No, “Tick Tock, Goes The Clock” is not a reference to Doctor Who poetry, Ke$ha (TiK ToK), or to that “TikTok” destination for mobile videos that’s been in the news recently. We’re talking about the countdown to October 1, 2020, when the Fiscal Year 2021 …
The American Conference Institute (“ACI”) is sponsoring its 14th Annual Paragraph IV Disputes Conference on October 6 – 7, 2020 (Eastern Daylight Time). Like a lot of conferences this year, the ACI conference format has changed from a live, in-person event to an interactive, virtual conference. ACI’s Paragraph …
Every so often, FDA revisits a policy set forth in FDA’s Manual of Policy and Procedures (“MAPP”) to reflect the Agency’s current practices. Though MAPPs really only govern the actions of the Agency, their content is important to understanding how FDA will approach certain requests. …
When California first passed its Pay for Delay bill, AB 824: Preserving Access to Affordable Drugs, we questioned whether the law could withstand a constitutional challenge, and indeed, the Association for Accessible Medicines (“AAM”) brought such a challenge in November 2019. For those of you …
Initially enacted in 2012 and reauthorized for the first time in 2017, the Generic Drug User Fee Act (“GDUFA”) was adopted to accelerate access to safe and improve the predictability of the generic drug review process. FDA touts the GDUFA as a “remarkable success” that …
FDA’s recent announcement (see our previous post here) that after 40 years the Orange Book may get a bit of a facelift – as well as a comment in a new draft guidance that folks could obtain prior editions of the Orange Book through the …
Much to our delight, the Orange Book is getting quite a bit of attention from FDA in 2020. And why not?!? After all, the Orange Book is celebrating its 40th anniversary this year. There was even a special “BPCIA Orange Book Transition Edition” published in …
From the enactment of the Medicaid Drug Rebate Statute in 1990 until last year, a term appearing in the statute – “original new drug application” – caused controversy and uncertainty. The term was not defined in the statute and the legislative history shone no light …
Since as early as 2005, industry has asked FDA for its input on the listing of device patents in the Orange Book (see our previous post here). FDA has, for the most part, refused to address this question. As such, industry has decided to just …
In a recent decision out of the Seventh Circuit, Antrim Pharms. Llc. v. Bio-Pharm, Inc., 2020 U.S. App. LEXIS 4772* (7th Cir. 2020), the court decided a battle of the experts: Bio-Pharm prevailed after Antrim unsuccessfully argued the court should preclude testimony by Bio-Pharm’s expert, HP&M’s …
Those familiar with the Hatch-Waxman Act and its various incentives to stimulate drug innovation know that New Chemical Entity (“NCE”) exclusivity is the holy grail of small molecule exclusivity. Though orphan drug may give a sponsor two more years of exclusivity than NCE, it only …
Only about 2 years after its last revision (which was only 5 months after its previous revision), FDA decided this week that MAPP 5240.3, Prioritization of Original ANDAs, Amendments, and Supplements, just wasn’t working. With too many ANDA submissions designated as priority, and thereby entitled …
The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 35th iteration – is scheduled to take place from March 24- 25, 2020 at DoubleTree By Hilton Metropolitan, New York, NY. The conference is billed as the premier event to provide folks with …
Back in September 2019, California passed AB 824: Preserving Access to Affordable Drugs. That law sought to discourage “reverse-payment agreements” in which a brand manufacturer enters into a patent settlement agreement with a potential generic sponsor that involves a transfer of value from the brand …
Earlier this week, House Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ), Ranking Member Greg Walden (R-OR) and Senate Health Committee Chairman Lamar Alexander (R-TN) announced that they reached agreement on a bipartisan, bicameral drug pricing bill, called The Lower Health Care Costs Act …
