`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`CIVIL ACTION
`
`NO. 22-252
`
`:
`:
`:
`:
`:
`:
`:
`:
`
`ORDER
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GMBH,
`
`
`
`
`
`
`
`
`
`
`
`
`Plaintiffs,
`
`
`
`
`
`
`
`
`
`
`v.
`
`
`
`
`
`
`
`
`
`
`
`MODERNA, INC. and MODERNATX, INC.,
`
`
`
`
`
`
`
`
`
`
`
`AND NOW, this 27th day of February, 2024, upon consideration of Plaintiffs’ Discovery
`
`Dispute letters (D.I. 161, 184, 206) and Defendant’s Responses (D.I. 183, 196, 212), and following
`
`a discovery hearing, it is hereby ORDERED that:
`
`1. With respect to the timing of Defendant’s production of samples,
`
`a. Within fourteen (14) days from the date of this Order, Defendant shall
`
`produce to Plaintiffs all remaining information about batch/lot numbers;
`
`b. Within fourteen (14) days from the date of this Order, Defendant shall
`
`produce all samples from the three lots/batches selected by Defendant; and
`
`c. Within twenty-one (21) days from the date that Plaintiffs identifies the
`
`three lots/batches it has selected for sampling, Defendant shall produce all
`
`samples from those lots/batches.
`
`2. With respect to Plaintiffs’ request to preclude Defendant from making arguments
`
`about the applicability of test data generated by Plaintiffs for any lot based on its
`
`expiration date, that request is denied as premature without prejudice to
`
`Plaintiffs’ right to re-raise this issue through motions in limine.
`
`3. With respect to Plaintiffs’ request for SM-102 LNP samples and related data,
`
`
`
`Case 1:22-cv-00252-MSG Document 229 Filed 02/27/24 Page 2 of 3 PageID #: 15342
`
`a. As to Plaintiffs’ request for samples, counsel are instructed to meet and
`
`confer regarding Plaintiff’s proposed compromise. If the parties are unable
`
`to reach an agreement, Plaintiffs may re-raise this issue with the Court; and
`
`b. As to certificates of analysis, Defendant shall complete production of all
`
`certificates of analysis showing SM-102 LNP lipid content. Plaintiffs must
`
`engage in a thorough review of the produced regulatory information, and, if
`
`they believe it is insufficient, Plaintiffs may re-raise this issue with the Court
`
`and establish how the need for the raw data underlying the certificates of
`
`analysis outweigh any undue burden on Defendants.
`
`4. With respect to Plaintiffs’ request for INDs for non-accused products, Defendant
`
`shall select three INDs that have molar ratios similar to the accused product and
`
`produce the Chemistry, Manufacturing, and Controls sections for each of those
`
`INDs. Following review of those documents, Plaintiffs may, if necessary, request
`
`additional INDs but only with a specific and detailed showing of need.
`
`5. With respect to Plaintiffs’ request for sales information about vaccines
`
`manufactured abroad and sold abroad, Plaintiffs shall propound to Defendant
`
`specific interrogatories about such sales that are narrowly-tailored to the factors
`
`enumerated in Halo Electronics, Inc. v. Pulse Electronics, Inc., 831 F.3d 1369 (Fed.
`
`Cir. 2016). After review of Defendant’s responses, if Plaintiffs are able to
`
`demonstrate that a specific sale could be deemed a “U.S. Sale,” they may renew
`
`their request for documents as to that sale.
`
`
`
`Case 1:22-cv-00252-MSG Document 229 Filed 02/27/24 Page 3 of 3 PageID #: 15343
`
`6. With respect to Plaintiffs’ request for Board of Directors’ Minutes and Materials
`
`Concerning the Accused Product, this request is denied as moot in light of the
`
`parties’ agreement on this issue.
`
`7. With respect to Plaintiffs’ request for litigation deposition transcripts of Moderna
`
`witnesses from Moderna v. Pfizer, No. 22-cv-11378 (D. Mass) and Alnylam v.
`
`Moderna, No. 22-cv-335 (D. Del.), Plaintiffs’ request is denied as moot in light of
`
`the parties’ agreement on this issue.
`
`8. With respect to Plaintiffs’ request for documents from litigation in Moderna v.
`
`Pfizer, No. 22-cv-11378 (D. Mass), Plaintiffs’ request is denied as moot in light of
`
`the parties’ agreement on this issue.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`BY THE COURT:
`
`
`
`/s/ Mitchell S. Goldberg
`MITCHELL S. GOLDBERG, J.
`
`
`
`
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
