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`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 OPPOSITION TO
`PATENT OWNER’S MOTION TO EXCLUDE
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`TABLE OF CONTENTS
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`I.
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`II.
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`PATENT OWNER’S MOTION TO EXCLUDE IS PROCEDURALLY
`IMPROPER ..................................................................................................... 2
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`THE BOARD SHOULD NOT EXCLUDE PARAGRAPHS 28-29 OF
`KOLLER’S REPLY DECLARATION ........................................................... 2
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`A.
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`B.
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`Patent Owner Failed to Satisfy the Procedural Requirements to Seek
`Exclusion of Mr. Koller’s Testimony ................................................... 2
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`Paragraphs 28-29 of Mr. Koller’s Reply Declaration Properly
`Respond to Arguments Raised in Patent Owner’s Response ................ 3
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`III. DR. COHEN’S DECLARATION IS PROPER REPLY EVIDENCE TO
`PATENT OWNER’S RESPONSE .................................................................. 6
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`IV. THERE IS NO PREJUDICE TO PATENT OWNER .................................. 10
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`V.
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`CONCLUSION .............................................................................................. 12
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`i
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`Patent Owner requests that the Board strike portions of the reply declaration
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`of Mr. Horst Koller (Ex. 1105 at ¶¶ 28-29) and the entirety of the declaration of Dr.
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`Joel Cohen (Ex. 1108) for allegedly being “outside the scope of proper reply.”
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`Paper 101 at 4. Contrary to Patent Owner’s assertion, however, neither the Koller
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`nor Cohen testimony at issue were necessary for Regeneron’s prima facie case of
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`obviousness set forth in the Petition. Instead, the testimony at issue responds
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`directly to argument in the Patent Owner Response (“POR”) that a POSITA would
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`have been deterred from using a Parylene C coating in a PFS for intravitreal
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`injection. Dr. Cohen’s testimony is also proper responsive testimony for the
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`further reason that Patent Owner asserted a different level of ordinary skill in the
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`art – that includes consulting with someone having “specialized skills” in
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`toxicology – in its POR, which Regeneron could not have addressed with Dr.
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`Cohen’s testimony in its earlier filed Petition. Patent Owner has failed to set forth
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`a justification for the extraordinary relief it seeks from the Board because
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`Regeneron was entitled to submit the testimony at issue to reply to the POR
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`arguments. Anacor Pharm., Inc. v. Iancu, 889 F.3d 1372, 1380–81 (Fed. Cir.
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`2018) (“[T]he petitioner in an inter partes review proceeding may introduce new
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`evidence after the petition stage if the evidence is a legitimate reply to evidence
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`introduced by the patent owner.”); see also PTAB’s Consolidated Trial Practice
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`Guide (November 2019) at 80 (explaining that the exclusion of evidence “is an
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`1
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`exceptional remedy that the Board expects will be granted rarely.”).
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`I.
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`PATENT OWNER’S MOTION TO EXCLUDE IS PROCEDURALLY
`IMPROPER
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`The proper procedure for addressing whether a reply raises new issues is to
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`request authorization to file a motion to strike, not filing a motion to exclude.
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`Puzhen Life USA, LLC, v. Esip Series 2, LLC, IPR2017-02197, Paper 24 at 48
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`(PTAB February 27, 2019) (denying patent owner’s motion to exclude and noting
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`that the proper procedure would have been to request authorization to file a motion
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`to strike). Although Patent Owner emailed the Board on May 16, 2022 requesting
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`authorization to submit a sur-reply declaration to respond to Mr. Koller and Dr.
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`Cohen, Patent Owner did not seek authorization from the Board to strike any of
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`Mr. Koller’s or Dr. Cohen’s testimony. Because Patent Owner never requested
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`authorization to file a motion to strike, its belated attempt to do so now should be
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`denied. See id. at 49 (declining to treat a motion to exclude as a motion to strike
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`because patent owner did not request authorization).
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`II. THE BOARD SHOULD NOT EXCLUDE PARAGRAPHS 28-29 OF
`KOLLER’S REPLY DECLARATION
`
`A.
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`Patent Owner Failed to Satisfy the Procedural Requirements to
`Seek Exclusion of Mr. Koller’s Testimony
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`Patent Owner’s assertion that it satisfied the procedural requirements with
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`respect to Mr. Koller’s testimony is incorrect. Pursuant to 37 C.F.R. § 42.64(c),
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`Patent Owner was required to specifically identify the grounds for objecting to Mr.
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`2
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`Koller’s testimony in its objections to evidence served on April 22, 2022. See 37
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`CFR § 42.64(c) (“[A]ny objection must be filed within five business days of
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`service of evidence to which the objection is directed. The objection must identify
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`the grounds for the objection with sufficient particularity.”) (emphasis added).
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`Although Patent Owner objected to Dr. Cohen’s declaration as including
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`“Improper New Evidence,” Paper 76 at 26, Patent Owner made no such objection
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`with respect to paragraphs 28-29 of the Reply Declaration of Mr. Horst Koller (Ex.
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`1105). See Paper 76 at 20-22. As such, Patent Owner is foreclosed from moving
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`to exclude any portion of Mr. Koller’s reply declaration on the basis of including
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`improper reply evidence because it failed to make a timely objection as required by
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`37 C.F.R. § 42.64(c).
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`B.
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`Paragraphs 28-29 of Mr. Koller’s Reply Declaration Properly
`Respond to Arguments Raised in Patent Owner’s Response
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`Even if the Board considers Patent Owner’s belated request, however,
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`paragraphs 28-29 of Mr. Koller’s reply declaration should not be excluded because
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`those paragraphs reply to evidence introduced by Patent Owner. Patent Owner is
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`also incorrect in asserting that Mr. Koller’s testimony in paragraphs 28-29 is
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`necessary for Petitioner’s case-in-chief. Paper 101 at 6.
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`The Petition set forth all the requisite argument and evidence to demonstrate
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`a prima facie case that the claims of U.S. Patent No. 9,220,631 (“the ’631 Patent”)
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`are obvious. This included demonstrating where in the prior art each claim
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`3
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`
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`limitation is disclosed (see Petition at 40-54), and explaining in detail why a
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`POSITA would have been motivated to combine the prior art with a reasonable
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`expectation of success. See Petition at 31-40.
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`For the Parylene C coated stopper disclosed in Boulange (Stopper B1), for
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`example, the Petition explained that a POSITA would have been motivated to use
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`it because it had “break loose and slide forces less than 5 N” and that “Parylene C
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`would have been suitable for use in a pre-filled syringe comprising a VEGF-
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`antagonist.” Petition at 37 (citing Ex. 1003 ¶¶ 171-177). As Mr. Koller explained
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`in his declaration in support of the Petition, Boulange “encourages the use of
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`Parylene C with the understanding that the coating must not negatively impact the
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`drug product” and that “it would have been clear to a POSITA that the syringe and
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`stopper design disclosed in Boulange would be suitable for a sensitive drug
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`product contained in a pre-filled syringe …” Ex. 1003, ¶¶ 173, 174. Thus, the
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`Petition unquestionably set forth a prima facie case of obviousness with respect to
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`using the Parylene C coated stopper in Boulange, including by addressing in detail
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`both motivation to combine and reasonable expectation of success.
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`In the POR, Patent Owner introduced the testimony of Mr. Leinsing and Dr.
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`Dillberger, and asserted that a POSITA would have been deterred from using
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`Parylene C because of potential negative interactions with the VEGF-antagonist.
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`Paper 35 at 10-13; Ex. 2202 ¶¶ 44-46, 54-55, 58-59, 65–74; Ex. 2201 ¶¶ 30–37,
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`4
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`154. As the party alleging that incompatibility between Parylene C and a VEGF-
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`antagonist would have negated any motivation to combine, it was incumbent on
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`Patent Owner to explain why the Parylene C coating and drug product would
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`necessarily interact with each other in the pre-filled syringe. Patent Owner,
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`however, failed to do so.
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`Accordingly, Mr. Koller in his reply declaration identified a flaw in Patent
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`Owner’s argument. In particular, Mr. Koller explained that Boulange describes
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`that the Parylene C coating can only be applied to the sides of the stopper, such
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`that the Parylene C coating and VEGF-antagonist drug product would not come
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`into contact with each other, thus obviating any alleged potential negative
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`interactions with the VEGF-antagonist. Ex. 1105, ¶¶ 28-29. Mr. Koller therefore
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`directly responded to Mr. Leinsing’s and Dr. Dillberger’s assertions that Parylene
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`C would have negated any motivation to combine Sigg or Lam and Boulange,
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`which is proper in a reply declaration. See Belden Inc. v. Berk-Tek LLC, 805 F.3d
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`1064, (Fed. Cir. 2015) (affirming Board’s decision not to strike reply declaration
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`that “fairly responds only to arguments made in Mr. Clark’s declaration and
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`Belden’s response.”).
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`The disclosure of the 631 Patent also confirms that Patent Owner’s assertion
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`that Mr. Koller’s reply testimony was needed for Regeneron’s prima facie
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`obviousness case is incorrect. The claims of the 631 Patent do not include any
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`5
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`limitations concerning stopper coatings. Nor does the specification of the 631
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`Patent describe stopper coatings or the location in which they can be applied to the
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`syringe. The location of the stopper coating in Boulange only became germane to
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`this IPR after Patent Owner argued in the POR that a POSITA would have been
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`deterred from using Parylene C because it could interact negatively with the drug
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`product. Thus, it was proper for Mr. Koller to address that issue in Reply in
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`response to the POR.1 Aisin Seiki Co., Ltd. et al v. Intellectual Ventures II LLC,
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`IPR2017-01539, Paper 43 at 69–70 (PTAB December 12, 2018) (denying Patent
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`Owner’s motion to strike as the evidence provided by Petitioner responded to
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`Patent Owner’s arguments, “as it was entitled to do”).
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`III. DR. COHEN’S DECLARATION IS PROPER REPLY EVIDENCE TO
`PATENT OWNER’S RESPONSE
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`Patent Owner contends that “Petitioner could have employed Dr. Cohen, or
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`some other toxicologist, to support its original petition.” Paper 101 at 8.
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`Testimony from a toxicologist such as Dr. Cohen, however, only became pertinent
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`to this proceeding after Patent Owner proposed a different level of ordinary skill in
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`the art in the POR that explicitly required a POSITA to consult with someone with
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`“specialized skills” in toxicology. Paper 35 at 6-7. For this reason alone,
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`1 As noted above, Mr. Koller addressed in detail the suitability of the Parylene C
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`stopper coating in his opening declaration. See Ex. 1003 at ¶¶ 171-177.
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`6
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`Regeneron was entitled to reply with Dr. Cohen’s declaration to address the POR
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`arguments that were based on a different level of ordinary skill than what
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`Regeneron had proposed in the Petition. See Paper 35 at 10 (Patent Owner arguing
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`that Mr. Koller could not offer opinions under its definition of a POSA because he
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`is not a toxicologist).
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`Indeed, it was not foreseeable that Patent Owner would propose a level of
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`ordinary skill that would require consultation with someone having “specialized
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`skills” in toxicology at the time Regeneron filed the Petition. The parties
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`extensively litigated the obviousness of the 631 Patent in an ITC Investigation
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`prior to the filing of this IPR. In the ITC proceeding, however, Patent Owner
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`never relied on expert testimony from a toxicologist and Patent Owner’s definition
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`of a POSITA in the ITC did not include any toxicology requirement:
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`Patent Owner ITC Definition
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`Patent Owner IPR Definition
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`An advanced degree (i.e., an M.S., a
`Ph.D., or equivalent), with research
`experience in mechanical engineering,
`biomedical engineering, mate1ials
`science, chemistry, chemical
`engineering, or a related field, and at
`least 2-3 years of professional
`experience in one or more of those
`fields. A POSA would also have had
`experience with the design of PFSs
`and/or the development of
`ophthalmologic drug products or drug
`delivery devices. Such a person would
`have been a member of a product
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`An advanced degree (i.e., an M.S., a
`Ph.D., or equivalent) in mechanical
`engineering, biomedical engineering,
`materials science, chemistry, chemical
`engineering, or a related field, and at
`least 2–3 years of professional
`experience, including in the design of a
`PFS and/or the development of
`ophthalmologic drug products or drug
`delivery devices. Such a person would
`have been a member of a product
`development team and would have
`drawn upon not only his or her own
`skills, but also the specialized skills of
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`
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`7
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`team members in complimentary fields
`including ophthalmology,
`microbiology and toxicology. Paper
`35 at 6-7.
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`development team and would have
`drawn upon not only his or her own
`skills, but also the specialized skills of
`team members with expertise in the
`development of ophthalmologic drug
`products and medical devices, the
`design of pre-filled syringes,
`sterilization of drug delivery devices
`including those containing sterilization-
`sensitive therapeutics, microbiology,
`administration of intravitreal injections,
`and/or treatment of ophthalmologic
`disorders. Ex. 1253.018-.019.
`
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`It was therefore permissible for Regeneron to include Dr. Cohen’s declaration in
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`Reply because Regeneron could not have predicted that Patent Owner would
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`change its definition of a POSITA to require consultation with a toxicologist. See
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`Micron Technology, Inc. v. Lone Star Silicon Innovations, LLC, IPR2017-01563,
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`Paper 29 at 32-33 (PTAB December 17, 2018) (“[It] would be difficult if not
`
`impossible for a petitioner to anticipate every argument it could have made in a
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`petition.”). It would also be nonsensical if a Patent Owner could offer a different
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`definition of a POSITA in its POR, and then preclude the Petitioner from
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`submitting evidence to address obviousness under that definition.
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`Furthermore, Regeneron does not “rel[y] on Dr. Cohen’s declaration in
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`support of its motivation to combine rationale,” as Patent Owner contends. Paper
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`101 at 7. As explained above, Regeneron set forth clear motivations to use the
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`Parylene C coated stopper in the Petition, including the numerous benefits
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`
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`8
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`described in Boulange. Petition at 31-40. In contrast, Dr. Cohen’s testimony
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`directly responds to Patent Owner’s and Dr. Dillberger’s assertions that a POSITA
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`would have been deterred from using Stopper B in Boulange because Parylene C
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`may absorb proteins and be toxic. For example, relying on Dr. Dillberger, Patent
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`Owner argued in the POR that issues related to protein adsorption and cytotoxicity
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`would have “dissuaded a POSA from using it in a terminally sterilized PFS
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`containing a VEGF-antagonist.” Paper 35 at 10 (citing Ex. 2202, ¶¶ 66-68); see
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`also id., at 11-12. In direct response, Dr. Cohen explained that a POSITA would
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`not have been deterred from using Parylene C because, inter alia, Parylene C had
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`comparable protein adsorption characteristics to other coatings used in syringes,
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`and had passed toxicity and biocompatibility testing required by ISO and was
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`extensively used in implantable medical devices. See Ex. 1108, ¶¶ 29-44. Thus,
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`Dr. Cohen’s testimony was allowably responsive to Dr. Dillberger’s testimony
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`submitted with the POR.
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`Notably, Dr. Cohen did not rely on any new evidence in his declaration, and
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`instead discussed the same publications that Dr. Dillberger relied on in his
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`declaration. Compare Ex. 2202 at ¶¶ 66-68 (Dr. Dillberger analyzing Ex. 2030 and
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`2031), with Ex. 1108 at ¶¶ 29-44 (Dr. Cohen analyzing Ex. 2030 and 2031). Dr.
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`Cohen’s direct response to Dr. Dillberger’s testimony concerning various prior art
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`publications, which Patent Owner introduced into the proceeding after the Petition
`
`
`
`9
`
`
`
`
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`was filed, is proper reply evidence. Anacor Pharm., Inc., 889 F.3d at 1380-81
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`(“[T]he petitioner in an inter partes review proceeding may introduce new evidence
`
`after the petition stage if the evidence is a legitimate reply to evidence introduced
`
`by the patent owner.”).
`
`IV. THERE IS NO PREJUDICE TO PATENT OWNER
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`Patent Owner has failed to identify any prejudice because Regeneron’s reply
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`did not “shift” its theory on motivation to combine, as Patent Owner alleges. Paper
`
`101 at 8.2 Regeneron has maintained the same theory throughout this
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`proceeding—that it would have been obvious to combine Sigg or Lam and
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`Boulange, including the motivation to use less silicone oil in a pre-filled syringe
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`that would result from the combination. Petition at 31-40. The evidence that
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`Patent Owner seeks to exclude, in contrast, is responsive testimony that addressed
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`a competing level of ordinary skill in the art and argument that alleged
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`incompatibilities between Parylene C and a VEGF antagonist would have negated
`
`
`2 Patent Owner’s reliance on Wasica Finance is misguided. Paper 101 at 8. There,
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`the Board declined to consider Petitioner’s obviousness argument and evidence
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`introduced in reply where the Petition included only a conclusory assertion that the
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`claims were obvious. Wasica Finance GMBH v. Continental Automotive Systems,
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`Inc., 853 F.3d 1272, 1286-87 (Fed. Cir. 2017).
`
`
`
`10
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`
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`
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`any motivation to combine the prior art – arguments that were raised in the POR.
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`Simply put, Regeneron never shifted its theory.
`
`There is also no prejudice because Patent Owner had a full opportunity to
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`address these issues in its POR. Mr. Koller’s testimony is in reply to the argument
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`raised in the POR concerning alleged incompatibilities between Parylene C and a
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`VEGF antagonist and is directed to the teachings of Boulange with regarding to
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`placement of the stopper coating. Mr. Leinsing and Dr. Dillberger both had the
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`opportunity to address Boulange’s disclosure regarding placement of the stopper
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`coating, but simply failed to do so. Similarly, Dr. Cohen’s testimony is in response
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`to the different level of ordinary skill in the art proffered in the POR and addresses
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`the teachings of Ex. 2030 and 2031, which Dr. Dillberger had a full opportunity to
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`address in his declaration.
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`Finally, Patent Owner cannot claim prejudice because it had the opportunity
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`to depose Mr. Koller and Dr. Cohen regarding the contents of their declarations.
`
`Merck Sharp & Dohme Corp. et al v. Wyeth LLC et al, PTAB-IPR2017-00390,
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`Paper 62, 63-64 (PTAB June 8, 2018) (finding admission of the expert’s
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`declaration presented no prejudice as Patent Owner had the opportunity to cross-
`
`examine the expert); Liquidia Technologies, Inc. v. United Therapeutics
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`Corporation, IPR2020-00770, Paper 45, 58 (PTAB Oct. 08, 2021) (finding no
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`prejudice where Patent Owner was able to depose expert on his opinions).
`
`
`
`11
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`
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`V. CONCLUSION
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`For the above reasons, Regeneron respectfully requests that Patent Owner’s
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`motion to exclude be denied.
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`
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`
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`12
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`
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`Dated: July 12, 2022
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`
`
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`
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`Respectfully submitted,
`
`/Anish R. Desai/
`Anish R. Desai (Reg. No. 73,760)
`Elizabeth S. Weiswasser (Reg. No. 55,721)
`Natalie Kennedy (Reg. No. 68,511)
`WEIL, GOTSHAL & MANGES LLP
`767 Fifth Avenue
`New York, NY 10153
`T: 212-310-8000
`F: 212-310-8007
`E: Regeneron.IPR.Service@weil.com
`
`Christopher Pepe (Reg. No. 73,851)
`Matthew D. Sieger (Reg. No. 76,051)
`Priyata Y. Patel (Reg. No. 76,861)
`WEIL, GOTSHAL & MANGES LLP
`2001 M Street NW, Suite 600
`Washington, DC 20036
`T: 202-682-7000
`F: 202-857-0940
`E: Regeneron.IPR.Service@weil.com
`
`
`
`
`13
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`
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`CERTIFICATE OF SERVICE
`
`
`
`The undersigned hereby certifies that on July 12, 2022, the foregoing
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`PETITIONER’S OPPOSITION TO PATENT OWNER’S MOTION TO
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`EXCLUDE was served via electronic mail upon the following:
`
`Elizabeth J. Holland
`Daniel P. Margolis
`Allen & Overy LLP
`1221 Avenue of the Americas
`New York, NY 10020
`elizabeth.holland@allenovery.com
`daniel.margolis@allenovery.com
`
`Nicholas K. Mitrokostas
`John T. Bennett
`Allen & Overy LLP
`1 Beacon Street
`Boston, MA 02108
`nicholas.mitrokostas@allenovery.com
`john.bennett@allenovery.com
`
`William G. James
`Allen & Overy LLP
`1101 New York Avenue, NW
`Washington, D.C 20005
`william.james@allenovery.com
`
`Linnea Cipriano
`Goodwin Procter LLP
`620 Eighth Avenue
`New York, NY 10018
`lcipriano@goodwinlaw.com
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Duncan Greenhalgh
`Joshua Weinger
`Goodwin Procter LLP
`100 Northern Avenue
`Boston, MA 02210
`dgreenhalgh@goodwinlaw.com
`jweinger@goodwinlaw.com
`
`
`
`/Ryan Sotnick/
`Ryan Sotnick
`IP Paralegal
`Weil, Gotshal & Manges LLP
`2001 M Street, NW, Suite 600
`Washington, D.C. 20036
`ryan.sotnick@weil.com
`202-682-7000
`
`
`
`
`
`
`
`
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