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Rothwell, Figg, Ernst & Manbeck, PC | USA | 17 Apr 2019

Eli Lilly Files PGR Petition against Genentech’s IL-17A/F Heterodimer Patent

On April 2, 2019, Eli Lilly and Company (“Lilly”) filed a Petition for Post-Grant Review (“PGR”) of Genentech’s U.S. Patent 10,011,654 (“the ’654…
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Rothwell, Figg, Ernst & Manbeck, PC | USA | 18 Mar 2019

Jury Finds Amgen Antibody Patents Not Invalid

Over four years ago, in October 2014, Amgen initiated a patent infringement suit against Sanofi and Regeneron regarding biologics for treatment of…
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Rothwell, Figg, Ernst & Manbeck, PC | USA | 24 Feb 2019

Sandoz Files Declaratory Judgment of Non-Infringement For Filgrastim-Related Patent

According to Sandoz, the ʼ997 patent is in the same patent family as U.S. Patent No. 8,940,878 (“the ʼ878 patent”), which Amgen asserted against…
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Proskauer Rose LLP | USA | 10 Jan 2019

ERISA Newsletter

As we closed the door on 2018, we were met by two surprising decisions—one from a panel of the Second Circuit addressing employer…
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Dinsmore & Shohl LLP | USA | 8 Jan 2019

Federal District Court Rules HHS Cuts to 340B Reimbursement 'Exceeded' Authority

In a recent opinion out of the U.S. District Court for the District of Columbia, U.S. District Court Judge Rudolph Contreras held that the U.S…
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Mintz | USA | 2 Jan 2019

340B, When a Price Adjustment is Not Really an Adjustment, and the Implications for CMS Efforts to Attack Drug Prices

The Federal Courts gave the America Hospital Association and 340B covered entities a late Christmas present and in doing so may have dealt a blow to…
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Bereskin & Parr LLP | USA | 29 Nov 2018

Amgen v Sanofi - Neutralizing Antibody to Antigen claims

Recent case law in the United States has changed the landscape for patenting antibodies. In Amgen v Sanofi, 872 F.3d 1367, the Federal Circuit ruled…
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Smart & Biggar | Canada | 1 Nov 2018

Amgen not precluded from asserting patent under current PMNOC Regulations even though unsuccessful under old PMNOC Regulations

The Federal Court of Canada has refused Pfizer’s motion to dismiss an action under the Patented Medicines (Notice of Compliance) Regulations (PMNOC…
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Smart & Biggar | Canada | 24 Sep 2018

Federal Court dismisses first motion for early dismissal under amended PMNOC Regulations

The Federal Court recently dismissed the first motion for summary dismissal brought under Section 6.08 of the amended Patented Medicines (Notice of Compliance) Regulations. The underlying action for infringement concerned Amgen Canada's regulatory submission for approval of its biosimilar of Hoffmann-La Roche's Herceptin. Amgen sought to dismiss the action regarding two of the four asserted......
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Rothwell, Figg, Ernst & Manbeck, PC | USA | 30 Aug 2018

Third Time’s a Charm? Amgen Files Another BPCIA Lawsuit Against Apotex

Earlier this month, Amgen initiated suit against Apotex in the Middle District of Florida, alleging infringement of U.S. Patent No. 9,856,287 (“the…
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