As we reported last week, Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively, “Janssen”) filed under seal a BPCIA complaint in the U.S. District Court for the District of Delaware against Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd. (collectively, “Defendants”), alleging that Accord and Bio-Thera infringe 17 patents in relation to their proposed golimumab biosimilar. A redacted version of that complaint has now been filed, revealing some additional details about the lawsuit.
According to the complaint, Defendants have developed and plan to sell biosimilar versions of Janssen’s SIMPONI® and SIMPONI ARIA®, which Defendants have identified as BAT2506. The complaint alleges that Bio-Thera is responsible for the development, manufacturing, and supply of BAT2506, and has entered into contracts under which it has received and will receive revenues and other financial compensation for the sale of BAT2506 in the United States. The complaint also alleges that Accord will sell BAT2506 in the United States.
The complaint asserts 17 patents across 34 counts (one direct infringement count and one declaratory judgment count per patent). The patents are generally directed to, among other things, manufacturing and method-of-treatment patents.
The complaint asserts that the parties engaged in pre-litigation disclosures under the BPCIA (the so-called “patent dance”) including disclosure of the aBLA and other documents under 42 U.S.C. § 262(l)(2)(A). However, Janssen alleges that, although Accord provided the aBLA for BAT2506, it failed to fully provide “such other information that describes the process or processes used to manufacture the biological product.”
The complaint further alleges that Janssen provided its list of patents which it believed a claim of patent infringement could reasonably be asserted consistent with 42 U.S.C. § 262(l)(3)(A).
Finally, according to the complaint, Defendants provided their non-infringement and invalidity disclosures and accompanying documents under § 262(l)(3)(B), but Janssen asserts that these disclosures failed to show that Defendants’ manufacture or sale of BAT2506 will not infringe the asserted patents.
In terms of relief, Janssen requests a judgment that Defendants have infringed Janssen’s patents under 35 U.S.C. § 271(e)(2)(C) by filing their aBLAs for BAT2506 and seeks to delay FDA approval of the aBLA until expiry of the asserted patents, an injunction, a determination that the case is willful and exceptional, costs and attorneys’ fees, and any available damages.
Stay tuned to Big Molecule Watch for further updates on this BPCIA case.
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