Tag Archives: Data

Licensees Obtaining Data from Other Licensees

When a drug candidate is licensed to different licensees in different territories, the ability of each licensee to obtain marketing approval for the product may depend on access to data generated by the other. While license agreements do not always address this issue, there are some terms that can be useful in this type of situation. Case Study … Continue reading this entry

Solving Utility Problems

The Federal Circuit decisions in Cancer Research Technolgoy Ltd. v. Barr Labs., Inc. (Nov. 2010) and In Re '318 Patent Infringement Litigation ("Janssen") (Sep. 2009) present an interesting contrast in utility issues. In Cancer Research, the USPTO raised utility rejections that the Applicant eventually overcame and the patent was found to be enforceable, while in Janssen, the USPTO never raised the issue but both the district court and the Federal Circuit found the patent invalid for lack of utility. The Federal Circuit may address the issue again this week, when it hears oral arguments in Eli Lilly & Co. v. Actavis on Thursday.bv … Continue reading this entry

Is Pre-Appeal Brief Review Worth The Effort?

The USPTO provided outcome statistics from the Pre-Appeal Brief Review program in the notice of proposed rulemaking for the proposed changes to ex parte appeal practice before the USPTO Board of Patent Appeals and Interferences. The data reveal mixed results, but are encouraging enough to justify the relatively low costs of the program. The Pre-Appeal Brief Review … Continue reading this entry