PHARMACEUTICALS AND BIOTECHNOLOGY PATENT LITIGATION

CD: Reflecting on the last 12-18 months, what do you consider to be the most significant developments shaping patent litigation in the pharma and biotech industries?

Sheridan: One significant development is that the US Food and Drug Administration (FDA) has recently begun publishing patent lists in the ‘Purple Book’, an online database with information about FDA-licensed biological products. Previously, biosimilar manufacturers had few options to identify the potential patents that might cover a branded biological product. In contrast, manufacturers of small molecule generic drugs have access to the FDA’s ‘Orange Book’ which lists all patents that a branded small molecule drug manufacturer might assert during Hatch-Waxman litigation. The publication of patent information in the Purple Book has now improved access to reliable patent information which should help biosimilar manufacturers evaluate their potential litigation exposure and improve their likelihood of successfully bringing biosimilar products to market.

Bornstein: The increasing complexity of the technologies involved drives shifts in the pharmaceutical and biotech industries and related patent litigation. We have seen an uptick in litigation dealing with complex platform technologies, which dovetails with a reduced frequency of seeking injunctions. The wide application of platform technologies in particular leads to increased awareness and consideration of public interest factors when contemplating whether to seek or whether the court is willing to grant a preliminary injunction. The shift in the true heart of the invention, for example a highly effective delivery vector instead of a new active pharmaceutical ingredient (API), also changes the way companies can prepare for and conduct patent litigation, as claim language becomes increasingly complicated. Over the last year, we have also seen high-stakes and topical litigation related to vaccines and clustered regularly interspaced short palindromic repeats (CRISPR)-related technologies, which look set to continue as these technologies mature.

Jan-Mar 2023 issue

Charles River Associates

Freshfields Bruckhaus Deringer LLP

Kirkland & Ellis International LLP