INTELLECTUAL PROPERTY 101
Biotechnology Patents
Christine R. Ethridge
© 2005 Kirkpatrick & Lockhart Nicholson Graham LLP
Boston – Dallas – Harrisburg – London - Los Angeles – Miami
Newark - New York - Pittsburgh - San Francisco -Washington DC
Intellectual Property 101: Summary of Presentation
I. Introduction
II. Procurement
A. Inventorship
B. Patentability
C. Prosecution
III. Exploitation
A. Ownership
B. Marketing
C. Licensing
IV. Enforcement
A. Infringement
B. Exemptions and Limitations
C. Remedies
D. Duty of Care
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I. Introduction:
Patent: What is it?
Pat·ent … 1. EXCLUSIVE RIGHT TO MARKET AN
INVENTION an exclusive right officially granted by a
government to an inventor to make or sell an invention.
(Microsoft) Encarta® World English Dictionary
Bloomsbury Publishing Plc. ©2005
NO!!
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Patent: What is it?
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A patent is a right granted by a
government for a limited period of time to
exclude others from making, using,
offering for sale, selling, or importing into
the granting country the subject matter
claimed in a patent.
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The right is granted in exchange for
disclosing to the public the details of the
invention.
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Patents: Historical Perspective
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Exclusive rights for certain valued skills and invention
have been granted by the heads of state throughout
history.
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As early as 300 B.C. there are written accounts of
grants of exclusive rights for innovation.
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In England, due to abuses associated with grants of
monopolies, Parliament passed in 1624 the Statute of
Monopolies which made monopolies illegal, except for
the limited privileges granted to the first inventor of any
manner of new manufacture.
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Patents: Historical Perspective
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The U.S. Constitution gives Congress the
power:
[to] promote the Progress of Science and useful
Arts by securing for limited Times to Authors
and Inventors the exclusive Right to their
respective Writings and Discoveries. (Article I,
Sec. 8, clause 8)
The first patent Act was passed in 1790.
The current Statute was enacted in 1952, but has
been amended several times.
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Patents:
Background of Biotech Patents
1873 – U.S. Patent No. 141,072 issued to Louis Pasteur for “yeast, free
from organic germs of disease, as an article of manufacture”.
1877 – U.S. Patent No. 197,612 issued to Cutler for vaccine prepared by
pulverizing pustules and mixing with lymph (Vaccinia).
1970’s - U.S. Patent Office adopted an administrative interpretation of the
law excluding patents on living matter.
1980 – U.S. Supreme Court, in a 5-4 decision, in Diamond v. Chakrabarty,
447 U.S. 303 (1980) ruled that claims to a bacterium containing two
stable energy generating plasmids, and an inoculation containing the
bacterium and a carrier were a composition of matter and an article of
manufacture under §101 of the Patent Act.
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Diamond v. Chakrabarty
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Diamond v. Chakrabarty, 447 U.S. 303 (1980)
The U.S. Supreme Court, in a 5-4 decision, held that the
organism was, as claimed, a “manufacture” or a “composition of
matter” within the meaning of 35 U.S.C. § 101.
Justice Burger, writing for the majority, quoted Thomas
Jefferson’s philosophy that “ingenuity should receive liberal
encouragement”, and the legislative history of the 1952 Patent
Act that statutory subject matter should “include anything under
the sun that is made by man.”
The inventor produced a new bacterium with markedly different
characteristics from any found in nature. The discovery was not
nature’s handiwork, but his own; therefore, it was patentable
subject matter under § 101.
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The Application: Types
ƒ Utility
– protects the way in which an invention is made,
how it is used or how it functions
ƒExpires 20 years from the effective filing
date, or, if filed before 6/8/95, the longer of 17 years
from issue or 20 years from the effective filing date.
ƒ Design
– protects new ornamental design for an article of
manufacture.
ƒExpires 14 years from date of grant.
ƒ Plant
– protects distinct and new plant varieties
ƒExpires 20 years from the effective filing date
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Format of Utility Application
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Specification
— Background (optional)
— Summary
— Brief description of the Drawings, if present
— Detailed description of the invention and how to
make and use it
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Claims – define the invention
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Drawings, if necessary to understand the invention
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Abstract
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Patent: What can it cover?
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process,
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machine,
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article of manufacture,
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composition of matter,
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any new and useful improvement of the
above
See 35 U.S.C. §101
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Patent Claims – Examples
(Process)
U.S. Patent No. 6,147,276 (Campbell and Wilmut)
1. A method of reconstituting a non-human mammalian
embryo, comprising
a. transferring the nucleus of a quiescent diploid
donor cell into a suitable enucleated recipient cell of
the same species, thereby obtaining a reconstituted
cell;
b. activating the recipient cell before, during or after
nuclear transfer;
c. incubating the reconstituted cell such that an
embryo develops.
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Patent Claims – Examples
(Machine)
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U.S. Patent No. 6,342,143 (Minden/Carnegie Mellon Univ.)
1. A sample retrieval apparatus comprising:
a support platform;
a support translation member for moving the support
platform to designated coordinates on X and Y axes;
a plurality of cutter members on the support platform;
a cutter translation assembly for moving a selected one
of the cutter members to designated positions on a Z axis,
said Z axis lying in a plane perpendicular to the support
platform; and,
a controller for designating the X, Y axis coordinates of
the support platform and the Z axis positions of the cutter
members.
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Patent Claims – Examples
(Article of Manufacture)
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U.S. Patent No. 4,736,866 to Leder et al. (The Harvard Mouse)
1.
A transgenic non-human mammal all of whose germ cells and somatic
cells contain a recombinant activated oncogene sequence introduced into said
mammal, or an ancestor of said mammal, at an embryonic stage.
6. The mammal of claim 1 wherein said oncogene sequence comprises a
coding sequence of a c-myc gene.
7. The mammal of claim 1 wherein transcription of said oncogene sequence is
under the control of a viral promoter sequence.
8. The mammal of claim 7 wherein said viral promoter sequence comprises a
sequence of an MMTV promoter.
9. The mammal of claim 7 wherein said viral promoter sequence comprises a
sequence of an RSV promoter.
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Patent Claims – Examples
(Composition of matter)
U.S. Patent No. 6,156,501 (Affymetrix)
1. A composition for analyzing interactions between
oligonucleotide targets and oligonucleotide probes
comprising an array of a plurality of oligonucleotide
analogue probes having different sequences, wherein
said oligonucleotide analogue probes are coupled to
a solid substrate at known locations and wherein
said plurality of oligonucleotide analogue probes are
selected to bind to complementary oligonucleotide
targets with a similar hybridization stability across
the array.
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Patent Claims – Examples
(Article of manufacture - Improvement)
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U.S. Patent No. 6,548,736 (Harvard Mouse 2)
1. A transgenic postnatal mouse whose genome is disrupted by
recombination at each 7B2 gene locus so as to produce a
phenotype, relative to a wild-type phenotype, comprising
absence of PC2 activity in the brain of said transgenic mouse.
8. A postnatal transgenic mouse, homozygous for a loss of
function mutation in each 7B2 gene, which loss of function
mutation is created by recombination with heterologous
nucleotide sequences, wherein said transgenic mouse has a
phenotype including at least one of hypoglycemia,
hyperproinsulinemia or hypercortisolism.
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II. Procurement:
Patents: On what terms?
In the United States, a patent will be granted on an
application filed by
(1) the first inventor of the claimed invention,
(2) if the invention falls within the scope of the subject
matter Congress has determined is deserving of patent
protection,
(3) if the invention is useful, novel and non obvious,
and
(4) if the invention is described in the manner required
by statute.
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Patents: Who is an Inventor?
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Inventorship Guidelines
— An inventor is a person who conceives an
invention claimed in a patent application or patent,
not someone who only reduces an invention to
practice.
— A person is not an inventor simply because he or
she is the boss, a friend, a deserving colleague or
employee, or a project financier, or because he or
she has toiled a complete lifetime developing an
invention conceived by another in an instant.
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Inventorship: Conception
Conception occurs when an inventor has a definite and
permanent idea of an operative invention, including
every feature of the subject matter sought to be
patented.
— Conception does not exist when the viability of the
invention is uncertain. Often experimentation is
needed to confirm the invention’s viability. In that
case, conception occurs at the same time the invention
is “reduced to practice.”
— Conception does not include suggesting to another a
problem and/or a desired result.
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Inventorship: Collaboration
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Conception can be collaborative and does not
require physical presence between
collaborators, or even that they discuss the
invention at the same time.
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Claim Utility and Subject Matter
35 U.S.C. §101
Whoever invents or discovers any
new and useful process, machine,
manufacture, or composition of
matter, or any new and useful
improvement thereof, may obtain a
patent therefor… .
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Novelty of Claims
§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
(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
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Novelty (continued)
(d) The invention was first patented or caused to be
patented,… by the applicant… in a foreign country prior
to the date of application for patent in this country on an
application for patent filed more than twelve months
before the filing of the application in the United States
(e) The invention was described in … an application
published by another filed in the United States before the
invention by the applicant … or a patent granted on an
application for patent by another filed in the United
States before the invention by applicant
(f) He did not himself invent the subject matter sought to be
patented
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Novelty (continued)
US: One Year Grace Period
Applications for patent in the United States
must be filed within one year of any of the first
offer for sale, first sale, the first public
disclosure or the first public use of the
invention.
Absolute Novelty Outside the United States
If patent protection outside the United States is
desired, then the US patent application has to
be filed before any of the foregoing events.
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Novelty (continued)
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Known is interpreted to mean “publicly known”.
Private or secret knowledge is not public. Woodland
Trust v. Flowertree Nursery Inc., 198 F.3d 1368 47
U.S.P.Q.2d 1363 (Fed. Cir. 1998).
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To anticipate a claim, a single reference which is
available to the public as prior art must contain,
expressly or inherently, all of the elements of the
claim. Orthokinetics, Inc. v. Safety Travel Chairs, Inc.,
806 F.2d 1565, 1 U.S.P.Q.2d 1081 (Fed. Cir. 1986).
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On Sale and Public Use Bar
Under § 102(b)
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§ 102(b) is intended to encourage prompt filing of
patent applications.
The term “on sale” includes offers to sell,
presentations or promotions for the purpose of a sale
or other activities intended to lead to a sale.
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An offer for sale may trigger § 102(b) even though
no details of the invention are disclosed and even
though the invention has not been reduced to practice,
or made.
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On Sale and Public Use Bar
Under § 102(b)
In Pfaff v. Wells Elecs. Inc., 525 U.S. 55 (1998), the U.S. Supreme
Court considered the applicability of the on sale bar when the invention
had never been reduced to practice. The court concluded that the bar
applies when two conditions are met before the critical date:
1.
the product must be the subject of a commercial offer for sale,
and
2.
the invention must be ready for patenting.
The latter point may be satisfied in at least two ways:
1.
reduction to practice, or
2.
preparation of drawings or other descriptions of the invention that
are sufficiently specific to enable a person skilled in the art to practice
the invention.
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On Sale and Public Use Bar
Under § 102(b)
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There is no exception even though the sale is made by
another who is not the inventor and who is not
authorized by the inventor to make the offer or sale.
Evans Cooling Systems, Inc. v. General Motors Corp.,
125 F.3d 1448 (Fed. Cir. 1997)
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A commercial use by the inventor, even if secret,
constitutes a bar under §102(b). A secret use by the
inventor of an invention for its intended purpose
triggers the public use bar. However, a secret
commercial use by one other than the inventor is not a
public use.
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Experimental Use Exception to Public Use Bar
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An experimental use is an exception to the public
use bar. City of Elizabeth v. American Nicolson
Pavement Co., 97 U.S. 126 (1877).
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Activities that are experimental, intended to test the
invention to see if it works for its intended purpose
are not public uses for purposes of § 102(b).
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Non-Obviousness of Claims
§103
A patent may not be obtained though the
invention is [novel], if the differences between
the subject matter sought to be patented and
the prior art are such that the subject matter as
a whole would have been obvious at the time
the invention was made to a person of
ordinary skill in the art to which the subject
matter pertains.
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Non-Obviousness (continued)
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In Graham v. John Deere & Co., 383 U.S. 1 (1966), the Supreme
Court held that, under 35 U.S.C. §103,
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“the scope and content of the prior art are to be determined;
differences between the prior art and the claims at issue are to be
ascertained; and the level of ordinary skill in the pertinent art are
resolved. Against this background, the obviousness or nonobviousness of the subject matter is determined. Such secondary
considerations as commercial success, long felt but unresolved
needs, failure of others, etc. might be utilized to give light to the
circumstances surrounding the original of the subject matter
sought to be patented. As indicia of obviousness or nonobviousness, these inquiries may have relevancy.”
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Non-Obviousness (continued)
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Whether a combination of the teachings of all
or any of the references would have suggested,
expressly or by implication, the claimed
invention; and
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Whether the claimed invention achieved more
than a combination of any or all of the
references suggested.
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Non-Obviousness (continued)
The CREATE Act
§103(c) of the Patent Statute was amended on December 10,
2004 by The Cooperative Research and Technology
Enhancement Act (CREATE Act). (S. 2192; Pub. L. No. 108-453)
The Act allows the sharing of confidential information among
research partners without creating a bar to patentability of
their joint inventions made as a result of activities within
the scope of the joint research agreement.
Under prior interpretations of §103, such secret information of
the other research partner could qualify as prior art to joint
inventions of collaborating Universities, the public sector
or private institutions.
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Things not to do before filing
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Publish manuscript, paper or thesis – beware of early
electronic publishing
Disclose invention in a presentation
Discuss with anyone without a confidentiality agreement
Offer for Sale or other commercial activity
Submit a non confidential grant application
All parties privy to invention (employees, research partners
and sales force) must be advised adequately of, and be
subject to, confidentiality requirements
Use Invention for its intended purpose.
Engage in Experimentation without meticulous record
keeping of activities and results
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Invention Disclosure Requirements
35 U.S.C. §112, 1st Paragraph
“The specification shall contain a written
description of the invention, and of the manner
and process of making it, in such full, clear,
concise, and exact terms as to enable any person
skilled in the art to which it pertains, or with
which it is most nearly connected, to make and
use the same, and shall set forth the best mode
contemplated by the inventor of carrying out his
invention.”
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Support For Claims (continued)
35 U.S.C. §112, 2d Paragraph
“The specification shall conclude with
one or more claims particularly
pointing out and distinctly claiming the
subject matter which the applicant
regards as his invention.”
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§112 Requirements
Disclosure and Claiming Requirements:
— Description of the Invention.
— Manner and Process of Making and Using the
Invention Sufficient to Enable One Skilled in
the Art to Make and Use the Claimed
Invention
— Best Mode
— Claiming with Particularity and Distinctness
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Written Description
To satisfy the written description
requirement, a patent specification must
describe the claimed invention in
sufficient detail that one skilled in the art
can reasonably conclude that the
inventor had possession of the claimed
invention at the time the application was
filed.
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How do you show possession of
the invention?
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By describing the claimed invention with all of its
limitations using: words, structures, figures,
diagrams, and formulas.
An applicant is not required to disclose every detail
of an invention.
The disclosure obligation varies with the maturity of
the art to which the invention pertains.
It is better to err on the side of over-inclusiveness
and over-description. The unacceptable alternative
is an unenforceable patent.
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Examples of Showing Possession
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Tests of the claimed composition to show its properties.
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For biomolecules, by identifying characteristics, such as a
sequence, structure, binding affinity, binding specificity,
molecular weight and length, unique cleavage by particular
enzymes, detailed restriction enzyme maps, isoelectric
points, and antibody cross-reactivity.
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For generic elements, by disclosure of a representative
number of species where the common attributes are either
known or identified in the specification.
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Sequence Listings
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For purposes of uniformity in patent documents and to
enable accurate classification and searching, information
provided about nucleic acid and amino acid sequences
must conform to internationally recognized standards.
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The Sequence Rules define a set of symbols and
procedures and other identifying information that are
mandatory for presentation of sequence data used in an
application, whether or not claimed.
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The Rules apply to all unbranched nucleotide sequences
with 10 or more bases and all unbranched, non-D amino
acid sequences with 4 or more amino acids.
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Enablement
“The specification shall contain a written
description … of the manner and process of
making [the invention], in such full, clear,
concise, and exact terms as to enable any
person skilled in the art to which it pertains, or
with which it is most nearly connected, to make
and use the same,..”
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Enablement (continued)
The test for enablement is whether one
reasonably skilled in the art could make
and use the full scope of the claimed
invention from the disclosures in the
patent, at the time the application was
filed, coupled with information known in
the art without undue experimentation.
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Enablement:
What is undue experimentation?
The test is not whether any
experimentation is necessary or even
complex, time consuming or
expensive – it is whether the
experimentation is undue.
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Enablement:
Correlation of Animal Models
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There must be correlation between in vivo or in
vitro animal model assays or treatments with the
claimed use.
If there is a known correlation of the disclosed
animal model to a particular human condition,
then an example using that animal model will
constitute a working example.
Without a known correlation, the example alone
does not correlate and therefore, is not enabling.
See, for example, the improved Harvard mouse
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Enablement: Deposit of Biological
Materials
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A deposit made in a recognized depository (for example,
the ATCC) of a viable biological material together with
as much information as is possible to permit verification
that the deposited material is in fact what is disclosed in
the application and to aid in the resolution of
infringement questions.
Includes bacteria, fungi, eukaryotic cells, plant tissue
cells and cell lines, hybridomas, plasmids, viruses and
seeds.
Replacements must be made if needed while application
is pending and after patent issues. Deposit must be
maintained for 30 years from the date of deposit and at
least 5 years after the last request for a sample.
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When Deposit Is Not Required
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Biological Materials need not be deposited if they are
known and readily available to the public.
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If the material and its natural location can be adequately
described so that one skilled in the art could obtain it
using ordinary skill, §112 is satisfied.
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Specification may adequately instruct on how to make the
biological material. Proof of ease of manufacture of
biological material is helpful. For instance, an example
may be provided showing a particular cell line was made
successfully on multiple occasions and/or multiple clones
meeting the claim were made in one experiment.
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Best Mode
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Must disclose the best way known by the
applicant of practicing the invention at the filing
date of the application.
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The requirement is the bargained for exchange
between the applicant and the government for
the right to exclude others.
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Cannot keep best way of practicing the
invention as a trade secret and also obtain a
patent.
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Where to File: Jurisdictions
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A patent is enforceable in the jurisdiction (country) in
which it is acquired.
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Each country has different laws, infringement statutes
and enforceability issues.
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Patents are available in countries world-wide.
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Patents may be obtained by filing directly in a
jurisdiction or by filing in an regional authority, and
later entering individual nations or sub-regional
authorities.
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Where to File: Jurisdictions
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The Paris Convention provides that one
application can claim priority to an earlier
application filed in a different member country
so long as the second application is filed within
one year of the first.
The Patent Cooperation Treaty provides a
unified means to file and prosecute an
application in a single jurisdiction and later enter
into national (or regional) prosecution.
Regional authorities - European Patent Office
(EPO), Eurasian and two African offices.
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US Utility Applications
Non-Provisional
Provisional
Claims required
No Claims necessary
(but recommended)
Filing fee is currently
Filing fee is
$1,000*(large entity); $500*( small)
$200 (large entity); $100 (small)
Will be examined and can mature
into patent
Will not be examined and expires
one year from filing.
*part of filing fee is for search ($200
(L)) and examination ($500 (L))
Non-provisional claiming priority
to the provisional must be filed
within one year.
Must satisfy invention disclosure
Must satisfy invention disclosure
requirements of §112, first paragraph requirements of §112, first
of Patent Statute
paragraph with respect to claims of
the eventual non-provisional
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Patents: US Prosecution
Exemplary progress in the US PTO
•File provisional (optional) or regular utility application
•Within one year of the first filing, convert the provisional
to a non-provisional and/or file a PCT or other foreign
applications
•Within 3 months of the non-provisional US filing, submit
an Information Disclosure Statement (IDS, err on side of
over-submission)
•After about 14 months from the non-provisional filing,
there will be an Office Action
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US Prosecution: Office Actions
• Restriction requirement – Examiner says you are
claiming more than one invention, pick one
invention for prosecution, file a second, third, etc.
divisional application on the other independently
patentable inventions
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First, and subsequent Office Action(s) – Examiner
says one or more claims are unpatentable - submit
amendments and argument in response.
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US Prosecution: Office Actions
(continued)
•Allowance, pay issue fee and 4, 8, 12 year maintenance fees,
or
• Final rejection when amendments and arguments were not
enough.
• The applicants options are to:
1. Appeal to United States Patent and Trademark
Office Administrative hearing Board, and then, if
needed, to Court of Appeals for the Federal Circuit,
2. File a Request for Continued Examination and
continue a new round of amendment and/or argument, or
3. Abandon Application.
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III. Exploitation:
Ownership
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Obligation of Employee to Assign to Employer
The general rule is that an individual owns the patent rights in the
subject matter of which he is an inventor even though he
conceived of the subject matter or reduced it to practice during the
course of employment. This general rule has two exceptions and
a limitation. An employee is obligated to assign rights in an
invention to his employer if
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(i) the employee has entered into a contract requiring
assignment of rights to the employer, or
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(ii) the employee is hired to invent or to solve a particular
problem and the invention is directed to the problem. University
Patents, Inc. v. Kligman, 762 F.Supp. 1212 (E.D. Pa. 1991).
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Ownership (continued)
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A contract to assign rights in an invention may be express or
implied. See, Fenn v. Yale University, case no. 3:96-cv-01647CFD, U.S.D.C.Conn. (2005), where a former Yale professor
who secretly patented his own invention in violation of Yale’s
IP policy was found liable for damages and attorney’s fees.
Pennsylvania courts will enforce express contracts to transfer
patent rights which are clear and unambiguous. See, e.g.,
White Heat Products Co. v. Thomas, 266 Pa. 551, 555, 109 A.
685 (1920); Mosser Industries, Inc. v. Hagar, 200 U.S.P.Q.
(BNA) 608 (C.P. Lehigh 1978); University Patents, 762
F.Supp at 1220.
Under Pennsylvania law, a contract may be implied if the
employee was hired for a particular purpose and the invention
relates to that purpose. University Patents at 1221 (citing
Standard Parts Co. v. Peck, 264 U.S. 52 (1924).
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Fiduciary Duty to Assign
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Decisions in other jurisdictions, cited in dicta in the University
Patents opinion, hold that an employee may have an implied duty
to assign patent rights where the employee holds a position of trust
as to the employer. (citing in dicta Great Lakes Press Corporation
v. Froom, 695 F. Supp. 1440 (W.D.N.Y. 1987) (holding president
of corporation had legal duty to assign to corporation those patents
he obtained during his tenure.)).
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However, in Mosser Industries, Inc. v. Hagar, 200 U.S.P.Q.
(BNA) 608 (C.P. Lehigh 1978), the Pennsylvania Court of
Common Pleas, Lehigh County, held that a vice-president of a
corporation had no fiduciary duty to assign to the corporation his
rights in inventions he developed while an officer of the
corporation.
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Shop Rights
Even if no obligation to assign exists, an employee
must provide his employer with a non-exclusive,
nontransferable, royalty-free license to use the
employee’s invention if the employee utilizes work
time or the facilities of his employer to conceive and
perfect an invention. The license is referred to as a
“shop right” in the invention. University Patents,
762 F.Supp. at 1220 (citing United States v. Dubilier
Condenser, 289 U.S. 178 (1933)).
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35 U.S.C. §262 Joint owners
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In the absence of any agreement to the contrary,
each of the joint owners of a patent may make, use,
offer to sell, or sell the patented invention within the
United States, or import the patented invention into
the United States, or license the patent, without the
consent of and without accounting to the other
owners.
In Europe and many other countries, joint owners
must cooperate in licensing inventions. A nonconsenting joint owner can hold the licensee of the
other joint owner liable infringement.
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Marketing
The patent owner or licensee can build a business
around the patented technology and enjoy a
sanctioned monopoly for the claimed invention for
many years.
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Marking
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The patent owner and any one making, offering for
sale or selling, within the United States, any
patented article may give notice by marking the
article or packaging with the patent number. This
provision has been applied to compositions of
matter, but not to processes.
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Failure to mark will preclude recovery of damages
for infringement until after the accused infringer had
received actual notice of the infringement and
continued to infringe.
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Licensing
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35 U.S.C. §261 “The applicant, patentee, or his
assigns or legal representatives may in like manner
grant and convey an exclusive right under his
application for patent, or patents, to the whole or any
specified part of the United States.”
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A license may be exclusive or non exclusive and
may be for all or part of the invention as well as for
all or part of the United States.
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If there are foreign patents, they too can be licensed.
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Security for loans under U.C.C. Article 9
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Article 9 defines “General Intangibles” as “any
personal property ... other than goods, accounts,
chattel paper, documents, instruments and money.”
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The comments include patents as examples of
general intangibles.
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35 U.S.C. §261 states that “patents shall have the
attributes of personal property”
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Assignment
I
35 U.S.C. §261 “Applications for patent, patents,
or any interest therein, shall be assignable in law by
an instrument in writing.”
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Assignments are recorded in the Patent and
Trademark Office. They should be recorded within
three months of the date of the assignment to be
effective as against a subsequent bona fide purchaser
for value.
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IV. Enforcement
35 U.S.C. §154 Right to Exclude
(a) In general
(1) Contents - Every patent shall contain a short title of the
invention and a grant to the patentee, his heirs or assigns, of
the right to exclude others from making, using, offering
for sale, or selling the invention throughout the United
States or importing the invention into the United States
and if the invention is a process, of the right to exclude
others from using, offering for sale or selling throughout
the United States, or importing into the United States,
products made by that process, referring to the
specification for the particulars, thereof ....
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Infringement
35 U.S.C. §271 Infringement of patent
(a) Except as otherwise provided in this title,
whoever without authority makes, uses, offers to
sell, or sells any patented invention, within the
United States or imports into the United States any
patented invention during the term of the patent
therefor, infringes the patent.
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Infringement (continued)
(b) Whoever actively induces infringement of a patent
shall be liable as an infringer.
(c) Whoever offers to sell or sells within the United States
or imports into the United States a component of a
patented machine, manufacture, combination or
composition, or a material or apparatus for use in
practicing a patented process, constituting a material part
of the invention, knowing the same to be especially
made or especially adapted for use in an infringement of
such patent, and not a staple article or commodity of
commerce suitable for substantial non-infringing use,
shall be liable as a contributory infringer.
67
Legal Standards For Determining
Patent Infringement
The claims of a patent are the operative language for
purposes of determining infringement. To determine
whether a claim of a patent is being infringed, the
Federal Circuit has set forth the following two-step
test:
(1) the proper construction of the asserted claims to
establish their meaning and scope, and
(2) a determination as to whether the accused product
infringes the asserted claims as properly construed.
The Johns Hopkins Univ. v. Cellpro Inc., 152 F.3d 1342,
1353 (Fed.Cir.1998).
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The Methodology of Claim Construction
The Supreme Court and the Federal Circuit decisions in
Markman v. Westview Instruments, Inc., 52 F.3d 967
(Fed.Cir.1995) (en banc), aff’d, 517 U.S. 370 (1996)
have held that patent claim construction is a question of
law:
“We therefore settle inconsistencies in our precedent
and hold that in a case tried to a jury, the court has
the power and the obligation to construe as a matter
of law the meaning of language used in the patent
claim. As such, ‘[a] patent covers the invention or
inventions which the court, in construing its
provisions, decides that it describes and claims.’ ”
Markman, 52 F.3d at 979.
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Claim Construction (continued)
Markman and its progeny have provided a
methodology for interpreting a claim of a patent. The
fundamental tenet of Markman spells out the sources
to be used in claim construction:
—the intrinsic evidence of record:
—the claims,
—the patent specification,
—the prosecution history
—certain extrinsic evidence:
—evidence of how those skilled in the art would
interpret the claims
—Dictionary meaning of terms
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The Methodology Of Determining Infringement Of A
Properly Construed Claim
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The Federal Circuit states that “the claim as properly
construed must be compared to the accused device .
. . .” Serrano v. Telular Corp., 111 F.3d 1578, 1582
(Fed.Cir.1997).
I
To be a literal infringement, every limitation of the
construed claim must be found in the accused
device. Mas-Hamilton Group Inc. v. LaGard Inc.,
156 F.3d 1206, 1211 (Fed.Cir.1998).
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Infringement Under the Doctrine of Equivalents
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A device that does not literally infringe the express terms of a
patent claim limitation (or element) may nonetheless be found to
infringe under the doctrine of equivalents if there is equivalence
between the element of the accused device and the claimed element
of the patented invention. Johnston v. IVAC Corp., 885 F.2d 1574,
1580-81 (Fed.Cir.1989).
One test deemed suitable for analyzing equivalence is the
"function-way-result" comparison between the accused device and
each of the claimed elements. Warner-Jenkinson Co. v. Hilton
Davis Chem. Co., 520 U.S. 17 (1997).
The doctrine of equivalents analysis asks whether the accused
device is substantially different from the claimed device.
Unidynamics Corp. v. Automatic Products Int’l Ltd., 157 F.3d
1311, 1322 (Fed.Cir.1998).
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Exemptions and Limitations
Prosecution History Estoppel
The Supreme Court has held that any
claim element narrowly amended for a
reason substantially related to
patentability is entitled to a range of
equivalents only under very limited
circumstances, such as where the
equivalent was unforeseeable at the time of
the application or if the amendment bore
no more than a tangential relationship to
the equivalent in question. Festo Corp. v.
Shoketsu Kinzoku Koygo Kabushiki, 535
U.S. 722 (2002).
73
Patent Infringement
Exceptions
and
Exemptions
74
The Drug Price Competition and Patent Term Restoration Act for 1984
§271(e)
The Generic Animal Drug and Patent Term Restoration Act of 1988 --35
U.S.C. §271(e)(1)
(e) (1) It shall not be an act of infringement to make, use, offer to
sell, or sell within the United States or import into the United
States a patented invention (other than a new animal drug or
veterinary biological product (as those terms are used in the
Federal Food, Drug, and Cosmetic Act and the Act of March 4,
1913) which is primarily manufactured using recombinant DNA,
recombinant RNA, hybridoma technology, or other processes
involving site specific genetic manipulation techniques) solely for
uses reasonably related to the development and submission of
information under a Federal law which regulates the
manufacture, use, or sale of drugs or veterinary biological
products.
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Exceptions Under 35 U.S.C. §271(e)(1); §271(e)(3)
(3) In any action for patent infringement brought
under this section, no injunctive or other relief may
be granted which would prohibit the making, using,
offering to sell, or selling within the United States or
importing into the United States of a patented
invention under paragraph (1).
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Exceptions Under 35 U.S.C. §271(e)(1); §271(e)(3)
On June 8, 2003, in Integra Lifesciences I, Ltd. v.
Merck KGaA, 331 F.3d 860 (Fed.Cir.2003), the
Federal Circuit stated that the exception to
infringement provided under 35 U.S.C. §271(e)(1)
“does not reach any exploratory research that may
rationally form a predicate for future FDA clinical
tests. … Extending §271(e)(1) to embrace new drug
development activities would ignore its language …
in an attempt to exonerate infringing uses only
potentially related to information related to FDA
approval.”
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Exceptions Under 35 U.S.C. §271(e)(1); §271(e)(3)
In the Integra case, Merck and the other defendants were
found to infringe claims of a patent for conducting research
on an active agent that arguably infringed the claims of the
patents at suit.
The Federal Circuit characterized the defendants’ research
activities as not clinical testing to supply information to the
FDA, but only general biomedical research to identify new
pharmaceutical compounds. The FDA has no interest in the
hunt for drugs that may or may not later undergo clinical
testing for FDA approval. For instance, the FDA does not
require information about drugs other than the compound
featured in an Investigational New Drug application. Thus,
the Scripps work was not ‘solely for uses reasonably related’
to clinical testing for FDA.
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Exceptions Under 35 U.S.C. 35 U.S.C. §271(e)(2)
(2) It shall be an act of infringement to submit -(A) an application under section 505(j) of the Federal Food, Drug, and
Cosmetic Act or described in section 505(b)(2) of such Act for a drug
claimed in a patent or the use of which is claimed in a patent,
or
(B) an application under section 512 of such Act or under the Act of
March 4, 1913 (21 U.S.C. 151-158) for a drug or veterinary biological
product which is not primarily manufactured using recombinant DNA,
recombinant RNA, hybridoma technology, or other processes involving
site specific genetic manipulation techniques and which is claimed in a
patent or the use of which is claimed in a patent, if the purpose of such
submission is to obtain approval under such Act to engage in the
commercial manufacture, use, or sale of a drug or veterinary biological
product claimed in a patent or the use of which is claimed in a patent
before the expiration of such patent.
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Exceptions Under 35 U.S.C. 35 U.S.C. §271(e)(2) & (e)(4)
(4) For an act of infringement described in paragraph (2) -(A) the court shall order the effective date of any approval of the
drug or veterinary biological product involved in the infringement to
be a date which is not earlier than the date of the expiration of the
patent which has been infringed,
(B) injunctive relief may be granted against an infringer to prevent
the commercial manufacture, use, offer to sell, or sale within the
United States or importation into the United States of an approved
drug or veterinary biological product, and
(C) damages or other monetary relief may be awarded against an
infringer only if there has been commercial manufacture, use, offer
to sell, or sale within the United States or importation into the United
States of an approved drug or veterinary biological product.
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Medical Practitioners Exemption –
35 U.S.C. §287(c)
(c) (1) With respect to a medical practitioner’s
performance of a medical activity that constitutes an
infringement under section 271(a) or (b) of this title,
the provisions of sections 281, 283, 284, and 285 of
this title shall not apply against the medical
practitioner or against a related health care entity
with respect to such medical activity.
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Medical Practitioners Exemption –
35 U.S.C. § 287(c)
(2)
For the purposes of this subsection:
(A) the term “medical activity” means the performance of a
medical or surgical procedure on a body, but shall not include
(i) the use of a patented machine, manufacture, or composition of
matter in violation of such patent, (ii) the practice of a patented
use of a composition of matter in violation of such patent, or (iii)
the practice of a process in violation of a biotechnology patent.
(B) the term “medical practitioner” means any natural person
who is licensed by a State to provide the medical activity
described in subsection (c)(1) or who is acting under the direction
of such person in the performance of the medical activity.
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Medical Practitioners Exemption –
35 U.S.C. §287(c)
“related health care entity” means:
ƒ
nursing home
ƒ
hospital
ƒ
university
ƒ
medical school
ƒ
health maintenance organization
ƒ
group medical practice
ƒ
medical clinic.
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Experimental Use Defense (or lack thereof)
European laws establishes an
experimental use exemption from patent
infringement, whereas the availability of
such as exemption in the United States is
very limited.
84
Experimental Use Defense (or lack thereof)
I
In Whittenmore v. Cutter, 29 F. Cas. 1120 (C.C.D. Mass.
1813), Justice Story wrote that “it could never have been
the intention of the legislature to punish a man who
constructed . . . a machine merely for philosophical
experiments.”
I
In Roche Products, Inc. v. Bolar Pharmaceuticals Co.,
733 F.2d 858 (Fed.Cir.1984), the Federal Circuit found
infringement when a generic drug manufacturer imported
a patented drug in the last year of the patent term solely
for use in obtaining stability and bioequivalency data to
support a new drug application. The Court found Bolar’s
experimental use to be solely for business purposes.
85
Experimental Use Defense (or lack thereof)
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Congress overruled the Bolar decision when it enacted
subsection (e)(1) of 35 U.S.C. §271.
Safe harbors also exist for research and
experimentation in plant breeding (7 U.S.C § 2544);
and experimentation with semiconductor masks (17
U.S.C. 906 (a)(1)).
In 1990, Congress considered, but did not pass the
Proposed Patent Competitiveness and Technological
Innovation Act. This Act would have excluded from
infringement the use of a patented invention solely for
research or experimentation unless the patent’s primary
purpose was research or experimentation.
86
Experimental Use Defense (or lack thereof) :
Madey v. Duke University
I
In Madey v. Duke University, 307 F.3d
1351 (Fed.Cir.2002), the Federal Circuit
reversed the district court's finding of noninfringement of Madey's patent on the
basis of application of the experimental
use exception to Duke's research.
I
The Court wrote that the experimental use
exception does not immunize any conduct
that is in keeping with the alleged
infringer's legitimate business.
87
Madey v. Duke University
Noncommercial research is University
business because:
— Research universities sanction and fund
research projects.
— Projects further the institution's
legitimate business objectives, including
educating and enlightening students
and faculty participating in these
projects.
— Projects increase the status of the
institution and lure lucrative research
grants, students and faculty.
88
Remedies: 35 U.S.C. §284 Damages
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Upon finding for the claimant the court shall award the
claimant damages adequate to compensate for the
infringement, but in no event less than a reasonable
royalty for the use made of the invention by the infringer,
together with interest and costs as fixed by the court.
When the damages are not found by a jury, the court
shall assess them. In either event the court may increase
the damages up to three times the amount found or
assessed. Increased damages under this paragraph shall
not apply to provisional rights under section 154(d) of
this title.
Attorneys’ Fees for Exceptional Cases
89
Willfulness is a Real Problem
In exceptional cases, courts are entitled to treble
damages and award attorney fees.
I
Primary consideration is whether infringement was
Willful.
I
I
Allegations of infringement are commonplace.
I
Willfulness is asserted 92.8% of time according to
recent study.
90
Enhanced Damages Determined by
Totality of Circumstances
I
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Deliberate copying
Whether infringer formed good faith belief of
noninfringement*
Litigation behavior
Defendant’s size and financial condition
Closeness of case
Duration of misconduct
Remedial action by defendant
Defendant’s motivation to harm
Attempts at concealment of infringement
91
The Duty of Care
“Where … a potential infringer has actual notice of another's
patent rights, he has an affirmative duty to exercise due care to
determine whether or not he is infringing.”
“Such affirmative duty includes, inter alia, the duty to seek
and obtain competent legal advice from counsel before the
initiation of any possible infringing activity.”
Underwater Devices, Inc. v. Morrison-Knudsen Co.,
717 F.2d 1380, 1389-90 (Fed.Cir.1983)
92
Satisfaction of the Duty of Due Care
How is the duty discharged?
Good faith belief, based upon due inquiry, that
the party had sound reason to believe that it
had the right to act in the manner that was
found to be infringing.
SRI Int’l, Inc. v. Advanced Tech. labs Inc., 127 F.3d
1462 (Fed. Cir. 1997)
93
Opinions from Counsel
I
Most important factor in deciding whether
infringement is willful.
I
In order to provide a shield against charges of
willfulness, an exculpatory opinion of counsel must:
1. Indicate a likelihood of non-liability, and be:
2. Thorough
3. Competent
4. Objective
94
Opinion of Counsel as a Defense
I
Recipient of opinion must actually rely on the
opinion.
I
Opinion must be timely.
95
Litigation Dilemma
I
Reliance on opinion at trial necessitates a waiver of
attorney-client privilege.
I
Scope of waiver intensely litigated
96
Adverse Inference Rule
I
Defendant has the right to assert attorney-client
privilege in deciding to introduce opinions of counsel
at trial.
I
Adverse inference from not asserting opinion of
counsel. Kloster Speedsteel AB v. Crucible Inc., 793
F.2d 1565 (Fed.Cir.1986).
97
Patent Opinions:
In Knorr-Bremse Systeme Fuer Nutzfarzeuge v. Dana Corp., 383 F.
3d 1337 (Fed.Cir.2004), the Federal Circuit ruled that
(1) no adverse inference could arise by invoking attorney-client privilege
with respect to legal opinions;
(2) there is no presumption that advice of counsel would have been
negative if the defendant fails to seek such advice;
(3) the existence of a substantial defense to infringement is not sufficient
to defeat liability for willful infringement even if no legal advice had
been secured; and,
(4) the question of willfulness is decided on the totality of the
circumstances, including whether a prudent person would have a
sound belief that the patent was not infringed and allowing the trial
court to accord each factor the weight warranted by its strength in the
case. (See slide 91).
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Contact information
Christine R. Ethridge
Kirkpatrick & Lockhart Nicholson Graham, LLP
Henry W. Oliver Building
535 Smithfield Street
Pittsburgh, PA 15222-2312
(412) 355-8619
(412) 355-6501 (fax)
cethridge@klng.com
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