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and Products, Questions and Answers, which provides answers to questions from public comments received on the draft Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products (“FDA stability guidance”) that was published in the Federal Register on September 25,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.
By Vicki G. Norton and Michael A. Swit
FDA-regulated firms — drug, device, biologic or otherwise — on both sides of the patent aisle concerned with the bounds of the “Safe Harbor” exception to patent infringement under 35 U.S.C. § 271(e)(1) can learn several key lessons from the recent decision in Isis Pharmaceuticals, Inc. v Santaris Pharma A/S Corp. (hereafter: “Isis”), particularly how to properly prove the safe harbor defense once the litigation unfolds and also when the harbor provides shelter from post-approval patent storms.
On March 16, 2013, Virginia became the first state to enact legislation regulating a pharmacist’s substitution of an interchangeable biologic drug for a prescribed reference biologic drug. Section 54.1-3408.04 of the Code of Virginia permits pharmacists to dispense a biosimilar in place of a prescribed biological product only if that biosimilar meets the higher safety standards for “interchangeability” under the federal Biologics Price Competition and Innovation Act of 2009. Section 54.1-3408.04 raises additional hurdles for biosimilar and interchangeable biologic drug manufacturers by imposing recordkeeping and prescriber and patient notification requirements on a pharmacist dispensing an interchangeable biosimilar in the place of a prescribed biological product. In contrast, pharmacists are not subject to those burdens when substituting a therapeutically equivalent small-molecule generic drug for a prescribed branded drug. The provisions of the Act are discussed in more detail in a March 28, 2013 Duane Morris client alert (click here).