by April Breyer Menon | Aug 10, 2021
Venable Fizpatrick partner Ha Kung Wong’s expert opinion was cited in an article about the Supreme Court’s opinion in California v. Texas, upholding the Affordable Care Act (ACA). According to Wong, it remains to be seen how future constitutional attacks,...
by April Breyer Menon | Jul 29, 2021
On July 28, 2021, the FDA approved Viatris (formerly Mylan) and Biocon Biologics’ Semglee® (insulin glargine-yfgn) as the first interchangeable biosimilar in the U.S. Semglee is both biosimilar to, and interchangeable with Sanofi’s Lantus® (insulin glargine). Based...
by April Breyer Menon | Jul 28, 2021
Venable Fizpatrick partner Ha Kung Wong spoke with Managing IP about the current rate of biologic drug post grant reviews (PGRs) at the Patent Trial and Appeal Board (PTAB) and a potential uptick in the future. He also discussed reasons PGRs may be filed instead of...
by April Breyer Menon | Jun 28, 2021
Venable Fizpatrick partner Ha Kung Wong spoke with Part B News about the Supreme Court’s opinion in California v. Texas, upholding the Affordable Care Act (ACA) for the third time, as well as another upcoming case regarding the ACA, Kelley v. Becerra. The...
by April Breyer Menon | Jun 22, 2021
On June 21, 2021, the Supreme Court in United States v. Arthrex Inc., No. 19-1434, held that the authority wielded by administrative patent judges (APJs) in inter partes review proceedings (IPRs) violates the Appointments Clause of the Constitution. The Supreme Court...
by April Breyer Menon | Jun 15, 2021
On June 25, 2021, the Biological Product Patent Transparency (BPPT) amendments to 42 U.S.C. 262(k) of the Biologics Price Competition and Innovation Act (BPCIA) will take effect. Those amendments make publication of the FDA “Purple Book” mandatory; require...