Case 1:14-cv-01451-RGA Document 175 Filed 06/29/16 Page 1 of 30 PageID #: 4669
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`RECKITT BENCKISER PHARMACEUTICALS
`INC., RB PHARMACEUTICALS LIMITED,
`and MONOSOL RX, LLC,
`
`Plaintiffs,
`
`v.
`
`TEVA PHARMACEUTICALS USA, INC.,
`
`Defendant.
`
`RECKITT BENCKISER PHARMACEUTICALS
`INC., and MONOSOL RX, LLC,
`
`Plaintiffs,
`
`v.
`
`PAR PHARMACEUTICAL, INC. and
`INTELGENX TECHNOLOGIES CORP.,
`
`Defendants.
`
`RECKITT BENCKISER PHARMACEUTICALS
`INC., and MONOSOL RX, LLC,
`
`Plaintiffs,
`
`v.
`
`WATSON LABORATORIES, INC. and
`ACTAVIS LABORATORIES UT INC.,
`
`Defendants.
`
`Civil Action No. 14-1451-RGA
`
`Civil Action No. 14-1573-RGA
`
`Civil Action No. 14-1574-RGA
`
`MEMORANDUM OPINION
`
`Mary W. Bourke, Esq., Dana K. Severance, Esq., Daniel M. Attaway, Esq., WOMBLE CARLYLE
`SANDRIDGE & RICE, LLP, Wilmington, DE; Daniel A. Ladow, Esq. (argued), James M.
`
`Par Pharm., Inc., et al.
`Exhibit 1025
`Page 001
`
`

`

`Case 1:14-cv-01451-RGA Document 175 Filed 06/29/16 Page 2 of 30 PageID #: 4670
`
`Bollinger, Esq., Timothy P. Heaton, Esq., J. Magnus Essunger, Esq., Bennet J. Moskowitz, Esq.,
`TROUTMAN SANDERS LLP, New York, NY; Puja Patel Lea, Esq., TROUTMAN SANDERS
`LLP, Atlanta, GA; Robert E. Browne, Jr., Esq., TROUTMAN SANDERS LLP, Chicago, IL;
`Charanjit Brahma, TROUTMAN SANDERS LLP, San Francisco, CA.
`
`Attorneys for Plaintiffs.
`
`Jeffrey B. Elikan, Esq., Jeffrey H. Lerner, Esq., Erica N. Andersen, Esq., COVINGTON &
`BURLING LLP, Washington, DC; Curt G. Calia, Esq., COVINGTON & BURLING LLP,
`Redwood Shores, CA.
`
`Attorneys for Plaintiff Reckitt Benckiser Pharmaceuticals, Inc. & RB Pharmaceuticals Limited.
`
`James F. Hibey, Esq., Timothy C. Bickham, Esq., Rachel M. Hofstatter, Esq., STEPTOE &
`JOHNSON LLP, Washington, DC; David L. Hecht, Esq., STEPTOE & JOHNSON LLP, New
`York, NY.
`
`Attorneys for Plaintiff MonoSol Rx, LLC.
`
`Megan C. Haney, Esq., John C. Phillips, Jr., Esq., David A. Bilson, Esq., PHILLIPS, GOLDMAN
`& SPENCE, P.A., Wilmington, DE; Michael K. Nutter, Esq., WINSTON & STRAWN, LLP,
`Chicago, IL; David P. Dalke, Esq., Ashlea Raymond Pflug, Esq., Stephen R. Smerek, Esq.
`(argued), Jason C. Hamilton, Esq., WINSTON & STRAWN, LLP, Los Angeles, CA; Melinda K.
`Lackey, Esq., Donald H. Mahoney, III, Esq., WINSTON & STRAWN LLP, Houston, TX.
`
`Attorneys for Defendant Watson Laboratories, Inc.
`
`John W. Shaw, Esq., Karen E. Keller, Esq., David M. Fry, Esq., SHAW KELLER LLP,
`Wilmington, DE; Elaine Blais, Esq. (argued), Robert Frederickson, III, Esq. (argued), Alexandra
`Lu, Esq., Kathryn Kosinski, Esq., GOODWIN PROCTER LLP, Boston, MA; Robert V.
`Cerwinski, Esq. (argued), GOODWIN PROCTER LLP, New York, NY; John Coy Stull, Esq.,
`GOODWIN PROCTER LLP, Washington, D.C.
`
`Attorneys for Defendant Teva Pharmaceuticals USA, Inc.
`
`Steven J. Fineman, Esq., Katharine Lester Mowery, Esq., RICHARDS LAYTON & FINGER,
`P.A., Wilmington, DE; Jennifer Koh, Esq., B. Thomas Watson, Esq., LATHAM & WATKINS
`LLP, San Diego, CA; Emily C. Melvin, Esq., Brenda L. Danek, Esq., LATHAM & WATKINS
`LLP, Chicago, IL; Terrance Kearney, Esq., Michelle P. Woodhouse, Esq., LATHAM &
`WATKINS LLP, Menlo Park, CA.
`
`Attorneys for Defendants Par Pharmaceutical, Inc. and Intelgenx Technologies Corp.
`
`June (cid:9)
`
`, 2016
`
`2
`
`Par Pharm., Inc., et al.
`Exhibit 1025
`Page 002
`
`

`

`Case 1:14-cv-01451-RGA Document 175 Filed 06/29/16 Page 3 of 30 PageID #: 4671
`
`ANDREWS, UPS. ISTRICT JUDGE:
`
`Presently before the Court is the issue of claim construction of multiple terms in U.S.
`
`Patent Nos. 8,906, 277 ("the '277 patent"), 8,900,497 ("the '497 patent"), 8,603,514 ("the '514
`
`patent"), 8,475,832 ("the '832 patent"), and 8,017,150 ("the '150 patent). The Court has
`
`considered the Parties' Joint Claim Construction Brief. (D.I. 108).1 The Court heard oral
`
`argument on March 31, 2016. (D.I. 174).
`
`I.
`
`BACKGROUND
`
`The present claim construction dispute arises from Hatch-Waxman litigation involving
`
`Suboxone® sublingual film, Plaintiffs' pharmaceutical film product for the treatment of opioid
`
`dependence. The parties divide the five patents at issue into two groupings: the process patents
`
`and the Orange Book patents. The process patents, which include the '277 and '497 patents,
`
`claim processes for manufacturing pharmaceutical films. The process patents are asserted
`
`against the Defendants in all three of the present actions.
`
`The Orange Book patents, which include the '150, '832, and '514 patents, claim various
`
`pharmaceutical film compositions. Plaintiffs' actions for infringement of the Orange Book
`
`patents against Defendants Watson and Par have already gone to trial and I have issued a final
`
`decision on the merits. (C.A. No. 13-1674-RGA, D.I. 446). Accordingly, the proposed claim
`
`constructions offered here for the '514, '832, and '150 patents only involve Civil Action No. 14-
`
`1451-RGA, Plaintiffs' action against Defendant Teva.
`
`II.
`
`LEGAL STANDARD
`
`"It is a bedrock principle of patent law that the claims of a patent define the invention to
`
`which the patentee is entitled the right to exclude." Phillips v. AWH Corp., 415 F.3d 1303, 1312
`
`Unless otherwise specifically noted, all references to the docket refer to Civil Action No. 14-1451-RGA.
`
`3
`
`Par Pharm., Inc., et al.
`Exhibit 1025
`Page 003
`
`

`

`Case 1:14-cv-01451-RGA Document 175 Filed 06/29/16 Page 4 of 30 PageID #: 4672
`
`(Fed. Cir. 2005) (en bane) (internal quotation marks omitted). ""[T]here is no magic formula or
`
`catechism for conducting claim construction.' Instead, the court is free to attach the appropriate
`
`weight to appropriate sources 'in light of the statutes and policies that inform patent law.'
`
`SoftView LLC v. Apple Inc., 2013 WL 4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips,
`
`415 F.3d at 1324) (alteration in original). When construing patent claims, a court considers the
`
`literal language of the claim, the patent specification, and the prosecution history. Markman v.
`
`Westview Instruments, Inc., 52 F.3d 967, 977-80 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370
`
`(1996). Of these sources, "the specification is always highly relevant to the claim construction
`
`analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term."
`
`Phillips, 415 F.3d at 1315 (internal quotation marks omitted).
`
`"[T]he words of a claim are generally given their ordinary and customary meaning.. .
`
`[Which is] the meaning that the term would have to a person of ordinary skill in the art in
`
`question at the time of the invention, i.e., as of the effective filing date of the patent application."
`
`Id. at 1312-13 (citations and internal quotation marks omitted). "[T]he ordinary meaning of a
`
`claim term is its meaning to [an] ordinary artisan after reading the entire patent." Id. at 1321
`
`(internal quotation marks omitted). "In some cases, the ordinary meaning of claim language as
`
`understood by a person of skill in the art may be readily apparent even to lay judges, and claim
`
`construction in such cases involves little more than the application of the widely accepted
`
`meaning of commonly understood words." Id. at 1314.
`
`When a court relies solely upon the intrinsic evidence—the patent claims, the
`
`specification, and the prosecution history—the court's construction is a determination of law.
`
`See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841 (2015). The court may also
`
`make factual findings based upon consideration of extrinsic evidence, which "consists of all
`
`4
`
`Par Pharm., Inc., et al.
`Exhibit 1025
`Page 004
`
`

`

`Case 1:14-cv-01451-RGA Document 175 Filed 06/29/16 Page 5 of 30 PageID #: 4673
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`evidence external to the patent and prosecution history, including expert and inventor testimony,
`
`dictionaries, and learned treatises." Phillips, 415 F.3d at 1317-19 (internal quotation marks
`
`omitted). Extrinsic evidence may assist the court in understanding the underlying technology,
`
`the meaning of terms to one skilled in the art, and how the invention works. Id. Extrinsic
`
`evidence, however, is less reliable and less useful in claim construction than the patent and its
`
`prosecution history. Id.
`
`"A claim construction is persuasive, not because it follows a certain rule, but because it
`
`defines terms in the context of the whole patent." Renishaw PLC v. Marposs Societa' per
`
`Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998). It follows that "a claim interpretation that would
`
`exclude the inventor's device is rarely the correct interpretation." Osram GMBH v. Int'l Trade
`
`Comm 'n, 505 F.3d 1351, 1358 (Fed. Cir. 2007) (citation and internal quotation marks omitted).
`
`III. CONSTRUCTION OF DISPUTED TERMS
`
`A. (cid:9)
`
`The '277 and '497 Patents (the Process Patents)
`
`The '277 and '497 patents both claim processes for making pharmaceutical films that
`
`contain substantially uniform amounts of the active ingredient. The two patents contain nearly
`
`identical specifications. Claim 1 of the '497 patent is representative and reads as follows:
`
`1. A process for making a film having a substantially uniform distribution of
`components, comprising the steps of:
`
`(a) forming a flowable polymer matrix comprising an edible polymer, a solvent
`and a desired amount of at least one active, said matrix having a substantially
`uniform distribution of said at least one active;
`
`(b) casting said flowable polymer matrix;
`
`(c) rapidly evaporating at least a portion of said solvent upon initiation of drying
`to form a visco-elastic film within about the first 4.0 minutes to maintain said
`substantially uniform distribution of said at least one active by locking-in or
`substantially preventing migration of said at least one active within said visco-
`elastic film;
`
`5
`
`Par Pharm., Inc., et al.
`Exhibit 1025
`Page 005
`
`

`

`Case 1:14-cv-01451-RGA Document 175 Filed 06/29/16 Page 6 of 30 PageID #: 4674
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`(d) further drying said visco-elastic film to form a self-supporting edible film
`having a substantially uniform distribution of said at least one active
`component; and wherein said substantially uniform distribution of said at least
`one active component is measured by substantially equally sized individual unit
`doses which do not vary by more than 10% of said desired amount of said at
`least one active.
`
`('497 patent, claim 1).
`
`1. "said [polymer] matrix having a substantially uniform distribution of [said/said
`pharmaceutical/at least one] active" ('277 patent claim 1; '497 patent, claims 1, 26, 27, 30)
`
`a.
`
`b.
`
`c.
`
`Plaintiffs' proposed construction: "[an active/a pharmaceutical active] is
`distributed in the [polymer] matrix such that individual dosage units do not vary
`by more than 10% from the intended amount of the active for that dosage unit."
`
`Defendants' proposed construction: Indefinite.
`
`Court's construction: "[an active/a pharmaceutical active] is distributed in the
`[polymer] matrix such that individual dosage units do not vary by more than 10%
`from the intended amount of the active for that dosage unit."
`
`Plaintiffs argue that their proposed construction "employs the same measure of
`
``substantial uniformity' as is used consistently throughout the Process Patents." (D.I. 108 at p.
`
`17). Plaintiffs further contend that the specifications support this construction because they
`
`"teach[] that uniformity is first created during the mixing of the matrix and then simply
`
``maintained' or `locked-in' through subsequent steps of the process, [therefore] 'substantial
`
`uniformity' must mean the same thing at every step of the process." (Id. at p. 19). Plaintiffs also
`
`assert that their proposed construction is consistent with my claim construction in Plaintiffs'
`
`related Orange Book infringement actions against Defendants Par and Watson, construing the
`
`term "substantially uniformly stationed" in the '514 patent. (Id. at pp. 20-21 (citing C.A. No.
`
`13-1674-RGA, D.I. 156 at 15-18)). Defendants assert that "Plaintiffs improperly conflate the
`
`required uniformity of the liquid matrix with the separate uniformity requirement of the final
`
`film product," which expressly requires less than 10% variation from the desired amount of the
`
`6
`
`Par Pharm., Inc., et al.
`Exhibit 1025
`Page 006
`
`

`

`Case 1:14-cv-01451-RGA Document 175 Filed 06/29/16 Page 7 of 30 PageID #: 4675
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`active. (Id. at p. 11). While Defendants concede that the claims define substantial uniformity
`
`with regard to the final film, they contend that no intrinsic evidence provides an objective
`
`boundary for the required uniformity of the liquid matrix that precedes the final film. (Id. at p.
`
`13). Thus, according to Defendants, the claim term is indefinite because "substantially uniform"
`
`is a term of degree and "neither the claim language, nor the specification, provides any objective
`
`boundaries to allow a [POSA] to determine when a flowable polymer matrix is 'substantially
`
`uniform' enough to fall within the claims." (Id. at p. 12).
`
`The Court will adopt Plaintiffs' construction. The claims containing the disputed term
`
`describe a process that involves several steps, including (1) forming a flowable polymer matrix
`
`with a substantially uniform distribution of at least one active, (2) casting the matrix, (3) rapidly
`
`drying the matrix thereby evaporating some of the solvent in order to lock in or prevent
`
`migration of the active from the resulting visco-elastic film, and (4) further drying the film to
`
`create a final edible film product where the amount of the active does not vary by more than 10%
`
`from the desired amount of the active. (See, e.g., '497 patent claim 1; '277 patent claim 1). The
`
`claims and the specifications clearly state the goal that the amount of the active in the final film
`
`product should not vary more than 10% from the desired dosage unit in order to comply with
`
`various world regulatory authorities. ('497 patent, col. 2,11. 48-52; '277 patent, col. 2,11.45-
`
`49). The specifications and claims also both contemplate achieving this level of uniformity by
`
`locking-in or preventing migration of the active during the drying process. (See, e.g., '497
`
`patent, col. 12,11.41-42 ("Uniformity must be maintained as the flowable mass was formed into
`
`a film and dried."); id. col. 12,11.49-50 ("The films are controllably dried to prevent aggregation
`
`and migration of components . . . .").
`
`7
`
`Par Pharm., Inc., et al.
`Exhibit 1025
`Page 007
`
`

`

`Case 1:14-cv-01451-RGA Document 175 Filed 06/29/16 Page 8 of 30 PageID #: 4676
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`In simpler terms, the patents describe a process that starts with a uniform liquid matrix
`
`and then seeks to maintain or lock-in uniformity when drying the liquid to form the resulting
`
`pharmaceutical films. Given the concern with losing uniformity during the drying process,
`
`discussed repeatedly in the specification, it seems fairly obvious that a POSA would understand
`
`that the distribution of the active in the liquid matrix should be as uniform as possible. ('497
`
`patent, col. 12, 11. 40-42 ("[T]he flowable mixture is prepared to be uniform in content in
`
`accordance with the teachings of the present invention.")). The claims at issue clearly
`
`contemplate forming a final film product that has a substantially uniform distribution of the
`
`active, where substantial uniformity is assessed by whether or not the unit doses vary by more
`
`than 10% from the desired amount of the active. Accordingly, it logically follows that, with the
`
`patent's concern for losing uniformity, the initial polymer matrix must not vary by more than
`
`10% from the intended amount of the active and ideally would be as uniform as possible.
`
`Plaintiffs' construction therefore provides a rather straightforward, precise meaning of the claim
`
`term read in light of the patents as a whole, and certainly does not leave a POSA contemplating
`
`an unbounded degree of possibilities. Accordingly, I conclude that the claim term is not
`
`indefinite. See Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1370 (Fed. Cir. 2014)
`
`("Claim language employing terms of degree has long been found definite where it provided
`
`enough certainty to one of skill in the art when read in the context of the invention.").
`
`2. (cid:9)
`
`"to maintain said uniform distribution of said [pharmaceutical/at least one] active by
`locking-in or substantially preventing migration of said [pharmaceutical/at least one]
`active" ('277 patent, claim 1; '497 patent, claims 1, 26, 27, 30)
`
`a. (cid:9)
`
`Plaintiffs' proposed construction: "to maintain a distribution of [an active/a
`pharmaceutical active] by limiting its migration such that individual dosage units
`do not vary by more than 10% from the intended amount of the active for that
`dosage unit"
`
`8
`
`Par Pharm., Inc., et al.
`Exhibit 1025
`Page 008
`
`

`

`Case 1:14-cv-01451-RGA Document 175 Filed 06/29/16 Page 9 of 30 PageID #: 4677
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`b.
`
`c.
`
`Defendants' proposed construction: The term "by locking-in or substantially
`preventing migration" should be construed as "dried to form a solid film." "Said
`[substantially] uniform distribution of said [pharmaceuticallat least one] active" is
`Indefinite.
`
`Court's construction: "to maintain a distribution of [an active/a pharmaceutical
`active] by drying to form a viscoelastic solid film, thereby limiting its migration
`such that individual dosage units do not vary by more than 10% from the intended
`amount of the active for that dosage unit"
`
`The parties address two disputes with regard to this claim term. First, Defendants renew
`
`their indefiniteness arguments, arguing that "said uniform distribution" of the active is indefinite.
`
`I conclude that it is not indefinite for the same reasons discussed above as to term one. The
`
`remaining dispute concerns whether the term "locking-in or substantially preventing migration"
`
`should be construed as "dried to form a solid film," or if that would be too narrow. Defendants
`
`argue that a POSA would understand a visco-elastic film to be solid and that "the specifications
`
`repeatedly describe the `visco-elastic film' as a solid." (D.I. 108 at p. 24). Defendants also point-
`
`to the declaration of their expert, Dr. Amiji, who opines that ‘" [a] visco-elastic solid would be
`
`understood to a [POSA] as a flexible, stretchable solid like Silly Putty.'" (Id. at p. 29 (alterations
`
`in original) (quoting D.I. 109-1 at ¶ 19)). Plaintiffs argue that the word "solid" never appears in
`
`the claims and that Defendants' proposed construction of a "solid film" effectively reads out the
`
`term "visco-elastic," which is actually used in the claims. (Id. at p. 27). Plaintiffs also cite
`
`extrinsic evidence that defines "'a viscoelastic material [as] one that possess both fluid and solid
`
`properties.'" (Id. (citing D.I. 109-3 at 2, N. Ozkaya, et al., FUNDAMENTALS OF BIONIECHANICS:
`
`EQUILIBRIUM, MOTION AND DEFORMATION)). Plaintiffs also point out that the specification
`
`never uses the world "solid" alone, but instead always pairs it with the modifier "visco-elastic"
`
`or other terms of degree. (Id.).
`
`I conclude that the proper construction is somewhere in between the two extremes
`
`proposed by the parties. Plaintiffs' proposed construction ignores the patents' repeated
`
`9
`
`Par Pharm., Inc., et al.
`Exhibit 1025
`Page 009
`
`

`

`Case 1:14-cv-01451-RGA Document 175 Filed 06/29/16 Page 10 of 30 PageID #: 4678
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`disclosures that "locking in" occurs as a result of the liquid matrix attaining more solid properties
`
`after undergoing a drying process. Indeed, Plaintiffs' proposed construction is so broad as to not
`
`even necessarily require that drying actually occur, even though drying is the only method
`
`disclosed to achieve this locking in. For these reasons, Plaintiffs' construction is clearly at odds
`
`with the claims and specifications of the patents. ('277 patent, 8:65-9:1 (explaining that stability
`
`must be maintained "in the wet film stage until sufficient drying has occurred to lock-in the
`
`particles and matrix into a sufficiently solid form such that uniformity is maintained"); '497
`
`patent, 8:65-9:1). However, Defendants' proposed construction seeks to characterize visco-
`
`elastic in absolute terms. It would require a 100% solid form where neither the claims nor the
`
`specifications require complete solidity at this particular stage of the claimed process. While the
`
`word solid is used in the specifications, it is always preceded by visco-elastic or other terms of
`
`degree. ('277 patent, col. 13,11.42-43 ("The resulting dried film 1 is a visco-elastic solid . . . .");
`
`'497 patent, col. 13,11. 55-56; '277 patent, col. 25,11. 14-15 ("[During] its initial setting period .
`
`. . a solid, visco-elastic structure is formed."); '497 patent, col. 27,11. 30-31; '277 patent, 8:67-
`
`9:1 ("a sufficiently solid form"); '497 patent, 8:67-9:1).
`
`Indeed, the best way to describe the resulting film is to use the language actually
`
`employed throughout the specification—"a visco-elastic solid." This construction comports with
`
`the teachings of the specifications, which clearly contemplate that the liquid matrix substantially
`
`solidifies and thereby gains sufficient structure at this phase, while not requiring that no liquid
`
`remain at all. ('277 patent, col. 13,11.45-48 ("Although minor amounts of liquid carrier, i.e.,
`
`water, may remain subsequent to formation of the visco-elastic, the film may be dried further
`
`without movement of the particles, if desired."); '497 patent, col. 13,11. 58-61; '277 patent, col.
`
`8,11. 38-40 ("Formation of a viscoelastic or a highly structured fluid phase provides additional
`
`10
`
`Par Pharm., Inc., et al.
`Exhibit 1025
`Page 010
`
`

`

`Case 1:14-cv-01451-RGA Document 175 Filed 06/29/16 Page 11 of 30 PageID #: 4679
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`resistive forces to particle sedimentation."); '497 patent, col. 8,11. 38-40). This construction also
`
`comports with the extrinsic evidence submitted by each party: the Ozkaya reference and the
`
`declaration of Dr. Amiji. (D.I. 109-3 at 2 ("[A] viscoelastic material is one that possess both
`
`fluid and solid properties."); D.I. 109-1 at ¶ 19 ("[A] [POSA] would understand that a solid film
`
`could contain water (or solvent) and could be subjected to further drying to remove water (or
`
`solvent).")).
`
`Accordingly, I will construe "locking-in or substantially preventing migration" to mean
`
`"drying to form a visco-elastic solid film."
`
`3. (cid:9)
`
`"film having a substantially uniform distribution of said at least one active component"
`('497 patent, claims 1, 26, 27)
`
`a.
`
`b.
`
`c.
`
`Plaintiffs' proposed construction: "[an active/a pharmaceutical active] is
`distributed in the film such that individual dosage units do not vary by more than
`10% from the intended amount of the active for that dosage unit."
`
`Defendants' proposed construction: Not disputed.
`
`Court's construction: "[an active/a pharmaceutical active] is distributed in the
`film such that individual dosage units do not vary by more than 10% from the
`intended amount of the active for that dosage unit."
`
`Defendants appear to have dropped their initial contention that this term, directed toward
`
`the substantial uniformity of the final film, is indefinite, conceding that "the claim itself provides
`
`the objective boundary for the final film's uniformity." (D.I. 108 at p. 30). Because the 10%
`
`boundary is expressly stated in the relevant claim language, I will adopt Plaintiffs' construction.
`
`4. (cid:9)
`
`"rapidly"2 ('277 patent, claim 1; '497 patent, claims 1, 26, 27, 30)
`
`a.
`
`b.
`
`Plaintiffs' proposed construction: Plain and ordinary meaning.
`
`Defendants' proposed construction: "within about the first 4 minutes"
`
`2 The parties propose four different terms that present nearly identical variations of the same dispute. However,
`it is clear to the Court that these four proposed claim terms only reflect two fundamental disputes that can be assessed
`by construing two single-word terms: "rapidly" and "drying." Accordingly, the Court will construe those two terms
`instead of the four, paragraph-long terms proposed by the parties.
`
`11
`
`Par Pharm., Inc., et al.
`Exhibit 1025
`Page 011
`
`(cid:9)
`(cid:9)
`

`

`Case 1:14-cv-01451-RGA Document 175 Filed 06/29/16 Page 12 of 30 PageID #: 4680
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`c. (cid:9)
`
`Court's construction: Plain and ordinary meaning.
`
`The parties dispute whether the term "rapidly"—when referring to drying, evaporating, or
`
`increasing viscosity—must mean "within about the first 4 minutes." In all of the claim
`
`limitations where the word rapidly appears, the claim expressly discloses that the visco-elastic
`
`film is formed or that the viscosity of the polymer matrix increases within about the first 4
`
`minutes. For example, subpart (c) of claim 1 of the '497 patent reads as follows:
`
`(c) rapidly evaporating at least a portion of said solvent upon initiation of drying
`to form a visco-elastic film within about the first 4.0 minutes . . . .
`
`('497 patent, claim 1). Plaintiffs argue that, because the claim limitations already expressly
`
`contain the temporal limitation advanced by Defendants (within the first 4 minutes), Defendants'
`
`proposed construction improperly renders the existing temporal claim limitation superfluous.
`
`(D.I. 108 at p. 35). Thus, Plaintiffs contend that the word rapidly must be read in the context of
`
`the claims in which it appears, and should merely be given its plain and ordinary meaning. (Id.
`
`at p. 36). Defendants argue that Plaintiffs are trying to, hedge their infringement case by arguing
`
`that the claimed four-minute time periods can take longer than four minutes. (Id. at p. 42).
`
`Indeed, Defendants correctly point out that Plaintiffs appeared to argue that they are not limited
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`by the four-minute time limitation by citing a passage of the specification that states "[d]esirably,
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`the drying of the film will occur within about ten minutes or fewer." (Id. at p. 43). Defendants
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`argue, however, that this passage "concerns the overall drying time needed to produce the final
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`film, not the initial rapid drying period that creates the solid, visco-elastic film." (Id.).
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`I conclude that there is no need to construe "rapidly" in isolation and that the plain and
`
`ordinary meaning of the term should govern. When read in the context of the claim language as
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`a whole, which includes a four minute temporal limitation, there is no need to read a second
`
`12
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`Par Pharm., Inc., et al.
`Exhibit 1025
`Page 012
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`Case 1:14-cv-01451-RGA Document 175 Filed 06/29/16 Page 13 of 30 PageID #: 4681
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`four-minute temporal limitation into the word "rapidly." That being said, I do not view this
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`construction as leaving Plaintiffs leeway to argue that they are not bound by the express claim
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`language requiring that the visco-elastic film be formed or viscosity increase "within about the
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`first 4 minutes" from the initiation of drying.3 (See, e.g., '277 patent, claim 1 ("by rapidly
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`increasing the viscosity of said polymer matrix upon initiation of drying within about the first 4
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`minutes"); '497 patent, claim 1 ("rapidly evaporating at least a portion of said solvent upon
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`initiation of drying to form a visco-elastic film within about the first 4.0 minutes . . . .")).
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`5. (cid:9)
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`"drying" ('277 patent, claim 1; '497 patent, claims 1, 26, 27, 30)
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`a.
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`b.
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`c.
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`Plaintiffs' proposed construction: Plain and ordinary meaning.
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`Defendants' proposed construction: "drying without solely employing
`conventional convection air drying from the top."
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`Court's construction: "drying without solely employing conventional convection
`air drying from the top."
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`The parties dispute whether "drying" covers all means of drying or whether the
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`specifications disavow certain methods of drying. Defendants argue that the specifications of
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`both the '277 and '497 patents disavow and repeatedly disparage the prior art method of solely
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`using conventional convection air drying from the top. (D.I. 108 at p. 37). Moreover,
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`Defendants argue that the patentee distinguished the claimed processes from conventional
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`convection air drying from the top, because the conventional method causes a ripple effect (a
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`skin forming on the top of the film that repeatedly breaks), which results in an uneven, non-
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`uniform film. (Id. at pp. 37-39). Defendants further assert that while the specifications
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`contemplate the use of some top air drying, "in every instance that top air drying is disclosed, it
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`is balanced with bottom air drying." (Id. at p. 41). Plaintiffs argue that the specifications only
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`3 I agree with Defendants that the mention of drying "within ten minutes or fewer" in the specification relates
`only to the time it takes to dry the entire final film product, not the early step of forming the visco-elastic film.
`
`13
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`Par Pharm., Inc., et al.
`Exhibit 1025
`Page 013
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`Case 1:14-cv-01451-RGA Document 175 Filed 06/29/16 Page 14 of 30 PageID #: 4682
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`warn that conventional air drying methods can cause a rippling effect but otherwise expressly
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`disclose that embodiments of the invention may still use top air drying. (Id. at pp. 33-34, 44).
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`Plaintiffs further contend that "neither statements about downsides of conventional drying nor
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`the individual exemplary embodiments qualify as a 'clear and unmistakable' disavowal of
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`employing only convection air drying from the top." (Id. at p. 34). Therefore, according to
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`Plaintiffs, "The patent thus teaches to recognize the potential negative effects of uncontrolled
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`drying using top air flow, not to negate entirely any top air flow or even top air flow by itself"
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`(Id. at p. 45). Defendants respond by reiterating that their construction recognizes that the
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`specification allows some top-air drying to be used, but only in conjunction with other drying
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`methods and never alone. (Id. at p. 48).
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`"[T]he specification and prosecution history only compel departure from the plain
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`meaning in two instances: lexicography and disavowal." GE Lighting Solutions, LLC v.
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`AgiLight, Inc., 750 F.3d 1304, 1309 (Fed. Cir. 2014). The standard for finding disavowal has
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`been described as "exacting" and "requires that the specification [or prosecution history] make[]
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`clear that the invention does not include a particular feature." Id. (alterations in original)
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`(internal quotation marks omitted). However, "[w]here the specification makes clear that the
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`invention does not include a particular feature, that feature is deemed to be outside the reach of
`
`the claims of the patent, even though the language of the claims, read without reference to the
`
`specification, might be considered broad enough to encompass the feature in question." Chicago
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`Bd. Options Exch., Inc. v. Int'l Sec. Exch., LLC, 677 F.3d 1361, 1372 (Fed Cir. 2012) (alteration
`
`in original) (internal quotation marks omitted). Disavowal need not be explicitly stated as long
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`as a POSA would understand—after reading the claims, specification, and prosecution history—
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`that the invention does not encompass a particular feature. See SciMed Life Sys., Inc. v.
`
`14
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`Par Pharm., Inc., et al.
`Exhibit 1025
`Page 014
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`

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`Case 1:14-cv-01451-RGA Document 175 Filed 06/29/16 Page 15 of 30 PageID #: 4683
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`Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1344 (Fed. Cir. 2001) ("[T]he written
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`description can provide guidance as to the meaning of the claims, thereby dictating the manner in
`
`which the claims are to be construed, even if the guidance is not provided in explicit definitional
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`format."). For instance, "repeated derogatory statements concerning one type of [feature can be]
`
`the equivalent of disavowal of that subject matter from the scope of the patent's claims."
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`Honeywell Int'l, Inc. v. ITT Indus., Inc., 452 F.3d 1312, 1320 (Fed. Cir. 2006).
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`After reviewing the specifications of the '497 and '277 patents, I conclude that the
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`patentee disavowed using solely conventional convection air drying from the'top, both through
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`express statements of what the invention is and repeated disparagement of top drying methods.
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`First, the specifications make clear that a key inventive aspect of the two patents is the claimed
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`processes' ability to avoid a problem occurring in the prior art: "a ripple effect." According to
`
`the specifications, a ripple effect occurs during the process of drying a pharmaceutical film when
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`surface water evaporates immediately, forming a top layer or skin that repeatedly rips and is
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`reformed as water vapor under the skin heats up and escapes, a process that is repeated until the
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`entire film is completely dried. ('497 patent, col. 3,11.43-63; '277 patent, col. 3,1