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Abbreviated New Drug Application (ANDA) › Certifications

Dechert LLP

Third Circuit Rejects IRS Assertion That Generic Manufacturers Must Capitalize Legal Fees Incurred in Hatch-Waxman Litigation

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Although legal fees spent preparing Paragraph IV notice letters must be capitalized (and thus amortized over 15 years), legal fees spent defending ANDA suits launched in response to those letters may be taken as deductions in...more

Dechert LLP

District of Delaware Holds that ANDA Filer’s Conversion from a PIV Certification to a PIII Certification Does Not Strip Court of...

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Generic manufacturers seeking to put an end to Hatch-Waxman Act patent litigation over a branded company’s Orange Book-listed patents can seek to do so by converting from Paragraph IV (“PIV”) patent certifications to...more

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