Paragraph IV Patent Litigation in the 2019 Landscape: Trends and Significant Developments Explored!
In recent years, generic drug manufacturers have been grappling with filing Paragraph IV (PIV) challenges to successfully gain market entry. The significant increase in the number of patent challenges on brand drugs, specifically on blockbuster drugs, is expected to continue in 2019. However, with the evolving regulatory paradigm, manufacturers become vulnerable to a myriad of risks, including the likelihood of a PIV lawsuit.
In the changing PIV landscape, it is imperative that pharmaceutical companies are abreast of the latest developments to avoid patent infringement, more so, the complexities of a PIV litigation. They must be well-versed with the litigation know-hows to efficiently and effectively win a PIV dispute.
Listen as a panel of distinguished professionals and thought leaders assembled by The Knowledge Group provide an in-depth discussion of the significant trends and developments in Paragraph IV Patent Litigation. Speakers will also offer best strategies that will help manufacturers and counsel in this evolving landscape.
Key issues that will be covered in this course are:
- Paragraph IV Patent Litigation and the Abbreviated New Drug Application (ANDA): Recent Trends and Developments
- Notable PIV Cases and Court Rulings
- Best Application Strategies
- Significant Litigation Techniques
- What Lies Ahead
Philip L. Hirschhorn, Shareholder
Buchanan Ingersoll & Rooney PC
- The intersection between Hatch-Waxman litigations and proceedings at the PTAB
- Section 101 and pharma patents in Hatch-Waxman litigations
Luke T. Shannon, Shareholder
- Continued presence of patent claims directed to solid forms
- Anticipation challenges to solid form claims: considerations explored
- Obviousness challenges to solid form claims: current state of the law
Who Should Attend:
- Patent Attorneys
- Pharma Industry Lawyers
- Patent Licensing Attorneys
- FDA Attorneys
- Patent Litigators
- Patent Consultants
- Pharmaceutical Company Executives
- Professionals coming from Biotech and Pharmaceutical Firms
- Professionals coming from Food and Drug Industries
- Drug Manufacturing Executives
- Other Related/Interested Professionals
Phil has more than 25 years' experience as an intellectual property (IP) trial lawyer. His extensive experience includes bench and jury trials and arbitrations. He has represented clients in Hatch-Waxman (Paragraph IV) litigations, has worked in diverse industries such as graphics, visualization technologies, medical device, chemical and consumer products, and also has experience handling copyright and trademark/trade dress litigation.
In patent litigation, Phil has counseled clients on the interplay between Patent Office and district court proceedings. He has represented clients involved in proceedings in or with the Patent Office, including § 145 actions to obtain patents, ex parte and inter partes reexaminations and, with the advent of the America Invents Act, adversarial post-grant proceedings, including inter partes reviews.
Phil is the managing shareholder for Buchanan's New York City office and the former co-chair of the firm's IP Section.
Phil has more than 25 years' experience as an intellectual property (IP) trial lawyer. His extensive experience includes bench and …
Luke T. Shannon is a shareholder in the Chicago office of Polsinelli PC and a member of the firm’s Hatch-Waxman Litigation Practice Group. Luke has been practicing for more than a decade and handles all types of IP disputes. His recent focus includes cases involving small molecules, compositions and formulations, polymorphs, combinatorial chemistry, methods of treatment, and pharmaceutical salt forms.
Luke T. Shannon is a shareholder in the Chicago office of Polsinelli PC and a member of the firm’s Hatch-Waxman …
Print and review course materials
Method of Presentation:
General knowledge of patent
NY Category of CLE Credit:
Areas of Professional Practice
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About Buchanan Ingersoll & Rooney PC
Buchanan is a national law firm with a strong reputation for providing progressive, industry-leading legal, business, regulatory and government relations advice to our regional, national and international clients. Our 450 attorneys and government relations professionals across 17 offices proudly represent some of the highest profile and innovative companies in the nation, including 50 of the Fortune 100. While we service a wide range of clients, Buchanan has especially deep experience in the energy, finance, healthcare and life sciences industries. We bring to our clients an intimate knowledge of the players, market forces and political and regulatory landscape and use our full-service offerings to protect, defend and advance our clients’ businesses.
About Polsinelli PC
Polsinelli is an Am Law 100 firm with more than 825 attorneys in 21 offices. Ranked #30 for Client Service Excellence and #10 for best client relationships among 650 U.S. law firms, Polsinelli was also named among the top 30 best-known firms in the nation . The firm’s attorneys provide value through practical legal counsel infused with business insight, and focus on health care, financial services, real estate, intellectual property, mid-market corporate, labor and employment, and business litigation.