Ha Kung Wong, JD, Partner at Fitzpatrick, Cella, Harper and Scinto, discusses whether the FDA might clarify its stance on the BPCIA.
Ha Kung Wong, JD, Partner at Fitzpatrick, Cella, Harper and Scinto
Transcript:
Justice Breyer seems to be indicating that the FDA’s interpretation of the [Biologics Price Competition and Innovation Act, BPCIA] would be eligible for Chevron deference. And that might make sense with respect to the timing of the notice of commercial marketing. So, for example, the FDA might have some incentive in the future to say that they interpret the BPCIA to require 180 days between formal FDA approval at the expiration of the biologic exclusivity and commercial marketing.
But with respect to the civil procedure requirements—the “patent dance” aspect of the Sandoz holding, it’s not really clear what the FDA’s incentive would be or how the FDA’s authority would extend to parties’ standing before the Article III courts. It’s uncertain if the FDA has any incentive to weigh in on the patent dance, and whether they would feel confident that their interpretation of the procedural aspects of patent litigation would be entitled to deference, you know, Justice Breyer’s concurrence notwithstanding.
Q&A With Dr Chelsee Jensen: Navigating FDA Approvals, Challenges in the Biosimilar Landscape
January 14th 2024Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, reacts to the biggest FDA approvals of 2023 and how she sees the adalimumab, natalizumab, and tocilizumab spaces playing out.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
IGBA 2023: Dr Monique Mansoura Highlights the Intersection of Geopolitical Issues, Biopharma
February 19th 2023COVID-19 allowed governments to critically examine the biopharma space to increase access to vaccines, but there's still a way to go, according to Monique Mansoura, PhD, MBA, executive director of global health security and biotechnology at the MITRE Corporation, at the International Generic and Biosimilar Medicines Association’s annual meeting.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.