- Taking Biologics for Granted? Takings, Trade Secrets, and Off-Patent Biological Products
By: Andrew Wasson
Biologics are complex medicines which are often genetically engineered, and which are sure to play an important role in curing some of humankind’s worst diseases. Not surprisingly, generic companies want a ...
- Disclosure of Clinical Trial Data: Why Exemption 4 of the Freedom of Information Act Should Be Restored
By: Janene Boyce
Clinical trial data generated during the FDA drug approval process can be very valuable. While patients and doctors desperately need this information to make informed choices about medical treatment, drug sponsors ...
- Patent Damage Strategies and the Enterprise License: Constructive Notice, Actual Notice, No Notice
By: James W. Soong
For the patent owner, early provision of patent notice can help maximize recoverable infringement damages during subsequent litigation. This iBrief recognizes a growing trend of infringement suits predicated on patented ...
- Regulating Innovative Medicine: Fitting Square Pegs in Round Holes
By: Mark Lavender
Increasingly, innovative medical products are creating a quandary for the Food and Drug Administration (“FDA”) because they often transcend the FDA’s traditional categorical approach to regulating medical products. In a recent ...
- Canning Spam: Consumer Protection or a Lid on Free Speech?
By: Grant C. Yang
The United States Congress recently passed the first federal legislation to curb the influx of spam. However, the Controlling the Assault of Non-Solicited Pornography and Marketing Act (“CAN-SPAM Act”) left ...
