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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`REGENERON PHARMACEUTICALS, INC.,
`Petitioner
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`v.
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`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owners
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`__________
`
`
`Case IPR2021-00816
`Patent 9,220,631
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`__________
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`
`PATENT OWNERS’ THIRD MOTION TO SEAL AND MOTION FOR A
`MODIFIED DEFAULT PROTECTIVE ORDER
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`__________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`__________
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`REGENERON PHARMACEUTICALS, INC.,
`Petitioner
`
`v.
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`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owners
`
`__________
`
`
`Case IPR2021-00816
`Patent 9,220,631
`
`__________
`
`
`PATENT OWNERS’ THIRD MOTION TO SEAL AND MOTION FOR A
`MODIFIED DEFAULT PROTECTIVE ORDER
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`
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`U.S. Patent No. 9,220,631
`Patent Owners Novartis Pharma AG, Novartis Technology LLC, and
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`
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`Novartis Pharmaceuticals Corporation (collectively, “Novartis”) respectfully
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`request that the Board seal portions of the Patent Owners’ Response (“POR”),
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`portions of Novartis’s Motion to Amend (“MTA”), and Exhibits 2099–2115,
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`2119–2121, 2123–2124, 2126, 2128–2134, 2136–2148, 2150, 2155–2159, 2166–
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`2172, 2194, 2201, 2203–2206, 2208, 2224, and 2254, which contain Novartis’s
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`confidential commercial and research and development information, confidential
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`information of third parties, and personal employee information. Novartis
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`concurrently requests entry of a Modified Default Standing Protective Order (Ex.
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`2323), to provide additional protections for confidential information of a third
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`party. Exhibit 2324 shows the proposed modifications to the order that the Board
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`previously entered in this case. Petitioner does not oppose entry of this Modified
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`Protective Order, set forth in Exhibit 2323.
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`In determining whether to grant a Motion to Seal, the Board must find “good
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`cause” to seal the information in question and “strike a balance between the
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`public’s interest in maintaining a complete and understandable file history and the
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`parties’ interest in protecting truly sensitive information.” Consolidated Trial
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`Practice Guide November 2019 at 19. The Board identifies confidential
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`information in a manner “consistent with Federal Rule of Civil Procedure
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`U.S. Patent No. 9,220,631
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`26(c)(1)(G), which provides for protective orders for trade secret or other
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`confidential research, development, or commercial information.” Id.
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`The information that Novartis seeks to seal is either Novartis’s confidential
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`research and development related to the subject matter of U.S. Patent No.
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`9,220,631 (“the ’631 patent”), Novartis’s confidential commercial information,
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`third party confidential information, or information that is subject to contractual or
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`statutory obligations of confidentiality to third party companies or individuals, as
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`explained in more detail below. To the undersigned’s knowledge, the information
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`sought to be sealed has not been published or otherwise made public. Public
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`disclosure of Novartis’s or third party confidential information would
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`competitively harm Novartis’s and/or the third parties’ business prospects and put
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`these companies at a competitive disadvantage relative to other similarly
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`positioned companies in the same industry. In addition, we are advised by Swiss
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`counsel that public disclosure of the third party confidential information or
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`personal information of employees could subject Novartis to civil and criminal
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`penalties under the laws of Switzerland. As such, good cause exists to seal the
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`confidential versions of the POR, portions of Novartis’s Motion to Amend, and
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`Exhibits 2099–2115, 2119–2121, 2123–2124, 2126–2128, 2129–2134, 2136–
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`2148, 2150, 2155–2159, 2166–2172, 2194, 2201, 2203–2206, 2208, 2224, and
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`2254. With this motion, Novartis is publicly filing redacted versions of Exhibits
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`2
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`U.S. Patent No. 9,220,631
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`2119–2121, 2123–2124, 2126–2128, 2129–2134, 2136–2148, 2150, 2155–2159,
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`2166–2172, 2201, 2203–2206, 2208, 2224, and 2254. These redactions are
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`narrowly tailored to protect the confidential information therein from public
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`disclosure.
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`Exhibits 2120, 2126, 2128–2131, 2136–2145, 2150, 2244, and 2254
`(Novartis’s Technical Documents)
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`Exhibits 2120, 2126, 2128–2131, 2136–2145, 2150, 2244, and 2254 are
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`Novartis presentations discussing its research and development of the ʼ631 patent
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`and project timelines, reports prepared for submission to regulatory authorities, and
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`emails regarding creating a product that would meet standards set by the European
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`Medicines Agency. Novartis relies on these documents to support its arguments
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`regarding secondary considerations of non-obviousness.
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`As in Novartis’s Second Motion to Seal, Novartis seeks to seal three
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`categories of information in these documents: (1) Novartis’s proprietary
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`development information, (2) business information of third parties, and (3)
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`personal information of Novartis and third party employees.
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`First, Exhibits 2120, 2126, 2128–2131, 2136–2145, 2150, 2244, and 2254
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`contain information pertaining to Novartis’s research and development work
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`related to the subject matter of the ’631 patent, and are therefore “confidential
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`research [and] development . . . information” pursuant to FRCP 26(c)(1)(G). This
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`work includes specific quantitative and qualitative details regarding the
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`U.S. Patent No. 9,220,631
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`development of the subject matter claimed in the ʼ631 patent, such as numerical
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`data measuring the effect of certain sterilization processes on the stability of the
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`drug product, discussions on dosing accuracy and particulate matter, and diagrams
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`of stopper and plunger designs. Public disclosure of this information would harm
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`Novartis because insight into its research and development processes would
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`provide a competitive advantage to Novartis’s competitors to Novartis’s detriment.
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`Second, portions of Exhibits 2120, 2128–2129, 2130–2131, 2136–2139,
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`2141–2145, 2150, and 2254 that Novartis seeks to seal certain third party
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`confidential information that Novartis is legally obligated to protect from public
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`disclosure. As previously explained in Novartis’s Second Motion to Seal, Articles
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`162 and 273 of the Swiss Criminal Code (“SCC”) prohibit the unauthorized
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`disclosure or communication of manufacturing or business secrets to third parties,
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`including foreign authorities, the opposing party or its counsel. See Paper No. 18
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`at 4–5 (stating that Swiss law protects “all information relating to a company’s
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`manufacturing and production process and any other elements of economic life
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`over which the owner of a secret is presumed to have an interest in
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`confidentiality”).
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`Under Articles 162 and 273, Novartis is prohibited from disclosing such
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`confidential information related to a third party unless the third party consents to
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`that disclosure or the disclosure is made during legal assistance proceedings under
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`4
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`U.S. Patent No. 9,220,631
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`the applicable Hague evidence convention. Ex. 2097 at ¶¶ 4–31; Ex. 2325 at ¶¶ 5–
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`6. In connection with this proceeding and the related litigations, Novartis has
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`diligently sought consent to disclose the information of the third parties referenced
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`in Novartis’s documents. Exhibit 2097 at ¶¶ 16, 19. The companies that provided
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`consent for Novartis to disclose their information in these proceedings did so only
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`under an agreement that Novartis would disclose this information in such a way
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`that would protect the information from public disclosure. Ex. 2097 at ¶ 17.
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`While some third parties provided consent for Novartis to use their
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`information in this proceeding, Novartis is still obligated pursuant to provisions of
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`the SCC to protect the third parties’ information from public disclosure. Ex. 2097
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`at ¶¶ 17, 18. Novartis may be exposed to criminal penalties under the SCC and
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`civil liabilities if this information is not sealed. Ex. 2097 at ¶¶ 15, 17–18.
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`Additionally, not all third parties referenced in these documents have
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`authorized disclosure of their information. As discussed above, Novartis is legally
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`obligated to prevent disclosure of information related to parties that did not provide
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`consent, and could be subject to civil liabilities and criminal penalties if this
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`information is disclosed to unauthorized third parties, regardless of whether a
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`protective order is in place. Thus, information related to the third parties that did
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`not provide consent to disclosure is redacted in the public and sealed versions of
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`5
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`U.S. Patent No. 9,220,631
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`Exhibits 2120, 2128–2129, 2130–2131, 2136, 2138–2139, 2141, 2144–2145, 2244,
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`and 2254.
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`Novartis additionally seeks to seal the third party confidential information in
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`these documents that relates to Novartis’s business relationships with two third
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`parties and details of these third parties’ siliconization and sterilization practices
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`and processes, respectively. This information falls squarely within the business
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`secrets covered by Articles 162 and 273. Ex. 2097 at ¶ 13.
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`Third, Exhibits 2120, 2126–2128, 2142–2145, and 2150 contain personal
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`information of Novartis and third party employees, including the identities of
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`Novartis and third party employees and their roles and responsibilities. As
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`discussed above, Novartis is legally obligated to prevent the public disclosure of
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`employee information, and public disclosure of this information may expose
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`Novartis to criminal sanctions and civil liability. Therefore, pursuant to Swiss law,
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`personal information regarding Novartis and third party employees is redacted in
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`both the public and sealed versions of these exhibits.
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`Therefore, good cause exists to seal Exhibits 2120, 2126, 2128–2131, 2136–
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`2145, 2150, 2244, and 2254 due to the presence of Novartis’s confidential
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`information and confidential information from a third party, the disclosure of
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`which would put Novartis and the third party at a competitive disadvantage. There
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`6
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`U.S. Patent No. 9,220,631
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`is also good cause to seal the personal information of individuals employed by
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`Novartis and third parties based on obligations under Swiss privacy laws.
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`Exhibits 2119, 2121, 2123–2124, 2132–2134, 2146–2147, 2155–2159,
`2204, 2205 (Novartis’s Commercial Information)
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`Exhibits 2119, 2121, 2123–2124, 2132–2134, 2146–2147, and 2155–2159
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`are contracts between Novartis and third parties. Novartis relies on these
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`documents to support its argument that Genentech’s licensing of the ʼ631 patent is
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`evidence of the non-obviousness of the challenged claims. The information that
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`Novartis seeks to seal in these exhibits includes Novartis’s confidential
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`commercial information, and personal information of Novartis and third party
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`employees that are protected from disclosure under Swiss law. Novartis also seeks
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`to seal confidential information from a third party in Exhibit 2147.
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`Novartis seeks to seal three categories of confidential information in
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`Exhibits 2119, 2121, 2123–2124, 2132–2134, 2146–2147, and 2155–2159: (1)
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`Novartis’s confidential commercial information, (2) personal information of
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`Novartis and third party employees, and (3) business information of a third party.
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`First, Exhibits 2119, 2121, 2123–2124, 2132–2134, 2146–2147, and 2155–
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`2159 contain contractual terms of the agreements between Novartis and third
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`parties. These agreements contain information that would provide insight into
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`Novartis’s business models, confidential business activities, and licensing and
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`contracting practices. Furthermore, many of these agreements include exhibits
`7
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`U.S. Patent No. 9,220,631
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`detailing research, development, and collaboration efforts on specific aspects of the
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`ʼ631 patent between Novartis and the third parties. Public disclosure of this
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`information would harm Novartis and its third party business partners because
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`insight into these specific contractual terms and business strategies would provide
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`a competitive advantage to Novartis’s competitors to Novartis’s detriment.
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`Additionally, Novartis’s confidential research and development strategies should
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`not be subject to public exposure as explained above.
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`Second, as discussed above, Novartis is legally obligated to prevent the
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`public disclosure of employee information, and public disclosure of this
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`information may expose Novartis to criminal sanctions and civil liability under the
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`Swiss Data Protection Act (“DPA”) and the Swiss Code of Obligations (“SCO.”).
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`See Paper No. 18 at 9 (explaining Novartis’s legal duties under Swiss law). This
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`protection extends to employee identities and their personal signatures.
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`The employee information that is redacted from both the public and sealed
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`versions of Exhibits 2119, 2121, 2123–2124, 2132–2134, and 2146–2147 relates to
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`employees who did not provide consent, and therefore, public disclosure of this
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`information may expose Novartis to criminal sanctions and civil liability under
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`both the DPA and the SCO. See Ex. 2097 at ¶¶ 30– 31.
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`Third, as explained in Novartis’s Second Motion to Seal, although the third
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`party referenced in Ex. 2147 provided consent for Novartis to use its information
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`8
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`U.S. Patent No. 9,220,631
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`in this proceeding, Novartis is obligated to protect the third party’s information
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`from public disclosure. Ex. 2097 at ¶¶ 17, 18. Novartis may be exposed to
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`criminal penalties under the SCC and civil liabilities if this information is not
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`sealed. Ex. 2097 at ¶¶ 15, 17–18; IPR2021-00816, Paper No. 18 at 5.
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`Thus, good cause exists to seal the confidential versions of Exhibits 2119,
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`2121, 2123–2124, 2132–2134, 2146–2147, and 2155–2159 due to the presence of
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`Novartis’s confidential commercial information and the personal information of
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`individuals employed by Novartis and third parties protected under Swiss law.
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`Exhibits 2099–2115, 2148, and 2194 (Genentech, Inc. Documents)
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`Exhibits 2099–2115 and 2148 are Genentech, Inc. (“Genentech”) documents
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`produced in the related International Trade Commission (“ITC”) investigation
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`regarding the ’631 patent. See Certain Pre-Filled Syringes for Intravitreal
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`Injection and Components Thereof, Inv. No. 337-TA-1207. Exhibit 2194 is the
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`deposition transcript of Genentech’s Fed. R. Civ. P. 30(b)(6) corporate designee,
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`taken in the ITC action. Novartis relies on these documents to support its argument
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`regarding secondary considerations and nexus to the claims of the ’631 patent.
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`Specifically, Exhibits 2099–2115, 2148, and 2194 contain confidential
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`information of Genentech that should not be subject to public disclosure, including,
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`for example, sales (see, e.g., Ex. 2099), Genentech’s sterilization processes and
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`timelines (see, e.g., Ex. 2100), investigation reports regarding sterilization
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`9
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`U.S. Patent No. 9,220,631
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`treatment (see, e.g., Ex. 2102), and testimony of Genentech discussing its research
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`and development efforts (Ex. 2194). These documents were part of the record
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`developed in the ITC action, and in that action, these documents were subject to a
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`protective order requiring that these documents only be accessible by outside
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`counsel. The parties to this IPR proceeding have agreed to modify the protective
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`order in this action to extend the same level of protection for these documents as
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`was provided in the ITC action. Exhibit 2323.
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`Public disclosure of the information in Exhibits 2099–2115, 2148, and 2194
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`would harm Novartis’s third party business partner, Genentech, because insights
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`into Genentech’s technical and business information would provide a competitive
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`advantage to the third party’s competitors to its detriment. Therefore, good cause
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`exists to seal the confidential versions of Exhibits 2099–2115, 2148, and 2194 and
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`to enter the modified protective order set forth in Exhibit 2323.
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`Exhibits 2166–2173, 2204, and 2205 (Novartis’s Internal Business and
`Financial Documents)
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`Exhibits 2166–2173 are Novartis’s internal business and financial
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`documents. Exhibits 2204 and 2205 are declarations from witnesses that discuss
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`Novartis’s business and financial documents. The information that Novartis seeks
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`to seal in these documents includes details on market and competitor analyses,
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`financial sales, business strategies, and data on consumer satisfaction regarding the
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`subject matter claimed in the ʼ631 patent. Novartis relies on this information in
`10
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`U.S. Patent No. 9,220,631
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`support of its argument that secondary considerations weigh in favor of a finding
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`of nonobviousness. Public disclosure of this information would competitively
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`harm Novartis because other businesses in the same industry would unfairly
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`benefit from Novartis’s market strategies and business models.
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`Additionally, Exhibits 2204 and 2205 contain confidential commercial
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`information of third parties. These documents include references to Genentech’s
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`sales of the subject matter of the ʼ631 patent (see, e.g., Ex. 2204 ¶¶ 20, 37, 40, Ex.
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`2205 ¶¶ 58 n.23, 70 n.70) and contractual agreements between Novartis,
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`Genentech, and a third party. Disclosing this information would lead to exposure
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`of Genentech’s business models and approaches to collaborating with Novartis and
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`third parties, thus harming Genentech to its detriment. This type of harm would
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`also apply to the third party to Novartis’s and Genentech’s contractual agreement.
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`Thus, good cause exists to seal the confidential versions of Exhibits 2166–
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`2171–2173, 2204, and 2205 due to the presence of Novartis’s and Genentech’s
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`confidential business and financial information.
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`Exhibits 2201, 2203, 2206, and 2208 (Novartis Declarations)
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`Novartis seeks to seal portions of Exhibits 2201, 2203, 2206, and 2208
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`because they contain information regarding Novartis’s and third party proprietary
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`technical and development information, confidential business information of third
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`11
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`U.S. Patent No. 9,220,631
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`parties, and contain references to the previously discussed exhibits, which have
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`confidential information that is protected under Swiss law.
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`First, Exhibits 2201, 2203, 2206, and 2208 contain information on
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`Novartis’s research and development efforts related to the subject matter of the
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`ʼ631 patent. This information includes references to Novartis’s approach to
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`siliconization and sterilization challenges (see, e.g., Ex. 2201 ¶¶ 93–104, Ex. 2203
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`¶¶ 72–73, 83, Ex. 2206 ¶¶ 20, 22, 25), pre-filled syringe testing and studies, (see,
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`e.g., Ex. 2206 ¶¶ 20–22, Ex. 2208 ¶¶ 116–20) and design modifications of the pre-
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`filled syringe (see, e.g., Ex. 2201 ¶ 104). As discussed above, public disclosure of
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`this information would harm Novartis because insight into its research and
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`development processes would provide a competitive advantage to Novartis’s
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`competitors to Novartis’s detriment.
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`Second, Exhibits 2201, 2203, 2206, and 2208 include information on
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`Novartis’s business relationships with third parties as well as third party
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`confidential business information. These documents contain details on
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`collaboration efforts to develop the sterilization process of the ʼ631 patent with
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`Genentech (see, e.g., Ex. 2201 ¶¶ 157–64, 2203 ¶¶ 72–73, 2206 ¶¶ 6–18, 52) and
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`with another third party sterilization specialist (see, e.g., Ex. 2203 ¶¶ 72–73),
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`discussions on whether Genentech’s product was an embodiment of the claims in
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`the ʼ631 patent (see, e.g., Ex. 2208 , ¶¶ 113–15), and references to contractual
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`12
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`U.S. Patent No. 9,220,631
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`agreements that include licensing rights (see, e.g., Ex. 2201 ¶ 164). Disclosure of
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`this information would harm Novartis and its third party business partners because
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`Novartis’s competitors would gain insight into Novartis’s business approaches and
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`commercial interests when collaborating with third parties, thereby placing
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`Novartis at a competitive disadvantage. Furthermore, the third parties discussed in
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`these documents would be harmed in the event of disclosure, because insights into
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`their technical and business information would provide a competitive advantage to
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`other companies at their expense.
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`Third, portions of Exhibits 2201, 2203, 2206, and 2208 rely on and cite to
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`confidential information appearing in Exhibits 2099–2115, 2119–2121, 2123–
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`2124, 2126–2128, 2129–2134, 2136–2148, 2150, 2155–2159, 2166–2172, 2194,
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`2201, 2203–2206, 2208, 2224, and 2254. For the same reasons that these exhibits
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`should be sealed, so should the corresponding portions of Exhibits 2201, 2203,
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`2206, and 2208.
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`Thus, good cause exists to seal the confidential versions of Exhibits 2201,
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`2203, 2206, and 2208 due to the presence of Novartis’s and third party proprietary
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`technical and development information, confidential business information of third
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`parties, and personal information of Novartis and third party employees.
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`13
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`U.S. Patent No. 9,220,631
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`Novartis’s Patent Owner Response and Motion to Amend
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`Novartis seeks to seal the portions of the POR and MTA that discuss the
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`confidential information disclosed in the Exhibits that Novartis currently seeks to
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`seal. For the same reasons that these exhibits should be sealed as discussed above,
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`there is also good cause to seal the portions of the POR and MTA that include
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`confidential information appearing in Exhibits 2099–2115, 2119–2121, 2123–
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`2124, 2126–2128, 2129–2134, 2136–2148, 2150, 2155–2159, 2166–2172, 2194,
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`2201, 2203–2206, 2208, 2224, and 2254.
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`*
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`*
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`*
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`The information redacted from the public versions of the POR, the MTA,
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`and Exhibits 2201, 2203–2206, 2099–2115, 2119–2121, 2123–2134, 2126–2134,
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`2136–2150, 2194, and 2254 is not essential to an understanding of the POR and
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`does not impede the public’s understanding of the file history of the ’631 patent.
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`Novartis’s public filing sets forth its arguments that (1) the named inventors
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`conceived of and diligently reduced the claimed invention to practice prior to the
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`publication of specific prior art and (2) secondary considerations of non-
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`obviousness support a finding that the challenged claims are patentable. This type
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`of information is routinely sealed in IPR proceedings. See, e.g., Array Biopharma,
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`Inc. v. Takeda Pharm. Co. Ltd., IPR2015-00754, Paper No. 62, at 3–6 (Aug. 12,
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`2016) (granting petitioner’s revised motion to seal exhibits covering the conception
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`14
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`U.S. Patent No. 9,220,631
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`of the patent-at-issue, including the testing and synthesis of biologic compounds);
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`Prong, Inc. v. Yeoshura Sorias, IPR2-15-01317, Paper No. 32, at 5–6 (Mar. 28,
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`2016) (granting patent owner’s motion to seal several exhibits, including patent
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`owner’s response, which contained “discussions of secondary considerations of
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`non-obvious[ness] based on commercial success” such as “the identity of the
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`manufacturers and other business partners, and confidential sales information”).
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`Here, Novartis’s interest in maintaining its proprietary commercial, research and
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`development information as confidential, its obligations of secrecy under Swiss
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`privacy laws, and the interests of a third party in protecting its commercial and
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`technical information outweigh the public’s interest in accessing this information
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`for the purposes of the patentability of the challenged claims in this proceeding.
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`Accordingly, Novartis respectfully requests that the Board grant Patent
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`Owners’ Third Motion to Seal.
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`Dated: January 18, 2022
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`By:
`
`
`/Elizabeth Holland/
`Elizabeth J. Holland (Reg. No. 47,657)
`Lead Counsel for Patent Owners
`Goodwin Procter LLP
`620 Eighth Avenue
`New York, NY 10018
`Phone: (212) 813-8800
`Fax: (212) 355-3333
`EHolland@goodwinlaw.com
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`15
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`U.S. Patent No. 9,220,631
`CERTIFICATE OF SERVICE
`A copy of this Patent Owners’ Second Motion to Seal has been served on
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`Petitioner’s attorneys of record as follows via electronic mail on this 18th day of
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`January 2022:
`
`Elizabeth Stotland Weiswasser (Reg. No. 55,721)
`Anish R. Desai (Reg No. 73,760)
`Natalie Kennedy (Reg No. 68,511)
`Andrew Gesior (Reg No. 76,588)
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`T: 212-310-8022
`F: 212-310-8007
`Regeneron.IPR.Service@weil.com
`
`Brian E. Ferguson (Reg No. 36,801)
`Christopher M. Pepe (Reg No. 73,851)
`Weil, Gotshal & Manges LLP
`2001 M Street, N.W., Suite 600
`Washington, D.C. 20036
`T: 202-682-7000
`F: 202-857-0940
`Regeneron.IPR.Service@weil.com
`Attorneys for Regeneron Pharmaceuticals, Inc.
`
`
`Dated: January 18, 2022
`
`By:
`
`
`
`
`
`
`
`/Elizabeth Holland/
`Elizabeth J. Holland (Reg. No. 47,657)
`Lead Counsel for Patent Owners
`Goodwin Procter LLP
`620 Eighth Avenue
`New York, NY 10018
`Phone: (212) 813-8800
`Fax: (212) 355-3333
`EHolland@goodwinlaw.com
`
`
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