AGENDA

17:00
Registration and Refreshments
17:50
Welcome Address by Informa Markets in India
18:00
Keynote Address by Cozen O’Connor
18:05
Moot Court by Cozen O’Connor & Judge Jose Linares
Moot Court Session is a simulated court room scene with patent attorneys discussing the litigation issues in detail in addition to the nuances of actual proceedings. The attendees will get an opportunity to clarify the most critical questions regarding the cases and achieve in-depth understanding of legal challenges in IPR.
19:45
Closing Remarks by Cozen O’Connor
20:00
Cocktail & Dinner
08:00
Registration and Refreshments
09:00
Inaugural Ceremony
  • Welcome Address by Informa Markets in India
  • Opening remarks by the CHAIR
USA
09:30
Do’s and Don’ts in the Courtroom
10:00
The New Era Blueprint of Global Pharma Intellectual Property Strategies
  • Updates on current IP Strategies and envisioning the future
  • IP Innovation Strategies to build a culture of IP Innovation and Innovation Powerhouse
10:40
FDA Regulatory Law from Cradle to Grave
Impact of FDA regulatory law on IP, Strategy and Launch management
11:20
Break and Networking
11:45
Current Patent and Infringement Updates to Ensure Successful Launch and Protection of Innovation
12:30
Generics to Complex Generics to Super Generics - The Reality and the Way Forward
How pharma companies should adapt and gear up to move in this direction?
13:15
Lunch and Networking
14:00
Brand and Generic Perspectives Latest FDA Initiatives in the Hatch-Waxman Space
  • Hatch- Waxman Legacy
  • FDA Hatch- Waxman Working Group initiatives aiming at increasing generic competition
14:40
Overcoming the Barriers to Build a Lucrative IP Business Strategy
15:20
Inter Partes Review, Litigation or Both: Strategic Considerations For Pharmaceutical Companies
15:50
Industry Insights on Hatch-Waxman and Paragraph IV Litigations
  • Latest developments in the federal courts and PTAB
  • Review of recent decisions involving Paragraph IV litigations
16:30
HIGH-TEA AND NETWORKING
17:00
Protection of Trade Secrets in a Globalized Environment
  • IPR policy to create awareness towards protecting trade secret
  • Technical know-how among the manufacturing and procurement groups
17:30
PANEL DISCUSSION
Evolution of Biosimilars: Global Harmonization
  • Overview on the recent patent situation of Indian Biosimilars industry
  • Updates on the recent guidelines released in May 2019
  • 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
  • Interchangeability key criteria for the future of biosimilar

18:30
Closing Remarks from the Chair

18:45
Cocktail Opening Address

08:30
REGISTRATION AND REFRESHMENTS

10:00
Opening Remarks by the CHAIR

USA
10:15
ANDA Filing and Litigation
  • Updates and strategies to improve certainty
  • Current trends in ANDA litigations
  • Analyzing recent FDA procedures affecting market access and exclusivities
  • Discussing the judicial approach on ANDA filing and litigation
10:50
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
  • Assessing ways to reduce cost in Para IV fillings
  • Evaluating necessities for 505(b)(2) to alter Para IV certifications
11:30
BREAK AND NETWORKING

12:00
Patent Law Amendment, IP Enforcement and Drug Regulatory Updates

12:40
Induced Infringement: Permissibility and Inevitability
  • Evolution of induced infringement
  • Inherency in an Obviousness Analysis
13:30
LUNCH AND NETWORKING
EUROPE
14:30
Latest Amendments in the European Patents
  • Understanding EU enforcement case laws on trademarks and patents
  • Trademark infringement and flow of generic medicines into the European regions
  • Latest reforms in patent litigations in EU
  • Updates on Unitary Patent System commencing in 2019
  • Brexit: Impact on Indian pharma
15:00
Re-Introduction of the Doctrine of Equivalents
  • Purposive Construction after Kirin Amgen
  • Actavis v Lilly Recap
  • Application of the doctrine of equivalents in UK case law
  • Impact on Indian Pharmaceutical Industry
15:30
Supplementary Protection Certificate (SPC) Regime : A Regulation to Rule the Market for an Extended Time Period
  • Evaluating the latest and upcoming reforms in SPC’s to leverage patent extension
  • Advantages of SPC’s due to the Indian pharma industry
  • Combination Drug Products: Deliberating the scope of SPC and landmark court cases
17:00
European Biosimilars Industry: Envisioning the Future
  • Current market overview of biosimilars in EU
  • Regulations and frameworks to introduce biosimilars
  • Parameters to ensure to safety and efficacy for patent eligibility
18:00
Closing Remarks by the CHAIR
18:30
Cocktail Opening Address
08:30
REGISTRATION AND REFRESHMENTS

09:30
Opening Remarks by the CHAIR

INDIA
09:45
Keynote Address
Evaluating Current Patent Regime in the Indian Patent Act for Pharmaceutical Companies to Understand IP Environment in the Country
10:30
National Pharmaceutical Pricing Authority (NPPA): The Price Control of the Life-Saving Drugs in India
11:00
BREAK AND NETWORKING
11:30
Patent Opposition vs. Patent Revocation: Which is a Better Strategy to Adopt by Indian Pharma Industry
12:00
Fixed Dose Combination Products and its Regulatory Challenges in Approval in India and its Future
12:30
Cost Effective Litigation Strategies for Generics
13:00
LUNCH AND NETWORKING
JAPAN
14:00
Country Focus: IP Revolution- Japanese National IP Strategies
  • Understanding the next-generation IP policies
  • Identifying the Key IP Issues
  • Shifting the global tides
  • Patent term extension
BRAZIL / MEXICO
14:30
Amendments in Patent Law and Recent Patent Infringement Case Laws
SOUTH AFRICA
15:00
Patent System and Litigation Strategies in South Africa
  • The best practices for litigating a variety of IP issues
  • Lessons for Indian generic drug manufacturers
AUSTRALIA/ NEW ZEALAND
15:30
Patents: Current Developments and Challenges in Australia and New Zealand
16:00
Closing Remarks by the CHAIR
16:10
End of the conference

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