Conference Agenda

  • Welcome Address
  • Opening remarks by the CHAIRPERSON
  • 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

Tedd Van Buskirk

Partner

Lerner David

  • Understanding the judicial approach and procedure on ANDA in US market 
  • Case laws and ANDA litigation proceedings to help Indian patent professionals

Steve Coyle

Partner

Cantor Colburn LLP

  • Review of recent decisions involving Paragraph IV litigation 
  • Complex challenges for both patent holders and patent challengers

Christopher Griffith

Partner

Green, Griffith & Borg-Breen LLP

  • 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

Shashank Upadhye

Partner

Amin Talati Upadhye

  • ‘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

Sailesh K. Patel

Partner

Schiff Hardin LLP

  • Entering the US markets and the implications of REMS 
  • Restricted distribution programs by branded drugs : Threat to generics market 
  • Analysing recent case laws

Stephen R Auten

Partner

Taft Stettinius & Hollister LLP

Paul A Braier

Partner

Greenblum & Bernstein, P.L.C., USA

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

Andy J. Miller

Partner

Locke Lord LLP

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)

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

by Locke Lord
by Schiff Hardin - (by invitation only)*
  • 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.

Dieter Tzschoppe

Director Operations Biotechnology / Pure and Applied organic Chemistry | Dir. 1.4

European Patent Office

  • 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.

Ravi Srinivasan

Partner

Patent Attorney, J A Kemp

  • 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

Andy Camenisch

Partner

HGF Ltd.

  • 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.

Alexander Wittkopp

Patentanwälte PartmbB Hamm&Wittkopp

Europe

  • 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

Geoff Hussey

Partner

A.A. Thornton & Co

Craig Turner

Partner

A.A. Thornton & Co

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.

  • Patent system and practice of Japan, especially in the field of Pharmaceutical 
  • Patent term extension (especially pharmaceutical)

Yoshiyuki OSABE

Deputy Director

Patent Information Policy Planning Division, Japan Patent Office.

  • '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 

OP Gupta (IAS)

Controller General of Patents, Designs & Trade Marks, DiPP

Ministry of Commerce and Industry, Government of India

  • Is India investing it right? 
  • Co-survival of the innovators and generics in the current patent scenario

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

  • BOLAR Exemption(Implications of Section 107 of Indian Patent Law on Indian Generics)
  • Biosimilar Litigation strategies

Saya Choudhary Kapur

Partner

Singh and Singh Law Firm

  • 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

Richa Pandey

Patent Attorney & Partner

Krishna and Saurastri Associates

  • Pre – grant Opposition and Post – grant Opposition
  • Considerations for filing the opposition
  • Working of Patents

Mythili Venkatesh

Managing Associate

S. Majumdar & Co.

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.

Sanjay Kumar

Former Head - Legal, Ethics and Compliance

GSKConsumer ( JV of GSK & Novartis)