Indeed, it is referred to in the pharmaceutical industry as the “patent dance” – and it’s closer to a tango than a two-step. The 'Patent Dance' And The 180-Day Notice Provision To kick off ...

Thus, biosimilar makers not currently involved in a patent dance with the RPS could not determine with certainty what patents an RPS might assert in future BPCIA litigation. This disparity between ...

The Optional Patent Dance: First Avenue For Pre-FDA Approval Patent Challenge One avenue for biosimilars to reduce patent litigation risk at commercial launch is to pursue the early patent ...

Valenti: What we colloquially refer to as the patent dance is the pre-litigation mechanism for an information exchange between biosimilar applicants and the reference product sponsor, or the brand ...

The reference to PHS Act §§ 351(l)(2)-(6) is to the BPCIA’s multi-step “patent dance” procedures: Step 1 – Transmission of Biosimilar Application; Step 2 – Reference Product Sponsor ...

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