`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`————————————————
`
`AZURITY PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`HELSINN HEALTHCARE S.A.,
`Patent Owner.
`
`————————————————
`Case IPR2025-00946
`Case IPR2025-00947
`Patent US 9,186,357 B2
`————————————————
`
`STATEMENT REGARDING MULTIPLE PETITIONS
`
`
`
`I.
`
`INTRODUCTION
`Petitioner Azurity Pharmaceuticals, Inc. (“Azurity”) has concurrently filed
`
`two petitions for inter partes review (“IPR”) to cancel disjoint claim sets of U.S.
`
`Patent 9,186,357 (“Trento’357”, EX1002), assigned to Patent Owner (Helsinn).
`
`Specifically, a IPR2025-00947 challenges claims 1, 5-10, 17-39, and 43-51, while
`
`IPR2025-00946 challenges claims 2-4, 11-16, 40-42, and 52-62. The multiplicity
`
`and complexity of the claims, as well as the necessity of addressing applicant-
`
`submitted evidence and argument in the prosecution history, makes “more than one
`
`petition … necessary” within the meaning of the PTAB Consolidated Trial Practice
`
`Guide (“CTPG”), 59-60 (Nov. 2019). For the reasons provided below, the Director
`
`should institute both petitions.
`
`II. RANKING
`
`As the following table shows, the claims do not overlap; hence, Azurity
`
`believes ranking petitions for non-overlapping claims is inapplicable except to
`
`comply with the TPG.
`
`Rank IPR2025
`
`Claims
`
`Grounds
`
`1, 5-10, 17
`
`1: Herrstedt (EX1010) & Bös
`
`(EX1014)
`
`18-19, 25-27 & 30-32 2: Herrstedt, Bös & Herrington
`
`-00947
`
`1
`
`(EX1016)
`
`-1-
`
`
`
`20
`
`3: Herrstedt, Bös, Herrington &
`
`ALOXI (EX1015)
`
`24 & 29
`
`5: Herrstedt, Bös, Hargreaves
`
`(EX1012) & Herrington
`
`28
`
`6: Herrstedt, Bös, Bonadeo (EX1017)
`
`& Herrington
`
`21-23, 33-35, 37-39,
`
`7: Herrstedt, Bös, Bonadeo,
`
`43-44 & 46-51
`
`Herrington & ALOXI
`
`36 & 45
`
`8: Herrstedt, Bös, Bonadeo,
`
`Hargreaves, Herrington & ALOXI
`
`2, 3, 4, 11-16, 40, and
`
`1: Herrstedt & Bös
`
`2
`
`-00946
`
`52-54 & 56-62
`
`41-42
`
`55
`
`2: Herrstedt, Bös & Herrington
`
`4: Herrstedt, Bös & Hargreaves
`
`III. MATERIAL DIFFERENCES; REASONS FOR INSTITUTION
`
`Trento’357 contains 62 claims with three independent claims: 1, 2, and 4.
`
`The petitions have been divided to treat claim 1 and its dependencies in the first
`
`petition, and to treat claims 2 and 4 and their dependencies in the other. The second
`
`petition is comparable in size (23 claims) to petitions Azurity is concurrently filing
`
`against other Helsinn patents, while the first petition by itself is larger (39 claims)
`-2-
`
`
`
`than the others.
`
`
`
`As patentee, Helsinn alone controlled the number and complexity of the
`
`claims it pursued in a single patent. The claims are both numerous and complex,
`
`spanning nearly six columns of the patent, and over 2400 words. Cf. AliveCor, Inc.
`
`v. Apple Inc., IPR2023-00948, #8, 24 (2024) (“[T]he claims themselves constitute
`
`almost 1,000 words.”); accord Meta Platforms v. SitNet LLC, IPR2024-00528,
`
`#10, 10 (2024) (“We agree with Petitioner that the claims in the patent are
`
`relatively lengthy. Moreover, the overlap of petitions (i.e., the prior art asserted),
`
`mitigates the potential that the parallel proceedings may place a substantial and
`
`unnecessary burden on the Board or the patent owner or that it could raise fairness,
`
`timing, and efficiency concerns.”) (simplified); see also, e.g., Visa, Inc. v. Cortex
`
`MCP, Inc., IPR2024-00486, Paper 8 at 41-43 (Aug. 2, 2024) (instituting multiple
`
`IPRs; patent with 33 claims totaling 1,691 words has “a relatively high number of
`
`claims and the claims are relatively lengthy”); Novartis Gene Therapies, Inc. v.
`
`Genzyme Corp., IPR2023-01045, Paper 10 at 3-5 (Jan. 17, 2024) (patent with 34
`
`claims justifies multiple petitions).
`
`
`
`Helsinn evinced an intent to cover different inventions in each of its
`
`independent claims, which each claim a method of treating chemotherapy-induced
`
`nausea and vomiting with:
`
`-3-
`
`
`
`active ingredient Claim 1
`
`Claim 2
`
`Claim 4
`
`palonosetron
`
`netupitant
`
`dexamethasone
`
`yes
`
`yes
`
`yes
`
`not required
`
`yes
`
`yes
`
`yes
`
`subtherapeutic not required
`
`Each set of claims starts with different limitations to be incorporated, and the
`
`dependent claims—while often similar—are not identical and indeed often diverge
`
`sharply. For example, only the claim-1 family has a dependent claim (28) with a
`
`specific impurity limitation. Thus, alternative forms of claim grouping that might
`
`work for some patents do not lend themselves to the complex, nonlinear way
`
`Helsinn chose to draft its claims here. Cf. 37 C.F.R. §1.75(g) (requiring claims to
`
`be logically ordered and grouped together). Sixty-two is objectively a large number
`
`of claims. Cf. 35 U.S.C. 41(a)(2)(ii) (defining “Excess claims” as more than twenty
`
`per application); accord 37 CFR §42.15(a)(3) (surcharge for more than 20 claims).
`
`
`
`Additionally, the petitions address secondary considerations raised during
`
`prosecution. Trento’357 issued from a child of an application in which the
`
`examiner expressly relied as reason for allowance on declaration testimony
`
`purporting to show unexpected results from using netupitant. Helsinn’s declaration
`
`and related argument warrant careful analysis supported with expert testimony to
`
`show precisely why they were both material to allowance and substantively
`
`misleading. EX1009, ¶32 (explaining materiality); cf. Gilead Sciences v. United
`-4-
`
`
`
`States, IPR2019-01453, #14, 29 (2020) (denying institution because unexpected
`
`results leading to allowance not addressed).
`
`
`
`A single IPR covering a subset of claims would not be sufficient. Because
`
`no collateral litigation is pending, Azurity cannot predict which claims Helsinn
`
`might choose to enforce. Cf. AliveCor, IPR2023-00948, #8, 24 (given litigation
`
`uncertainty, “it is not unreasonable for Petitioner to challenge all the claims”). If
`
`Azurity waited for litigation to file a second IPR, it would face a Catch-22
`
`accusation of having waited and filed a serial petition for tactical advantage. Both
`
`Board efficiency and public interest are best served by resolving patentability for
`
`all claims now.
`
`
`
`Additionally, because Azurity is filing the two IPR petitions simultaneously,
`
`they will be able to follow the same schedule post-institution, maximizing the
`
`efficiency of depositions, briefing, and oral argument, as well as allowing the
`
`Board the option to eliminate any inefficiencies by consolidating the proceedings.
`
`See, e.g., Visa, IPR2024-00486, #8, 42. Further, the petitions apply consistent
`
`claim constructions and are supported by the same expert witness, meaning a
`
`single deposition should be sufficient.
`
`IV. CONCLUSION
`
`All Trento’357 claims are unpatentable. Azurity respectfully requests both
`
`inter partes reviews be instituted so all these claims receive review.
`
`-5-
`
`
`
`
`
`
`
`Dated: 1 May 2025
`
`
`
`
`
`Respectfully submitted,
`
`
`/Richard Torczon/
`Richard Torczon, Reg. No. 34,448
`Counsel for Azurity Pharmaceuticals, Inc.
`
`-6-
`
`
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
