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United States District Court, N.D. Illinois, Eastern Division
June 3, 2005.
ABBOTT LABORATORIES Plaintiff,
ANDRX PHARMACEUTICALS, INC., TEVA PHARMACEUTICALS USA, INC., and ROXANE LABORATORIES, INC. Defendants.
This matter comes before the court on plaintiff Abbott
Laboratories, Inc.'s ("Abbott") motion for a preliminary
injunction against defendant Teva Pharmaceuticals USA, Inc.
("Teva"). Plaintiff seeks to enjoin Defendant Teva from marketing
a generic version of the antibiotic drug, clarithromycin, in an
extended release formulation. Abbott is the patent holder on a
series of patents relating to clarithromycin, which Abbott
markets under the brand name "BIAXIN" and, in its extended
release formulation, "BIAXIN XL." Abbott alleges that Teva's
generic product infringes Plaintiff's U.S. Patent Nos. 4,680,386
("the `386 patent"); 6,010,718 ("the `718 patent"); and 6,551,616
("the `616 patent"), relating to its BIAXIN XL product.
Abbott Laboratories filed a complaint against Andrx
Pharmaceuticals, Inc. ("Andrx"), Teva Pharmaceuticals USA, Inc.,
and Roxane Laboratories, Inc. ("Roxane"), alleging patent
infringement. Andrx, Teva, and Roxane manufacture and market
generic versions of branded pharmaceuticals in the United States. Abbott sought a declaratory judgment
that these defendants would infringe the `386 patent. In addition, Abbott
sought a declaratory judgment against both Teva and Andrx of infringement of
Abbott's United States Patent Nos. 6,551,616 ("the `616 patent"), 6,010,718
("the `718 patent"), and 6,872,407 ("the `407 patent"). Each of these
patents pertains to Abbott's branded antibiotic product, BIAXIN XL, which is
an extended release formulation of clarithromycin, an erythromycin
Clarithromycin is a macrolide antibiotic used to treat
bacterial infections, particularly those of the skin and upper
respiratory system. Abbott held a patent on the immediate release
version of clarithromycin, marketed as BIAXIN, until the patent
expired on May 23, 2005. Abbott began marketing BIAXIN in the
United States in approximately 1991. In 2000, Abbott was issued
two formulation patents (the `616 and the `718 patents) on an
extended release formulation of clarithromycin. Abbott began
marketing this extended release formulation under the name BIAXIN
XL in 2000. As of May 2005, Abbott estimated that BIAXIN XL
accounted for approximately 70% of the sales in the BIAXIN
market. Generic competitors entered the market for immediate
release clarithromycin on May 24, 2005.
Abbott brought an application for a temporary restraining order
against Andrx and Teva in this court. Andrx and Abbott entered a
stipulated temporary restraining order on May 20, 2005. This
court held a hearing and entered a temporary restraining order
against Teva on May 20, 2005.*fn1 This court then held a
hearing on Abbott's motion for a preliminary injunction against
Teva. Teva does not dispute that its generic clarithromycin extended
release formulation infringes Abbott's `718 and `616 patents.
Rather, Teva asserts that those patents, along with the `386
patent, are invalid for obviousness under 35 U.S.C. § 103 (2004).
In addition, Teva asserts that it does not infringe the `386
A party seeking a preliminary injunction must make a four-part
threshold showing that (1) the movant has some likelihood of
success on the merits of the underlying litigation; (2) immediate
irreparable harm will result if the relief is not granted; (3)
the balance of hardships to the parties weighs in the movant's
favor; and (4) the public interest is best served by granting the
injunctive relief. Polymer Techs., Inc. v. Bridwell,
103 F.3d 970, 973 (Fed. Cir. 1996).
A. Likelihood of Success on the Merits
In order to show that it has a likelihood of success on the
merits, in light of the burdens and presumptions that will be
present at trial, the movant must first prove that the non-movant
infringes the patents in suit, and also that the movant's
infringement claim will likely survive the non-movant's
challenges on the basis of patent invalidity and
unenforceability. Genentech, Inc. v. Novo Nordisk, A/S,
108 F.3d 1361, 1364 (Fed. Cir. 1997). A patent is presumed to be
valid, 35 U.S.C. § 282 (2002), and at trial, the party raising a
validity challenge must prove invalidity by clear and convincing
evidence. This presumption does not relieve a patentee who moves
for a preliminary injunction from carrying its normal burden of
demonstrating a likelihood of success on all disputed liability
issues at trial, including validity. Id. at 1364, n. 2. A
validity challenge at the preliminary injunction stage can
succeed on evidence that would not support a judgment of validity at trial. Amazon.com, Inc. v. Barnesandnoble.com,
Inc., 239 F.3d 1343, 1359 (Fed. Cir. 2001). "Vulnerability is
the issue at the preliminary injunction stage, while validity is
the issue at trial." Id. The alleged infringer must identify at
least some persuasive evidence of invalidity at this early stage
to overcome the presumption of validity. Pharmacia & Upjohn Co.
v. Ranbaxy Pharmaceuticals, Inc., 274 F. Supp. 2d 597, 601 (N.D.
Ill. 2003). The patentee also is held to a less stringent
standard and must only present a "clear case supporting the
validity of the patent in suit." Id. A patentee can make such a
case by showing, for example, that the patent in suit has
withstood previous validity challenges in other proceedings or
benefitted from a long period of industry acquiescence in its
Abbott asserts that it is likely to succeed on the merits
because it will likely prove infringement at trial of one or more
of the claims of the patents-in-suit. Plaintiff also contends
that it likely will demonstrate that Defendant's challenges to
the validity of the patents in suit lack substantial merit.
Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343,
1351 (Fed. Cir. 2001).
1. Infringement Analysis
An infringement inquiry proceeds in two steps. Pharmacia,
274 F. Supp. 2d at 601. First, the court must determine, as a matter
or law, the correct scope and meaning of the disputed claim term.
Then, the court must compare the properly construed claim to the
accused device and ascertain whether that device contains every
limitation of the claim or a substantial equivalent thereof.
There is a "`heavy presumption' that a claim term carries its
ordinary and customary meaning." CCS Fitness Inc. v. Brunswick
Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002). Claim terms should therefore be accorded their ordinary meaning unless
the patentees "clearly set forth a definition of the disputed
claim term in either the specification or prosecution history."
Id. When interpreting an asserted patent claim, the court
should look first to the intrinsic evidence of record, which is
the patent itself, including its claims, specification, and
complete prosecution history. Markman v. Westview Instruments,
Inc., 52 F.3d 967, 979 (Fed. Cir. 1995) (en banc), aff'd
517 U.S. 370 (1996). This intrinsic evidence is the primary and most
significant source of the legally operative meaning of any claim
language that is in dispute. Vitronics Corp. v. Conceptronic,
Inc. 90 F.3d 1576, 1583 (Fed. Cir. 1996). The court may also
consider extrinsic evidence such as expert declaration evidence
provided for the parties. Pharmacia, 274 F. Supp. 2d at 602.
Abbott is the exclusive U.S. licensee of the `386 patent which
discloses a compound (and the salts thereof) formed during the
most commonly used process for the synthesis of
6-0-methylerythromycin, commonly known as clarithromycin. This
compound is referred to in the patent as an "intermediate" for
the preparation of clarithromycin. The compound itself is
referred to as 6-0-methylerythromycin A 9-oxime ("9-oxime") and,
according to the patent, "is useful in the preparation of
clarithromycin and useful as an antibacterial agent." U.S. Pat.
No. 4,680,386 at 1:5-10.
Abbott claims that 9-oxime is present in trace amounts in
Teva's extended release clarithromycin product. Teva denies that
9-oxime is present in its product, but asserts that if it is
present, the quantities are insignificant and cause no harm to
Abbott (or benefit to Teva) and, finally, that the `386 patent is
invalid because of obviousness. At this early stage of the proceedings, the parties have raised
no issue as to claim construction.
Teva resists Abbott's claim that its product infringes the `386
patent. Abbott's expert, Alexander Schilling, tested Teva's bulk
product and found 9-oxime in the amount of one part per million
(ppm). Teva's expert, George Gokel, disputes this finding and
criticizes Schilling's methodology. The Court is not persuaded
that Schilling's methodolology and finding are unreliable,
especially in light of exhibit A to the Declaration of Jennifer
L. Polse in Support of Abbott's Motion for a Preliminary
Injunction against Teva. That exhibit appears to be a letter (on
Teva letterhead) from Michaela Rapaport of the Regulatory Affairs
Department, Teva, API Division to Mr. Moshe Nulman. The reference
is: "RE: Impurity. Clarithromycin 9-oxime (CLM oxime)." In
substance, the letter reads:
Please be informed that the impurity Clarithromycin
9-oxime (CLM oxime) will no longer be listed on the
Certificate of Analysis. Furthermore, it will not be
included in the official Drug Master File as a
potential impurity. However, due to different
regulatory considerations, the levels of this
impurity will be monitored continually but will not
officially be reported.
As this court noted in a prior decision regarding a temporary
restraining order, Teva apparently concedes that if the `718 and
`616 patents are valid, it will be infringing them. For that
reason, this court will turn directly to a validity analysis of
those two patents.
2. Invalidity Defense-Obviousness
Only a valid patent gives the patent owner the right to exclude
others; an invalid patent cannot be infringed. For this reason,
accused patent infringers often seek to demonstrate that the patentee's patent is invalid and that they cannot be held liable
for infringement. One of the requirements for patentability is
that a new and useful product or process be "nonobvious."
35 U.S.C. § 103 (2004). Section 103 denies patents to those devices
where "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 having ordinary skill in the art to which said
subject matter pertains." The "person . . . of ordinary skill" is
not the inventor but rather someone "who . . . is not one who
undertakes to innovate, whether by patient, and often expensive,
systematic research or by extraordinary insights. . . ."
Standard Oil Co. v. Am. Cyanamid Co., 774 F.2d 448, 454 (Fed.
Cir. 1985). Obviousness must be evaluated not by reference to
each individual part claimed, but rather by reference to the
invention as a whole. Gillette Co. v. S.C. Johnson & Son, Inc.,
919 F.2d 720, 724 (Fed. Cir. 1990). To avoid the temptation of
what the Federal Circuit has termed the "hindsight trap," courts
require some motivation or teaching that would lead a person of
ordinary skill in the art to arrive at the claimed invention.
See In Re Rouffet, 149 F.3d 1350 (Fed. Cir. 1998).
An assessment of the likelihood of validity of a patent claim
over the prior art involves a two-step process similar to that
used for assessing the likelihood of success on the merits.
Oakley, Inc. v. Sunglass Hut Int'l, 316 F.3d 1331, 1339 (Fed.
Cir. 2003); Smiths Indus. Med. Sys., Inc. v. Vital Signs, Inc.,
183 F.3d 1347, 1353 (Fed. Cir. 1999). In the first step, the
court must construe the claims asserted. Smiths Indus. Med.
Sys., Inc. v. Vital Signs, Inc., 183 F.3d 1347, 1353 (Fed. Cir.
1999). The second step requires the court to compare the asserted
claims with the prior art. Whether a claim would have been
obvious under 35 U.S.C. § 103 is a question of law based on
findings of fact. Smiths, 183 F.3d at 1354. When the
presumptions and burdens that will inhere at trial are considered, the injunction should
not issue if the opposing party raises "a substantial question
concerning infringement or validity, meaning that it asserts a
defense that [the moving party] cannot prove lacks substantial
merit." Tate Access Floors, Inc. v. Interface Architectural
Resources, Inc., 279 F.2d 1357, 1365 (Fed. Cir. 2002).
Teva alleges that Abbott's patents in suit are invalid because
of obviousness. The party alleging invalidity has the burden of
persuasion on demonstrating invalidity. To establish a prima
facie case of obviousness, there must be a showing of a teaching
in the prior art that would lead one of ordinary skill to combine
the relevant teachings of the prior art references. Tec Air,
Inc. v. Denso Mfg. Mich. Inc., 192 F.3d 1353, 1359-60 (Fed. Cir.
1999). In a challenge based on obviousness under 35 U.S.C. § 103,
the party alleging invalidity must show prior art references
which alone or combined with other references would have rendered
the invention obvious to one of ordinary skill in the art at the
time of invention. The party seeking a finding of patent
invalidity based on obviousness must also show some motivation or
suggestion to combine the prior art teachings. See In re
Rouffet, 149 F.3d 1350, 1355 (Fed. Cir. 1998); Motorola Inc. v.
Interdigital Technology Corp., 121 F.3d 1461, 1472 (Fed. Cir.
1997). A suggestion or motivation to combine generally arises in
the references themselves, but may also be inferred from the
nature of the problem or occasionally from the knowledge of those
of ordinary skill in the art. See Rouffet, 149 F.3d at 1355.
To determine obviousness, a court examines 1) the scope and
content of the prior art; 2) the level of ordinary skill in the
art; 3) the difference between the claimed invention and the
prior art; and 4) the objective evidence of nonobviousness. Iron
Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1320
(Fed. Cir. 2004) (citing Graham v. John Deere Co., 383 U.S. 1,
17-18 (1966)). The standard for obviousness does not require absolute
predictability but rather looks for a "reasonable expectation of
success." See In re O'Farrell, 853 F.2d 894, 904-904 (Fed. Cir.
a. Claims 2 and 4 of the `718 patent
Claim 2 of the `718 patent*fn2 describes "the
pharmaceutical compound of claim 1 ["A pharmaceutical composition
for extended release of an erythromycin derivative in the
gastrointestinal environment, comprising an erythromycin
derivative and from about 5 to about 50% by weight of a
pharmaceutically acceptable polymer, so that when ingested
orally, the composition induces statistically significantly lower
mean fluctuation index in the plasma than an immediate release
composition of the erythromycin derivative while maintaining
bioavailability substantially equivalent to that of the immediate
release composition of the erythromycin derivative"], wherein the
polymer is a hydrophilic water-soluble polymer." U.S. Pat. No.
6,010,718, at 11:39-40. Put in simpler terms, the claim describes
a composition of "an erythromycin derivative" combined with a
hydrophilic water-soluble pharmaceutically acceptable polymer to
make an extended release formulation.
Claim 4 repeats the description of the pharmaceutical
composition from claim 1 and adds that "upon oral ingestion,
maximum peak concentrations of the erythromycin derivative are
lower than those produced by an immediate release pharmaceutical
composition, and area under the concentration-time curve and the
minimum plasma concentration are substantially equivalent to that
of the immediate release pharmaceutical composition." U.S. Patent
No. 6,010,718, at 11:48-58. This means that the concentration-time curve
representing the concentration of drug in blood plasma will be
flatter and lower for the extended release formulation than for
the immediate release formulation, but will have an area under
the curve ("AUC") that is substantially equivalent to that of its
immediate release corollary. At the same time, the minimum plasma
concentration for the extended release formulation will be
substantially the same as that of the immediate release
formulation, meaning that the drug will be present in the blood
at the same minimum level at all times for both the immediate
release and extended release formulations.
The parties do not dispute that clarithromycin is an
erythromycin derivative. The extended release composition at
issue is designed for release in the gastrointestinal environment
(e.g., oral administration). They agree that both Abbott's and
Teva's products contain from about 5 to about 50% of a
pharmaceutically acceptable polymer (specifically HPMC).
The language of the `718 patent itself states that the
"pharmaceutically active compound" of the composition "is an
erythromycin derivative." It goes on, "[p]referably, the
erythromycin derivative is 6-O-methoxy erythromycin A, known as
clarithromycin." The language of the claim is definite ("is an
erythromycin derivative") but not closed. It does not specify
that the pharmaceutically active compound "is a member selected
from the group consisting of A, B, and C." The patent further
defines "erythromycin derivative" as meaning "erythromycin having
no substituent groups, or having conventional substituent groups,
in organic synthesis, in place of a hydrogen atom of the hydroxy
groups and/or a methyl group of the 3'-dimethylamino group, which
is prepared according to the conventional manner." U.S. Pat. No.
6,010,718, at 3:34-39. From this language, "erythromycin derivative" includes only two
macrolides: erythromycin A and clarithromycin. See also Teva's
2d Lee Decl., at ¶ 75.
The `718 patent description of the "pharmaceutically acceptable
polymer" uses a closed term. Claim drafters often use the term
"group of" to signal a Markush group, which lists specified
alternatives in a patent claim. The typical form of a Markush
group is "a member selected from the group consisting of A, B,
and C." See Manual of Patent Examining Procedure § 803.2 (2004)
(quoted in Gillette Co. v. Energizer Holdings, Inc.,
405 F.3d 1367, 1372 (Fed. Cir. 2005)). By its nature, the Markush group is
closed. The `718 patent describes the "pharmaceutically
acceptable polymer" as "a water-soluble hydrophilic polymer
selected from the group consisting of polyvinylpyrrolidine,
hydroxypropyl cellulose, hydroxypropylmethyl cellulose, methyl
cellulose, vinyl acetate/crotonic acid copolymers, methacrylic
acids copolymers, maleic anhydride/methyl vinyl ether copolymers
and derivatives and mixtures thereof." U.S. Pat. No. 6,010,718,
at 3:65-4:4. It describe the "more preferabl[e]" polymer as
hydroxypropylmethyl cellulose, or HPMC. There is no dispute over
whether the claim includes HPMC; clearly, it does. The term
excludes other forms of polymers, such as hydrophobic or water
insoluble substances (e.g., wax).
Teva notes that Abbott defined "erythromycin derivative" in the
`718 patent in such a way as to leave out azithromycin.
Azithromycin is the name for
9a-aza-9a-methyl-9-deoxo-9a-homoerythromycin A. Pfizer, the
patent holder on azithromycin, describes azithromycin as a "broad
spectrum antimicrobial compound derived from erythromycin A." WO
95/30422 (the `422 patent"). It is likely that Abbott consciously
defined "erythromycin derivative" as it did to avoid infringing
Pfizer's existing `422 patent. Abbott argues and Teva concedes
that azithromycin is not identical to clarithromycin. The questions
are: how similar and dissimilar are the two molecules; and what
are the implications of these similarities and dissimilarities to
a person of ordinary skill in the art in light of prior art at
the time of the invention. Specifically, would a person of
ordinary skill in the art have had a reasonable expectation of
success in creating an extended release formulation of
clarithromycin using a hydrophilic water-soluble polymer based on
the prior art, including the `422 patent for an extended release
formulation of azithromycin with such a polymer?
Teva's expert contends that the prior art was sufficient such
that it would have been obvious to a person of ordinary skill in
the art*fn3 that there was a reasonable expectation of
success in making an extended release formulation of
clarithromycin with the claimed attributes. From the 1950s
onward, Teva asserts, extended release formulations were known to
persons skilled in the art. By at least the mid-1960s, persons
skilled in the art would have known about the use of HPMC in
formulating extended release drugs. The basic patent for this
technology, U.S. Patent No. 3,065,143, was granted in 1962, and
describes "a dosage unit form for the administration of
medicaments which releases the medicament at a relatively uniform
rate over a long period of tine." The patent goes on to describe
motivations for designing an extended release dosage form,
including avoiding gastrointestinal side effects. By the late
1980s, using HPMC to formulate extended release dosage forms of
pharmaceuticals was "well within the skill of the art." Teva's 2d
Lee Decl., at ¶ 50. In addition, by the early 1990s, leading
pharmacokinetics textbooks disclosed the ideal pharmacokinetic profile of an extended
release dosage form. Specifically, the textbooks taught that the
ideal formulation would have a longer time to maximum blood
plsama concentration of the drug (Tmax) and lower maximum
blood plasma concentration of the drug (Cmax), but maintain
substantially the same bioavailability as the corresponding
immediate release form. Textbooks also disclosed that the degree
of fluctuation of blood plasma drug levels was a useful parameter
for evaluating extended release formulations. Id. at ¶ 54. By
the mid-1980s, extended release formulations were being used to
reduce or minimize gastrointestinal side effects associated with
fluctuating blood plasma drug levels. 2 Robert S. Langer & Donald
L. Wise, Medical Applications of Controlled Release 23 (1984).
Teva's expert notes that an extended release form of
azithromycin, another macrolide, had been developed for the
purpose of reducing GI side effects. Teva describes this dosage
form as "essentially identical to the dosage form disclosed in
the `718 patent." Teva's 2d Lee Decl., at ¶ 58.
Teva argues that by the early 1990s, persons of ordinary skill
in the art would have known that erythromycin A, clarithromycin,
and azithromycin, all closely related molecules, had similar
properties for the purpose of designing dose forms.
Clarithromycin and azithromycin, both erythromycin derivatives,
were developed by making small changes to the molecular structure
of erythromycin. The principal considerations for formulating a
drug in a particular dosage form are molecular size, solubility,
and compound acidity (or pKa). Erythromycin A, azithromycin, and
clarithromycin have similar sizes, solubilities, and pKa values.
Teva's 2d Lee Decl., at ¶ 63. In addition, Abbott's U.S. Patent
No. 5,705,190 ("the `190 patent"), filed in 1995, disclosed and
claimed that the three compounds can be used in similar
formulations with similar results. Taisho Pharmaceutical Co.,
Abbott's licensor for clarithromycin (international patent
application WO 93/17667, published in 1993) disclosed dosage forms for improving
the taste of "an unpleasantly tasting basic drug," including
forms such as erythromycin A, azithromycin, and clarithromycin.
Teva purports to set out a series of prior art references that
would support a finding of invalidity for obviousness of Abbott's
extended release formulation patents. Teva points to two patents
issued in the 1980s which disclosed dosage forms for extended
release compositions including erythromycin stearate and HPMC.
U.S. Patent No. 4,369,172; U.S. Patent No. 4,871,548. During the
1990s, Pfizer's `422 patent application disclosed using
hydrophilic polymers, such as HPMC, to make extended release
dosage forms of azithromycin to control gastrointestinal side
Teva's expert opines that the subject matter of each of
Abbott's claims asserted under the `718 patent would have been
obvious. Teva bases this on the prior art, which it argues
created a motivation to make an extended release formulation of
clarithromycin. The half life of immediate release clarithromycin
was between three and seven hours, depending on dosage; thus,
patients had to take the drug twice per day, which led to greater
blood plasma drug level fluctuations and consequently, greater
negative side effects such as gastrointestinal distress and taste
perversion. Teva contends that a person of ordinary skill in the
art would have known that an extended release formulation would
reduce these side effects and that formulations using HPMC had
been previously made with clarithromycin's close molecular
relatives erythromycin A and azithromycin. Thus, a person of
ordinary skill in the art would have had a reasonable expectation
of success in making an extended release formulation of
clarithromycin using HPMC with the described characteristics. In
addition, Teva asserts that claim 2 of the `616 patent is invalid
for obviousness because the use of extended release formulations
in reducing gastrointestinal side effects of drug was widely
known by the mid-1990s. It was also known that the principal side effects of erythromycin and its derivatives, including
clarithromycin, are gastrointestinal and that the effects vary
with dosage amount.
Abbott notes that most inventions arise from a combination of
old elements. The Federal Circuit has stated that "identification
in the prior art of each individual part claimed is insufficient
to defeat patentability of the whole claimed invention." In re
Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000). Instead, "there
must be some motivation, suggestion or teaching of the
desirability of making the specific combination that was made by
the applicant."
Abbott submitted declarations from its own experts.*fn4
According to its expert testimony, Abbott contends that its `718
and `616 patents would not have been obvious. Abbott contends
that Teva incorrectly assumes that the active pharmaceutical
compound in a formulation is interchangeable. Instead, Abbott
contends that even similar molecular compounds such as the
erythromycin derivatives azithromycin and clarithromycin are too
different to be exchanged in such a manner. As an initial
question, drug formulators seeking to create an extended release
formulation closely consider such parameters as metabolism and
excretion characteristics of a drug. Drugs with very short or
very long half lives are often unsuited for extended release
formulations. Azithromycin has a half-life of almost 70 hours,
compared to clarithromycin's half life of three to four hours.
Abbott notes that although Pfizer patented an extended release
formulation of azithromycin (the `422 patent), it has apparently
never attempted to commercially exploit the product. Banker Supp. Decl., at ¶ 31. Azithromycin
and clarithromycin are also metabolized very differently by the
human body. Clarithromycin produces an active metabolite, whereas
azithromycin does not. Banker Supp. Decl. at ¶ 29. Azithromycin
can be taken with or without food, but extended release
clarithromycin must be taken with food (the "food effect") in
order to maintain substantially the same bioavailability as the
immediate release version. Id. at ¶ 33. The chemical structure
of the molecules differs as well. Azithromycin has a 15-member
ring structure with a nitrogen atom in the 10-position, which
makes it somewhat more stable in the gastric environment than
clarithromycin, a macrolide without such a structure. Id. at ¶
34. Thus, Abbott argues, a person of ordinary skill in the art
would not have had a reasonable expectation that the azithromycin
formulation disclosed in the `422 patent was applicable to
clarithromycin or would lead to the features claimed in the `718
In addition, Abbott notes that the polymer selected for the
invention was not obvious. There were other polymers available.
Indeed, Abbott had patented another form, alginate, and conducted
several years of research on extended release formulations of
clarithromycin with alginate. Teva contends that Abbott's failure
with the alginate formulation does not make the use of HPMC any
less obvious but rather implies a reluctance to abandon a
research avenue. Teva also notes that Abbott held a broad patent
on alginate formulations and so had a financial incentive to
exploit it. However, Abbott contends that "numerous other
extended release [formulation] methods existed at the time of the
invention, including osmotic pumps, microspheres,
diffusion-controlling films and membranes, and ion exchange
technology." Banker Supp. Decl., at ¶ 6. Teva has provided prior art consisting of textbook excerpts,
government publications to the industry, previously issued
patents, industry sales brochures, an excerpt from the
Physicians' Desk Reference, and articles from trade journals. A
review of these materials demonstrates that there were sources in
the prior art discussing extended release formulations and
seeking ways to develop formulations that achieved desirable
pharmacokinetic goals. The key difference between the prior art
and the claims at issue in the `718 patent is that none of the
prior art specifically discloses the combination of an
erythromycin derivative with a water soluble hydrophilic polymer
to achieve the asserted claims. The question is whether combining
clarithromycin with the prior art references, with a reasonable
expectation of achieving the asserted claims, would have been
obvious to one skilled in the art.
Abbott contends that Teva's argument is fatally flawed because
it fails to analyze the obviousness of the invention as a whole.
Abbott admits that Teva can identify references in the prior art
with discrete elements of the invention. However, none of these
individual prior art references alone or in combination
constitute the invention that is the subject of the `718 patent.
Abbott argues that Teva has failed to show the existence of any
suggestion or motivation to combine these prior art references or
to demonstrate how they would be combined to arrive at the
claimed invention.
This court finds that Teva has failed to raise a substantial
question as to the validity of Abbott's claims 2 and 4. The prior
art cited by Teva discloses discrete portions of the asserted
claims, but Teva fails to demonstrate that this would be
sufficient to give a person of ordinary skill in the art a
reasonable expectation of success. Teva's prior art references
reveal that using HPMC was a logical line of inquiry but the
dissimilarities between the drugs with which HPMC had been successfully combined and clarithromycin defeat Teva's
claim of obviousness. This court is mindful of the Federal
Circuit's warning about the risk of the "hindsight trap," or the
post facto belief that an invention, which seems obvious once
created, would have been obvious to people skilled in the art at
the time. Abbott has provided ample evidence that its invention
was not obvious and that there were many other extended release
formulation methods known in the prior art. In fact, the
existence of alternate methods and the attempted exploitation of
some of those methods provide secondary considerations of
nonobviousness. These factors suggest that there was a long-felt
need for the invention, that others, including Abbott, initially
failed to develop the invention, and go a long way to account for
the commercial success that Abbott has unquestionably enjoyed
with its BIAXIN XL product. See, e.g., Iron Grip Barbell Co.,
Inc. v. USA Sports, Inc., 392 F.3d 1317, 1324 (Fed. Cir. 2004);
see also For Your Ease Only, Inc. v. Natural Sci. Indus., Ltd.,
No. 02-C-1584, 2003 WL 22112997, at *7-*9 (N.D. Ill., Sept. 10,
b. Claim 6 of the `718 patent
Claim 6 is defined as "an extended release pharmaceutical
compound comprising an erythromycin derivative and a
pharmaceutically acceptable polymer, the composition having an
improved taste profile as compared to the immediate release
formulation." U.S. Pat. No. 6,010,718, at 12:23-27. The terms of
the patent do not explicitly define "taste profile." Rather, they
define "taste perversion" as "the perception of a bitter metallic
taste normally associated with the erythromycin derivatives,
particularly, with clarithromycin." U.S. Pat. No. 6,010,718, at
3:53-55. In the description of Example 3, the words "taste
profile" appear in parentheses immediately following the words "taste perversion." Id. at
9:23-24. A reasonable inference is that the terms are used
Teva contends that claim 6 should be found invalid for
obviousness. It was known that clarithromycin caused taste
perversion and this created a motivation for formulators to try
to create an extended release formulation that would have a
improved taste profile. As support, Teva cites a 1993 article
written by Abbott researchers, discussing the pharamacokinetics
of single- and multiple-dose clarithromycin. S.-y. Chu et al.,
Single- and Multiple-dose Pharmacokinetics of Clarithromycin, a
New Macrolide Antimicrobial, 33 J. CLIN. PHAMACOL. 719-26
(1993). The article disclosed a study performed on thirty-eight
human subjects, of whom one reported taste perversion as a side
effect at the 500 milligram dose level. One subject also reported
incidences of hot flashes and another reported nausea at that
dosage level. Id. at 721. This study and its publication in an
industry journal demonstrate that an invention that would reduce
taste perversion would have been obvious to a person of ordinary
skill in the art at the time, according to Teva.
Abbott notes that Teva provides evidence only with reference to
"taste masking," and not to "taste perversion." Taste masking,
somewhat inscrutably, is "a process that prevents the dosage from
dissolving in the mouth." Banker Supp. Decl., at ¶ 37 n. 6. Taste
perversion, by contrast, continues while the drug is present in
the bloodstream and commonly results in a chronic unpleasant
metallic taste. In addition, Abbott argues that Teva's reliance
on the Abbott study disclosed in the Journal of Clinical
Pharmacology overstates its case. Only one of thirty-eight
subjects reported taste perversion as a side effect, and only at
one of four different dosage levels. Teva's additional reliance
on Pfizer's `422 patent is inapposite, according to Abbott, because nothing in the `422 patent discusses either taste masking
or taste perversion at all. Banker Supp. Decl., at ¶ 39. Abbott
asserts, moreover, that the mere fact of taste perversion does
not make the `718 patent, specifically claim six, obvious. It
also states that Teva has not shown evidence that taste
perversion is, in fact, dose dependent. Abbott's expert testified
that taste perversion is a poorly understood physiological
phenomenon and that even if it is dose dependent, it does not
logically follow that an extended release formulation would
reduce the phenomenon. Banker Supp. Decl., at ¶ 41. Abbott
contends Teva has offered insufficient evidence to support a
finding of obviousness.
This court agrees with Abbott that Teva has not met its burden
of raising a substantial question as to the validity of claim 6.
Teva relies primarily on only one study, cited apparently in only
one article, that mentions taste perversion as a known side
effect of clarithromycin, and even then, in only one of
thirty-eight research subjects. This court finds that Teva has
failed to provide sufficient evidence to demonstrate that
improved taste profile as a result of an extended release
formulation of clarithromycin would have been obvious to an
ordinary person skilled in the art.
c. Claim 2 of the `616 patent
Claim 2 of the `616 patent*fn5 describes "a method of
reducing gastrointestinal adverse side effects comprising
administering an effective amount of an extended release
pharmaceutical composition comprising an erythromycin derivative
and a pharmaceutically acceptable polymer, wherein the
erythromycin derivative is clarithromycin." U.S. Patent No.
6,551,616, at 12:39-46. Teva asserts that claim 2 of the `616 patent should be found
invalid because it claims an obvious method. Well before the
invention of the patent, adverse gastrointestinal effects were
widely known as side effects of both erythromycin and
clarithromycin and, to a lesser degree, azithromycin. In
addition, persons skilled in the art knew that one way to reduce
these gastrointestinal effects was to formulate the drug in a
polymer matrix, e.g., an extended release formulation. Teva's 2d
Lee Decl., ¶ 56. The GI side effects of clarithromycin were known
to be dependent on the drug concentration in the blood. Moreover,
the `422 patent for extended release azithromycin disclosed that
extended release compositions of that closely-related compound
reduced gastrointestinal side effects. Thus, "the `616 patent
represents nothing more than the routine application of routine
skill." Def.'s Opp. Br. at 8.
With respect to claim 2 of the `616 patent, Abbott contends
that the gastrointestinal side effects of different active
pharmaceutical agents are so distinct that the pharmacokinetic
properties of a formulation with one drug are not predictive of a
similar formulation with another drug. Abbott concedes, however,
that it was generally known in the prior art that an extended
release formulation could cause a reduction in adverse
gastrointestinal side effects. Abbott disagrees that this
"general knowledge" would support "a reasonable expectation that
such an effect could even be achieved." Banker Supp. Decl., at ¶
46. Specifically, Abbott contends that simply knowing that an
extended release formulation would reduce the maximum blood
plasma concentration of the drug (Cmax) and that such a
reduction might lead to reduced GI side effects, one would not
know by how much to lower the Cmax in order to reduce the GI
side effects. Id. at ¶ 47. Therefore, claim 2 of the `616
patent was not obvious but represents a genuine invention. This court finds that Teva has raised substantial question
about the validity of the `616 patent and that Abbott has failed
to meet its burden of demonstrating that Teva's opposition lacks
substantial merit. This court finds that the prior art,
specifically the discussions in industry treatises and medical
journals of formulations that reduced GI irritation, the
teachings of the `422 patent, and the reference material in the
Physicians' Desk Reference regarding side effects, would lead a
person of ordinary skill in the art to expect that an extended
release formulation of clarithromycin would reduce adverse GI
side effects.
d. The `386 patent
Teva argues that the `386 patent is invalid for two distinct
reasons. First, Teva asserts that erythromycin A 9-oxime had been
disclosed (prior to the `386 patent) in the `014 and `185 patents
as both an antibiotic by itself and as a useful intermediate in
the synthesis of other products. Teva posits that clarithromycin
and erythromycin A are structurally very similar (differing only
by the presence of a single "methyl" group) and that they are
both broad spectrum antibiotics. Therefore, Teva concludes, a
person skilled in the art would have recognized that
clarithromycin 9-oxime would likely be an active antibiotic on
its own, and would also be an intermediate in the synthesis of
other compounds. As the discussion, supra, of the `718 patent
reveals, erythromycin A, clarithromycin, and azithromycin, while
closely related molecules, have some very different, in addition
to some very similar, characteristics.
The characteristic of 9-oxime as an effective antibiotic
appears to be a constant in the process. Moreover, Abbott has not
demonstrated that there is anything disclosed in the `386 patent
that, given the known utility of 9-oxime as a facilitator in the
synthesis of other products, would have made the teaching of that
patent nonobvious. Abbott's expert, Stephen Martin, examined the `803 patent (prior art) and concluded that it taught
three things about the superiority of clarithromycin over
erythromycin A. Clarithromycin had: 1) increased stability in
acid; 2) better in vitro antibacterial activity; and 3)
remarkable in vivo activity. The `014 patent (prior art) taught
that erythromycin A 9-oxime had three beneficial properties: 1)
increased acid stability over erythromycin A; 2) usefulness as an
intermediate in the preparation of new compounds with
"antibacterial activity" and 3) antibiotic activity.
Dr. Martin concludes that "[w]hile the `014 patent teaches that
erythromycin A 9-oxime retains its antibiotic activity, it does
not disclose whether it has in vivo antibacterial activity."
From that conclusion, he goes on to opine that one skilled in the
art would have appreciated only that erythromycin A 9-oxime
exhibited in vitro antibacterial activity and would not have
concluded that erythromycin A 9-oxime could be used as an
intermediate in the production of other compounds with in vivo
antibacterial activity. The court does not agree. While there may
be persons who care deeply about destroying infectious bacteria
in Petrie dishes, this court will assume that persons skilled in
the art would be motivated to use the teachings of prior art for
their in vivo applications. Unless the person skilled in the
art was wearing blinders, he or she would have recognized some
relationship between in vitro and in vivo antibacterial
agents. The relationship may not have been one-to-one, but the
teaching would have suggested a relationship. The standard for
obviousness does not require absolute predictability, but rather
looks for a reasonable expectation of success. Even without
hindsight, a person skilled in the art would have anticipated the
in vivo usefulness of clarithromycin 9-oxime in light of the
in vitro benefits of erythromycin A 9-oxime. Therefore, in
light of the obviousness of the invention, Abbott has not
demonstrated a likelihood of success as to the `386 patent. B. Irreparable Harm
The party seeking the preliminary injunction must not only show
a likelihood of success on the merits but also that it will
suffer irreparable harm in the absence of an injunction. The
court now turns to this analysis.
If the movant can establish a clear showing of the validity of
the patents in suit and infringement thereof, then a presumption
of irreparable harm attaches. The burden then shifts to the
non-movant to rebut the presumption. Amazon.com v.
Barnesandnoble.com, Inc., 239 F.3d 1343, 1350 (Fed. Cir. 2001).
A successful rebuttal is a showing that the non-movant either has
or shortly will cease its allegedly infringing activities; that
the movant has a pattern of granting licenses for the patents in
suit so that it is reasonable to believe money damages would be
enough to satisfy any harm to the patentee; or that the movant
unduly delayed in bringing suit on its patents. Polymer Techs.,
Inc. v. Bridwell, 103 F.3d 970, 974 (Fed. Cir. 1996).
As a threshold matter, Abbott is entitled to a presumption of
irreparable harm regarding only those patents for which this
court has found that it made a clear showing of both infringement
and validity. Teva, therefore, bears the burden of rebutting that
presumption. To the extent that this court has found that Abbott
has not made a clear showing that it will succeed on both
infringement and validity, Abbott bears the burden of
demonstrating that it will suffer irreparable harm in the absence
of the presumption.
Abbott contends it has demonstrated irreparable harm because it
has shown that it will suffer loss of market share, goodwill, and
profits; will be constrained to lay off several hundred sales
representatives; and will face losses that will never be fully
compensable in money damages. Abbott argues that Teva's assertion
that it has sufficient funds to answer for Abbott's future harm is insufficient to rebut the presumption of
irreparable injury. Polymer Techs., 103 F.3d at 975. In
addition, Abbott offers again a declaration from its BIAXIN brand
manager. This declaration describes a financial model that
predicts that generic entry would "crush" the market for Abbott's
branded extended release clarithromycin. See Pl.'s Reply Br. at
13 n. 11. Abbott cites Hybritech Inc. v. Abbott Laboratories,
849 F.2d 1446 (Fed. Cir. 1988), which stated that "the nature of
the patent grant weighs against holding that monetary damages
will suffice to make the patentee whole." Id. at 1457; see
also Pretty Punch Shoppettes, Inc. v. Hauk, 844 F.2d 782 (Fed.
Cir. 1988) ("A money award is not the sole remedy for future
infringement of a patent."). The Federal Circuit has stated that
evidence on likelihood of price erosion and loss of market
position resulting from competitor's entry in a pharmaceutical
patent infringement case may support a finding of irreparable
harm. See Purdue Pharma L.P. v. Boehringer Ingelheim, GMBH,
237 F.3d 1359, 1368 (Fed. Cir. 2001) (noting that patentee was
entitled to presumption of irreparable harm but analyzing
sufficiency of patentee's proferred expert evidence). According
to Abbott's brand manager, after two months of generic
competition, Abbott will face a 75% decline in market share.
Considering competition from the generic immediate release
formulations that entered the market on May 24, 2005, Abbott
predicts it will lose approximately sixty percent of its market
share in the first two months of generic extended release
competition. Abbott reiterates the irreversible market share
losses it will face as it loses its preferred position on
pharmacy and insurance formularies.*fn6 Finally, Abbott
notes that although Teva criticizes Abbott's financial model as unduly speculative, Teva provides no alternate model or
estimate of Abbott's future losses.
Teva asserts that Abbott has failed to establish irreparable
harm. It characterizes Abbott's case as "an assertion that it
will lose money in the event of competition." Def.'s Opp. Br. at
11. Teva contends that Abbott's financial model is "entirely
speculative" and biased because Abbott's own BIAXIN brand manager
generated it. Further, Teva criticizes Abbott's estimate of
market erosion due to generic immediate release clarithromycin.
The model predicts a nearly instant fifteen percent erosion that
then continues at that constant rate indefinitely. Teva contends
that previous cases where generic immediate release formulations
competed against branded extended release formulations
demonstrate that this model is inaccurate. See, e.g., 2d
Scott-Morton Decl., at ¶ 41. Teva asserts that the market erosion
due to the generic immediate release will be much greater than
fifteen percent, although Teva provides no estimate of just how
great it might be. In addition, Teva notes that Abbott's
estimates of the remaining profitability of BIAXIN XL suggest
that it would generate ample revenue to fund a marketing and
publicity drive designed to return the product to the preferred
tier on managed care and Medicaid formularies. Such an effort
would help restore much, if not all, of Abbott's market share in
the event that a generic competitor entered and subsequently
exited the market. Teva has not offered an estimate of how much
such a marketing effort would cost, especially given the
complexity of the market and the impact of the entry of generic
immediate release clarithromycin formulations.
This court finds that Abbott has made a showing that it will
suffer irreparable harm with respect to the `718 patent in the
absence of a preliminary injunction. In so finding, however, the
court reiterates that the parties' models of how the market will
react to generic competition for extended release clarithromycin remain highly speculative. As
noted in its May 20, 2005 order, this is in large part due to the
entry of generic immediate release formulations on May 24, 2005.
There is insufficient data to determine whether and the degree to
which the generic immediate release product erodes the market for
extended release clarithromycin. However, the very fact of this
instant proceeding strongly suggests that the parties perceive a
robust market remaining for the extended release formulation,
even with generic competition on the immediate release level.
Thus, as previously noted, this court concludes that entry of a
generic extended release formulation competitor will likely crush
the market.
With respect to the `386 patent, specifically, even if Abbott
had successfully met the likelihood of success burden, the motion
for a preliminary injunction would be denied because Abbott
cannot establish irreparable harm for infringement. Abbott has
not suffered and could not prove monetary damages even if the
`386 patent had been infringed. As Judge Posner noted, "[d]amages
is the amount of loss to a patentee." Smithkline Beecham Corp.
v. Apotex Corp., 247 F. Supp. 2d 1011, 1046 (N.D. Ill. 2003)
(citing Smithkline Diagnostics, Inc. v. Helena Laboratories
Corp., 926 F.2d 1161, 1164 (Fed. Cir. 1991)). In the trace
amounts in which 9-oxime appears in the Teva product, Teva
derives no competitive advantage and Abbott suffers no
competitive disadvantage. As this court noted in its opinion on
the TRO, the `386 patent is not a process patent and the presence
of 9-oxime in the Teva product is, at best, a fingerprint of a
process. Abbott does not claim (and given the minute quantities
involved, could not claim) that 9-oxime is used in the Teva
product for its antibacterial characteristics. If Teva used
exactly the same process to produce its product but removed all
of the 9-oxime, Abbott could not assert that any of its patents
would be infringed. More importantly, Abbott has not established
that it will suffer any loss as a result of infringement of the `386 patent
but instead must rely on the presumption that follows from a
finding of infringement. Because this Court concludes,
preliminarily, that the `386 patent is invalid, the presumption
does not arise. If Abbott should prevail on its infringement
claim at trial, we will revisit the question of damages (if any).
C. Balance of Hardships
The third factor in determining whether a preliminary
injunction should issue requires the court to examine the balance
of the hardships between the two parties. Hybritech,
849 F.2d at 1457. The court weighs the hardship to the patentee if no
injunction is entered against the harm to the alleged infringer
if the injunction is granted incorrectly. Id.
The structure of the pharmaceutical market makes it difficult
to determine the effect of generic competitor market entry. Most
prescription drug purchases in the United States are paid for, at
least in part, by employer-sponsored health insurance plans or by
government programs like Medicaid. When a pharmaceutical enters
the market, insurance companies, managed care organizations, and
Medicaid plans decide whether to place the drug on their
pharmaceutical formularies. The formulary is a list of approved
medications for which the plan will pay some part of the cost.
These formularies are, in many instances, divided into three
tiers. The first tier comprises low cost generic products. The
second tier comprises "preferred branded" products. The third
tier comprises "non-preferred branded" products, Patients must
pay more out-of-pocket for drugs listed on a higher tier than for
a drug of the same price listed on a lower tier. The managed care
provider typically pays more for drugs listed on a lower tier
(e.g., Tier 1) than for a drug of the same price listed on a
higher tier (e.g., Tier 3). The Medicaid formulary does not have
tiers; either a drug is listed on the formulary (also known as
the preferred drug list) or it is not. If the drug is not on the Medicaid formulary, the program will not
cover any portion of its cost. If a doctor prescribes a
non-formulary drug to a Medicaid patient, the patient must pay
the entire cost out-of-pocket.
When a generic version of a branded product enters the market,
managed care providers generally add the generic to their
formulary on Tier 1. They will then move the branded product to a
higher position (e.g., from Tier 2 to Tier 3). Some plans will
remove the branded drug from their formulary altogether. If the
generic product is AB rated, meaning that the FDA considers it
therapeutically equivalent to the branded product, many
pharmacies will substitute the generic product for the branded
product unless the physician specifies on the prescription form
"Dispense as Written." Medicaid programs typically remove branded
products from their formularies altogether once a generic has
entered the market.
Abbott argues that the balance of hardships weighs in favor of
granting the preliminary injunction because it will face
devastating loss of market share. Abbott predicts that it will
lose 40 percent of its sales of BIAXIN XL within one month of
generic entry, 64 percent within two months, and 78 percent after
eleven months. In addition, it estimates it will suffer
approximately $1.37 billion in lost profits (discounted to
present value) over the remaining twelve years of its patents;
will be constrained to lay off several hundred members of its
sales force; and will lose a significant portion of the market
for a product which it asserts represents six percent of its
annual domestic sales. Moreover, Abbott contends that its loss of
market share will be permanent. Once a managed care organization
moves a drug to a higher tier on its formulary or, in the case of
Medicaid, removes the drug entirely, it is costly and difficult
to regain a preferred position. Abbott contends that it will be
unable to regain its position on the second tier of most managed care organization formularies and will be unable to be relisted
on the Medicaid formulary. Competition from related antibiotics,
the financial incentive to the prescription benefit providers of
keeping a drug on a higher tier, and simple inertia on the part
of the formulary administrators will combine to prevent Abbott
from regaining more than a fraction of its current market share,
even if a generic competitor subsequently exits the market.
Teva argues that the balance of hardships does not tip in favor
of Abbott. It contends that BIAXIN XL represents only 1.5 percent
of Abbott's annual sales of approximately $20 billion,*fn7
and that lost sales would not represent a hardship. In addition,
it asserts that Abbott will be able to regain all or almost all
of its market share through a marketing drive. Because Abbott has
spent only $250 million on the production and marketing of its
BIAXIN portfolio of products to date, Teva contends that the
expense of a campaign to get BIAXIN XL returned to its preferred
formulary position represents only a minimal hardship. Teva has
not stated what its estimate of potential sales of its generic
extended release clarithromycin will be, nor how much it has
invested in development, production, and marketing to date.
Instead, it contends that such a figure will depend on how many
other generic competitors enter the market for extended release
clarithromycin and when, and what the state of the market is at
the time this case is decided. Although these are real
considerations, this court is perplexed by Teva's reluctance or
inability to quantify the hardship, if any, it will face if an
injunction is incorrectly entered. As a result, this court is
left to balance the hardships without information about one half
of the balance. In such a situation, there is little choice but to conclude that the
balance of the hardships favors the patentee.
D. Public Interest
The final factor a court should consider in determining whether
to issue a preliminary injunction is the impact it will have on
the public interest. Hybritech, 849 F.2d at 1458. "[I]n a
patent infringement case, although there exists a public interest
in protecting rights secured by valid patents, the focus of the
district court's public interest analysis should be whether there
exists some critical public interest that would be injured by the
grant of preliminary relief." Id.
Abbott states that granting the preliminary injunction will
serve the public interest by furthering the important public
policy of encouraging innovation in pharmaceutical development.
It emphasizes the value of the right to exclude inherent in a
patent. See, e.g., Smith Int'l, Inc. v. Hughes Tool Co.,
718 F.3d 1573, 1578 (Fed. Cir. 1983). Abbott states that it invests
approximately nine percent of its annual net sales revenue in
research and development.*fn8 The company has invested over
$250 million to research, produce, and market its BIAXIN and
BIAXIN XL products. McKercher Decl., at ¶ 7. If it cannot reap
the full benefit of the twenty-year monopoly conferred by its
patent, it argues that its incentive to invest such large amounts
in a product would diminish because of the lower expected return
from R&D investments. Abbott suggests that it "might well choose
instead to divert its resources to other efforts such as
advertising, increased customer service, or the like." Pl.'s Br.
at 15 (quotations omitted). Thus, the public's "strong interest
in creating adequate incentives to innovate" outweighs its
interest in allowing generic competition before patent
expiration. Teva contends that the public interest is served by permitting
competition and allowing companies offering low cost generic
products to enter the market and ease the public's burden of high
prescription drug costs. In addition, Teva argues that the public
interest is not served by the enforcement of allegedly invalid
patents or the extension of monopoly pricing by means of invalid
patents over the distribution of low cost pharmaceuticals. Teva
does, however, admit that there is a public interest in the
enforcement of valid patents.
The court recognizes the public interest in competition in the
pharmaceutical market. It also recognizes, however, the public
interest in creating beneficial and useful products and the cost
involved in that process. To the extent that this court has found
that the patents in suit are valid, the public interest is best
served by enforcing them.
For the foregoing reasons, this court preliminarily finds the
`386 patent and claim 2 of the `616 patent invalid for
obviousness. The court finds that Teva has not established that
claims 2, 4, and 6 of the `718 patent are invalid for
obviousness. The court grants Abbott's motion for a preliminary
injunction against Teva.
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text:
How to Ignite an Atmospheric Pressure Microwave Plasma Torch without Any Additional Igniters
1Institute of Interfacial Process Engineering and Plasma Technology, University of Stuttgart
1Institute of Interfacial Process Engineering and Plasma Technology, University of Stuttgart
1National Institute for Materials Science, Japan, 2Graduate School for Advanced Science and Engineering, Waseda University, 3Center for Research in Isotopes and Environmental Dynamics, Tsukuba University
1Sector for Marine Waters, Institute for water of the Republic of Slovenia, 2Laboratory for Polymer Chemistry and Technology, National Institute for Chemistry Slovenia
1Bioenergy Research Unit, National Center for Agricultural Utilization Research, 2Mycotoxin Prevention and Applied Microbiology Research Unit, National Center for Agricultural Utilization Research, 3Chemical Engineering and Material Science, Great Lakes Bioenergy Center, Michigan State University
1United States Army-Natick Soldier RD&E Center, Warfighter Directorate, 2Department of Molecular Biology and Biophysics, University of Connecticut Health Center, 3Lawrence Livermore National Laboratory, 4Children's Hospital Oakland Research Institute
1Department of Biomedical Engineering, University of Rochester, 2Department of Chemical Engineering, University of Rochester, 3Center for Musculoskeletal Research, University of Rochester Medical Center
1Department of Chemical and Systems Biology, Stanford University School of Medicine
1Department of Industrial and Physical Pharmacy, Purdue University
1Department of Chemistry, Durham University, 2School of Medicine, Pharmacy and Health, Durham University
1Institute of Manufacturing Technology and Department of Mechanical Engineering, National Taipei University of Technology (TAIPEI TECH)
1Division of Physical Therapy, Department of Orthopedics & Rehabilitation, University of New Mexico, 2Department of Ecosystem Science and Management, University of Wyoming, 3School of Pharmacy, University of Wyoming, 4Department of Environmental and Radiological Health Sciences, Colorado State University, 5Center for Environmental Medicine, Colorado State University, 6College of Pharmacy, California Northstate University
1Laboratory for Chemical Technology, Faculty of Engineering and Architecture, Ghent University
1Chemical & Biological Process Development, Pacific Northwest National Laboratory
1Biology Department, Western Washington University, 2Washington State University Northwestern Research and Extension Center, 3Department of Plant and Soil Science, Texas Tech University
1X-ray Science Division, Advanced Photon Source, Argonne National Laboratory, 2Department of Physics and Astronomy, Northwestern University
1Industrial Process Engineering, University of Technology of Compiègne, 2Institute for Particle Technology, Technische Universität Braunschweig
1Department of Organic Chemistry, Weizmann Institute of Science
JoVE Science Education
Source: Laboratory of Dr. Yee Nee Tan — Agency for Science, Technology, and Research
Titration is a common technique used to quantitatively determine the unknown concentration of an identified analyte.1-4 It is also called volumetric analysis, as the measurement of volumes is critical in titration. There are many types of titrations based on the types of reactions they exploit. The most common types are acid-base titrations and redox titrations.5-11 In a typical titration process, a standard solution of titrant in a burette is gradually applied to react with an analyte with an unknown concentration in an Erlenmeyer flask. For acid-base titration, a pH indicator is usually added in the analyte solution to indicate the endpoint of titration.12 Instead of adding pH indicators, pH can also be monitored using a pH meter during a titration process and the endpoint is determined graphically from a pH titration curve. The volume of titrant recorded at the endpoint can be used to calculate the concentration of the analyte based on the reaction stoichiometry. For the acid-base titration presented in this video, the titrant is a standardized sodium hydroxide solution and the analyte is domestic vinegar. Vinegar is an acidic liquid that …
1School of Science, Faculty of Science, Engineering and Technology, Swinburne University of Technology, 2BlueScope Steel Research, 3Infrared Microspectroscopy Beamline, Australian Synchrotron, 4School of Science, College of Science, Engineering and Health, RMIT University
1Materials Engineering Division, Lawrence Livermore National Laboratory, 2Assembly Test and Technology Development Failure Analysis Labs, Intel Corporation, 3Advanced Light Source, Lawrence Berkeley National Laboratory
1Department of Electrical Engineering and Computing Systems, University of Cincinnati
1Department of Chemical Engineering, Konkuk University, 2Department of Chemical Engineering, University of Michigan
1Cellular Networks Proteomics Unit, Laboratory of Systems Biology, National Institute of Allergy and Infectious Diseases, National Institutes of Health
1Department of Applied Chemistry, School of Applied Science, National Defense Academy of Japan, 2Department of Applied Physics, School of Applied Science, National Defense Academy of Japan, 3Department of Materials Science and Technology, Faculty of Engineering, Niigata University
1Department of Mechanical Engineering, Hanyang University, 2Institute of Nanoproduct Safety Research, Hoseo University
1Leslie Dan Faculty of Pharmacy, University of Toronto
1Materials Sciences Division, Lawrence Berkeley National Laboratory, 2Department of Polymer Science and Engineering, University of Massachusetts Amherst, 3Advanced Light Source, Lawrence Berkeley National Laboratory
1Department of Physics and Nuclear Engineering, United States Military Academy, 2Department of Nuclear Engineering, University of Tennessee, 3Radiochemistry Center of Excellence (RCoE), University of Tennessee, 4Institute for Nuclear Security, University of Tennessee
1CanmetENERGY, Natural Resources Canada
1Department of Chemical Engineering and Centre for Regenerative Medicine, University of Bath, 2MRC Centre for Drug Safety Science and Institute of Translational Medicine, University of Liverpool, 3Mechanical Engineering, University College London, 4Department of Applied Mathematics, Liverpool John Moores University
1Soil and Crop Sciences Department, Texas A&M University, 2The Scotts Miracle-Gro Company
1MatTek Corporation, 2MatTek In Vitro Life Science Laboratories
1Human Development & Health Academic Unit, Faculty of Medicine, University of Southampton
1Department of Biotechnology, Delft University of Technology, 2Delft Center for Systems and Control, Delft University of Technology
JoVE Science Education
Source: Laboratory of Dr. B. Jill Venton - University of Virginia
Gas chromatography (GC) is used to separate and detect small molecular weight compounds in the gas phase. The sample is either a gas or a liquid that is vaporized in the injection port. Typically, the compounds analyzed are less than 1,000 Da, because it is difficult to vaporize larger compounds. GC is popular for environmental monitoring and industrial applications because it is very reliable and can be run nearly continuously. GC is typically used in applications where small, volatile molecules are detected and with non-aqueous solutions. Liquid chromatography is more popular for measurements in aqueous samples and can be used to study larger molecules, because the molecules do not need to vaporize. GC is favored for nonpolar molecules while LC is more common for separating polar analytes. The mobile phase for gas chromatography is a carrier gas, typically helium because of its low molecular weight and being chemically inert. Pressure is applied and the mobile phase moves the analyte through the column. The separation is accomplished using a column coated with a stationary phase. Open tubular capillary columns are the most popular columns and have the stationary phase coated on the walls of the capillary. Stationary phases a…
1Institute for Society and Genetics, University of California, Los Angeles, 2Environmental Health Sciences, University of California, Los Angeles, 3California Nanosystems Institute, Department of Molecular and Medical Pharmacology, University of California, Los Angeles
1Department of Chemistry, Virginia Military Institute
1Department of Animal Science, University of Wyoming, 2Department of Chemistry, Colorado State University, 3Department of Environmental and Radiological Health Sciences, Colorado State University, 4Department of Animal Sciences, Colorado State University, 5Department of Plant Sciences, University of California, Davis, 6Department of Food Science and Human Nutrition, Citrus Research and Education Center, University of Florida, 7Department of Food Science and Agricultural Chemistry, McGill University
1BioEnergy Science Center, National Renewable Energy Laboratory
1Petroleum & Geosystems Engineering, The University of Texas at Austin
1Synthetic Biology & Bioengineering Research Center, Korea Research Institute of Bioscience and Biotechnology, 2Biosystems and Bioengineering Program, University of Science and Technology, Daejeon, South Korea
JoVE Science Education
Source: Laboratory of Dr. Neil Branda — Simon Fraser University
Degassing refers to the process by which dissolved gases are removed from a liquid. The presence of dissolved gases such as oxygen or carbon dioxide can impede chemical reactions that utilize sensitive reagents, interfere with spectroscopic measurements, or can induce unwanted bubble formation. A number of different techniques are available for degassing liquids; some of these include heating, ultrasonic agitation, chemical removal of gases, substitution with inert gas by bubbling and freeze-pump-thaw cycling. Freeze-pump-thaw cycling is a common and effective method for small scale degassing, and will be demonstrated here in more detail.…
1School of Materials Science and Engineering, Nanyang Technological University, 2Centre for Biomimetic Sensor Science, Nanyang Technological University, 3School of Chemical and Biomedical Engineering, Nanyang Technological University
1Lasers, Optics, & Targets for the National Ignition Facility, Lawrence Livermore National Laboratory
1Jülich Supercomputing Centre, Forschungszentrum Jülich, 2Materials Science and Technology of Polymer, MESA+ Institute for Nanotechnology, University of Twente, 3Department of Materials Science and Engineering, Universität des Saarlandes
1Department of Biotechnology, Delft University of Technology, 2Department of Biotechnology, Norwegian Biopolymer Laboratory (NOBIPOL), Norwegian University of Science and Technology
1Department of Biological Sciences, Macquarie University, 2Vital-IT group, Swiss Institute of Bioinformatics, 3Laboratory of Microbiology, University of Neuchatel
JoVE Science Education
Source: Laboratory of Dr. Neal Abrams — SUNY College of Environmental Science and Forestry
An ionic compound's solubility can be determined via qualitative analysis. Qualitative analysis is a branch of analytical chemistry that uses chemical properties and reactions to identify the cation or anion present in a chemical compound. While the chemical reactions rely on known solubility rules, those same rules can be determined by identifying the products that form. Qualitative analysis is not typically done in modern industrial chemistry labs, but it can be used easily in the field without the need of sophisticated instrumentation. Qualitative analysis also focuses on understanding ionic and net ionic reactions as well as organizing data into a flow chart to explain observations and make definitive conclusions. Many cations have similar chemical properties, as do the anion counterparts. Correct identification requires careful separation and analysis to systematically identify the ions present in a solution. It is important to understand acid/base properties, ionic equilibria, redox reactions, and pH properties to identify ions successfully. While there is a qualitative test for virtually every elemental and polyatomic ion, the identification process typically begi…
1Biological and Environmental Sciences and Engineering Division, King Abdullah University of Science and Technology (KAUST), 2Division of Applied Chemistry, Faculty of Engineering, Hokkaido University, 3Department of Organic and Polymeric Materials, Tokyo Institute of Technology
1Department of Chemistry and Biochemistry, Central Michigan University, 2Department of Chemistry, University of Southern Maine


text:
WR Reliability: a Data Point. What's Your Story?
Posted April 24, 2012 - 03:53 PM
Posted April 24, 2012 - 05:31 PM
Posted April 24, 2012 - 07:18 PM
A year ago, I lost the water pump seal, had to run it dry for about 10 miles to get to where I could get some help. I was overheating badly. I finally got it home, replace the water pump seal and a malfunctioning ignition coil and have been riding it for the past year. Unknown to me, I have been riding it the past year with a blown head gasket and a rusty piston. Go figure...
I took the head to the shop to get checked out, only the two exhaust valves needed to be replaced because of pitting. I also had the seats recut and new springs to the tune of $350. Not bad.
In all these years, hours and miles, I am about to put in the second piston. That's amazing.
I am currently doing a frame up restoration on another thread. I like the bike that much where I would bother to do that. The next bike I buy to replace my play bike has some really, really, really big shoes to fill.
Edited by mauricedorris, April 24, 2012 - 07:32 PM.
Posted April 24, 2012 - 08:43 PM
Posted April 24, 2012 - 09:19 PM
Overall I've been very happy with it. I've seen and experienced some problems but most of it has been neglect from the previous owners:
-Jetting was very lean top and bottom and I have a feeling it had been ridden like this since new.
-I noticed the drain plug was stripped and replaced with a heli-coil at some point in time.
-Lower allen bolt on oil filter cover was pulling threads and added a few extra shavings to the oil filter (yikes) because of it.
-Chrome on lower fork tubes lasted about two rides. I think its a poor plating job on KYB's part personally. I replaced it with another used set from Ebay and so far so good.
-I just re-shimmed the exhaust valves (took out the factory shims) because they were .001 too tight but intakes were still in spec lol.
-Recently started burning a bit of oil after a cold start. But clears up completely when warm Hmmm......
Great bike that for sure. I would recommend one to anyone
Edited by Rot Box, April 24, 2012 - 09:24 PM.
Posted April 25, 2012 - 06:23 AM
Posted April 25, 2012 - 09:50 AM
Posted April 25, 2012 - 10:26 AM
Posted April 25, 2012 - 11:29 AM
Haha my 96 xt225 has 15000km on it and idles/runs nicer than my wr
rejet your wr... my wr starts up easier and runs better than any of my XRs did
Posted April 25, 2012 - 02:03 PM
Only jet I can change is my main jet
Why, the pilot is right next to the main jet and is even easier to get to.
Oh... change out the leak jet too.
Posted April 25, 2012 - 03:06 PM
I'm currently waiting on my cylinder to be replated since the new valves, head work, tensioner, cam chain, and guides never fixed my issues. If the new cylinder, piston, rings, etc don't solve the problem, time for a part out.
Posted April 25, 2012 - 07:25 PM
I've had trouble since the day I bought mine used probably 5 years ago. It was my first bike and I babied it, yet somehow brainwashed myself into thinking all these problems were normal. I've put only a handful of hours on it the last 5 years (I estimate 10-15 hours or so) because it's normally broken down and I'm stuck waiting on parts, then sending them back when I get the wrong parts for my obscure '98 model.
I'm currently waiting on my cylinder to be replated since the new valves, head work, tensioner, cam chain, and guides never fixed my issues. If the new cylinder, piston, rings, etc don't solve the problem, time for a part out.
5 years ago you bought a then 9 year old dirt bike. I am assuming you paid very little for it, right?
Even the 98's I hear are pretty good. You must be doing something that the rest of us are not doing.
Posted April 27, 2012 - 05:52 AM
1. replace full exhaust when I pancaked the stock head pipe
2. replaced clutch cover when the stock one met a rock going way fast
3. replaced the tires once every couple months
4. smashed the bracket that mounts the front brake and had to replace that
5. lots of oils changes along the way
6. rebuilt and revalved the suspension when I blew the rear shock seal, stock stuff lasted about 3 years
7. new battery after about 2 years
8. I have a bent and cracked foot peg so I bought set of fastaways and have yet to do the switch. I like the stock pegs.
9. replaced the fork guards after a few years as the plastic around the screws gave way
10. I have a bent radiator but it doesn't leak so I am not going to mess with it
11. bent the rear brake rotor
The only thing I can think of that I had to fix that wasn't my fault was the rear shock seal. The wr is a rock solid bike
Posted April 27, 2012 - 08:26 AM
10. I have a bent radiator but it doesn't leak so I am not going to mess with it
Send that puppy over to Myler's in UT they will fix it for cheap
Mine was accordianed pretty bad and they fixed it for $35. Turn around was fast too.
Posted April 27, 2012 - 08:31 AM
Posted April 27, 2012 - 08:32 AM
Send that puppy over to Myler's in UT they will fix it for cheap
Mine was accordianed pretty bad and they fixed it for $35. Turn around was fast too.
I used to live right there and have used them a lot. Mine isn't bad enough to need that yet. Just a minor tweek.
Posted April 27, 2012 - 11:24 AM
Posted April 27, 2012 - 03:08 PM
I bought my 05 new. I'm 57 and may never be able to use the excuse that my bike is wore out in order to get a new one.
Even durability has a downside, I suppose. Probably why Honda killed the XR line.
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25 Apr 2006
Spoleto offers eclectic array for its 30th year
Raphaela Papadakis seems to like 'playing with fire'. After her acclaimed performance as the put-upon maid, Anna, in Independent Opera's production of Šimon Voseček's Beidermann and the Arsonists at Sadler's Wells last year, she is currently rehearsing for the premiere this week of And London Burned, a new opera by Matt Rogers which has been commissioned by Temple Music Foundation to commemorate the 350th anniversary of The Great Fire of London.
[Times and Democrat, 25 April 2006]
CHARLESTON — Spoleto Festival USA has slated its 2006 festival for May 26 to June 11 and promises performances from around the globe.


text:
My current obsession are these yummy Sennelier Oil Pastels. These small sticks of pure pigment and wax are super creamy and blendable.
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I would love to collect all 120 colours in the Sennelier collection. I only have a measly 26 sticks. (#artsupplyjunkie)...*LOL*
These eye sketches took like 10 minutes each. Seriously. Go get some.


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THIS IS A DIRECTORY PAGE. Britannica does not currently have an article on this topic.
Learn about this topic in these articles:
Burgess Shale formation
...belong to established phyla and reveal important information about phylogenetic development, there are many other genera that do not fit so easily into modern phyla. Such unusual fossils as Hallucigenia, a creature with a long tubular body and two rows of tall dorsal spines; Wiwaxia, an oval creature with two rows of spines down its plated back; and Opabinia, which had...


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Electronifying B2B Payments
Giving suppliers access to supply chain finance is helping persuade them to accept payments in electronic formats.
By Greg Farrell, Bloomberg, Ambereen Choudhury, Bloomberg |
February 5, 2014
As probes into FX manipulation allegations grow, so does turnover among traders.
By Joram Borenstein |
November 5, 2013
What corporate treasurers need to know, and do, about the birth and growth of virtual currencies.
By Laura Marcinek and Greg Farrell, Bloomberg |
October 31, 2013
Prospective merger puts issue of auditor independence "front and center," according to Arthur Levitt.
By Greg Farrell, Bloomberg |
August 12, 2013
New York subpoenas Bitcoin-related firms in probe on criminal risk.
By Ian Katz and Cheyenne Hopkins |
August 9, 2012
U.S. Treasury to work with New York regulator on investigation of charges.
By Gavin Finch and Greg Farrell |
August 7, 2012
New York regulators charge bank with money laundering for Iranian banks, threaten to pull its state license.
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on May 6th, 2009
0 Comment
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