`
`
`
`
`
`
`
`
`
`Filed: December 24, 2018
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`___________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`
`v.
`
`
`BIOGEN MA INC.,
`Patent Owner.
`____________________________________________
`
`IPR2018-01403
`Patent No. 8,399,514
`____________________________________________
`
`
`PATENT OWNER SUR-REPLY
`
`
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`The Federal Circuit’s recent FWP decision confirms that Mylan is wrong
`
`about WO ’342 and provides further support for denying institution. In its Petition,
`
`Mylan states that WO ’342 “discloses daily doses of 480 mg of DMF, and
`
`describes therapeutic efficacy in treating MS.” Pet., 32; see also id., 48-50.
`
`Because both the Board and the Federal Circuit have found that WO ’342 does not
`
`disclose using 480 mg/day of DMF and/or MMF to treat MS, Mylan’s obviousness
`
`challenge in Ground 3 must fail.
`
`I.
`
`The Federal Circuit Decision Confirms That Mylan’s Arguments Based
`on WO ’342 are Wrong
`
`At the time that Mylan prepared and filed its Petition, the parties were
`
`awaiting the Federal Circuit’s decision in the FP Interference. The Board’s
`
`interference decision was available, but Mylan chose to advocate a position in
`
`direct conflict with it.
`
`In particular, Mylan argued that the Board had purportedly not considered
`
`“the disclosure of 480 mg/day DMF for the treatment of MS in WO ’342.” Pet., 65.
`
`But the Board evaluated WO ’342 in the FP Interference and found the exact
`
`opposite: “[WO ’342] does not indicate 480 mg/day is a therapeutically effective
`
`dose with respect to any condition or disease or is otherwise of any particular
`
`significance with respect to treatment of MS . . . .” Biogen MA Inc. v. Forward
`
`Pharma A/S, Intf. 106,023, Doc. 813 at 22 (PTAB Mar. 31, 2017) (Judges Schafer,
`
`
`
`1
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`Katz, Lane) (Ex. 2030). Mylan made no effort to address or reconcile its position
`
`with the Board’s prior decision.
`
` The Federal Circuit’s decision does not help Mylan. In affirming the Board,
`
`it confirms that Mylan’s arguments regarding WO ’342 are wrong. The Court
`
`concluded that WO ’342 does not disclose Biogen’s claimed invention. FWP IP
`
`ApS v. Biogen MA Inc., No. 17-2109, slip op. at 13 (Fed. Cir. Oct 24, 2018). In
`
`addition, the Court concluded that the “prior art [cited by FP] does not teach the
`
`key limitation of the count: the 480 mg daily dosage.” Id. at 14.
`
`Mylan’s Reply fails to address these conclusions, just as Mylan’s Petition
`
`disregarded the Board’s interference decision. Instead, Mylan attempts to
`
`downplay the decision in FWP by categorizing it as addressing only written
`
`description, not obviousness. Reply, 1-2. But any differences between the legal
`
`standards are irrelevant because the challenge in Mylan’s Petition depends on WO
`
`’342 disclosing what the Board—and now the Federal Circuit—have held that it
`
`does not disclose, i.e., the 480 mg daily dosage of DMF and/or MMF for treating
`
`MS. See, e.g., Pet., 65; Ex. 1002, 77 n.6.
`
`II. FWP Supports the Denial of Mylan’s Petition
`Mylan argues that Biogen “overread[s]” the FWP decision when it comes to
`
`obviousness. Reply, 1. This is incorrect. During the FWP appeal, as Mylan admits,
`
`Biogen cited to the Court the Board’s decision in Coalition for Affordable Drugs V
`
`
`
`2
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`LLC v. Biogen MA Inc., IPR2015-01993 (PTAB Mar. 21, 2017) (“Coalition II”)
`
`(Judges Schafer, Katz, Lane). Coalition II and the FP Interference were decided by
`
`the same Board panel on a coordinated schedule, resulting in contemporaneously
`
`issued decisions. Ex. 2030; Ex. 2038. In Coalition II, the Board weighed the
`
`evidence and found “that the magnitude of clinical efficacy of the 480 mg/day
`
`treatment would have been unexpected by those working in the art.” Ex. 2038, 26
`
`(emphasis added); id., 2. In its POPR, Biogen referred to the Board’s finding and
`
`the Federal Circuit’s acknowledgement of Biogen’s discovery. POPR, 2, 15-16;
`
`FWP at 14-15. It is appropriate for the Board to consider all proceedings relating to
`
`the patent in exercising its discretion to deny institution. See, e.g., NetApp Inc. v.
`
`Realtime Data LLC, IPR2017-01195, Paper 9 at 11-13 (PTAB Oct. 12, 2017). The
`
`Federal Circuit decision thus supports denial of institution.
`
`III. Conclusion
`For the reasons set forth herein and in Biogen’s POPR, the Board should
`
`deny Mylan’s Petition.
`
`Dated: December 24, 2018
`
`
`
`
`By: /Barbara C. McCurdy/
`Barbara C. McCurdy, Reg. No. 32,120
`Erin M. Sommers, Reg. No. 60,974
`Pier D. DeRoo, Reg. No. 69,340
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`Counsel for Patent Owner
`Biogen MA Inc.
`
`
`
`3
`
`
`
`U.S. Patent No. 8,399,514
`IPR2018-01403
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing Patent Owner Sur-
`
`Reply was served electronically via e-mail on December 24, 2018, in its entirety
`
`on the following:
`
`Brandon M. White
`Perkins Coie LLP
`700 13th St., NW, Suite 600
`Washington, D.C. 20005
`Telephone: (202) 654-6206
`E-mail: bmwhite@perkinscoie.com
`
`Emily Greb
`Perkins Coie LLP
`One East Main St., Suite 201
`Madison, WI 53703
`Telephone: (608) 663-7494
`E-mail: egreb@perkinscoie.com
`
`Petitioner has agreed to electronic service.
`
`
`
`By: /Barbara C. McCurdy/
`Barbara C. McCurdy, Reg. No. 32,120
`
`
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`
`
`
`Dated: December 24, 2018
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
