IP & FDA Challenges Related to Pharmaceutical Compounding of Human and Animal Drugs
Pharmacy Compounding Out of approximately 56,000 U.S. pharmacies, about 7,500 specialize in pharmaceutical compounding. As such, these pharmacists spend a great deal of time preparing special medications and treatments for patients. Due to the nature of compounding, pharmacists who specialize in this practice are closely regulated by federal and state authorities. Drug compounding is a […]
Willful Patent Infringement – Did it matter?
As a patent litigator and patent litigation book author, I read lots of cases. And everyone once in a while, there is one that just pops out because it’s interesting. As a patent holder, you may one day assert your patent in court. Typically you claim the defendant infringed the patent. You stitch together your […]
Trade Secrets Theft In Life Sciences
Examples of Trade Secrets In Life Sciences The term trade secret refers to intellectual property—including but not limited to an idea, pattern, formula, or process—that is kept secret by the owner of that information to prevent its theft or misuse. Examples of trade secrets in the life sciences include drug compounds, formulations, routes of synthesis, […]
FDA’s 505(b)(2) Application
The 505(b)(2) new drug application (NDA) is an attractive regulatory and commercial strategy for clients. This hybrid NDA application helps avoid duplicative and costly studies that others have already completed. FDA’s rules allow (b)(2) applicants to rely on this prior body of work. And because of this reliance, the (b)(2) development is cheaper and faster […]
Staying Compliant with FDA’s Good Manufacturing Practice (GMP), and Handling Violations
We concentrate a large part of our work helping clients to solve legal problems when dealing with FDA compliance. Particularly, we help clients comply with the myriad of FDA statutes, regulations, and policies as they relate to drugs and devices. This includes helping with financial, operational, marketing, and investigatory/enforcement issues. Our particular focus is helping clients […]
