5 th Annual Pharma IPR Conference 2016

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1 5 th Annual Pharma IPR Conference March 2016, Mumbai DAY 1 : 9 th March 2016 Country: US 09:40 American Invents Act Updates on Americas Invents Act and current scenario of US Patent laws Implications of inter partes review on the Indian pharma industry Recent litigation case laws Speaker Company: Sterne, Kessler, Goldstein & Fox 10:20 Ascertaining strategies for filing Para IV for generic drug makers to ensure secure early market entry Highlighting key provisions in Para IV litigations Understanding the current trends in ANDA litigations Explaining critical aspects that should be considered by generic companies while challenging patents of innovator companies Speaker Company: Sterne, Kessler, Goldstein & Fox 11:00 Refreshments and Networking 11:30 Gaining clear understanding of Anti-trust Regulations and its impact on the Indian pharma industry Reviewing recent developments in the US Anti-trust laws Determining if reverse payment settlements lead to violation of anti-trust laws Examining latest litigation cases under Hatch Waxman Litigation Highlighting the best practices for handling Risk Evaluation and Mitigation Strategies (REMS) 12:10 12:50 Understanding the implications of REMS to devise strategies to entry US markets Determining if REMS is the next generation anti-trust issue Analysing recent case laws Speaker Company: Winthrop & Weinstine Formulating the best litigation strategies in US to optimise cost for pharma and biopharma companies Identifying ways to minimise the overall litigation cost in USA Highlighting ways and means of circumventing bottleneck patents Discussing recent litigation Case Law Speaker Company: Greenblum & Bernstein, P.L.C

2 13:30 Lunch and Networking 14:40 Overcoming Patent Barriers to Introduce Biosimilars in the United States Overview of BPCIA patent litigation (the patent dance ) Latest developments in U.S. biosimilar patent litigation Case Laws: Amgen v. Sandoz Amgen v. Apotex Janssen v. Celltrion Amgen v. Hospira Use of Inter Partes Review by biosimilar companies Speaker Company: McAndrews, Held & Malloy, Ltd. 15:20 Recent 101 Patentability Decisions and Their Potential Impact on Method of Treatment Patents. Discussion of section 101, Ariosa v Seqenom, and Prometheus v. Mayo Why these cases may make it harder to obtain, or easier to challenge, method of treatment patents The substantive and procedural differences between a section 101 patentability and a section 103 obviousnesschallenge Does the patent claim an inherent characteristic of the prior art, or a new and useful method? Speaker Company: Merchant & Gould 16:10 Speed Networking: Benefit from this unique opportunity to meet all the key industry players in quick succession and develop long-term business relationships 16:30 17:00 Refreshments and Networking Panel Discussion: Assessing the pros and cons of Patent Linkage on the generic pharma industry Recent developments in Patent Linkage and its impact on the generic industry Overcoming the challenges faced by Indian generic pharma companies due to patent linkage in US 17:50 Closing remarks from the Chair 18:00 End of Conference Day One DAY 2 : 10 th March 2016 Continent: Europe

3 09:40 Navigating the legal challenges of generic entry in Europe Current developments in European SPCs Likelihood of injunctions being granted in European jurisdictions under the present law How the practice of issuing injunctions will change under the new Unitary Patent system Litigation of a unitary patent Steps generic companies will need to take to minimise risk under the new Unitary Patent system Speaker Company: HGF Intellectual Property Specialists 10:10 Understanding the implications of Unified Patent System and the European patent laws to formulate strategies for sustainable business growth Ascertaining basis of patent invalidation Overcoming challenges faced by generic drug industry while entering European markets Possibilities for declaration of non-infringement in Europe 10:50 Refreshments and Networking 11:20 Understanding the preliminary procedures and necessary compliances to be met to successfully launch your pharma products Product launch day planning and infringement issues to be considered when the product is in transit in the European countries The effect of the unitary patent on launch strategy and on litigation strategy Recent case laws on cross border measures in Europe to formulate your IP strategy 12:00 A new European trade secrets regime takes shape how the new rules will impact the Pharma Industry Background and Status of the Legislative Process Protection of Trade Secrets: Current legal situation in selected Member States of the European Union Key provisions and relevant issues of the Draft Trade Secrets Directive Impact on the Pharmaceutical Industry Speaker Company: Osborne Clarke International Country: Brazil 12:30 Understanding the patent laws of Brazil to devise growth strategies for Indian pharma companies Examining the regulatory data protection offered in Brazil Understanding the ways to gain marketing exclusivity to gain higher profit margins Examining the patent laws of Brazil to plan a strategic entry and get first mover advantage Speaker Company: Montaury Pimenta, Machado & Vieira de Mello

4 13:10 Lunch and Networking Country: Japan 14:10 Assessing Patent scenario in Japan to create a roadmap for exploring business opportunities in the market Filing pharma patent applications successfully Procedural aspects and diversity in various aspects of patenting Infringement analysis in the Japanese courts Case Studies Speaker Company: YUASA and HARA Country: South Africa 14:50 15:30 16:20 16:30 Understanding the pharmaceutical patenting in South Africa by critically examining the recent case laws and IP scenario Analysing the various patent prosecution challenges to mitigate risks and select best strategy for your products Analysing the enforcement trends in pharmaceutical in South Africa to effectively design your IP strategy World Café Join together in smaller groups with your industry colleagues and debate over latest patent cases hitting the newspaper headlines across the globe Closing remarks from the Chair Moot Court Session: A simulated court experience where a pharma patent litigation case law would be discussed. 18:30 End of Conference Day Two DAY 3 : 11 th March 2016 Country: India 09:40 Evaluating the current trends of compulsory licensing to overcome the challenges faced by the domestic pharmaceutical companies 10:20 Gaining clear understanding of the TRIPS agreement and its impact on Indian generic drug industry 11:00 Refreshments and Networking 11:30 Exploring recent developments in trademarks and copyrights in the Indian pharmaceutical industry Examining counterfeiting cases within the pharmaceutical industry Understanding importance of trademarks and copyrights for generic drug industry 12:10 Case Study of Sofosbuvir on compulsory licensing 12:50 Panel Discussion: Moving Indian Pharma Industry into Innovation

5 13:30 Lunch and Networking Country: Australia 14:30 Understanding the updates on the Australian patent system and litigation strategies to learn the best practices for litigating a variety of IP issues Country: China 15:10 Examining the current patent scenario in China to get faster and hassle free access into the Chinese markets Understanding the Chinese patent laws to identify the right processes that need to be followed to get timely product approvals Evaluating the data exclusivity and its provisions as per the Chinese patent laws to assess its impact on the Indian pharma companies Exploring ways to overcome language challenges associated with data in patent information to get better access to reliable patent data without compromising on the quality Countries: GCC 15:50 Discussing Patent laws for GCC market to ensure hassle free market entry 16:30 Closing remarks from the Chair 16:40 End of the Conference

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