Orange Book Blog

ACI "FDA Boot Camp" Conference, San Francisco, May 29-30

American Conference Institute's very popular "FDA Boot Camp" returns to San Francisco later this month, May 29-30.

The conference is designed to give patent lawyers, product liability lawyers, and life sciences investment and securities experts a strong working knowledge of core FDA regulatory competencies.  The conference features FDA regulatory and patent law experts from pharmaceutical companies and outside law firms.

Presentations on the agenda include:

• The Basics: Understanding and Working with the FDA -- Jurisdiction, Functions, Organization, and Operations
• The Nature of the Approval Process
• Patent and IP Overview: Hatch-Waxman, Trademark Protection, and More
• From Theory to Practice: FDAAA, Future FDA and Legislative Priorities, Other Enforcement Initiatives, and Beyond
• Non-Patent Exclusivity
• Bioequivalence: What Lawyers Need to Know
• Follow-On (Comparable or Biosimilar) Biologics

For more information or to register, please visit the conference website.

ACI "In-House Counsel Forum on Pharmaceutical Antitrust," National Harbor, Maryland, May 20-21

American Conference Institute is holding its fourth annual "Pharmaceutical Antitrust" conference on May 20-21, in National Harbor, Maryland.

According to ACI, at the conference, "leading in-house pharmaceutical counsel, government regulators, and expert attorneys will provide practical advice on how to successfully tackle the most complex antitrust issues facing brand-name and generic pharmaceutical companies."

Several of the presentations look particularly interesting:

• A Keynote Address by Stephen Calkins, Former General Counsel of the Federal Trade Commission
• "Assessing What the Authorized Generic Study and Report on Intellectual Property Collectively Mean for the Pharmaceutical Industry"
• "The Law of Hatch-Waxman Patent Infringement Settlements and Where it is Going"
• "Congressional Action on Pharmaceutical Patent Settlements: Pending Legislation and Strategies to Employ"
• "Life Cycle Management Strategies for Protecting Your Product and Reducing Antitrust Exposure"
• "DOJ Perspective on Recent Developments in Antitrust and IP Law"
• A Keynote Address by Jon Leibowitz, Commissioner, Federal Trade Commission

The conference also features a Master Class on May 2: "Navigating the Pharmaceutical Merger Process."

For more information or to register, please visit the conference website.

WBR "PharmaBiotech IP Summit," Philadelphia, May 28-30

Worldwide Business Research will be holding a conference entitled "PharmaBiotech IP Summit," May 28-30 at the Ritz-Carlton in Philadelphia.

According to WBR, "the event balances the challenges of IP protection, enforcement and management, providing both strategic and actionable insights through case studies and interactive session formats."

The conference will bring together over 35 speakers from the pharmaceutical and biotechnology industries, who will focus on protecting critical patents while driving sustainable growth through IP-driven business strategies.  They will address how patent reform legislation will impact IP practitioners in these industries.  In addition, they will tackle key issues such as strategic patent portfolio management, IP lifecycle extension and IP commercialization.

The conference begins with a "Patent Enforcement and Protection Master Class," on May 28.  The main conference, May 29-30, includes the following panel presentations:

• "Aligning IP Strategy and the Business -- Becoming a Resource Not a Roadblock," with Scott Brown, VP, General Counsel, Head of NIBR Patents, Novartis; Guy Donatiello, VP IP, Endo Pharmaceuticals; and Karen F. Clark, Assoc. General Counsel, Global Health, Well Being and Beauty Care, Procter & Gamble Co.
• "Patent Reform, Resolutions and Additional Rulings -- Interpretations, Impacts and Strategies for the Challenge Ahead," with Robert Hrubiec, VP IP and Chief Patent Counsel, Cephalon; Gary Creason, VP IP, Aveo Pharmaceuticals; and John T. Li, Patents, Head, Biology and Biologics, Novartis
• "Biosimilars and Follow-on Biologics -- Preparing for the Road Ahead," with James Kelley, Assoc. General Counsel, Eli Lilly & Co.; John M. Engel, Managing Partner, Engel & Novitt, LLP; and Bradford J. Badke, Partner, Ropes & Gray LLP
• "Ensuring Protection and Enforcement Post-KSR," with James Gould, Legal Director, Global Patent Litigation, Schering-Plough; Kathleen Fonda, Legal Advisor, Office of Patent Legal Administration, USPTO; and Cindy Clay, Sr. Counsel, IP, Global Personal Health Care and Pharmaceuticals, Procter & Gamble Co.

Orange Book Blog readers can receive a 15% discount on registration with Booking Code WUS_XZ206EN.

For more information or to register, please visit the conference website.

ACI "Paragraph IV Disputes" Conference, New York City, April 30-May 1

American Conference Institute will be holding its 2nd annual "Paragraph IV Disputes" conference in New York City next week, April 30 to May 1.  This should be an excellent meeting, with many great speakers on the agenda.

Specific talks of interest include the following:

• Strategic Considerations for the ANDA Applicant's Pre-Litigation Strategy and Initial Obligations
• Rethinking Paragraph IV Challenges in View of Shifting Obviousness Standards
• Litigating with Multiple ANDA Filers: Brand-Name and Generic Perspectives
• View From the Bench: Judicial Views on Paragraph IV Litigation (with three federal judges on the panel)
• Mitigating Antitrust Concerns When Settling a Paragraph IV Action
• Mastering the Interplay Between 180-Day Exclusivity, Forfeiture Provisions and Paragraph IV Litigation
• The Company Perspective on Paragraph IV Disputes: Branded and Generics Views (with in-house counsel from Schering-Plough and Mylan)

In addition, there will be a Master Class on Friday, May 2, entitled "Negotiating and Settling Paragraph IV Disputes: Brand-Name and Generic Perspectives."

For more information or to register, please visit the conference website.

Informa Life Sciences "EU Pharmaceutical Law Forum," Brussels, Belgium, May 8-9

Informa Life Sciences will be holding its 17th annual "EU Pharmaceutical Law Forum" in Brussels, Belgium, on May 8 and 9.  This conference is billed as the "must attend" meeting for in-house counsel in pharmaceutical companies and lawyers in private practice who specialize in the life sciences.  Speakers will examine in detail the recent developments in trade, competition, intellectual property and regulatory matters of concern to the pharmaceutical industry.

Conference highlights include:

• Article 81: licensing, distribution arrangements, settlement agreements
• Article 82: the Astra/Zeneca case and its consequences for the pharmaceutical industry, plus lessons to be learned from Microsoft
• Restructuring distribution systems in Europe
• Analysis of patent actions in Europe
• European legislation initiatives: EPC 2000, EPLA and the Enforcement Directive
• Implementation of the New Medicines Legislation and adoption of the New Penalties Regulation
• Update on the state of play with biosimilars
• The European Clinical Trials Directive
• Practical experience of working with the new EU Pediatric Medicines Regulation
• Marketing and promotion: ensuring compliance with ABPI code of practice

In addition, in light of the recent announcement by the EC of the launch of a pharmaceutical antitrust inquiry, the conference has added a new speaker to the agenda, Tony Woodgate of Simmons & Simmons, who will explore the EU Antitrust Inquiry and provide an update on its progress.

For more information or to register, please visit the conference website.

IQPC "Optimising Pharmaceutical Patent Lifecycles" Conference, London, April 29-30

Legal IQ, a division of IQPC, will be holding a highly interactive two-day conference, "Optimising Pharmaceutical Patent Lifecycles," in London, April 29-30.  The conference will focus on how to maximize product revenues and yet avoid anti-competitive issues through strategic patent lifecycle management.

Featuring seventeen international experts, the conference will cover hot topics such as how to maintain a competitive advantage by integrating legal and commercial strategies to extend product lifecycles, how to update patent strategies by assessing the implications of current U.S. and European case law, how to prevent competition law violations and how to maximize the commercial value of patents by strategically managing the interplay between generics and innovators.

The conference features two practical tutorials ("P.I.T. Stop" sessions), led by experts from Bristows and Simmons & Simmons, which will allow attendees to discuss and work through common industry problems guided by the experts' perspectives.  The main focus will be on building a commercially sound patent lifecycle management strategy and reassessing the impact that patent practices have on competition law positions in Europe and the U.S.

The conference is specifically designed to answer pressing questions from top figures at EPO, UK IPO, Indian PO and USPTO, provide practical lessons in how to apply the key patent lifecycle extension strategies, and ensure that attendees maximize the efficiency of potential collaborations between innovators and generics.

For more information or the register, please visit the conference website.

Informa Life Sciences "Global Generics Strategy Summit" Conference, Barcelona, March 4-5

Informa Life Sciences will hold its 7th annual "Global Generics Strategy Summit" conference in Barcelona, Spain, March 4-5, 2008.  The conference "represents the largest gathering of Generics leaders from across the globe and will explore new and emerging strategies and regulations that must be followed to remain competitive in this cut-throat industry."

The conference features keynote presentations from executives of Ratiopharm Group, Ranbaxy, Barr Labs, and Biogenerics.  In addition, several talks are offered on each of the following subjects: legal and regulatory issues; biosimilars; pricing and reimbursement; and business development.

Moreover, four pre- and post-conference workshops will be offered: on March 3rd, "Merger and Acquisition Within the Generics Marketplace" and "Evaluation of Existing and Development of New Strategic Business Models to Stay Ahead in the Generics Sector"; and on March 6th, "Criteria for Selecting Member States to Include in a Decentralised Procedure Application" and "Implementing Fast-Track Development and Launch Strategies and Being the First Generic to Market."

For more information or to register, please visit the conference website.

IQPC "Pharmaceutical Patent Litigation Strategies 2008" Conference, London, March 31 - April 1

IQPC will be holding its 3rd annual "Pharmaceutical Patent Litigation Strategies" conference in London, March 31 to April 1.

The conference is split into two days--one focusing on European law, the other focusing on U.S. law--and includes an optional third day, with workshops.  The European Focus Day will emphasize proposals for supranational patent litigation; EPLA; and the community patent and how to push it forward.  The U.S. Focus Day will analyze the trends and developments in the pharmaceutical and biotech law sector; the Patent Reform Act 2007; parallel US and European patent litigation strategies; and key rulings.

Margot Fröhlinger, Director, European Commission, will be speaking during the European Focus Day on "How to Achieve Consistency Across European Courts in the Future."  Dr. Fröhlinger leads an exceptional speaker panel that will discuss successful litigation practices and a changing regulatory framework in order to provide superior practical intelligence.

IQPC's 3rd annual "Pharmaceutical Patent Litigation Strategies" conference is sharply focused on improving in-house patent litigation for pharmaceutical companies.  The event will feature the latest updates from both in-house experts and outside counsel.  Key issues to be covered include the link between regulations and actual litigation practices; international litigation processes; patent life extension; and new industry developments.

For more information or to register, please visit the conference website.

ACI "Pharma/Biotech IP Due Diligence" Conference, New York, January 30-31

American Conference Institute will hold its fifth annual "Pharma/Biotech IP Due Diligence" conference January 30-31 in New York.  ACI describes this conference as the "complete guide for M&As, licensing and other collaborations."

The agenda includes several talks that sound especially interesting, including:

• "Factoring Patent Reform, PTO Rulemaking and New Case Law Into Your Due Diligence Analysis"
• "Managing Due Diligence When Dealing with Industry/University Collaborations and Licenses"
• "Evaluating the Scope, Validity, and Enforceability of the Target's Patents"
• "Freedom to Operate: Ensuring the Purchaser/Licensee Has the Right to Commercialize the IP at Issue"
• "FDA Regulation of Small Molecule Drugs and Biologics: Understanding How This Affects the Diligence Review"

In addition, ACI is offering an optional master class on February 1, entitled "Drafting an Effective Due Diligence Report."

For more information or to register, please visit the conference website.

Orange Book Blog is a media partner of this conference.

iiBIG "New Directions for Drug Delivery" Conference, Las Vegas, October 29-30

The International Institute for Business Information & Growth will hold a conference entitled "New Directions for Drug Delivery," October 29-30 in Las Vegas, Nevada.  The conference is designed for pharmaceutical scientists and specialty pharma, biopharmaceutical, and nanotechnology licensing and business development team leaders.  According to iiBIG, attendees will learn "how new scientific technologies are driving investments, alliances and clinical trials to bring novel drug delivery technologies to market."

The agenda includes several interesting sessions, including:

• "Rapid Evaluation of Drug Delivery Technologies"
• "FDA & Patents -- Case Study of Transdermal Patches"
• "Innovations and Success Strategies: Learning and Un-learning from Key Players" (a panel on which I'll be speaking)
• "Eye on the Future -- Breakthrough Scientific and Partnership Strategies"
• "Converting from Drug Delivery to Specialty Pharma -- The Road More Traveled"

For more information or to register, please visit the conference website.

Orange Book Blog is a media partner of this conference.