LES Webinar: Pharma Series: Part 2 - IP Litigation in the Pharmaceutical Industry

Pharmaceutical Industry: The Case of Brand vs Generic Products

The drug patent system was created to reward pharma companies for innovation and ensure returns on investment. IP protection and commercial exclusivity regulated by the Drug Price Competition and Patent Restoration Act (Hatch-Waxman Act) provides protection to drug innovators and also provides the pathway for generic manufacturers to challenge NDA holders patent(s) and apply for a PIV-Abbreviated New Drug Application ( ANDA) for approval of a generic product prior to the expiration of the innovator product patents. Resolution of patent infringement becomes the subject of a litigation.

Intellectual Property litigation in the pharmaceutical industry will be the subject of discussion of our next webinar series. Our panel of experienced experts have represented either the brand or generic side of this dynamic and will present a three- part overview of these and related issues. 

Part 2: Patent Infringement Lawsuit
• ANDAs, 502(b) applications, Biosimilars and PIV notices; Confidential Access; Hatch-Waxman case timing, venue, court rules and mandatory disclosures; Inducement of Infringement; Unlisted patents; and Manufacturing patents.

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