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FDA Issues Interim Response to PhRMA/BIO Joint Citizen Petition on Biosimilar Labeling

As we previously reported, late last year the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Industry Organization (BIO) trade associations jointly submitted a Citizen Petition asking the FDA to impose stricter labeling requirements on biosimilar applicants. Last month, the Generic Pharmaceutical Association (GPhA) submitted a comment in opposition…

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Janssen Sues HyClone Laboratories Over Cell Cultures Used to Grow Celltrion’s Remicade Biosimilar

In the ongoing litigation over infliximab biosimilars, Janssen has filed two new complaints alleging infringement of claims in U.S. Patent No. 7,598,083: one against Celltrion and Hospira, and a second against HyClone Laboratories, Celltrion’s Utah-based supplier of cell culture media.  These complaints follow Judge Wolf’s recent order in Janssen’s original…

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Merck's Lantus Biosimilar Queued for an FDA Submission?

Merck, known as MSD outside the United States and Canada, announced promising results from two Phase III studies evaluating MK-1293  – Merck’s biosimilar to Lantus (insulin glargine).  Lantus is used for the treatment of people with type 1 and type 2 diabetes.  In both Phase III studies, MK-1293 demonstrated statistical…

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Amgen v. Sandoz: Reply Briefs Submitted to Supreme Court

As we previously reported, on February 16, 2016, Sandoz petitioned the United States Supreme Court for a writ of certiorari regarding the Federal Circuit’s interpretation of the BPCIA’s “notice of commercial marketing” provision—subsection (l)(8)(A)—as authorizing such notice only after FDA approval of an aBLA. In response, on March 21, Amgen…

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Halo Electronics, Inc. v. Pulse Electronics Inc.: the U.S. Supreme Court Establishes a New Framework for Awarding Enhanced Damages in Patent Suits

Yesterday, the Supreme Court announced its decision in Halo Electronics, decision in Halo Electronics, Inc. v Pulse Electronics, Inc., in which the Court rejected the Federal Circuit’s Seagate test and established a new framework for imposing enhanced damages for patent infringement.  Under the new framework, district courts will have greater…

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