Consequences of counterfeit pharmaceutical product sales
Recently, both the FDA and EMA have raised concerns about counterfeit drug products, including GLP-1s used for weight loss and diabetes, being marketed in the...
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CRA has assisted clients in intellectual property (IP) matters concerning products and services in the life sciences sector, including Hatch-Waxman and BPCIA matters. We have also addressed patent, trademark, and copyright infringement, trade secret misappropriation, and IP licensing. Our experts have quantified damages based on lost profit and reasonable royalty methods and provided opinions on irreparable harm. In addition, we have experience addressing other forms of relief, such as rescission and disgorgement.
Our understanding of the unique dynamics of different therapeutic areas informs assessments of commercial success as a secondary indicator of non-obviousness and the claimed nexus between patented technologies and product success.
Recently, both the FDA and EMA have raised concerns about counterfeit drug products, including GLP-1s used for weight loss and diabetes, being marketed in the...
Branded pharmaceutical manufacturers are required by law to list all patents in the Orange Book that cover an approved drug product. However,...