Upadhye Cwik LLP advises on Pharmaceutical and FDA Issues in

|Jul 1|magazine6 min read

CHICAGO, July 1, 2020 /PRNewswire/ -- 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.

Our commercial practice also includes helping clients defend against false advertising allegations involving COVID-19. Many companies are accused of falsely claiming that their products treat or cure coronavirus. The FDA and FTC (including State AG's) are taking enforcement action against companies alleging false advertising.

Our FDA practice is busy too. We are helping clients on the product approval side to help speed product approvals. The FDA has several initiatives that applicants can rely upon to expedite approvals. We are also helping clients on the GMP compliance side by working with the FDA to get approvals or to get enforcement actions lifted despite the lack of on-site physical inspections. The FDA is sensitive that the lack of inspections is playing havoc with drug approvals and drug shortages.

Call Upadhye Cwik LLP at 312-327-3326 or view our website: ipfdalaw.com for more information about our innovative legal practice and how we help solve a client's problems.

Media Contact: Shashank Upadhye, (312)327-3326, [email protected]

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