The PTAB recently denied institution of two IPRs filed by CSL Behring LLC, CSL Behring GMBH, and CSL Behring Recombinant Facility AG...
BLA
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Litigation Spotlight Update: Epogen® Litigation Status in Face of Retacrit Regulatory Approval
By Spencer Johnson Comments are off
As we recently covered, May 15, 2018, saw the FDA granting approval to Hospira (now a Pfizer subsidiary) for its Retacrit injection, a...
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By Seth Cockrum Comments are off
As we previously reported here and here, Celltrion filed suit against Genentech seeking declaratory judgment that a number of patents...
Tagged with: BLA, BPCIA, Celltrion, District Court, Genentech, Herceptin®, News, Patent Dance, Rituxan®, Rituximab, trastuzumab
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By Seth Cockrum Comments are off
Last week, on April 18, 2018, Judge Stark in the District of Delaware entered the Final Judgment and Order dismissing the patent...
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By Aydin Harston Comments are off
Biologic drugs are large molecules, such as therapeutic proteins, DNA vaccines, monoclonal antibodies, and fusion proteins, that are...
Tagged with: Amgen, Apotex, BLA, FDA, Federal Circuit, filgrastim, IPR, Neulasta®, Neupogen®, pegfilgrastim, PTAB
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By Spencer Johnson Comments are off
In October, we reported on a growing number of IPR challenges to Genentech’s U.S. Patent No. 6,407,213 (“the ʼ213 patent”) to...
Tagged with: BLA, Boehringer Ingelheim, BPCIA, Celltrion, District Court, Genentech, Herceptin®, IPR, Litigation, Mylan, Pfizer, Samsung Bioepsis, Teva, trastuzumab
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By Nicole DeAbrantes Comments are off
On August 8, 2017, Sanofi-Aventis (“Sanofi”) filed a patent infringement suit in the United States District Court for the District of...
Tagged with: 351(k) pathway, 505(b)(2), BLA, District Court, Guidance, Merck, NDA, Patent Dance, Sanofi
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