Competitor vs. Competitor Biopharma Patent Litigation: Current Trends and Best Practices

Competitor vs. Competitor Biopharma Patent Litigation: Current Trends and Best Practices

View Session Speakers

This panel will examine current trends and best practice in competitor vs. competitor biopharma patent litigation, including both Hatch-Waxman litigation and biosimilar litigation.

Among the specific items to be discussed, the panel will address: (1) The effect of In re Cellect on the Hatch-Waxman industry; (2) How a patent owner and generic can settle an ANDA case while minimizing anti-trust risk; (3) The impact of Amgen on 112 defenses and why they are more viable in the pharmaceutical industry than ever before; (4) How the unpredictability of the art can create a 112 problem, and how the response to the 112 issue can walk you into an obviousness trap; (5) Skinny label issues, including whether you can avoid inducement with a skinny label; (6) Strategic considerations, including whether a PTAB petition should be filed before the paragraph IV window opens and whether second ANDA filers can or should file a PTAB petition; and (7) Identifying biosimilar cases that are likely to be litigated through to conclusion and which tend to settle, and why.

Materials

U.S. Government Sides with Teva in Skinny Label SCOTUS Fight

Two Pharma and Biotech Cases to Watch

Hatch-Waxman and BPCIA Cases and Trends to Watch