26 - 28 S 2016 H T K , H

28 - 30 S 2016 H H , (A E ) M

03DAYS

IN-HOUSE IP COUNSELS, R&D SCIENTISTS, IP PRACTITIONERS PATENT AGENTS, ATTORNEYS IN PHARMACEUTICAL, BIOTECH, CHEMICAL & DRUG INDUSTRY

INTERNATIONAL SYMPOSIUM

| SUGHRUE MION, PLLC, USA

Khurana KhuranaAdvocates and IP Atorneys

INSTITUTE OF INTELLECTUAL PROPERTYRESEARCH AND DEVELOPMENT

ABOUT THE WORKSHOP

WithWith Patents becoming a core part of existing economic ecosystem, particu-larly for Pharmaceutical, Biotech, and Chemical Industries, exploitation of Patent Portfolio has become an industry in itself; especially with the cost of de-velopment and protection of the portfolio being enormous. It is therefore cru-cial to understand important Patent issues, not only for In-House IP Counsels, but even more importantly for R&D Scientists so as to minimize efforts in Patent Development, and maximize commercial gains. It is therefore important for Corporates and concerned stakeholders to understand nitty-gritty’s of patent portfolio creation, protection, management, and commercialization, without which there would always remain an open door for a serious blow either from an infringement perspective or from a patent invalidation perspective or the portfolio would remain under-commercialized. Exclusivity rights granted through patents can only be utilized if there is com-prehensive knowledge of various patent related issues, more so when Na-tional Patent Laws & Practices relating to prosecution practices, drafting practices, examination practices, enforcement practices and commerciali-zation practices differ substantially across geographies. Furthermore, stand-ards for protection and enforcement as applied by different National judiciar-ies often vary widely and therefore in the global business scenario, besides understanding of Patent Laws and Practices prevalent in India we also need to understand the practices in economically and financially important geog-raphies such as United States, Europe, and Korea. It is in this direction that the three days International Symposium is being organized to impart comprehen-sive knowledge to understand the nitty-gritty of Patent Regime. HOW THE SYMPOSIUM IS UNIQUE ThisThis Symposium features presentation of all important patent issues, as men-tioned in this brochure. The speakers are a unique gathering of Patent Attor-neys, Litigators and Legal Counsels, who have extensive years of experience in their professional fields and are well acquainted with the Industry’s need. These speakers will put across to the delegates the real insight of Patent Laws, Practices and Commercial perspectives as prevalent and practiced in United States, Europe, and Korea. The Workshop will provide an opportunity to receive first-hand information including recent Judgment on various issues from the experts in the fields.WHY THE DELEGATES SHOULD ATTENDThis is an opportunity when Patent Experts, Litigators, and Legal Counsels from varied backgrounds and having enormous expertise and different percep-tion would be interacting with limited delegates and would answer to any question that the delegates may have. The speakers have thorough knowl-edge on the subject and have been working in the field for many decades. The speakers are selected such that R&D Scientists, In-House Counsels, Patent Attorneys, and IP Practitioners can get to know real insights and nitty-gritties followed in the United States, Europe, and Korea in Patent Domain. The speakers would share real-life cases and experiences that can help attend-ees in following best practices for building their respective patent portfolios so as to best commercialize. WHO SHOULD ATTENDIP Groups of R&D Organizations, Research & Development Scientists, In-House IP/Legal Counsels, Patent Agents & Attorneys in the field of Practice, Patent Litigators, and Professionals in Legal Domain related to Pharmaceuticals, Bio-tech and Chemicals.

26-28 September 2016, at Hotel Taj Krishna, Hyderabad 28-30 September 2016, at Hotel Hilton, (Andheri East) Mumbai

Registration Fees: For Indian Delegates: INR 12000 Per Delegate For Foreign Delegates: USD 300 Per Delegate Please Forward the Delegate Fees with the following details: Name, Organization, Designation, Address and Contact Details along with the cheque drawn in favour of " M/S IIPRD”

Mr. Tarun Khurana IIPRD E-13, UPSIDC Site-IV, Kasna Road, Greater Noida-201308, UP, India.

OR

Transfer Funds at our Bank; details are as Follow:Bank Name: UCO BankBank Account Number: Bank Account Number: 19620210002476Bank Branch Name: Greater NoidaBank Address: G N Shopping Plaza, Plot No.S-7/1, Site -IV, Kasna Road, Greater Noida.MICR Code: 110028055 IFSC Code (Local Vendor): UCBA0001962Name of the Account Holder: M/S IIPRD

FOR ANY QUERY CONTACT:FOR ANY QUERY CONTACT:Ms. Meenakshi Khurana, (M) : +91-9910307992, E-mail: Meenakshi@iiprd.com

Mr. R Srinivasan, (M): +91-9716064337, E-mail: Srinivas@iiprd.com, iiprd@iiprd.comPh: Ph: +91-120-4296878/2399113/2399010, Fax: +91-120-2399011

SCHEDULE DATE & VENUE

PROGRAMME OUTLINE[US Scenario]

Day

0109.00 - 09.30 : Registration 09.30 - 11.00 : Session IRecentRecent developments on Subject Matter Patentability in Patent Invalidity Challenges: Understanding the implications of Ariosa v. Sequenom and Endo Pharmaceuticals Inc. v. Actavis Inc and related jurisprudence on method of use patents; Strategies for due diligence and patent prosecution for small molecules in view of these case laws11.00 - 11.15 : Tea Break 11.15 - 12.15 : Session II ExploringExploring Lilly v. Teva and its wider implications for Divided and Induced In-fringement rulings in ANDA litigation: Review of the Limelight v, Akamai ap-peals; Understanding role of the label in the determination of divided and in-duced infringement in view of Lily;12.15 - 13.15 : Session IIIStrategic Considerations for invalidating a patent at the PTAB vis-a-vis District Court: procedural and substantive comparisons to evaluate best options of the two; When an Inter partes (IPR) route is more suited vis-a-vis a District Court litigation; Review of outcomes of recent pharma patent invalidity challenges at the PTAB; Latest legislative developments at the PTAB and District courts im-pacting ANDA litigation13.15 - 14.15 : Lunch 14.15 - 15.45 : Session IVEvolvingEvolving obviousness standard: Evaluating inherency by anticipation in view Purdue Pharma L.P. et al v. Amneal Pharmaceuticals, LLC and Gilead v. Natco; Secondary considerations and unexpected results in view of Pro-metheus Laboratories, Inc. v. Roxane Laboratories and Spectrum Pharma-ceuticals Inc. v. Sandoz Inc.; Exploring obvious-type double patenting in view of G.D. Searle LLC v. Lupin Pharmaceuticals, Inc.; Discussion on obvious find-ings at PTAB.15.45 - 16.00 : Tea Break16.00 - 17.15 : Session-VClaim Construction and Markman Strategies Post-Teva: Review of recent Fed-eral Circuit and District Court opinions addressing Teva applicability; Teva ap-plicability in IPR proceedings before the PTAB; Considering claim drafting in view of Teva with respect of written description and enablement require-ments; Devising Markman strategies in view of Teva in Para IV challenges

PROGRAMME OUTLINE[US Scenario]

Day

02 09.15 - 10.30 : Session-VIA review of the provisions of the BPCIA and the Amgen v. Sandoz case: How the Federal Circuit Interprets 'Patent Dance' Provisions of BPCIA; Statutory construction of the disclosure and marketing provisions; Sandoz non-disclo-sure arguments; Amgen's marketing notice arguments; Consequences of the Federal Circuit decision on the biosimilar process and future litigations10.30 - 11.30 : Session-VIIA shift in focus: from molecules to stem cells and biosimilars; Understanding how BPCIA timelines, transition of NDAs to BLAs in under the BPCIA, FDA’s pro-posed naming guidance and potential impact on biosimilars, Biosimilars patent tactics under new section 101 and 112, 11.30 - 11.45 : Tea Break11.45 - 13.00 : Session-VIIIHow has the Supreme Court's decision in Daimler AG v. Bauman defined per-sonal and general jurisdiction in Hatch-Waxman setting? Review of Hatch-Waxman jurisdiction cases since AstraZeneca AB v. Mylan Pharms, Inc and Acorda Therapeutics v. Mylan; Status of Mylan appeals pending before the Federal Circuit; What strategies should be used to assert or challenge jurisdi-ction in ANDA litigation? Devising interim jurisdictional strategie13.00 - 14.00 : Networking Lunch14.00 - 15.00 : Session-IXComparison of the Federal Circuit’s latest Momenta ruling with its original safe harbor ruling; Understanding the implications of this ruling to ANDA litigation; Review of Angiomax case and 35 U.S.C. § 102(b) prior to and post AIA; Under-standing the implications of this case in experimental use exception15.00 - 16.00 : Session-XEvaluating ex parte reexamination in view of other post-grant proceedings vis-a-vis double patenting, and how it can be used to invalidate vulnerable patents; : Discussing Gilead v. Natco with focus on tips for patent prosecution, as well as litigation outlook. strategies for managing ex parte appeals and AIA trials16.00 - 16.15 : Tea Break16.15 - 17.15 : Session-XIReviewReview of the recent at-risk-launches; Analysis of launching at-risk during trial or appeal; Examining New Guidance for Calculating Damages post an at-risk Launch; Damages calculation in view of AstraZeneca AB v. Apotex Corp.; Review of recent inequitable conduct cases impacting ANDA litigation post Therasense;

PROGRAMME OUTLINE[EP, Korea, Indian Scenario]

Day

0309.30 - 11.30 : Session-IAn overview on the new Unitary Patent system: Discussing advantages and drawbacks, describing the nature of the new patent and the related pros-ecution process; discussing the introduction of the Unified Patent Court; How to make informed decisions on the upcoming issues related to patent protec-tion in Europe.

11.30 - 11.45 : Tea Break

11.45 - 13.00 : Session-IIProsecution of pharmaceutical/chemical/biotech patent in Korea, Patent-ability Requirements; Grace Period; Patent Obligation Penalties; Impact of new law on future patent litigation, recent IP trends and regulatory changes in Korea. Amendments to the Patent Law and important changes

13.00 - 14.00 : Networking Lunch

14.00 - 15.00 : Session-IIIMarketing authorization process in EP; Medicinal Product Directive and Medi-cal Device Directives, Patent term extension for patented medical product; German Federal Patent Court’s decision on SPCs and Medical Devices.

15.00 - 15.15 : Tea Break

15.15 - 17.00 : Session-IIIRecent Changes in Indian Patent Procedures and Practices, Key Pharmaceu-tical Prosecution and Litigation Cases, Take Aways and Recommended Prac-tices

ABOUT THE ORGANIZERS

IIPRD:IIPRDIIPRD is a premier IP Consulting and Licensing Firm with a diversified business practice providing services in the domain of Commercialization, Valuation, Li-censing, Transfer of Technology and Due-Diligence of Intellectual Property Assets along with providing complete IP and Patent Analytics, Transactional, and Litigation Support Services to Indian and International Corporates, Licens-ing Firms, and Global Law Firms. IIPRD has been established precisely to assist the business houses in strategizing their growth by leveraging their IPR's through effective Creation, Promotion, Protection, and Commercialization of IP. IIPRD has a legacy of over fifteen years of existence, and is among the first Indian IP Firms to have core focus on Commercialization, Technology Transfer, and Licensing. IIPRD as strong team of over 65 professionals focus in complete Patent Support and Technology Consulting Matters ranging from conducting all types of Patent Searches, Research and Analytics, Preparation/Prosecution Support, Landscape Analysis, and Claim Charts/Infringement Analysis/Litigation Support.Charts/Infringement Analysis/Litigation Support.

SUGHRUE MION:Sughrue Mion is one of the world's leading intellectual property law firms man-aging traditional and non-traditional intellectual property rights, for about five decades, with a wide range of clients around the world. Sughrue's more than 100 lawyers protect ideas- all ideas- and for the last 50 years have been help-ing their clients to develop, obtain, protect and leverage their intellectual property rights in technology areas ranging from a submicroscopic sequence of DNA to a vast constellation of satellites circling the globe. Sughrue's Pharmaceuticals, Biotechnology, Chemical attorneys are trained in technical dis-ciplines that include molecular and cellular biology, biophysics, pharmaceuti-cals, chemistry, immunology, virology, genetics and agriculture biotechnol-ogy. Their experts are particularly well versed in drafting claims to ensure the broadest possible coverage and have a long established expertise in han-dling patent interference proceedings that may be critical to determining basic patent rights in new areas of biotechnological and pharmaceuticaldustries. Their litigators who specialize in chemistry have tried cases relating to pharmaceuticals, biotechnology, industrial chemical processes, specialty chemicals, and nanotechnology. Sughrue Mion handles a wide range of IP litigation matters for clients around the world, and when it comes to serving their clients, they go beyond traditional boundaries, advocating innovative theories and redefining the frontiers of law as they apply to creativity and in-vention.

KHURANA & KHURANA ADVOCATES & IP ATTORNEYS:KhuranaKhurana & Khurana, Advocates and IP Attorneys (K&K) is more than a full ser-vice Intellectual Property and Commercial Law firm. K&K was formed in the year 2007 with a very firm focus of providing end-to-end IP Prosecution/Litigation and Commercial Law services in a manner that is Cor-porate centric and follows stringent delivery practices that are consistent and are above defined quality standards. K&K works closely with its sister concern IIPRD, both of which supplement each other in order to provide end-to-end IP Legal and Commercialization/Licensing services to over 3000 Corporates. K&K is a team of over 65 professionals spread across 5 Offices in India, and has strong rankings from Legal 500, MIP, IAM, Chambers, Asia IP, among others. Our team of IP Attorneys/Practitioners, having high level of technical and legal competence, gives us the right competitive edge and positioning, as a law firm focused on creating immense IP value for our clients. K&K through its experienced and qualified team of Attorneys/Practitioners, across Technol-ogy and Legal Domains, gives a rare synergy of legal opinion, out-of-box thinking for protection of ideas/IP's and entrepreneurial spirits to its client base. K&K earnestly believes that success comes only when one has a long-term perspective and this is why we concentrate on building long-term relation-ships through high level of client orientation.

HAMM &WITTKOPP:A German based IP Law firm, as a team of chemists and biochemists with many years of experience, Hamm & Wittkopp represents its clients in all areas of intellectual property. A major focus of our activities lies in the fields of chem-istry and pharmaceutics – with particular emphasis on generic pharmaceuti-cals and biosimilars. We offer a comprehensive service of the highest level, from analyzing and clarifying the IP situation, for example via oppositions and nullity actions against troublesome patents, to securing your own innovations via patent applications and defending your interests in litigation proceedings. Our structure allows us to provide tailor-made support in all patent and trade-mark matters, whereby we are able to act flexibly and efficiently, whilst adapting to the specific needs of each individual case.

DR. AHN INTERNATIONAL PATENT LAW OFFICE:Patent Law Firm has focused on pharmaceutical / bio / chemistry incidentsS-ince 2006. Dr. Ahn International Patent Law Office firm is a member of both the Attorney combines Ahn So-young researchers and patent examiners career as a patent Attorney and a representative of Pharmacy led by Dr. Byeonri to perform tasks based on a correct understanding of the technology majors in the field. Dr. Ahn International Patent Law Office firm has represent-ed patent trail and patent litigation related to G-CSF as playing a role in the development and accumulation of landmark patent case law of the interna-tional pharmaceutical and biotechnology industries such as Baraclude, Gleevec, docetaxel, janidip, Avista, Lipitor, came to Plavix, Norvasc, Elrok Satin among others . The Law firm offers R&D technology trends trough patent map from the planning stage, patent acquisition and exercise of rights stages from research avoiding the design, patent portfolio construction, patent in-fringement whether preliminary review, patent strategy with every step, including patent monitoring competitors’ products.

ABOUT THE ORGANIZERS

Mr. Chid Iyer: Chid received a B. Tech in Chemical Engineering from IIT, Bombay in 1984, MS in Chemical Engineering from Univer-sity of Akron and MS in Computer Science from the Univer-sity of Tennessee Space Institute. He received his JD from Georgetown University in 1997.

Chid is a partner of International Law Firm of Sughrue Mion and is involved in all aspects of patent practice including litigation, prosecution and client counselling in a variety of technologies with focus on chemical and pharma-ceutical. Chid has prepared and prosecuted over 100 applications for a leading research laboratory.

Mr. Michael R. Dzwonczyk Michael is a partner at Sughrue Mion and has about 20 years of experience in successfully representing multina-tional companies in patent litigation, including trials and appeals of patent cases. His experience has encom-passed technical areas that include pharmaceuticals,

recombinantly produced hormones, protein synthesis and expression prod-ucts, fibers, and medical devices. Michael also counsels clients on intellec-tual property issues, including validity and infringement of intellectual prop-erty rights, licensing and contract matters and Hatch-Waxman issues.

Ms. Aiyda Ghahramani: Ms. Ghahramani practices in all areas of intellectual prop-erty law with a focus on litigation, rendering opinions on pa-tentability, infringement, and validity, as well as on the pros-ecution of intellectual property matters.

Ghahramani has served as litigation counsel in matters involving the chemi-cal, pharmaceutical and mechanical arts and has significant experience in nearly all pre-trial, trial, and post-trial aspects of patent litigation. She also en-gages in pharmaceutical/biotechnology patent infringement and validity opinion practice and counseling particularly in connection with preparation of Paragraph IV Notifications under section 505(b), as well as freedom-to-operate, due diligence and product clearance work, licensing and conntract matters, including joint ventures

ABOUT THE FACULTY

Mr. Shackelford: is an associate in the chemical patent and biotechnology / pharmaceutical practice groups, where he maintains an active patent prosecution and litigation practice. Mr. Shackelford earned his J.D. from the IIT Chicago-Kent Col-lege of Law.

He received his B.S. in Biochemistry from the University of Missouri-Columbia and M.S. in Chemistry and Chemical Biology from the University of California, San Francisco. As an undergraduate and graduate research scientist, Mr. Shackelford focused his research in the area of protein chemistry, studying protein superfamilies to identify mechanisms of enzymatic function and routes through which enzymes develop new functionality.

Ms. Azy S. Kokabi: Azy S. Kokabi practice focuses on worldwide procurement, defense and enforcement of patents in the biotechnology and pharmaceutical industries, with focus on prosecution, interference, and litigation motions practice.

Kokabi did her post graduation in Biology and JD from George Mason Uni-versity School of Law . Kokabi has served as counsel in interference proceed-ings and related matters, before the Board of Patent Appeals and Interfer-ences and the Court of Appeals for the Federal Circuit. Kokabi counsels cli-ents about preinterference matters, such as provoking or avoiding interfer-ence proceedings, copying claims, and evaluating inventorship disputes. Prior to joining Sughrue Mion, Ms. Kokabi also served at the U.S. Patent and Trademark Office as an Examiner.

ABOUT THE FACULTY

Dr. Ahn: is a Korean patent attorney and the founder/CEO of Dr. Ahn International Patent Law Office. She has extensive ex-perience in all areas of IP matters in the pharma/bio/chemical fields. Dr. Ahn has successfully han-dled litigation cases in Korea, including Baraclude,

Viagra, Gleevec, Taxotere, Zanedip, Evista, Lipitor, Plavix, Hepsera, Norvasc, Eloxatin, Ultracet, Gemzar, Cozaar Plus, Arimidex, EPO and G-CSF. Before es-tablishing her own office, Dr. Ahn worked as a patent examiner at the KIPO, a litigator at the Tribunal (KIPT) and a senior researcher at Cancer Research Center. Dr. Ahn is a member of the Committee for Fostering Pharmaceutical Industry of the Ministry of Health & Welfare and a member of the Industrial In-tellectual Property Dispute Resolution Committee. Dr. Ahn also served as an expert advisor for Free Trade Agreement of the Ministry of Foreign Affairs and Trade. She has pharmacist license and oriental medicine pharmacist license.

Alexander WittkoppDipl. Chem., Dr. rer. nat.Alexander is a partner at Hamm&Wittkopp Patent Attor-neys, based in Hamburg (Germany). He represents his inter-national clients in the areas of German, European, and US

Tarun KhuranaTarun has over 14 years of experience in a broad range of Intellectual Property subject matters, and is the Co-Found-ing Partner and Patent Attorney of Khurana & Khurana, which is among the Leading IP Practices in India with 4 Offices and over 65 Practitioners.

intellectual property law, including patent prosecution, oppositions, nullity and infringement proceedings, as well as preparing freedom-to-operate and validity opinions in the field of chemistry, biochemistry, and pharmaceu-ticals. Alexander is a qualified German and European Patent Attorney, as well as a US Patent Agent. He regularly provides complete FTO-analyses for generic products and biosimilars, conducts detailed assessments of the rel-evance and validity of crucial proprietary rights, and represents his clients in oppositions and revocation actions.

Tarun is among the top 12 Patent Prosecution Practitioners in India as rated by IAM, and has executed numerous assignments related to exercises of Patent Portfolio Creation, Protection, Prosecution, Litigation, Valuation and Commercialization for Indian and International Corporates. Tarun focuses on the Patent Preparation, Patent Valuation, Commercialization, Prosecution and Litigation opinions for Electronics, Computer Implemented, and Me-chanical subject matters. Tarun has, apart from handling Indian and Interna-tional Clients for filing and prosecuting cases in India, helped numerous US and European Patent Attorneys in providing Patent Support Services includ-ing Patentability Searches, Invalidation Searches, FTO, Infringement Analysis, Patent Preparation and Responding to Office Actions. Tarun has drafted and prosecuted over 1000 patent applications and represents large Corpo-rates on complex infringement and invalidation matters. Tarun has a Bach-elors in Computer Science Engineering, a Masters in Software Systems, Bachelors in Law, an MBA from IIM Lucknow, and is in pursuit of his PhD.

ABOUT THE FACULTY