UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`BIOCON BIOLOGICS INC.,
`Petitioner,
`
`v.
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`
`Inter Partes Review No.: IPR2024-00298
`
`
`U.S. Patent No. 11,253,572
`Filed: June 21, 2021
`Issued: February 22, 2022
`Inventor: George D. Yancopoulos
`
`Title: USE OF A VEGF ANTAGONIST TO TREAT
`ANGIOGENIC EYE DISORDERS
`
`
`PETITIONER’S MOTION FOR JOINDER PURSUANT TO 35 U.S.C.
`§ 315(c) AND 37 C.F.R. §§ 42.22 AND 42.122(b)
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`BIOCON BIOLOGICS INC.,
`Petitioner,
`
`v.
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`
`Inter Partes Review No.: IPR2024-00298
`
`
`U.S. Patent No. 11,253,572
`Filed: June 21, 2021
`Issued: February 22, 2022
`Inventor: George D. Yancopoulos
`
`Title: USE OF A VEGF ANTAGONIST TO TREAT
`ANGIOGENIC EYE DISORDERS
`
`
`PETITIONER’S MOTION FOR JOINDER PURSUANT TO 35 U.S.C.
`§ 315(c) AND 37 C.F.R. §§ 42.22 AND 42.122(b)
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`I.
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`II.
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`TABLE OF CONTENTS
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED. ......................... 1
`
`STATEMENT OF MATERIAL FACTS. ....................................................... 2
`
`III.
`
`STATEMENT OF REASONS FOR RELIEF REQUESTED. ....................... 3
`
`A.
`
`Reasons Why Joinder is Appropriate. ................................................... 5
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`1.
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`2.
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`3.
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`4.
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`5.
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`Substantively Identical Petitions. ................................................ 5
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`Simplification of Briefing and Discovery as an
`“Understudy.” ............................................................................. 7
`
`No New Grounds of Unpatentability. ......................................... 8
`
`No Impact on IPR Trial Schedule. .............................................. 9
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`Joinder Will Not Prejudice Patent Owner or Samsung. ............. 9
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`IV. PROPOSED ORDER. ...................................................................................10
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`V.
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`CONCLUSION. .............................................................................................10
`
`
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`
`i
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`TABLE OF AUTHORITIES
`
`Cases
`
`Amneal Pharms. LLC v. Yeda Rsch. & Dev. Co., Ltd.,
`IPR2015-01976 (P.T.A.B. Dec. 28, 2015) ............................................................. 2
`
`Celltrion, Inc. v. Regeneron Pharms., Inc.,
`IPR2022-00257 (P.T.A.B. Dec. 9, 2021) ............................................................... 7
`
`Dell Inc. v. Network-1 Sec. Sols., Inc.,
`IPR2013-00385 (P.T.A.B. July 29, 2013) .............................................................. 4
`
`Kyocera Corp. v. Softview LLC,
`IPR2013-00004 (P.T.A.B. Apr. 24, 2013) ............................................................. 1
`
`Motorola Mobility LLC v. Softview LLC,
`IPR2013-00256 (P.T.A.B. June 20, 2013) ............................................................. 2
`
`Mylan Pharms. Inc. v. Novartis AG,
`IPR2015-00268 (P.T.A.B. Apr. 10, 2015) ............................................................. 7
`
`Samsung Bioepis Co., Ltd. v. Regeneron Pharms., Inc.,
`IPR2023-00884 (P.T.A.B. Nov. 17, 2023) .................................................. 1, 6, 10
`
`Statutes
`
`35 U.S.C. § 315(b) ..................................................................................................... 4
`
`35 U.S.C. § 315(c) .................................................................................................1, 3
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`35 U.S.C. § 316(b) ..................................................................................................... 5
`
`Other Authorities
`
`157 CONG. REC. S1376 (daily ed. Mar. 8, 2011) ....................................................... 6
`
`Regulations
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`37 C.F.R. § 42.1(b) .................................................................................................... 5
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`37 C.F.R. § 42.122(b) ....................................................................................... 1, 2, 3
`ii
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`37 C.F.R. § 42.22 .............................................................................................. 1, 2, 3
`37 CPR. § 42.22 eee ceeceseeseeeseecseecesesssessseseseeeseessesesseeeseeseaseesessaseseseeeeeneees 1, 2,3
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`37 C.F.R. § 42.53 ....................................................................................................... 7
`37 CAFR. § 42.53 vccccssscssccsssscscesssuescessssessessssessessusessesssssesssssvsssesssesesesssssssessssesesssseeees7
`
`iii
`ill
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`I.
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`STATEMENT OF THE PRECISE RELIEF REQUESTED.
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`Petitioner Biocon Biologics Inc. (“Biocon”) filed the present petition for inter
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`partes review (the “Biocon IPR”) and respectfully submits this Motion for Joinder.
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`Pursuant to 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.22, and 42.122(b), Biocon requests
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`institution of inter partes review concerning U.S. Patent No. 11,253,572 (“the ‘572
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`patent”) and joinder with the inter partes review concerning the same patent in
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`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc., assigned Case No.
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`IPR2023-00884 (the “Samsung IPR”), which was instituted on November 17, 2023.
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`Samsung Bioepis Co., Ltd. (“Samsung”) indicated it does not oppose Petitioner’s
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`motion.
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`In accordance with the Patent Trial and Appeal Board’s (“Board”)
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`Representative Order identifying matters to be addressed in a motion for joinder,
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`Kyocera Corp. v. Softview LLC, IPR2013-00004, Paper 15 (P.T.A.B. Apr. 24, 2013),
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`Biocon submits that: (1) joinder is appropriate because it will promote efficient
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`determination of the validity of the ‘572 patent without prejudice to the prior
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`petitioner, Samsung, or to the owner of the ‘572 patent, Regeneron Pharmaceuticals,
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`Inc. (“Regeneron” or “Patent Owner”); (2) Biocon’s Petition raises the same grounds
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`of unpatentability over the same prior art as those instituted by the Board in the
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`Samsung IPR; (3) joinder would not affect the pending schedule in the Samsung IPR
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`nor increase the complexity of that proceeding, thereby minimizing costs; and (4)
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`1
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`Biocon is willing to agree to consolidated filings with Samsung to minimize the
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`burden and the impact on the schedule. See, e.g., Motorola Mobility LLC v. Softview
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`LLC, IPR2013-00256, Paper 10 (P.T.A.B. June 20, 2013) (granting motion for
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`joinder under similar circumstance); Amneal Pharms. LLC v. Yeda Rsch. & Dev.
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`Co., Ltd., IPR2015-01976, Paper 9 (P.T.A.B. Dec. 28, 2015) (same).
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`This Motion for Joinder is timely under 37 C.F.R. §§ 1.7, 42.22 and 42.122(b),
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`as it is submitted within one month of November 17, 2023, the date on which the
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`Samsung IPR was instituted.
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`II.
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`STATEMENT OF MATERIAL FACTS.
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`Biocon requests institution of an inter partes review on the ‘572 patent and
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`asserts the same grounds of unpatentability that were instituted in the Samsung IPR.
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`On November 17, 2023, the Board instituted trial on claims 1-30 (the
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`“Challenged Claims”) of the ‘572 patent in the Samsung IPR based on several
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`grounds of unpatentability raised by Samsung. The instant petition for IPR filed by
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`Biocon challenges the same patent claims,1 contains the same grounds of
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`1 Following a finding of no patentable weight for the results limitations, Patent
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`Owner stipulated to summary judgment on claims 1-5, 8-11, 14, and 26-28 in the
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`associated district court litigation, Regeneron Pharms., Inc. v. Mylan Pharms. Inc.,
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`1:22-cv-00061-TSK (N.D.W. Va.) (“Mylan Litigation”), but subject to all “appellate
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`2
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`unpatentability, and those grounds are the same in all substantive aspects as the
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`Samsung IPR. Both petitions contain the same analysis and exhibits, and rely upon
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`the same expert declaration.
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`III. STATEMENT OF REASONS FOR RELIEF REQUESTED.
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`Biocon respectfully requests that the Board exercise its discretion and grant
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`joinder of the Biocon IPR and the Samsung IPR proceedings pursuant to 35 U.S.C.
`
`§ 315(c), 37 C.F.R. § 42.22, and 37 C.F.R. § 42.122(b). In support of this motion,
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`Biocon proposes consolidated filings and other procedural accommodations
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`designed to streamline the proceedings.
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`The Leahy-Smith America Invents Act (AIA) permits joinder of inter partes
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`review proceedings. The statutory provision governing joinder of inter partes review
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`proceedings is 35 U.S.C. § 315(c), which reads as follows:
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`(c) JOINDER.—If the Director institutes an inter partes
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`review, the Director, in his or her discretion, may join as a
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`party to that inter partes review any person who properly
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`files a petition under section 311 that the Director, after
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`receiving a preliminary response under section 313 or the
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`rights, including but not limited to rights of appeal concerning claim construction.”
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`Ex.1068, 1.
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`3
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`expiration of the time for filing such a response,
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`determines warrants the institution of an inter partes
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`review under section 314.
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`Congress further clarified that the one-year litigation time bar, “shall not apply to a
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`request for joinder under subsection (c).” 35 U.S.C. § 315(b).
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`In exercising its discretion to grant joinder, the Board considers the impact of
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`substantive and procedural issues on the proceedings, as well as other
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`considerations, while being “mindful that patent trial regulations, including the rules
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`for joinder, must be construed to secure the just, speedy, and inexpensive resolution
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`of every proceeding.” See Dell Inc. v. Network-1 Sec. Sols., Inc., IPR2013-00385,
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`Paper 17, 3 (P.T.A.B. July 29, 2013). The Board should consider “the policy
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`preference for joining a party that does not present new issues that might complicate
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`or delay an existing proceeding.” Id., 10. Under this framework, joinder of the
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`present Biocon IPR with the Samsung IPR is appropriate.
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`“A motion for joinder should: (1) set forth the reasons why joinder is
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`appropriate; (2) identify any new grounds of unpatentability asserted in the petition;
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`(3) explain what impact (if any) joinder would have on the trial schedule for the
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`existing review; and (4) address specifically how briefing and discovery may be
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`simplified.” Id., 4. Each of these is addressed fully below.
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`4
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`A. Reasons Why Joinder is Appropriate.
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`Joinder is appropriate in this case because it is the most expedient way to
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`secure the just, speedy, and inexpensive resolution of the two related proceedings.
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`See 35 U.S.C. § 316(b); 37 C.F.R. § 42.1(b). Joinder will allow the Board to resolve
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`the unpatentability of the Challenged Claims without any significant impact on the
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`Samsung IPR. Intentionally, the Biocon IPR is substantively identical with respect
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`to the grounds in the Samsung IPR in an effort to avoid multiplication of issues
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`before the Board. Given the duplicative nature of these petitions, joinder of the
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`related proceedings is appropriate and conserves Board resources. Further, Biocon
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`will agree to consolidated filings and discovery, and procedural concessions, so that
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`in this matter Biocon will be bound by the schedule set forth in the Samsung IPR.
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`1.
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`Substantively Identical Petitions.
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`The instant petition for IPR filed by Biocon challenges the same patent claims,
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`contains the same grounds of unpatentability, and is the same in all substantive
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`aspects as the Samsung IPR, aside from minor non-substantive edits to accommodate
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`word count.2 Both petitions contain the same analysis and exhibits, and Biocon
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`2 Petitioner Biocon is mindful of the Board’s findings in its Institution Decision, and
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`that its findings in-part conflict with the decision of the Court in the Mylan Litigation
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`with regard to the patentable weight of the Results Limitations. Biocon also is aware
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`5
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`intends to rely upon the same expert declaration. The only differences are in the
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`party-specific portions of the petition (e.g., discretionary denial, mandatory notices,
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`etc.). Because the Board has already instituted trial in the Samsung IPR, see Samsung
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`Bioepis Co., Ltd. v. Regeneron Pharms., Inc., IPR2023-00884, Paper 13 (P.T.A.B.
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`Nov. 17, 2023), the substantively identical Biocon IPR will not require additional
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`Board resources to determine that institution on the same grounds as in the Samsung
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`IPR institution decision is appropriate here. Indeed, in circumstances such as these,
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`the PTO anticipated that joinder would be granted as a matter of right. See 157 CONG.
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`REC. S1376 (daily ed. Mar. 8, 2011) (statement of Sen. Kyl).
`
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`that the Board expressed skepticism about some of the Grounds initially asserted in
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`the Samsung Petition. Given Biocon’s limited understudy role, and for as long as
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`Samsung remains a party in its IPR, Biocon will defer to Samsung with regard to
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`these arguments and Grounds. To be clear, the inclusion of all arguments and
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`Grounds included in the Samsung Petition in the Biocon Petition is for purposes of
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`providing a “copycat” petition along with Biocon’s concurrent joinder motion, and
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`is not intended to signal that Biocon will present additional argument or modify the
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`Samsung Petition Grounds, or, for the purposes of this IPR only, contest the Board’s
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`decision regarding the patentable weight of the Results Limitations, while in its
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`limited understudy role.
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`6
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`2.
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`Simplification
`“Understudy.”
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`of Briefing
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`and Discovery
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`as
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`an
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`Because the grounds of unpatentability and the prior art relied on in the
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`Biocon IPR and the instituted Samsung IPR are the same, Biocon is amenable to
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`undertaking the role of an “understudy” to simplify the proceeding. As an
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`“understudy,” Biocon agrees that, if joined, the following conditions will apply so
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`long as Samsung remains an active party:
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`• All filings by Biocon in the joined proceeding will be consolidated
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`with the filings of IPR2023-00884, unless a filing solely concerns
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`issues that do not involve Samsung;
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`• Going forward, in the event of joinder, Biocon agrees to
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`consolidated filings and discovery;
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`• Biocon shall not be permitted to raise any new grounds, or art
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`combinations, not instituted by the Board in the Samsung IPR, or
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`introduce any argument not already introduced by Samsung;
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`• With regard to taking of testimony, Biocon will abide by 37 C.F.R.
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`§ 42.53 or any agreement between the Patent Owner and Samsung.
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`See Mylan Pharms. Inc. v. Novartis AG, IPR2015-00268, Paper 17, 5-6 (P.T.A.B.
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`Apr. 10, 2015) (defining the aforementioned conditions as “consistent with the
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`‘understudy’ role that [Biocon] agrees to assume”); see also Celltrion, Inc. v.
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`Regeneron Pharms., Inc., IPR2022-00257, Paper 3, 6 (P.T.A.B. Dec. 9, 2021)
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`7
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`(motion requesting the same granted in related Regeneron patent proceedings).
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`Biocon further agrees that Samsung will manage all depositions and will lead in all
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`discovery matters, and that Biocon will not receive any separate cross-examination
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`or redirect time from that of Samsung, and will not have separate oral argument time
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`at the hearing, unless agreed to by the parties or requested by the Board.
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`Should joinder be granted, Biocon is prepared to rely solely on the testimony
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`of Samsung’s expert, Dr. Chaum. To be clear, as long as the Samsung IPR remains
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`pending following joinder, no additional discovery from Biocon would be needed,
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`and Biocon would agree to a subordinate role, allowing Samsung to take lead in all
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`discovery matters and the cross-examination of any witness produced by Patent
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`Owner.
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`3.
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`No New Grounds of Unpatentability.
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`The Biocon IPR contains the same grounds of unpatentability instituted in the
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`Samsung IPR. In fact, the grounds of unpatentability are identical in all substantive
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`respects. The Biocon IPR contains the same analysis and exhibits, and relies on the
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`same expert opinions. The Biocon IPR does not alter, nor otherwise seek to
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`supplement the arguments or prior art combinations instituted in the Samsung IPR,
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`nor in Dr. Chaum’s expert opinions already submitted in the Samsung IPR. As a
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`result, the Biocon IPR raises no new grounds of unpatentability from those of the
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`Samsung IPR.
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`8
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`4.
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`No Impact on IPR Trial Schedule.
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`The difference between the filing date of the Biocon IPR and the Samsung
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`IPR is without consequence should the proceedings be joined. The trial schedule for
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`the Samsung IPR would not need to be delayed to effect joinder based on Patent
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`Owner’s preliminary response and later-filed Biocon IPR, and Biocon agrees to be
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`bound by the Scheduling Order in the Samsung IPR. Indeed, given that the Biocon
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`IPR asserts substantively identical grounds of unpatentability as those instituted in
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`the Samsung IPR, and presents no new invalidity arguments or evidence for the
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`Board or Patent Owner to address, there should be no need for the Patent Owner to
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`submit a preliminary response, and because no new issues are being raised, there
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`will be no need for the Board to alter or extend any of the current deadlines. The
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`joint proceeding would allow the Board and parties to focus on the merits in one
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`consolidated proceeding, and in a timely manner.
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`5.
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`Joinder Will Not Prejudice Patent Owner or Samsung.
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`Biocon’s participation in this proceeding does not result in any prejudice to
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`Patent Owner for several reasons. First, no additional grounds or arguments are
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`being introduced. Second, no new evidence or issues are being added and no
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`additional briefing should be necessary. Third, joinder preserves judicial economy
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`9
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`without prejudice to Patent Owner, who will be involved in the Samsung IPR
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`regardless of Biocon’s participation.
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`IV. PROPOSED ORDER.
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`Petitioner proposes a joinder order for consideration by the Board as follows:
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`• The Biocon IPR will be instituted and joined with the Samsung IPR
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`on the same grounds as those for which review was instituted in the
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`Samsung IPR.
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`• The scheduling order for the Samsung IPR will apply to the joined
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`proceeding.
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`• Biocon will take an “understudy” role to Samsung in the proceeding.
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`V. CONCLUSION.
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`For the foregoing reasons, Biocon respectfully requests that its Petition for
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`inter partes review of claims 1-30 of U.S. Patent No. 11,253,572 be instituted and
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`that the proceeding be joined with Samsung Bioepis Co., Ltd. v. Regeneron
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`Pharmaceuticals, Inc., IPR2023-00884. Although no additional fee is believed to be
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`required for this Motion, the Commissioner is hereby authorized to charge any
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`additional fees which may be required for this Motion to Deposit Acct. No. 503626.
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`10
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`Respectfully Submitted,
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`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`
`/Paul J. Molino/
`Paul J. Molino
`Registration No. 45,350
`6 West Hubbard Street
`Chicago, IL 60654
`Telephone:
`(312) 222-6300
`Facsimile:
`(312) 843-6260
`paul@rmmslegal.com
`
`
`Counsel for Petitioner
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`Dated: December 18, 2023
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`11
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a true and correct copy of the foregoing
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`Petitioner’s Motion for Joinder Pursuant to 35 U.S.C. § 315(c) and 37 C.F.R.
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`§§ 42.22 and 42.122(b) was served on December 18, 2023, via FedEx Priority
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`Overnight on the Patent Owner at the correspondence address of record for U.S.
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`Patent No. 11,253,572 as evidenced in Patent Center:
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`A&P - Regeneron (Prosecution)
`601 Massachusetts Ave., NW
`Washington, DC 20001-3743
`
`/Paul J. Molino/
`Paul J. Molino (Reg. No. 45,350)
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