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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`____________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________________
`
`EISAI INC.
`Petitioners
`
`v.
`
`CRYSTAL PHARMACEUTICAL (SUZHOU) CO., LTD.
`Patent Owner
`
`____________________
`
`Case PGR2021-00047
`Patent 10,759,779
`____________________
`
`SECOND DECLARATION OF
`WILLIAM MAYO, PH.D. IN SUPPORT OF PETITION
`FOR POST-GRANT REVIEW OF U.S. PATENT NO. 10,759,779
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`EISAI EXHIBIT 1050
`Eisai v. Crystal Pharm.
`PGR2021-00047
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`Page 1 of 24
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`PGR2021-00047
`U.S. Patent No. 10,759,779
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`TABLE OF CONTENTS
`I.
`Introduction ..................................................................................................... 1
`Background and Qualifications ...................................................................... 2
`II.
`Summary of Opinions ..................................................................................... 2
`III.
`IV. Lemborexant Samples Received from Dr. Bihovsky ..................................... 2
`A.
`Samples Received from
`Dr. Bihovsky’s First Set of Experiments ............................................. 2
`Samples Received from
`Dr. Bihovsky’s Second Set of Experiments ......................................... 5
`V. Analysis of Samples from Dr. Bihovsky’s Second Set of Experiments ....... 7
`A. XRPD Protocol for Analysis ................................................................ 7
`B.
`XRPD Patterns of Sample 13-134-1x .................................................. 8
`C.
`XRPD Patterns of Sample 13-137-1x ................................................ 12
`D. XRPD Patterns of Sample 13-143-1x ................................................ 15
`E.
`XRPD Patterns of Sample 13-144-1x ................................................ 18
`VI. Conclusion .................................................................................................... 21
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`B.
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`I, William Mayo, Ph.D., declare as follows:
`
`PGR2021-00047
`U.S. Patent No. 10,759,779
`
`
`
`I.
`
`INTRODUCTION
`1.
`I have been retained by Eisai Inc. (“Petitioner”) as an independent
`
`expert consultant in this proceeding before the United States Patent and Trademark
`
`Office (“PTO”) regarding U.S. Patent No. 10,759,779 (“the ’779 patent”)
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`(Ex. 1001). I have been asked by counsel to determine whether the lemborexant
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`samples provided to me by Dr. Ron Bihovsky from his second set of experiments
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`have the same characteristic peaks, as determined by XRPD, recited in Claims 1-3
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`of the ’779 patent.
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`2.
`
`I am the same William Mayo, Ph.D. that submitted a declaration in
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`this proceeding titled “Declaration of William Mayo, Ph.D. in Support of Petition
`
`for Post-Grant Review of U.S. Patent No. 10,759,779” on January 30, 2021. (Ex.
`
`1023.)
`
`3.
`
`I am being compensated at my normal consulting rate for my time
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`working on this proceeding. My compensation is not contingent on the nature of
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`my findings, the presentation of my findings in testimony, or the outcome of this or
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`any other proceeding. I have no other interest in this proceeding.
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`II. BACKGROUND AND QUALIFICATIONS
`4. My background and qualifications were provided in my First
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`Declaration. (Ex. 1023, ¶¶ 3-14.) A copy of my curriculum vitae was also
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`provided as Exhibit 1024.
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`III. SUMMARY OF OPINIONS
`5.
`The opinions contained in this Declaration are based on the
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`documents I reviewed, XRPD testing of lemborexant samples prepared by Dr.
`
`Bihovsky from his second set of experiments, and my professional judgment, as
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`well as my education, experience, and knowledge regarding XRPD.
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`6.
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`In forming my opinions expressed in this Declaration, I reviewed the
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`documents that I reference in this Declaration.
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`7.
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`Based on my experience and expertise, and my review of the relevant
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`documents, it is my opinion that each of the lemborexant samples I received from
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`Dr. Bihovsky’s second set of experiments exhibit the characteristic XRPD peaks
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`recited in Claims 1-3 of the ’779 patent.
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`IV. LEMBOREXANT SAMPLES RECEIVED FROM DR. BIHOVSKY
`A.
`Samples Received from Dr. Bihovsky’s First Set of Experiments
`8.
`As discussed during my deposition, I received samples from Dr.
`
`Bihovsky’s first set of experiments in October 2020. (Ex. 2051, 147:10-148:3.)
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`Dr. Bihovsky shipped the samples from his laboratory outside of Philadelphia,
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`Pennsylvania directly to my home address in Pittsburgh, Pennsylvania. (Ex. 2051,
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`146:19-147:9.) The samples were put into individual vials that were sealed inside
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`a storage bag, which was placed in an insulated Styrofoam box with ice packs.
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`(Ex. 2051, 145:21-146:5, 150:19-21.) When I received the shipment, the ice packs
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`were still frozen, which indicated that the low temperature within the package had
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`been maintained. (Ex. 2051, 146:14-18.)
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`9.
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`Dr. Bihovsky sent the package overnight via FedEx’s next-day
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`delivery, and I retained the shipping label from FedEx that was attached to the
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`outside of the shipping container in a plastic envelope. (Ex. 2051, 115:1-24,
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`146:5-13.) As shown by the shipping label, Dr. Bihovsky sent the package to me
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`on October 20, 2020, and I received the package on October 21, 2020. (Ex. 1051.)
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`I ran the XRPD analysis of the samples the same day I received them from Dr.
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`Bihovsky. (Ex. 2051, 152:2-11.)
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`10.
`
`I understand that Patent Owner’s expert, Dr. Robin Rogers, opines
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`that Dr. Bihovsky and I provide different descriptions of the sample resulting from
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`Dr. Bihovsky’s experiment following the first procedure of Example G of the ’109
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`patent. (Ex. 2044, ¶ 31.) Dr. Bihovsky described the solid product he obtained as
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`a “fluffy flocculent white solid,” while I described the same sample I received as a
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`“fine,” “white powder” solid. (Ex. 1013, 2:18; Ex. 2049, 216:13-20; Ex. 2051,
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`152:19-153:5.) I also understand that Dr. Rogers opines that this difference in
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`description implies that some changes had taken place in the sample, and that the
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`solid I analyzed may have not been in the same solid form that Dr. Bihovsky
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`obtained from his experiments. (Ex. 2044, ¶ 31.) Dr. Rogers states that these “are
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`considerably different visual appearances and textures” and the “change . . . was
`
`not generated by physical processing” because neither of us processed the “solids”
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`at any point. (Id.)
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`11. First, I disagree that these descriptions are inconsistent. Dr. Bihovsky
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`and I both reported a “solid” having the same color. While I observed that the
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`samples were fine white powder (Ex. 2051, 153:1-5, 15-16), the difference in
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`descriptions of textures merely represents the observations of the same solid by
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`two different people. Looking at the powder particles together as a whole, the
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`agglomeration of the particles was quite loose, and this loosely bound
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`agglomeration of the particles is consistent with Dr. Bihovsky’s description of a
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`“fluffy flocculent” solid. In other words, my description was based on the
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`observation of an individual particle, which is analogous to a snowflake, while Dr.
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`Bihovsky’s description was based on observation of the particles that were loosely
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`bound together, which is analogous to a snowball made up of individual
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`snowflakes.
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`12. Second, I have no reason to believe the samples I received from Dr.
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`Bihovsky were not, in fact, from Dr. Bihovsky, or that any tampering had occurred
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`during shipment. The shipping label was intact and the vials were sealed. (Ex.
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`1051; Ex. 2051, 115:1-24.) The shipping label also confirms that the samples were
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`sent to me directly from Dr. Bihovsky. (Ex. 1051.)
`
`B.
`Samples Received from Dr. Bihovsky’s Second Set of Experiments
`13. On January 4, 2022, Dr. Bihovsky provided me with four additional
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`samples of lemborexant. Since conducting XRPD analysis of Dr. Bihovsky’s
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`samples from his first set of experiments, I retired and relocated from New Jersey
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`to Florida in late December. At the time that the samples from Dr. Bihovsky’s
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`second set of experiments were prepared and ready for shipment, I was in Florida.
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`Because of this, I asked that Dr. Bihovsky send his samples to the laboratory at
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`H&M Analytical Services (“H&M”), a company which I founded and in which I
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`had an ownership interest prior to my retirement in December. I maintain an
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`ongoing relationship with H&M through occasional consulting, and the testing was
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`to take place there. In my absence, I asked my successor at H&M, Dr. Steven
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`Miller,1 to receive the package and store the samples according to my instructions.
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`(Ex. 1052.) He reported to me that the shipping label for the package with the
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`samples was intact, and upon receipt, the samples were stored in a lab freezer
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`at -20 °C.
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`14. Because I was not able to go to New Jersey when the samples arrived
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`on January 4, 2022, I also asked Dr. Miller to perform a preliminary XRPD
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`analysis of the samples from Dr. Bihovsky. (Ex. 1052.) Results confirmed that all
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`of the samples were CS2. (Ex. 1054.) I then flew to New Jersey from Florida on
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`January 13, 2022 to run the samples myself. I took a picture of the shipping
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`container, which was a small Styrofoam insulated ice box that included ice packs.
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`(Ex. 1053, 3.) I also took a close up picture of the four samples with labels on
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`them. (Ex. 1053, 4.) This work serves as the basis for my analysis, which I
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`discuss below.
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`
`1
`I trained Dr. Miller for several years while I was a Professor at Rutgers
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`University and for an additional two years at H&M prior to his becoming its new
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`owner.
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`V. ANALYSIS OF SAMPLES FROM
`DR. BIHOVSKY’S SECOND SET OF EXPERIMENTS
`15. Once again, I was asked to use XRPD to analyze samples of
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`lemborexant that Dr. Bihovsky prepared and securely provided to me. Using
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`techniques well known to those of ordinary skill in the art of XRPD, I compared
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`the XRPD patterns resulting from my analysis of these samples to the
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`characteristic peak positions recited in Claims 1-3 of the ’779 patent.
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`16. Tables 1 through 4 below correspond to Figures 1 through 12, and
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`also set forth the 2θ values required by Claims 1-3 of the ’779 patent along with
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`the 2θ values of the peak positions of the XRPD patterns, which I obtained by
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`testing Dr. Bihovsky’s samples. Based on my experiments, I determined that all of
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`the samples fall within the scope of Claims 1-3 of the ’779 patent.
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`A. XRPD Protocol for Analysis
`17. To analyze these lemborexant samples, I followed the standard
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`protocols and methods for XRPD analysis, as described in my First Declaration.
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`(Ex. 1023, ¶¶ 26-38.)
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`18. Each sample was back-loaded into a standard sample holder and
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`placed into a Panalytical X’pert X-ray Diffractometer equipped with a Pixcel
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`detector and using CuKα Radiation at 45KV/40mA. I then ran X-ray diffraction
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`scans over the range of 2°- 40° with a step size of 0.0131°, a counting time of 100
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`seconds per step, a Nickel filter, ¼° fixed divergence slit, and ½° fixed anti-scatter
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`slit. During data collection, the sample was spun in-plane at a speed of 4
`
`seconds/revolution to help eliminate preferred orientation of the grains in the
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`sample, which might otherwise lead to anomalous peak intensities.
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`19. The ’779 patent indicates that the patentee obtained the X-ray
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`diffraction patterns on a Bruker D2 PHASER X-ray Powder Diffractometer using
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`CuKα Radiation at 30kV/10mA with a scan range from 3.0°- 40.0°. (Ex. 1001,
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`6:28-46.)
`
`B. XRPD Patterns of Sample 13-134-1x
`20.
`I ran triplicate XRPD scans on the sample received from Dr. Bihovsky
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`identified as 13-134-1x. The XRPD patterns of this sample, with sticks overlaid
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`for the peak positions in Claims 1-3 of the ’779 patent, are shown below.
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`Figure 1: XRPD Pattern for Dr. Bihovsky’s Sample 13-134-1x (scan #1)
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`Figure 2: XRPD Pattern for Dr. Bihovsky’s Sample 13-134-1x (scan #2)
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`Figure 3: XRPD Pattern for Dr. Bihovsky’s Sample 13-134-1x (scan #3)
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`Claim 1 Peak Positions
`7.8°
`15.6°
`11.4°
`
`Claim 2 Peak Positions
`12.5°
`21.3°
`27.3°
`
`Claim 3 Peak Positions
`24.0°
`19.4°
`22.3°
`
`
`
`Sample 13-134-1x
`(scan #1)
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`7.9°
`(+0.1°)
`
`15.7°
`(+0.1°)
`
`11.6°
`(+0.2°)
`
`12.7°
`(+0.2°)
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`21.2°
`(-0.1°)
`
`Sample 13-134-1x
`(scan #2)
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`8.0°
`(+0.2°)
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`15.7°
`(+0.1°)
`
`11.6°
`(+0.2°)
`
`12.7°
`(+0.2°)
`
`21.2°
`(-0.1°)
`
`Sample 13-134-1x
`(scan #3)
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`8.0°
`(+0.2°)
`
`15.7°
`(+0.1°)
`
`11.6°
`(+0.2°)
`
`12.7°
`(+0.2°)
`
`21.2°
`(-0.1°)
`
`27.3°
`(0.0°)
`
`27.3°
`(0.0°)
`
`27.3°
`(0.0°)
`
`24.0°
`(0.0°)
`
`24.0°
`(0.0°)
`
`24.0°
`(0.0°)
`
`19.5°
`(+0.1°)
`
`19.5°
`(+0.1°)
`
`19.5°
`(+0.1°)
`
`22.3°
`(0.0°)
`
`22.3°
`(0.0°)
`
`22.3°
`(0.0°)
`
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`Table 1: Comparison of Peak Positions in Figures 1-3 to Claims 1-3 of the ’779
`patent
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`11
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`C. XRPD Patterns of Sample 13-137-1x
`21.
`I ran triplicate XRPD scans on the sample received from Dr. Bihovsky
`
`identified as 13-137-1x. The XRPD patterns of this sample, with sticks overlaid
`
`for the peak positions in Claims 1-3 of the ’779 patent, are shown below.
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`Figure 4: XRPD Pattern for Dr. Bihovsky’s Sample 13-137-1x (scan #1)
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`12
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`Figure 5: XRPD Pattern for Dr. Bihovsky’s Sample 13-137-1x (scan #2)
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`Figure 6: XRPD Pattern for Dr. Bihovsky’s Sample 13-137-1x (scan #3)
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`
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`Claim 1 Peak Positions
`7.8°
`15.6°
`11.4°
`
`Claim 2 Peak Positions
`12.5°
`21.3°
`27.3°
`
`Claim 3 Peak Positions
`24.0°
`19.4°
`22.3°
`
`
`
`Sample 13-137-1x
`(scan #1)
`
`8.0°
`(+0.2°)
`
`15.7°
`(+0.1°)
`
`11.6°
`(+0.2°)
`
`12.7°
`(+0.2°)
`
`21.2°
`(-0.1°)
`
`27.2°
`(-0.1°)
`
`27.2°
`(-0.1°)
`
`24.0°
`(0.0°)
`
`24.0°
`(0.0°)
`
`24.0°
`(0.0°)
`
`19.5°
`(+0.1°)
`
`19.5°
`(+0.1°)
`
`19.6°
`(+0.2°)
`
`22.3°
`(0.0°)
`
`22.3°
`(0.0°)
`
`22.3°
`(0.0°)
`
`Sample 13-137-1x
`(scan #2)
`
`8.0°
`(+0.2°)
`
`15.7°
`(+0.1°)
`
`11.6°
`(+0.2°)
`
`12.7°
`(+0.2°)
`
`21.2°
`(-0.1°)
`
`Sample 13-137-1x
`(scan #3)
`
`8.0°
`(+0.2°)
`
`15.7°
`(+0.1°)
`
`11.6°
`(+0.2°)
`
`12.7°
`(+0.2°)
`
`21.2°
`(-0.1°)
`
`27.3°
`(0.0°)
`
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`Table 2: Comparison of Peak Positions in Figures 4-6 to Claims 1-3 of the ’779
`patent
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`D. XRPD Patterns of Sample 13-143-1x
`22.
`I ran triplicate XRPD scans on the sample received from Dr. Bihovsky
`
`identified as 13-143-1x. The XRPD patterns of this sample, with sticks overlaid
`
`for the peak positions in Claims 1-3 of the ’779 patent, are shown below.
`
`
`Figure 7: XRPD Pattern for Dr. Bihovsky’s Sample 13-143-1x (scan #1)
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`Figure 8: XRPD Pattern for Dr. Bihovsky’s Sample 13-143-1x (scan #2)
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`Figure 9: XRPD Pattern for Dr. Bihovsky’s Sample 13-143-1x (scan #3)
`
`
`
`
`Claim 1 Peak Positions
`7.8°
`15.6°
`11.4°
`
`Claim 2 Peak Positions
`12.5°
`21.3°
`27.3°
`
`Claim 3 Peak Positions
`24.0°
`19.4°
`22.3°
`
`
`
`Sample 13-143-1x
`(scan #1)
`
`7.9°
`(+0.1°)
`
`15.7°
`(+0.1°)
`
`11.6°
`(+0.2°)
`
`12.7°
`(+0.2°)
`
`21.2°
`(-0.1°)
`
`Sample 13-143-1x
`(scan #2)
`
`7.9°
`(+0.1°)
`
`15.7°
`(+0.1°)
`
`11.6°
`(+0.2°)
`
`12.6°
`(+0.1°)
`
`21.2°
`(-0.1°)
`
`Sample 13-143-1x
`(scan #3)
`
`8.0°
`(+0.2°)
`
`15.7°
`(+0.1°)
`
`11.6°
`(+0.2°)
`
`12.7°
`(+0.2°)
`
`21.2°
`(-0.1°)
`
`27.2°
`(-0.1°)
`
`27.2°
`(-0.1°)
`
`27.2°
`(-0.1°)
`
`24.0°
`(0.0°)
`
`24.0°
`(0.0°)
`
`24.0°
`(0.0°)
`
`19.5°
`(+0.1°)
`
`19.5°
`(+0.1°)
`
`19.6°
`(+0.2°)
`
`22.3°
`(0.0°)
`
`22.3°
`(0.0°)
`
`22.3°
`(0.0°)
`
`
`Table 3: Comparison of Peak Positions in Figures 7-9 to Claims 1-3 of the ’779
`patent
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`E. XRPD Patterns of Sample 13-144-1x
`23.
`I ran triplicate XRPD scans on the sample received from Dr. Bihovsky
`
`identified as 13-144-1x. The XRPD patterns of this sample, with sticks overlaid
`
`for the peak positions in Claims 1-3 of the ’779 patent, are shown below.
`
`
`Figure 10: XRPD Pattern for Dr. Bihovsky’s Sample 13-144-1x (scan #1)
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`
`Figure 11: XRPD Pattern for Dr. Bihovsky’s Sample 13-144-1x (scan #2)
`
`
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`19
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`Page 21 of 24
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`PGR2021-00047
`U.S. Patent No. 10,759,779
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`
`Figure 12: XRPD Pattern for Dr. Bihovsky’s Sample 13-144-1x (scan #3)
`
`
`
`
`Claim 1 Peak Positions
`7.8°
`15.6°
`11.4°
`
`Claim 2 Peak Positions
`12.5°
`21.3°
`27.3°
`
`Claim 3 Peak Positions
`24.0°
`19.4°
`22.3°
`
`
`
`Sample 13-144-1x
`(scan #1)
`
`7.9°
`(+0.1°)
`
`15.6°
`(0.0°)
`
`11.5°
`(+0.1°)
`
`12.6°
`(+0.1°)
`
`21.2°
`(-0.1°)
`
`27.3°
`(0.0°)
`
`Sample 13-144-1x
`(scan #2)
`
`7.9°
`(+0.1°)
`
`15.7°
`(+0.1°)
`
`11.6°
`(+0.2°)
`
`12.7°
`(+0.2°)
`
`21.2°
`(-0.1°)
`
`27.2°
`(-0.1°)
`
`Sample 13-144-1x
`(scan #3)
`
`8.0°
`(+0.2°)
`
`15.7°
`(+0.1°)
`
`11.6°
`(+0.2°)
`
`12.7°
`(+0.2°)
`
`21.2°
`(-0.1°)
`
`27.3°
`(0.0°)
`
`24.0°
`(0.0°)
`
`24.0°
`(0.0°)
`
`24.0°
`(0.0°)
`
`19.5°
`(+0.1°)
`
`19.5°
`(+0.1°)
`
`19.5°
`(+0.1°)
`
`22.3°
`(0.0°)
`
`22.3°
`(0.0°)
`
`22.3°
`(0.0°)
`
`Table 4: Comparison of Peak Positions in Figures 10-12 to Claims 1-3 of the ’779
`patent
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`PGR2021-00047
`U.S. Patent No. 10,759,779
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`24.
`
`In my opinion, all of the XRPD patterns shown in Figures 1 through
`
`12 have the characteristic peaks for CS2 in Claims 1-3 in the ’779 patent.
`
`Moreover, any slight differences in peak locations are within the acceptable error
`
`range of ±0.2°, as specified in Claims 1-3 of the ’779 patent.
`
`VI. CONCLUSION
`25.
`In my opinion, all of the samples provided to me by Dr. Bihovsky
`
`from his second set of experiments are the same CS2 crystalline form of
`
`lemborexant recited in Claims 1-3 of the ’779 patent.
`
`26.
`
`I declare that all statements made herein of my knowledge are true,
`
`and that all statements made on information and belief are believed to be true, and
`
`that these statements were made with the knowledge that willful false statements
`
`and the like so made are punishable by fine or imprisonment, or both, under
`
`Section 1001 of Title 18 of the United States Code.
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`21
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`Page 23 of 24
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`PGR2021-00047
`U.S. Patent No. 10,759,779
`
`Dated: February 4, 2022
`
`By:
`
`2 ),
`
`William Mayo, Ph.D.
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`22
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`Page 24 of 24
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