Pharmaceutical and biotechnology patents have increased aggressively in recent years. Consequently, this upward trend has posed a greater risk for the U.S. pharma patents. Political and economic troubles such as claims of patent evergreening abuse have also added complexity on existing challenges.
Inter partes review (IPR) proceedings have been an attractive ground for drug companies seeking to challenge the patentability of pharmaceutical products. The IPR allows challengers to maximize the streamlined process of the Patent Trial and Appeal Board (PTAB) while also taking advantage of the benefits provided by the Hatch-Waxman Act. Given this backdrop, the number of challenges utilizing the IPR process is predicted to continuously climb this year and beyond.
The COVID-19 pandemic has resulted in a major shift in FDA regulatory and enforcement priorities and has had a drastic impact on the broader regulatory landscape. At the end of 2019, the agency was focused, among other issues, on opioids, youth vaping, food safety, compounding and overhauling the regulatory framework for dietary supplements. Today, FDA is focused on helping industry bring to market drugs, devices and vaccines critical to fighting the pandemic. Its enforcement efforts are focused on those who peddle false cures or distribute counterfeit or otherwise poor quality products. The world has changed, and with it the regulatory environment.
As the biosimilar industry continues to grow, significant legal developments and trends also continue to emerge and pose challenges to market participants. Questions currently hounding the future of the Biologics Price Competition and Innovation Act (BPCIA) litigation and regulatory pathway include the newly introduced Biologic Patent Transparency Act, the ongoing debates on the constitutionality of the Affordable Care Act (ACA), and the potential unavailability of inter partes and post-grant review proceedings for biosimilar manufacturers.