Coronavirus Cured? FDA/FTC Warning Letters

FDA/FTC Warning Letters Although discovering a cure for COVID-19 would certainly be welcome news, any current mention of a cure or vaccine is more likely to be fake news. Furthermore, with economic ramifications and health concerns affecting the entire global population, anyone making false claims about their product’s ability to treat or cure this deadly disease may […]

Patent Acquisition and Patent Litigation in Economic Downturn Times

How Companies Respond To An Economic Downturn During an economic downturn, companies typically respond in one of two ways. They either conserve limited cash resources, or they use the downturn as an opportunity to invest those limited resources in tomorrow. In this article, we discuss patent applications and patent enforcement and the issues involved in […]

Force Majeure Clause & Other Defenses in Contract Law Because of Covid-19

The Global Impact of Covid-19 Cannot Be Understated The global impact of Covid-19 cannot be understated. Businesses are shut, employees are at home, and the supply chain is breaking. What rights do parties in a contract have because of the Covid-19 impact? Force majeure clauses and other principles of contract law are discussed here. Covid-19 […]

State Drug Price Transparency Laws – Avoiding Penalties and Navigating the Current Climate

Avoiding Penalties and Navigating the Current Climate In response to concerns about the increase in pharmaceutical drug pricing, many States are taking legislative action to increase price transparency and also to curb further increases. Because no federal legislation exists to control these price increases, States are taking their own action. Many States passed new legislation […]

Holiday Season IP Issues

Holiday Season IP Issues The holidays are a season of joy, celebration, and time spent with family and friends. Of course, in recent decades, the holidays have also become synonymous with Black Friday sales, consumers fighting over popular products, and a general feeling of stress. This demand for competitively-priced, exciting new products means that companies […]

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 […]