UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS
`USA, INC., WATSON LABORATORIES, INC., DR. REDDY’S
`LABORATORIES, INC., DR. REDDY’S LABORATORIES, LTD., and
`SUN PHARMACEUTICALS INDUSTRIES LTD.,
`Petitioner,
`
`v.
`
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`__________________
`
`Case IPR2020-000401
`U.S. Patent 7,326,708
`__________________
`
`THIRD DECLARATION OF ROBERT M. WENSLOW, PH.D.
`
`
`
`
`1 Teva Pharmaceuticals USA, Inc. and Watson Laboratories, Inc. were joined as
`parties to this proceeding via Motion for Joinder in IPR2020-01045; Dr. Reddy’s
`Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. were joined as parties to this
`proceeding via a Motion for Joinder in IPR2020-01060; and Sun Pharmaceuticals
`Industries Ltd. was joined as a party to this proceeding via Motion for Joinder in
`IPR2020-01072.
`
`Merck Exhibit 2281, Page 1
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS
`USA, INC., WATSON LABORATORIES, INC., DR. REDDY’S
`LABORATORIES, INC., DR. REDDY’S LABORATORIES, LTD., and
`SUN PHARMACEUTICALS INDUSTRIES LTD.,
`Petitioner,
`
`v.
`
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`__________________
`
`Case IPR2020-000401
`U.S. Patent 7,326,708
`__________________
`
`THIRD DECLARATION OF ROBERT M. WENSLOW, PH.D.
`
`
`
`
`1 Teva Pharmaceuticals USA, Inc. and Watson Laboratories, Inc. were joined as
`parties to this proceeding via Motion for Joinder in IPR2020-01045; Dr. Reddy’s
`Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. were joined as parties to this
`proceeding via a Motion for Joinder in IPR2020-01060; and Sun Pharmaceuticals
`Industries Ltd. was joined as a party to this proceeding via Motion for Joinder in
`IPR2020-01072.
`
`Merck Exhibit 2281, Page 1
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`THIRD DECLARATION OF ROBERT M. WENSLOW, PH.D.
`
`I, Robert M. Wenslow, Ph.D., hereby declare as follows:
`
`1.
`
`I am a named inventor of subject matter claimed in U.S. Patent No.
`
`7.326,708 (“the ’708 patent”). At the time of Januvia®’s development, I led a
`
`small team of scientists in the Physical Measurements group, which was then a part
`
`of the Analytical Research department of Merck Research Laboratories. The
`
`primary responsibility of my team was to perform solid-state characterization of
`
`candidate drugs, including the discovery and validation of new polymorphic crystal
`
`forms.
`
`2.
`
`I have previously provided two other declarations in connection with
`
`IPR2020-00040, which have been designated as Exhibit 2003 and Exhibit 2116. I
`
`incorporate herein by reference the testimony in my previous declarations,
`
`including with respect to my professional background, my previous roles and
`
`responsibilities at Merck, and some of the work I did in connection with the
`
`development of the claimed subject matter.
`
`3.
`
`In this declaration, I have been asked to comment on the language,
`
`“characteristic absorption bands obtained from the X-ray powder diffraction
`
`pattern at spectral d-spacings of 7.42, 5.48, and 3.96 angstroms” in claim 5, and the
`
`identical language that lists other numeric d-spacings in claims 6 and 7:
`
`2
`
`Merck Exhibit 2281, Page 2
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`THIRD DECLARATION OF ROBERT M. WENSLOW, PH.D.
`
`
`That language is a mistake. As scientists who perform X-ray powder
`
`4.
`
`diffraction would know, and I knew at the time the application was filed, X-ray
`
`powder diffraction does not involve absorption or absorption bands, nor are d-
`
`spacings “spectral.” Rather, X-ray powder diffraction is a process in which X-rays
`
`are diffracted through a sample. From the resulting diffraction peaks, one can
`
`calculate “d-spacings,” which are physical distances between planes of atoms
`
`within a crystal lattice and can be used to characterize a particular crystalline form.
`
`5.
`
`The correct language that should have been included in claims 5, 6,
`
`and 7 is found in column 13 of the patent:
`
`
`
`3
`
`Merck Exhibit 2281, Page 3
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`THIRD DECLARATION OF ROBERT M. WENSLOW, PH.D.
`
`The d-spacings listed in this paragraph in column 13 characterize a particular form
`
`of the crystalline monohydrate of sitagliptin dihydrogenphosphate. I note that the
`
`same d-spacings are listed in claims 5–7, which confirms my recollection that
`
`those claims are directed to that same crystal form.
`
`6.
`
`This mistake was made in good faith. The term “absorption bands” is
`
`a concept from spectrographic techniques that can be used to characterize salts and
`
`crystal forms in other ways. Language involving these concepts—“absorption
`
`bands” and “spectral” d-spacings—was incorrectly imported into the claims when
`
`they were drafted. When I reviewed the draft patent application, I did not catch the
`
`error in these claims. I am not aware of any reason why anyone at Merck would
`
`have chosen deliberately to refer to “absorption bands” or “spectral” d-spacings in
`
`the claims, and if I had noticed the mistake during the prosecution of the patent, I
`
`would have taken steps to correct this error then.
`
`*
`
`*
`
`*
`
`I hereby declare that all statements made herein of my own knowledge true
`
`and that all statements made on information and belief are believed to be true; and
`
`further 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.
`
`
`
`4
`
`Merck Exhibit 2281, Page 4
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
`
`THIRD DECLARATION OF ROBERT M. WENSLOW, PH.D.
`
`Dated: November 17, 2020
`
`Robert M. Wenslow, Ph.D.
`
`5
`
`Merck Exhibit 2281, Page 5
`Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme Corp.
`IPR2020-00040
`
`
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