Recent Posts
- Hikma v. Vanda: Oral Argument Recap
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Category: Biosimilars
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Since it has been a while since my last post, I’m going to do something a little different and do a quick run down of ten Federal Circuit cases that have issued in the past few months and highlight some key takeaways. I’ll give a quick bullet point review of the cases, with slightly more…
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By: Rocco Screnci In today’s blog, we are straying from our Orange Book roots to discuss the Federal Circuit's recent decision in Regeneron Pharmaceuticals v. Mylan Pharmaceuticals, a case arising under the BPCIA. Regeneron owns several patents covering its EYLEA® product. EYLEA® contains the protein aflibercept, a VEGF antagonist, and is used to treat various…
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In a recently unsealed opinion, a N.D.W.V. court denied Regeneron's motion for a preliminary injunction against Amgen seeking to enjoin Amgen's ABP 938, a biosimilar version of Eylea. Regeneron had previously been successful in obtaining preliminary injunctions in the same court against a number of other defendants. But Amgen's formulation differed from those defendants, resulting…
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Hospira, Inc. v. Genentech, Inc., IPR2017-00731 (PTAB) by Aaron F. Barkoff Apparently it is not impossible to change the PTAB's mind. In a rare decision last week, the Board granted Hospira's request for rehearing of its earlier decision denying institution, and instituted review of U.S. Patent No. 7,846,441. Genentech is expected to assert the…
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Amgen v. Sandoz, No. 15-1499 (Fed. Cir. May 5, 2015) by Aaron F. Barkoff In a per curium Order today, the Federal Circuit granted Amgen's Emergency Motion for an Injunction Pending Appeal, stalling, at least temporarily, Sandoz's commercial launch of Zarxio, a biosimilar version of Amgen's Neupogen (filgrastim). Zarxio is the first biosimilar product…
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McAndrews Shareholder Sandra Frantzen will be one of the featured speakers at American Conference Institute's "Summit on U.S. Biosimilars" conference in Munich, Germany, April 20-21. Ms. Frantzen will be speaking on "Incorporating Inter-Partes Review and New USPTO Procedures into Branded and Biosimilar Litigation Strategies." Other speakers include in-house counsel and executives from AbbVie, Boehringer Ingelheim,…
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Celltrion Healthcare v. Janssen Biotech, No. 14-11613 (D. Mass.) by Sandra A. Frantzen As we previously reported, Celltrion filed a Complaint for Declaratory Judgment against Janssen Biotech on March 31, seeking a declaration of invalidity and unenforceability of three Janssen patents. In its complaint, Celltrion alleged that Remsima®, a biosimilar version of Janssen's Remicade®…
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Celltrion Healthcare v. Janssen Biotech, No. 14-11613 (D. Mass.) by Sandra A. Frantzen On March 31, Celltrion filed a Complaint for Declaratory Judgment in the District of Massachusetts against Janssen Biotech, seeking a declaration of invalidity and unenforceability of three Janssen patents. In its Complaint, Celltrion alleges that it has developed Remsima®, a biosimilar version…
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Sandoz v. Amgen and Hoffman-La Roche, No. 13-204 (N.D. Cal.) by Aaron F. Barkoff In what appears to be the first court decision interpreting the patent litigation provisions of the BPCIA (the "Biosimilar Act"), the U.S. District Court for the Northern District of California granted Amgen's motion to dismiss Sandoz's declaratory judgment complaint concerning…
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FDA has been busy preparing for the day when the first biosimilar application is filed. In February, FDA published three draft guidance documents on biosimilars. In May, FDA held a public hearing on the guidance. And earlier this week, FDA announced biosimilar user fee rates for fiscal year 2013. Patent lawyers have been busy preparing…
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