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Expansion of the Prior-User Rights Defense - Its Implications for Bioproduction Methods

  • 05.01.12
  • Paul A. Calvo, Ph.D.
  • BioProcess International

A common reaction to some patents directed to manufacturing processes (especially of biotherapeutics) is “How did they get a patent for that when we've been doing the same thing for years?”

The number of patents covering biotherapeutic production processes is steadily increasing along with the realization that upstream and downstream processing events provide a potentially abundant source of so-called “second-generation” patent protection for biologics, especially those facing biosimilar competition. Although some groups are prolific patent filers claiming a wide range of processes — from methods of culturing cells with a particular chemically defined media to methods for regenerating chromatography matrices — others choose to keep their manufacturing products and processes secret.

Until recent US patent reforms introduced by the Leahy–Smith America Invents Act (AIA) became law, many organizations keeping their processes secret ran the risk of being sued for patent infringement, even if they'd been using a patented process before the filing date of the third-party patent. However, a major change in patent law came into effect on 26 September 2011. The AIA now affords a defense to patent infringement if a party can prove a commercial prior use of a patented process.

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