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Pharma Series: Part 2 - IP Litigation in the Pharmaceutical Industry
Webinar hosted by the Boston, Montreal, Wisconsin and New Jersey Chapters and Life Science Sector Part 2 of the PHARMA Series(This is a 3 part series - If you want to register for the Full Pharma Series click here)
Thursday, May 20, 2021
(Registrations accepted until 5/20/21)
4:00 pm - 5:00 pm Eastern
3:00 pm - 4:00 pm Central
2:00 pm - 3:00 pm Mountain
1:00 pm - 2:00 pm Pacific
Program: 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. Part 1: May 3rd IP Litigation in the Pharmaceutical Industry: Pre-Litigation Strategies : PIV and Biosimilars Part 2: May 20th- IP Litigation in the Pharmaceutical Industry: Patent Infringement Lawsuit Part 3: May 26th - IP Litigation in the Pharmaceutical Industry: IP litigation Settlement / Antitrust Litigation
 Daisy Daisy Rivera-Muzzio, R.Ph, MS, MBA, President of Acumen BioPharma
Daisy Rivera-Muzzio is the president of Acumen BioPharma, a firm that offers scientific and commercial operational consulting and laboratory services to pharmaceutical companies and law firms related to intellectual property and antitrust litigation in pharma. Mrs. Muzzio also serves as the Chief Operating Officer for Integra Continuous Manufacturing Systems, a consulting firm dedicated to advanced pharmaceutical manufacturing technologies integrating services of equipment manufacturers, PAT controls, and formulation expertise in the development and implementation of continuous manufacturing technologies in the life science industries.  Josh Reisberg, Esq., Partner at Axinn
Josh Reisberg is a Partner at Axinn and focuses his practice on intellectual property and high-stakes commercial litigation with broad experience in life sciences. Josh has a degree in Molecular Biology and has employed his science background in patent litigation matters related to diverse technologies, such as pharmaceuticals, polymer materials, semiconductor materials, medical devices, agricultural genetics, and advanced display technologies. Josh's expertise in Hatch Waxman litigations extends from drafting notice letters on behalf of generic manufacturers through trial, and all strategic considerations in between.
 Shane A. Brunner, J.D., Partner at Michael Best
Shane Brunner focuses his practice on intellectual property litigation involving patents, trademarks, trade secrets and licenses. Shane has substantial experience representing generic pharmaceutical manufacturers in litigation brought under the Hatch-Waxman Act. Shane’s expertise includes cases involving Section vii care-outs, including arguing a leading case on the issue AstraZeneca Pharmaceuticals LP v. Apotex Corp., 669 F.3d 1370, 101 U.S.P.Q.2d 1675 (Fed. Cir. 2012), and jurisdictional and venue issues.  Jeffrey I. D. Lewis, J.D., Partner at Foley Hoag's New York
Jeffrey I. D. Lewis is a partner in Foley Hoag's New York Intellectual Property Litigation practice. A chemical engineer and registered patent attorney, Jeff has represented numerous pharmaceutical innovators in Hatch-Waxman litigations. He is a past President of the American Intellectual Property Law Association (AIPLA) and is currently chair of the international amicus committee for the Association Internationale pour la Protection de la Propriété Intellectuelle (AIPPI). Jeff was an adjunct professor at Cardozo School of Law, where he received his J.D. cum laude, and he also served an Alexander Judicial Fellow to Judge Marion T. Bennett of the Federal Circuit. Jeff is consistently recognized in publications such as Chambers, and he frequently publishes and speaks on litigation and intellectual property issues.  Neill W. Clark, J.D., Counsel to Faruqi & Faruqi, LLP and Founding Partner of NW Clark Law Firm, LLC
Neill
W. Clark, J.D., has been involved in pharmaceutical antitrust
litigation for over twenty years. Those cases have recovered billions of
dollars on behalf of direct purchasers injured by pharmaceutical
companies' anticompetitive practices. Much of his work
focusses on experts in and discovery related to launching generic and
authorized generic pharmaceuticals, market definition, and restrictions
in pharmaceutical patent litigation settlements on a brand company's
ability to launch authorized generics . He is Of-Counsel
to Faruqi & Faruqi, LLP and Founding Partner of NW Clark Law Firm,
LLC, both of which have offices in the Philadelphia area.  Ha Kung Wong, , Esq, Partner at Venable, LLP
Ha
Kung Wong, , Esq. practices general intellectual property law with an
emphasis on complex patent and trade secret litigation as well as
intellectual property transactions and contract negotiations for
mergers, acquisitions, vendor agreements and collaborations in
pharmaceuticals, biologics, chemistry and medical devices. Cases Ha Kung
has litigated include those related to proton pump inhibitors,
anti-epileptic drugs, anti-tussives, ADHD medications, injectable
microspheres, RNAi products, neurotoxin proteins and other
pharmaceuticals. Ha Kung also has extensive experience with inter partes
review, post grant review, intellectual property counseling, pre-suit
investigations, licensing and due diligence, including patent strength
and freedom-to-operate analyses. LES Members Price: FREE
(LES International Members please contact info@les.org for a code)
Non-Members: $69 ($45 Early Bird until April 26) (This is a 3 part series - If you want to register for the Full Pharma Series click here)
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