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Amgen Files Reply Brief in Sandoz v. Amgen

On April 14, Amgen filed its reply brief in Sandoz v. Amgen. We have previously reported on Sandoz’s response and reply brief, Amgen’s consolidated opening and responsive brief and Sandoz’s opening brief. As we have previously covered, Sandoz, in response to the cross-petition, argued that when Congress specified that a…

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Delaware Court Declines to Enter "Judgment" in Genentech v. Amgen

We have previously reported on letters submitted by Genentech and Amgen to the District of Delaware regarding Genentech’s decision not to file an amended complaint.  In its letter, Genentech requested entry of judgment without prejudice, which Amgen argued was unnecessary given the court’s prior order of dismissal without prejudice.  This morning,…

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Amgen Responds to Genentech's Letter in Bevacizumab Case

As we reported on Friday, Genentech has informed the District of Delaware that it will not file an amended complaint in its declaratory judgment action against Amgen regarding Amgen’s application to market a biosimilar of Avastin® (bevacizumab). Today, Amgen filed a letter in response, informing the court that, on March 24, Genentech…

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Genentech Will Not File Amended Complaint in Case Against Amgen

As we previously reported, the District of Delaware granted a motion to dismiss by Amgen in Genentech v. Amgen, finding a lack of subject matter jurisdiction over Genentech’s declaratory judgment complaint under the Federal Circuit’s holding in Amgen v. Sandoz.  The court granted the motion with leave for Genentech to amend its complaint…

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Summary of Sandoz’s Response and Reply Brief in Sandoz v. Amgen

On March 31, Sandoz filed its consolidated response and reply brief in Sandoz v. Amgen. We have previously covered Amgen’s consolidated opening and responsive brief and Sandoz’s opening brief.  Amgen’s final reply brief was filed today, and argument is scheduled for April 26, 2017. Sandoz’s brief replied to Amgen’s counterarguments regarding whether an…

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Aragen Bioscience Files Three Petitions for IPR on Cell-Line Patents

Aragen Bioscience, Inc. and Transposagen Biopharmaceuticals, Inc. have filed three petitions for IPR of Kyowa Hakko Kirin Co., Ltd.’s patents:  IPR2017-01262 on U.S. Patent 7,425,446; IPR2017-01252 on U.S. Patent 6,946,292; and IPR2017-01254 on U.S. Patent 8,067,232.  According to the petitions, the challenged claims are “directed to an isolated mammalian host…

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Amgen V. Hospira: Federal Circuit Oral Argument Held

On April 3, 2017, the Federal Circuit heard oral argument concerning the discovery dispute between Amgen and Hospira in their litigation concerning Hospira’s proposed biosimilar of Amgen’s product Epogen®/ Procrit® (epoetin alfa) (audio available here).  In this dispute, Amgen is seeking to compel production of information concerning Hospira’s manufacturing process, including…

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