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 ...

This gives the brand-name manufacturer an opportunity to determine whether the biosimilar company may violate any patents, a procedure that is designed to create a level playing field, but has ...

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Several justices suggested that if biosimilar drug applicants won’t comply with the so-called patent dance prescribed by the law, perhaps branded drugmakers can pursue remedies under state ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation ...