The U.S. Food and Drug Administration took another step to implement its Drug Competition Action Plan on June 18, 2019, by updating the information provided in the Paragraph IV Certifications List. The updated list will provide greater transparency regarding Paragraph IV certifications and potential exclusivities. That transparency will in turn lead to greater predictability for generic manufacturers regarding the potential timing of approval for their ANDAs and the potential degree of competition. The additional information will also give the public better insight into the status of generic regulatory exclusivities and the potential future availability of lower-cost generic alternatives for specific drug products.
The Generic Drug User Fee Amendments of 2012 (GDUFA) were signed into law on July 9, 2012, in an effort “to speed access to safe and effective generic drugs to the public and reduce costs to industry.” In July 2014, the U.S. Food and Drug Administration issued two draft Guidances for Industry: one relating to Prior Approval Supplements Under GDUFA and one relating to Amendments and Easily Correctable Deficiencies Under GDUFA.
The U.S. Food and Drug Administration (FDA) recently published a new Guidance for Industry, titled ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers, which provides answers to questions from public comments received on the draft Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products (“FDA stability guidance”) that was published in the Federal Register on September 25, 2012. It also incorporates comments received on the same draft, which were previously published in the Federal Register on August 27, 2013.
By Vicki G. Norton, Siegfried J.W. Ruppert, and Michael Swit
In a trio of March 6, 2014 inter partes review (IPR) decisions, the Patent Trial and Appeal Board (PTAB) canceled patent claims related to next generation DNA sequencing technology, after Illumina, Inc. countered Columbia University’s patent infringement suit by successfully petitioning for IPR of claims in three of five of Columbia’s patents-in-suit.
The decisions illustrate the utility of the new IPR process before the PTAB, implemented under the America Invents Act (AIA), as a parallel venue in which patent litigation defendants can challenge the patentability of claims asserted against them in litigation, more expeditiously and less costly than in court proceedings.