Medical Regulation > Nova Content
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... Read More »
Written by Daniel K. Yarbrough, Ph.D. and Brenden S. Gingrich, Ph.D.
On August 1, 2017, the U.S. Food and Drug Administration released its draft guidance titled... Read More »
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 ... Read More »
Written by Marc Chatenay-Lapointe, Ph.D. and Jason Jardine
On July 13, 2017, the U.S. Food and Drug Administration approved Tremfya (guselkumab), a biologic... Read More »
Written by Peter E. Heuser, Schwabe, Williamson & Wyatt, P.C.
The Circuit issued only one precedential patent case this week, reversing a determination of... Read More »
Written by Caleb A. Bates, Ph.D. and Agnes Juang, Ph.D.
On June 19, 2017, the U.S. Food and Drug Administration approved the use of the fluoroquinolone... Read More »
Written by Robert J. Hilton, Ph.D. and Jason J. Jardine
On May 24, 2017, the Food and Drug Administration (FDA) approved the final label for Syndros™... Read More »
Written by Jane Xia and Michael L. Fuller
The U.S. Food and Drug Administration (FDA) recently approved Keytruda (pembrolizumab) for treatment of patients whose... Read More »
Written by Marc Chatenay-Lapointe, Ph.D. and Jing Liu, Ph.D.
On May 17, 2017, Vertex Pharmaceuticals small molecule drug Kalydeco® (ivacaftor) was approved by ... Read More »
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... Read More »
In Novartis AG v. Torrent Pharmaceuticals Limited, [2016-1352] (April 12, 2017), the Federal Circuit affirmed the PTAB’s determination that the challenged... Read More »
Written by Marc Chatenay-Lapointe, Ph.D. and Jing Liu, Ph.D.
On March 13, 2017, the use of Novartis cell cycle inhibitor Kisqali® (ribociclib, LEE011) in... Read More »
Written by Daniel K. Yarbrough, Ph.D. and Jing Liu, Ph.D.
Once considered parasites, free riders, or “opportunistic pathogens,” in recent years the... Read More »
Written by Marc Chatenay-Lapointe, Ph.D. and Michael L. Fuller
On December 23, 2016, the U.S. Food and Drug Administration approved SPINRAZA™ (nusinersen)... Read More »
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... Read More »
Comments
Curtis LeeSo in essence, the doctrine of estoppel is being applied to statements or positions taken outside the courtroom?
Oct 12, 2016
Jeff McIntyreNot necessarily estoppel. More like reliable evidence which can help prove the fact and which is difficult to rebut
Oct 12, 2016
In an en banc decision on July 12, 2016 in The Medicines Co. v. Hospira, Inc., the Federal Circuit established the circumstances under which a product manufactured... Read More »
ACTION: Infringement of U.S. Patent 5,827,529 (referred to as “529 Patent) by Noven Therapeutics/Noven Pharmaceuticals, makers of products such as the... Read More »
Ever forget to take your morning pills? Or can’t remember if you have to take the blue pill today or the yellow one? Suddenly, life just got a lot... Read More »
Could it be possible to one day deliver miniscule factories to the human body to produce medicine? In an article in the American Chemical Society’s journal Nano... Read More »
Medtronic, Inc. is developing a new stent graft system designed to repair thoracic aortic aneurysm. It has been selected by the FDA for an early feasibility pilot... Read More »