by April Breyer Menon | Jun 4, 2020
In an extended interview with the Center for Biosimilars, Venable’s Ha Kung Wong and April Breyer Menon discussed potential biosimilars legislation, including the Hatch-Waxman Integrity Act, Stop STALLING Act, Biologic Patent Transparency Act, Affordable and...
by April Breyer Menon | May 28, 2020
It’s no secret that the US biosimilar industry has had a slow start in terms of uptake. Although the Hatch-Waxman Act and the Biologic Price Competition and Innovation Act (BPCIA) established pathways to approval for both generic drugs and biosimilars, there is still...
by April Breyer Menon | May 5, 2020
On March 9, 2020, FDA and the US Federal Trade Commission (FTC) held a public workshop to discuss issues related to biosimilars in the United States. According to FDA and FTC, the workshop’s purpose was to discuss the “FDA and FTC’s collaborative efforts to support...
by April Breyer Menon | Jan 22, 2020
Venable partner Ha Kung Wong spoke at the Specialty Therapies and Biosimilars Conference as part of a panel that discussed biosimilar litigation and patent issues. He focused on the impact of inter partes reviews (IPRs) and post grant reviews (PGRs) on how patents...
by April Breyer Menon | Dec 12, 2019
The Supreme Court on December 11, 2019 unanimously ruled in Peter v. NantKwest, Inc., No. 18-801, that the United States Patent and Trademark Office (USPTO) cannot shift the fees of its attorneys and paralegals to litigants in district court proceedings brought under...
by April Breyer Menon | Nov 22, 2019
Heralded as a less expensive, faster way to challenge patents, inter partes review (IPR) before the US Patent Trial and Appeal Board (PTAB) has proven remarkably popular. IPR was first available on September 12 2012, and within days, the first petitions challenging...