This simply means that Hatch-Waxman periods will apply, for the first generic after patent expiry. [Mid 2022 backgrounder here; full PDF of the May settlement order here -- and a bit:]
. . .As used in this Consent Judgment, (i) the term "Zenara Product" shall mean the drug product sold, offered for sale or distributed pursuant to Abbreviated New Drug Application No. 216842 (and defined in greater detail in the Settlement Agreement); (ii) the term "Licensed Patent" shall mean United States Patent Number 8,080,580; and (iii) the term "Affiliate" shall mean any entity or person that, directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with Zenara; for purposes of this definition, "control" means (a) ownership, directly or through one or more intermediaries, of (1) more than fifty percent (50%) of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or (2) more than fifty percent (50%) of the equity interests in the case of any other type of legal entity or status as a general partner in any partnership, or (b) any other arrangement whereby an entity or person has the right to elect a majority of the Board of Directors or equivalent governing body of a corporation or other entity or the right to direct the management and policies of a corporation or other entity.
Unless otherwise specifically authorized pursuant to the Settlement Agreement, Zenara, including any of its Affiliates, successors and assigns, is enjoined from infringing the Licensed Patent, on its own part or through any Affiliate , by making, having made, using, selling, offering to sell, importing or distributing of the Zenara Product.
Compliance with this Consent Judgment may be enforced by Merck and its successors in interest, or assigns, as permitted by the terms of the Settlement Agreement. . . .
Now you know -- onward, grinning on a warm, sunny Chicago noon-time stroll. . . .
नमस्ते
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