Analysis of patent litigation, PTAB practice, prosecution and pharma IP, written on the data behind LexDana.
Tagged fda · clear
Less than two months ago, Curevac filed a lawsuit in the German Regional Court in Düsseldorf against BioNTech over patent infringement alleging that BioNTech’s Covid-19 vaccine infringed its patents related to mRNA technology. With their…
Small molecule drugs have been the norm for much of medicine’s history. Only in the past decade has there been a rise in large molecule drugs which also obtained FDA approval. When it comes to the world of pharmaceuticals, they are divided into two…
Last year, in a lengthy split decision, a Fed. Cir. panel affirmed the district court’s ruling that four “add-on” patents that Acorda owned were invalid as obviousness in view of a number of prior art references (Acorda Ther., Inc. v.…
On July 13, 2018, the Federal Circuit decided Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC , affirming the Patent Trial and Appeal Board (PTAB)’s finding of invalidity of certain claims of seven Orange Book-listed patents for Xyrem®.…
In Bayer v. Watson , the panel throws out Bayer’s patent to its Staxyn erectile dysfunction drug as being obvious, noting that the district court focused too heavily on the commercial availability of the prior art. The panel also noted that potential…
On Tuesday, a Delaware district court judge ruled that a group of Mallinckrodt patents failed the Alice/(mostly)Mayo test as claiming a natural phenomenon. The patents are directed to a method of safely using the Innomax system, which administers nitric…
Written by Jane Xia and Jing Liu, Ph.D. MILLENNIUM PHARMACEUTICALS, INC. v. SANDOZ INC (Fed. Cir. July 17, 2017) (NEWMAN, Mayer, O’Malley) This case arose out of an ANDA litigation between Millennium and a number of generic-drug companies who sought…
Written by Peter E. Heuser , Schwabe, Williamson & Wyatt, P.C. The Circuit issued only one precedential patent case this week, reversing a determination of obviousness as to a Millennium Pharmaceutical patent covering its blockbuster cancer drug…
In Pfaff v. Wells Electronics, 525 US 55 (1988), the Supreme Court attempted to focus the factors invoking the on-sale bar of s . 102, by holding that the claimed invention must both be the subject of a “commercial sale”(including offers for…
In Novartis AG v. Torrent Pharmaceuticals Limited, [2016-1352] (April 12, 2017), the Federal Circuit affirmed the PTAB’s determination that the challenged claims of U.S. Patent No. 8,324,283, and Novartis’ proposed substitute claims, were…
Written by Daniel K. Yarbrough, Ph.D. and Jing Liu, Ph.D. Once considered parasites, free riders, or “opportunistic pathogens,” in recent years the roughly 100 trillion symbiotic bacteria that inhabit the various tissues of the human body have…
In Intendis v Glenmark , the Federal Circuit affirmed a finding of infringement under the doctrine of equivalents based on statements made by Glenmark to the FDA. The issue was whether isopropyl myristate in Glenmark’s formulation was equivalent to…
