Transcript Fed. Cir. 2002

Boston Bar Association
2002
YEAR IN REVIEW
PATENT LAW and LITIGATION
Robert M. Asher
Erik Paul Belt
BROMBERG & SUNSTEIN LLP
125 Summer Street
Boston, MA 02110
617-443-9292
January 16, 2003
Topics
Festo/Doctrine of Equivalents
Patent Reexamination
Inherency
Patent Prosecution
Patent Litigation
Generic Drug/Hatch-Waxman Litigation.
Copyright © 2003. Robert M. Asher
and Erik Paul Belt. All rights reserved
Festo/Doctrine of
Equivalents
Federal Circuit’s Festo Decision
Claims narrowed by amendment create
prosecution history estoppel for any reason
substantially related to patentability
Estoppel applies as well to voluntary
amendments
Prosecution history estoppel acts as an
absolute
bar
against
doctrine
of
equivalents
Festo/Doctrine of
Equivalents
 Supreme Court Nibbles Away at the Festo Bar
Affirms that estoppel applies even when
amendment was not for overcoming prior art
Affirms absolute bar when reason for
amendment is indiscernible
But . . .
Festo/Doctrine of
Equivalents
 Supreme Court Nibbles Away at the Festo Bar
Rebuttable presumption replaces absolute
bar
Patentee has burden to show equivalent
was not surrendered – Festo 2003
Festo/Doctrine of
Equivalents
 Plaintiff’s burden to rebut presumptive bar
Equivalent unforeseeable, or
Rationale for amendment bears no more than
tangential relation to equivalent, or
Patentee can not reasonably be expected to
have described the equivalent
 Impossible Burden?
At time of amendment one skilled in the art
could not reasonably be expected to have
drafted a claim that would have literally
encompassed the alleged equivalent
Festo/Doctrine of
Equivalents
Patent Practice Post-Festo
Make
reasons
apparent
for
all
amendments
Get claims right the first time – particularly
with respect to Sec. 112
Fight harder to avoid making narrowing
amendments
Get the broadest possible literal claims
Consider using “means for” in
amendments
Doctrine of Equivalents
Abbott Labs v. Dey L.P., 287 F.3d 1097
(Fed. Cir. 2002)
Summary judgment of noninfringement
vacated to permit doctrine of equivalents
Claim 1 requires 68.6%-90.7%
phospholipid
Statement in prosecution of related patent
application not prosecution estoppel when
applications are not formally related
Numeric ranges do not preclude DOE
Doctrine of Equivalents
 Johnson & Johnston v. R.E. Service, 285 F.3d
1046 (Fed. Cir. 2002)
Steel disclosed in Specification:
 While aluminum is currently the preferred material
for the substrate, other metals, such as stainless
steel or nickel alloys, may be used.
But not recited in the claims:
 a sheet of aluminum which constitutes…
Jury found copper-steel and copper-aluminum
laminates to be equivalent
Reversed on grounds that use of steel was
dedicated to the public
Doctrine of Equivalents
 Cooper Cameron v. Kvaerner
Oilfield, 291 F. 3d 1317 (Fed. Cir.
2002)
 Claim 10: “a workover port extending
laterally . . . from between the two
plugs”
 All Elements Rule
 What is an element – each word!!
 Defendant had a “workover port”
but not “between” the two plugs
 Infringement by equivalents barred
because “between” could not be
ignored
Patent Reexamination
Becomes More Appealing
Inter Partes Reexamination may be
appealed to Federal Circuit by third party
requestor
May now be based on previously cited
reference - In re Portola Packaging
overruled by 2002 Justice Department
Authorization Act
Patent Reexamination
Much less expensive than litigation
No presumption of validity
Broadest reasonable interpretation of
claims
Can weaken patent by cancelling or
amending claims
Can strengthen patent by providing
USPTO second stamp of approval
Inter Partes Reexamination
Available only for patents filed after
November 29, 1999
Requestor estopped from asserting
invalidity over prior art documents in
litigation
No interviews with Examiner on the merits
May be used to obtain a stay of litigation
Inherency
Inherency tough sell, except when it
comes to broccoli
Crown Operations Int’l v. Solutia, 289 F.3d
1367 (Fed. Cir. 2002) - ‘511 patent not invalid
Rosco v. Mirror Lite, 304 F.3d 1373 (Fed. Cir.
2002) – anticipation reversed
In re Cruciferous Sprout Litigation, 301 F.3d
1343 (Fed. Cir. 2002) – invalidity upheld
Elan Pharmaceuticals v. Mayo Found., 304
F.3d 1221 (Fed. Cir. 2002) – anticipation
reversed
Inherency
 Crown Operations Int’l v. Solutia
Claim 1. Solar/safety film for
use in laminated window
assembly
 Flexible, transparent plastic
layer
 Multilayer solar control
coating
 Flexible, transparent, energy
absorbing plastic safety
layer
 Wherein said solar control
film contributes no more
than about 2% visible
reflectance
2% limitation not necessarily
present
Inherency
 Rosco, Inc. v. Mirror Lite Co.
Claim 1: a convex ellipsoid mirror lens “having a
varying radius of curvature” along the major axis
Defendant argued the vacuum thermoforming process
necessarily
yields mirror with varying radius of
curvature, even though it prefers a constant curvature
Prior art patent does not specify vacuum process
Inherency
In re Cruciferous Sprout Litigation:
Broccoli Patent Loses
Claim 1. a method of preparing a
food product rich in glucosinolates
Identifying seeds which
produce cruciferous sprouts . . .
containing high Phase 2
enzyme-inducing potential
Invalid over prior art eating of
broccoli sprouts even though
properties were not known
Inherency
 Elan Pharmaceuticals v. Mayo Found.
Claim 1: A transgenic rodent
 A transgene encoding a heterologous APP polypeptide
having the Swedish mutation
 The transgene is expressed to produce a human APP
polypeptide having the Swedish mutation
 Said polypeptide is processed to ATF-betaAPP in a
sufficient amount to be detectable in a brain
homogenate of said transgenic rodent
Inherency
 Elan Pharmaceuticals v. Mayo Found.
ATF-betaAPP not disclosed in humans until after prior
art Mullan patent was filed
Dyk dissent argues Mullan disclosed Swedish form
APP and that ATF-betaAPP would necessarily result
Later, Federal Circuit vacates decision and agrees to
rehearing en banc rehearing. Watch for it in 2003
Patent Prosecution
Provisional Application Trap
Specification requirements are the same for
regular and provisional applications
Provisional must satisfy written description,
enablement, and best mode requirements to
provide effective priority or invention dates
Patent Prosecution
Provisional Application Trap
New Railhead Mfg. v. Vermeer Mfg., 298 F.3d
1290 (Fed. Cir. 2002)
 Patent invalidated when it could not benefit from
provisional application filing date
Patent Prosecution
 Prosecution Laches (the Lemelson Defense)
 Symbol Technologies v. Lemelson Med. Found.,
277 F.3d 1361 (Fed. Cir. 2002)
Patents-in-suit claim benefit of filing dates as early as
1954
Customers began receiving notices of infringement in
1998
Patent applicant complied with USPTO statutes and
rules
Defense of prosecution laches may be asserted
Patent Prosecution
In re Bogese, 303 F.3d 1362 (Fed. Cir.
2002)
USPTO may apply laches to reject a patent
application
Patent Litigation
Year of the Plaintiff
Festo saves Doctrine of Equivalents
Claim construction: Harder to narrow
scope of claims.
 Invalidity becomes even harder to prove
Patent Litigation
Jurisdiction
 Holmes Group Inc. v. Vornado Air
Circulation Systems Inc., 535 U.S. 826
(2002) (Scalia, J.)
Held: Federal Circuit has no
jurisdiction over appeal in which
the only patent law issue is
asserted in the counterclaim.
Result: Regional circuits could
decide some patent law issues
Patent Litigation
Jurisdiction
Holmes v. Vornado facts:
Holmes sued Vornado in District of Kansas
seeking a declaratory judgment that it does
not infringe Vornado’s trade dress for spiral
grill design fans.
Vornado counterclaimed for patent
infringement.
Declaratory judgment granted.
Patent infringement counterclaim stayed.
Patent Litigation
Jurisdiction
Holmes v. Vornado facts (cont’d):
Vornado bypasses 10th Circuit and appeals
directly to Federal Circuit
Federal Circuit accepts jurisdiction and
vacates judgment.
Holmes petitions Supreme Court, which
grants cert.
Patent Litigation
Jurisdiction
Holmes v. Vornado Legal Reasoning:
Key question: whether action is one “arising
under” federal patent law. § § 1338(a) and
1295(a).
Answer turns on “well-pleaded complaint” rule
Complaint did not allege patent infringement
Counterclaim cannot serve as basis for
“arising under” jurisdiction
Patent Litigation
Jurisdiction
Back to 1981?
Federal Circuit formed in 1982 with the
mission of unifying patent law and eliminating
forum shopping
Supreme Court sidesteps Congress’s goal in
establishing Federal Circuit.
The regional circuits may again hear patent
appeals in some cases
May lead to circuit conflict and forum
shopping
Patent Litigation
Jurisdiction
 Bailey v. Dart Container Corp. of Michigan et al.,
292 F.3d 1360 (Fed.Cir. 2002)
Judgment winner may not file cross-appeal merely to
argue alternative grounds for affirming the judgment
May file cross-appeal only to seek reversal or
modification of judgment
Patent Litigation
Claim Construction
Trend: Ordinary Meaning Rules.
Trend: Terms given broader scope.
Federal Circuit appears fed up with
defense gimmicks and wordplay.
Comeback for “extrinsic” evidence,
particularly dictionaries
Patent Litigation
Claim Construction
 CCS Fitness, Inc. v. Brunswick Corp., 288
F.3d 1359 (Fed. Cir. 2002)
Disputed term: “reciprocating member”
Defendant says it must be limited to
drawing showing the member (432) to be
a single-component, straight-bar structure.
Plaintiff says nothing in claim limits the
member to a particular shape. Term
covers multi-component, curved bar.
Patent Litigation
Claim Construction
CCS Fitness: Ordinary Meaning
Triumphs
“Heavy presumption” that claim has its
ordinary meaning.
Claim term will cover any size or shape
structure unless expressly limited.
Inventor need not describe every
conceivable and future embodiment
Patent Litigation
Claim Construction
 CCS Fitness: Hard to Beat Presumption.
Only four ways to narrow ordinary meaning:
Patentee as lexicographer
 clear “definition” in specification or file history
Clear disavowal of claim scope
 Patentee distinguishes prior art based on particular
embodiment
Means-plus-function term
Claim is so unclear that intrinsic evidence
is needed to understand it.
Patent Litigation
Claim Construction
Teleflex, Inc. v. Ficosa North America
Corp., 299 F.3d 1313 (Fed. Cir. 2002)
 The CCS Fitness presumption gets
heavier.
Claim not limited to single disclosed
embodiment
Claim narrowed only if specification or file
history shows
 “words or expressions of manifest exclusion
or restriction” and
 “clear disavowal of claim scope”
Patent Litigation
Claim Construction
CCS Fitness and Teleflex Rules
Key inquiry is whether the patent expressly
describes alleged narrow embodiment as
“important” to the invention.
Can’t use intrinsic evidence’s silence to
narrow the meaning of the term
Can’t confine claim to single disclosed
embodiment unless there is clear
disavowal of claim scope.
Patent Litigation
Claim Construction
 Beckson Marine, Inc. v. NFM, Inc., 292 F.3d
718 (Fed. Cir. 2002)
Term not limited to specific shape or dimensions
shown in patent drawings
 Inverness Medical Switzerland GmbH v.
Warner Lambert Co., 309 F3d 1373 (Fed. Cir.
2002)
Term (“on” and “onto”) having two possible
meanings is construed to cover both meanings,
unless otherwise limited.
Ambiguous prosecution history does not limit term
Patent Litigation
Claim Construction
Dictionary Definitions
Dictionaries make comeback
But which dictionary to use?
Patent Litigation
Claim Construction
 Texas Digital Systems, Inc. v. Telegenix, Inc.,
308 F.3d 1193 (Fed. Cir. 2002)
“Dictionaries are always available” for helping
define disputed term
“Most meaningful” source for claim construction
Court may consult dictionary
at any stage of litigation, even if
no party has offered it into
evidence
Patent Litigation
Claim Construction
Texas Digital: Dictionaries in Twilight
Zone
Dictionaries are not really “extrinsic”
evidence
If all dictionary definitions are consistent
with the patent, claim will be construed to
cover all such definitions
Must consult dictionary that was available
“at the time the patent issued.”
Patent Litigation
Claim Construction
 Transclean Corp. v. Bridgewood Services,
Inc., 290 F.3d 1364 (Fed. Cir. 2002)
Disputed term is “resilient”
Technical dictionary or standard English
dictionary?
Technical dictionary is better
source when term is used in a
technical context to describe
component of a mechanical
device
Patent Litigation
Claim Construction
 Inverness Medical Switzerland GmbH v.
Princeton Biomeditech Corp., 309 F.3d 1365
(Fed. Cir. 2002).
Disputed term is “mobility”
Technical or standard English dictionary?
Standard English dictionary
will provide proper definition in
most cases.
Especially if no established
meaning in technical treatise
Patent Litigation
Claim Construction
General Creation LLC v. LeapFrog Enterprises, Inc.,
2002 WL 31548117 (W.D. Va., Nov. 18, 2002)
What does “book” mean?
Person of ordinary skill would
not turn to a dictionary to
determine its meaning.
Patent
is
better
than
dictionary
for
defining
common words in context of
the invention
Patent Litigation
Extrinsic Evidence
 Markman and Vitronics (1995-96) discredited
extrinsic evidence. Showed lack of faith in
juries.
 2002 saw comeback for extrinsic evidence.
Could mean more use of witnesses at Markman
hearings
 Verve, LLC v. Crane Cams, Inc., 311 F.3d 1116
(Fed. Cir. 2002)
Judge erred in excluding all extrinsic evidence
Patents written for skilled artisans and must be read
through their eyes. Extrinsic evidence aids that view.
Patent Litigation
Infringement Defenses
 Tate Access Floors, Inc. v. Interface Architectural
Resources, Inc., 279 F.3d 1357 (Fed. Cir. 2002).
Held: No “practicing the
prior art” defense to patent
infringement
Can’t avoid presumption
of validity and burden of
proof by raising prior art as
infringement defense
Patent Litigation
Validity Defenses
 Proof of Prior Public
Use -- §102(b)
 Juicy Whip, Inc. v.
Orange Bang, Inc.,
292 F.3d 728 (Fed.
Cir. 2002)
“post-mix” beverage
dispenser with
simulated display
Patent Litigation
Validity Defenses
Juicy Whip: G*d is my witness – and
that’s not enough
Six witnesses testified that they
saw or
used an anticipatory beverage dispenser
years before the patent application date.
Not enough.
Testimony must be corroborated by
physical evidence to be clear and
convincing
Patent Litigation
Validity Defenses
Juicy Whip: What do Barbed Wire and
Drink Dispensers have in common?
Uncorroborated testimony of witnesses
recalling long-past events is not clear and
convincing
Rules applies no matter whether witness is
interested or independent.
Witness’s
credibility not an issue.
Preferred proof:
contemporaneous
records, photos, models
Patent Litigation
Validity Defenses
Rosco, Inc. v. Mirror Lite Co., 304 F.3d
1373 (Fed. Cir. 2002)
Must corroborate testimony of prior invention
under § 102(g). Juicy Whip déjà vu.
Testimony alone is not clear and convincing
Alleged prior inventor must also show that, at
the time, he recognized and appreciated the
features of the invention
Patent Litigation
Validity Defenses
 Written description. The Federal Circuit takes
a mulligan.
Enzo Biochem, Inc. v. Gen-Probe Inc., 285 F.3d
1013 (Fed. Cir., April 2, 2002) (affirms summary
judgment of invalidity)
Enzo Biochem, Inc. v. Gen-Probe Inc., 63
USPQ.2d 1618 (Fed. Cir., July 15, 2002) (court
grants panel rehearing)
Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d
1316 (Fed. Cir., July 15, 2002)(reverses summary
judgment)
Patent Litigation
Validity Defenses
Enzo Biochem: Facts
Patent directed to nucleic acid probes
used in tests for gonorrhea
Inventors deposited biological samples at
the American Type Culture Collection
Specification describes the claimed
“composition of matter” only by its
biological activity or function—i.e., its ability
to hybridize to N. gonorrhoeae at a certain
ratio.
Patent Litigation
Validity Defenses
Enzo Biochem: The Holding
Deposit of biological materials in a public
depository can satisfy written description
requirement.
Departs from Regents of Univ. of Calif. v. Eli
Lilly, 119 F.3d 1559 (Fed. Cir. 1997), which
held that description of a gene’s function is
not enough to meet the requirement.
Now, some functional descriptions of genetic
material can satisfy description requirement.
Patent Litigation
Validity Defenses
Enzo Biochem (cont’d)
Adopts MPEP Guidelines
Holding comports with Festo’s recognition
that words cannot always fully describe an
invention
Liberalizes written description requirement
Complete about-face from court’s original
holding that “deposit is not a substitute for
a written description of the claimed
invention”
Patent Litigation
Validity Defenses
 All Dental Prodx, LLC v. Advantage Dental
Prods., Inc., 309 F.3d 774 (Fed. Cir. 2002)
Further liberalization of written description
requirement
Held: specification need not mention a limitation
introduced by amendment, so long as one of
ordinary skill would recognize that the new
limitation reflects the invention shown in the
specification
My Prediction: written description disputes will
depend on battle of the experts
Generic Drug/HatchWaxman
Exception to Year of the Plaintiff
Rulings favor Defendant Generic Drug
makers
Generic Drug/HatchWaxman
 Pending Legislation. All bark, little bite.
 McCain-Schumer bill passes Senate
Limits situation in which pioneer drug company
can seek automatic 30-month stay against generic
drug maker
Generic drug makers can file suit to de-list patents
from the FDA’s “Orange Book”
 Proposed New FDA Regulations
Permit only one automatic 30-month stay per
generic drug application
Generic Drug/HatchWaxman
 “Scare-the-pants off you”
Jurisdiction
Dr. Reddy’s Labs Ltd v.
aaiPharma Inc., 2002 WL
31059289 (S.D.N.Y., Sept. 13,
2002)
Prilosec patent owner’s vague
threats to the generic drug
industry as a whole, made in
Wall Street Journal article,
supported declaratory judgment
action by one generic drug
maker
Generic Drug/HatchWaxman
 Abbott Labs v. TorPharm, Inc., 300 F.3d 1367
(Fed. Cir. 2002)
ANDA specification defines the accused product for
purposes of determining infringement
If ANDA description of a
compound meets the claim
limitation, then there is no fact
question about infringement of
that limitation.
Why? Generic mfr. is bound
to sell a drug conforming to the
ANDA filing
Generic Drug/HatchWaxman
 McNeil-PPC, Inc. v. L. Perrigo Co., 207 F.
Supp.2d 356 (E.D. Pa. 2002)
Patents for particular formulation of Immodium A-D
(antidiarrheal drug) held to be obvious
Generic drug maker awarded attorneys’
fees. Exceptional case.
McNeil’s prosecution misconduct and
persistence in prosecuting “exceedingly
obvious” inventions criticized.
Patents part of a “scheme” for protecting
drug about to go off patent
IP YEAR IN REVIEW
PATENT LAW AND LITIGATION
The End