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Regarding the Encapsulation of mRNA (‘651) Patent, the court held that “wherein at least 70% / at least 80% / about 90% of the mRNA in the formulation is fully encapsulated in the lipid vesicles” means “wherein at least 70% / at least 80% / about 90% of the mRNA is fully, as distinct from partially, contained inside the lipid vesicles”.
−Removed: Fact discovery is ongoing and next steps include expert reports and depositions.
−Removed: A trial date has been set for April 21, 2025 and is subject to change.
+Added: On August 5, 2024, we and Genevant, along with Moderna, filed a Stipulation to Extend Time (the Stipulation) with the court requesting an amended case schedule to accommodate certain outstanding discovery from Moderna and third parties, as specified in the Stipulation, which would move the start of the trial from April 21, 2025 to September 24, 2025, subject to the court’s availability.
+Added: The Stipulation, and the new deadlines set forth therein, are subject to the approval of the court.
+Added: A conference to discuss the Stipulation has been scheduled by the court for August 15, 2024.
Acuitas Declaratory Judgment Lawsuit
3 unchanged sentences
8,058,069, 8,492,359, 8,822,668, 9,006,417, 9,364,435, 9,404,127, 9,504,651, 9,518,272, and 11,141,378 do not infringe Pfizer and BioNTech’s COVID-19 vaccine, COMIRNATY, which uses an mRNA lipid provided, under license, by Acuitas.
−Removed: Acuitas also seeks a declaration that each of the listed patents is invalid.
+Added: seeks a declaration that each of the listed patents is invalid.
On June 24, 2022, we and Genevant sought a pre-motion conference concerning our anticipated motion to dismiss all of Acuitas’ claims due to lack of subject matter jurisdiction.
12 unchanged sentences
Acuitas filed a request to commence discovery on November 18, 2023, to which we and Genevant responded on November 20, 2023.
−Removed: A ruling on the motion to dismiss, which is expected to be decided on the papers, has not yet issued.
−Removed: Discovery has not yet commenced in this action.
+Added: On May 20, 2024, the court granted our and Genevant’s motion to dismiss, so we believe this matter is now concluded.
Moderna Inter Partes Review Petition
34 unchanged sentences
On October 31, 2023, the Opposition Division issued a summons for oral proceedings and provided its preliminary and non-binding opinion on the subject matter to be discussed at the hearing.
−Removed: On November 3, 2023, we responded to the summons and on January 15, 2024, Moderna and Merck filed their reply to the written opinion of the Opposition Division, as well as to our written submission of November 3, 2023.
+Added: November 3, 2023, we responded to the summons and on January 15, 2024, Moderna and Merck filed their reply to the written opinion of the Opposition Division, as well as to our written submission of November 3, 2023.
We responded to Moderna and Merck’s reply on April 5, 2024.
−Removed: Oral proceedings are presently scheduled to be held on June 6, 2024.
+Added: Oral proceedings were held on June 6, 2024, and the Opposition Division upheld the ‘254 Patent but declined our and Genevant’s request to broaden certain claims in the ‘254 Patent.
+Added: We have not received any indication from Moderna and Merck if they plan to appeal the decision, and Genevant and we are currently evaluating whether to appeal the Opposition Division’s decision not to allow Genevant and us to broaden our claims under the ‘254 Patent.
While we are the patent holder, the ‘127 Patent, the ‘254 Patent, the other patents in our LNP portfolio have been licensed to Genevant and are included in the rights licensed by us to Genevant under the Genevant License.
11 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.