Legal - Page 3

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.
According to the Congressional Budget Office (CBO), enacting the bill would increase direct spending by about $18.7 billion and increase direct revenues by $26.2 billion, resulting in a net decrease in the deficit of $7.6 billion by 2029.
Samsung Bioepis, developer of the biosimilar trastuzumab, Ontruzant, and Genentech, maker of the reference trastuzumab, Herceptin, have asked a court to dismiss their patent litigation.
In this case, Pfizer hoped to launch its biosimilar bevacizumab in the UK market after the basic patent on the reference product, Genentech and Roche’s Avastin, expires in June 2020. However, the biosimilar maker has been hindered by what it has termed a patent thicket related to secondary patents.
Under which situations might the International Trade Commission (ITC) be the right choice for biosimilar patent disputes instead of federal district court? A panel discussed these questions at the ACI 10th Summit on Biosimilars on Monday in New York City.

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