`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`
`PHARMACOSMOS A/S,
`Petitioner,
`
`
`v.
`
`
`AMERICAN REGENT, INC.,
`Patent Owner.
`
`________________
`
`
`Case No. IPR2019-01142
`United States Patent No. 8,431,549
`
`________________
`
`
`EXPERT DECLARATION OF
`ROBERT LINHARDT, PH.D.
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`
`
`
`
`
`
`IPR2019-01142
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`Petitioner Ex. 1009 - Page 1
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`TABLE OF CONTENTS
`
`1.
`
`Introduction ...................................................................................................... 1
`
`(a) Qualifications and Experience ............................................................... 2
`
`(b) Compensation ........................................................................................ 3
`
`(c) Materials Relied Upon ........................................................................... 3
`
`2.
`
`3.
`
`Summary of Opinions Regarding the ’549 Patent ........................................... 4
`
`Relevant Law ................................................................................................... 4
`
`(a) Claim Construction ................................................................................ 4
`
`(b) Anticipation ........................................................................................... 5
`
`(c) Person of Ordinary Skill in the Art ....................................................... 6
`
`4.
`
`The ’549 Patent ................................................................................................ 6
`
`(a) The Claims of the ’549 Patent ............................................................... 7
`
`(b) Person of Ordinary Skill in the Art ....................................................... 7
`
`5.
`
`Claim Construction .......................................................................................... 8
`
`(a)
`
`“Substantially Non-Immunogenic Carbohydrate Component” ............ 8
`
`(b)
`
`“Iron Polyisomaltose Complex” ............................................................ 8
`
`6.
`
`Analysis of the Prior Art .................................................................................. 9
`
`(a) Ground 1: Anticipation by van Zyl-Smit ............................................ 10
`
`(b) Ground 2: Anticipation by Groman ..................................................... 12
`
`7.
`
`Right to Supplement ...................................................................................... 15
`
`
`
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`-i-
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`Petitioner Ex. 1009 - Page 2
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`I, Robert Linhardt, declare as follows:
`
`1.
`
`INTRODUCTION
`
`1.
`
`I am the Ann and John H. Broadbent Senior Constellation Chair in
`
`Biocatalysis and Metabolic Engineering and Professor of Chemistry, Biology and
`
`Chemical and Biological Engineering at Rensselaer Polytechnic Institute.
`
`2.
`
`I have been retained by Petitioner’s counsel, Fenwick & West LLP
`
`(“Counsel”), to serve as an expert in this inter partes review. I understand that this
`
`declaration will be provided in connection with Petitioner’s petition challenging U.S.
`
`Patent No. 8,431,549 (the “’549 patent”; Ex. 1001).
`
`3.
`
`In this declaration, I set forth my opinions regarding the unpatentability of
`
`claims 7, 8, 15, and 21 of the ’549 patent. I also describe the relevant scientific
`
`background, the bases for my opinions, my qualifications, and my compensation for
`
`the services I rendered in relation to this proceeding.
`
`4.
`
`I previously provided a declaration and deposition testimony in support of
`
`Petitioner’s challenge to the ’549 patent in IPR2015-01493 (the “First IPR”). A
`
`copy of my declaration in the First IPR (my “First Declaration”) is Exhibit 1011 in
`
`this inter partes review. My analyses and opinions set out in the present declaration
`
`are consistent with the analyses and opinions I provided in the First IPR, as well as
`
`my understanding of the Board’s Final Written Decision in the First IPR
`
`(Pharmacosmos A/S v. Luitpold Pharmaceuticals, Inc., No. IPR2015-01493, Paper
`
`
`-1-
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`54 (P.T.A.B. Dec. 28, 2016) (“FWD”), aff’d Luitpold Pharms., Inc. v.
`
`Pharmacosmos A/S, 718 Fed.Appx. 989 (Mem) (Fed. Cir. 2018)).
`
`(a) Qualifications and Experience
`
`5. My curriculum vitae is Exhibit 1010 in this inter partes review.
`
`6.
`
`I received my Ph.D. in Organic Chemistry from Johns Hopkins University in
`
`1979, and a postdoctoral degree in Biochemical Engineering from the Massachusetts
`
`Institute of Technology in 1982.
`
`7.
`
`Thereafter, I joined the University of Iowa as an Assistant Professor of
`
`Medicinal and Natural Products Chemistry, College of Pharmacy, and was
`
`ultimately promoted to F. Wendell Miller Distinguished Professor of Chemistry.
`
`8.
`
`In 2008, I joined Rensselaer Polytechnic Institute as the Ann and John H.
`
`Broadbent Senior Constellation Chair in Biocatalysis and Metabolic Engineering,
`
`Professor of Chemistry, Biology, Chemical and Biological Engineering, and
`
`Biomedical Engineering, a position I currently hold today. I am also currently
`
`Adjunct Professor of Orthopedics at the Icahn School of Medicine, Mount Sinai,
`
`New York.
`
`9.
`
`I am a member of various professional societies, including the American
`
`Chemical Society (Divisions of Medicinal Chemistry, Biotechnology and
`
`Carbohydrate Chemistry) and the American Society of Biochemistry and Molecular
`
`Biology. I have served on numerous editorial boards and advisory committees, such
`
`
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`as The Journal of Biological Chemistry (from 1995-2000 and 2005-present), Journal
`
`of Carbohydrate Chemistry (from 1995-present), and the FDA Adverse Reactions
`
`Working Group (in 2008).
`
`10.
`
`I am a named author on over 900 publications in the fields of chemistry and
`
`biochemistry and am a named inventor of over 50 patents in the same fields. My
`
`work has been recognized with various academic honors, including the 2010
`
`Melville L. Wolfrom Award from the American Chemical Society, Division of
`
`Carbohydrate Chemistry for outstanding service to the Carbohydrate Division and
`
`to the field of carbohydrate chemistry and the 2003 American Chemical Society
`
`Claude S. Hudson Award in Carbohydrate Chemistry.
`
`(b) Compensation
`
`11.
`
`I am acting as an independent consultant in this proceeding. I am being
`
`compensated at $750.00 per hour. I am also reimbursed for expenses. My
`
`compensation is unrelated to the outcome of these matters.
`
`12.
`
`I have no financial interest in the outcome of this proceeding, Petitioner, or
`
`the ’549 patent.
`
`(c) Materials Relied Upon
`
`13. A list of the materials that I have relied upon and otherwise considered in
`
`formulating my opinions is attached to this declaration as Appendix A. I have also
`
`relied on the materials referred to herein and my general knowledge and experience
`
`
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`as a professor and researcher in the fields of carbohydrate chemistry (for about 40
`
`years) and medicinal chemistry/pharmacy (for about 25 years).
`
`2.
`
`SUMMARY OF OPINIONS REGARDING THE ’549 PATENT
`
`14.
`
`I have been asked to assess the patentability of claims 7, 8, 15, and 21 of the
`
`’549 patent from a scientific perspective, in light of the teachings of the van Zyl-
`
`Smit reference (Ex. 1004) and the Groman reference (Ex. 1003) and the Board’s
`
`findings in its Final Written Decision in the First IPR (FWD). My opinions are as
`
`follows:
`
`a. Ground 1: Claims 7, 8, and 15 are anticipated by van Zyl-Smit; and
`
`b. Ground 2: Claim 21 is anticipated by Groman.
`
`3.
`
`RELEVANT LAW
`
`15.
`
`I have been advised by Counsel of the following relevant legal principles:
`
`(a) Claim Construction
`
`16.
`
`I understand that I am to interpret the claims of the ’549 patent according to
`
`their plain and ordinary meaning, which is the meaning that they would have to a
`
`person of ordinary skill in the art as of the relevant date—here, January 6, 2006.
`
`17.
`
`I understand that the claims of a patent define the invention to which the
`
`patentee has the right to exclude. I further understand that the claims must be read
`
`in view of the specification, which I am told is the single best guide to the meaning
`
`of a disputed term and acts as a dictionary when it expressly defines terms used in
`
`
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`the claims or when it defines terms by implication. I understand that the prosecution
`
`history can often inform the meaning of the claim language by demonstrating how
`
`the inventor understood the invention and whether the inventor limited the invention
`
`during prosecution, making the claim scope narrower than it would otherwise be.
`
`Finally, I understand that extrinsic evidence can help educate the Board regarding
`
`the field of the invention and can help the Board determine what an ordinary skilled
`
`person would understand claim terms to mean, but is generally viewed as less
`
`reliable than the patent and its prosecution history in determining how to read claims.
`
`(b) Anticipation
`
`18.
`
`I have been asked by Counsel to consider whether, in view of the Board’s
`
`findings in the Final Written Decision in the First IPR and my reading of van Zyl-
`
`Smit and Groman from the perspective of one of ordinary skill, any of claims 7, 8,
`
`15, or 21 were anticipated as of January 6, 2006.
`
`19.
`
`I understand that a patent claim is anticipated where the claimed invention
`
`was patented or described in a printed publication before the invention thereof by
`
`the applicant for a patent. Anticipation requires that each claim limitation be
`
`disclosed, either expressly or inherently, in a single prior art reference.
`
`20.
`
`I further understand that when a claim covers several structures or
`
`compositions, either generically or as alternatives, the claim is deemed anticipated
`
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`if any of the structures or compositions within the scope of the claim is disclosed in
`
`a prior art reference.
`
`(c) Person of Ordinary Skill in the Art
`
`21.
`
`I understand that my analysis must be conducted from the perspective of a
`
`person of ordinary skill as of the relevant date. I understand that in defining the
`
`person of ordinary skill, the following factors may be considered: (1) the education
`
`level of the inventor, (2) the type of problems encountered in the art, (3) prior art
`
`solutions to those problems, (4) the rapidity with which innovations are made, and
`
`(5) the sophistication of the technology and educational level of active workers in
`
`the field.
`
`4.
`
`THE ’549 PATENT
`
`22. The ’549 patent relates to methods of treating various disorders and conditions
`
`associated with iron deficiency or dysfunctional iron metabolism in which a single
`
`dosage unit of iron carbohydrate complex providing about 0.6 grams of elemental
`
`iron is administered. See Ex. 1001 at Abstract, 1:16–17. The patent states that prior
`
`art “iron dextrans” had been administered to treat iron-related conditions but that
`
`they caused adverse anaphylactoid-type reactions. Id., 1:47-52. It alleges that the
`
`claimed iron carbohydrate complexes can be administered at relatively high single
`
`unit dosages safely and efficiently. See id., 2:27-31.
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`(a) The Claims of the ’549 Patent
`
`23. The sole independent claim of the ’549 patent reads:
`
`1. A method of treating a disease, disorder, or condition characterized by iron
`deficiency or dysfunctional
`iron metabolism resulting
`in reduced
`bioavailability of dietary iron,
`
`comprising administering to a subject in need thereof an iron carbohydrate
`complex in a single dosage unit of at least about 0.6 grams of elemental iron,
`
`wherein,
`
`the iron carbohydrate complex is selected from the group
`consisting of an
`iron mannitol complex, and an
`iron
`polyisomaltose complex, an iron polymaltose complex, an iron
`gluconate complex, and an iron sorbitol complex,
`
`the iron carbohydrate complex has a substantially non-
`immunogenic carbohydrate component, and
`
`the disease, disorder or condition is not Restless Leg Syndrome.
`
`24. The claims at issue in this inter partes review each directly depend from claim
`
`1. Claim 7 recites that “the single dosage unit of elemental iron is at least about 1.0
`
`grams.” Claim 8 recites that “the single dosage unit of elemental iron is at least
`
`about 1.5 grams.” Claim 15 recites that “the iron carbohydrate complex is
`
`administered parenterally.” Claim 21 recites that “the iron carbohydrate complex is
`
`an iron polyisomaltose complex.”
`
`(b) Person of Ordinary Skill in the Art
`
`25. The field of the ’549 patent is the treatment of iron deficiency-related
`
`conditions with iron carbohydrate complexes. In my opinion, a person of ordinary
`
`
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`skill would hold at least a bachelor’s level degree in chemistry or biochemistry with
`
`some related post-graduate experience (academic or industrial) in the area of
`
`carbohydrates and their metal complexes. I note that is the definition I provided in
`
`the First IPR. See Ex. 1011 at ¶ 6.
`
`5.
`
`CLAIM CONSTRUCTION
`
`(a) “Substantially Non-Immunogenic Carbohydrate Component”
`
`26.
`
`I have reviewed the Board’s Final Written Decision in the First IPR. From
`
`my review, the Board construed the term “substantially non-immunogenic
`
`carbohydrate component” to mean a “carbohydrate component resulting in a low
`
`risk of anaphylactoid/hypersensitivity reactions, wherein a low risk is an incidence
`
`of adverse events lower than dextran.” See First IPR, FWD at p. 12.
`
`27.
`
`I have applied this construction in arriving at my opinions set out in this
`
`declaration.
`
`(b) “Iron Polyisomaltose Complex”
`
`28.
`
`In my First Declaration, I explained that I had reviewed the Declaration Under
`
`37 C.F.R. § 1.132 by co-inventor Richard Lawrence that was submitted during
`
`prosecution of the ’549 patent (the “Lawrence Declaration”; Ex. 1006). See Ex.
`
`1011 at ¶¶ 13-15. The Lawrence Declaration takes the position that the claim term
`
`“iron polyisomaltose complex” includes iron complexed with an essentially purely
`
`linear chemical structure of repeating α-1-6 linked glucose units which is reduced
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`(hydrogenated) and has a molecular weight of 1000 Da. See id.; Ex. 1006 at ¶¶ 4-5.
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`The Lawrence Declaration further takes the position that, despite the claim’s use of
`
`the term “polyisomaltose,” iron oligosaccharides can fall within the scope of this
`
`claim term. See Ex. 1011 at ¶ 13; Ex. 1006 at ¶ 4-5. I explained in my First
`
`Declaration that, although I disagreed with the statements in the Lawrence
`
`Declaration, the reduced Dextran Tl described in Example 10 of Groman is an
`
`essentially linear oligoisomaltoside and, when it is complexed with iron according
`
`to Example 28, it would fall within the Lawrence Declaration’s definition of “iron
`
`polyisomaltose complex.” See Ex. 1011 at ¶¶ 13-17. I therefore concluded that if
`
`one applies the statements made in the Lawrence Declaration regarding “iron
`
`polyisomaltose complex”, then Groman’s disclosure regarding reduced Dextran T1
`
`would meet all the limitations of claim 1 of the ’549 patent. Id. at ¶ 18.
`
`29.
`
`I have again used
`
`the Lawrence Declaration’s definition of “iron
`
`polyisomaltose complex” in forming my opinions in this declaration, as did the
`
`Board in issuing its Final Written Decision in the First IPR. See First IPR, FWD at
`
`p. 20-21.
`
`6.
`
`ANALYSIS OF THE PRIOR ART
`
`30. As I explain below, based on my First Declaration and the Board’s prior
`
`decision, van Zyl-Smit anticipates claims 7, 8, and 15, and Groman anticipates claim
`
`21 of the ’549 patent. The scientific background relevant to my analysis and
`
`
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`described below would have been known to a person of ordinary skill as of January
`
`6, 2006.
`
`(a) Ground 1: Anticipation by van Zyl-Smit
`
`31.
`
`van Zyl-Smit was published in the journal Nephron in 2002. I understand that
`
`van Zyl-Smit is therefore prior art to the ’549 patent.
`
`32.
`
`In the First IPR, I concluded that van Zyl-Smit teaches every limitation of
`
`independent claim 1 (amongst other claims), and therefore anticipates it. Ex. 1011
`
`at ¶¶ 26-29. The Board agreed. See First IPR, FWD at p. 27. I maintain my prior
`
`opinion in this proceeding.
`
`33. As I explained in my First Declaration, van Zyl-Smit teaches iron polymaltose
`
`(dextrin) as an effective means for treating iron deficiencies (including anemia) and
`
`raising hemoglobin levels. Ex. 1004 at Abstract.
`
`34.
`
`van Zyl-Smit teaches a dose range of 900-3200 mg of iron over a four hour
`
`period. Ex. 1004 at p. 2.
`
`35.
`
`van Zyl-Smit indicates that the interaction of iron carbohydrate supplements
`
`with anti-dextran antibodies can cause dangerous anaphylactic reactions but reports
`
`that in its studies iron polymaltose (dextrin) did not cause anaphylaxis. Ex. 1004 at
`
`pp. 6-7. Because van Zyl-Smit did not observe anaphylactoid reactions upon
`
`administration of iron polymaltose, and refers to iron polymaltose as a “safe and
`
`effective way of correcting iron deficiency” (Ex. 1004 at p. 8), I consider van Zyl-
`
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`Smit to teach one of skill in the art that the polymaltose in the complexes is
`
`substantially non-immunogenic.
`
`36.
`
`In sum, because van Zyl-Smit discloses a method of treating iron deficiency,
`
`including anemia, by administering an iron polymaltose complex that contains more
`
`than 0.6 grams of elemental iron and suggests that this treatment is non-
`
`immunogenic and unreactive to antidextran antibodies, I concluded in my First
`
`Declaration that claim 1 and various dependent claims are not novel over van Zyl-
`
`Smit. See Ex. 1011 at ¶ 26. The Board credited my testimony on this point and held
`
`that van Zyl-Smit anticipates claims 1–5, 9, 16, and 19. See First IPR, FWD at p.
`
`12-18.
`
`37.
`
`I adopt my prior opinions, approved by the Board, and for the same reasons,
`
`conclude that the additional limitations of claims 7, 8, and 15 are anticipated by van
`
`Zyl-Smit.
`
`38. Claim 7 recites that “the single dosage unit of elemental iron [in claim 1] is
`
`at least about 1.0 grams.” As I noted above, and as the Board held in the First IPR,
`
`van Zyl-Smit teaches administration in single dosage units of 0.9-3.2 grams of iron,
`
`meeting this additional limitation. Ex. 1004 at p. 2; First IPR, FWD at p. 12-18.
`
`Thus, van Zyl-Smit anticipates claim 7.
`
`39. Claim 8 recites that “the single dosage unit of elemental iron [in claim 1] is
`
`at least about 1.5 grams.” “At least about 1.5 grams” is squarely within the range
`
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`taught in van Zyl-Smit (0.9-3.2 grams). Ex. 1004 at p. 2; First IPR, FWD at p. 12-
`
`18. Thus, van Zyl-Smit anticipates claim 8.
`
`40. Claim 15 recites that “the iron carbohydrate complex [in claim 1] is
`
`administered parenterally.” van Zyl-Smit teaches that the iron carbohydrate
`
`complex is administered parenterally, specifically by intravenous infusion. Ex. 1004
`
`at p. 1-2. In my First Declaration, I addressed this limitation when I described how
`
`van Zyl-Smit anticipates claim 16. See Ex. 1011 at ¶¶ 28-29. Claim 16 depends
`
`from claim 15 and also requires parenteral administration. In the First IPR, the
`
`Board also found that van Zyl-Smit teaches parenteral administration and therefore
`
`invalidated claim 16. See First IPR, FWD at p. 12-18. Thus, van Zyl-Smit
`
`anticipates claim 15.
`
`(b) Ground 2: Anticipation by Groman
`
`41. Groman is a patent application published in December 2003. I understand
`
`that Groman is therefore prior art to the ’549 patent.
`
`42. As explained above, in the First IPR, I applied the Lawrence Declaration’s
`
`statements regarding the scope of the claim term “iron polyisomaltose complex” and
`
`concluded that, under that definition, Groman teaches every limitation of and
`
`anticipates independent claim 1 (amongst other claims). See Ex. 1011 at ¶¶ 16-22.
`
`The Board agreed. See First IPR, FWD at p. 27. I maintain my prior opinion in this
`
`proceeding.
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`43. As I explained in my First Declaration, Groman discloses the preparation and
`
`use of iron complexed with a reduced (hydrogenated) dextran, which can be a
`
`reduced (hydrogenated) Dextran T1. See Ex. 1003.
`
`44.
`
`In particular, in Example 10 (Ex. 1003 at ¶¶ [0177]-[0178]), Groman
`
`describes the reduction of Dextran T1, which I understand to be a primarily α-1-6
`
`linked polymer of glucose of a molecular weight of approximately 1000 Da. See
`
`U.S. Pharmacopeia for Dextran 1 (Ex. 1007) at p. 601; “Pharmaceutical Quality
`
`Dextran” and “Technical Quality Dextran” printouts from Pharmacosmos website
`
`(Ex. 1008); see also Ex. 1011 at ¶¶ 10-11.
`
`45. Groman then discloses that the reduced Dextran T1 is reacted with ferric
`
`chloride in Example 28 (Ex. 1003 at ¶¶ [0230]-[0231]) to prepare an iron
`
`carbohydrate complex.
`
`46.
`
`I would consider the reduced Dextran T1 described in Example 10 of Groman
`
`to be an essentially linear oligoisomaltoside which, when complexed with iron
`
`according to Example 28, would fall within the Lawrence Declaration’s definition
`
`of “iron polyisomaltose complex,” as the Board applied it in the First IPR.1
`
`
`1 As I explained in my First Declaration, Dextran T1 is an oligoisomaltose, not a
`polyisomaltose. See Ex. 1011 at ¶¶ 17-18. But given the Lawrence Declaration’s
`view of what the claim term iron polyisomaltose encompasses, Groman’s complex
`would fall within it.
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`47.
`
`In addition to disclosing reduced Dextran T1, Groman also discloses treating
`
`patients suffering from anemia (Ex. 1003 at ¶ [0082]) by administering a dose of
`
`elemental iron, comprised in an iron/reduced dextran complex (Ex. 1003 at
`
`¶¶ [0008], [0020], [0029], [0034] and [0091]), of up to 0.6 g (Ex. 1003 at ¶¶ [0015]-
`
`[0016]).
`
`48. Groman further teaches that its iron carbohydrate complexes have “minimal
`
`detectable free iron,” “minimal incidence of anaphylaxis” and are “immunosilent”.
`
`Ex. 1003 at ¶¶ [0004], [0005], [0009], [0016], and [0104].
`
`49. Therefore, as I explained in my First Declaration, if one construes “iron
`
`polyisomaltose complex” to include iron complexed with an essentially purely linear
`
`chemical structure of repeating α-1-6 linked glucose units which is reduced
`
`(hydrogenated) and has a molecular weight of 1000 Da, and if one construes “iron
`
`polyisomaltose complex” to include iron oligosaccharides, then Groman’s
`
`disclosure regarding reduced Dextran T1 would meet all the limitations of claim 1
`
`of the ’549 patent. See Ex. 1011 at ¶ 18. The Board explicitly preferred my
`
`testimony on this point to that of Patent Owner’s expert and held that Groman
`
`anticipates claim 1. See First IPR, FWD at p. 19-23.
`
`50.
`
`I adopt my prior opinions, which were approved by the Board, and for the
`
`same reasons, conclude that claim 21 is anticipated by Groman. Claim 21 requires
`
`that “the iron carbohydrate complex [in claim 1] is an iron polyisomaltose
`
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`complex.” As I just explained, Groman teaches the method of claim 1 using a “iron
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`polyisomaltose complex”. See also Ex. 1011 at ¶¶ 16-18. The Board came to the
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`same conclusion in the First IPR. See First IPR, FWD at p. 19-23. Thus, Groman
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`anticipates claim 21.
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`7.
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`RIGHT TO SUPPLEMENT
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`51.
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`I reserve the right to change, amend, and/or supplement my opinions as
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`necessary, in response to new information and evidence made available to me,
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`additional scientific analysis that leads me to conclude that supplementation is
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`necessary, new issues that may arise, and any additional discovery, arguments,
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`evidence or testimony presented in this matter.
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`52.
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`I reserve the right to supplement my opinions in the future to respond to any
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`arguments that Patent Owner raises and to take into account new information as it
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`becomes available to me.
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`53.
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`I declare that all statements made herein of my own knowledge are true and
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`that all statements made on information and belief are believed to be true, and
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`IPR2019-01142
`Pharamacosmos v. American Regent
`Petitioner Ex. 1009 - Page 17
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`further that these statements were made with the knowledge that willful false
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`statements and the like so made are punishable by fine or imprisonment, or both,
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`under Section 1101 of Title 18 of the United States Code.
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`Dated: June 13, 2019
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`Robert Linhardt, PhD.
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`IPR2019-01142
`Pharamacosmos v. American Regent
`Petitioner Ex. 1009 - Page 18
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`APPENDIX A: Materials Considered
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`IPR2019-01142
`Pharamacosmos v. American Regent
`Petitioner Ex. 1009 - Page 19
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`APPENDIX A: Materials Considered
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`• Ex. 1001: U.S. Patent No. 8,431,549
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`• Ex. 1002: Certified File History of U.S. Patent Application No. 12/787,283
`(issued as U.S. Patent No. 8,431,549)
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`• Ex. 1003: U.S. Patent App. Pub. No. 2003/0232084
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`• Ex. 1004: van Zyl-Smit and Halkett, Experience with the Use of an Iron
`Polymaltose (Dextrin) Complex Given by Single Total Dose Infusion to Stable
`Chronic Haemodialysis Patients, 92 Nephron, 316-323 (2002)
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`• Ex. 1005: Patent Assignment recorded at Reel: 048067 Frame: 0271 -
`Assignment and Change of Name from Luitpold Pharmaceuticals, Inc. to
`American Regent, Inc., executed Jan. 2, 2019
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`• Ex. 1006: Declaration of Richard P. Lawrence under 37 C.F.R. § 1.132
`(Pharmacosmos A/S v. Luitpold Pharmaceuticals, Inc., No. IPR2015-01493,
`Ex. 1011)
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`• Ex. 1007: U.S. Pharmacopeia for Dextran 1 (USP 28:2005)
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`• Ex. 1008: Material Specification Sheet for Dextran T1
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`• Ex. 1011: Declaration of Robert Linhardt, dated June 22, 2015 (Pharmacosmos
`A/S v. Luitpold Pharmaceuticals, Inc., No. IPR2015-01493, Ex. 1014)
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`• Decision of Institution of Inter Partes Review (Pharmacosmos A/S v. Luitpold
`Pharmaceuticals, Inc., No. IPR2015-01493, Paper 11 (P.T.A.B. Jan. 8, 2016))
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`• Final Written Decision of the Patent Trial and Appeal Board (Pharmacosmos
`A/S v. Luitpold Pharmaceuticals, Inc., No. IPR2015-01493, Paper 54 (P.T.A.B.
`Dec. 28, 2016))
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`IPR2019-01142
`Pharamacosmos v. American Regent
`Petitioner Ex. 1009 - Page 20
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