Managing Pharma, Biotech & Chemical Patent Portfolios in US, EP, and Korea
26-28’th September 2016 at Hotel Taj Krishna, Hyderabad and 28-30’th September 2016 at Hotel Hilton, (Andheri East) Mumbai
About the Workshop
With Patents becoming a core part of the existing economic ecosystem, particularly
for Pharmaceutical, Biotech, and Chemical Industries, exploitation of
Patent Portfolio has become an industry in itself; especially with the cost of development
and protection of the portfolio is enormous. It is therefore crucial
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 the 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
the portfolio would remain under-commercialized.Exclusivity rights granted through patents can only be utilized 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 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 geographies
such as United States, Europe, and Korea. It is in this direction that the
three days International Symposium is being organized to impart comprehensive
knowledge to understand the nitty-gritty of the Patent Regime.
How The Symposium Is Unique
This Symposium features the presentation of all important patent issues, as mentioned
in this brochure. The speakers are a unique gathering of Patent Attorneys,
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 Attend
This is an opportunity when Patent Experts, Litigators, and Legal Counsels from
varied backgrounds and having enormous expertise and different perception
would be interacting with limited delegates and would answer to any
the question that the delegates may have. The speakers have thorough knowledge
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-gritty
followed in the United States, Europe, and Korea in Patent Domain. The
speakers would share real-life cases and experiences that can help attendees
in following best practices for building their respective patent portfolios so
as to best commercialize.
Who Should Attend
IP 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, Biotech
and Chemicals.
About the Organizers
About IIPRD
IIPRD is a premier IP Consulting and Licensing Firm with a diversified business practice providing services 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, Transactional,
and Litigation Support Services to Indian and International Corporates, Licensing
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 a core focus on Commercialization, Technology Transfer,
and Licensing. IIPRD has a strong team of over 65 professionals who focuses on 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 Suppor.
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 more than
100 lawyers protect ideas- all ideas- and for the last 50 years have been helping
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 Phar
maceuticals, 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
dustries. 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 invention.
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 chemistry
and pharmaceutics – with particular emphasis on generic pharmaceuticals
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 trademark
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 incidentsSince
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 represented
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 international
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 infringement
whether preliminary review, patent strategy with every step, in
cluding patent monitoring competitors’ products.
About Khurana & Khurana, Advocates and IP Attorneys
Khurana & Khurana, Advocates and IP Attorneys (K&K) is more than a full service
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 Corporate
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 Technology
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 relationships
through high level of client orientation.
DAY 01 - Programme Outline (US Scenario)
0900-0930: Registration
Session-I
0930-1100: Recent 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 laws
1100-1115: Tea Break
Session-II
1115-1215: Exploring Lilly v. Teva and its wider implications for Divided and Induced Infringement rulings in ANDA litigation: Review of the Limelight v, Akamai appeals; Understanding role of the label in the determination of divided and induced infringement in view of Lily;
Session-III
1215-1315: Strategic 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 impacting ANDA litigation
1315-1415: Lunch
Session-IV
1415-1545: Evolving 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 Prometheus
Laboratories, Inc. v. Roxane Laboratories and Spectrum Pharmaceuticals
Inc. v. Sandoz Inc.; Exploring obvious-type double patenting in view
of G.D. Searle LLC v. Lupin Pharmaceuticals, Inc.; Discussion on obvious findings
at PTAB.
1545-1600: Tea Break
Session-V
1600-1715: Claim Construction and Markman Strategies Post-Teva: Review of recent Federal
Circuit and District Court opinions addressing Teva applicability; Teva applicability
in IPR proceedings before the PTAB; Considering claim drafting in
view of Teva with respect of written description and enablement requirements;
Devising Markman strategies in view of Teva in Para IV challenge
DAY 02 - Programme Outline (US Scenario)
Session-VI
0915-1030: A 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-disclosure
arguments; Amgen's marketing notice arguments; Consequences of the
Federal Circuit decision on the biosimilar process and future litigations
Session-VII
1030-1130: A 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 proposed
naming guidance and potential impact on biosimilars, Biosimilars
patent tactics under new section 101 and 112
1130-1145: Tea Break
Session-VIII
1145-1300: How has the Supreme Court's decision in Daimler AG v. Bauman defined personal
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 jurisdiction
in ANDA litigation? Devising interim jurisdictional strategie
1300-1400: Networking Lunch
Session-IX
1400-1500: Comparison 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; Understanding
the implications of this case in experimental use exception
Session-X
1500-1600: Evaluating 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
trials
1600-1615: Tea Break
Session-XI
1615-1715: Review 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;
DAY 03 - Programme Outline (EP, Korea, Indian Scenario)
Session-I
0930-1130: An overview on the new Unitary Patent system: Discussing advantages and
drawbacks, describing the nature of the new patent and the related prosecution
process; discussing the introduction of the Unified Patent Court; How
to make informed decisions on the upcoming issues related to patent protection
in Europe.
1130-1145: Tea Break
Session-II
1145-1300: Prosecution of pharmaceutical/chemical/biotech patent in Korea, Patentability
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
1300-1400: Networking Lunch
Session-III
1400-1500: Marketing authorization process in EP; Medicinal Product Directive and Medical
Device Directives, Patent term extension for patented medical product;
German Federal Patent Court’s decision on SPCs and Medical Devices.
1500-1515: Tea Break
Session-III
1515-1700: Recent Changes in Indian Patent Procedures and Practices, Key Pharmaceutical
Prosecution and Litigation Cases, Take Aways and Recommended Practices
Speaker Profile
Mr. Chid Iyer 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
Mr. Michael R. Dzwonczyk 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.
Ms. Aiyda Ghahramani 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.
Ghahramani has served as litigation counsel in matters involving the chemical,
pharmaceutical and mechanical arts and has significant experience in
nearly all pre-trial, trial, and post-trial aspects of patent litigation. She also engages
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-tooperate,
due diligence and product clearance work, licensing and con
ntract matters, including joint ventures.
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 College
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 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. Kokabi counsels clients
about preinterference matters, such as provoking or avoiding interference
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.
Dr. Ahn is a Korean patent attorney and the founder/CEO of Dr.
Ahn International Patent Law Office. She has extensive experience
in all areas of IP matters in the
pharma/bio/chemical fields. Dr. Ahn has successfully handled
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 establishing
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 Intellectual
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 Wittkopp is a partner at Hamm&Wittkopp Patent Attorneys,
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.
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 relevance
and validity of crucial proprietary rights, and represents his clients in
oppositions and revocation actions.
Tarun Khurana has over 14 years of experience in a broad range of
Intellectual Property subject matters, and is the Co-Founding
Partner and Patent Attorney of Khurana & Khurana,
which is among the Leading IP Practices in India with 4
Offices and over 65 Practitioners.
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 Mechanical
subject matters. Tarun has, apart from handling Indian and International
Clients for filing and prosecuting cases in India, helped numerous US
and European Patent Attorneys in providing Patent Support Services including
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 Corporates
on complex infringement and invalidation matters. Tarun has a Bachelors
in Computer Science Engineering, a Masters in Software Systems, Bach
elors in Law, an MBA from IIM Lucknow, and is in pursuit of his PhD.
Registration Fees
For Indian Delegates : INR 12,000/- Per DelegateFor Foreign Delegates : USD 300/- Per Delegate
Nomination Form
Please Forward the Delegate Fees with the following details:
Name, Organization, Designation, 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, IndiaORTransfer Funds at our Bank; details are as Follow:
Bank Name: UCO Bank Branch, Branch Name: Greater Noida
Bank Account Number: 19620210002476Bank 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
