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Written by Daniel A. Kamkar and Michael L. Fuller
On October 9, 2017, California Governor Jerry Brown signed the new drug price transparency bill SB 17.[1] ... Read More »
Written by Robert J. Hilton, Ph.D. and Jing Liu, Ph.D.
On September 14, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Aliqopa... Read More »
Written by Peter Law and Kerry S. Taylor, Ph.D.
In a creative move to take advantage of recent PTAB decisions regarding Sovereign Immunity, (see e.g., Covidien LP ... Read More »
Written by Scott Siera, Ph.D. and Eric Furman, Ph.D.
Seven years after Mylotarg® (gemtuzumab ozogamicin) was voluntarily withdrawn from the market, the U.S... 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On August 1, 2017, the U.S. Food and Drug Administration released its draft guidance titled...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 Casey D. Donahoe, Ph.D. and Kerry S. Taylor, Ph.D.
Hospira (owned by Pfizer) filed five IPR petitions against Genentech patents that Genentech asserted ... 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 Mark Speegle and Sean Murray
Edited by John Sganga, Joseph Cianfrani, and Boris Zelkind
On July 14, 2017, in a stunning reversal of fortune, a... Read More »
Written by Stephanie M. Johnson and Paul Stewart
Edited by John Sganga, Joseph Cianfrani, and Boris Zelkind
On July 18, 2017, after two years of litigation... Read More »
In Regeneron Pharmaceuticals v. Merus N.V., Appeal No. 2016-1346 (Fed. Cir., July 27, 2017), a split three-judge panel of Prost, Wallach and Newman (Newman... 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 »
In the 2003 panel decision in Schering Corp. v. Geneva Pharm., Inc., the panel rejected “the contention that inherent anticipation requires recognition [of the... Read More »
Written by Daniel A. Kamkar and Agnes Juang, Ph.D.
Janssen Biotech Inc. and Celltrion Healthcare have taken the next step over Janssen’s blockbuster... 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 »
Written by Michael Garcia and Andrea Cheek
The Federal Circuit affirmed the PTAB’s final written decisions holding that claims directed to Novartis’s... Read More »
Written by Daniel P. Hughes and Karen M. Cassidy
The Federal Circuit affirmed the PTAB’s final written decision holding that claims directed to... Read More »
Written by Daniel A. Kamkar and Nathanael Luman, Ph.D.
The PTAB issued a Final Written Decision in Amerigen Pharm. Ltd. v. Shire LLC, IPR2015-02009, Paper 38... Read More »