The opinion of the court was delivered by: DAVID COAR, District Judge
MEMORANDUM OPINION AND ORDER
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
II. PRELIMINARY INJUNCTION STANDARD
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).
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.
This letter appears to represent an acknowledgment by Teva that
9-oxime is present in minute (impurity) amounts in Teva's product
and the Court will so find.
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.,