Pharmaceutical Resources, Inc. v. Roxane Laboratories, Inc.
U.S. Court of Appeals10/26/2007
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NOTE: This disposition is nonprecedential.
United States Court of Appeals for the Federal Circuit
2007-1093, -1134
PHARMACEUTICAL RESOURCES, INC.
and PAR PHARMACEUTICALS, INC.,
Plaintiffs-Appellants,
v.
ROXANE LABORATORIES, INC.,
Defendant-Appellee.
Edgar H. Haug, Frommer, Lawrence & Haug LLP, of New York, New York,
argued for plaintiffs-appellants. With him on the brief were Kevin F. Murphy and
Stephen J. Lieb. Of counsel was Jennifer Chung.
Martin B. Pavane, Cohen Pontani Lieberman & Pavane LLP, of New York, New
York, argued for defendant-appellee. With him on the brief were Mindy H. Chettih and
Edward M. Reisner.
Jeffrey L. Light, Patients not Patents, Inc., of Washington, DC, for amicus curiae.
Appealed from: United States District Court for the District of New Jersey
Senior Judge Dickinson R. Debevoise
Note: This disposition is nonprecedential.
United States Court of Appeals for the Federal Circuit
2007-1093, -1134
PHARMACEUTICAL RESOURCES, INC.
and PAR PHARMACEUTICALS, INC.,
Plaintiffs-Appellants,
v.
ROXANE LABORATORIES, INC.,
Defendant-Appellee.
___________________________
DECIDED: October 26, 2007
___________________________
Before MICHEL, Chief Judge, MOORE, Circuit Judge, and COTE, District Judge. ∗
MOORE, Circuit Judge.
Pharmaceutical Resources, Inc. and Par Pharmaceuticals, Inc. (Par, collectively)
appeal the district court’s grant of summary judgment of invalidity of the asserted claims
in U.S. Patent Nos. 6,593,318 (the ’318 patent) and 6,593,320 (the ’320 patent) in favor
of defendant Roxane Laboratories, Inc. (Roxane). Pharm. Res., Inc. v. Roxane Labs.,
Inc., No. 03-3357, 2006 U.S. Dist. LEXIS 34474 (D.N.J. Nov. 8, 2006) (Summary
Judgment Order). Because the district court properly determined that the asserted
∗
Honorable Denise Cote, United States District Judge for the Southern District of
New York, sitting by designation.
claims of the ’318 and ’320 patents are invalid as a matter of law under 35 U.S.C. § 112,
first paragraph, for lack of enablement, we affirm the judgment.
BACKGROUND
The ’320 patent is a divisional of the ’318 patent. Both patents share a common
specification, which was first filed as Serial No. 09/063,241 (“the ’241 application,” now
U.S. Patent No. 6,028,065). The ’318 and ’320 patents relate to stable flocculated
suspensions of megestrol acetate and methods for making such suspensions.
Bristol-Myers Squibb (BMS) was the first company to develop and patent a liquid
pharmaceutical composition of megestrol acetate. BMS’ U.S. Patent No. 5,338,732 (the
Atzinger patent) teaches that stable suspensions of megestrol acetate can be created
but that the type and concentration of the surfactant in solution is critical to creating a
stable flocculated suspension. The Atzinger patent discloses only one stable
flocculated suspension composition, combining megestrol acetate with polyethylene
glycol as a wetting agent and polysorbate 80 as a surfactant.
When Par formulated a generic version of BMS’s patented product, it sought to
design around the Atzinger patent claims by utilizing other surfactants and wetting
agents. In developing its own product, Par discovered that flocculated suspensions of
megestrol acetate could be formed using a much wider range of ingredients and
concentrations than taught in the Atzinger patent, including other surfactants and
wetting agents. Through those efforts, Par received a series of patents on its
flocculated suspensions, including the ’318 and ’320 patents.
Par brought the present suit in 2003, asserting that Roxane infringes certain
claims in the ’318 and ’320 patents. Roxane denies infringement and asserts that the
2007-1093,-1134 2
claims of the ’318 and ’320 patents are invalid and unenforceable. After the district
court issued a Markman order, Roxane moved for summary judgment of invalidity,
arguing, inter alia, that the asserted claims in the ’318 and ’320 patents are invalid for
lack of enablement. At issue are independent claims 19 and 41 of the ’318 patent (and
claims 20, 25-27, 32, 34, 42, 47, and 53 dependent thereon) and independent claim 1
from the ’320 patent (and claims 2 and 6 dependent thereon). Claim 19 of ’318 patent
recites:
Claim 19. An oral pharmaceutical composition in the form of a stable
flocculated suspension in water comprising: (a) megestrol acetate; (b) at
least two compounds selected from the group consisting of polyethylene
glycol, propylene glycol, glycerol, and sorbitol; and (c) a surfactant.
The district court granted Roxane’s motion for summary judgment, concluding
that “as a matter of law Par is not entitled to the broad claims it asserts in this action.”
Summary Judgment Order, at 30.
Par appeals the district court’s grant of summary judgment of invalidity. We have
jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).
ANALYSIS
We review a district court's grant of summary judgment de novo, reapplying the
standard applicable at the district court. See Rhodia Chimie v. PPG Indus., Inc., 402
F.3d 1371, 1376 (Fed. Cir. 2005). Although a patent claim is presumed enabled unless
proven otherwise by clear and convincing evidence, Ormco Corp. v. Align Tech., Inc.,
Nos. 2006-1240 & 2006-1274, 2007 U.S. App. LEXIS 20185, at*24, -- F.3d -- (Fed. Cir.
2007), to defeat Roxane's motion for summary judgment Par must put forth evidence
that does “more than simply raise some doubt regarding enablement: ‘If the evidence is
merely colorable, or is not significantly probative, summary judgment may be granted.’”
2007-1093,-1134 3
John Hopkins Univ. v. Cellpro, Inc., 152 F.3d 1342, 1359 (Fed. Cir. 1998) (quoting
Anderson v. Liberty Lobby, Inc. 477 U.S. 242, 249-50 (1986)).
Whether the subject matter of a patent claim satisfies the enablement
requirement under 35 U.S.C. § 112, first paragraph, is a question of law, reviewed de
novo, based on underlying facts, reviewed for clear error. AK Steel Corp. v. Sollac &
Ugine, 344 F.3d 1234, 1238-39 (Fed. Cir. 2003). In In re Wands, 858 F.2d 731, 737
(Fed. Cir. 1988), this court set forth eight factors relevant to the enablement analysis:
(1) the quantity of experimentation necessary, (2) the amount of direction
or guidance presented, (3) the presence or absence of working examples,
(4) the nature of the invention, (5) the state of the prior art, (6) the relative
skill of those in the art, (7) the predictability or unpredictability of the art,
and (8) the breadth of the claims.
In this case, Par sought extremely broad claims in a field of art that it
acknowledged was highly unpredictable, therefore, Par has set a high burden that its
patent disclosure must meet to satisfy the requisite quid pro quo of patent enablement.
See Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371, 1380 (Fed. Cir. 2007) (“The
motto, ‘beware of what one asks for,’ might be applicable here.”). The scintilla of
evidence put forward by Par to suggest that the claims are enabled, most of which
actually conflicts with the intrinsic evidence in this case, does not raise a genuine issue
of material fact. See Anderson, 477 U.S. at 252 (“The mere existence of a scintilla of
evidence in support of the plaintiff’s position will be insufficient [to overcome summary
judgment].”).
A. Unpredictability of the Art
In this case, all of the record evidence establishes that the art of making stable
flocculated suspensions of megestrol acetate is highly unpredictable. The common
disclosure of the ’318 and ’320 patents discusses this unpredictability:
2007-1093,-1134 4
The surfactants in a stable flocculated suspension need to be selected
carefully and be used within a critical concentration range because even
minor changes can have an effect on the properties of such a stable
formulation. This is particularly true for megestrol acetate because
predictability based on prior art teachings does not apply in this case, as
noted hereinabove.
’318 Patent col.3 l.66-col.4 l.5. Par also stressed the unpredictability of this particular
pharmaceutical formulation field during prosecution of the ’241 application:
[B]ased on the uncertainty of results once any modification in types of
ingredients or amounts is made, as discussed in the prior art including
Atzinger at al. [sic] . . ., a person skilled in the art would not have any
reasonable expectation of success in maintaining a stable flocculated
suspension of megestrol acetate once a change in the type or amount of
surfactant or wetting agent is made.
The extrinsic evidence also supports the conclusion that the relevant field is
unpredictable. During its previous litigation with BMS, for instance, Par relied in part on
the unpredictability of this art field. Par’s technical expert opined on the nature of the
art, stating:
Formulating a flocculated suspension is, in my view, one of the most
delicate formulation efforts in terms of balancing the excipients, and it is
also very difficult to predict in terms of what its properties will be or what
the effect of different excipients will be. There is no known method in the
art to predict whether a change in inactive ingredients will produce a
stable suspension.
Summary Judgment Order, at 25-26 (quoting Expert Report of Dr. Stanley Hem). In the
current litigation, Par’s technical expert, Dr. Klibanov, explained that “megestrol acetate
is sufficiently unique as a compound [such] that prior art references teaching how to wet
other insoluble compounds provide absolutely no guidance with regard to wetting
megestrol acetate.” Id. at 26 (paraphrasing and quoting Expert Report of Dr. Aleander
Klibanov). Similarly, Dr. Chao, a named inventor of the ’318 and ’320 patents, testified
that predictions could not be made regarding whether or not particular combinations of
2007-1093,-1134 5
ingredients including megestrol acetate would form a stable flocculated compound, but
rather, this required actual experimentation. Id. at 25 (quoting Jan. 5, 2005 Dep. Tr. of
Dr. Chao, 278:4–280:2).
B. Breadth of the Claims
In addition, the district court concluded that claims 19 and 41 of the ’318 patent
and claim 1 of the ’320 patent “have an extraordinarily broad scope.” Summary
Judgment Order, at 21.
Par argued that the claims at issue are not as broad as suggested by the district
court because the hypothetical pharmaceutical formulator would start experimenting
with the twenty-two surfactants that the United States Pharmacopoeia and National
Formulary (USP-NF) has recognized and approved for use in oral pharmaceuticals in
order to practice the invention. In addition, Par argues that the district court erred in
assuming that the claims covered use of a surfactant in any concentration.
The claims allow the choice of any surfactant in any concentration (with the
exception that claim 1 of the ’320 patent does not permit polysorbate as the surfactant if
polyethylene glycol is the chosen wetting agent). The language of the claims and the
specification 1 both suggest that the claims encompass hundreds of possible
surfactants. Par admitted as much in oral argument. Pharm. Res., Inc. v. Roxane
Labs., Inc., No. 07-1093, Oral Argument at 3:05 (Fed. Cir. Sept. 5, 2007). Further, the
disclosure of the ’318 and ’320 patents list dozens of “suitable” surfactant genera
beyond those listed by the USP-NF. ’318 Patent col.4 ll.11-36.
1
The specification explicitly states that the patented invention is not limited
to particular surfactants, stating “[w]hat is surprising about the present invention is that
any surfactant can effectively wet megestrol acetate and together form a stable
flocculated suspension.” ’318 Patent col.4 ll.5-7 (emphasis added).
2007-1093,-1134 6
Moreover, nothing in the language of the claims limits the concentration of
surfactant. The specification gives a preferred concentration range for only one
surfactant, docusate sodium. Id. at col.5 ll.9-10, 46. To the extent that Par now
suggests that an ordinarily skilled artisan would know that surfactant concentrations
over 0.030% weight-per-volume would not work, it follows that a large part of the
asserted claims’ scope is directed toward inoperative embodiments. 2 The number of
inoperative combinations is significant when assessing the experimentation that an
ordinarily skilled artisan would need to practice the claimed invention. Atlas Powder Co.
v. E.I. Du Pont De Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984).
We thus conclude that the district court properly determined that the claims at
issue “have an extraordinarily broad scope.” The district court also correctly noted in its
analysis that our case law requires that the full scope of the claims be enabled. See
Liebel-Flarsheim Co., 481 F.3d at 1379; AK Steel, 344 F.3d at 1241.
C. Enablement of the Asserted Claims
Taking into account the broad scope of the claims and the highly unpredictable
nature of the art, Par’s evidence regarding enablement fails to establish a genuine issue
of material fact as to whether or not the claims are enabled and therefore fails to defeat
summary judgment.
Par’s specification discloses only three working examples, utilizing only one new
surfactant. Given the highly unpredictable nature of the invention and the extremely
2
In fact, Par’s attorneys acknowledged in the Summary Judgment
proceedings that the claims did not contain a limit on the range of surfactant
concentration and that higher concentrations, perhaps even 1.0% weight-per-volume
could produce an operative embodiment.
2007-1093,-1134 7
broad scope of the claims, these three working examples do not provide an enabling
disclosure commensurate with the entire scope of the claims.
Additionally, the two declarations from Par’s expert witnesses on the issue of
enablement are conclusory and lack evidentiary support or specifics as to the
experimentation that would be needed to practice the entire scope of the claims.
Accordingly, these declarations are legally insufficient to raise a genuine issue of
material fact as to whether the claims are enabled. See, e.g., Automotive Tech. Int’l v.
BMW of N. Am., Inc., No. 2006-1013, 2007 U.S. LEXIS 21271, at *26, -- F.3d -- (Fed.
Cir. 2007) (“[H]aving failed to provide any detail regarding why no experimentation was
necessary, the declaration does not create a genuine issue of material fact as to
enablement.”).
Finally, Par argues that its own experiments with megestrol acetate solutions, to
which the inventor, Dr. Femia, testified, are sufficient to create a genuine issue of
material fact regarding enablement of the asserted claims. The district court determined
that this evidence supports a conclusion of lack of enablement because it evidences
numerous unsuccessful attempts by Par to practice subject matter within the scope of
the claims. 3 Summary Judgment Order, at 27.
3
Roxane argues that this evidence is irrelevant to enablement because the
experiments were not disclosed during prosecution of the applications at the PTO. We
disagree with Roxane. It was appropriate for the district court to consider evidence on
the quantity of experimentation necessary to practice the claimed invention. Wands,
858 F.2d at 737 (listing relevant considerations); Atlas Powder, 750 F.2d at 1577
(considering results of experiments performed by patentee prior to filing the patent);
Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 1373 (Fed. Cir. 1999) (determining
evidence of the patentee’s own experimental failures was appropriate to consider). Our
ruling in Genetech, Inc. v. Novo Nordisk, A/S, 108 F.3d 1361 (Fed. Cir. 1997), is not to
the contrary. Although extrinsic evidence cannot be used to supplement a non-enabling
2007-1093,-1134 8
Interpreting Dr. Femia’s testimony in the light most favorable to Par, that Dr.
Femia was successful in formulating the claimed composition with seven surfactants, 4
gives rise to “merely colorable” evidence, and fails to create a genuine issue of material
fact as to enablement of the full scope of the claims. It is highly relevant that the
intrinsic evidence stresses the criticality of the choice of surfactant and concentration.
Given this fact, the extraordinarily broad scope of the claims, which encompasses
hundreds of surfactants, the high degree of unpredictability of the art, and the minimal
guidance provided by the three working examples in the specification, the mere fact that
Par’s inventors were able to create successfully a stable flocculated megestrol acetate
suspension with seven surfactants does not create a genuine issue of material fact
regarding enablement.
Based on the foregoing, we conclude as a matter of law that each of the asserted
claims of the ’318 and ’320 patents is invalid under 35 U.S.C. § 112, first paragraph, for
lack of enablement. Accordingly, we affirm.
specification, such evidence can shed light on whether the specification is itself
enabling.
4
Only three of Dr. Femia’s seven formulations remained stable for as long
as three months.
2007-1093,-1134 9