Conference Agenda

09:00

Registration & Refreshment

09:30

Inaugural Ceremony
  • Welcome Address
  • Opening remarks by the CHAIRPERSON
USA

10:15

Five years of Inter Partes Review : Effectiveness and Expectations
  • Analyzing the validity of existing patents – violations on extinguishing private property rights through a non-Article III forum
  • The amendment process implemented by the PTO in inter partes review 
  • The “broadest reasonable interpretation” of patent claims 
  • Implications of the process and time of litigation
Speakers
Tedd Van Buskirk,
Partner
Lerner David

10:45

ANDA filing and litigation : Strategies to Respond
  • Understanding the judicial approach and procedure on ANDA in US market 
  • Case laws and ANDA litigation proceedings to help Indian patent professionals
Speakers
Steve Coyle,
Partner
Cantor Colburn LLP

11:25

BREAK

11:50

Update for Para IV Litigation: Latest Developments in the Federal Courts and PTAB
  • Review of recent decisions involving Paragraph IV litigation 
  • Complex challenges for both patent holders and patent challengers
Speakers
Christopher Griffith,
Partner
Green, Griffith & Borg-Breen LLP

12:30

Solving The Roadblocks : Increasing efficiency while limiting the US Litigation Costs
  • Solving The Roadblocks : Increasing efficiency while limiting the US Litigation Costs 
  • Pre-Litigation considerations (Strategising the litigation, Pre- Litigation guidelines to the IPR teams of pharma companies in India) 
  • Litigation Stratagem (Joint - Defence Groups & Jurisdictional Issues, Alternative Fee Arrangements) 
  • Settlement Strategies
Speakers
Shashank Upadhye,
Partner
Amin Talati Upadhye

01:10

LUNCH

02:00

‘On-Sale Bar’ : Understanding The Impact of Helsinn on Pharmaceutical Patents in a Post-AIA Setting
  • ‘On-sale bar’ in a pre-AIA setting in the Medicines Company’s Angiomax case 
  • Anticipating the Federal Circuit’s decision in Helsinn 
  • Exploring the consequences of either scenario in future Hatch- Waxman settings
Speakers
Sailesh K. Patel,
Partner
Schiff Hardin LLP

02:20

Induced Infringement: Product Labeling and the Implications of the Federal Circuit’s Decision in Sanofi v. Watson
Speaker: Ronald M. Daignault

02:50

Risk Evaluation and Mitigation Strategies (REMS): Update
  • Entering the US markets and the implications of REMS 
  • Restricted distribution programs by branded drugs : Threat to generics market 
  • Analysing recent case laws
Speakers
Stephen R Auten,
Partner
Taft Stettinius & Hollister LLP
Paul A Braier,
Partner
Greenblum & Bernstein, P.L.C., USA

03:40

Refreshments and Networking

04:00

Speed Networking:
Benefit from this unique opportunity to meet all the key industry players in quick succession and develop long-term business relationships

04:30

Role of Information Governance for Cost effective eDiscovery
Speakers
Kirit Palsana,
Director, Software Development
Knovos

04:50

Inherent Obviousness: Available IPR Rationale
  • The Evolving obviousness standard and evaluating inherency
  • Laying the Foundation for an Obviousness Framework
  • PTAB’s novel claim on section 102 and 103
  • Understanding the decision with recent examples
Speakers
Andy J. Miller,
Partner
Locke Lord LLP

05:30

Interactive Discussion:
REINVENTING THE WHEEL THROUGH SUPER GENERICS WITH 505(b)(2)
Session Synopsis: The 505(b) (2) pathway may be little-known, but it's no longer little-used. In the recent years, Indian pharmaceutical companies are increasingly using a lesser-known regulatory pathway to get new doses, formulations or combinations of drugs approved by the US FDA. 505 (b)(2), one of the most popular alternative pathway is designed to allow the approval of a drug which isn't new, but differs in several meaningful aspects.

The interactive panel discussion will highlight on how innovation can be encouraged without creating duplicates in the India generic sector.
  • Reason for choosing a 505(b)(2) 
  • Patent/Regulatory/Medical Factors of approvals under 505 (b)(2) 
  • Comparison with 505(b)(1) & Litigation Challenges for 505(b)(2) 
  • Advantages and disadvantages of 505(b)(2) 
  • Some practical examples of successful 505(b)(2)
Speakers
Bharati Nadkarni,
Vice President
Sun Pharma
Seema Singh,
Associate Director
Abbott
Taranpreet Singh Lamba,
Vice President of Intellectual Property and Product Portfolio Management
Glenmark Pharmaceuticals Limited

06:00

Closing remarks from the Chair

06:15

Cocktail Opening Address 
by Locke Lord

07:30

POWER BREAKFAST 
by Schiff Hardin - (by invitation only)*

09:00

Registration

10:00

Opening Remarks by the CHAIR
Speakers
Martyn Fish,
HGF – Intellectual Property Specialists
Europe
Europe

10:00

Update on latest developments at the EPO
  • Early Certainty initiative
  • Understanding the Unitary Patent System
  • New structure and the new Central Opposition procedure 
  • Overview of patentable inventions in the field of pharmaceutical and biotechnology, including the change of the Implementing Regulations as regards plant and animal patenting.
Speakers
Dr. Dieter Tzschoppe,
Director Operations Biotechnology / Pure and Applied organic Chemistry | Dir. 1.4
European Patent Office

10:40

Strategic considerations and Supplementary Protection Certificate regime
  • Governing the choice of “basic patent” to support an SPC 
  • Possibility of filing an SPC on more than one “basic patent” 
  • SPCs on combination products 
  • Neurim-type SPCs (new medical uses and formulations) – discussion of pending CJEU referral 
  • Pending CJEU referral on Art 3(a): level of specificity needed in the claims of the basic patent for the authorised product.
Speakers
Ravi Srinivasan,
Partner
Patent Attorney, J A Kemp

11:00

Break

11:30

Patent Interpretation: What has changed?
  • The legislative provisions governing the scope of protection
  • Landmark decision (Actavis v Eli Lilly) re-steering the law of patent infringement ? 
  • Doctrine of Equivalents in the UK
  • File Wrapper Estoppel in the UK
Speakers
Andy Camenisch,
Partner
HGF Ltd.

12:00

Precious biosimilars are kicking off – the present situation in the EU
  • Current status of the biosimilar-market in Europe
  • Trends and status of protection of biopharmaceuticals before the EPO
  • Challenges and recent achievements in revoking secondary biosimilar patents
  • Filing biosimilar patents: opportunities for sponsors at every step of the manufacturing process – protecting developments and clearing paths.
Speakers
Dr. Alexander Wittkopp,
Patentanwälte PartmbB Hamm&Wittkopp
Europe

12:30

Implications of Brexit on Indian pharma companies
  • Understanding impact of Brexit on the backdrop of EU legislation
  • The pan European IP Market : What to expect Post Brexit?
  • Commercial aspects of pharma in Europe
  • Possible mechanisms to address European Union Trade Marks and Community Designs
Speakers
Geoff Hussey,
Partner
A.A. Thornton & Co
Craig Turner,
Partner
A.A. Thornton & Co

01:00

LUNCH

02:00

Interactive World Cafe

In this session all your queries will be answered by the experts.

Drop in your questions specifically addressed to a speaker in a fishbowl on your table and our expert speakers will give their best to resolve your queries.

SOUTH AFRICA

03:00

South African Approach in utilizing fragmented strategies to build respect for IP based on article 45 of the Development Agenda
Speakers
Amanda LOTHERINGEN,
Senior manager Copyright and IP enforcement
Companies and Intellectual Property Commission, South Africa
JAPAN

03:40

The Long Road : Meeting Japanese IP Standards
  • Patent system and practice of Japan, especially in the field of Pharmaceutical 
  • Patent term extension (especially pharmaceutical)
Speakers
Yoshiyuki OSABE,
Deputy Director
Patent Information Policy Planning Division, Japan Patent Office.

04:15

Break

04:30

Fireside Chat

05:30

Closing Remarks by the CHAIR

05:45

Cocktail Opening Address

09:00

Registration

09:30

Opening Remarks by Chair
India

09:45

Keynote Address
  • 'Modi'fied IPR Policy: Benefits for the Indian generic pharma market and focus on R&D Investments for new drugs
  • Indian Patent Office: Innovation and Upgradation to support the changing patent regime in the country 
  • Regulations and Current price ceiling mechanism: Proposed dramatic changes to regulations to keep a check on prices of medicines 
Speakers
OP Gupta (IAS),
Controller General of Patents, Designs & Trade Marks, DiPP
Ministry of Commerce and Industry, Government of India

10:30

PANEL DISCUSSION:
Patents Vs. Early Market Entry of Indian Generics
  • Is India investing it right? 
  • Co-survival of the innovators and generics in the current patent scenario
Speakers
Srikanta Patra,
Pellets Pharma
Head, Global IP & Strategic Planning
Dr. Poonam Raghuvanshi,
Vice-President & Head, Intellectual Property
Dr. Reddy’s
Ranjna Mehta Dutt,
Vice-President
Asian Patent Attorneys Association (APAA).
Vidya Subramanian,
Deputy General Manager- IPR
Reliance Life Sciences

11:30

Refreshments & Networking

12:00

Overview on the Patent Litigation in India
  • BOLAR Exemption(Implications of Section 107 of Indian Patent Law on Indian Generics)
  • Biosimilar Litigation strategies
Speakers
Saya Choudhary Kapur,
Partner
Singh and Singh Law Firm

12:15

Addressing Compulsory Licensing Issue
  • Compatibility with IPR laws of WIPO, TRIPS and other major dominant countries like US & UK 
  • Discussing case laws to understand reasons why Compulsory Licenses are not granted
  • Bridging the gap between unutilised CLs and need and affordability
Speakers
Richa Pandey,
Patent Attorney & Partner
Krishna and Saurastri Associates

12:30

Patent Invalidation by the Way of OPPOSITION
  • Pre – grant Opposition and Post – grant Opposition
  • Considerations for filing the opposition
  • Working of Patents
Speakers
Mythili Venkatesh,
Managing Associate
S. Majumdar & Co.

12:45

Managing IP while Adopting Innovative Pharma Marketing strategy with Social Media
SYNOPSIS: With the growth in number of internet users, social media will bear a much larger influence on people’s lives in the coming years. There is no doubt that social media is a powerful channel for pharmaceutical marketing. The question is, “Are Indian drug manufacturers making the most of it?” In this session, the speaker will discuss managing copyright in the digital era and risk and rewards of social media with a focus on digital review process and how this data can be leveraged in the clinical trials.
Speakers
Sanjay Kumar,
Former Head - Legal, Ethics and Compliance
GSKConsumer ( JV of GSK & Novartis)

01:15

Closing Remarks by the CHAIR
Speakers
Yoshiyuki OSABE,
Deputy Director
Patent Information Policy Planning Division, Japan Patent Office.

01:30

LUNCH

02:00

End of the conference