Back in June 2017, we introduced folks to a system we dubbed “ANDA Arbitrage.” It’s an effort undertaken by a company called ANDA Repository, LLC to help companies potentially decrease annual user fee liability under the second iteration of the Generic Drug User Fee Amendments …
We recently came into possession of a small stack of Letter Decisions issued by the Exclusivity Board in the Center for Drug Evaluation and Research – the “CDER Exclusivity Board” – and decided that a series of posts on each decision would be an entertaining …
Last month, Representatives John Sarbanes (D-MD) and Bill Johnson (R-OH) introduced H.R. 6478, the “Biosimilars Competition Act of 2018.” The bill would amend the Public Health Service Act (“PHS Act”) to require that certain agreements between biosimilar applicants and reference product sponsors be reported to …
Well, we haven’t quite waited the lifetime that Foreigner did, but it’s exciting nonetheless. Only about one year after signing the provisions into law, FDA announced the approval of the first generic drug with a Competitive Generic Therapy (“CGT”) designation: ANDA 211067 for potassium chloride …
With one paragraph in a Summary Judgment Order issued last week, the Northern District of California further expanded the patent safe harbor under 37 U.S.C. § 271(e)(1). Though not a huge leap from previous safe harbor decisions, the Order in Nevro Corp. v. Boston Scientific Corp. …
For those of us in the Hatch-Waxman Community, June 14, 2018 sowed a lot of confusion. That’s the date on which FDA approved three ANDAs for generic versions of Indivior Inc.’s SUBOXONE (buprenorphine and naloxone) Sublingual Film, 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 …
By Michelle L. Butler & Eliot Markman* – On July 4, 2018, 2017 ME S 432, titled “An Act To Require Drug Manufacturers To Comply with Federal Law” (the “Act”), became law without Maine Governor Paul LePage’s signature. The Act amends 32 M.R.S.A. § 13702-A and …
Way back in September 2014, the President’s Council of Advisors on Science and Technology (“PCAST”) released a report to the President, titled “Combating Antibiotic Resistant Bacteria.” The report was part of a broader initiative announced by the Obama Administration to address the growing challenges posed …
In an attempt to ensure that implementation of the FDCA requirement for shared REMS does not cause undue burden, FDA released two new guidance documents targeting shared REMS systems. We have seen the negotiation of shared REMS systems succeed – and fail spectacularly resulting in waivers. …
More than 10 years after the enactment of FDC Act § 505(q), titled “Petitions and Civil Actions Regarding Approval of Certain Applications,” interest in citizen petitions remains high. Each year we see several analyses of the effects of citizen petitions on generic competition, as well as …
FDA announced last week its newest initiative to address alleged “gaming” tactics that FDA believes are used to circumvent the delicate balance of innovation and competition set forth by Congress in the Hatch-Waxman Act. As part of FDA’s Drug Competition Action Plan, FDA has published …
On April 27, 2018, Petitioners Breckenridge Pharmaceutical, Inc. and Nexgen Pharma, Inc. filed a Petition for Review in the United States Court of Appeals for the District of Columbia Circuit. The Petition seeks review of a final FDA order published in the Federal Register on …
Declaring its intent to stand on the original complaint in FTC v. Shire ViroPharma, the FTC has appealed the District Court for the District of Delaware’s decision to dismiss the Commission’s unfair competition case against Shire without prejudice. We previously blogged about this case here, …
As folks know by now, each month we pore over the latest Orange Book Cumulative Supplement in an effort to keep our popular 180-Day Exclusivity Tracker as current as possible, and to look for interesting precedents. One recent entry in particular caught our attention. It …
The so-called “Rule of Three” is that the first instance of something occurring is chance; the second instance is considered a coincidence; while the third instance is perceived as a pattern. This rule comes into play every so often in this blogger’s practice when I …
