The Orange Book’s Therapeutic Equivalence Codes (TE Codes) play a critical role in our drug distribution and payment system. All states have “automatic substitution” laws that require prescriptions to be filled using a generic where available (unless otherwise ordered by the physician), and those substitutions …
Drug pricing has been a hot button issue in the U.S. for decades, and patent protections have been cited as a source of “gamesmanship” allowing brand companies to keep drug prices high. Yet, as long as FDA and FTC have been trying to address anticompetitive …
The Build Back Better Act—the food and drug law implications of which we discussed last year—has popped up again in Congress, and it is just as dense as ever. With 190 pages dedicated to prescription drug pricing reform, the program is ambitious…and complicated. As we explained …
Readers of this blog surely are familiar with FDA’s repeated efforts to rein in Congress’s 180-day exclusivity reward to the first generic applicant that challenges an NDA holder’s patent monopoly (most recently by lobbying Congress to effectively end 180-day exclusivity together – see our prior …
Market exclusivities—patent or otherwise—are a critical part of the Hatch-Waxman compromise, intended to encourage continued innovation in spite of the introduction of generic competition. Even a month of market exclusivity is financially lucrative enough to fight for, so it is no surprise that a company …
A little less than a year ago, it was PANDA-monium at FDA when the Agency created a new category of drug applications called the PANDA—or the Pre-Hatch-Waxman Abbreviated New Drug Application—which referred to abbreviated drug applications submitted and approved prior to the enactment of the …
On June 14-15 in Washington, DC, the Food and Drug Law Institute (FDLI) will hold its first in-person Annual Conference since 2019. The conference brings together leading regulators and a wide range of stakeholders to discuss current issues and trends of importance to FDA-regulated industries. …
Thanks to years of watching @eavoss of New Rockstars, we have a pretty good handle on the Marvel Cinematic Universe (“MCU”). We know that Earth-199999, known in-universe as Earth-616, is the designated universe number for the main MCU; that there are a multitude of other …
Over the past few years, this blogger – in prior blog posts (here, here, here, and here) and in Congressional testimony – has been pretty critical of efforts to significantly revise and weaken the 180-day generic drug exclusivity incentive and framework first established with the passage of the 1984 …
Hyman, Phelps, and McNamara’s Sara Koblitz will be presenting at the DC Bar’s annual webinar, “FDA for IP Lawyers” on May 25, 2022 with Brian Malkin of McDermott, Will, and Emery. The webinar will provide practical tips for integrating FDA regulatory law into IP law practices …
The American Conference Institute (“ACI”) is hosting its 17th Annual Paragraph IV Disputes Conference in New York (and livestream) from April 26-27, 2022 (Eastern Daylight Time). Over the course of two days, this event will provide impactful and practical programming all geared towards assessing the implications and …
It was some time ago that we posted on what we though was “the Good” in an avalanche of FDA-related legislation that we sorted into three categories: the Good, the Bad, and the Ugly. Our prior post took a look at a couple of bills …
It’s not often that FDA issues an “Immediately in Effect Guidance,” but it’s not often that a case like Genus v. FDA comes along and upends twenty years of FDA practice. Almost a year after the D.C. Circuit held that products that simultaneously meet both …
I don’t mean to be so pessimistic, but 18 months after opening a docket requesting comments on potential “modernizations” for the Orange Book and one year after the passage of the Orange Book Transparency Act, FDA issued its Report on Orange Book reform essentially concluding …
Since the August 2021 decision in GSK v. Teva, the generic industry has been waiting with bated breath to see whether the section viii carve-out (and thus skinny-labeled generic drugs) will survive. With the District Court of Delaware’s January 4 decision in a similar case …
