Upadhye Cwik LLP Guides About Innovative Legal Practices On Pharmaceutical and FDA Issues in COVID-19 World

Upadhye Cwik LLP | July 02, 2020

The COVID-19 pandemic continues to turn the world upside down. And when upside down, the legal issues surrounding pharmaceuticals and the FDA become apparent. We identify a few areas that our law firm is working on for clients.

Our patent work remains busy helping clients with rationalizing patent portfolios, conducting infringement-mapping exercises to find potential licensing revenues, and patent litigation to enforce patent rights. Interestingly we see some clients not cutting the pipeline and thus increasing their patent activities to be ready with new products once the economy returns. Other companies are using the 505(b)(2) platform to come up with new products in less costly ways.

The COVID-19 crisis has caused a serious disruption on contracts, from supplying raw materials to end producers, up to the inability to pay for product received due to cash-flow problems. We are seeing clients invoking the Force Majeure clause to get out of contracts and similarly helping clients to force the other party to stay in the contract. The failure to supply may also cause consequential problems such as stock-out penalties, product recalls, or mitigation. We are also drafting new contracts to account for pandemics and other viral/bacterial outbreaks. Nevertheless, business is business and we are helping clients in commercial litigation in order to enforce contracts. Other clients are using commercial litigation to protect market share.


Population pharmacokinetic (PopPK) analysis has become a key tool for clinical pharmacology experts when working with data from human subjects. In the recent past, new drug registrations utilized pharmacokinetic (PK) information from healthy volunteers, in whom intensive PK sampling could be performed. In an effort to examine possible dosage adjustments for patients or other subgroups (eg, elderly, children, individuals with compromised liver function, etc) PopPK techniques were developed.


Population pharmacokinetic (PopPK) analysis has become a key tool for clinical pharmacology experts when working with data from human subjects. In the recent past, new drug registrations utilized pharmacokinetic (PK) information from healthy volunteers, in whom intensive PK sampling could be performed. In an effort to examine possible dosage adjustments for patients or other subgroups (eg, elderly, children, individuals with compromised liver function, etc) PopPK techniques were developed.

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