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Janssen v. Celltrion: Court Denies Celltrion’s Summary Judgment Motion,...
This morning, in the district court action in Janssen v. Celltrion, Judge Wolf issued an oral order denying the defendants’ motion for partial summary judgment of non-infringement of U.S. Patent No....
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Hospira Files Two Petitions for Inter Partes Review of Genentech’s...
Yesterday, Hospira filed two petitions for inter partes review of Genentech’s U.S. Patent 7,371,379 (IPR2017-00805) and U.S. Patent 6,627,196 (IPR2017-00804). According to the petitions, these patents...
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Janssen v. Celltrion: Trial Postponed, Briefing and Hearings Scheduled on...
As we previously reported, a jury trial in the ongoing infliximab biosimilar litigation, Janssen v. Celltrion (D. Mass., J. Wolf), was scheduled to begin on February 13, 2017. The district court,...
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PTAB Institutes IPR in Hospira’s Challenge to Genentech’s Trastuzumab Patent
The PTAB has instituted IPR2016-01837, in which Hospira challenges Genentech’s U.S. Patent 7,807,799. The institution decision extends to all challenged claims, claims 1-3 and 5-11. According to the...
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FDA Advisory Committee Recommends Approval of Pfizer’s EPOGEN®/PROCRIT®...
As we previously reported, the FDA Oncologic Drugs Advisory Committee (“ODAC”) held a public meeting today regarding Hospira’s application for its proposed biosimilar of Amgen’s Epogen®/Procrit®...
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Amgen Seeks Preliminary Injunction Against Hospira’s Launch of Epoetin Alfa...
On Friday, in the ongoing Amgen v. Hospira district court litigation regarding Hospira’s proposed biosimilar of Epogen®/Procrit® (epoetin alfa), Amgen filed a motion for preliminary injunction seeking...
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Pfizer Files Two Petitions for IPR of Genentech’s Trastuzumab Patent
Pfizer has filed two petitions for IPR of U.S. Patent 8,591,897, owned by Genentech: IPR2017-01726 and IPR2017-01727. According to the petitions, the ‘897 patent is directed to methods for treating...
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Hospira Opposes Amgen’s PI Motion in Amgen v. Hospira
On July 6, 2017, Hospira filed a publically available redacted version of its brief responding to Amgen’s motion for a preliminary injunction (PI). As we previously reported, following the Supreme...
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Amgen Withdraws Its Motion For Preliminary Injunction Against Hospira
On July 12, 2017, Amgen filed a Notice of Withdrawal of its Motion for Preliminary Injunction. As we previously reported, Amgen had filed an amended opening brief in support of its motion for...
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Board Grants Hospira Mixed Results on its Five Petitions for IPR of...
The Board granted Hospira a mixed result in its numerous challenges to Genentech’s patents directed to different aspects of Genentech’s trastuzumab product: The Board instituted IPR of U.S. Patent No....
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Amgen v. Hospira: Litigation Update
With the September 18, 2017 trial date fast approaching, the district court in Amgen v. Hospira last week denied Hospira’s motion for summary judgment of non-infringement of its proposed biosimilar of...
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Hospira Files Motion for JMOL, Challenging Jury’s $70M Damages Award
As we recently reported, a federal jury awarded Amgen $70 million in damages last week after finding that Hospira’s manufacture of 14 batches of drug substance between 2013 and 2015 was not protected...
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Janssen v. Celltrion: Janssen Appeals Judgment Invalidating the ’471 Patent
As we previously reported, on September 26, 2016, the district court in Janssen v. Celltrion entered partial final judgment that the ’471 patent, asserted by Janssen, was invalid. Today, Janssen filed...
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Janssen v. Celltrion: Motions to Exclude or Limit Evidence and Testimony from...
With the pre-trial conference set to begin on February 6, 2017, the parties in Janssen v. Celltrion have filed several motions seeking to exclude or limit certain evidence and testimony that may be...
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Janssen v. Celltrion: Summary Judgment Update
The past week saw further developments in the ongoing patent dispute between Janssen and Defendants Celltrion and Hospira relating to Inflectra® (infliximab-dyyb), a biosimilar of Remicade®. First, on...
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Judge Sets Trial Date in Janssen v. Celltrion Should Summary Judgment Be Denied
As we reported here, in the patent dispute between Janssen and Defendants Celltrion and Hospira relating to Inflectra® (infliximab-dyyb), a biosimilar of Remicade®, there are multiple motions for...
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Final Judgment Entered Against Hospira for Infringing Amgen’s Epoetin Patent
As we have previously reported, a jury in September 2017 issued a $70,000,000 verdict against Hospira based on its drug substance manufacturing activity in 2013-2015 in connection with its biosimilar...
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Hospira Appeals $80 Million Judgment in Epoetin Alfa Biosimilar Case
As we reported, last month in the Amgen v. Hospira litigation concerning Hospira’s Retacrit (epoetin alfa) biosimilar, the Delaware district court entered final judgment against Hospira, awarding Amgen...
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Amgen Files Cross-Appeal In Epoetin Alfa Biosimilar Case
Early last month, we reported that in the Amgen v. Hospira BPCIA litigation concerning Hospira’s Retacrit (epoetin alfa) biosimilar, Hospira had filed an appeal to the Federal Circuit from the Delaware...
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Amgen Responds to Hospira’s Motion For Rehearing En Banc of the Safe Harbor...
We previously reported that Hospira filed a petition for rehearing en banc of the Federal Circuit’s affirmance of a $70 million damages award to Amgen in the parties’ BPCIA litigation regarding...
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