Professor Margo A. Bagley
University of Virginia School of Law

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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)

 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)

 Word (COKE, YAHOO!, HOME DEPOT)
 Name (RALPH LAUREN, KATE SPADE)
 Symbol/Logo
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Container/product
Shape

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Packaging
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Building Design

Color

Sound

Smell

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 . . .”

First FDA-approved DNA-based diagnostic testing kit for cystic fibrosis (Approved May 2005)
Greta Burkholder

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POK family of genes called “Pokemon”
(2001)
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Fly gene “Velcro” alternative name required (1993)

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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)

 the right to reproduce the copyrighted work;
 the right to prepare derivative works based upon the work;
 the right to distribute copies of the work to the public;
 the right to perform the copyrighted work publicly; and
 the right to display the copyrighted work publicly.





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)

1. What is a patent?
2.
-paper document
-property right granted by federal government (USPTO)
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
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Some reasons why patent cannot be practiced by owner:
 Illegality
 Blocked or dominated
 Lack FDA approval
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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.
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 Utility Patents: for useful, novel, and nonobvious 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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Type (machine, composition of matter, article of manufacture, process) “anything under the sun made by man”
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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

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

Biotechnology
Computer Implemented inventions
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(35 U.S.C. §§ 101)
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(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
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“An isolated DNA comprising . . .”
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“A method for determining a germline alteration in a BRCA1 gene . . .”
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“An apparatus for . . .”

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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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 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.
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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.
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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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
“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)

Diamond v. Diehr, USSC 1981)
A method of operating a rubber-molding press for precision molded compounds with the aid of a digital computer, comprising: providing said computer with a data base for said press including at least, 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), 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.
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 Hub and spoke system for administering mutual funds
Mutual
Fund
Mutual
Fund
Mutual
Fund
HUB
(Pooled fund)
Mutual
Fund
Mutual
Fund
 Business methods patentable as long as “useful, concrete, tangible “ result
Mutual
Fund
Mutual
Fund
Mutual
Fund
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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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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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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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Widely expected to limit patent eligibility of business method patents. USSC dismissed cert. as improvidently granted (DIG) June 22,
2006.
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From the Breyer Dissent (from dismissal as improvidently granted):
Neither does the Federal Circuit’s 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 figures —even though the result would seem useful, concrete, and at least arguably (within the computer’s wiring system) tangible. Gottschalk .
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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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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

 Correlation between drug metabolite levels and therapeutic efficacy/toxicity
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“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.”
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“The claims ‘wholly pre-empt’ use of the correlation such that the ‘practical effect is a patent on the [correlation] itself.’”
Greta Burkholder

 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

 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

 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

 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

 Normally low threshold, some useful purpose is generally sufficient
 Applicant must assert a specific , substantial , and credible utility (USPTO
Examination Guidelines 2001)
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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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 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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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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 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

2 Slices of Bread
Cheese
Edible Salad
Meat Product
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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.
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October 23 , 1980
Hamburger Weekly
Say Goodbye to Unmanageable Burgers
J. Fadrigo
ALL ELEMENTS ARE MET.
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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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.
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October 23 , 1980
Hamburger Weekly
Say Goodbye to Unmanageable Burgers
J. Fadrigo
All elements are NOT met.
?
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.
The publication does NOT anticipate the technology.
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 Two Important Dates:

Before Applicant’s invention date
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More than one year before Applicant’s filing date
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§ 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,
We already knew about that.
Date of invention Application Filed
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§ 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
May 6, 1997
Application Filed
May 7, 1998
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○ No global patent
○ Rules vary by country
○ Some treaties aid multi-country filing
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
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.
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 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
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No “PCT patent”
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 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).
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 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.espacenet.com
(free technology database, may be largest in the world)
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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
 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.
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Problems:
 Single patent examination, but applicant must still enter national phase
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Significant costs in national phase
(validation-translation only)
Patent must be enforced in each jurisdiction
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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”
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