Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. · ¶13

But the FDA cannot authorize a generic drug that would infringe a patent. So, while the FDA does not control the approval of drug patents, it keeps track of them in a volume called Approved Drug Products With Therapeutic Equivalence Evaluations, or more memorably, the Orange Book. A manufacturer seeking to market a generic version of a drug that appears in the Orange Book has two options. The first is to file a “paragraph IV certification,” which states that a patent “is invalid or will not be infringed by the manufacture, use, or sale of the [generic] drug.” §355(j)(2)(A) (vii)(IV). Such filing is an act of infringement under patent law, and it gives the brand-name manufacturer the right to file a lawsuit against the generic manufacturer to determine the validity and scope of the patent. Caraco, 566 U. S., at 407 (citing 35 U. S. C. § 271(e)(2)(A) (2012 ed.)). The generic manufacturer…

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