PHARMACEUTICALS & BIOTECHNOLOGY IP FORUM

richessebaldknobBiotechnology

Dec 1, 2012 (4 years and 4 months ago)

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The America Invents Act: How
Will Patent Reform Impact Your
IP Strategy?

Building The Pipeline: Evaluating
Internal And External Research
And Development

Mergers & Acquisitions And Joint
Ventures: The Prescription For
Prosperity?

Standardizing Global Processes:
Improving The Patent Application
Process

Is There A Safe Harbor?
Debunking Post-Approval Activity
Under The §271(e)(1)
In today’s fiercely competitive markets,
the use and protection of intellectual property could very well be
the difference between success and failure, particularly in the pharmaceutical and biotechnology industries.
Now, more than ever, Chief Intellectual Property Counsel are expected to turn corporate innovation into profit
by implementing the right market protection strategies, ultimately contributing to the company’s bottom line.
The protection of IP, and keeping a close watch for shifts in patent law, are an integral part of life cycle
management in an expanding market and ever-changing regulatory environment.
Consero’s 2012 Pharmaceuticals & Biotechnology IP Forum will address the most crucial, top-of-mind issues
facing heads of intellectual property, offering a unique, intimate opportunity to exchange best practices,
benchmark efforts, and explore strategies and tactics to ensure continued success.
PHARMACEUTICALS &
BIOTECHNOLOGY IP FORUM
December 2-4, 2012 | PGA National Resort & Spa | Palm Beach Gardens, FL
PGA National Resort & Spa
400 Avenue of the Champions
Palm Beach Gardens, FL 33418
T (800) 863-2819
www.pgaresort.com
Topics for Discussion Include:
CONSERO GROUP LLC
| 4915 ST. ELMO AVE., SUITE 100 | BETHESDA, MD 20814, U.S.A. | +1 (202) 595-9300
WWW.CONSERO.COM
2 |
PHARMACEUTICALS & BIOTECHNOLOGY IP FORUM
| DEC. 2-4, 2012 | PGA NATIONAL RESORT & SPA
WWW.CONSERO.COM
SUNDAY, DECEMBER 2
1:30 pm



2:00 pm |
Opening Remarks
2:00 pm

3:00 pm
The America Invents Act: How Will Patent Reform Impact Your IP Strategy?
On September 16, 2011, Congress passed the Leahy-Smith America Invents Act (AIA), initiating the biggest change in U.S.
patent law since 1952. One of the biggest reforms in this law is the move from a first-to-invent to first-to-file system. These
new rules could have a sweeping effect on everything from IP department management to filing costs to the relationship with
outside counsel. While this subject has been the topic of many CLE programs, this interactive discussion will allow Chief IP
Counsel to share recent lessons learned and brainstorm about the looming changes resulting from AIA.
What complexities does AIA present for those who manage the patent
portfolio?
Will AIA change the approach to the in-house patent process?
What are the implications in the U.S. and abroad for companies that file
patents too early?
What qualifies as “prior art,” and how is the AIA redefining this term?
Judy Jarecki-Black
Global Head, Intellectual Property
Merial Limited
Bryan Zielinski
Vice President & Assistant
General Counsel
Pfizer Inc.
MODERATOR:
Gwilym Attwell
Principal
Fish & Richardson P.C.
3:00 pm

4:00 pm
Understanding Emerging Markets: Successful Strategies For Protecting Intellectual Property Abroad
As companies set their sights on expanding their global footprints into emerging markets, Chief IP Counsel are tasked with
creating new processes to develop, distribute, promote, and ensure reimbursement for their products. However, regulatory
reforms and challenges in countries like China, India, and Brazil leave in-house counsel evaluating how best to seek IP and
regulatory protections in these markets. Chief IP Counsel must become more strategic, formulating appropriately tailored,
aggressive brand- and IP-protection plans to expand their markets beyond the U.S. and Europe. Understanding regulatory
challenges and new law regimes in Tier 1 and Tier 2 countries are imperative for increasing your company’s visibility and
long-term success.
When the government is the central decision maker, what effect can
having a patent on an approved drug product have on pricing and demand
?
How can you leverage your investment in intellectual property combined
with other strategies to increase demand and revenue for approved
products?
How do you get your drug on formulary in certain emerging markets?
What criteria should you consider to determine in which markets to file
intellectual property, especially to protect a supply-chain?
Konstantina Katcheves
Chief US IP Counsel
Lonza Group
Jonathan Provoost
Associate General Counsel
Ikaria, Inc.
Peter Tu
Vice President, Legal & Chief IP
Counsel
Moksha8 Pharmaceuticals, Inc.
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PHARMACEUTICALS & BIOTECHNOLOGY IP FORUM
| DEC. 2-4, 2012 | PGA NATIONAL RESORT & SPA
WWW.CONSERO.COM
SUNDAY, DECEMBER 2
6:00 pm

7:00 pm
Key Case Law Development: A Year in Review
In 2012, U.S. Supreme Court justices faced two high-profile patent cases that will have widespread effects. The decision in
the
Caraco v. Novo
Nordisk trial holds that a generic manufacturer may take legal action seeking changes to the use code
for a patent listed in the FDA Orange. The
Mayo v. Prometheus
case held that Prometheus Lab’s attempt to patent diagnostic
claims was invalid, prompting a shift in the way Chief IP Counsel can incorporate natural phenomena and the laws of nature
into patents. Now, more than ever, Chief IP Counsel must ensure that diagnostics and medical treatment methods are
patentable and can withstand scrutiny.
How does Caraco v. Novo Nordisk impact strategy for use codes section
(viii) (“skinny label”) ANDA filings?
Should brand pharmaceutical companies re-evaluate their use codes for
certain Orange Book listed patents on existing approved drugs?
How is Mayo v. Prometheus impacting the financial incentives that are
fueling the growth of personalized medicines?
Can Chief IP Counsel decipher the difference between natural law and
science? If so, what are the best practices for doing so?
What implications do these cases have on the Myriad case?
Luisa Bigornia
Vice President, Intellectual
Property
BioMarin Pharmaceutical Inc.
Michael Morris
Vice President, Intellectual
Property
Boehringer Ingelheim USA
Corporation
Zoran Zdraveski
Senior Director of Intellectual
Property

Epizyme Inc.
MODERATOR:
Gerald M. Murphy,
Jr.
Partner
Birch, Stewart, Kolasch, &
Birch, LLP
7:00 pm |
Welcome Cocktail Reception and Dinner
4 |
PHARMACEUTICALS & BIOTECHNOLOGY IP FORUM
| DEC. 2-4, 2012 | PGA NATIONAL RESORT & SPA
WWW.CONSERO.COM
MONDAY, DECEMBER 3
7:30 am



8:30 am
|
Networking Breakfast
8:30 am

9:30 am
Building The Pipeline: Evaluating Internal And External Research And Development
With research and development at an all-time low and few blockbuster products on the horizon, pharmaceutical and
biotechnology companies are implementing new methods to extend the patent lifecycle. With so much risk and expense
associated with R&D, it is imperative for Chief IP Counsel to employ new cost containment strategies without sacrificing
quality or quantity. To account for the lack of new products developed internally, Chief IP Counsel are contracting R&D from
third-party laboratories to bolster their pipelines. Companies must align research goals with incentives, attract and retain top
R&D talent, and create new ways to differentiate their products from typically saturated markets, and Chief IP Counsel must
contribute proactively to this mission.
What are the best practices to optimize the life span of each patent?
Given the size of the company, when should patents be filed?
When do you file early patent applications, and how broad should they be?
How do you value and evaluate patents at different stages of the patent
lifecycle?
When is the right time to stop investing in a program that is not working?
How do you determine from which companies to contract R&D?
How do you indentify the right contract manufacturer to produce your
product?
Barbara McClung
Vice President and General Counsel
Intarcia Therapeutics, Inc.
Amy Mendel
Vice President and Associate
General Counsel, IP
ZIOPHARM Onocology, Inc.
Raymond Parker
Assistant General Counsel, Vice
President, Patents
Aptalis Pharmaceuticals
MODERATOR:
Drew Lowery
Director of Life Sciences
Global Prior Art, Inc.
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PHARMACEUTICALS & BIOTECHNOLOGY IP FORUM
| DEC. 2-4, 2012 | PGA NATIONAL RESORT & SPA
WWW.CONSERO.COM
MONDAY, DECEMBER 3
11:30 am

12:30 pm
Is There A Safe Harbor? Debunking Post-Approval Activity Under U.S.C. § 271(e)(1)
The “Safe Harbor” of U.S.C. § 271(e)(1) provides an exemption from certain otherwise infringing activities performed solely for
uses reasonably related to the development and submission of information under federal laws that regulate the manufacture,
use, or sale of drugs. Chief IP Counsel advising research and development activities need a thorough understanding of
what activities are and are not within the Safe Harbor. Identifying R&D activities within § 271(e)(1) is essential, and Chief IP
Counsel must explore where infringement stops and exemption begins.
How expansive is the exemption in § 271(e)(1) for the infringement of drug
patents in pursuit of FDA approval of generic drugs? How are Chief IP
Counsel clarifying some of the statute’s ambiguous key words?
How can companies define the scope of infringement protection under §
271(e)(1)?
How are companies protecting their post-approval activities and
managing the risk associated with drug discovery (particularly in light
of recent Federal Circuit decions including Momenta Pharmaceuticals,
Inc. v. Amphastar Pharmaceuticals, Inc. (Fed. Cir. 2012) and Classen
Immunotherapies, Inc. v. Biogen IDEC (Fed. Cir. 2011))?
Nicholas Boivin
Director, Intellectual Property
Cubist Pharmaceuticals, Inc.
Liz Bui
Vice President & IP Counsel
ViaCyte, Inc.
Charles Kinzig
Vice President, Global IP
GlaxoSmithKline
Li Westerlund
Vice President, Global IP
BN ImmunoTherapeutic
12:30 pm



1:30 pm
|
Networking Luncheon
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PHARMACEUTICALS & BIOTECHNOLOGY IP FORUM
| DEC. 2-4, 2012 | PGA NATIONAL RESORT & SPA
WWW.CONSERO.COM
MONDAY, DECEMBER 3
1:30 pm

2:30 pm
The Road Diverged: How Biopharmaceuticals Will Get To Market
Biopharmaceuticals, such as biologics and biosimilars, are creating a new market expected to change the pharmaceutical
and biotechnology industries. Between 2009 and 2019, 21 blockbuster biopharmaceuticals with a total market value of over
$50 Billion will lose patent protection, creating an opportunity for pharmaceutical and biotechnology companies to enter the
biopharmaceutical market and leverage their products. Chief IP Counsel are now, more than ever, inclined to explore the
possibility of including biosimilars and follow-on biologics in their IP strategy.
What is the future of biopharmaceuticals, and how are companies aligning
their IP strategy?
For companies behind the biosimilar and follow-on biologic curve, what is
the best defense strategy?
What role will trade secrets play in biopharmaceuticals, and how will that
affect FDA regulation?
How will the industry be impacted by FDA guidance regarding
“biosimilarity” and “interchangeability.”
David Abraham
General Counsel & Corporate
Secretary
Selecta Biosciences, Inc.
Andrew Cohen
Vice President & General Counsel
KBI Biopharma, Inc.
2:30 pm

3:30 pm
KnowledgeBridge
TM
: Recent Developments On Subject Matter Eligibility/Split Infringement, And
Their Impact On Life Cycle Management, Clinical Trials, And Companion Diagnostics
In this interactive session, attendees are encouraged to participate in the dialogue. Sterne, Kessler, Goldstein, & Fox will
lead the discussion taking the viewpoints of Innovators, Generics, and Diagnostics companies, and addressing related
topics, such as:
IP implications of clinical trials in Pharma and Biopharma
Impact of the Myriad II and Prometheus decisions on existing patent rights
and strategies for patent holders and their potential opponents
Implications for Personalized Medicine patents in View of Akamai/
McKesson
The future of diagnostic discoveries for Personalized Medicine
John Covert
Director, Biotechnology/Chemical
Practice
Sterne, Kessler, Goldstein & Fox
Elizabeth J. Haanes, Ph.D
Director
Sterne, Kessler, Goldstein & Fox
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PHARMACEUTICALS & BIOTECHNOLOGY IP FORUM
| DEC. 2-4, 2012 | PGA NATIONAL RESORT & SPA
WWW.CONSERO.COM
MONDAY, DECEMBER 3
4:30 pm

5:30 pm
Standardizing Global Processes: Improving The Patent Application Process
Chief IP Counsel have never experienced more pressure to contain costs, especially regarding patent applications. With
costs for everything from formation search and outside counsel to language translation, patent filing can be very complex
and is increasingly expensive. Globally, the patent application process is extremely tedious, creating a need for an efficient
and regimented global patent application policy. It is more important than ever to understand how to articulate the true ROI
of patent applications to executives and work through the various relevant processes efficiently.
From a business perspective, how do you determine if a patent is
worthwhile?
How do companies estimate budgets and resources to set proper
expectations for the business unit?
How can in-house counsel make the patent procurement process more
efficient and effective?
How do Chief IP Counsel work with their outside counsel in the patent
application process?
Tony Garcia-Rivas
Senior Patent Counsel
Ironwood Pharmaceuticals
Alan Koller
Chief Patent Counsel
Purdue Pharma
6:30 pm
|
Networking Dinner and Entertainment
8 |
PHARMACEUTICALS & BIOTECHNOLOGY IP FORUM
| DEC. 2-4, 2012 | PGA NATIONAL RESORT & SPA
WWW.CONSERO.COM
TUESDAY, DECEMBER 4
7:30 am

8:30 am |
Networking Breakfast
8:30 am

9:30 am
Paragraph IV Litigation: Managing Outside Counsel Efficiently And Effectively
While there are numerous CLE programs concerning Hatch-Waxman litigation strategies, Chief IP Counsel must shift their
focus to managing successfully the litigation caseload. ANDA filings with Paragraph IV certifications require in-house legal
departments to outline clearly a managerial strategy. The cost, time, and resources associated with litigating Orange Book
listed patents require Chief IP Counsel to re-evaluate how to work with other in-house attorneys, the company’s business,
and outside counsel.
When should Chief IP Counsel start pre-litigation diligence and how are
they preparing?
When do you issue litigation holds?
What are best practices when streamlining processes between local
counsel and counsel at larger law firms?
How do you properly set the business unit’s expectations for a possible
loss?
When and what criteria should be considered in a possible settlement?
John Dauer
Chief Patent Counsel
Sun Pharmaceutical Industries,
Inc.
Jim Harrington
Chief Intellectual Property
Counsel
Shire Pharmaceuticals
Hany Rizkalla
Senior Director of Legal
Glenmark Generics, Inc.
10:30 am

11:30 am
Mergers And Acquisitions And Joint Ventures: The Prescription For Prosperity
The Wall Street Journal recently published an article stating that pharmaceutical deals announced for 2012 had already
reached $18.5 billion by April, with deal flow only expected to increase. Chief IP Counsel play a crucial role in M&A by
valuating the target company’s patent portfolio and how it will impact the buyer. As another means to build brand value and
increase market share, companies are entering into strategic joint ventures. However, are buyouts and strategic partnering
simply a result of less-than-promising R&D, and are they ultimately contributing to the bottom-line? Further, companies are
strategically outsourcing various technical work, but how can Chief IP Counsel manage risk and protect IP when working
with other companies?
Is acquiring a company with a strong R&D pipeline a safe decision? If so,
how do you valuate the R&D?
What role are emerging markets playing in M&A and how can companies
capitalize on these new markets?
What criteria should Chief IP Counsel look for when deciding with which
companies to partner strategically?
What are the contract, business and patent risks that strategic sourcing
creates and how do you manage these risks?
How do Chief IP Counsel retain the IP rights when sourcing to third parties
both in the U.S. and abroad?
Tom Anderton
Vice President, Intellectual
Property and Legal Affairs
Presidio Pharmaceuticals
Barbara McClung
Vice President and General
Counsel
Intarcia Therapeutics, Inc.
Michele Wales
Vice President, Litigation &
Intellectual Property
Human Genome Sciences
12:30 pm |
Networking Luncheon
9 |
PHARMACEUTICALS & BIOTECHNOLOGY IP FORUM
| DEC. 2-4, 2012 | PGA NATIONAL RESORT & SPA
WWW.CONSERO.COM
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