Trials@uspto.gov
`571-272-7822
`
`
`
`
`Paper 47
`Entered: February 5, 2018
`
`
`
`
`APOTEX INC., APOTEX CORP.,
`ARGENTUM PHARMACEUTICALS LLC,
`ACTAVIS ELIZABETH LLC, TEVA PHARMACEUTICALS USA, INC.,
`SUN PHARMACEUTICAL INDUSTRIES, LTD.,
`SUN PHARMACEUTICAL INDUSTRIES, INC., and
`SUN PHARMA GLOBAL FZE,
`Petitioners,
`
`v.
`
`NOVARTIS AG.,
`Patent Owner.
`____________
`Case IPR2017-008541
`Patent US 9,187,405 B2
`_______________
`
`
`Before LORA M. GREEN, CHRISTOPHER M. KAISER,
`and ROBERT A. POLLOCK, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge.
`
`
`ORDER
`Granting-in-part Petitioner’s Request for Additional Discovery
`37 C.F.R. § 42.51(b)(2)
`37 C.F.R. § 42.5
`
`
`
`In our Order of January 11, 2018, we granted lead Petitioner Apotex’s
`request for discovery under 37 C.F.R. § 42.51(b)(2) of (1) minutes of a February 2,
`
`
`1 Cases IPR2017-01550, IPR2017-01946, and IPR2017-01929 have been
`joined with this proceeding.
`
`
`
`
`571-272-7822
`
`
`
`
`Paper 47
`Entered: February 5, 2018
`
`
`
`
`APOTEX INC., APOTEX CORP.,
`ARGENTUM PHARMACEUTICALS LLC,
`ACTAVIS ELIZABETH LLC, TEVA PHARMACEUTICALS USA, INC.,
`SUN PHARMACEUTICAL INDUSTRIES, LTD.,
`SUN PHARMACEUTICAL INDUSTRIES, INC., and
`SUN PHARMA GLOBAL FZE,
`Petitioners,
`
`v.
`
`NOVARTIS AG.,
`Patent Owner.
`____________
`Case IPR2017-008541
`Patent US 9,187,405 B2
`_______________
`
`
`Before LORA M. GREEN, CHRISTOPHER M. KAISER,
`and ROBERT A. POLLOCK, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge.
`
`
`ORDER
`Granting-in-part Petitioner’s Request for Additional Discovery
`37 C.F.R. § 42.51(b)(2)
`37 C.F.R. § 42.5
`
`
`
`In our Order of January 11, 2018, we granted lead Petitioner Apotex’s
`request for discovery under 37 C.F.R. § 42.51(b)(2) of (1) minutes of a February 2,
`
`
`1 Cases IPR2017-01550, IPR2017-01946, and IPR2017-01929 have been
`joined with this proceeding.
`
`
`
`
`
`IPR2017-00854
`Patent 9,187,405 B2
`2005 face-to-face meeting between FDA and Novartis (“the FDA minutes”); (2)
`Novartis’s briefing book for a March 26, 2007 End-of-Phase II meeting (“the
`briefing book”); and (3) an unredacted version of Exhibit 2063. Paper 34. In
`accord with our Order, the Apotex submitting briefing directed to the discovery of
`those documents (Paper 35 (“Mot.”)); Patent Owner Novartis filed a simultaneous
`brief opposing Apotex’s motion (Paper 39 (“Opp.”)).
`Apotex’s brief, however, further argued for the production of a fourth
`document, the Phase III clinical trial protocol mentioned in Exhibit 2065 (“the
`protocol”). In the conference call of January 24, 2018, Novartis sought to strike
`the entirety of Apotex’s briefing on the grounds that we had not authorized briefing
`with respect to the protocol, whereas Apotex argued that the protocol was
`reasonably within the scope of our Order. Upon weighing the equities, we
`authorized Novartis to submit additional briefing directed to Apotex’s request for
`the protocol. Paper 41.
`Novartis submitted its supplemental briefing on January 29. Paper 45 (“Sup.
`Br.”). The parties filed their briefs under seal. See Paper 36 (Petitioner’s motion
`to seal); Paper 37 (Patent Owner’s motion to seal); Papers 38, 45 (redacted
`versions of Patent Owner’s motions); redacted versions of Exhibits 1042–1045 and
`2088. In light of the time necessary for briefing and any resultant discovery, we
`issued an Order extending each of DUE DATES 2 through 6. Paper 46.
`
`RELEVANT STANDARDS
`“The test for a party seeking additional discovery in an inter partes review is
`a strict one.” Symantec Corp. v. Finjan, Inc., Case IPR2015-01545, slip op. at 4
`(PTAB Dec. 11, 2015) (Paper 9). “The moving party must show that such
`additional discovery is in the interests of justice.” 37 C.F.R. § 42.51(b)(2)(i).
`
` 2
`
`
`
`
`
`
`
`IPR2017-00854
`Patent 9,187,405 B2
`Among the factors important to this analysis is whether Petitioner can show more
`than “[t]he mere possibility of finding something useful, and mere allegation that
`something useful will be found.” See Garmin Int’l, Inc. v. Cuozzo Speed Techs.
`LLC, Case IPR2012–00001, slip op. at 6 (PTAB Mar. 5, 2013) (Paper 26)
`(precedential). “The mere possibility of finding something useful, and mere
`allegation that something useful will be found, are insufficient to demonstrate that
`the requested discovery is necessary in the interest of justice.” Id. A party should
`already be in possession of evidence tending to show beyond speculation that in
`fact something useful will be uncovered. Id. We also consider whether the
`requested discovery seeks the other party’s litigation positions or the basis for
`those positions; seeks information that reasonably can be generated without the
`discovery requests; is easily understandable; and whether the requests are overly
`burdensome to answer (“Requests should be sensible and responsibly tailored
`according to a genuine need.”). Id. at 6–7.
`
`ANALYSIS
`In the Patent Owner Response (Paper 27, “PO Resp.”), Novartis contends
`that it “included a 0.5 mg daily dose in the Phase III trials
`
`
`
`
` PO Resp. 25–26 (citing Ex. 2025 ¶¶ 5, 39–42).
`According to Dr. Lublin, the study, therefore, included a “futility analysis”
`procedure
`
`
`
` Ex. 2025 ¶¶ 6, 44–47. Apotex now argues that the
`requested “documents are relevant because they contain or refer to
`communications between Patent Owner and the FDA addressing the justification
`for administering the 0.5 mg dose” and “[t]he only way to prove or disprove
`
` 3
`
`
`
`
`
`
`
`IPR2017-00854
`Patent 9,187,405 B2
`Novartis’s argument is to see the actual documents.” Mot. 2.
`The Phase III clinical trial protocol
`1.
`Patent Owner’s expert, Dr. Lublin, “participated in an advisory board of
`physicians that helped Novartis to design the Phase III trials.” Ex. 2025 ¶ 43.
`
`
`
`
`
`
`By March 2007, Dr. Lublin or his assistant had provided a copy of the trial
`protocol to the Mount Sinai IRB. Ex. 1042, 185:14—24, 187:2–188–4;
`
`
`
`
`
`
`
`
`
`As we understand the testimony, section 11, or some like portion of the
`Phase III clinical trial protocol, contains Novartis’s justification to the FDA for
`administering the 0.5 mg dose. Because Novartis has placed its reasons for
`including that dose at issue, we consider Apotex’s discovery request reasonable.
`In particular, such discovery would provide means for testing Novartis’s position
`here against statements it made to the FDA in submitting the protocol and is,
`thereby, “useful” to Petitioner’s case. Moreover, in pointing to the statements of
`Dr. Lublin and Ms. Farrell, Apotex demonstrates more than a “mere allegation that
`something useful will be found” in the protocol, as required under Garmin
`Factor 1.
`We balance this strong showing under Garmin Factor 1 against Novartis’s
`arguments that production of the protocol would be unduly burdensome for the
`
` 4
`
`
`
`
`
`
`
`IPR2017-00854
`Patent 9,187,405 B2
`reasons set forth in the Second Declaration of Peter J. Waibel, Esq. Sup. Br. 5,
`Ex. 2088.
`
`it would be unreasonable in terms of time and effort to determine the
`exact version provided to Mount Sinai in March 2007. Ex. 2088 ¶¶ 6–13. Such
`investigations are unnecessary because we focus here not on what information the
`Mount Sinai IRB relied on in objecting to the 0.5 mg study arm, but on what
`justification for that dose Novartis provided to the FDA.2
`
`
`
`
` We, therefore, infer that Novartis
`maintains a database of those amendments, such that it can readily identify which
`version[s] of the protocol were provided to the FDA.
`Upon weighing the equities, we find the thrust of Apotex’s request in the
`interest of justice. Accordingly, Novartis shall produce a copy of each unique
`version of the section of the Phase III clinical trial protocol provided to the FDA
`that contains Novartis’s justification for administering the 0.5 mg dose.
`Novartis’s briefing book
`2.
`Dr. Lublin relies on an excerpt of the Novartis briefing book quoted in
`Exhibit 2064,
`
`
`
`
`
` Ex. 2025 ¶ 46. Dr. Lublin testified that he did not rely on any
`other portion of the briefing book in preparing his declarations. Ex. 1042, 157:25–
`158:7. And though the remaining portions of the FDA minutes may bear on
`
`
`2 Patent Owner’s argument that “FDA is not a person of ordinary skill” is
`inapposite because we focus on Novartis’s representations to the FDA, and not
`what the FDA understood from those representations. See Sup. Br. 4.
`
` 5
`
`
`
`
`
`
`
`IPR2017-00854
`Patent 9,187,405 B2
`Novartis’s justification for the 0.5 mg dose, we find that possibility speculative. In
`any event, such disclosure would likely be cumulative to the information Novartis
`provided to the FDA in the Phase III clinical trial protocol.
`3. Minutes of the February 2, 2005 Meeting
`A brief excerpt of the FDA minutes is quoted in Exhibit 2066, which is a
`letter from Novartis to Dr. Miller of Mount Sinai School of Medicine.
`
`
`
`
` But because Dr. Lublin did not rely on any other
`portion of the FDA minutes in preparing his report, the minutes as a whole are not
`relevant to understanding Mr. Sinai’s position on the 0.5 mg study arm. See
`Ex. 1042, 195:11–13 (“Q.: Have you ever reviewed the FDA’s minutes? A.: No.”)
`As with the Novartis meeting book, the possibility that non-disclosed portions of
`the FDA minutes may bear on Novartis’s justification for the 0.5 mg dose is
`speculative, and would likely be cumulative to the information Novartis provided
`to the FDA in the Phase III clinical trial protocol.
`An Unredacted Version of Exhibit 2063.
`4.
`Dr. Lublin relies on Exhibit 2063 as evidence of communications in the
`Spring of 2007 between Novartis and Dr. Lublin’s assistant, Colleen Farrell, on
`behalf of the Mount Sinai IRB. Ex. 2025 ¶¶ 51, 56; see also Paper 26, 26–27. As
`set forth in the Declaration of Peter J. Waibel executed on December 5, 2017, “the
`redacted portion of [Exhibit 2063] constitutes internal conversation at Novartis
`only and does not include additional communication with any personnel at Mount
`Sinai School of Medicine.” Ex. 2078, ¶ 11. Apotex does not dispute the truth of
`Mr. Waibel’s declaration, but argues that Novartis’s “internal conversations are
`facially relevant because they relate to the information Novartis chose to give and
`
` 6
`
`
`
`
`
`
`
`IPR2017-00854
`Patent 9,187,405 B2
`withhold from the IRB.” Mot. 5. We do not find this argument persuasive because
`Dr. Lublin relies on the disclosed emails to explain
`
` and that basis did not include internal
`Novartis emails. See Ex. 2025 ¶ 52. Accordingly, Apotex’s argument amounts to
`mere speculation that something useful will be uncovered.
`
`
`ORDER
`Having considered the parties’ positions, it is:
`ORDERED Novartis shall produce a copy of each unique version of the
`section of the Phase III clinical trial protocol provided to the FDA that contains
`Novartis’s justification for administering the 0.5 mg dose. Each such copy will be
`identified by the date it was provided to the FDA. To the extent the justification
`appears in a discreet subsection, Novartis need not produce successive versions
`that do not contain amendments to that subsection.
`FURTHER ORDERED that Apotex’s remaining requests for discovery are
`DENIED.
`FURTHER ORDERED that, for good cause shown, the parties’ motions to
`seal Papers 35, 39, and 43 and Exhibits 1042–1045 and 2088 (see Papers 36 and
`37) are GRANTED; parties have 10 business days in which to jointly submit a
`proposed redacted version of this Order. The record of this proceeding shall be
`preserved in its entirety and the sealed documents will not be expunged or made
`public, pending the outcome of this proceeding and any appeal taken from the
`Final Decision. At the conclusion of any appeal or, if no appeal is taken, after the
`time for filing a notice of appeal has expired, the documents may be made public.
`See Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,761 (Aug. 14,
`
` 7
`
`
`
`
`
`
`
`IPR2017-00854
`Patent 9,187,405 B2
`2012). At that time, either party may file a motion to expunge the sealed
`documents from the record pursuant to 37 C.F.R. § 42.56.
`
`
`
`
`FOR PETITIONER APOTEX:
`
`Steven W. Parmelee
`Michael T. Rosato
`Jad A. Mills
`WILSON SONSINI GOODRICH & ROSATI
`sparmelee@wsgr.com
`mrosato@wsgr.com
`jmills@wsgr.com
`
`FOR PETITIONER ARGENTUM:
`Teresa Stanek Rea
`Deborah H. Yellin
`Shannon M. Lentz
`CROWELL & MORING LLP
`trea@crowell.com
`dyellin@crowell.com
`slentz@crowell.com
`
`Tyler C. Liu
`ARGENTUM PHARMACEUTICALS, LLC
`tliu@agpharm.com
`
`FOR PETITIONER TEVA:
`
`Amanda Hollis
`Eugene Goryunov
`KIRKLAND & ELLIS LLP
`Amanda.hollis@kirkland.com
`egoryunov@kirkland.com
`
`
` 8
`
`
`
`
`
`
`
`IPR2017-00854
`Patent 9,187,405 B2
`FOR PETITIONER SUN PHARMA:
`
`Samuel Park
`WINSTON & STRAWN LLP
`spark@winston.com
`
`FOR PATENT OWNER:
`
`Jane M. Love
`GIBSON, DUNN & CRUTCHER LLP
`jlove@gibsondunn.com
`
` 9
`
`
`
`
`
`
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
