Professor Margo A. Bagley University of Virginia School of Law

tanktherapistBiotechnology

Oct 23, 2013 (3 years and 11 months ago)

82 views

Professor Margo A. Bagley

University of Virginia School of Law

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)



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)

Examples of Trademarks



Word (COKE, YAHOO!, HOME DEPOT)



Name (RALPH LAUREN, KATE SPADE)



Symbol/Logo


Container/product
Shape

Examples of Trademarks



Packaging


Sound


Smell


Building Design


Color

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 . . .”

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

Greta Burkholder

Gene Trademark Disputes


POK family of genes called “
Pokemon

(2001)


Fly gene “Velcro” alternative name
required (1993)

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)



Copyright Rights


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.

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)



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


Patent Features Cont.

-
Some reasons why patent cannot be
practiced by owner:


Illegality


Blocked or dominated


Lack FDA approval

13

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

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)

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



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

18


Eligibility and Patentability

Biotechnology


Computer Implemented inventions


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

Sample claim types


“An isolated DNA comprising . . .”


“A method for determining a
germline

alteration in a BRCA1 gene . . .”


“An apparatus for . . .”

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

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

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

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



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)

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)

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

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?

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.”

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.”


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.

32

Laboratory Corp. v. Metabolite

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
.

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.

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

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

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

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


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

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

Utility


Normally low threshold, some useful
purpose is generally sufficient


Applicant must assert a
specific
,
substantial
, and
credible

utility (USPTO
Examination Guidelines 2001)

40

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

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”

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

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

Claim Elements

45

Meat Product

2 Slices of Bread

Edible Salad

Cheese

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.

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.

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.

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.

Novelty


Two Important Dates:



Before Applicant’s
invention

date


More than one year before Applicant’s
filing

date

50

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

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

International Patent Law


No global patent


Rules vary by
country


Some treaties aid
multi
-
country filing

53

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

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

56

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

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.espacenet.com

(free technology database,
may be largest in the world)

58

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



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

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

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




Thank You!!!!