throbber
UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owner.
`______________________
`
`Case No. IPR2021-00816
`U.S. Patent No. 9,220,631
`______________________
`
`PETITIONER’S SECOND OBJECTIONS TO
`ADMISSIBILITY OF EVIDENCE SUBMITTED BY PATENT OWNER
`
`
`
`
`
`
`

`

`
`
`Pursuant to 37 C.F.R. § 42.64(b), Petitioner Regeneron Pharmaceuticals, Inc.,
`
`hereby objects as follows to the admissibility of evidence filed by Patent Owners
`
`Novartis Pharma AG, Novartis Technology LLC, Novartis Pharmaceuticals
`
`Corporation, in conjunction with the Patent Owner Response, filed on January 18,
`
`2022.
`
`Evidence
`Exhibits 2099-
`2126, 2128-2134,
`2136-2148, 2150,
`2152-2164, 2166-
`2172, 2174-2188
`
`Objections
`FRE 105: To the extent that any portion of these exhibits
`
`may be deemed admissible, such admissibility should be for
`
`a limited purpose.
`
`FRE 402: each of these exhibits is not relevant to any
`
`ground upon which trial was instituted.
`
`FRE 403: The probative value of each of these exhibits to
`
`any ground upon which trial was instituted is substantially
`
`outweighed by the danger of unfair prejudice, confusing the
`
`issues, undue delay, wasting time, or needlessly cumulative
`
`evidence.
`
`FRE 802: The entirety of these exhibits are inadmissible
`
`hearsay if offered to prove the truth of any matter allegedly
`
`asserted therein.
`
`
`
`1
`
`

`

`Evidence
`
`Objections
`FRE 901: Patent Owner has not produced evidence
`
`sufficient to support a finding that the exhibits are what
`
`Patent Owner claims they are.
`
`Exhibit 2189
`
`Petitioner refers to the objections made during the
`
`deposition of Horst Koller, which are incorporated herein by
`
`reference.
`
`Exhibits 2190-
`2193
`
`FRE 105: To the extent that any portion of these exhibits
`
`may be deemed admissible, such admissibility should be for
`
`a limited purpose.
`
`FRE 402: each of these exhibits is not relevant to any
`
`ground upon which trial was instituted.
`
`FRE 403: The probative value of each of these exhibits to
`
`any ground upon which trial was instituted is substantially
`
`outweighed by the danger of unfair prejudice, confusing the
`
`issues, undue delay, wasting time, or needlessly cumulative
`
`evidence.
`
`FRE 802: The entirety of these exhibits are inadmissible
`
`hearsay if offered to prove the truth of any matter allegedly
`
`asserted therein.
`
`2
`
`
`
`

`

`Evidence
`
`Objections
`FRE 901: Patent Owner has not produced evidence
`
`sufficient to support a finding that the exhibits are what
`
`Patent Owner claims they are.
`
`Exhibit 2194
`
`FRE 105: To the extent that any portion of this exhibit may
`
`be deemed admissible, such admissibility should be for a
`
`limited purpose.
`
`FRE 402: The exhibit is not relevant to any ground upon
`
`which trial was instituted.
`
`FRE 403: The exhibit’s probative value to any ground upon
`
`which trial was instituted is substantially outweighed by the
`
`danger of unfair prejudice, confusing the issues, undue
`
`delay, wasting time, or needlessly cumulative evidence.
`
`FRE 802: The entirety of the exhibit is inadmissible hearsay
`
`if offered to prove the truth of any matter allegedly asserted
`
`therein.
`
`Petitioner refers to the objections made during the
`
`deposition of Mr. Overcashier, which are incorporated
`
`herein by reference.
`
`
`
`3
`
`

`

`Evidence
`Exhibits 2195
`
`Objections
`FRE 105: To the extent that any portion of these exhibits
`
`may be deemed admissible, such admissibility should be for
`
`a limited purpose.
`
`FRE 402: each of these exhibits is not relevant to any
`
`ground upon which trial was instituted.
`
`FRE 403: The probative value of each of these exhibits to
`
`any ground upon which trial was instituted is substantially
`
`outweighed by the danger of unfair prejudice, confusing the
`
`issues, undue delay, wasting time, or needlessly cumulative
`
`evidence.
`
`FRE 802: The entirety of these exhibits are inadmissible
`
`hearsay if offered to prove the truth of any matter allegedly
`
`asserted therein.
`
`FRE 901: Patent Owner has not produced evidence
`
`sufficient to support a finding that the exhibits are what
`
`Patent Owner claims they are.
`
`Exhibits 2196
`
`FRE 105: To the extent that any portion of these exhibits
`
`may be deemed admissible, such admissibility should be for
`
`a limited purpose.
`
`4
`
`
`
`

`

`Evidence
`
`Objections
`FRE 402: each of these exhibits is not relevant to any
`
`ground upon which trial was instituted.
`
`FRE 802: The entirety of these exhibits are inadmissible
`
`hearsay if offered to prove the truth of any matter allegedly
`
`asserted therein.
`
`FRE 901: Patent Owner has not produced evidence
`
`sufficient to support a finding that the exhibits are what
`
`Patent Owner claims they are.
`
`Exhibits 2198
`
`FRE 105: To the extent that any portion of these exhibits
`
`may be deemed admissible, such admissibility should be for
`
`a limited purpose.
`
`FRE 402: Each of these exhibits is not relevant to any
`
`ground upon which trial was instituted.
`
`FRE 403: The probative value of each of these exhibits to
`
`any ground upon which trial was instituted is substantially
`
`outweighed by the danger of unfair prejudice, confusing the
`
`issues, undue delay, wasting time, or needlessly cumulative
`
`evidence.
`
`
`
`5
`
`

`

`Evidence
`
`Objections
`FRE 802: The entirety of these exhibits are inadmissible
`
`hearsay if offered to prove the truth of any matter allegedly
`
`asserted therein.
`
`
`
`Exhibits 2199
`
`FRE 105: To the extent that any portion of these exhibits
`
`may be deemed admissible, such admissibility should be for
`
`a limited purpose.
`
`FRE 402: Each of these exhibits is not relevant to any
`
`ground upon which trial was instituted.
`
`FRE 802: The entirety of these exhibits are inadmissible
`
`hearsay if offered to prove the truth of any matter allegedly
`
`asserted therein.
`
`FRE 901: Patent Owner has not produced evidence
`
`sufficient to support a finding that the exhibits are what
`
`Patent Owner claims they are.
`
`Exhibits 2200
`
`FRE 105: To the extent that any portion of these exhibits
`
`may be deemed admissible, such admissibility should be for
`
`a limited purpose.
`
`
`
`6
`
`

`

`Evidence
`
`Objections
`FRE 402: Each of these exhibits is not relevant to any
`
`ground upon which trial was instituted.
`
`FRE 403: The probative value of each of these exhibits to
`
`any ground upon which trial was instituted is substantially
`
`outweighed by the danger of unfair prejudice, confusing the
`
`issues, undue delay, wasting time, or needlessly cumulative
`
`evidence.
`
`FRE 802: The entirety of these exhibits are inadmissible
`
`hearsay if offered to prove the truth of any matter allegedly
`
`asserted therein.
`
`FRE 901: Patent Owner has not produced evidence
`
`sufficient to support a finding that the exhibits are what
`
`Patent Owner claims they are.
`
`Exhibit 2201
`
`FRE 105: To the extent that any portion of this exhibit
`
`may be deemed admissible, such admissibility should be
`
`for a limited purpose.
`
`FRE 602: As to at least paragraphs 4-8, and 19-288, the
`
`exhibit includes assertions for which evidence has not been
`
`
`
`7
`
`

`

`Evidence
`
`Objections
`introduced sufficient to show that the witness has personal
`
`knowledge of the matter asserted.
`
`FRE 701/702 and/or 37 C.F.R. § 42.65: As to at least
`
`paragraphs 9-18, 30-37, 47-128, 138-140, and 145-288, the
`
`declarant is not qualified to opine on what a person of
`
`ordinary skill in the art would understand, to opine on patent
`
`claim limitations, to perform claim construction, and/or to
`
`perform legal analysis of invalidity. The opinion testimony
`
`offered in this exhibit is not based on scientific, technical, or
`
`other specialized knowledge, and is also not based on
`
`personal knowledge. The opinion testimony includes
`
`unsubstantiated leaps and advances inaccurate, unqualified
`
`and unsupported generalizations. The opinion testimony
`
`fails to properly disclose the underlying facts or data on
`
`which the opinion is based. The opinion testimony includes
`
`testimony on United States patent law and/or patent
`
`examination practice.
`
`FRE 705 and /or 37 C.F.R. § 42.65: As to at least
`
`paragraphs 4-8 and 19-288, the exhibit includes expert
`
`
`
`8
`
`

`

`Evidence
`
`Objections
`testimony that does not disclose the underlying facts or data.
`
`FRE 802: The entirety of the exhibit is inadmissible hearsay
`
`if offered to prove the truth of any matter allegedly asserted
`
`therein.
`
`Exhibit 2202
`
`FRE 105: To the extent that any portion of this exhibit
`
`may be deemed admissible, such admissibility should be
`
`for a limited purpose.
`
`FRE 602: As to at least paragraphs 9-12, 21, and 35-74, the
`
`exhibit includes assertions for which evidence has not been
`
`introduced sufficient to show that the witness has personal
`
`knowledge of the matter asserted.
`
`FRE 701/702 and/or 37 C.F.R. § 42.65: As to at least
`
`paragraphs 15-16, 19, 23-25, 30, 44-59, and 69-74, the
`
`declarant is not qualified to opine on what a person of
`
`ordinary skill in the art would understand, to opine on patent
`
`claim limitations, to perform claim construction, and/or to
`
`perform legal analysis of invalidity. The opinion testimony
`
`offered in this exhibit is not based on scientific, technical, or
`
`other specialized knowledge, and is also not based on
`
`
`
`9
`
`

`

`Evidence
`
`Objections
`personal knowledge. The opinion testimony includes
`
`unsubstantiated leaps and advances inaccurate, unqualified
`
`and unsupported generalizations. The opinion testimony
`
`fails to properly disclose the underlying facts or data on
`
`which the opinion is based. The opinion testimony includes
`
`testimony on United States patent law and/or patent
`
`examination practice.
`
`FRE 705 and /or 37 C.F.R. § 42.65: As to at least
`
`paragraphs 9-12, 21, and 35-74, the exhibit includes expert
`
`testimony that does not disclose the underlying facts or data.
`
`FRE 802: The entirety of the exhibit is inadmissible hearsay
`
`if offered to prove the truth of any matter allegedly asserted
`
`therein.
`
`Exhibit 2203
`
`FRE 105: To the extent that any portion of this exhibit
`
`may be deemed admissible, such admissibility should be
`
`for a limited purpose.
`
`FRE 602: As to at least paragraphs 18-25, 30-53, and 59-
`
`103, the exhibit includes assertions for which evidence has
`
`
`
`10
`
`

`

`Evidence
`
`Objections
`not been introduced sufficient to show that the witness has
`
`personal knowledge of the matter asserted.
`
`FRE 701/702 and/or 37 C.F.R. § 42.65: As to at least
`
`paragraphs 26-29, 50-58, 83-88, and 91-103, the declarant is
`
`not qualified to opine on what a person of ordinary skill in
`
`the art would understand, to opine on patent claim
`
`limitations, to perform claim construction, and/or to perform
`
`legal analysis of invalidity. The opinion testimony offered
`
`in this exhibit is not based on scientific, technical, or other
`
`specialized knowledge, and is also not based on personal
`
`knowledge. The opinion testimony includes unsubstantiated
`
`leaps and advances inaccurate, unqualified and unsupported
`
`generalizations. The opinion testimony fails to properly
`
`disclose the underlying facts or data on which the opinion is
`
`based. The opinion testimony includes testimony on United
`
`States patent law and/or patent examination practice.
`
`FRE 705 and /or 37 C.F.R. § 42.65: As to at least
`
`paragraphs 18-25, 30-53, and 59-103, the exhibit includes
`
`expert testimony that does not disclose the underlying facts
`
`
`
`11
`
`

`

`Evidence
`
`or data.
`
`Objections
`
`FRE 802: The entirety of the exhibit is inadmissible hearsay
`
`if offered to prove the truth of any matter allegedly asserted
`
`therein.
`
`Exhibit 2204
`
`FRE 105: To the extent that any portion of this exhibit
`
`may be deemed admissible, such admissibility should be
`
`for a limited purpose.
`
`FRE 602: As to at least paragraphs 28-36, 43-52, 54-55, 57-
`
`58, 61-112, 117-118, 121-125, and 128-137, the exhibit
`
`includes assertions for which evidence has not been
`
`introduced sufficient to show that the witness has personal
`
`knowledge of the matter asserted.
`
`FRE 701/702 and/or 37 C.F.R. § 42.65: As to at least
`
`paragraphs 14-31, 37-42, 67-112, and 128-137, the
`
`declarant is not qualified to opine on what a person of
`
`ordinary skill in the art would understand, to opine on patent
`
`claim limitations, to perform claim construction, and/or to
`
`perform legal analysis of invalidity. The opinion testimony
`
`offered in this exhibit is not based on scientific, technical, or
`
`
`
`12
`
`

`

`Evidence
`
`Objections
`other specialized knowledge, and is also not based on
`
`personal knowledge. The opinion testimony includes
`
`unsubstantiated leaps and advances inaccurate, unqualified
`
`and unsupported generalizations. The opinion testimony
`
`fails to properly disclose the underlying facts or data on
`
`which the opinion is based. The opinion testimony includes
`
`testimony on United States patent law and/or patent
`
`examination practice.
`
`FRE 705 and /or 37 C.F.R. § 42.65: As to at least
`
`paragraphs 28-36, 43-52, 54-55, 57-58, 61-112, 117-118,
`
`121-125, and 128-137, the exhibit includes expert
`
`testimony that does not disclose the underlying facts or data.
`
`FRE 802: The entirety of the exhibit is inadmissible hearsay
`
`if offered to prove the truth of any matter allegedly asserted
`
`therein.
`
`Exhibit 2205
`
`FRE 105: To the extent that any portion of this exhibit may
`
`be deemed admissible, such admissibility should be for a
`
`limited purpose.
`
`
`
`13
`
`

`

`Evidence
`
`Objections
`FRE 602: As to at least paragraphs 15-25, 27, 37-44, 46-49,
`
`50-52, the exhibit includes assertions for which evidence
`
`has not been introduced sufficient to show that the witness
`
`has personal knowledge of the matter asserted.
`
`FRE 701/702 and/or 37 C.F.R. § 42.65: As to at least
`
`paragraphs 11-13, 36, 39-44, 48, 50-52, the declarant is not
`
`qualified to opine on what a person of ordinary skill in the
`
`art would understand, to opine on patent claim limitations,
`
`to perform claim construction, and/or to perform legal
`
`analysis of invalidity. The opinion testimony offered in this
`
`exhibit is not based on scientific, technical, or other
`
`specialized knowledge, and is also not based on personal
`
`knowledge. The opinion testimony includes unsubstantiated
`
`leaps and advances inaccurate, unqualified and unsupported
`
`generalizations. The opinion testimony fails to properly
`
`disclose the underlying facts or data on which the opinion is
`
`based. The opinion testimony includes testimony on United
`
`States patent law and/or patent examination practice.
`
`
`
`14
`
`

`

`Evidence
`
`Objections
`FRE 705 and /or 37 C.F.R. § 42.65: As to at least
`
`paragraphs 11-13, 15-25, 27, 36-44, 46-49, 50-52, the
`
`exhibit includes expert testimony that does not disclose the
`
`underlying facts or data.
`
`FRE 802: The entirety of the exhibit is inadmissible
`
`hearsay if offered to prove the truth of any matter allegedly
`
`asserted therein.
`
`Exhibit 2206
`
`FRE 105: To the extent that any portion of this exhibit may
`
`be deemed admissible, such admissibility should be for a
`
`limited purpose.
`
`FRE 602: As to at least paragraphs 6-52, the exhibit
`
`includes assertions for which evidence has not been
`
`introduced sufficient to show that the witness has personal
`
`knowledge of the matter asserted.
`
`FRE 701/702 and/or 37 C.F.R. § 42.65: As to at least
`
`paragraphs 16, 27, 29, 40, the declarant is not qualified to
`
`opine on what a person of ordinary skill in the art would
`
`understand, to opine on patent claim limitations, to perform
`
`claim construction, and/or to perform legal analysis of
`
`
`
`15
`
`

`

`Evidence
`
`Objections
`invalidity. The opinion testimony offered in this exhibit is
`
`not based on scientific, technical, or other specialized
`
`knowledge, and is also not based on personal knowledge.
`
`The opinion testimony includes unsubstantiated leaps and
`
`advances inaccurate, unqualified and unsupported
`
`generalizations. The opinion testimony fails to properly
`
`disclose the underlying facts or data on which the opinion is
`
`based. The opinion testimony includes testimony on United
`
`States patent law and/or patent examination practice.
`
`FRE 802: The entirety of the exhibit is inadmissible hearsay
`
`if offered to prove the truth of any matter allegedly asserted
`
`therein, including paragraphs 24-25, 27, 28-29, 52-53. By
`
`way of non-limiting example, Dr. Sigg’s assertions
`
`concerning what “Vetter told us” and what particular
`
`employees of Vetter purportedly stated are inadmissible
`
`hearsay.
`
`Exhibit 2208
`
`FRE 105: To the extent that any portion of this exhibit may
`
`be deemed admissible, such admissibility should be for a
`
`limited purpose.
`
`16
`
`
`
`

`

`Evidence
`
`Objections
`FRE 602: As to at least paragraphs 24-28, 33, 36-44, 46-59,
`
`61-68, 70-73, 74-121, the exhibit includes assertions for
`
`which evidence has not been introduced sufficient to show
`
`that the witness has personal knowledge of the matter
`
`asserted.
`
`FRE 701/702 and/or 37 C.F.R. § 42.65: As to at least
`
`paragraphs 10, 24-28, 33, 36-44, 46-59, 61-68, 70-73, 74-
`
`121, the declarant is not qualified to opine on what a person
`
`of ordinary skill in the art would understand, to opine on
`
`patent claim limitations, to perform claim construction,
`
`and/or to perform legal analysis of invalidity. The opinion
`
`testimony offered in this exhibit is not based on scientific,
`
`technical, or other specialized knowledge, and is also not
`
`based on personal knowledge. The opinion testimony
`
`includes unsubstantiated leaps and advances inaccurate,
`
`unqualified and unsupported generalizations. The opinion
`
`testimony fails to properly disclose the underlying facts or
`
`data on which the opinion is based. The opinion testimony
`
`
`
`17
`
`

`

`Evidence
`
`Objections
`includes testimony on United States patent law and/or patent
`
`examination practice.
`
`FRE 705 and /or 37 C.F.R. § 42.65: As to at least
`
`paragraphs 10, 24-28, 33, 36-44, 33, 36-44, 46-59, 61-68,
`
`70-73, 74-121, the exhibit includes expert testimony that
`
`does not disclose the underlying facts or data.
`
`FRE 802: The entirety of the exhibit is inadmissible
`
`hearsay if offered to prove the truth of any matter allegedly
`
`asserted therein.
`
`Exhibit 2209
`
`FRE 105: To the extent that any portion of this exhibit may
`
`be deemed admissible, such admissibility should be for a
`
`limited purpose.
`
`FRE 602: As to at least paragraphs 28-38, the exhibit
`
`includes assertions for which evidence has not been
`
`introduced sufficient to show that the witness has personal
`
`knowledge of the matter asserted.
`
`FRE 701/702 and/or 37 C.F.R. § 42.65: As to at least
`
`paragraphs 29, 30, 35-38, the declarant is not qualified to
`
`opine on what a person of ordinary skill in the art would
`
`
`
`18
`
`

`

`Evidence
`
`Objections
`understand, to opine on patent claim limitations, to perform
`
`claim construction, and/or to perform legal analysis of
`
`invalidity. The opinion testimony offered in this exhibit is
`
`not based on scientific, technical, or other specialized
`
`knowledge, and is also not based on personal knowledge.
`
`The opinion testimony includes unsubstantiated leaps and
`
`advances inaccurate, unqualified and unsupported
`
`generalizations. The opinion testimony fails to properly
`
`disclose the underlying facts or data on which the opinion is
`
`based. The opinion testimony includes testimony on United
`
`States patent law and/or patent examination practice.
`
`FRE 705 and /or 37 C.F.R. § 42.65: As to at least
`
`paragraphs 28-38, the exhibit includes expert testimony that
`
`does not disclose the underlying facts or data.
`
`FRE 802: The entirety of the exhibit is inadmissible
`
`hearsay if offered to prove the truth of any matter allegedly
`
`asserted therein.
`
`Exhibits 2210-
`2211
`
`FRE 402: The exhibits are not relevant to any ground upon
`
`which trial was instituted.
`
`
`
`19
`
`

`

`Evidence
`
`Objections
`FRE 403: The probative value of each of these exhibits to
`
`any ground upon which trial was instituted is substantially
`
`outweighed by the danger of unfair prejudice, confusing the
`
`issues, undue delay, wasting time, or needlessly cumulative
`
`evidence.
`
`Exhibits 2212
`
`FRE 402: The exhibits are not relevant to any ground upon
`
`Exhibits 2213-
`2215, 2218, 2222,
`2224, 2228-2230,
`2232, 2253-2255
`
`which trial was instituted.
`
`FRE 105: To the extent that any portion of these exhibits
`
`may be deemed admissible, such admissibility should be for
`
`a limited purpose.
`
`FRE 402: each of these exhibits is not relevant to any
`
`ground upon which trial was instituted.
`
`FRE 403: The probative value of each of these exhibits to
`
`any ground upon which trial was instituted is substantially
`
`outweighed by the danger of unfair prejudice, confusing the
`
`issues, undue delay, wasting time, or needlessly cumulative
`
`evidence.
`
`
`
`20
`
`

`

`Evidence
`
`Objections
`FRE 802: The entirety of these exhibits are inadmissible
`
`hearsay if offered to prove the truth of any matter allegedly
`
`asserted therein.
`
`FRE 901: Patent Owner has not produced evidence
`
`sufficient to support a finding that the exhibits are what
`
`Patent Owner claims they are.
`
`Exhibit 2256
`
`FRE 402: The exhibit is not relevant to any ground upon
`
`which trial was instituted.
`
`FRE 403: The exhibit’s probative value to any ground upon
`
`which trial was instituted is substantially outweighed by the
`
`danger of unfair prejudice, confusing the issues, undue
`
`delay, wasting time, or needlessly cumulative evidence.
`
`Exhibit 2257
`
`Petitioner refers to the objections made during the
`
`deposition of Dr. Kiss, which are incorporated herein by
`
`reference.
`
`Exhibits 2258-
`2262, 2264-2266,
`2269
`
`FRE 105: To the extent that any portion of these exhibits
`
`may be deemed admissible, such admissibility should be for
`
`a limited purpose.
`
`
`
`21
`
`

`

`Evidence
`
`Objections
`FRE 402: each of these exhibits is not relevant to any
`
`ground upon which trial was instituted.
`
`FRE 403: The probative value of each of these exhibits to
`
`any ground upon which trial was instituted is substantially
`
`outweighed by the danger of unfair prejudice, confusing the
`
`issues, undue delay, wasting time, or needlessly cumulative
`
`evidence.
`
`FRE 802: The entirety of these exhibits are inadmissible
`
`hearsay if offered to prove the truth of any matter allegedly
`
`asserted therein.
`
`FRE 901: Patent Owner has not produced evidence
`
`sufficient to support a finding that the exhibits are what
`
`Patent Owner claims they are.
`
`Exhibit 2270
`
`FRE 402: The exhibit is not relevant to any ground upon
`
`which trial was instituted.
`
`
`
`Exhibit 2271
`
`FRE 105: To the extent that any portion of these exhibits
`
`may be deemed admissible, such admissibility should be for
`
`a limited purpose.
`
`22
`
`
`
`

`

`Evidence
`
`Objections
`FRE 402: The exhibit is not relevant to any ground upon
`
`which trial was instituted.
`
`FRE 403: The exhibit’s probative value to any ground upon
`
`which trial was instituted is substantially outweighed by the
`
`danger of unfair prejudice, confusing the issues, undue
`
`delay, wasting time, or needlessly cumulative evidence.
`
`FRE 802: The entirety of the exhibit is inadmissible hearsay
`
`if offered to prove the truth of any matter allegedly asserted
`
`therein.
`
`FRE 901: Patent Owner has not produced evidence
`
`sufficient to support a finding that the exhibits are what
`
`Patent Owner claims they are.
`
`Exhibit 2272
`
`FRE 105: To the extent that any portion of these exhibits
`
`may be deemed admissible, such admissibility should be for
`
`a limited purpose.
`
`FRE 402: The exhibit is not relevant to any ground upon
`
`which trial was instituted.
`
`FRE 403: The exhibit’s probative value to any ground upon
`
`which trial was instituted is substantially outweighed by the
`
`
`
`23
`
`

`

`Evidence
`
`Objections
`danger of unfair prejudice, confusing the issues, undue
`
`delay, wasting time, or needlessly cumulative evidence.
`
`FRE 802: The entirety of the exhibit is inadmissible hearsay
`
`if offered to prove the truth of any matter allegedly asserted
`
`therein.
`
`Exhibits 2273-
`2281
`
`FRE 105: To the extent that any portion of these exhibits
`
`may be deemed admissible, such admissibility should be for
`
`a limited purpose.
`
`FRE 402: each of these exhibits is not relevant to any
`
`ground upon which trial was instituted.
`
`FRE 403: The probative value of each of these exhibits to
`
`any ground upon which trial was instituted is substantially
`
`outweighed by the danger of unfair prejudice, confusing the
`
`issues, undue delay, wasting time, or needlessly cumulative
`
`evidence.
`
`FRE 802: The entirety of these exhibits are inadmissible
`
`hearsay if offered to prove the truth of any matter allegedly
`
`asserted therein.
`
`
`
`24
`
`

`

`Evidence
`
`Objections
`FRE 901: Patent Owner has not produced evidence
`
`sufficient to support a finding that the exhibits are what
`
`Patent Owner claims they are.
`
`Exhibit 2282
`
`FRE 403: The exhibit’s probative value to any ground upon
`
`which trial was instituted is substantially outweighed by the
`
`danger of unfair prejudice, confusing the issues, undue
`
`delay, wasting time, or needlessly cumulative evidence.
`
`FRE 802: The entirety of the exhibit is inadmissible hearsay
`
`if offered to prove the truth of any matter allegedly asserted
`
`therein.
`
`FRE 901: Patent Owner has not produced evidence
`
`sufficient to support a finding that the exhibit is what
`
`Petitioner claims it is.
`
`Exhibits 2283-
`2285, 2287-2289,
`2291-2322
`
`FRE 105: To the extent that any portion of these exhibits
`
`may be deemed admissible, such admissibility should be for
`
`a limited purpose.
`
`FRE 402: each of these exhibits is not relevant to any
`
`ground upon which trial was instituted.
`
`
`
`25
`
`

`

`Evidence
`
`Objections
`FRE 403: The probative value of each of these exhibits to
`
`any ground upon which trial was instituted is substantially
`
`outweighed by the danger of unfair prejudice, confusing the
`
`issues, undue delay, wasting time, or needlessly cumulative
`
`evidence.
`
`FRE 802: The entirety of these exhibits are inadmissible
`
`hearsay if offered to prove the truth of any matter allegedly
`
`asserted therein.
`
`FRE 901: Patent Owner has not produced evidence
`
`sufficient to support a finding that the exhibits are what
`
`Patent Owner claims they are.
`
`Exhibits 2286
`
`FRE 105: To the extent that any portion of these exhibits
`
`may be deemed admissible, such admissibility should be for
`
`a limited purpose.
`
`FRE 402: each of these exhibits is not relevant to any
`
`ground upon which trial was instituted.
`
`FRE 802: The entirety of these exhibits are inadmissible
`
`hearsay if offered to prove the truth of any matter allegedly
`
`asserted therein.
`
`26
`
`
`
`

`

`Evidence
`
`Objections
`FRE 901: Patent Owner has not produced evidence
`
`sufficient to support a finding that the exhibits are what
`
`Patent Owner claims they are.
`
`Exhibit 2325
`
`FRE 402: The exhibit is not relevant to any ground upon
`
`which trial was instituted.
`
`FRE 403: The exhibit’s probative value to any ground upon
`
`which trial was instituted is substantially outweighed by the
`
`danger of unfair prejudice, confusing the issues, undue
`
`delay, wasting time, or needlessly cumulative evidence.
`
`FRE 802: The entirety of the exhibit is inadmissible hearsay
`
`if offered to prove the truth of any matter allegedly asserted
`
`therein.
`
`Exhibit 2326
`
`FRE 402: The exhibit is not relevant to any ground upon
`
`which trial was instituted.
`
`FRE 802: The entirety of the exhibit is inadmissible hearsay
`
`if offered to prove the truth of any matter allegedly asserted
`
`therein.
`
`
`
`
`
`
`
`27
`
`

`

`Date: January 26, 2022
`
`
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`Respectfully submitted,
`/s/ Elizabeth Stotland Weiswasser
`Elizabeth S. Weiswasser
`Reg. No. 55,721
`Lead Counsel for Petitioner
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`T: 212-310-8000
`elizabeth.weiswasser@weil.com
`
`
`
`28
`
`

`

`CERTIFICATE OF SERVICE
`
`I hereby certify that on January 26, 2022, copies of the foregoing
`
`PETITIONER’S SECOND OBJECTIONS TO ADMISSIBILITY OF
`EVIDENCE SUBMITTED BY PATENT OWNER was served via electronic
`mail upon the following:
`
`Elizabeth J. Holland
`Linnea Cipriano
`Goodwin Procter LLP
`620 Eighth Avenue
`New York, NY 10018
`EHolland@goodwinlaw.com
`LCipriano@goodwinlaw.com
`
`William G. James
`Goodwin Procter LLP
`1900 N Street, N.W.
`Washington, D.C. 20036
`WJames@goodwinlaw.com
`
`Joshua Weinger
`Nicholas K. Mitrokostas
`Goodwin Procter LLP
`100 Northern Avenue
`Boston, MA 02210
`JWeinger@goodwinlaw.com
`Nmitrokostas@goodwinlaw.com
`
`DG-NovartisPFS@goodwinlaw.com
`
`
`/Lauren McDuffie/
`Lauren McDuffie
`Senior IP Paralegal
`Weil, Gotshal & Manges LLP
`2001 M Street N.W., Suite 600
`Washington, D.C. 20036
`202-682-7000
`lauren.mcduffie@weil.com
`
`
`
`
`
`
`
`

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