Legal - Page 2

In an email to The Center for Biosimilars®, a Pfizer representative said that, after having agreed to the terms of a settlement with Genentech and Roche that provides the biosimilar developer with global licenses for its product, Pfizer plans to launch its biosimilar bevacizumab, Zirabev, in the US market on December 31, 2019.
In the US context, legal issues surrounding patents are often cited as one of the main hurdles to biosimilars. Despite the fact that patents on innovator drugs are often fewer in Europe, the patent landscape in the European Union remains complex and continues to evolve. During the SMi 10th Annual Biosimilars Conference, Gregory Bacon, DPhil, GDipIPLaw, partner at Bristows LLP, gave attendees a closer look at one emerging feature of the EU patent landscape that is of particular concern to biosimilar developers: the Arrow declaration.
The United States Court of Appeals for the Third Circuit has sided with Johnson & Johnson (J&J) and its Janssen division, requiring a dispute between the Remicade maker and Rochester Drug Cooperative to be sent to arbitration.
Genentech has reached a memorandum of understanding with JHL Biotech in its civil lawsuit related to the theft of Genentech’s trade secrets.
Last week, the Patent Trial and Appeal Board (PTAB) instituted 3 inter partes review proceedings concerning patents on Alexion’s brand-name eculizumab, Soliris, a complement inhibitor that treats rare diseases. Amgen is the petitioner in all 3 cases, which were filed in February of this year.  
Amgen, maker of the brand-name pegfilgrastim (Neulasta), and Mylan, which partnered with Biocon to develop a biosimilar (Fulphila), have entered a joint status report in the District Court for the Western District of Pennsylvania.
In a one-page order filed last week, a panel of judges for the US Court of Appeals for the Federal Circuit denied Genentech’s motion for an injunction that would have blocked Amgen from selling its biosimilar bevacizumab, Mvasi, pending the outcome of an appeal.
A judge for the United States District Court for the District of New Jersey has ruled in favor of Amgen in a long-running patent litigation concerning Sandoz’s biosimilar etanercept, Erelzi.
A panel of judges for the United States Court of Appeals for the Federal Circuit has denied Genentech’s motion to block sales of Amgen’s biosimilar trastuzumab pending the outcome of an ongoing appeal.
Alexandra Valenti, JD, associate at Goodwin, discusses the future of the Biologics Price Competition and Innovation Act (BPCIA) in light of challenges to the Affordable Care Act.

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