Case 1:14-cv-02758-PAC Document 61 Filed 05/08/15 Page 1 of 18
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF NEW YORK
`
`
`Kowa Company, Ltd. et al.,
`
`
`Plaintiffs,
`
`v.
`
`Aurobindo Pharma Limited et al.,
`
`
`Defendants.
`
`Kowa Company, Ltd. et al.,
`
`
`Plaintiffs,
`
`v.
`
`Amneal Pharmaceuticals LLC,
`
`
`Defendant.
`
`Kowa Company, Ltd. et al.,
`
`
`Plaintiffs,
`
`v.
`
`Mylan Inc. et al.,
`
`
`Defendants.
`
`
`Kowa Company, Ltd. et al.,
`
`
`Plaintiffs,
`
`v.
`
`Orient Pharma Co., Ltd.,
`
`
`Defendant.
`
`
`
`
`
`
`
`
`Civil Action No. 14-CV-2497 (PAC)
`
`Civil Action No. 14-CV-2758 (PAC)
`
`Civil Action No. 14-CV-2647 (PAC)
`
`Civil Action No. 14-CV-2759 (PAC)
`
`
`
`

`

`Case 1:14-cv-02758-PAC Document 61 Filed 05/08/15 Page 2 of 18
`
`Kowa Company, Ltd. et al.,
`
`
`Plaintiffs,
`
`v.
`
`Zydus Pharmaceuticals (USA) Inc. et al.,
`
`
`Defendants.
`
`Kowa Company, Ltd. et al.,
`
`
`Plaintiffs,
`
`Civil Action No. 14-CV-2760 (PAC)
`
`Civil Action No. 14-CV-5575 (PAC)
`
`
`
`
`
`
`
`
`
`Sawai USA, Inc. et al.,
`
`
`v.
`
`Defendants.
`
`DECLARATION OF DAVID H. SHERMAN, Ph.D. IN SUPPORT
`OF DEFENDANTS’ JOINT OPENING CLAIM CONSTRUCTION BRIEF
`
`
` 2
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`

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`Case 1:14-cv-02758-PAC Document 61 Filed 05/08/15 Page 3 of 18
`
`I.
`
`INTRODUCTION.
`
`1.
`
`I, Dr. David H. Sherman, submit this Declaration on behalf of Defendants Amneal
`
`Pharmaceuticals LLC, Aurobindo Pharma Limited and Aurobindo Pharma USA Inc., Mylan
`
`Pharmaceuticals Inc. and Mylan Inc., Orient Pharma Co., Ltd., Sawai USA, Inc. and Sawai
`
`Pharmaceutical Co., Ltd., Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd. (dba
`
`Zydus Cadila) (collectively, “Defendants”) in the above-captioned actions.
`
`2.
`
`I understand that the meaning of a term, as disclosed in claim 1 of U.S. Patent No.
`
`5,856,336 (“the ‘336 patent”),1 is in dispute. I disclose herein my opinions concerning how the
`
`person of ordinary skill in the art, in the relevant timeframe, would have understood that term
`
`and the bases and reasons supporting my opinions.
`
`II.
`
`BACKGROUND AND QUALIFICATIONS.
`
`3.
`
`My work and career primarily have specialized in the fields of medicinal
`
`chemistry, biochemistry and drug discovery.
`
`4.
`
`I received a B.A. in Chemistry, with Honors, from the University of California,
`
`Santa Cruz, in 1978, and a Ph.D. in Organic Chemistry from Columbia University in 1981.
`
`5.
`
`My dissertation research focused on development of organic chemistry reaction
`
`methodology and applications toward natural product total synthesis. This research involved
`
`developing synthetic schemes and processes for several small molecules, including steroids and
`
`prostaglandins.
`
`
`1 The ‘336 patent is attached as Exhibit 1 to the Declaration of Thomas R. Burns in Support of
`Defendants’
`Joint Opening Claim Construction Brief
`(“Burns Decl.”),
`submitted
`contemporaneously herewith.
`
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`Case 1:14-cv-02758-PAC Document 61 Filed 05/08/15 Page 4 of 18
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`6.
`
`I previously served as a Postdoctoral Researcher in molecular immunology at
`
`Yale University (1981-1982) and in immunochemistry at the Massachusetts Institute of
`
`Technology (1982-1984).
`
`7.
`
`I was a Research Scientist in the Department of Molecular Immunology at Biogen
`
`Research Corporation (1984-1987) and in the Department of Genetics at the John Innes Institute
`
`in Norwich, U.K. (1987-1990).
`
`8.
`
`From 1990 through 2000, I progressed from Assistant Professor, to Associate
`
`Professor, to Professor in the Department of Microbiology and in the separate BioTechnology
`
`Institute at the University of Minnesota. In 2003, I was awarded the John Gideon Searle
`
`Professorship and was appointed Professor in the Departments of Microbiology & Immunology
`
`(Medical School), Medicinal Chemistry (College of Pharmacy) and Chemistry (College of
`
`Literature, Science and the Arts) at the University of Michigan. In 2007, I was awarded the Hans
`
`W. Vahlteich Professorship at the University of Michigan.
`
`9.
`
`From 1996 through 1998, I served as Director of the Center for Microbial
`
`Physiology and Metabolic Engineering at the University of Minnesota. In 1997 (while on
`
`University sabbatical leave), I served as Senior Director of ChromaXome Corporation, in San
`
`Diego, California. From 1998 through 2001, I was Director of the Microbiology, Immunology
`
`and Cancer Biology Graduate Program at the University of Minnesota. Additionally, during the
`
`period 2004 through 2014, I served as the founding Director of the Center for Chemical
`
`Genomics at the University of Michigan Life Sciences Institute. I was appointed Associate Dean
`
`for Research and Graduate Education in the College of Pharmacy at the University of Michigan
`
`in 2011.
`
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`Case 1:14-cv-02758-PAC Document 61 Filed 05/08/15 Page 5 of 18
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`10.
`
`Additionally, in 2008, I founded Alluvium Biosciences with Dr. Michael
`
`Brownstein. Alluvium Biosciences focuses on various types of drug discovery and development
`
`programs, as well as other biological and chemical research projects. I am currently Chief
`
`Technical Consultant to Alluvium Biosciences.
`
`11.
`
`I also currently serve as the Hans W. Vahlteich Professor of Medicinal Chemistry
`
`and Associate Dean for Research (College of Pharmacy) at the University of Michigan and hold
`
`appointments as Professor in the Department of Microbiology & Immunology (Medical School),
`
`the Department of Medicinal Chemistry (College of Pharmacy) and the Department of Chemistry
`
`(College of Literature, Science, and the Arts). I am also a Research Professor in the Life
`
`Sciences Institute at the University of Michigan.
`
`12.
`
`I am currently a member of the American Chemical Society (since 1978),
`
`American Association for the Advancement of Science (since 1982), American Society for
`
`Microbiology (since 1987) and the Society for Industrial Microbiology (since 2000).
`
`13.
`
`I also currently serve as a referee of research articles submitted to the following
`
`scientific journals: ACS Chemical Biology; Antimicrobial Agents and Chemotherapy; Applied
`
`Microbiology and Biotechnology; Canadian Journal of Microbiology; Gene; Journal of Applied
`
`and Environmental Microbiology; Journal of Bacteriology; Journal of
`
`Immunology;
`
`Microbiology; Molecular Microbiology; Proceedings of the National Academy of Sciences USA;
`
`Tetrahedron; Science; Nature; Journal of the American Chemical Society; Journal of Medicinal
`
`Chemistry; Journal of Organic Chemistry; Organic Letters; Chemistry & Biology; Biotechnology
`
`Progress; Journal of Natural Products; Nature Biotechnology; Nature Chemistry; and Nature
`
`Chemical Biology.
`
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`Case 1:14-cv-02758-PAC Document 61 Filed 05/08/15 Page 6 of 18
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`14.
`
`I currently serve as a Grant Reviewer for: The Wellcome Trust; USDA; NSF;
`
`American Cancer Society; NIH SBIR Review Panel; National Research Initiative Competitive
`
`Grants Program; Canadian NSERC; NIH Natural Products and Bioorganic Chemistry Study
`
`Section (ad hoc reviewer, 1997, 2002, 2003, 2004); and NIH Special Emphasis Review Panel
`
`(March 2000, April 2000, December 2001).
`
`15.
`
`I most recently served as a Permanent Member of the National Institutes of Health
`
`(NIH) Synthetic Biological Chemistry B Study Section (2005-2009). In 2010, I was appointed to
`
`the College of NIH Reviewers by the NIH Center for Scientific Review.
`
`16.
`
`In 2008, I was elected Fellow of the American Association for the Advancement
`
`of Science. I received both the A.C. Cope Scholar Award by the American Chemical Society
`
`and the Charles Thom Award from the Society of Industrial Microbiology in 2009. In 2015, I
`
`received the Distinguished Lecturer award by the American Society for Microbiology.
`
`17.
`
`I have worked extensively in my research and teaching career with a variety of
`
`biomolecules that serve as receptors for medicinal agents. These include enzymes, small
`
`molecule transporters and G-protein-coupled receptors.
`
`18.
`
`During my 30-year career, I have published over 230 peer-reviewed research
`
`publications in the fields of synthetic organic chemistry, bioorganic and medicinal chemistry,
`
`molecular microbiology, microbial pathogenesis, biochemistry and enzymology, structural
`
`biology, molecular immunology and immunochemistry. Thus, my background includes a
`
`combination of research experience that spans the multi-disciplinary fields of synthetic medicinal
`
`chemistry, biochemistry, microbiology and immunology, particularly relating to the molecular
`
`characterization of small molecule interactions with complex biomolecules, including diverse
`
`classes of proteins and receptors.
`
` 6
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`Case 1:14-cv-02758-PAC Document 61 Filed 05/08/15 Page 7 of 18
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`19.
`
`I am a named inventor on nine issued U.S. patents relating to, among other things,
`
`classes of drug molecules, nucleic acids, metabolic and genetic engineering, and organic and
`
`chemoenzymatic synthesis of antibiotics and anticancer agents.
`
`20.
`
` Since 1995, I have worked with the fungal strains that produce the naturally-
`
`occurring HMG-CoA reductase inhibitors lovastatin and compactin. I have also served as a
`
`consultant to pharmaceutical companies that produce lovastatin and related semi-synthetic
`
`molecules. Moreover, my teaching of Pharm. D. students at the University of Minnesota, and
`
`currently at the University of Michigan, has focused on cardiovascular agents, including all of
`
`the clinically-approved “statin” class of cholesterol-lowering agents, such as pitavastatin.
`
`Stereochemical issues are a major focus of my research program, including as they relate to the
`
`synthesis of small molecules and the isolation of novel natural products from a range of
`
`microorganisms, including fungi.
`
`21.
`
`Further details concerning my education, employment history and experience are
`
`set forth in my Curriculum Vitae attached hereto as Exhibit 1.
`
`III. OPINIONS.
`
`A.
`
`22.
`
`The Person of Ordinary Skill in the Art.
`
`I understand Plaintiffs have taken the position in proceedings before the U.S.
`
`Patent and Trademark Office that the ‘336 patent is entitled to a priority date of no later than
`
`August 20, 1987. I have been asked to consider what level of skill, education and training the
`
`person of ordinary skill in the art relevant to the ‘336 patent would be expected to have as of that
`
`date.2
`
`
`2 I understand that Defendants do not concede Plaintiffs can establish a priority date as early as
`August 20, 1987. However, regardless of whether the priority date is August 20, 1987, or in
`1988, my opinions herein as to how the person of ordinary skill in the art would interpret the
`‘336 patent claim term in dispute would be the same.
`
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`Case 1:14-cv-02758-PAC Document 61 Filed 05/08/15 Page 8 of 18
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`23.
`
`I understand that the person of ordinary skill in the art is a hypothetical person
`
`who is presumed to be aware of all pertinent art, follows conventional wisdom in the art and is a
`
`person of ordinary creativity. In my opinion, with respect to the ‘336 patent, the person of
`
`ordinary skill in the art would have held an advanced degree, such as an M.S. or a doctorate in
`
`one of the fields of medicinal or synthetic chemistry, pharmacology, pharmacy or medicine, with
`
`several years of experience in one of the fields of medicinal or synthetic chemistry,
`
`pharmacology, pharmacy or medicine. In addition, the person of ordinary skill in the art would
`
`have either personally possessed, or had access to, knowledge and skills from medicinal and/or
`
`synthetic chemists, as well as biologists, pharmacists and/or clinicians, including possessing
`
`knowledge of statins, their mechanisms of action and other cholesterol treatments. Such person
`
`typically would have consulted with one or more members of a team of experienced
`
`professionals in the relevant field in order to solve a particular problem.
`
`B.
`
`How the Person of Ordinary Skill in the Art Would Have Understood the
`Claim Term at Issue in the ‘336 Patent.
`
`24.
`
`I have been asked to offer my opinions as to how the person of ordinary skill in
`
`the art would interpret the following disputed term of claim 1 of the ‘336 patent:
`
`“A compound of the formula,
`
`
`Z=―CH(OH)―CH2―CH(OH)―CH2―COO.1/2Ca.”
`
`25.
`
`To arrive at my opinions, I have reviewed, among other things, the ‘336 patent, its
`
`prosecution history and other materials identified herein upon which the person of ordinary skill
`
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`Case 1:14-cv-02758-PAC Document 61 Filed 05/08/15 Page 9 of 18
`
`in the art as of the relevant timeframe would have relied. I have also relied on my own personal
`
`education, training and experience.
`
`26.
`
`In my opinion, the person of ordinary skill in the art would have understood the
`
`term in dispute, as disclosed in claim 1 of the ‘336 patent, to mean:
`
`A genus3 including each optical isomer of the formula
`
`
`Z=―CH(OH)―CH2―CH(OH)―CH2―COO.1/2Ca. and all mixtures thereof.
`
`1.
`
`Stereochemistry of a molecule – generally.
`
`27.
`
`Two or more structures may have the same molecular formula and the same atom-
`
`connectivity, yet they can be distinct chemical compounds if they are arranged differently in
`
`three-dimensional space. Such compounds are called stereoisomers. Two stereoisomers that are
`
`non-superimposable mirror image structures are called enantiomers, or “optical isomers,” and are
`
`different chemical substances. These structures are also sometimes referred to as chiral, or
`
`having chirality. The hands depicted below provide a simple illustration of mirror image
`
`structures:
`
`
`3 Based on his or her training and education alone, the person of ordinary skill in the art would
`understand “genus” to refer to a group, as opposed to a single compound or optical isomer.
`
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`Case 1:14-cv-02758-PAC Document 61 Filed 05/08/15 Page 10 of 18
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`
`
`
`
`28.
`
`In the case of optical isomers, the two molecules have identical physical and
`
`chemical properties, except for their ability to rotate plane-polarized light. By contrast, however,
`
`optical isomers can have markedly different biological properties such as in vivo efficacy.
`
`29. Molecules containing multiple stereogenic centers or asymmetric carbon atoms
`
`give rise to stereoisomers that are not mirror images of one another. Such molecules are called
`
`diastereomers. Diastereomers may have different physical and chemical properties, and very
`
`different biological properties. Molecules containing two stereogenic centers give rise to two
`
`pairs of optical isomers.
`
`30.
`
`The person of ordinary skill in the art would have understood these basic concepts
`
`of stereochemistry by at least 1987. (Burns Decl. Ex. 4, ERNEST L. ELIEL, STEREOCHEMISTRY OF
`
`CARBON COMPOUNDS 1-4, 10-12, 16-21 (1962) (“Eliel”) (MYLAN(Pitav) 017297-82, 017288-
`
`90, 017294-99)).
`
`2.
`
`Stereochemistry of the molecule disclosed in claim 1.
`
`31.
`
`Based on his or her knowledge of organic chemistry, the person of ordinary skill
`
`in the art would have also immediately understood that the chemical structure described in claim
`
`1 of the ‘336 patent would have two stereogenic centers. A stereogenic or asymmetric center
`
`refers to a specific atom within a molecule that is bonded to four different types of atoms or
`
`groups of atoms (referred to in chemistry as substituents). (Burns Decl. Ex. 4, Eliel at 9-10, 16-
`
`21 (MYLAN(Pitav) 017287-88, 017294-99)). For example, it is evident within the molecule
`
` 10
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`Case 1:14-cv-02758-PAC Document 61 Filed 05/08/15 Page 11 of 18
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`below that only two of the carbon atoms are bonded to four unique substituents; thus, a person of
`
`ordinary skill in the art would recognize them as stereogenic centers (identified in asterisks in the
`
`below drawing). These carbon atoms represent the only two chiral positions on the drug
`
`molecule. I note that in addition to the three bonds indicated in the picture, the two stereogenic
`
`centers also include a bond to a hydrogen atom, which is not depicted. It is typical practice in
`
`drawing chemical structures not to depict the hydrogen atom, even though it is present.
`
`
`
`.
`
`32.
`
` The person of ordinary skill in the art would have further understood that these
`
`two stereogenic centers allow for two pairs of optical isomers, for a total of four different optical
`
`isomers. In other words, a person of ordinary skill in the art would have understood that the
`
`molecule depicted in Paragraph 31 above may have 4 different spatial arrangements of its
`
`atoms4. This is because every stereogenic center can have two different spatial arrangements
`
`(“R” or “S”). Therefore the total number of spatial arrangements a molecule may have is two to
`
`the power of the number of stereogenic centers. In this case, that would be 22 (2 times 2), to
`
`equal four. The structures of these four different optical isomers are depicted below using
`
`dashed and filled-in wedges to represent the spatial configuration of the OH groups at the
`
`4 The person of ordinary skill in the art would understand optical isomers are a particular kind of
`spatial arrangement of the atoms, based on his or her training and education alone.
`
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`Case 1:14-cv-02758-PAC Document 61 Filed 05/08/15 Page 12 of 18
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`stereogenic centers. These wedges are used by persons of ordinary skill in the art in routine
`
`course to denote the specific spatial configuration of the molecule:
`
`.
`
`33. More specifically, the dashed wedges are used to indicate that the OH group is
`
`pointing away from the viewer, while the filled-in wedges indicate that the OH group is pointing
`
`towards the viewer. Thus, as relevant to the above, in the top left structure, for example, both
`
`OH groups are pointing away from the viewer and in the bottom right structure, both OH groups
`
`are pointing towards the viewer.
`
`34.
`
`In contrast to the stereospecific drawings set out above in Paragraph 32, the
`
`chemical structure in the disputed term disclosed in claim 1 of the ‘336 patent would have been
`
`recognized by a person of ordinary skill in the art as “flat,” i.e., depicted in two dimensions. A
`
`person of ordinary skill in the art would therefore have recognized that the structure does not
`
`contain any limitations concerning stereochemistry or three-dimensional shape. Despite the fact
`
` 12
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`Case 1:14-cv-02758-PAC Document 61 Filed 05/08/15 Page 13 of 18
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`that the structure depicted in claim 1 of the ‘336 patent does not provide stereochemical
`
`information, a person of ordinary skill in the art would have readily understood that the
`
`compound contains two stereogenic centers, with the possibility of four different optical isomers,
`
`in view of the information that would have been known to such person. This is because, as
`
`discussed above, a person of ordinary skill in the art would have recognized the two carbon
`
`atoms in the side chain that have four distinct substituents are both stereogenic centers. Further,
`
`each stereogenic center would give rise to its own pair of optical isomers.
`
`35.
`
`Therefore, in light of the discussion above, the person of ordinary skill in the art
`
`would have understood, as a matter of convention, that the structure depicted in claim 1
`
`represents a genus including each of the four possible optical isomers, as well as all mixtures
`
`thereof. (Burns Decl. Ex. 4, Eliel at 16-21 (MYLAN(Pitav) 017294-99)).
`
`3.
`
`The ‘336 patent specification.
`
`36.
`
`The specification of the ‘336 patent further supports my opinions concerning how
`
`a person of ordinary skill in the art would understand the meaning of the disputed claim term:
`
`“A compound of the formula,
`
`
`Z=―CH(OH)―CH2―CH(OH)―CH2―COO.1/2Ca.”
`
`37.
`
` More specifically, the specification of the ‘336 patent discloses in relevant part
`
`the genus of the “novel mevalonolactone derivatives of the present invention.” (Burns Decl. Ex.
`
`1, the ‘336 patent at col. 1, l. 38 – col. 2, l. 65 (MYLAN(Pitav)009115)). As with the compound
`
` 13
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`Case 1:14-cv-02758-PAC Document 61 Filed 05/08/15 Page 14 of 18
`
`in claim 1 of the ‘336 patent, the structures disclosed as the “present invention” are silent as to
`
`stereochemistry. (Id.). In describing the compounds of the alleged invention, the ‘336 Patent
`
`specification further explains that “[t]hese compoundsmay [sic] have at least one or two
`
`asymmetric carbon atoms and may have at least two to four optical isomers. The compounds of
`
`the formula I include all of these optical isomers and all of the mixtures thereof.” (Id. at col. 2, l.
`
`66 – col. 3, l. 2 (emphasis added) (MYLAN(Pitav)009115-16))5. Therefore, in my opinion, the
`
`person of ordinary skill in the art would have understood from the specification that the
`
`compound(s) disclosed and claimed in the ‘336 patent encompass a genus including each optical
`
`isomer of the depicted structures, and all mixtures thereof.
`
`4.
`
`The ‘336 patent prosecution history.
`
`38. My review of the prosecution history of the ‘336 patent did not reveal anything
`
`that would alter the understanding of the disputed claim term of the ‘336 patent I have described
`
`above. For example, the claims as filed and/or amended in U.S. patent application numbers
`
`07/233,752 (“the ‘752 application”), 07/631,092 and 07/883,398 are all, as with claim 1 of the
`
`‘336 patent, silent as to stereochemistry. (See, e.g., Burns Decl. Ex. 5, the ‘752 application at 85-
`
`97 (MYLAN(Pitav)011320-32)). Yet, the specification, as filed in these applications, includes
`
`the same explanatory language as to stereochemistry: “[t]hese compounds may have at least one
`
`or two asymmetric carbon atoms and may have at least two to four optical isomers. The
`
`compounds of the formula I include all of these optical isomers and all of the mixtures thereof.”
`
`(Id. at 5 (emphasis added) (MYLAN(Pitav)011244)).
`
`
`5 In addition, the inventors of the ‘336 patent stated in synthesis Example 4 therein that the
`compound presented in two diastereomers, which “were separated and isolated by silica gel thin
`layer chromatography.” (Burns Decl. Ex. 1, the ‘336 patent at col. 18, ll. 39-46 (Example 4)
`(MYLAN(Pitav)009123); see also id. col. 18, ll. 54-67 (Example 5) (MYLAN(Pitav)009123)).
`
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`Case 1:14-cv-02758-PAC Document 61 Filed 05/08/15 Page 15 of 18
`
`C.
`
`Plaintiffs’ Proposed Construction Does Not Appear Consistent with How a
`Person of Ordinary Skill in the Art Would Have Understood the Term.
`
`39.
`
`I understand that Plaintiffs have offered a proposed construction for the disputed
`
`term in claim 1 of the ‘336 patent as follows:
`
`“A compound having the following structure:
`
`
`Z=―CH(OH)―CH2―CH(OH)―CH2―COO.1/2Ca.”
`
`
`40.
`
`This construction does not explicitly encompass each optical isomer and all
`
`mixtures thereof. Plaintiffs have simply replaced the word “formula” with “the following
`
`structure.” This change in wording does not provide any information with respect to
`
`stereochemistry, and which optical isomers or mixtures thereof are included in the claim. To the
`
`extent the Court understands Plaintiffs’ proposed construction not to include all of the optical
`
`isomers and mixtures of the compound disclosed in claim 1 of the ‘336 patent,6 such construction
`
`would not be consistent with the understanding of the person of ordinary skill in the art and the
`
`teachings of the specification of the ‘336 patent for the reasons already discussed above.
`
`Therefore, in my opinion, Defendants’ proposed construction is the more proper construction in
`
`view of the relevant evidence and understanding of the person of ordinary skill in the art.
`
`
`6 It is not clear whether or not Plaintiffs intend for their construction to include all optical
`isomers and mixtures thereof (consistent with the understanding of the person of ordinary skill in
`the art and the ‘336 patent specification), or only some optical isomers and/or some mixtures. As
`such, in my opinion, it is ambiguous.
`
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`Case 1:14-cv-02758-PAC Document 61 Filed 05/08/15 Page 16 of 18
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`D.
`
`41.
`
`Conclusion.
`
`For at least the reasons discussed above, in my opinion, the person of ordinary
`
`skill in the art relevant to the ‘336 patent would have understood the disputed term of claim 1 of
`
`the ‘336 patent to mean:
`
`“A genus including each optical isomer of the formula
`
`
`Z=―CH(OH)―CH2―CH(OH)―CH2―COO.1/2Ca. and all mixtures thereof.”7
`
`IV. ADDITIONAL INFORMATION.
`
`42.
`
`I am being compensated for the time I have spent on this litigation at my
`
`customary rate of $600.00 (US) per hour, plus reasonable expenses for all time spent. My
`
`compensation does not depend in any way on the outcome of this litigation.
`
`43.
`
`This Declaration sets forth the opinions I have formed based on information
`
`available as of the date below. Because other as yet unknown and unidentified material may be
`
`introduced during this litigation, which may fall within my area of expertise, I may have relevant
`
`and important opinions regarding such as yet unknown and unidentified material. I reserve the
`
`right to offer opinions on any such material. I further reserve the right and intend to testify and
`
`offer additional opinions in response to any opinions offered by Plaintiffs or any of their
`
`proposed experts.
`
`
`7 As discussed above, a person of ordinary skill in the art would understand that the genus would
`include the optical isomers identified in Paragraph 32 herein, and all mixtures of those optical
`isomers.
`
` 16
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`Case 1:14-cv-02758-PAC Document 61 Filed 05/08/15 Page 17 of 18
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`44.
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`I specifically reserve the right to supplement my opinions based on any claim
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`construction materials submitted on behalf of Plaintiffs or in order to clarify the information
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`provided herein.
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`I declare under penalty of perjury that the foregoing is true and correct.
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` 17
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`Case 1:14-cv-02758-PAC Document 61 Filed 05/08/15 Page 18 of 18
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`______________________________
` David H. Sherman
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` May 8, 2015
` Date
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` 18
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