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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`APOTEX CORP.,
`Petitioner
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`v.
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`ALCON RESEARCH, LTD.,
`Patent Owner.
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`
`Case IPR2013-00428
`U.S. Patent No. 8,268,299 B2
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`DECLARATION OF BHAGWATI P. KABRA, Ph.D.
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`1
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`ALCON 2057
`Apotex Corp. v. Alcon Research, Ltd.
`Case IPR2013-00428
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`I.
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`I, Bhagwati P. Kabra, Ph.D., hereby declare as follows:
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`INTRODUCTION
`1.
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`I am over the age of eighteen and otherwise competent to make this
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`declaration.
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`2.
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`I am the first named inventor on U.S. Patent No. 8,268,299 (the “’299
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`patent”). I have been asked to provide a declaration attesting to how certain data in
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`the specification of the ’299 patent were generated.
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`II. BACKGROUND AND QUALIFICATIONS
`3.
`I received a B.S. in Chemical Engineering in 1986 from the
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`Department of Chemical Technology, University of Bombay. Between 1986 and
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`1993, I studied at the University of Cincinnati, where I was awarded a M.S. (1988)
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`and a Ph.D. (1993) in Chemical Engineering.
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`4.
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`I joined Alcon in 1993 as a Senior Scientist in the Drug Delivery
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`Group, a position I held until 2001. As a Senior Scientist in this group, the majority
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`of my work related to the development of novel ophthalmic drug delivery systems.
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`5.
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`Between 2001 and 2010, I was Manager, and later Associate Director,
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`of the Formulation Development Group at Alcon. In this position, I directed
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`formulation development activities for ophthalmic products, including Alcon’s
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`travoprost products TRAVATAN® and TRAVATAN Z®.
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`2
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`6.
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`Between 2010 and March 2013, I was Head of the CMC (“Chemistry,
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`Manufacturing, Controls”) Teams Group. In March 2013, I was appointed to my
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`current position as Head of CMC. My responsibilities now include directing the
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`CMC project leaders in the development and execution of the CMC strategy for
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`development and exploratory projects, including in the area of drug formulation.
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`III. DATA IN THE ’299 PATENT SPECIFICATION
`7.
`As the Manager, and later Associate Director, of the Formulation
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`Development Group, I was involved in the research within the Group which led to
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`the inventions claimed in the ’299 patent. In particular, I was involved in the
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`development of many of the Example formulations described in the specification
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`of the ’299 patent, and as such, I have first-hand knowledge of how certain
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`formulations described in the specification of the ’299 patent were made and
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`tested, including the Example formulations discussed herein.
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`8.
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`In general, when a formulator at Alcon prepares a new formulation, a
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`formulation identification, or “FID,” number is assigned. The FID number
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`uniquely identifies a specific combination of ingredients. At times, however, if the
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`combination of ingredients in a particular formulation is adjusted in a way that a
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`new FID number is not deemed necessary, rather than the new formulation being
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`assigned a new FID number, it instead may be assigned a version number, for
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`example FID xxxxxx -1 or FID xxxxxx v. 2.
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`3
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`9.
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`Each batch of a formulation that is made will also be assigned a batch
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`number (and, in some cases, a lot number representing parts of a batch). The batch
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`or lot numbers identify a particular preparation of a particular formulation
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`(identified by the FID number). Batches of a particular formulation are made for a
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`variety of purposes, including to conduct testing on a particular aspect of the
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`formulation—for example, its physical or chemical stability, or its preservative
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`efficacy.
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`10.
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`I am familiar with Alcon’s records relating to this type of formulation
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`and development work. In its usual and ordinary course of business, Alcon issues
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`numbered laboratory notebooks to scientists and technicians, who use the
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`notebooks to record their work relating to the preparation of new formulations.
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`Notebooks may relate to more than one project. A notebook page should generally
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`identify the notebook number, the page number, the title of the experiment and the
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`project number.
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`11. Other than the formulation and development information, laboratory
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`notebooks may also record other types of testing carried out by other Alcon
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`employees on a particular formulation, such as preservative efficacy testing,
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`chemical stability testing, or physical stability testing. If a formulator wishes to
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`test the preservative efficacy of a formulation, for example, he or she typically
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`sends samples to the microbiology laboratory for testing. Once the testing is
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`4
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`completed, the laboratory provides the formulator with a report. These test results
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`are recorded in the Laboratory Information Management System (LIMS).
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`12. Alcon maintains laboratory notebooks and laboratory testing reports
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`in the usual and ordinary course of its business, and did so during the discovery
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`and development of the inventions claimed in the ’299 patent, including the
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`making and testing of the Examples discussed herein.
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`A. Examples D – F, L – N, and U – W
`13. Examples D, E, F, L, M, N, U, V, and W as set forth in the
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`specification of the ’299 patent are each formulations that were created during the
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`discovery and development of the inventions claimed in the ’299 patent. The ’299
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`patent correctly identifies the ingredients of each formulation and their
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`concentrations. The ’299 patent also correctly identifies (with one minor exception
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`discussed in paragraph 15 below) the particular FID and lot number for each
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`formulation. The particular batches were created by scientists in the Formulation
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`Development Group for the purpose of testing the preservative efficacy of each
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`formulation. I am familiar with the creation by scientists in the Formulation
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`Development Group of the particular batches described in Examples D – F, L – N,
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`and U – W of the ’299 patent.
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`14. Each batch was formulated by scientists in the Formulation
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`Development Group according to standard practices in the field, which are
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`5
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`described in detail in laboratory notebook entries for each batch record. True and
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`correct copies of the relevant laboratory notebook entries are attached as exhibits
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`to this declaration as follows:
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`EXAMPLE
`D
`E
`F
`L
`M
`N
`U
`V
`W
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`FID
`106737
`106757
`106039
`107047
`109032
`109033
`112148
`112286
`112287
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`LOT NO. LAB NB NO. & PAGE
`04-36171
`11068/17-24
`04-36176
`11068/17-24
`04-36405
`9988/87
`04-37157
`11118:77-82
`05-40452
`11781:19-21
`05-40453
`11781:19-21
`07-46931
`13160/66
`07-47249
`13292/38-39
`07-47250
`13292/39-39
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`EXHIBIT
`2063
`2063
`2064
`2059
`2060
`2060
`2065
`2066
`2066
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`15. For clarity, there is a typographical error in the formulation lot
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`number listed in the ’299 patent for example W. The specification incorrectly lists
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`the lot number as 07-47632. The correct lot number is 07-47250, as is reflected in
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`the laboratory notebook.
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`16. Once each batch was completed, it was provided to Alcon’s
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`microbiology lab for the lab to conduct preservative efficacy testing (“PET”). The
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`results from this preservative efficacy testing were either reported back to me or
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`the members of my group, or were made available to us in the LIMS.
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`B.
`Example Y
`17. Example Y of the ’299 patent describes the results of testing designed
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`to study the effect of pH on the formation of particulate matter that results from an
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`interaction between the zinc ions in the formulation and an impurity and
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`degradation product of polyoxyl 40 hydrogenated castor oil. Various samples at
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`differing pH levels were created by scientists in the Formulation Development
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`Group, which were then tested for their turbidity and particulates. The
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`specification of the ’299 patent correctly identifies the ingredients of the
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`formulation used in Example Y. I am familiar with the creation by scientists in the
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`Formulation Development Group of the particular samples described in Example Y
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`of the ’299 patent, and with the visual particulate analysis conducted by scientists
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`in the Formulation Development Group of these samples. I am also familiar with
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`microscopic analysis of particulates in selected samples conducted in the analytical
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`chemistry group.
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`18. The samples created for Example Y were made by scientists in the
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`Formulation Development Group according to standard procedures, which are
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`described in detail in laboratory notebook entries for this particular test.
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`Additionally, the turbidity and particulate formation visual observations were taken
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`by one of the scientists in the Formulation Development Group according to
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`standard practices in the field and are also recorded in the lab notebook entries for
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`this particular test. True and correct copies of the relevant laboratory notebook
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`entries are attached as exhibits to this declaration as follows:
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`EXAMPLE LAB NB NO. & PAGE
`11781/81-83
`Y
`Adjunctive Pages
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`EXHIBITS
`2067
`2068
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`7
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`C. The Data in the Specification
`19. Based on my involvement and the involvement of the Formulations
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`Development Group in the formulations of Examples D – I, L – N, U – W, and Y, I
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`have personal knowledge that, aside from the one typographical error I mentioned
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`in paragraph 15, the formulation and testing data set forth in the patent are true and
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`correct for Examples D – F, L – N, U – W, and Y.
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`20.
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`I hereby declare under penalty of perjury under the laws of the United
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`States of America that the foregoing is true and correct, and that all statements
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`made of my own knowledge are true and that all statements made on information
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`and belief are believed to be true.
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`8
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