Seminar Pharmaceutical – Oct 2015

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And

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khurana & khurana, advocates and IP attorneys

In Association With

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SUGHRUE MION, PLLC, USA

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TEE & HOWE IP ATTORNEYS, CHINA

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MAIWALD, GERMANY

Presents

THREE DAYS INTERNATIONAL SYMPOSIUM

for

R&D SCIENTISTS AND IP PROFESSIONALS

5’th – 7’th October 2015, at Hotel Hyatt,Vastrapur, Ahmedabad

7’th – 9’th October 2015, at Hotel Hilton (Andheri East), Mumbai

Click here to Download Presentations

About the Symposium

With Patents becoming a core part of existing economic ecosystem, particularly for Pharmaceutical, Biotechnology, Chemical, and Drug Industries, exploitation of Patent Portfolio has become an industry in itself especially with the cost of development and protection of the portfolio being enormous. It is therefore crucial to understand important Patent issues, not only for IP teams but even more importantly for R&D Scientists so as to minimize efforts in Patent Development and maximize commercial gains. It is also 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. This is precisely why the number of major patent litigations are growing between competitors and contemporaries, besides the growing threat from international exploiters.

Exclusivity rights granted through patents can only be utilised if there is comprehensive knowledge of various patent related issues, more so when the National Patent Laws & Practices relating to prosecution practices, drafting practices, examination practices, enforcement practices and commercialization practices differ substantially across geographies. Furthermore, standards for protection and enforcement as applied by different National judiciaries often vary widely and therefore in global business scenario, besides understanding of Patent Laws and Practices prevalent in India, we also need to understand practices in economically and financially important geographies such as in United States, Europe, and China. It is in this direction that the three days International Symposium is being organized to impart comprehensive knowledge to understand nitty-gritty of Patent Regime. The Symposium will provide an opportunity to receive -hand information including recent Judgments on various issues from experts in the field.

Who Should Attend

IP Management Teams, Research & Development Scientists, Patent Agents & Attorneys in the field of Practice, Patent Litigators, Professionals in Legal-Business domain related to Pharma, Biotech and Chemical Industry.

About the Organizers

About IIPRD

IIPRD is a premier IP Consulting and Licensing Firm with a diversified business practice providing services in the domain of Commercialization, Valuation, Licensing, Transfer of Technology and Due-Diligence of Intellectual Property Assets along with providing complete IP and Patent Analytics and Litigation Support Services to Indian and International Corporate and Global Law Houses. IIPRD has a legacy of over fifteen years of existence, and is among the Indian IP Firms to have core focus on Commercialization, Technology Transfer, and Licensing for numerous Indian and Global Corporate.

About Sughrue Mion

Sughrue Mion is one of the world's leading intellectual property law firms managing traditional and non-traditional intellectual property rights, for about five decades, with a wide range of clients around the world. Sughrue's Pharmaceuticals, Biotechnology, Chemical attorneys are trained in technical disciplines that include molecular and cellular biology, biophysics, pharmaceuticals, chemistry, immunology, virology, genetics and agriculture biotechnology. Their experts are particularly well versed in drafting claims to ensure the broadest possible coverage and have a long established expertise in handling patent interference proceedings that may be critical to determining basic patent rights in new areas of biotechnological and pharmaceutical industries. 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 invention.

About Khurana & Khurana, Advocates and IP Attorneys

To most of our clients, Khurana & Khurana, Advocates and IP Attorneys (K&K) is more than a full service Intellectual Property and Commercial Law firm. K&K was formed with a very firm focus of providing End-to-End IP Legal Services in a manner that is Corporate centric and follows delivery practices that are consistent and are above defined quality standards so as to ensure "Above Expectations" for all clients. Khurana & Khurana is among the leading Indian IP and Commercial Law Firms with over 65 Associates and Practitioners across IP subject matters and spread across its offices in Delhi (Noida), Mumbai, Bangalore, and Pune. K&K has been consecutively ranked and recommended by premier magazines and organisations namely Managing IP, IAM, Legal 500, Asia IP, Chambers & Partners, Corp- INTL, Acquisition INTL, among many others. K&K has won the ''IP Patents Law Firm of the Year in India'' and "IP Valuation Firm of the Year" consecutively for the three years 2012-13, 2013-14, and 2014-15 by Corporate INTL and Acquisition INTL magazine respectively. K&K has been a member of various renowned IP bodies including, APAA, INTA, AIPPI, LES, TIE, ABLE etc.

About Tee & Howe IP Attorneys

Tee & Howe is one of the leading Chinese IP Firm advising multinational clients since early 1990s. Tee &Howe's practice covers all aspects of patent and trademark law, encompassing all phases of pursuing, licensing, maintaining, and litigating patent and trademark rights.Tee & Howe is one of the patent firms licensed by Chinese government to represent foreign clients. The firm has 32 patent attorneys, one US patent attorney, 10 trademark attorneys, 6 attorneys at law and about 60 patent engineers and assistants.Most Tee & Howe attorneys have more than 10 years experience in advising and representing clients in patent prosecution, invalidation and infringement litigation.Tee &Howe has a strong practice in Pharmaceutical and Biotech domains.

About Maiwald

Maiwald is one of the largest IP firms in Germany representing clients in the prosecution and litigation of patents in all fields of intellectual property, including all procedures before the patent and trademark offices as well as litigation before the relevant courts through all appeal instances. Maiwald's patent attorneys and attorneys-at-law have long experience and expertise in protecting a wide variety of technical inventions.

programme outline

DAY-1 US Scenario
Session-I

0930-1100: Possible new grounds of Paragraph IV invalidity challenges: How 101 rejections under Myriad and findings of 112 indefiniteness under Nautilusmay alter Paragraph IV Litigation; How 101 prosecution rejections may translate to 101 invalidity challenges of a small molecule drug in a Paragraph IV setting at the District Court level; Analyzing CLS Bank v. Alice Corp.and its relationship to Myriad relative to 101.
1130-1145:Tea Break

Session-II

1145-1215: Study of new obviousness criteria for Paragraph IV compound patent challenges post-KSR and in light of Bristol-Myers Squibb Company v. Teva Pharmaceuticals USA (BMS v. Teva): Analyzing the criteria for lead compound analysis and understanding how BMS v. Teva will impact both prosecution and litigation under Hatch-waxman.

Session-III

1215-1315:Analysis regarding the impact of Supreme Court decision Teva v. Sandoz on patent litigation; discussion on standard of review for claim Construction: De Novo vs. Deferential; Review of other Key Supreme Court Cases that May Alter the Course of Paragraph IV Litigation.
1315-1415:Networking Lunch.

Session-IV

1415-1545:New USPTO interim guidance on patent subject matter eligibility: Best practices for applying the new guidelines in application drafting and prosecution; How will examiners apply the new guidance?; Insight into how the Interim Eligibility Guidance may impact strategies involving owned or in-licensed intellectual property.
1545-1600:Tea Break.

Session-V

1600-1730:Advanced Strategies for Pleading and Effectively Using Motions Practice in Paragraph IV Disputes; New Exclusivity Challenges for Brand Names and Generic and Related Implications for Paragraph IV Challenge.

DAY-2 US Scenario
Session-VI

0915-1015:Evaluating the risk and commercial opportunity in the emerging US Biosimilars space; Meeting USFDA's standards for biosimilarity Incorporating inter-partes review into Branded and Biosimilar Litigation Strategies; Anticipating how the complex patent resolution provisions in the BPCIA will interplay with the patent validity proceedings at the USPTO;

Session-VII

015-1115:Understanding how BPCIA timelines play out in practice: How to prepare for ''early'' and ''late'' phase litigation: Designing around the timelines; Specific considerations for brand-vs-brand and generic-vs-generic; A review of the BPCIA cases Sandoz v. Amgenand Celltrion v. Janssen.
1115-1130:Tea Break.

Session-VIII

1130-1300:How monumental changes under the AIA including inter parties review (IPR) and post-grant review (PGR) should influence Paragraph IV litigation strategies; Assessing strategic benefits that can be derived from IPR as opposed to district court litigation; how the different burdens of proof in obviousness challenges before the federal courts and PTO may impact litigation strategies;
1300-1400:Networking Lunch.

Session-IX

1400-1500:Post-Grant Patent Challenges at the PTAB: Proven strategies for asserting or defending a patent challenge at the PTAB - avoiding common procedural pitfalls and effective litigation tips for obtaining successful results; parallel patent proceedings before the PTAB and federal court post-AIA; What challenges are being faced when challenging or defending patent validity in concurrent proceedings?

Session-X

1500-1600:Best Practices to Secure Patent Allowance using Evidence: Evidentiary declarations under the to File system including declarations relating to the 1-year grace period under the new section 102(b); How Rule 132 declarations and other evidence are explained to overcome obviousness rejections; How to avoid common pitfalls that can sink a patent during litigation;
1600-1615:Tea Break.

Session-XI

1615-1730:How do AIA changes impact the on sale bar and the public use bar? How are courts treating the on sale bar and the public use bar? What best practices can be employed to adapt patent prosecution and enforcement strategies?

DAY-3 EP & Chinese Scenario
Session-I

0930-1030:

  • Best practices to prosecute pharmaceutical/chemical/biotech related patent applications in China
  • Obviousness - what arguments would help you get through a Chinese Examiner more easily?
  • Non-patentable subject matter - what are subject matters that will not be allowed?
  • Support - importance of including experimental data in your Patent Specification
  • Sufficiency - particularly related to testing methods
  • Understanding requirements for obtaining a valid patent

1030-1045:Tea Break.

Session-II

1045-1200:

  • Freedom-to-operate searches and opinions in China
  • Overcoming the challenge of obtaining reliable search data
  • How do FTO processes and procedures in China differ?
  • IP trends and regulatory changes in China that can shape your FTO strategies
  • Protecting your patents from infringement in China
  • How are Chinese Courts dealing with infringements?
  • Take away message
Session-III

1200-1330:Recent decisions in pharmaceutical patent law of the EPO, the ECJ, and the national patent courts in Europe; Consequences for the drafting and filing of generic patents, for the validity of patents and supplementary protection certificates, and for the handling and marketing of generic products.
1330-1430: Networking Lunch.

Session-IV

1430-1530:Update on the implementation of the Unified Patent System and the Unified Patent Court.
1530-1545: Tea Break.

Session-V

1545-1700:IP Portfolio management, Assignment, Infringement Issues in india, Importance of Due Diligence in Managing IP Portfolio, and Understanding Methodology of IP Valuation.

About the Faculty
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Mr. Chid Iyer Chid received a B. Tech in Chemical Engineering from IIT, Bombay in 1984, MS in Chemical Engineering from University of Akron and MS in Computer Science from the University 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 pharmaceutical. Chid has prepared and prosecuted over 100 applications for a leading research laboratory.

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Mr. Michael R. Dzwonczyk Michael is a partner at Sughrue Mion and has about 20 years of experience in successfully representing multinational companies in patent litigation, including trials and appeals of patent cases. His experience has encompassed technical areas that include pharmaceuticals, recombinantly produced hormones, protein synthesis and expression products, fibers, and medical devices. Michael also counsels clients on intellectual property issues, including validity and infringement of intellectual property rights, licensing and contract matters and Hatch-Waxman issues.

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Ms. Aiyda Ghahramani Ms. Aiyda practices in all areas of intellectual property law with a focus on litigation, rendering opinions on patentability, infringement, and validity, as well as on the prosecution of intellectual property matters. Aiyda is actively involved 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 contract matters, including joint ventures.

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Mr. Shackelford Mr. Shackelford is an associate in the chemical patent and biotechnology / pharmaceutical practice groups, where he maintains an active patent prosecution and litigation practice. Prior to joining Sughrue Mion, Mr. Shackelford taught IP courses for LL.M. and J.D. students and conducted research into patent claim construction. During law school, Mr. Shackelford earned his J.D. from the IIT Chicago-Kent College of Law, where he was a member of the Moot Court Honor Society and Law Review. 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.

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Ms. Azy S. Kokabi Azy S. Kokabi's 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 University School of Law. Kokabi has served as counsel in interference proceedings and related matters, before the Board of Patent Appeals and Interferences and the Court of Appeals for the Federal Circuit. Prior to joining Sughrue Mion, Ms. Kokabi also served at the U.S. Patent and Trademark Office as an Examiner.

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Dr. Toby Mak Dr. Toby Mak is a registered Chinese Patent Attorney and has a PhD degree in Chemistry. Toby has over 10 years of experience in patents and designs. He has substantive experiences in handling both contentious and noncontentious matters, including prosecution, invalidation and enforcement. Dr. Mak, He has served many clients of different technical fields and has a strong focus on Pharma and Bio practice and has been closely associated with research institutes and universities. Dr. Mak is a member of the All-China Patent Agents Association, and a foreign member of the UK Chartered Institute of Patent Attorneys."

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Ms. Yeping DING Ms. Ding graduated from Sichuan University in 1989 with a BS degree in bio-engineering and obtained her M.S. in genetics from Chinese Academy of Sciences (CAS) in 1995. Ms. Ding was admitted to practice as a certified patent attorney in 1996. From 1995 to 2004, Ms Ding worked with China Sinda Intellectual Property Ltd as an assistant and patent attorney. Her 10-year practice in Chinese patent prosecution covers the technical areas of biology, pharmaceuticals, chemistry and chemical engineering.

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Dr. Alexander Wittkopp Alexander is a managing partner at Maiwald Patentanwalts GmbH, based in Hamburg (Germany). He represents his international clients in the areas of German, European, and US 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 pharmaceuticals. His experience encompasses the synthesis and morphology of APIs, pharmaceutical compositions of generic drugs and biosimilars, medical nd devices, combinations of pharmaceutical agents, and 2 medical uses. Alexander is a qualified German and European Patent Attorney, as well as a US Patent Agent. He practices regularly before the German and European Patent Office, the German District Courts, the German Patent Court, and the Federal Court of Justice.

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Mr. Vinod Khurana Vinod has been in the field of Legal-Finance, Investigation and Prosecution for the last 40 years. Vinod is the Founder Director of IIPRD (www.iiprd.com). Vinod is also the Founder President of the Institute of Forensic Accounting and Investigative Audit (www.ifaia.org). Vinod is also a Senior Partner legal 500 Khurana & Khurana Advocates & IP Attorneys (www.khuranaandkhurana.com) and Litigates Fraud/ Infringement/ Contractual-disputes related matters. Vinod has undertaken more than 150 National and International symposiums globally on fraud/ infringement issues and has investigated hundreds of frauds and infringement matters. Vinod is member of Delhi Bar Council.

Registration Fees

Indian Delegates : INR 12,000/- Per Delegate (If 3 or more delegates are nominated by any company, delegate fees will be Rs. 10000/- Per delegate)
Foreign Delegates : USD 300 Per Delegate

Nomination Form

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 " to 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 Bank Branch, Branch Name: Greater Noida
Bank Account Number: 19620210002476
Bank Address: G.N. Shopping Plaza, Plot No.-S-7/1, Site-IV, Kasna Road,
Greater Noida MICR Code: 110028055 IFSC Code: UCBA 0001962
Name of the Account Holder: M/S IIPRD

for any query contact

Contact Person:
Ms. Meenakshi Khurana
Mobile: +91-9910307992
Email: Meenakshi@iiprd.com
Mr. Tarun Khurana,
+91-9810617992, +91-9810281321,
Email: tarun@iiprd.com, iiprd@iiprd.com
Ph : +91-120-2342010/4296878, Fax: +91-120-2342011