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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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`__________________________________
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`PFIZER, INC.
`Petitioner
`
`v.
`
`GENENTECH, INC.
`Patent Owner
`___________________________________
`
`U.S. Patent No. 9,249,218
`Issue Date: February 2, 2016
`Title: PROTEIN PURIFICATION
`
`___________________________________
`
`Inter Partes Review No. Unassigned
`___________________________________
`
`U.S. Patent No. 6,339,142
`Issue Date: January 15, 2002
`Title: PROTEIN PURIFICATION
`
`___________________________________
`
`Inter Partes Review No. Unassigned
`___________________________________
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`
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`DECLARATION OF KEITH L. CARSON
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`Pfizer Ex. 1020
`Page 1 of 6
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`I, Keith L. Carson, declare as follows:
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`1. My name is Keith L. Carson. I was the founder and Managing
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`Director of the Williamsburg BioProcessing Foundation (“WilBio”), a corporation
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`that existed from 1994 to 2008 in Norfolk Virginia. The mission of WilBio was
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`stated on our website:
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`The Williamsburg BioProcessing Foundation sponsors
`conferences and events related to the bioprocessing
`industry. Using a highly focused technical content and
`format developed at our previous conferences, we
`explore the problems faced while developing
`bioprocessing related products, and then turning them
`into viable commercial products. To do this, the
`Williamsburg BioProcessing Foundation brings together
`the most talented and experienced people in the field and
`facilitates the exchange of information with a stimulating
`but relaxed environment.
`
`(Ex. 1040, https://web.archive.org/web/19971008053500/http://wilbio.com/.)
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`2.
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`One of the main functions of WilBio was to host meetings and
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`conferences throughout the year for skilled people in the field of monoclonal and
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`recombinant antibodies to come together and present the most current ideas and
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`findings at the time. From 1996 to 2008, I was personally involved in organizing
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`and hosting these conferences. In that time period, at least one meeting or
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`conference took place every year, with some years having up to twelve. To the
`
`best of my recollection, I attended each and every one of the meetings that WilBio
`
`organized.
`
`- 1 -
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`Pfizer Ex. 1020
`Page 2 of 6
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`3.
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`One of the first annual meetings WilBio organized was titled “The
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`Waterside Monoclonal Conference” (“Conference”), and was held at the Omni
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`Waterside Hotel in Harborside – Norfolk, Virginia. The Conference lasted four
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`days from April 22-25, 1996. On three of those days (April 23-25), scientists in
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`the field presented their work related to process development and production issues
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`for monoclonal antibodies to the other scientists in attendance. In addition to the
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`conference presentations, exhibitors from commercial suppliers were present at the
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`Conference.
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`4.
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`The Conference was publicized in several ways. Mail and facsimile
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`announcements were sent to individuals whom I had identified as skilled persons
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`in the field of monoclonal antibodies and recombinant protein processing and
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`purification. To the best of my recollection, we also advertised the Conference in a
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`publication currently known as Genetic Engineering and Biotechnology News.
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`5.
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`At least two hundred individuals attended the Conference, which
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`included people skilled in the field of monoclonal antibodies, and recombinant
`
`protein processing and purification. My role at the Conference was Conference
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`Chairman. As Conference Chairman, I provided an introduction to the
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`Conference, introduced and attended each presentation, and had overall
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`responsibility for the Conference.
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`- 2 -
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`Pfizer Ex. 1020
`Page 3 of 6
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`6. When attendees signed in at the Conference, they were provided with
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`a binder that contained a cover page with general information about the
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`Conference, an agenda that included the schedule of the presentations and other
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`events, and printed slide presentations from the Conference. These printed slide
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`presentations were provided to WilBio by the speaker prior to the Conference. The
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`printed slide presentations were then copied, assembled into binders with the cover
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`page and agenda, and distributed at the meeting by my staff. In order to make it
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`easier for attendees to follow presentations with their copy of the slides, two or
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`three presentation slides were usually printed on each page.
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`7.
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`Once attendees received their binders, they were free to do with it as
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`they wished. We did not restrict use of materials distributed at the meeting.
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`However, if speakers wished to redact certain portions of their presentation from
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`their printed slide presentation, we allowed them to do so. It was WilBio’s view at
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`the time that the Conference presentations and printed slides were public, therefore
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`we allowed speakers to control what was distributed to the public in printed form.
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`8.
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`I have reviewed Exhibit 1005. The first page of Exhibit 1005 is the
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`cover page from the exhibit binder for the Conference. (Ex, 1005 at 1.) The cover
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`page includes the name, date, location, and topic of the Conference, which is
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`consistent with the best of my recollection. I also note that the cover page states
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`that this was the first annual Waterside Conference presented by the Williamsburg
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`- 3 -
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`Pfizer Ex. 1020
`Page 4 of 6
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`BioProcessing Foundation, which is also consistent with the best of my
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`recollection. I recognize and acknowledge that the fonts and images on the cover
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`page are consistent with what we used at the time.
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`9.
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`The second page of Exhibit 5 is a copy of the agenda that we
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`distributed with the Conference binder. (Ex, 1005 at 2.) The agenda shows the
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`presentations for the first and second day of the Conference. I recognize and
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`acknowledge that the fonts and formatting of this page would have been consistent
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`with what we used at the time.
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`10. Pages three through seven of Exhibit 1005 is a printed slide
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`presentation in a format that is consistent with the format that WilBio used when
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`distributing printed slides at Foundation conferences. (Ex, 1005 at 3-7.) To the
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`best of my recollection, the formatting of the slides as two to a page is consistent
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`with how the printed slide presentations were prepared and distributed at the
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`Conference. The slide presentation on page 3 of Exhibit 1005 is entitled
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`“Chromatographic Techniques for the Characterization of Human Monoclonal
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`Antibodies: rhuMAb HER2.” The speaker named on page three of Exhibit 1005 is
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`Reed Harris. The speaker and title on page three matches the speaker and title
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`listed on the Conference agenda on page 2 of Exhibit 1005. (Ex. 1005 at 2-3.) The
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`fact that the speaker and title of the printed slide presentation and the agenda match
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`- 4 -
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`Pfizer Ex. 1020
`Page 5 of 6
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`is consistent with the practice of WilBio to include printed slide presentations with
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`a matching agenda when preparing conference binders.
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`11.
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`Exhibit 1005 is a true and correct copy of what it purports to be on its
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`face: an excerpt from the exhibit binder that we distributed at the Conference in
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`1996. As Conference Chairman, I was personally involved in the organization and
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`the proceedings of the Conference, including the creation and distribution of
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`Conference exhibit binders, of which included Exhibit 1005.
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`12.
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`I declare that I am competent to make this declaration. The statements
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`in this declaration are made to the best of my knowledge and recollection, and I
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`have personal knowledge of the facts set forth in this Declaration.
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`I also 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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`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,
`5'H
`under 18 D.S.C. § 1001. Executed this _' _ day of December, 2017.
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`Keith L. Carson
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`B!'~~
`
`- j -
`
`Pfizer Ex. 1020
`Page 6 of 6
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