Various alphabetized medical records
Industries

Life Sciences Intellectual Property

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.

Engagements

  • 01
    Evaluation of an asthma medication with once-a-day dosing
    In a Hatch-Waxman litigation involving a drug for asthma, CRA was asked to assess commercial success and its nexus to the patent. In this case, the patent...
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  • 02
    Assessment of irreparable harm for an osteoporosis treatment
    Following a district court finding of invalidity and/or non-infringement and plaintiff’s stated intention to appeal, CRA was asked to assess whether branded...
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  • 03
    At risk generic entry and impact of formulary status
    In a Hatch-Waxman litigation, a first-to-file generic manufacturer asked CRA to assess changes in formulary status that would result from the at-risk entry and...
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