08:00
REGISTRATION AND REFRESHMENTS
09:00
Inaugural Ceremony
- Welcome Address by Informa Markets
- Opening remarks by the CHAIR
09:15
Keynote Address - Legal Perspective and Industry Insights
10:00
Overview on Hatch-Waxman Act and Its Impact on Drug Development Process
- Paragraph IV : Latest advancements and resulting effect in the Hatch-Waxman space
- Investigating the enumerations of recent Hatch-Waxman cases
10:40
Legal Perspective on Paragraph IV Proceedings
- Assessing ways to reduce cost in Para IV fillings
- Evaluating necessities for 505(b)(2) to alter Para IV certifications
- Discussing the judicial approach on ANDA filing and litigation
11:20
REFRESHMENTS AND NETWORKING
11:50
FDA Drivers for ANDA Filing and Litigation
- Updates and strategies to improve certainty and reduce cost in Para IV litigation
- Current trends in ANDA litigations
- Analyzing recent FDA procedures affecting market access and exclusivities
12:30
Victory without Trial: Rule 12(b) and 12(c) Motions for Judgement on the Pleadings
13:10
LUNCH AND NETWORKING
14:00
Section 101: Interplay between Patent Law and Reproducibility
- Challenges of reproducibility
- Utility vs. enablement
14:40
Industry Insights on Hatch-Waxman and Paragraph IV Litigations
- Industry Insights on Hatch-Waxman and Paragraph IV Litigations
- Review of recent decisions involving Paragraph IV litigations
15:20
Antitrust Recent Developments in Pharma
16:00
COFFEE AND NETWORKING
16:30
Analysis of Emerging Doctrine of Equivalents (DOE) in ANDA Cases
- Outline of recent cases
- Procedures for reciprocating to allegations of infringement under the DOE
17:10
Panel Discussion:
Induced Infringement: Permissibility and Inevitability
- Evolution of induced infringement
- Inherency in an Obviousness Analysis
18:15
Closing Remarks by Chair
08:00
REGISTRATION AND REFRESHMENTS
09:00
Opening Remarks by the CHAIR
09:30
Global Perspective: The Patent Linkage for Pharmaceuticals
- Overcoming the challenges faced by branded and generic pharma companies due to patent linkage
- Patent Infringement Actions in the US International Trade Commission
- Examining matters of international trade and impacting the value of pharmaceutical patents
10:15
Patent Law Amendment, IP Enforcement and Drug Regulatory Updates
11:00
REFRESHMENTS AND SPEED NETWORKING
Benefit from this unique opportunity to meet all the key industry players in quick succession and develop long-term business relationships
12:15
Integrating Inter-Partes Review and New USPTO Procedures Into Generics, Branded and Biosimilar Litigation Strategies
BIOPHARMA & BIOSIMILARS
13:00
Biopharma Litigation Highlight: Instantaneous Action Plans for Innovators and Biosimilars to Prepare for the Future Battles
- Recent US Legal Developments Affecting Biopharma-Related Contentious Matters
- Latest litigations and patent disputes in Biosimilars arena
- Interchangeability updates as per the recent guideline released
14:45
Panel Discussion
Evolution of Biosimilars: Global Harmonization
- BPCIA - Biologics Price Competition and Innovation Act
- Understanding patent skeleton for Biosimilars to fast-track the launch of Biosimilars
- Patent eligibility threshold to ensure safety and efficacy
- Comparing and Evaluating the U.S and EU Biosimilars Experience
16:00
Closing Remarks by Chair