Maureen Rurka To Discuss Challenging Patents on Reference Drugs at ACI’s Summit on Biosimilars & Innovator Biologics

Winston & Strawn Partner Maureen Rurka spoke at the 13^th Summit on Biosimilars & Innovator Biologics, June 28-29, in Boston, MA.

The summit—which attracts distinguished speakers, including leading in-house counsel and representatives from key government agencies and trade associations—explored the contours of the rapidly changing landscape for biosimilars and innovator biologics.

On June 28, Maureen spoke on a panel titled “Challenging Patents on Reference Drugs: Litigation Strategies in the IPR Forum.” 

Among other topics, the interactive panel covered:

• Reducing risk by challenging patents in advance of launching biosimilars at risk
• Understanding the advantages for applicants to resolve prior art invalidity disputes via IPRs
• Establishing standing to appeal in an IPR in connection with BPCIA and the FDA approval process for biosimilars
• Anticipating an answer to the unresolved question as to how much investment is required in the biosimilar context under Article III to establish standing
• Appreciating the timing for applicants to file petitions for IPRs relative to filing BLAs and BPCIA litigation
• Analyzing biosimilars IPR filings and recent PTAB decisions

Learn more about Winston’s Patent Litigation Practice.