Claim Construction of U.S. Pharmaceutical
Patents
April 19, 2005
Brian V. Slater
Partner
www.fitzpatrickcella.com
U.S. Claim Construction: An Overview
• Claim construction is exclusively a question of law
for the judge*
• Frequently the subject of a special hearing prior to
trial (so-called “Markman hearing)
• Court of Appeals for the Federal Circuit reviews
claim construction decisions de novo on appeal**
* Markman v. Westview Instr., 517 U.S. 370 (1996)
** Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998)
2
www.fitzpatrickcella.com
U.S. Claim Construction: An Overview
• Often dispositive issue in patent lawsuit:
• “[T]o decide what the claims mean is nearly
always to decide the case.”*
• This is true of pharmaceutical patent suits:
• E.g., claim term “hydroxypropyl
methylcellulose” (HPMC) not limited to
particular grade of HPMC recited in examples
(summary judgment of no infringement
vacated)**
* Markman v. Westview, 52 F.3d 967 (Fed. Cir. 1995)(Mayer J., dissenting)
** Glaxo Wellcome, Inc. v. Andrx Pharmaceuticals, 344 F.3d 1226 (Fed. Cir.
2003)
3
www.fitzpatrickcella.com
Claim Construction Facts & Figures
• Between 1/1/98 and 4/30/2000, Federal Circuit
modified claim construction in 78 of 179 cases
(44%)*
• In about 30% of Federal Circuit claim construction
cases in 2004 there was either a concurrence or
dissent**
* Christian A. Chu, Empirical Analysis of the Federal Circuit’s Claim
Construction Trends, 16 BERKTLJ 1075 (2001)
** Claim construction Project. See ClaimConstruction.com.
4
www.fitzpatrickcella.com
Recent Developments
5
www.fitzpatrickcella.com
En Banc Rehearing: Phillips v. AWH
• On July 21, 2004, the Federal Circuit agreed to rehear
Phillips v. AWH en banc, asking:
• Which has primacy: dictionaries or specification?
• Should claims be construed to preserve validity?
• What is the role of the prosecution history?
• What is the role of expert testimony?
• What deference should Federal Circuit accord?
• Chief Judge Mayer dissented saying it is “futile” unless
Court reconsiders its holdings that claim construction
is question of law
6
www.fitzpatrickcella.com
Evolution of U.S. claim construction
jurisprudence
7
www.fitzpatrickcella.com
Balancing Tensions
• Ensuring the notice function of a patent
• “[I]t is only fair (and statutorily required) that
competitors be able to ascertain to a
reasonable degree the scope of the
patentee’s right to exclude.”*
Versus
• Giving a patent owner a fair and reasonable
scope of protection
* Markman v. Westview, 523 F.3d 967 (Fed. Cir. 1995).
8
www.fitzpatrickcella.com
Balancing Tensions
• Relying on intrinsic record (claims, specification
and prosecution history)
Versus
• Relying on the “ordinary meaning” of claim terms
(e.g., dictionaries) and refusing to import limiting
features from the specification into the claims
9
www.fitzpatrickcella.com
Markman v. Westview Instruments, 52 F.3d
967 (Fed. Cir. 1995) (en banc)
• “Claims must be read in view of the specification
of which they are a part.”
BUT
• “The written description part of the specification
itself does not delimit the right to exclude.”
10
www.fitzpatrickcella.com
Markman v. Westview Instruments, 52 F.3d
967 (Fed. Cir. 1995) (en banc)
• The Court should also consider the patent’s
prosecution history, if it is in evidence
BUT
• “. . . the prosecution history . . . cannot ‘enlarge,
diminish or vary’ the limitations in the claims”
11
www.fitzpatrickcella.com
Markman v. Westview Instruments, 52 F.3d
967 (Fed. Cir. 1995) (en banc)
• Extrinsic evidence (including inventor testimony,
dictionaries, and learned treatises) may be
“helpful” to explain scientific principles/and the
meaning of technical terms and terms of art
BUT
• Cannot be used “for the purpose of varying or
contradicting the terms of the claims”
12
www.fitzpatrickcella.com
Vitronics: The Door for Dictionaries Opens
13
www.fitzpatrickcella.com
Vitronics v. Conceptronic, 90 F.3d 1576
(Fed. Cir. 1996)
• Intrinsic evidence is “most significant source” in
claim construction
• Only if “genuine ambiguity” exists after reviewing
intrinsic evidence may extrinsic evidence be used
• Dictionaries and prior art are “more objective and
reliable guides” than opinion testimony
• Footnote 6: dictionaries worthy of “special note”
14
www.fitzpatrickcella.com
Claim Construction After Vitronics
15
www.fitzpatrickcella.com
Wang Labs v. America Online, 197 F.3d
1377 (Fed. Cir. 1999)
• Issue: Construction of the term “information
frame”
• Parties agreed that the term in its general usage
could be applied to both bit-mapped and
character based systems
• Court held claims limited to character-based
systems because it was only system enabled
16
www.fitzpatrickcella.com
Dictionaries Gain Ground
17
www.fitzpatrickcella.com
Bell Atl. Network v. Covad Communications,
262 F.3d 1258 (Fed. Cir. 2001)
• Citing Vitronics footnote 6 (that dictionaries have
a “special place”), does not list dictionaries as
extrinsic evidence and almost treats dictionaries
as intrinsic evidence
CCS Fitness v. Brunswick, 288 F.3d 1359
(Fed. Cir. 2002)
•Held claim term “member” was to be construed in
accordance with common and technical dictionaries
where nothing in specification or prosecution history
overcame that meaning
18
www.fitzpatrickcella.com
Dictionary is King
19
www.fitzpatrickcella.com
Texas Digital v. Telegenix, 308 F.3d 1193,
(Fed. Cir. 2002)
• A “heavy presumption” in favor of ordinary
meaning unless disavowed in intrinsic record
• “Dictionaries, encyclopedias and treatises,
publicly available at the time the patent issued,
are objective resources that serve as reliable
sources of information on the established
meanings that would have been attributed to the
terms of the claims by those of skill in the art . . .
Indeed, these materials may be the most
meaningful sources of information to aid judges .
..“
• “Categorizing dictionaries as ‘extrinsic evidence’ .
. . is misplaced.”
20
www.fitzpatrickcella.com
The Specification Pushes Back
21
www.fitzpatrickcella.com
Combined Sys. v. Defense Tech., 350 F.3d
1207 (Fed. Cir. 2003)
• Some recent opinions, when read in isolation,
may have sent the message that the specification
should be consulted “solely for the limited purpose
of determining whether it contradicts the
dictionary meaning of a claim term”
• Instead, intrinsic evidence must be reviewed not
only to rebut the ordinary meaning, but also to aid
in every case of claim construction
• Despite clarification, court heavily relied on
dictionary definitions to determine ordinary
meaning
22
www.fitzpatrickcella.com
Ferguson Beauregard/Logic v. Delaware
Capital, 350 F.3d 1327 (Fed. Cir. 2003)
• “Dictionary definitions, while reflective of the
ordinary meaning of words, do not always
associate those meanings with context or reflect
the customary usage of words by those skilled in
a particular art.”
• “It is the use of the words in the context of the
written description and customarily by those
skilled in the relevant art that accurately reflects
both the ‘ordinary’ and the ‘customary’ meaning of
the terms in the claims of a patent.”
23
www.fitzpatrickcella.com
The Tension Resurfaces
24
www.fitzpatrickcella.com
Merck v. Teva Pharm. USA Inc., 347 F.3d
1367 (Fed. Cir. 2003)
• Majority (Newman, J.; Prost, J.): claimed method
of treatment using alendronic “acid” encompasses
administration of salt form because:
• specification describes active as
encompassing both acid and salt forms
• experts testified pharmacologists would
understand use of acid encompasses salt
• Dissent (Mayer, J.):
• both sides’ experts agreed acid is a different
compound than its salt
• specification distinguishes between the two
25
www.fitzpatrickcella.com
Novartis v. Eon Labs., 363 F.3d 1306 (Fed.
Cir. 2004)
• Invention: small solid particles of cyclosporin (a
very poorly soluble drug) dispersed in an aqueous
medium (called a “hydrosol”)
• Issue: Whether claim term “hydrosol” is limited to
products made outside the body or includes
products formed in vivo after ingestion
• Both parties’ experts agreed “hydrosol” means
small solid particles of cyclosporin dispersed in an
aqueous medium
26
www.fitzpatrickcella.com
Novartis v. Eon Labs. Majority (Dyk, J.;
Prost, J.)
• Court first consulted general purpose dictionary
not cited by parties that defined “hydrosol” as a
“sol in which the liquid is water”
• Then looked up “sol”, which was defined as “a
dispersion of solid particles in a liquid colloidal
solution”
• Then looked up “solution”, which gave multiple
meanings including “a liquid and usu. aqueous
medicinal preparation with the solid ingredients
soluble.”
27
www.fitzpatrickcella.com
Novartis v. Eon Labs. Majority (Dyk, J.;
Prost, J.)
• Then looked up “medicinal preparation” in
dictionary and found it to relate to “medicine”,
which in turn was defined as a “preparation”
• And, finally, looked up “preparation” in three
dictionaries that define it as “ready for use”
• Then stated that “medicinal preparation” is a
“preexisting product that is administered to treat
disease and therefore must necessarily be
prepared outside the body”
28
www.fitzpatrickcella.com
Novartis v. Eon Labs. Majority (Dyk, J.;
Prost, J.)
• Court found term “hydrosol” is ambiguous
because it has two possible definitions:
• broad one unlimited to place of formation; and
• narrow one limited to products made outside
body
• According to Court, intrinsic record supported
adoption of narrower definition
• no examples to hydrosols formed in patient’s
stomach
• specification says hydrosol “intravenously
applicable”
29
www.fitzpatrickcella.com
Novartis v. Eon Labs. Dissent (Clevenger,
J.)
• None of several dictionary definitions of “hydrosol”
limits where hydrosol is made
• Term “hydrosol” is not ambiguous and deserves
full scope
• Applicant made no explicit disclaimer or
disavowal of hydrosols made inside the body
• Dictionary exercise went “too far” by pursuing
definition of “medicinal preparation” which
required ingredients be “soluble” (cyclosporin is
poorly soluble)
30
www.fitzpatrickcella.com
Nystrom v. Trex Co., 374 F.3d 1105 (Fed.
Cir. 2004)
• Majority (Linn, J.; Mayer, J.) held “board” has
multiple dictionary meanings not all of which are
limited to sawn lumber so term was not so limited
• Dissent (Gajarsa, J.) claimed majority’s approach
was inconsistent with Novartis v. Eon where court
determined which dictionary definition was most
consistent with intrinsic
• Majority counters that, under prior precedent,
claim terms are construed to encompass all
dictionary definitions not inconsistent with intrinsic
record
31
www.fitzpatrickcella.com
Phillips v. AWH Corp., 363 F.3d 1207 (Fed.
Cir. 2004)
• Invention: vandalism-resistant building modules
consisting of modular wall panels
• Issue: Whether claim term “baffles” limited to
those at other than at 90º
• Ordinary meaning of “baffle” from dictionary:
“something for deflecting, checking, or otherwise
regulating flow”
32
www.fitzpatrickcella.com
Phillips v. AWH Corp. (Majority (Lourie, J.;
Newman, J.)
• Specification is rife with references to impact
resistance against projectiles, and baffles directed
at 90º cannot deflect projectiles
• None of the figures shows any baffle that is not at
an angle other than 90º
• “Inspection of the patent shows that baffles
angled at other than 90º is the only embodiment
disclosed in the patent; it is the invention.”
33
www.fitzpatrickcella.com
Phillips v. AWH Corp. (Dissent (Dyk, J.)
• Majority improperly limited claim to preferred
embodiment
• “We however have ‘expressly rejected the
contention that if a patent describes only a single
embodiment, the claims of the patent must be
construed as being limited to that embodiment.’”
• Projectile resistance is only one of several
objectives of the invention (including load bearing
and thermal-acoustical isolation)
34
www.fitzpatrickcella.com
Phillips Petition for Rehearing En Banc:
Positions in Amicus Briefs
35
www.fitzpatrickcella.com
Which has Primacy: the Specification or
Dictionaries?
• NYIPLA/U.S/IPO: The primary source of claim
construction should be the intrinsic evidence
• FCBA/ABA: “middle ground”: neither has primacy
• IPO: No other evidence should be considered if
the claims can be construed from intrinsic sources
• Boston PLA: The primary audience for a patent
includes the workers in the field, not “the tweedjacketed editorial staff of the OED”
36
www.fitzpatrickcella.com
Should Claims be Construed to Preserve
their Validity?
NYIPLA/U.S.: Where there are two plausible
constructions of a claim term, courts should adopt
the one that preserves validity.
FCBA/ABA: Claims should be construed without
regard to their validity.
IPO: “Claims should be construed to preserve their
definiteness but IPO has serious reservations
regarding interpreting claims to preserve validity
on other grounds.”
37
www.fitzpatrickcella.com
What is the Role of Expert Testimony?
NYIPLA: “Expert testimony by a credible witness,
particularly when supported by documentary
evidence, may be highly persuasive.”
FCBA: “Expert testimony should also be permitted
to the extent the trial court believes it may be
useful.”
ABA: “Secondary sources, such as expert
testimony, may always be considered.”
38
www.fitzpatrickcella.com
What Deference should the Federal Circuit
Accord Claim Construction Determinations?
NYIPLA/ABA/FCBA: Subsidiary findings of fact
should be accorded deference under a clearly
erroneous standard but the ultimate construction
should be subject to de novo review
United States: Court should give “due consideration
to a persuasive claim construction by the district
court and accord due weight to its evaluation of
any live testimony on this issue”
39
www.fitzpatrickcella.com
Phillips En Banc Oral Argument
Phillips (appellant):
• You should read the specification, then the claims.
If the claims are broader, you should rely on the
claims. The purpose of the specification is to
provide written description and enablement, not to
narrow the claims.
• If you are construing an ordinary term, you can
rely on a dictionary to see if there is a definition
that fits with the specification.
• Ordinary person would know main purpose of
baffle is load bearing (not bullet deflection).
40
www.fitzpatrickcella.com
Phillips En Banc Oral Argument
AWH:
• You should read the specification to determine the
invention.
• If an element is described as essential to the
invention, and there are no other examples given,
then it is implicitly narrowed.
• Load supporting function is not part of the term
baffle; the only function of the baffles is bullet
deflection.
41
www.fitzpatrickcella.com
Phillips En Banc Oral Argument
U.S.:
• As a practical matter, patent examiners do not use
dictionaries.
• Specification has primacy over dictionaries.
42
www.fitzpatrickcella.com
THANK YOU
43
www.fitzpatrickcella.com
ADDENDUM
44
www.fitzpatrickcella.com
Phillips En Banc Rehearing: Seven
Questions
Question #1
• WHICH HAS PRIMACY, DICTIONARIES OR THE
SPECIFICATION?
– “Is the public notice function of patent claims better served by
referencing primarily to technical and general purpose
dictionaries and similar sources to interpret a claim or by looking
primarily to the patentee’s use of the term in the specification? If
both sources are to be consulted, in what order?”
45
www.fitzpatrickcella.com
Phillips Rehearing: Seven Questions
Question #2
• IF IT’S THE DICTIONARY, WHAT IS THE ROLE
OF THE SPECIFICATION?
– “If dictionaries should serve as the primary source for claim
interpretation, should the specification limit the full scope of claim
language (as defined by the dictionaries) only when the patentee
has acted as his own lexicographer or when the specification
reflects a clear disclaimer of claim scope? If so, what language
in the specification will satisfy those conditions? What use
should be made of general as opposed to technical dictionaries?
How does the concept of ordinary meaning apply if there are
multiple dictionary definitions of the same term? If the dictionary
provides multiple potentially applicable definitions for a term, is it
appropriate to look to the specification to determine what
definition or definitions should apply?”
46
www.fitzpatrickcella.com
Phillips Rehearing: Seven Questions
Question #3
• IF IT’S THE SPECIFICATION, WHAT IS THE
ROLE OF THE DICTIONARY?
– “If the primary source for claim construction should be the
specification, what use should be made of dictionaries? Should
the range of the ordinary meaning of claim language be limited to
the scope of the invention disclosed in the specification, for
example, when only a single embodiment is disclosed an no
other indications of breadth are disclosed?”
47
www.fitzpatrickcella.com
Phillips Rehearing: Seven Questions
Question #4
• SHOULD THERE BE A DUAL RESTRICTION?
– “Instead of viewing the claim construction methodologies in the
majority and dissent of the now-vacated panel decision as
alternative, conflicting approaches, should the two approaches
be treated as complementary methodologies such that there is a
dual restriction on claim scope, and a patentee must satisfy both
limiting methodologies in order to establish the claim coverage it
seeks?”
48
www.fitzpatrickcella.com
Phillips Rehearing: Seven Questions
Question #5
• SHOULD CLAIMS BE CONSTRUED TO
PRESERVE THEIR VALIDITY?
– “When, if ever, should claim language be narrowly construed for
the sole purpose of avoiding invalidity under, e.g., 35 U.S.C. §§
102, 103 and 112?”
49
www.fitzpatrickcella.com
Phillips Rehearing: Seven Questions
Question #6
• WHAT IS THE ROLE OF PROSECUTION
HISTORY?
• WHAT IS THE ROLE OF EXPERT TESTIMONY?
– “What role should prosecution history and expert testimony by
one of ordinary skill in the art play in determining the meaning of
the disputed claim terms?”
50
www.fitzpatrickcella.com
Phillips Rehearing: Seven Questions
Question #7
• WHAT DEFERENCE SHOULD THE FEDERAL
CIRCUIT ACCORD?
– “Consistent with the Supreme Court’s decision in Markman v.
Westview Instruments, Inc., 517 U.S. 370 (1996), and our en
banc decision in Cybor Corp. v. FAS Technologies, Inc., 138 F.3d
1448 (Fed. Cir. 1998), is it appropriate for this court to accord
any deference to any aspect of trial court claim construction
rulings? If so, on what aspects, in what circumstances, and to
what extent?”
51
www.fitzpatrickcella.com