Legal Proceedings
+Added: From time to time, we may be a party or subject to legal proceedings and claims, either asserted or unasserted, which arise in the ordinary course of business.
+Added: Some of these proceedings that we may be involved in the future, are claims that are subject to substantial uncertainties and unascertainable damages or other remedies.
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: The notice letter included a Paragraph IV certification with respect to our US Patent Nos.
−Removed: 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”).
−Removed: The notice letter asserts that these patents will not be infringed by Annora’s proposed product, are invalid and/or are unenforceable.
−Removed: Annora’s notice letter does not provide a Paragraph IV certification against our other patents listed in the Orange Book.
−Removed: 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.
−Removed: 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.
−Removed: We filed an answer to Annora’s counterclaims on October 12, 2022.
+Added: 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.
+Added: In September 2022, Annora and its affiliates answered and counterclaimed for declaratory judgment of non-infringement and invalidity of certain patents.
+Added: We filed an answer to Annora’s counterclaims in October 2022.
+Added: Annora served invalidity and non-infringement contentions in December 2022.
+Added: We filed an answer to Annora’s invalidity and non-infringement contentions in March 2023.
We intend to vigorously enforce and defend our intellectual property related to TAVALISSE.
−Removed: We may also from time to time become a party or subject to other legal proceedings and claims, either asserted or unasserted, which arise in the ordinary course of business.
−Removed: Some of these proceedings that we may be involved in the future, are claims that are subject to substantial uncertainties and unascertainable damages or other remedies.
+Added: 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.