Patent litigation is an increasingly inevitable fact of life for companies that develop and launch branded pharmaceutical products.  Generic competitors have an initial window to challenge patents on products containing new chemical entities just four years after FDA approval.  Further, even outside of the realm of potential generics, a product launch may spur litigation by branded competitors or non-competitor patent owners claiming mechanisms of action, platform technologies, or treatment methodologies.  Early preparation is key for maximizing chances of success in litigation.  This presentation will discuss how focusing early on critical facts, evidence, and witnesses allows coordination among the varied stakeholders in the company while allowing time to make necessary corrections in patents or initiate action against potential third-party patents.

Early preparation for patent litigation on pharmaceutical products

246th National Meeting (2013)

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