Patent Infringement
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Transcript of Patent Infringement
Patent InfringementPatent Infringement
Spec
PHOSITA
Judge
Obviousness
Jury
Damages
Claims
Experts
Hasit Seth
This communication is not legal advice and is not intended to form or solicit an attorney-client relationship.
About meAbout me
• Hasit Seth, Pune, India
• .edu = B.Sc, LL.M. (Mumbai Uni., Gold
Medal), LL.M. (IP, Franklin Pierce)
• Asia Patent Manager with a Fortune
200 US MNC in Industrial sector
• Hasits at gmail dot com
The Law
Patent InfringementPatent Infringement
1. 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.
Patent InfringementPatent Infringement
The Basic Law – 35 U.S.C. The Basic Law – 35 U.S.C. §271§271
© Hasit Seth, 2006
• Knowledge of Patented Invention is Not
Required
• Intent of Infringement is Not Required
Patent InfringementPatent Infringement
© Hasit Seth, 2006
What 35 U.S.C. Does Not RequireWhat 35 U.S.C. Does Not Require
Basics
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Facts:
• Plaintiff sued the United States for infringing 16 patents on helicopter
technology.
• Trial court: Held that 15 patents are valid and infringed
• Appeal Court: Upheld infringement of 11 patents
Patent InfringementPatent Infringement
© Hasit Seth, 2006
AUTOGIRO Co. of America v. United StatesAUTOGIRO Co. of America v. United States
Case summarizes many basics:
• Patent Act of 1952 first codified infringement in the statute .
• “The claims …provide the concise formal definition of the invention”
• “No matter how great the temptations of fairness or policy making, courts
do not rework the claims. THEY ONLY INTERPRET THEM.” (emphasis
added)
• “Although courts are CONFINED BY THE LANGUAGE of the CLAIMS,
THEY ARE NOT…CONFINED TO THE LANGUAGE of the CLAIMS
in INTERPRETING THEIR MEANING” (emphasis added)
Patent InfringementPatent Infringement
© Hasit Seth, 2006
AUTOGIRO Co. of America v. United States AUTOGIRO Co. of America v. United States 384 F.2d 391 (1967)384 F.2d 391 (1967) §112: “…one or more claims
particularly pointing out and distinctly claiming the subject matter… invention”
Case summarizes many basics… (contd.)
• “Things are not made for the sake of words,
but words for the sake of things. To overcome
this lag, patent law allows the inventor to be
his own lexicographer”
Patent InfringementPatent Infringement
© Hasit Seth, 2006
AUTOGIRO Co. of America v. United States AUTOGIRO Co. of America v. United States 384 F.2d 391 (1967)384 F.2d 391 (1967)
• All elements of the claim should read on the
accused device, either literally or through
equivalence
Patent InfringementPatent Infringement
© Hasit Seth, 2006
All Elements RuleAll Elements Rule
Two Step Process
• Determine the meaning of the Claim
• Read the claims on the accused structure
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Source:
AUTOGIRO Co. of America v. United States AUTOGIRO Co. of America v. United States 384 F.2d 391 (1967)384 F.2d 391 (1967)
Two Step Process
• Determine the meaning of the Claim
To derive the meaning of the claim and to reach the “felt
meaning” of the claim three documents are used:−Specification (includes claims)
−Drawings
−File Wrapper (a.k.a. Prosecution History)
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Source:
AUTOGIRO Co. of America v. United States AUTOGIRO Co. of America v. United States 384 F.2d 391 (1967)384 F.2d 391 (1967)
Two Step Process
• Read the claims on the accused structure−Literal Infringement
−Doctrine of Equivalence
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Source:
AUTOGIRO Co. of America v. United States AUTOGIRO Co. of America v. United States 384 F.2d 391 (1967)384 F.2d 391 (1967)
• Literal Infringement−Claim should read literally on the accused
structure− Claim 1.A writing device comprising:
an enclosure for holding a marker; and
a curved clip attached to the enclosure.
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Source: Image Source – Wikipedia.org
AUTOGIRO Co. of America v. United States AUTOGIRO Co. of America v. United States 384 F.2d 391 (1967)384 F.2d 391 (1967)
Elements
Preamble
Literal Infringement−“..law is to benefit the inventor’s genius and not the
scrivener’s talents…”
−Claims must read on the accused structures, and• structures must do the same function,
• in the same way, and
• accomplish substantially the same result
− Westinghouse v. Boyden Power Brake Co., 170 U.S. 537, at 568 (1898)
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Source: Image Source – Wikipedia.org
AUTOGIRO Co. of America v. United States AUTOGIRO Co. of America v. United States 384 F.2d 391 (1967)384 F.2d 391 (1967)
Two Step Process−Doctrine of Equivalence (DoE)
• Substance is more important than form• Guides:
−PHOSITA would have known of the interchangeable ingredient
−Pioneer patents a have wider range of equivalence
−DoE is subservient to file wrapper estoppel
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Source:
AUTOGIRO Co. of America v. United States AUTOGIRO Co. of America v. United States 384 F.2d 391 (1967)384 F.2d 391 (1967)
• DoE−Even without a literal overlap, a structure infringes
if it performs the substantially – same function, same way, and in the same way.
−Test: F-W-R (Function-Way-Result) Penwalt Corp. v. Durand-Wayland, Inc. 833 F.2d 931,934 (Fed. Cir. 1987)
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Source: Image Source – Wikipedia.org
AUTOGIRO Co. of America v. United States AUTOGIRO Co. of America v. United States 384 F.2d 391 (1967)384 F.2d 391 (1967)
• DoE
Patent InfringementPatent Infringement
© Hasit Seth, 2006
AUTOGIRO Co. of America v. United States AUTOGIRO Co. of America v. United States 384 F.2d 391 (1967)384 F.2d 391 (1967)
Claim
• DoE• A seating apparatus comprising:
a vertical support portion;
a horizontal seating portion attached to the vertical support portion; and
at least three support bases attached to the horizontal seating portion.
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Source: Image Source – Wikipedia.org
AUTOGIRO Co. of America v. United States AUTOGIRO Co. of America v. United States 384 F.2d 391 (1967)384 F.2d 391 (1967)
−Preamble: Does it include limitations? Or is it only an introduction?
−Generally, preamble is not used to interpret the claims, but it can be used if it breathes meaning into the claim
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Preamble and Claim InterpretationPreamble and Claim Interpretation
−General rule: Limitations may not be read into claims from specifications
−Yet, specification is used to interpret the claims
−Is there a dichotomy to be resolved here?
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Specification and Claim InterpretationSpecification and Claim Interpretation
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Source: Image Source – Wikipedia.org
Unique Concepts, Inc v. Brown Unique Concepts, Inc v. Brown 939 F.2d 1558 (Fed. Cir. 1991)939 F.2d 1558 (Fed. Cir. 1991)
• Facts:
• District Court (S.D.N.Y.) held that Brown’s certain
products do not infringe Unique’s patent US 4,018,260
(Baslow, April 19, 1977). Federal Circuit affirms.
• Apparatus: Assembly pieces to attach a fabric to the wall
• Applicant states during prosecution that “…an
amateur can practice the present invention”
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Source: Image Source – Wikipedia.org
Unique Concepts, Inc v. Brown Unique Concepts, Inc v. Brown 939 F.2d 1558 (Fed. Cir. 1991)939 F.2d 1558 (Fed. Cir. 1991)
• Claim 1 “…said assembly comprising linear border pieces and right
angle corner border pieces which are arranged …”
• Claim 9 (later cancelled) recited “…right angle corner pieces are formed
by a pair of short linear pieces whose ends are mitered and spaced from
each other to define a slot therebetween…”
• BROWN’s Assembly:− Mitered (cut at 45 degrees) pieces made from linear pieces aligned to form a
right angle
- Does not use pre-formed pieces
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Source: Image Source – Wikipedia.org
Unique Concepts, Inc v. Brown Unique Concepts, Inc v. Brown 939 F.2d 1558 (Fed. Cir. 1991)939 F.2d 1558 (Fed. Cir. 1991)
• Spec, Col. 8, lines 28-41
• Unique’s Spec describes both, mitered and preformed pieces
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Unique Concepts, Inc v. Brown Unique Concepts, Inc v. Brown 939 F.2d 1558 (Fed. Cir. 1991)939 F.2d 1558 (Fed. Cir. 1991)
• Majority− Claim 1 mentions two kinds of pieces – linear and corner one.
− Applied the “all element rule” and that the claim does not include unnecessary terms.
− The mitered alternative to preformed pieces was dedicated to the public since the claim covering it (claim 9) was cancelled. Now, you cannot use the specification support for that alternative to say that Claim 1 be interpreted to cover mitered alternative.
− Prosecution history’s use of “easy for Do-it-yourself” as an advantage shows that it was the preformed alternative that was the invention as claimed in Claim 1.
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Unique Concepts, Inc v. Brown Unique Concepts, Inc v. Brown 939 F.2d 1558 (Fed. Cir. 1991)939 F.2d 1558 (Fed. Cir. 1991)
• Dissent (Rich, J.)
− Cancelled Claim 9 indicates that the Claim 1 was intended to be a genus for both variants – mitered and preformed. The fact that it was cancelled has no consequence in interpreting Claim 1.
− The emphasis on “do-it-yourself” in the prosecution history is misplaced since it is tenuous. It is used only once in specification and once in the file-wrapper and is preceded by “somewhat”
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Unique Concepts, Inc v. Brown Unique Concepts, Inc v. Brown 939 F.2d 1558 (Fed. Cir. 1991)939 F.2d 1558 (Fed. Cir. 1991)
• Majority on DoE
− Majority upheld the trial court’s finding of no infringement under DoE
− “One of the main objects of the invention was stated to be to make something useful for a do-it-yourselfer. …The accused device has a different and complicated way of doing what the right-angle piece does in the patented device. It is a lot simpler for a the do-it-yourselfer to use the preformed right-angle pieces…”
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Graver Tank & Mfg. Co. v. Linde Air Products Co. Graver Tank & Mfg. Co. v. Linde Air Products Co. 339 U.S. 605 (1950) 339 U.S. 605 (1950)
• Linde is the owner of the Jones patent (2,043,960, June 9, 1936) for an
electric welding process and for fluxes used in that process
• Linde sued Graver for patent infringement for ‘960 patent
• District Court held four flux claims valid and infringed, and rest all
processes and some flux claims as invalid.
• Appeal court upheld the trial court’s validity and infringement findings
but reversed the invalidity findings.
• Supreme Court reversed the Appeal Court on the reversal and reinstated
the District Court finding.
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Graver Tank & Mfg. Co. v. Linde Air Products Co. Graver Tank & Mfg. Co. v. Linde Air Products Co. 339 U.S. 605 (1950) 339 U.S. 605 (1950)
Identical in operation, kind and quality of the welding
Mechanical methods of employing the compositions are the same
Lincolnweld 660 - FluxUnionmelt Grade 20 - Flux
Same composition as the product,
except it uses silicates of calcium
and manganese (not an earth
metal)
Patent - Combination of alkaline
earth metal silicate and calcium
fluoride
Product – Silicates of calcium and
magnesium, two alkaline earth
metal silicates
AccusedPatented
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Graver Tank & Mfg. Co. v. Linde Air Products Co. Graver Tank & Mfg. Co. v. Linde Air Products Co. 339 U.S. 605 (1950) 339 U.S. 605 (1950)
• Trial Court invoked DoE to find the flux claims valid and infringed
• Main issue – substitution of manganese (not an alkaline earth metal) for
magnesium (an alkaline earth metal) - is this change of material
insignificant and hence DoE applies or is it a change that makes DoE
inapplicable?
• Trial court said yes, DoE applies, and the Supreme Court agreed too.
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Hilton Davis Chemical Co. v. Warner-Jenkinson Co. Hilton Davis Chemical Co. v. Warner-Jenkinson Co. 62 F.3d 1512 (Fed. Cir. 1995), cert. granted, 116 S. Ct. 1014 62 F.3d 1512 (Fed. Cir. 1995), cert. granted, 116 S. Ct. 1014
(1996)(1996)
• Hilton Davis sued Warner-Jenkison for infringing US 4,560,746
• Jury found ‘746 as not invalid and that Warner-Jenkinson infringed
under DoE, and hence the Trial Court entered judgment on the jury
verdict
• The appeal court upheld the Trial Court judgment.
• Tests Used:
−The F-W-R (Function-Way-Result) test, and
−The “insubsantial differences” test
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Hilton Davis Chemical Co. v. Warner-Jenkinson Co. Hilton Davis Chemical Co. v. Warner-Jenkinson Co. 62 F.3d 1512 (Fed. Cir. 1995), cert. granted, 116 S. Ct. 1014 62 F.3d 1512 (Fed. Cir. 1995), cert. granted, 116 S. Ct. 1014
(1996)(1996)
• Hilton Davis (HD) sued Warner-Jenkison(WJ) – business of Food, Drug
and Cosmetic dyes
• Dye making process yield impurities that must be removed using a
purification process
• HD & WJ used a “salting out” purification process that was expensive
• ‘746 patent brought by HD used “ultrafiltration” (osmosis) to remove
impurities
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Hilton Davis Chemical Co. v. Warner-Jenkinson Co. Hilton Davis Chemical Co. v. Warner-Jenkinson Co. 62 F.3d 1512 (Fed. Cir. 1995), cert. granted, 116 S. Ct. 1014 62 F.3d 1512 (Fed. Cir. 1995), cert. granted, 116 S. Ct. 1014
(1996)(1996)
• Inventors added the phrase “at a pH from approximately 6.0 to 9.0”
during prosecution to distinguish U.S. 4,189,380 to Booth that used
ultrafiltration and operates at a pH above 9 and preferably between 11
and 13
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Hilton Davis Chemical Co. v. Warner-Jenkinson Co. Hilton Davis Chemical Co. v. Warner-Jenkinson Co. 62 F.3d 1512 (Fed. Cir. 1995), cert. granted, 116 S. Ct. 1014 62 F.3d 1512 (Fed. Cir. 1995), cert. granted, 116 S. Ct. 1014
(1996)(1996)
• WJ also tried to develop an ultrafiltration technique. They used an
“already salted out” solution for their test which was carried out one
week before HD’s test (both tests were done by Osmonics under a
secrecy agreement). WJ did not get the desired results.
• At trial HD showed that WJ’s ultrafiltration process at pressures in a
range of 200 to nearly 500 p.s.i.g. and a pH of 5.
P,S.I.G. – Pound per Square Inch Gauge
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Hilton Davis Chemical Co. v. Warner-Jenkinson Co. Hilton Davis Chemical Co. v. Warner-Jenkinson Co. 62 F.3d 1512 (Fed. Cir. 1995), cert. granted, 116 S. Ct. 1014 62 F.3d 1512 (Fed. Cir. 1995), cert. granted, 116 S. Ct. 1014
(1996)(1996)
• WJ also tried to develop an ultrafiltration technique. They used an
“already salted out” solution for their test which was carried out one
week before HD’s test (both tests were done by Osmonics under a
secrecy agreement). WJ did not get the desired results.
• At trial HD showed that WJ’s ultrafiltration process at pressures in a
range of 200 to nearly 500 p.s.i.g. and a pH of 5.
P,S.I.G. – Pound per Square Inch Gauge
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Hilton Davis Chemical Co. v. Warner-Jenkinson Co. Hilton Davis Chemical Co. v. Warner-Jenkinson Co. 62 F.3d 1512 (Fed. Cir. 1995), cert. granted, 116 S. Ct. 1014 62 F.3d 1512 (Fed. Cir. 1995), cert. granted, 116 S. Ct. 1014
(1996)(1996)
• Graver Tank case is said to have introduced the “substantiality of differences test”. For DoE to apply the differences must be insubstantial.
• Graver Tank uses substantiality in addition to the F-W-R test, meaning that F-W-R is not conclusive though often shows substantiality of differences. Factors other than F-W-R are considered for substantiality of differences determination
• Factors, e.g.:− PHOSITA’s knowledge of interchangeability would mean that the changes
are insubstantial− Evidence of copying indicates that the objectively measured differences are
insubstantial− Evidence of “designing around” works against finding DoE infringement.
But independent creation is irrelevant for DoE.
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Hilton Davis Chemical Co. v. Warner-Jenkinson Co. Hilton Davis Chemical Co. v. Warner-Jenkinson Co. 62 F.3d 1512 (Fed. Cir. 1995), cert. granted, 116 S. Ct. 1014 62 F.3d 1512 (Fed. Cir. 1995), cert. granted, 116 S. Ct. 1014
(1996)(1996)
• Infringement under DoE is a question of fact to be tried by a jury in a
jury trial
• Trial judge has no discretion to apply DoE when literal infringement is
not possible. Which means the Trial judge must apply DoE is there is not
literal infringement.
Patent InfringementPatent Infringement
© Hasit Seth, 2006
What Limits the Application Scope of DoE’s?What Limits the Application Scope of DoE’s?
• Prior Art
• Prosecution History Estoppel
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Equivalents for Means Plus Function ClaimsEquivalents for Means Plus Function Claims
• To determine whether a claim limitation is met
literally, where expressed as a means for performing
a stated function, the court must compare the
accused structure with the disclosed structure, and
must find equivalent structure as well as identity of
claimed function for that structure.Penwalt Cited in LaitramCorp v. Rexnord, Inc, 939 F.2d 1533 (Fed. Cir.
1991)
35 U.S.C. 112 para 6 - An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Equivalents for Means Plus Function ClaimsEquivalents for Means Plus Function Claims
• Literal infringement of a means-plus-function claim limitation requires that the relevant structure in the accused device perform the identical function recited in the claim and be identical or equivalent to the corresponding structure in the specification. Lockheed Martin Corp. v. Space Sys./Loral, Inc., 324 F.3d 1308, 1320 (Fed. Cir. 2003). Once the relevant structure in the accused device has been identified, a party may prove it is equivalent to the disclosed structure by showing that the two perform the identical function in substantially the same way, with substantially the same result. Kemco Sales, Inc. v. Control Papers Co., 208 F.3d 1352, 1364 (Fed. Cir. 2000). As the party asserting infringement, Applied ultimately bears the burden of proof.
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Equivalents for Means Plus Function ClaimsEquivalents for Means Plus Function Claims
• Literal infringement of a means-plus-function claim limitation requires that the relevant structure in the accused device perform the identical function recited in the claim and be identical or equivalent to the corresponding structure in the specification. Lockheed Martin Corp. v. Space Sys./Loral, Inc., 324 F.3d 1308, 1320 (Fed. Cir. 2003). Once the relevant structure in the accused device has been identified, a party may prove it is equivalent to the disclosed structure by showing that the two perform the identical function in substantially the same way, with substantially the same result. Kemco Sales, Inc. v. Control Papers Co., 208 F.3d 1352, 1364 (Fed. Cir. 2000). As the party asserting infringement, Applied ultimately bears the burden of proof.
• APPLIED MEDICAL RESOURCES CORPORATION, V. UNITED STATES SURGICAL CORPORATION (Fed. Cir. 2006)
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Equivalents for Means Plus Function ClaimsEquivalents for Means Plus Function Claims
• Means+Function Application:A. Find in the accused device the identical function recited in the
claimB. Find in the accused device the structure that is identical or
equivalent to the corresponding structure in the specificationC. To show equivalence between the structure of the accused device
and structure in the specification use the Function-Way-Result test. The equivalence is shown such that the two structures perform the identical function in substantially the same way to achieve substantially the same result.
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Indirect InfringementIndirect Infringement
• 35 U.S.C. 271
− 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 noninfringing use, shall be liable as a contributory infringer.
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Foreign Activity as InfringementForeign Activity as Infringement
• 35 U.S.C. 271 (f)(1) Whoever without authority supplies or causes to be supplied in or from the United States all or a substantial portion of the components of a patented invention, where such components are uncombined in whole or in part, in such manner as to actively induce the combination of such components outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer.
• (2) Whoever without authority supplies or causes to be supplied in or from the United States any component of a patented invention that is especially made or especially adapted for use in the invention and not a staple article or commodity of commerce suitable for substantial noninfringing use, where such component is uncombined in whole or in part, knowing that such component is so made or adapted and intending that such component will be combined outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer.
Patent InfringementPatent Infringement
© Hasit Seth, 2006
Process PatentsProcess Patents
• (g) Whoever without authority imports into the United States or offers to sell, sells, or uses within the United States a product which is made by a process patented in the United States shall be liable as an infringer, if the importation, offer to sell, sale, or use of the product occurs during the term of such process patent. In an action for infringement of a process patent, no remedy may be granted for infringement on account of the noncommercial use or retail sale of a product unless there is no adequate remedy under this title for infringement on account of the importation or other use, offer to sell, or sale of that product. A product which is made by a patented process will, for purposes of this title, not be considered to be so made after -
• (1) it is materially changed by subsequent processes; or
• (2) it becomes a trivial and nonessential component of another product.
Some Recent Cases
Patent InfringementPatent Infringement
© Hasit Seth, 2006
ORTHO-McNEIL v. CARACOORTHO-McNEIL v. CARACO(Fed. Cir. 2007) (Fed. Cir. 2007)
• Ortho (Plaintiff) appeals Dist. Courts summary judgment of non-infringment
• Federal Circuit Affirm, i.e., non-
infringement is upheld
ORTHO-McNEIL v. CARACOORTHO-McNEIL v. CARACO(Fed. Cir. 2007) (Fed. Cir. 2007)
• The ’691 patent has fifteen claims directed to a pharmaceutical composition comprising certain weight ratios of two known drugs, tramadol and acetaminophen – both are analgesics
• Certain ratios of both analgesics have super additive or
synergistic effect
ORTHO-McNEIL v. CARACOORTHO-McNEIL v. CARACO(Fed. Cir. 2007) (Fed. Cir. 2007)
• The [acetaminophen] and the tramadol material are generally present in a weight ratio of tramadol material to [acetaminophen] from about 1:1 to 1:1600. Certain ratios result in a composition which exhibits synergistic analgesic effects. For example, in a composition comprising a tramadol material and [acetaminophen], the ratio of the tramadol material: [acetaminophen] is preferably from about 1:5 to 1:1600; and, more preferably, from about 1:19 to 1:800. The most preferred ratios are from about 1:19 to 1:50. Compositions of a tramadol material and [acetaminophen] within these weight ratios have been shown to exhibit synergistic analgesic effects. In addition, the particular compositions wherein the ratio of the components are [sic] about 1:1 and about 1:5 are encompassed by the present invention.
ORTHO-McNEIL v. CARACOORTHO-McNEIL v. CARACO(Fed. Cir. 2007) (Fed. Cir. 2007)
• Caraco’s Abbreviated New Drug Application (“ANDA”) #77-184, as amended on or about July 26, 2005, evidences Caraco’s intent to make and sell a pharmaceutical composition containing tramadol and acetaminophen with an average weight ratio of tramadol to acetaminophen of 1:8.67. Caraco’s ANDA also expressly requires Caraco’s formulation to have a weight ratio of no less than 1:7.5.1 In response to Caraco’s ANDA, Ortho alleged that Caraco infringed claim 6 of the ’691 patent.
ORTHO-McNEIL v. CARACOORTHO-McNEIL v. CARACO(Fed. Cir. 2007) (Fed. Cir. 2007)
• Claim 6
• [A pharmaceutical composition comprising a tramadol
material and acetaminophen], wherein the ratio of the
tramadol material to acetaminophen is a weight ratio of
about 1:5.”
ORTHO-McNEIL v. CARACOORTHO-McNEIL v. CARACO(Fed. Cir. 2007) (Fed. Cir. 2007)
• Ortho: Proper construction is “approximately 1:5, and . . . encompasses a range of ratios of at least 1:3.6 to 1:7.1.”
• Caraco: Proper construction is “approximately 1:5, subject
perhaps to minor measuring errors of, say, 5 or 10%.”
• Carcao: Under either construction – NO LITERAL
INFRINGEMENT
• DoE: See Case Text Page 5 onwards
Patent InfringementPatent Infringement
© Hasit Seth, 2006
The End
ORTHO-McNEIL v. CARACOORTHO-McNEIL v. CARACO(Fed. Cir. 2007) (Fed. Cir. 2007)
• The ’691 patent has fifteen claims directed to a pharmaceutical composition comprising certain weight ratios of two known drugs, tramadol and acetaminophen – both are analgesics
• Certain ratios of both analgesics have super additive or
synergistic effect