UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`AYLA PHARMA LLC,
`Petitioner
`
`v .
`
`ALCON RESEARCH, LTD.,
`Patent Owner.
`
`U.S. Patent No. 9,533,053 to Gamache et al.
`Case No.: IPR2020-00295
`
`DECLARATION OF DR. S. CRAIG DYAR, PH.D., R.PH.
`
`142708260v1
`
`Ayla Pharma LLC (IPR2020-00295) Ex. 1042 p. 001
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`AYLA PHARMA LLC,
`Petitioner
`
`v .
`
`ALCON RESEARCH, LTD.,
`Patent Owner.
`
`U.S. Patent No. 9,533,053 to Gamache et al.
`Case No.: IPR2020-00295
`
`DECLARATION OF DR. S. CRAIG DYAR, PH.D., R.PH.
`
`142708260v1
`
`Ayla Pharma LLC (IPR2020-00295) Ex. 1042 p. 001
`
`
`
`I, S. Craig Dyar, Ph.D., R.Ph., do hereby declare and state as follows:
`
`1.
`
`I am over the age of eighteen (18) and otherwise competent to make
`
`this Declaration.
`
`2. My name is S. Craig Dyar. I am currently President of SCD Pharma
`
`Consulting and a Senior Associate (Per Diem) at Lachman Consultants. I
`
`understand that my declaration is being submitted in connection with a Petition for
`
`inter partes review (h@FGi’ of J[VaRQ HaNaR‘ FNaR[a D\* 5(1//(,1/ &haUR j,1/
`
`FNaR[ai’ (Exhibit 1002).
`
`3.
`
`I am an expert in the field of developing and evaluating
`
`topical, ophthalmic, oral, transdermal, sublingual, rectal and sustained
`
`release dosage forms, and I have been an expert in this field since well before
`
`2011, which I understand is the priority date of the j,1/ patent. A more complete
`
`recitation of my professional experience and qualifications may be found in my
`
`Curriculum Vitae (Exhibit 1043).
`
`4.
`
`I have a Ph.D. in Pharmaceutical Sciences from the Medical University of
`
`South Carolina, Charleston; a B.S. Degree in Pharmacy from the Medical University
`
`of South Carolina, Charleston; and a B.S. Degree of Biology from the University of
`
`South Carolina.
`
`5.
`
`I am currently, and have been since 2008, President of the SCD
`
`Pharma Consulting group and also have been since 2010 a Senior Associate (Pre-
`
`Diem) at Lachman Consultants. In this capacity, I have provided recommendations
`1
`
`142708260v1
`
`Ayla Pharma LLC (IPR2020-00295) Ex. 1042 p. 002
`
`
`
`to clients regarding the development of quality products beginning from discovery
`
`all the way to post-launch, life-cycle planning, intellectual property, project
`
`management, compound licensing and business development with a focus on drug
`
`delivery technologies related to dermal and ophthalmic ointments and other
`
`delivery technologies.
`
`6.
`
`From 2008-2016, I was Assistant Professor at the School of Pharmacy of
`
`South University. During that time, I taught classes in pharmacokinetics and
`
`pharmaceutics, including ocular delivery methods and strategies, to graduate pharmacy
`
`students.
`
`7.
`
`From 1998-2008, I was employed at Pfizer as a Scientist (1998-2000),
`
`Senior Scientist (2000-2001), Senior Principle Scientist (2001-2004) and Associate
`
`Research Fellow (2004-2008). During this time, I served on the Global Intellectual
`
`Property Board, the Global Drug Delivery Group, and managed several drug delivery
`
`projects related to immediate and sustained release oral tables, topical creams and
`
`ointments, sublingual tablets, transdermal formulations, targeted delivery systems
`
`(dendrimer and others), and orally dissolving tablets. I was also the lead on several
`
`pharmaceutical science teams directing numerous ophthalmology and dermatology
`
`projects. In particular from 2007-2008, I managed the NCE (New Chemical Entity) to
`
`phase 2 Ophthalmology portfolio, where I was responsible for the oversite of the
`
`chemistry, formulation and regulatory components of the programs.
`
`8.
`
`142708260v1
`
`From 1987-1994, I worked as a Registered Pharmacist where I was the
`2
`
`Ayla Pharma LLC (IPR2020-00295) Ex. 1042 p. 003
`
`
`
`Pharmacist in Charge.
`
`9.
`
`During my tenure, I have been an honorary member of Rho Chi Honor
`
`Society and American Association of Pharmaceutical Sciences and have been a
`
`Fellow of the American Foundation for Pharmaceutical Education (AFPE), and I
`
`have served as Chair of the AAPS year-round Task Force on Novel Drug Delivery
`
`Technology. In addition, I have published over 15 patents, patent applications,
`
`research publications, presentations, and/or posters and authored numerous Good
`
`manufacturing Practice/Good Laboratory Practice guidelines (GMP/GLP) and
`
`standard operating procedures (SOP).1
`
`10.
`
`@ UNcR ORR[ _RaNV[RQ V[ aUV‘ ZNaaR_ Of 8fYN FUN_ZN BB: &h8fYNi’ N‘ N
`
`aRPU[VPNY Re]R_a a\ ]_\cVQR N[NYf‘V‘ N[Q \]V[V\[‘ _RTN_QV[T aUR j,1/ ]NaR[a*
`
`I am
`
`being compensated for my time in connection with this IPR at my standard
`
`consulting rate, which is $350 per hour for consulting. My compensation does not
`
`depend in any way on the outcome of any of the IPR.
`
`11.
`
`I b[QR_‘aN[Q aUNa aUR j,1/ FNaR[a V‘ N‘‘VT[RQ a\ 8YP\[ GR‘RN_PU( LLC.
`
`&h8YP\[(i hFNaR[aRR(i \_ hFNaR[a Ed[R_i’* @ have no personal or financial stake or
`
`interest in Petitioner, FNaR[a Ed[R_ \_ aUR j,1/ FNaR[a*
`
`12.
`
`I understand that Dr. Paul Laskar previously submitted a combined
`
`1 I reserve the right to further explain my background and qualifications in deposition
`
`where needed.
`
`142708260v1
`
`3
`
`Ayla Pharma LLC (IPR2020-00295) Ex. 1042 p. 004
`
`
`
`declaration (EX1014) in connection with the j,13 patent in Cipla Ltd. v. Alcon
`
`Research Ltd., IPR2018-01021 and its _RYNaRQ J*H* FNaR[a D\* 4(35-(-10 &haUR j-10
`
`FNaR[ai’ V[ Cipla Ltd. v. Alcon Research Ltd., IPR2018-01020.
`
`13.
`
`In the context of this retention, I have reviewed the Laskar declaration
`
`and its underlying materials. I agree with ;_* BN‘XN_k‘ _RN‘\[‘( findings and
`
`conclusions, and hereby adopt those reasons, findings and conclusions as if they
`
`were my own, including those dVaU _RTN_Q a\ aU\‘R ]R_aNV[V[T a\ aUR j,1/ patent as if
`
`I had signed the declaration myself with no changes to any opinions expressed
`
`therein.2
`
`14. Although Dr. Laskar referred to the Abelson reference for his general
`
`statement of unpatentability of claims 1-13 under Grounds 1-3, I do note that Dr.
`
`Lasker only utilized Abelson as a prior art reference for claims 7 and 13. The
`
`remaining claims were shown unpatentable as obvious by Bhowmick in view of
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`Yanni and Castillo under Ground 1, obvious by Schneider in view of Hayakawa,
`
`Bhowmick and Castillo under Ground 2, and obvious by Bhowmick, Schneider and
`
`Castillo under Ground 3. In this regard, I agree with Dr. Laskar's specific findings
`
`and conclusions on the obviousness of each challenged claim under Grounds 1-3.
`
`2 @[ ;_* BN‘XR_k‘ ;RPYN_NaV\[ ]N_NT_N]U 05( UR ‘U\d‘ aUR ‘a_bPab_R \S EY\]NaNQV[R
`
`and references the PDR. The structure is not shown in the PDR, but is well known
`
`and can be drawn from the chemical name in the PDR.
`
`142708260v1
`
`4
`
`Ayla Pharma LLC (IPR2020-00295) Ex. 1042 p. 005
`
`
`
`
`
`W D
`
`I hereby declare that all statements made herein of my own knowledge
`
`re true anc t1at a
`
`statements mace 011 111 ormat1on anc ue 1e are, to t1e est 0
`
`11y
`
`110W ec ge, ue1evec to ue true; anc urt 1er t1at t1ese statements are mace W1t 1
`
`t1e 110W ecge t1at W1 u a se statements anc t1e 1 e s0 mace are pun1s 1a e uy
`
`mm or 1mpr1sonment, 0r 0t1, un er Sect10n 1001 0 T1t e 18 0 t1e U111tec States
`
`Respect
`
`y Su u mm
`
`EE-lmam
`
`Ay a P 1arma LLC IPR2020-00295 EX. 1042 p. 006
`
`
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