Professor Margo A. Bagley University of Virginia School of
Law
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Intellectual Property Trade Secrets information that provides
economic advantage and is maintained as a secret. Term: perpetual
(if secret) Trademarks non-functional word, symbol, color, phrase,
etc. that can indicate source/avoid consumer confusion. Term:
perpetual (with use) Copyrights protect non-functional original
expression of an idea, e.g., musical, sculptural, literary,
graphic. Term: life of author + 70 years (95 yrs for work for hire)
Patents (Utility)- protects functional embodiments of ideas, e.g.
machines, processes, compositions, articles of manufacture. Term:
20 years from application filing date (Design and plant patents
also available)
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Trademarks Purpose: Identify source of goods or services,
protect goodwill of owner Duration: Perpetual, as long as used in
commerce Form: Adjective (Coca Cola brand soft drinks, Bayer brand
pain reliever)
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Examples of Trademarks Word (COKE, YAHOO!, HOME DEPOT) Name
(RALPH LAUREN, KATE SPADE) Symbol/Logo Container/product Shape
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Examples of Trademarks Packaging Sound Smell Building Design
Color
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Sound Marks NBC Status: renewed The mark comprises a sequence
of chime-like musical notes which are in the key of C and sound the
notes G, B, C, the G being the one just below middle C, and the C
being middle C...
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First FDA-approved DNA-based diagnostic testing kit for cystic
fibrosis (Approved May 2005) Greta Burkholder
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Gene Trademark Disputes POK family of genes called Pokemon
(2001) Fly gene Velcro alternative name required (1993)
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Intellectual Property Trade Secrets information that provides
economic advantage and is maintained as a secret. Term: perpetual
(if secret) Trademarks non-functional word, symbol, color, phrase,
etc. that can indicate source/avoid consumer confusion. Term:
perpetual (with use) Copyrights protect non-functional original
expression of an idea, e.g., musical, sculptural, literary,
graphic. Term: life of author + 70 years (95 yrs for work for hire)
Patents (Utility)- protects functional embodiments of ideas, e.g.
machines, processes, compositions, articles of manufacture. Term:
20 years from application filing date (Design and plant patents
also available)
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Copyright Rights the right to reproduce the copyrighted work;
the right to reproduce the right to prepare derivative works based
upon the work; the right to prepare derivative works the right to
distribute copies of the work to the public; the right to
distribute copies the right to perform the copyrighted work
publicly; and the right to perform the right to display the
copyrighted work publicly. the right to display
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Intellectual Property Trade Secrets information that provides
economic advantage and is maintained as a secret. Term: perpetual
(if secret) Trademarks non-functional word, symbol, color, phrase,
etc. that can indicate source/avoid consumer confusion. Term:
perpetual (with use) Copyrights protect non-functional original
expression of an idea, e.g., musical, sculptural, literary,
graphic. Term: life of author + 70 years (95 yrs for work for hire)
Patents (Utility)- protects functional embodiments of ideas, e.g.
machines, processes, compositions, articles of manufacture. Term:
20 years from application filing date (Design and plant patents
also available)
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Patent Features 1. What is a patent? -paper document -property
right granted by federal government (USPTO) 2. Nature of the
property right? -Negative right to exclude others from making,
using, selling, or offering to sell invention; term of exclusivity
limited to 20 years from date of filing; not affirmative right to
practice 12
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Patent Features Cont. - Some reasons why patent cannot be
practiced by owner: Illegality Blocked or dominated Lack FDA
approval 13
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Patent Features Cont. Nature of the property right Territorial
: must obtain patent in every country where protection is desired
Personal property : can be bought, sold, licensed, bequeathed, etc.
14
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Types of U.S. Patents Utility Patents: for useful, novel, and
non- obvious machines, processes, articles of manufacture or
compositions >7 million) Design Patents: for a new, original,
ornamental, and non-obvious design for an article of manufacture
(~400,000) Plant Patents: for new and distinct varieties of
asexually reproducing plants (~15,000)
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Patent Primer Type (machine, composition of matter, article of
manufacture, process) anything under the sun made by man Not
patentable: laws of nature, abstract ideas, natural phenomena
Utility useful Novelty new Nonobviousness to person of ordinary
skill in the art Description, enablement, best mode
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Incentives Time limited rights: Art. I, Sec. 8, cl. 8 of the
Constitution authorizes Congress to promote the progress of science
and useful arts, by securing for limited times... patents added the
fuel of interest to the fire of genius Abraham Lincoln
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18 Eligibility and Patentability Biotechnology Computer
Implemented inventions
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Patent Eligibility (35 U.S.C. 101) (Utility Patents): 35 U.S.C.
101 whoever invents... any new and useful process, machine,
manufacture, or composition of matter... may obtain a patent
therefor. Not patentable: laws of nature, abstract ideas, natural
phenomena 19
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Sample claim types An isolated DNA comprising... A method for
determining a germline alteration in a BRCA1 gene... An apparatus
for...
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21 Controversial biotech patent subject matter (patents on
life) Includes: Transgenic animals (animal suffering, de-valuing
life) Genetically modified plants (impact on farmers, the
environment, food supply) Genes/DNA (products of nature, building
blocks of life/research) Methods of cloning/cloned humans
(ownership of humans) Human embryonic stem cells (destroying human
embryos, hindering research) Mixed human/animal chimeras (human
dignity, species integrity) http://ipgeek.blogspot.com
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Patent Subject Matter Diamond v. Chakrabarty (1980): Patentable
subject matter includes anything under the sun made by man, living
or non-living. A living creature can be a manufacture or
composition of matter. 22
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DNA/Gene Patents Sample claim: A purified and isolated DNA
sequence consisting essentially of a DNA sequence encoding a
polypeptide having an amino acid sequence sufficiently duplicative
of that of erythropoietin to allow possession of the biological
property of causing bone marrow cells to increase production of
reticulocytes and red blood cells, and to increase hemoglobin
synthesis or iron uptake. (#4,703,008) A patent on a gene covers
the isolated and purified gene, but does not cover the gene as it
occurs in nature. 23
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24 DNA/Gene Patents H.R. 977: bill introduced in Congress
2/9/07 to prohibit patenting of human genetic material no patent
may be obtained for a nucleotide sequence, or its functions or
correlations, or the naturally occurring products it specifies
Concerns: Interference with research on diagnoses and cures (fears
of liability) Data withholding and secrecy among researchers
Patenting of diseases can impact timeliness of public health
testing
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Limits on Patent Subject Matter 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 = mc 2 ; nor could Newton have patented the law of gravity. Such
discoveries are manifestations of... Nature, free to all men and
reserved exclusively to none. Funk Bros. v. Kalo (USSC 1948)
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26 A method of operating a rubber-molding press for precision
molded compounds with the aid of a digital computer, comprising:
natural logarithm conversion table (ln), the activation energy
constant (C) unique to each batch of said compound being molded, a
constant (x) dependent upon the geometry of the particular mold of
the press, initiating an interval timer in said computer upon the
closure of the press for monitoring the elapsed time of said
closure, constantly determining the temperature (Z) of the mold at
a location closely adjacent to the mold cavity in the press during
the molding, constantly providing the computer with the temperature
(Z), providing said computer with a data base for said press
including at least, repetitively calculating in the computer, at
frequent intervals during each cure, the Arrhenius equation for
reaction time during the cure, which is ln v = CZ + x where v is
the total required cure time, repetitively comparing in the
computer at said frequent intervals during the cure each said
calculation of the total required cure time calculated with the
Arrhenius equation and said elapsed time, and Opening the press
automatically when a said comparison indicates equivalence. Diamond
v. Diehr, USSC 1981)
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27 State Street Bank v. Signature Financial CAFC (1998) Hub and
spoke system for administering mutual funds Business methods
patentable as long as useful, concrete, tangible result HUB (Pooled
fund) Mutual Fund Mutual Fund Mutual Fund Mutual Fund Mutual Fund
Mutual Fund Mutual Fund Mutual Fund
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28 Amazon.com 1-Click Patent U.S. Patent No. 5,960,411 (issued
Sept. 28, 1999). Claim 1 of the 411 patent reads: a method of
placing an order for an item comprising: under control of a client
system, displaying information identifying the item; and in
response to only a single action being performed, sending a request
to order the item along with an identifier of a purchaser of the
item to a server system; under control of a single-action ordering
component of the server system, receiving the request; retrieving
additional information previously stored for the purchaser
identified by the identifier in the received request; and
generating an order to purchase the requested item for the
purchaser identified by the identifier in the received request
using the retrieved additional information; and fulfilling the
generated order to complete purchase of the item whereby the item
is ordered without using a shopping cart ordering model.
Patent-eligible method or abstract idea?
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29 Laboratory Corp. v. Metabolite Claim at issue: 13. A method
for detecting a deficiency of cobalamin or folate in warm-blooded
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.
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30 Laboratory Corp. v. Metabolite Question Presented: Whether a
method patent setting forth an indefinite, undescribed, and
non-enabling step directing a party simply to correlate test
results can validly claim a monopoly over a basic scientific
relationship used in medical treatment such that any doctor
necessarily infringes the patent merely by thinking about the
relationship after looking at a test result.
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31 Laboratory Corp. v. Metabolite Widely expected to limit
patent eligibility of business method patents. USSC dismissed cert.
as improvidently granted (DIG) June 22, 2006.
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32 Laboratory Corp. v. Metabolite From the Breyer Dissent (from
dismissal as improvidently granted): Neither does the Federal
Circuits decision in State Street Bank help respondents. That case
does say that a process is patentable if it produces a "useful,
concrete, and tangible result." But this Court has never made such
a statement and, if taken literally, the statement would cover
instances where this Court has held the contrary. The Court, for
example, has invalidated a claim to the use of electromagnetic
current for transmitting messages over long distances even though
it produces a result that seems "useful, concrete, and tangible."
Morse. Similarly the Court has invalidated a patent setting forth a
system for triggering alarm limits in connection with catalytic
conversion despite a similar utility, concreteness, and
tangibility. Flook. And the Court has invalidated a patent setting
forth a process that transforms, for computer-programming purposes,
decimal figures into binary figureseven though the result would
seem useful, concrete, and at least arguably (within the computers
wiring system) tangible. Gottschalk.
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33 In re Bilski et al. Claim 1: A method for managing the
consumption risk of a commodity sold by a commodity provider at a
fixed price comprising the steps of: Initiating a series of
transactions... Identifying market participants for said commodity
Initiating a series of transactions.... Court: not patent eligible
under 35 USC 101. Process must be tied to a particular machine or
transforms an article.
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Analysis 1. Claim to a natural phenomena? If yes, then 2.
Preemption test to determine if the claim is only to the natural
phenomena Does it substantially/wholly preempt other uses of the
natural phenomena? Are there actual limitations on the use of the
natural phenomena? 3. Can the process be performed entirely in the
human mind? If so, it is obviously not tied to any machine and does
not transform any article into a different state or thing. Bilski
Greta Burkholder
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Prometheus Labs v. Mayo, WL878910 Correlation between drug
metabolite levels and therapeutic efficacy/toxicity The claims have
three steps: (1) administer the drug to a subject; (2) determine
metabolite levels; and (3) be warned that an adjustment in dosage
may be required. The claims wholly pre-empt use of the correlation
such that the practical effect is a patent on the [correlation]
itself. Greta Burkholder
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So, What Does this Mean? Are biotechnology process patents
patentable or not? Maybe Bilski gets rid of diagnostic patents
where the novelty is interpreting a specific concentration as an
indication of a disease. Greta Burkholder
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Diagnostic Patents After Bilski Method of diagnosing breast
cancer and compositions therefor A method of diagnosing breast
cancer in an individual aged younger than 41 or older than 54 is
provided. The method comprises obtaining a nucleic acid from the
individual and determining a nucleotide at a polymorphic site of
the nucleic acid Determining that the female has an increased risk
of having breast cancer or developing breast cancer when a TT or TO
is determined at SMBC.sub.--013; Patent No. 7,517,650 (filed March
3, 2006) Greta Burkholder
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Diagnostic Patents After Bilski Diabetes Gene The method of
claim 2 useful for determining whether a human subject has or is at
risk for developing diabetes mellitus comprising the steps of: a)
obtaining a sample from a subject, said sample comprising nucleic
acid molecules containing AGT gene; and b) detecting the presence
or absence of a genetic polymorphism in the gene of said subject,
wherein the presence of said genetic polymorphism identifies a
subject that has or is at risk for developing diabetes. Patent No.
7,374,884 (filed May 13, 2004) Greta Burkholder
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Potential Fixes for Diagnostic Patents? Look to Diamond v.
Diehr Incorporated mathematical formula, but entire process was
considered patent-eligible How? Add significant extra solution
activity Add limitations, like a treatment or a novel assay to
gather the relevant data Tie it to a machine or add transformation
(NOT just a mental process) Diamond v. Diehr Greta Burkholder
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Utility Normally low threshold, some useful purpose is
generally sufficient Applicant must assert a specific, substantial,
and credible utility (USPTO Examination Guidelines 2001) 40
Slide 42
41 In re Fisher (CAFC 2005) Claim to A substantially purified
nucleic acid molecule that encodes a maize protein or fragment
thereof comprising a nucleic acid sequence selected from the group
consisting of SEQ ID NO: 1 through SEQ ID NO: 5 rejected for lack
of utility Fisher did not know precise structure or function of
either the genes or the proteins encoded for by those genes at time
of filing
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42 In re Fisher (CAFC 2005) Asserted utilities (e.g., serving
as a molecular marker for mapping the entire maize genome) were
generally applicable to any EST; also, no known use for the
proteins produced as a result of ESTs; asserted uses are just a
laundry list of research plans
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43 In re Fisher (CAFC 2005) Substantial utility requires an
invention to have a significant and presently available benefit to
the public Specific utility requires a well-defined and particular
benefit to the public Credible Utility: whether a person of
ordinary skill in the art would accept that the invention is
currently available for its purported use
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Novelty: Anticipation Every element of claimed invention must
be found in a single* prior art reference (Strict Identity/Single
Reference Rule) Reference must be enabling to one of ordinary skill
in the art (teach how to make) Each claim of the patent is
considered separately * Some exceptions apply
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Claim Elements 45 Meat Product 2 Slices of Bread Edible Salad
Cheese
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Prior Art Reference I 46 Hamburger Weekly October 23, 1980 Say
Goodbye to Unmanageable Burgers - J. Fadrigo Finally, the
scientists at Acme Burger emerged from the depths of their
laboratories. With their resurfacing, the scientists brought the
latest in burger technology. This revolutionary new burger has an
edible salad component, meat product and cheese, all between the
two slices of bread. The edible salad component makes for a better
handling burger. Look for these new burgers to hit the market early
next year.
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Anticipation Analysis I 47 October 23, 1980 Hamburger Weekly
Say Goodbye to Unmanageable Burgers - J. Fadrigo Finally, the
scientists at Acme Burger emerged from the depths of their
laboratories. With their resurfacing, the scientists brought the
latest in burger technology. This revolutionary new burger has an
edible salad Component, meat product and cheese, All between the
two slices of bread. The edible salad component makes for a better
handling burger. Look for these new burgers to hit the market early
next year. ALL ELEMENTS ARE MET. Rejected
Slide 49
Prior Art Reference II 48 October 23, 1980 Hamburger Weekly Say
Goodbye to Unmanageable Burgers - J. Fadrigo Finally, the
scientists at Acme Burger emerged from the depths of their
laboratories. With their resurfacing, the scientists brought the
latest in burger technology. This revolutionary new burger has an
edible salad component and meat product, both, between the two
slices of bread. The edible salad component makes for a better
handling burger. Look for these new burgers to hit the market early
next year.
Slide 50
Anticipation Analysis II 49 October 23, 1980 Hamburger Weekly
Say Goodbye to Unmanageable Burgers - J. Fadrigo Finally, the
scientists at Acme Burger emerged from the depths of their
laboratories. With their resurfacing, the scientists brought the
latest in burger technology. This revolutionary new burger has an
edible salad component and meat product, both, between the two
slices of bread. The edible salad component makes for a better
handling burger. Look for these new burgers to hit the market early
next year. ? All elements are NOT met. The publication does NOT
anticipate the technology.
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Novelty Two Important Dates: Before Applicants invention date
More than one year before Applicants filing date 50
Slide 52
Novelty 102(a) 102 (a) A person shall be entitled to a patent
unless: - the invention was [publicly] known or [publicly] used by
others in this country, or - patented or described in a printed
[enabling] publication in this or a foreign country, - before the
invention thereof by the applicant for the patent, 51 Application
Filed We already knew about that. Date of invention
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Novelty 102(b) 102 (b) A person shall be entitled to a patent
unless: - 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 52 Application Filed
May 7, 1998 May 6, 1997
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International Patent Law No global patent Rules vary by country
Some treaties aid multi-country filing 53
Slide 55
Paris Convention Oldest IP Treaty, Two Key Provisions: National
Treatment: apply domestic law the same way to both foreigners and
domestic applicants Right of Priority: applicant has 12 months (6
months for design patents) from filing an application in their home
country to file an application on the same invention in another PC
country and claim benefit of the earlier date for prior art
purposes. 54
Slide 56
PCT (Patent Cooperation Treaty) Allows deferral of national
stage examination for up to 30 months from initial filing date Can
blanket designate multiple countries for one fee Can obtain
preliminary international search report and examination No PCT
patent 55
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56
Slide 58
Some Regional Patent Offices EPO: European Patent Office,
Grants patents for EU countries plus others EAPO: Eurasian Patent
Office, Grants patents for Russia and eight former territories
ARIPO: African Regional Industrial Property Organization, grants
patents for a group of English speaking African countries (similar
to EPO) OAPI: Organisation Africaine de la Propriete Intellectuelle
(OAPI), grants patents for group of French-speaking countries (no
national offices, still bundle of patents). 57
Slide 59
European Patent Convention Signed in 1973, entered into force
1977 Provides for the grant of European patents using a single
application procedure, results in a bundle of national patents
European Patent Organization (contracting states, EPO, legislative
body) www.epo.org www.epo.org www.espacenet.com (free technology
database, may be largest in the world) www.espacenet.com 58
Slide 60
European Patent Office European Patent Office: grants European
patents for the contracting states (EU states plus others), based
in Munich, offices in the Hague and Berlin as well www.epo.org
www.epo.org Received 140,700 patent applications in 2007 (up 3.9%),
granted 54,699 patents (down 12%) 34 member states: Austria,
Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Monaco, the
Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland, Turkey, Norway, Croatia, and the United
Kingdom. 59
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European Patent Office Problems: Single patent examination, but
applicant must still enter national phase Significant costs in
national phase (validation-translation only) Patent must be
enforced in each jurisdiction 60
Slide 62
European Patent Convention EPC Article 53: European patents
shall not be granted in respect of: (a) Inventions the publication
or exploitation of which would be contrary to ordre public or
morality... Implementing Rule 23(d): explicitly excludes processes
for cloning human beings; processes for modifying the germ line
genetic identity of human beings; uses of human embryos for
industrial or commercial purposes; processes for modifying the
genetic identity of animals which are likely to cause them
suffering without any substantial medical benefit to man or animal,
and also animals resulting from such processes 61