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Our threshold for disclosing material environmental legal proceedings involving a government authority where potential monetary sanctions are involved is $1.0 million.
−Removed: In June 2022, we received a notice letter regarding an ANDA submitted to the FDA by Annora, requesting approval to market a generic version of TAVALISSE.
−Removed: In July 2022, we filed a lawsuit in the United States District Court for the District of New Jersey against Annora and its subsidiaries for infringement of certain of our US patents.
−Removed: In September 2022, Annora and its affiliates answered and counterclaimed for declaratory judgment of non-infringement and invalidity of certain patents.
+Added: In June 2022, we received a notice letter regarding an ANDA submitted to the FDA by Annora Pharma Private Limited (Annora), requesting approval to market a generic version of TAVALISSE.
+Added: The notice letter included a Paragraph IV certification with respect to our US Patent Nos.
+Added: 8,771,648 and 8,951,504, which are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (referred to as the “Orange Book”).
+Added: The notice letter asserts that these patents will not be infringed by Annora’s proposed product, are invalid and/or are unenforceable.
+Added: Annora’s notice letter does not provide a Paragraph IV certification against our other patents listed in the Orange Book.
+Added: On July 25, 2022, we filed a lawsuit in the US District Court for the District of New Jersey against Annora and its affiliates, Hetero Labs Ltd., and Hetero USA, Inc., for infringement of our US patents identified in Annora’s Paragraph IV certification.
+Added: On September 21, 2022, Annora and its affiliates answered and counterclaimed for declaratory judgment of non-infringement and invalidity of the ’458, ’122, ’492, ’648, and ’504 patents.
We served an answer to Annora’s counterclaims in October 2022.
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We served an answer to Annora’s invalidity and non-infringement contentions in March 2023.
−Removed: Litigation continues with preparation for a Markman hearing expected early next year.
+Added: Litigation continues, and no trial date is currently set.
We intend to vigorously enforce and defend our intellectual property related to TAVALISSE.
−Removed: For a more detailed discussion of this litigation matter, see Part I, Item 3, “Legal Proceedings” of our Annual Report on Form 10-K as of December 31, 2022.
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.