Case 2:15-cv-01455-WCB Document 214 Filed 12/13/16 Page 1 of 52 PageID #: 8859
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
`
`Case No. 2:15-CV-1455-WCB
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`§§§§§§§§§§
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`ALLERGAN, INC.
`
`Plaintiff,
`
`v.
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`TEVA PHARMACEUTICALS USA, INC.,
`et al.,
`
`Defendants.
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`CLAIM CONSTRUCTION MEMORANDUM OPINION AND ORDER
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`On August 26, 2016, the Court held a hearing to address the proper construction of the
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`disputed terms of the six patents at issue in this case, U.S. Patent Nos. 8,629,111 (“the ’111
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`patent”); 8,633,162 (“the ’162 patent”); 8,642,556 (“the ’556 patent”); 8,648,048 (“the ’048
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`patent”); 8,685,930 (“the ’930 patent”); and 9,248,191 (“the ’191 patent”). After considering the
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`arguments made by the parties at the hearing (Dkt. No. 182), in their claim construction briefing
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`(Dkt. Nos. 155, 165, and 171), and in their supplemental claim construction briefs (Dkt. Nos.
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`190, 211, and 213), the Court issues this order setting forth the Court’s construction of the claim
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`terms identified by the parties as being in dispute.
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` The patents in suit are directed to an emulsion containing cyclosporin, a compound that
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`is useful for treating an ophthalmic condition known variously as “dry eye,” “dry eye disease,”
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`or “dry eye syndrome,” and a related condition known as keratoconjunctivitis sicca.1 The
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`1 Cyclosporin is often spelled cyclosporine, including in many research papers. The
`patents generally spell the term cyclosporin (with a few inconsistencies). The Court will spell
`the term as the asserted patents (generally) do. The difference in spelling does not reflect any
`difference in the designated compound or group of compounds.
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`patents are mainly directed to the composition of the emulsion containing the cyclosporin
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`component.
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`All six patents are entitled “Methods of Providing Therapeutic Effects Using Cyclosporin
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`Components.” The patents share a common specification, except for a 14-line passage found in
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`the ’111 patent, the ’048 patent, and the ’930 patent that is not found in the other three.2 The
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`emulsion that is the subject of many of the claims of the patents contains cyclosporin A, water,
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`and castor oil (a hydrophobic component), as well as certain other named constituents. The
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`claims recite that cyclosporin A is present in an amount of about 0.05% by weight of the
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`composition and castor oil is present in an amount of about 1.25% by weight of the composition.
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`It was known as early as the 1980s that cyclosporin was effective in treating dry eye. See
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`U.S. Patent No. 4,839,342 to Kaswan. By the mid-1990s, it was known that an emulsion
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`consisting of between about 0.05% and about 0.40% by weight of cyclosporin A and between
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`about 0.625% and 5.0% by weight of castor oil, along with certain other components, could be
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`used in direct administration to the eye. See U.S. Pat. No. 5,474,979 to Ding. The claimed
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`improvement described in the group of asserted patents at issue in this case is that at the
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`particular percentages of cyclosporin A and castor oil recited in the claims, the emulsion
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`surprisingly has therapeutic efficacy roughly equal to that of an emulsion having twice the
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`relative concentration of cyclosporin. The low concentration of cyclosporin in the claimed
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`emulsion had the advantage of not resulting in substantial concentrations of cyclosporin in the
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`patient’s bloodstream. The claimed emulsion thus avoided triggering the side effects that often
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`accompany treatments employing higher concentrations of cyclosporin.
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`2 That passage is found at column 2, line 65, through column 3, line 11, of the ’111
`patent; column 2, line 65, through column 3, line 11, of the ’048 patent; and column 2, line 64,
`through column 3, line 10, of the ’930 patent.
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`The claim construction issues that are in dispute fall into eight categories. One claim
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`term that was initially in dispute has been agreed upon by the parties: The parties have agreed
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`that the phrase “substantially no detectable concentration of cyclosporin A” should be construed
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`to mean “a blood concentration under one-tenth nanogram per milliliter.” The Court accepts that
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`construction of the term. The remaining terms in dispute are addressed below.
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`1. dry eye, dry eye disease, dry eye syndrome, and keratoconjunctivitis sicca
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`The patents use the terms “dry eye,” “dry eye disease,” and “dry eye syndrome” at
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`different times. The term “dry eye” is used in claims 20, 23, and 25 of the ’111 patent and
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`claims 13 and 23 of the ’930 patent. The term “dry eye disease” is used in claims 1, 22, and 23
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`of the ’162 patent; claims 1, 11, and 13 of the ’556 patent; and claims 1 and 17 of the ’191
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`patent. The term “dry eye syndrome” is used in claims 18 and 21 of the ’162 patent. All three
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`terms are used in the common specification of the six patents. See ’111 patent, col. 12, line 4
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`(“dry eye”); id., col. 2, ll. 40, 66, and col. 14, ll. 34, 39, 44, 67 (“dry eye disease”); id., col. 2, ll.
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`60-61, 64, and col. 5, ll. 14-15, 19, 29-30, and col. 14, line 55 (“dry eye syndrome”). Allergan
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`argues that all three terms refer to the same condition and that the difference in terminology is
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`not significant. Allergan proposes the following definition for “dry eye” and “dry eye disease”:
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`“a group of disorders of the tear film, including those caused by reduced tear production or tear
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`evaporation or an imbalance of tear film components associated with clinical signs, ocular
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`discomfort and/or visual symptoms.”
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`The term keratoconjunctivitis sicca (“KCS”) is used in claims 21 and 26 of the ’111
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`patent; claims 18, 21, and 22 of the ’048 patent; claims 1, 11, 25, and 35 of the ’930 patent; and
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`in the portion of the common specification that is found only in the ’111, ’048, and ’930 patents,
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`see ’111 patent, col. 2, line 66, and col. 3, ll. 4-5; ’048 patent, col. 2, line 66, and col. 3, ll. 4-5;
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`’930 patent, col. 2, line 65, and col. 3, ll. 3-4. Allergan argues that KCS is a subset of the
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`condition known as dry eye, and that in patients suffering from KCS the symptoms of dry eye are
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`associated with inflammation of the conjunctiva, the tissue that lines the inside of the eyelids. It
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`proposes the following definition for KCS: “a subset of dry eye disease, characterized by
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`inflammation of the conjunctiva and of the cornea, associated with decreased tears.”
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`The defendants offer no competing definitions of these terms. Instead, they argue that the
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`term “KCS” and all three variants of the term “dry eye”—“dry eye,” “dry eye disease,” and “dry
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`eye syndrome”—are indefinite. The defendants point out that none of those terms are explicitly
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`defined in the common specification, and they argue that the terms have been used in varying
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`ways in the field over time. Accordingly, they contend that none of the terms would convey a
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`well-understood meaning to a person of ordinary skill in the art.
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`As the defendants point out, medical literature acknowledges that there is “considerable
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`confusion regarding the definition of dry eye.” Stephen C. Pflugfelder et al., The Diagnosis and
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`Management of Dry Eye: A Twenty-five-Year Review, 19 Cornea 644 (2000). The defendants’
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`expert, Dr. Andrew F. Calman, said the same thing in his declaration. He stated that “[a] number
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`of different terms have been used by various authors to describe various subgroups of patients
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`with ‘dry eye’ symptomatology: dry eye, dry eye syndrome, dry eye disease, keratoconjunctivitis
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`sicca (KCS), keratitis sicca, sicca syndrome, sicca complex, Sjogren syndrome, aqueous
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`deficient dry eye, evaporative dry eye, dry eye associated with Meibomian gland dysfunction,
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`and others.” Declaration of Andrew F. Calman, Dkt. No. 165-24, at 7. He explained that
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`different authors have used those terms in different ways, and that the terminology in the field
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`“has been murky and inconsistent at best, and self-contradictory at worst.” Id. His declaration
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`cites several authorities that have noted the heterogeneity of dry eye and the variety of tear film
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`abnormalities that are included within the general category of “dry eye.” Id. at 8-11.
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`Allergan responds that despite differences in usage, persons of ordinary skill in the art
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`know the meaning of KCS and “dry eye,” including the terms “dry eye disease” and “dry eye
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`syndrome.” Allergan’s expert, Dr. Robert J. Noecker, stated that “[d]ry eye encompasses a
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`broad group of tear film disorders generally caused by reduced tear production, tear evaporation,
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`or an imbalance in tear film components (leading to decreased tear quality).” Declaration of
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`Robert J. Noecker, M.D. in Support of Plaintiff Allergan’s Claim Constructions, Dkt. No. 155-
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`35, ¶ 19, at 7. Dr. Noecker defined KCS as “a disease falling within the broader category of ‘dry
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`eye’ disease,” which is characterized by inflammation of the conjunctiva and cornea “associated
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`with decreased tears and decreased tear quality.” Id. ¶ 22, at 9; id. ¶¶ 30-31, at 12-13. He added
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`that although KCS is sometimes colloquially referred to as “dry eye,” a person of ordinary skill
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`in the art “would understand that dry eye is a broader category of disorders of the tear film, and
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`that KCS is a subset of dry eye disease or dry eye syndrome.” Id. ¶ 30, at 12.
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`In support of those assertions, Dr. Noecker referred to various resources, including a
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`2011 publication of the American Academy of Ophthalmology, which defined “dry eye
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`syndrome” as referring to “a group of disorders of the tear film that are due to reduced tear
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`production or excessive tear evaporation that is associated with ocular discomfort and/or visual
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`symptoms and may cause disease of the ocular surface. This group of disorders is usually
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`referred to as dry eye.” American Academy of Ophthalmology Cornea/External Disease Panel,
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`Dry Eye Syndrome—Limited Revision 3 (2011). Dr. Noecker also relied on the definition set
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`forth in a 1999 patent, which stated: “Dry eye generally refers to any tear film abnormality,
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`usually with epithelial abnormalities. A specific deficiency of the aqueous component of the tear
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`film is known as keratoconjunctivitis sicca (KCS) . . . . Literally, the term denotes inflammation
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`of the cornea and conjunctiva secondary to drying.” U.S. Patent No. 5,981,607, col. 1, ll. 18-24.
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`With respect to Dr. Calman’s views on the indefiniteness issue, Allergan notes that
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`during his deposition Dr. Calman provided a general definition of the term “dry eye,” which he
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`said he used colloquially to refer to a complex of related conditions. While he stated that there is
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`“a lot of different terminology in this field . . . . a lot of confusion and contradictions, many
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`different definitions,” he explained that he used the term “dry eye” as a non-specific term to
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`encompass “a group of disorders that have in common some feature of symptoms and/or signs
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`and/or objective findings related to problems with the tear film, whether it’s problems of quantity
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`or quality or other conditions that may manifest with similar symptomatology and/or signs or
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`objective findings. So it’s a catch-all term.” Videotaped Deposition of Andrew Calman, M.D.,
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`Dkt. No. 165-2, at 15:4 to 15:10. The upshot of Dr. Calman’s testimony is that, while there is
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`disagreement about the precise definition of “dry eye” and its related terms, “dry eye” is
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`generally used to refer to tear film disorders that result in a reduction in the quantity or quality of
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`tears.
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`Allergan also points to articles and other patents in the field that use the term “dry eye” or
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`its variants in a way that indicates a consensus as to the general meaning of the term, while
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`recognizing that there has for some time been a lack of precision in the definitions used by
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`experts in the field. An article by Dr. Kenneth Sall and others that was cited and “incorporated
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`in its entirety . . . herein by reference” in the patents in suit, see, e.g., ’111 patent, col. 1, ll. 52-
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`53,3 referred to “dry eye disease” as a condition that is characterized by “discomfort, burning,
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`3 The parties dispute whether the definitional discussion in the Sall article was properly
`incorporated by reference in the patents in suit. For present purposes, however, it is not
`important to resolve that question. At minimum, the article represents the views of persons of
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`Case 2:15-cv-01455-WCB Document 214 Filed 12/13/16 Page 7 of 52 PageID #: 8865
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`irritation, photophobia, and . . . blurred vision, gradual contact lens intoleration, and the inability
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`to produce emotional tears.” Kenneth Sall et al., Two Multicenter, Randomized Studies of the
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`Efficacy and Safety of Cyclosporine Ophthalmic Emulsion in Moderate to Severe Dry Eye
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`Disease, 107 Ophthalmology 631 (2000). Other articles in the field had much the same thing to
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`say about what was variously termed “dry eye” and “dry eye disease.” As the disorder has
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`become better understood over time, the definition has become more precise.
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`A 1995 report summarized the results of the meetings of the National Eye
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`Institute/Industry Workshop on Clinical Trials in Dry Eyes, held at the National Institutes of
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`Health in 1993 and 1994. The meetings were held to identify areas of consensus and
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`disagreement in the design and interpretation of clinical trials regarding dry eye. Michael A.
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`Lemp, Report of the National Eye Institute/Industry Workshop on Clinical Trials in Dry Eyes, 21
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`CLAO Journal 221 (1995). The report noted that there were varying definitions of the terms
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`“dry eye” and “KCS” among practitioners in the field. The report recommended the following
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`definition: “Dry eye is a disorder of the tear film due to tear deficiency or excessive tear
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`evaporation which causes damage to the interpalpebral ocular surface and is associated with
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`symptoms of ocular discomfort.” Id. at 222; see also Stephen C. Pflugfelder, The Diagnosis and
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`Management of Dry Eye, 19 Cornea 644, 645-46 (2000).
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`Other contemporaneous authorities offered similar definitions. A text published in 1998
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`referred to the “colloquial, nonspecific” term “dry eye” as referring to “any tear film
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`abnormality, usually with corneal epithelial abnormalities.” The text equated “dry eye” with tear
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`film dysfunction, which it defined as “any tear film abnormality and specifically includes
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`skill in the art at a time near the September 15, 2003, priority date of the patents. For that reason,
`regardless of whether the article was properly incorporated by reference in the common
`specification, it is relevant to the indefiniteness issue.
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`disorders of the aqueous, mucin and lipid components of the tear film.” R. Doyle Stulting et al.,
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`Diagnosis and Management of Tear Film Dysfunction in Corneal Disorders: Clinical Diagnosis
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`and Management 482-83 (2d ed. 1998). The text defined KCS as denoting “inflammation of the
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`cornea and conjunctiva caused by drying,” and it characterized “dry eye” as resulting from
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`decreased aqueous tear production or from increased evaporative loss. Id. at 483. A subsequent
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`publication of the American Academy of Ophthalmology characterized dry eye disorders
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`generally as a “common disorder of the tear film [that] results from either decreased tear
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`production or excessive tear evaporation.” American Academy of Ophthalmology, Basic and
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`Clinical Science Course: External Disease and Cornea—Section 8 75 (2002).
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`The American Academy of Ophthalmology has continued to use that definition.
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`Moreover, as noted above, the Academy uses the terms “dry eye syndrome” and “dry eye”
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`synonymously, defining “dry eye syndrome” as “a group of disorders of the tear film,” usually
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`referred to as “dry eye,” that are “due to reduced tear production or excessive tear evaporation.”
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`American Academy of Ophthalmology Cornea/External Disease Panel, Dry Eye Syndrome—
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`Limited Revision 3 (2011).4
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`A 2007 report of the Dry Eye Workshop, an international panel of experts in dry eye
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`disease, reviewed the definition of dry eye disease adopted in the 1995 report of the National Eye
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`Institute/Industry Dry Eye Workshop. The Definition and Classification of Dry Eye Disease, 5
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`The Ocular Surface No. 2 (2007). The 2007 report contained a glossary that defined “dry eye
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`syndrome” as “that collection of clinical conditions that produce abnormalities of the tears and
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`ocular surface, usually by decreased tear production or increased tear evaporation”; it defined
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`4 A 2006 study recommended the use of the term “dysfunctional tear syndrome” in place
`of “dry eye” as a more appropriate term for the disease. Ashley Behrens et al., Dysfunctional
`Tear Syndrome—A Delphi Approach to Treatment Recommendations 25 Cornea 900, 902-03
`(2006).
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`KCS as “the condition of dry eye and inflammation of the ocular described by Henrik Sjogren,
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`MD. Now commonly used interchangeably with dry eye syndrome.” Id. at 73. The text of the
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`2007 report suggested that the definition set forth in the 1995 workshop report could be
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`improved in light of “new knowledge about the roles of tear hyperosmolarity and ocular surface
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`inflammation in dry eye and the effects of dry eye on visual function.” Id. at 75. Accordingly,
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`the 2007 report defined “dry eye” as “a multifactorial disease of the tears and ocular surface that
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`results in symptoms of discomfort, visual disturbance, and tear film instability with potential
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`damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and
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`inflammation of the ocular surface.” Id.
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`In addition to citing these publications by experts in the field, Allergan relies on
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`statements by defendant Mylan during the inter partes review proceedings relating to the patents
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`in suit, in which Mylan adopted the definition of KCS as “an ‘inflammation of the conjunctiva
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`and of the cornea’ that is ‘associated with decreased tears’ and is a species of, and is often used
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`interchangeably with, or as a partial synonym of, dry eye disease.” Petition for Inter Partes
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`Review of U.S. Patent No. 8,629,111, Case No. IPR2016-01128 (June 3, 2016), Dkt. No. 155-27,
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`at 14. Allergan also relies on a statement by one of the defendants’ experts, Dr. Erning Xia, who
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`stated in a declaration submitted in the inter parties review proceeding that, as of the priority date
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`of the patents, “it was known that dry eye disease was an ophthalmic condition that resulted in
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`many troublesome symptoms, such as burning, irritation, discomfort, photophobia, blurred
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`vision, lack of natural tear production, contact lens intolerance, and an increased risk of ocular
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`surface damage and infection.” Declaration of Erning Xia, Ph.D. (May 21, 2015), Dkt. No. 155-
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`26, at 21. A person of ordinary skill in the art, according to Dr. Xia, “would have known that dry
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`eye was characterized by an elevated inflammatory state of certain eye tissues.”
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`In light of all the evidence presented by the parties, the Court is persuaded that as of the
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`patent’s September 15, 2003, priority date the terms “dry eye,” “dry eye disease,” and “dry eye
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`syndrome” were used interchangeably in the art to describe the same disorder. That disorder was
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`subject to somewhat varying definitions, but the core meaning was clear. In light of the 1995
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`report on the National Eye Institute/Industry Workshop, it is clear to the Court that at least as of
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`that time, the terms dry eye, dry eye disease, and dry eye syndrome were generally used
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`synonymously in the art and that the meaning of those terms was reasonably certain. The Court
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`concludes that the meaning of that group of terms to a person of ordinary skill as of the patents’
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`priority date is best captured by the American Academy of Ophthalmology’s 2002 definition: “a
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`tear film dysfunction, or a disorder of the tear film that is due to reduced tear production or
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`excessive tear evaporation.”
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`As for the term “KCS,” the Court’s analysis is affected by the fact that the three patents
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`that contain claims referring to KCS (the ’111 patent, the ’048 patent, and the ’930 patent)
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`contain a specification passage that provides enlightenment as to the patentees’ understanding of
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`that term.5 In that passage, the specification of those three patents equates KCS to “dry eye
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`disease” and refers to KCS as “an absolute or partial deficiency in aqueous tear production.” See
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`’111 patent, col. 2, line 65, and col. 3, ll. 3-5. In effect, then, the ’111 patent, the ’048 patent,
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`and the ’930 patent offer a definition of KCS. Although that definition is arguably somewhat
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`broader than the definition used by practitioners in the art at the time, the Court regards that
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`definition as controlling for purposes of those three patents. And because the term KCS has
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`5 The portion of the common specification that contains those references to KCS is found
`in the patents that contain claims referring to KCS, but not in the other three patents. See ’111
`patent, col. 2, line 65, through col. 3, line 11; ’048 patent, col. 2, line 65, through col. 3, line 11;
`’930 patent, col. 2, line 64, through col. 3, line 10.
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`what amounts to an explicit definition in those three patents, the Court concludes that the term as
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`used in the claims of those patents is not indefinite.
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`With respect to the remaining challenged terms, the defendants point out that the patents
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`use the terms “dry eye,” “dry eye disease,” and “dry eye syndrome” in different claims without
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`clearly distinguishing among them. For example, the ’111 and ’930 patents use the term “dry
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`eye” or KCS in each of the claims in which any form of dry eye disorder is referenced. The ’556
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`and ’191 patents exclusively use the term “dry eye disease.” The ’048 patent exclusively uses
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`the term “KCS.” The ’162 patent uses the term “dry eye disease” in most of the claims that refer
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`to the disorder, but it uses the term “dry eye syndrome” in one independent claim and in the
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`claims that depend form that claim (claims 18 through 22).
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`That pattern of inconsistent usage is not explained, and it makes construing the patents
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`more difficult, but in the end it is not fatal. The common specification of the patents in suit uses
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`the terms “dry eye syndrome” and “dry eye disease” interchangeably, with no apparent intent to
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`assign those terms different meanings. See, e.g., ’111 patent, col. 2, ll. 64, 66; and col. 14, ll. 34,
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`39, 67 (all referring to “dry eye disease”); col. 2, line 64; col. 5, ll. 14-15, 18, 29-30; col. 14, line
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`55 (all referring to “dry eye syndrome”); and col. 12, line 4 (referring to “dry eye”). For
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`example, in the discussion of Example 1, the specification refers to the two exemplary
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`compositions as being employed in a study of the treatment of “dry eye disease,” id., col. 14, ll.
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`34, 39; then, in connection with the reference to composition II from that example, the
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`specification refers to the benefits of castor oil “to assist in treating dry eye syndrome,” id., col.
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`14, line 55. The text then notes that the breakdown of the emulsion facilitates the therapeutic
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`effectiveness of the composition “in treating dry eye disease.” Id., col. 14, line 67. It is apparent
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`from that passage that the terms “dry eye disease” and “dry eye syndrome” are being used
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`interchangeably.
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`The defendants argue that the terms “dry eye,” “dry eye disease,” dry eye syndrome,” and
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`“KCS” cannot all have the same meaning in the patents, because of the manner in which they are
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`used in the some of the asserted claims. For example, claim 20 of the ’111 patent claims the
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`topical emulsion of claim 1, “wherein the topical ophthalmic emulsion is therapeutically
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`effective in treating dry eye,” while claim 21 claims the same topical emulsion “wherein the
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`topical emulsion is therapeutically effective in treating keratoconjunctivitis sicca.” In another
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`context, the use of those two different terms in parallel claims might suggest that the terms were
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`intended to have a different meaning. In this context, however, the Court interprets the claims to
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`be structured so as to ensure that, given the sometimes varying meaning attached to those terms,
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`the claims would cover the entire range of disorders generally grouped under the terms dry eye
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`or KCS. The intended purpose of obtaining breadth of coverage is further revealed by claim 22,
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`the third dependent claim in that series, which claims the same topical emulsion “wherein the
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`topical emulsion is therapeutically effective in increasing tear production.”
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`The same analysis applies to other sets of claims throughout the asserted patents, such as
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`dependent claims 21 and 22 of the ’162 patent. Claim 21 refers to the use of a particular
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`emulsion “for treating dry eye syndrome,” while claim 22 refers to the use of the same emulsion
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`“in treating dry eye disease.”
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`An example that is instructive in suggesting how the claim terms should be construed is
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`found in claims 18 and 22 of the ’162 patent. Claim 18 recites a method of “reducing the side
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`effects in a human being treated for dry eye syndrome.” Claim 22, which depends from claim
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`18, recites the method of claim 18, “wherein the emulsion is effective in treating dry eye
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`disease.” While the use of different terms in the independent and dependent claims might
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`ordinarily suggest that they be assigned different meanings, it does not have that effect here. The
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`independent claim recites the use of a particular emulsion to reduce side effects; the dependent
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`claim adds that, in addition to reducing side effects, that particular emulsion provides effective
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`treatment for the underlying disorder. Read together, the two claims make sense only if the
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`terms “dry eye disease” and “dry eye syndrome” mean the same thing. Otherwise, the dependent
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`claim would have the odd effect of claiming an emulsion that was effective in treating one
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`condition while reducing side effects in persons treated for a different condition. The Court
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`therefore concludes that the terms are used to mean the same thing.
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`Because the Court finds that the meanings of the terms “dry eye,” “dry eye disease,” and
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`“dry eye syndrome” would be reasonably clear to a person of ordinary skill in the art as of the
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`patents’ priority date, the Court concludes that the defendants have failed to show that the claims
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`containing those terms are indefinite. As for the term KCS, the Court is satisfied that that term is
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`adequately defined in the common specification. For purposes of the asserted patents, the Court
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`will give that term the meaning it has in the specification.
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`Accordingly, the Court construes the terms “dry eye,” “dry eye disease,” and “dry eye
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`syndrome,” as those terms are used in the asserted patents, to mean “a disorder of the tear film
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`due to reduced tear production or excessive tear evaporation that is associated with ocular
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`discomfort and/or visual symptoms and may cause disease of the ocular surface.” The
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`Court defines keratoconjunctivitis sicca to mean “a type of dry eye disease involving an
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`absolute or partial deficiency in aqueous tear production.” The Court concludes that none of
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`those terms is indefinite.
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`Case 2:15-cv-01455-WCB Document 214 Filed 12/13/16 Page 14 of 52 PageID #: 8872
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`2. “effective in treating dry eye/dry eye disease/keratoconjunctivitis sicca;
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`therapeutically effective in treating dry eye/dry eye disease/keratoconjunctivitis
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`sicca; therapeutic effectiveness; therapeutic efficacy”
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`Allergan argues that these related phrases should be given their plain and ordinary
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`meaning, which is “effective in treating the underlying disease.” The defendants offer no
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`competing definitions, but argue that all of the “efficacy” phrases in the patents are indefinite.
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`The defendants’ principal argument with respect to these limitations is that the claimed
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`invention cannot be effective in treating the underlying disease because, in light of “the
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`imprecise and haphazard use of the dry eye terms and KCS within the claims and specification,”
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`the patents “fail to state the precise disease being treated.” Because the Court has rejected the
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`defendants’ argument that the identity of the diseases being treated is indefinite, the Court
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`likewise rejects the argument that it is necessarily indiscernible whether the invention is effective
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`in treating the underlying disease.
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`The defendants also argue that it is impossible to determine whether a particular
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`treatment is effective against a particular disease without knowing “which of the underlying
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`causes of dry eye, dry eye disease, dry eye syndrome, or KCS are to be treated using the alleged
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`invention.” Defendants’ Responsive Claim Construction Brief, Dkt. No. 165, at 11. Because
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`“there are multiple causes of dry eye and KCS,” the defendants argue that a person of ordinary
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`skill in the art “would not be able to pinpoint the underlying disease to be treated, and would not
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`understand with a reasonable certainty the metes and bounds of the asserted claims.” Id.
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`In fact, however, it is not uncommon that an effective remedy for particular maladies is
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`discovered even though those who have devised the remedy do not understand the causes of the
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`maladies or the mechanism by which the remedy works. In this case, the test of efficacy is
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`Case 2:15-cv-01455-WCB Document 214 Filed 12/13/16 Page 15 of 52 PageID #: 8873
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`simply whether the invention successfully treats the condition. It is not necessary that the
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`process by which the emulsion works to address the condition be fully understood.
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`The defendants suggest that because dry eye symptoms can be produced by a variety of
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`causes, such as, for example, environmental pollution, the claims cannot be therapeutically
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`effective against dry eye because there are some forms of dry eye that will not respond to the
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`treatments set forth in the claims. Nothing in the claims, however, requires that the claimed
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`emulsions be effective against all forms of dry eye, no matter what the cause of the condition.
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`The “therapeutic efficacy” claims simply recite an emulsion that is generally effective against
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`dry eye disorders, or at least against some subset of all dry eye disorders. An emulsion that is
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`not effective against at least some types of dry eye disorders will not infringe. Thus, it is
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`incumbent upon the plaintiff in an infringement action to prove that the accused product is
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`therapeutically effective against the recited condition in at least some instances. The plaintiff’s
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`inability to show that a particular emulsion is effective against the pertinent dry eye disorder in at
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`least some category of cases will result in a judgment for the defendant.
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`The defendants argue that the patents fail to describe methods for determining whether a
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`particular emulsion is effective, but a protocol for measuring efficacy is not required as a
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`prerequisite for patenting the