On December 4, 2018, Ha Kung Wong was quoted in a webcast for The Center for Biosimilars about how upcoming changes to the regulation of biologics are generating industry uncertainty. Here is an excerpt:
By 2020, some products that are currently regulated as drugs, like insulin, will be regulated as biologics. Does this fact pose any challenges—or opportunities—from the patent litigation standpoint? There is an incredible amount of uncertainty that surrounds the change in regulation of these products, not only with respect to the FDA approval process, but also when it comes to litigation. While the FDA has put out a draft guidance titled "Implementation of the 'Deemed to be a License' Provision of the Biologics Price Competition and Innovation Act of 2009"—that's a mouthful—there still remain a host of questions for innovators and generic and biosimilar manufacturers.