform Bill
Since 1952
AGENDA
1. Patents vs. Copyrights for Software
2. America Invents Act
Patents vs. Copyrights for Software
Copyrights
Patents
Subject Matter
Tangible form of
Expression:
-Book
-Art
-Film
-Song
-Software
Invention:
-Process
-Machine
-Product
-Composition
-Improvement
Basic Requirements for
Protection
Original, tangible
expression
-Useful
-New
-Non-obvious
Nature of Rights
Prevent:
-Copying
-Distributing
-Adapting
-Displaying
-Performing
-Digital audio transmission
Prevent:
-Making
-Using
-Selling
-Offering for sale
-Importing
Created by
Fixation in tangible
medium
Granting a patent by
Patent Office
Duration
Life plus 70
20 years from filing
application
Is Software Copyrightable? Patentable?
What’s the Difference?
Is Software Copyrightable?
• Yes in all forms:
–
–
–
–
–
–
Documentation
Packaging
Screens
Source Code
Object Code
User Interface
Is Software Patentable?
• Yes in almost all forms:
– As a system
– As a method
– As a computer program product
Any software that has a practical application is potentially eligible for
patent protection.
Abstract Idea
Patent
Process
Procedure
Copyright
Discovery
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Idea
System
Method
Principle
Laws of Nature
A Real World Example
CLAIM 1
1. A diagnostic/prognostic system for a physical system comprising:
a plurality of sensors that are configured to repeatedly monitor variables of the
physical system during operation;
a first associative memory;
a novelty detection system that is responsive to the plurality of sensors and that is
configured to repeatedly observe into the first associative memory, states of associations among
the variables that are repeatedly monitored during a learning phase, that is further configured to
thereafter imagine at least one state of associations among the variables that are monitored
relative to the states of associations that are observed in the first associative memory, to identify
a novel state of associations among the variables, and that is further configured to determine
whether the novel state is indicative of normal operation or of a potential abnormal operation;
a second associative memory that includes therein associations of attributes of failure
modes of the physical system; and
a failure mode learning system that is responsive to the novelty detection system and
to the second associative memory and that is configured to imagine attributes of the novel state
relative to the associations of attributes of failure modes of the physical system to identify and/or
predict a potential failure mode of the physical system.
Inventorship/Authorship Standards
Who is an Inventor? One who contributes to
conception of claimed subject matter.
Who is an Author? One who translates an idea
into a copyrightable expression.
Two Examples
1. The “Real World” Example
2. Biotech Example – “Inventorship Horrors”
Inventorship Horrors:
Shawna C. Lemon, Ph.D.
Inventorship Horrors
• If the inventive entity listed on an issued patent is
incorrect and the patent cannot be corrected, the
patent can be deemed invalid.
• If the patent is invalid, it cannot be enforced.
How Inventorship Problems Arise
Two scenarios:
1. Naming a person who is not an inventor (misjoinder).
2. Failing to name a person who is an inventor (nonjoinder).
Who Is An Inventor?
• One who contributes to conception of claimed subject
matter.
• An exemplary case for how to determine inventorship:
Burroughs Wellcome Co. v. Barr Laboratories Inc.,
40 F.3d 1223 (CAFC 1994)
Burroughs Wellcome (cont’d)
Facts:
• BW tested AZT and several other compounds for antiretroviral activity in two
mouse retroviruses and subsequently prepared a draft patent application
covering treatment of persons infected with HIV by using AZT.
• NIH scientists developed a test using live HIV through a line of T-cell clones
that allowed the testing of compounds against HIV in humans.
• Two days prior to finalizing the draft patent application, BW sent a sample of
AZT under a code number to the NIH for testing in its cell line noting BW’s
results using the mouse retrovirus tests.
• The NIH found the sample (AZT) to be effective against HIV in its test and
advised BW who soon thereafter filed the patent application in the UK
naming the scientists at BW only as inventors.
Burroughs Wellcome (cont’d)
• In an infringement action, Barr Labs argued that the invention
was not made until the NIH testing was done and that the NIH
scientists who performed the tests were co-inventors. In
Barr’s view, up to that point, conception of the invention was
not complete.
• The court stated that each inventor had to contribute to the
conception of the invention and this was complete when only
ordinary skill is necessary to reduce the invention to practice
without extensive research or experimentation-- The draft
patent application was found to be ample evidence that the
invention had been made without the contribution of the NIH.
• If an omission had been made with deceptive intent, the
patents in question could have been invalidated.
Chou v. Univ. of Chicago
254 F.3d 1347 (CAFC 2001)
• An exemplary case of failing to name a person who is an
inventor (nonjoinder).
Facts:
• A graduate student and later post-doctoral research assistant
informed her supervisor that her discoveries should be patented.
• The supervisor had already filed a patent application directed to the
subject matter, began prosecuting the same and subsequently
licensed an issued patent without disclosing any of these actions to
Chou.
• The University did not follow up on its conclusions and statements
to Chou regarding its inventorship analysis.
Nonjoinder—Chou (Cont’d)
• On appeal, Chou was found to have standing to sue
for correction of inventorship.
• The court also reversed the dismissal of her claims of
fraudulent concealment, breach of fiduciary duty,
unjust enrichment and breach of implied contract
against her supervisor as well as fraudulent
concealment and breach of an express contract
against the University.
Take Home Tips
1.
Inventorship is not authorship.
2.
Inventorship does not necessarily equate to ownership.
3.
Take the time to assess inventorship early.
4.
Assess inventorship when filing a continuation
application, divisional application or canceling claims
upon amendment.
5.
Document, Document, Document!
•
Lab notebooks, witnesses
Hurdles in Obtaining a Patent
• Legal Standard
– Utility/Patentable Subject Matter
– Novelty - later
– Non-obviousness - later
Novelty
• Not in the public domain (“prior art”)
• Prior art can be patents, publications, grant
proposals, prior products, or any publicly
disclosed devices or processes
• Prior art can be your work or someone else’s
work
• An old idea, whose time has come, is not
patentable
Nonobviousness
• Not suggested by a prior art item or a combination of prior art
items to “one skilled in the art”
• Prior art can be patents, publications, prior products, or any
other publicly disclosed devices or processes
Invention
Difference: Obvious to one
skilled in the art?
Prior Art
Prior Art
Prior Art
Prior Art
Software IP at UNC
•
•
•
•
•
•
Patent Rights are Generally Owned by the University
Copyrights are Generally Owned by the Author
Works Subject to Both Copyright and Patent Protection (e.g., much software)
– if OTD determines to retain title to patent rights, the copyright also is
assigned to the university
OTD works with Office of University Counsel to determine ownership of
software
See the OTD Website http://research.unc.edu/otd_policies.html
Ask OTD
America Invents Act (AIA)
• First Major Patent Reform Bill Since 1952
– Far reaching
– Balanced between patentees and defendants
AIA – The Big Changes
• Switches to First-to-File System - later
• Expands Scope of Prior Art - later
• Expands Post-Grant Review of Issued Patents in
Patent Office
• Allows Third Party Submission of Prior Art
• Increases Patent Office Fees
Switch to First-to-File Patent System
to the
Effective March 16, 2013
First-to-Invent vs. First-to File
X Conceives
X Reduces to Practice
July
January
Y Conceives
March
Y Files Application
August
• First-to-Invent – X Wins Patent Rights
– Must prove diligence
• First-to-File – Y Wins Patent Rights
– Assumes no exception applies
X Files Application
November
Impact of First-to-File
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Race to Patent Office
Harmonizes Law with Other Countries
Less Uncertainty Regarding Priority
Eliminates Interference Practice
Adds Derivation Proceedings
Increases Scope of Prior Art
Impact of First-to-File
• Change Less Significant than Touted
– Foreign patents already governed by first-to-file
– Not a true first-to-file system
Practice Changes Based on Switch to First-toFile System
• Expedite Invention Disclosures
– Quicker submissions, approvals, and assignment to
outside counsel
• Quickly File Provisional Application
• Immediately Work to Prepare and File Regular
Application
Changes to What Qualifies as Prior Art
Effective March 16, 2013
Expansion of Prior Art
• Three Significant Expansions of the Prior Art
– Temporal
– Geographic
– Foreign Patents
Temporal Expansion of Prior Art
• First-to-Invent – Prior Art Based on
Conception or 1-Year Before Filing Date
Conception
Reduction to
Practice
Filing
Prior Art
Prior
PriorArt
Art
1-Year
Filing
• First-to-File – Prior Art Based on Filing Date
Filing
Prior Art
Exceptions May Reduce Impact
• 1-Year Grace Period for Inventor Disclosures
• Exceptions for Commonly Owned Patents and
Applications
Geographic Change to Prior Art
• Foreign Public Uses and Sales Now Prior Art
– Old Law
New Law
• Limited Impact as Use/Sale Art Hard to Find
• Most Likely to Come Into Play in Litigation Against
Foreign Corporations
Expansion of Foreign Patent Art
• Foreign Priority Dates Now Considered in
Determining if U.S. Patents are Prior Art
• Significantly Expands Universe of Prior Art
• First-to-File Magnifies Effect
– Cannot prove earlier invention
Expansion of Prior Art
• Three Significant Expansions of the Prior Art
– Temporal
– Geographic
– Foreign Patents
America Invents Act – Impact on
Universities
• Universities Rock!
• 75% Fee Discount for Micro Entities
– University Exception
• Prior Use Defense Expanded
– University Exception
Prior Use Defense Expanded
• Old Rule -- Secret Uses Not Prior Art
– Exception for business method patents
• Exception Expanded to Cover All Secret Uses
Practice Changes
• Expedite Invention Disclosure Process
– Submission, approvals, assignment to law firms
• Routinely File Quick Provisional
– Follow-up (3-months) with regular application
– Remember my “real world example”?
– Easier said than done for “unpredictable
technologies”
How to Handle the
“Unpredictable Technologies”
Karen A. Magri, Ph.D.
Unpredictable Technologies
• In general, chemical (pharmaceutical) and biotechnology
inventions are considered more unpredictable and therefore
more disclosure is required in the patent application.
• Patent office may request evidence that invention works as
claimed.
• Provisional applications: disclosure can be critical
– Determines priority date for claimed invention
– Heightened importance under the AIA (first to file, expansion of prior
art)
Disclosure Requirements
• Policy: the patent right should be
commensurate in scope with what the
inventor has given to the public
Must describe the invention:
– So that others can make and use
– To show that the inventors had “possession” of
the claimed invention
– Cannot patent a “mere wish or plan”
The Enablement Requirement
• Enablement: application must provide enough
guidance so that others skilled in the art can make
and use the invention
• Test: Can one skilled in the art practice the invention
without “undue experimentation”?
What is an Enabling Disclosure?
• Method of producing live nonpathogenic vaccines against any
RNA virus or retrovirus. Evidence presented with one
retrovirus (In re Wright)
– Court held the claims were not enabled. Disclosure not
commensurate in scope with claims.
• Invention directed to compounds for treating tumors.
Applicant presented evidence of anti-tumor activity in two
animal models.
– Court held that the claims were enabled. The animal models were
recognized as relevant tumor models. Clinical testing in humans not
required (In re Brana).
Written Description
• The application must provide a clear written
description of the invention so that those skilled in
the art will appreciate that, at the time of filing the
application, the inventor had possession of the
claimed invention.
• Can be difficult for unpredictable arts: heightened
disclosure requirement acts to limit claim scope.
U. of California vs. Eli Lilly,
119 F.3d 1559 (CAFC 1997)
• Patent claimed a cDNA encoding human insulin
• Application disclosed cDNA for rat insulin and a
method of identifying human cDNA based on rat
cDNA.
• Court invalidated claims on the basis of no written
description of the claimed human cDNA.
– Patent only described a “mere wish or plan”
– Cannot claim something by what it “does” rather than by
what it “is.”
Disclosure
Take Home Tips
1. Brainstorm your invention prior to filing
2. Describe as many ways of practicing your invention as
you can conceive in a concrete way
3. Describe broad, intermediate and narrow ways of
practicing invention
4. Describe “back up” positions in the application
Take Home Tips (cont’d)
5.
Provide more disclosure for unpredictable aspects
6.
Describe structural and functional characterization of
claimed compounds, nucleic acids, proteins and other
reagents
7.
Disclose representative number of examples
8.
Data in relevant animal models for claims to therapeutic
and diagnostic methods
AIA – The Big Changes
• Switches to First-to-File System
• Expands Scope of Prior Art
• Expands Post-Grant Review of Issued Patents in
Patent Office
• Allows Third Party Submission of Prior Art
• Increases Patent Office Fees
You may be thinking…
• How will AIA help American entrepreneurs
and businesses?
• How will AIA create new business and new
jobs?
• Who will benefit?
– Multinationals
– Patent lawyers
A great summary of AIA
www.myersbigel.com
[email protected]
Myers Bigel Newsletter on the Leahy-Smith
America Invents Act
AMERICA INVENTS ACT: PATENT REFORM
AND INVENTORSHIP STANDARDS
Carolina Innovations Seminar
December 1, 2011
Mitchell S. Bigel
Myers Bigel Sibley & Sajovec, P.A.
Patent Lawyers
919-854-1400
[email protected]
www.myersbigel.com
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