Court Opinion

ID: 210263
Source: CourtListenerOpinion
Date Created: 2011-03-13 08:05:29+00
Date Added: 2024-06-11T17:28:00.496547
License: Public Domain

NOTE: This disposition is nonprecedential.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                       Note: This disposition is nonprecedential.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