A featured document in the Docket Report recently highlighted an Amended Opinion by Judge Cavanaugh of New Jersey: “The court granted plaintiff’s motion for summary judgment of indirect infringement based on defendants’ use of a label containing “instructions on how to use the product in a manner that encourages acts of infringement” even though “doctors […]
The FDA and Xavier University have co-developed the first annual Global Outsourcing Conference to be held June 13-16, 2010. GOC 2010, which is billed as “being designed collaboratively by FDA, Innovator Companies, and Contract Organizations to address Global Outsourcing challenges that reside on all sides,” focuses on four key discussions: Global Compliance The “Business” of […]
“To amend the public health service act to establish a pathway for the licensure of biosimilar biologic products, to promote innovation in the life sciences.” Amendment No. 297. The U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee voted Monday in favor of a proposal by Sens. Kay Hagan (D-NC), Michael Enzi (R-WY), and Orrin […]
Sens. Bill Nelson [D, FL] and Sen. Herbert Kohl [D, WI] have introduced a bill (s. 1315) to amend the Federal Food, Drug, and Cosmetic (Hatch-Waxman) Act to define the term “first applicant” for purposes of filing an abbreviated new drug application (ANDA) in order to give generic drug makers challenging brand-name patents an chance […]
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Editor-in-Chief Barista Stephen Jenei is a patent attorney and Owner of Jenei LLC. When not serving up patent chat over a steaming cup of java, he's handling a diverse intellectual property practice in the biotechnology, pharmaceutical and chemical fields. More info @ Jenei LLC
