Blogs and Other Musings

October 2018 --  Legal Letter from America.  Published in GMP Review

This article illustrates how data integrity (DI) issues sunk the proposed acquisition by Fresenius of U.S. generic drug maker, Akorn, detailing how those DI issues came to Fresenius' attention leading to Fresenius cancelling the merger in April 2018 and the unsuccessful efforts by Akorn to salvage the detail in litigation in Delaware state courts.  The article explores what went wrong and the lessons for quality professionals -- and their senior management -- on how to ensure that the same fate does not derail their deals.  

        To read the article, click here.

March 26, 2014 -- Duane Morris Life Sciences Law Blog

Successful Use of Inter Partes Review to Cancel Claims Asserted in Parallel Litigation 

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.  

        To read the blog entry, click here. 

March 4, 2014 -- Duane Morris Life Sciences Law Blog

Court Offers Insights On When the 271(e)(1) Safe Harbor Applies to the Use of Patented Technology in Early – and Late — Drug Development  

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. 

       To read the blog entry, click here.

November 15, 2012 -- Posted on LinkedIN

Challenges of bringing mHealth products to the market are highlighted in Duane Morris mHealth Practice Group's latest newsletter, including my article on an FDA-friendly avenue to commercialization. 

       To read my article, see p. 10 in the newsletter, accessible if you click here. 

August 8, 2012 -- Duane Morris Alert

D.C. Circuit's July 27 decision in Friedman v. Sebelius upholds HHS order excluding three ex-Purdue Pharma executives--including ex-General Counsel--from federal healthcare programs.  

Decision highlights severe legal risks faced by officials at FDA-regulated firms under the strict liability tenets of the Responsible Corporate Official (RCO) doctrine articulated in U.S. v. Park  (1975 U.S. Supreme Court decision).

        For a copy of the Duane Morris client alert on this key decision, which I penned, click here. 


Sign up to hear about upcoming talks, presentations, and blogs by Michael Swit.