The U.S. Court of Appeals for the Federal Circuit has reinstated its ruling that a company’s isolation of human genetic material, and its process for using that material to determine the effectiveness of certain cancer therapies, meet the threshold test for patent-eligibility. McCarter & Continue Reading
The US Approach to Biosimilars Explained
5 Ways to Ramp Up Your Patent Portfolio
Off the Beaten Path
Zacharakis’s story When Maria Laccotripe Zacharakis started her molecular biology PhD at Boston University School of Medicine, she never envisioned herself as a lawyer. But partway through her research on the structure-function relationship of one of the proteins in “good” cholesterol, she Continue Reading
Biotechs, Pharma Look at What’s Next for Biosimilars
The rubber has hit the road in the debate over legislation, approved in March, to create a regulatory pathway for generic versions of cell-based drugs known as biosimilars. The U.S. Food and Drug Administration has yet to issue rules on the new law, which would give the “innovator companies” — those Continue Reading
Biotech industry focuses on how gene patent case turns out
The local biotechnology industry is on tenterhooks, waiting to see if a court ruling that invalidates patents on genes will be overturned. The federal court case, decided March 29, received an inordinate amount of attention from both the media and the legal community, prompting nine amicus briefs on Continue Reading