Orange Book Blog

FTC Roundtable, "Competition Issues Involving Follow-On Biologic Drugs," Washington, November 21

The Federal Trade Commission is hosting a roundtable entitled "Competition Issues Involving Follow-On Biologic Drugs," Friday, November 21, at its headquarters in Washington.  Speakers include industry leaders, government officials, outside counsel and others.

The agenda includes the following presentations:

• Welcoming remarks, FTC Commissioner Pamela Jones Harbour
• Opening remarks, Rachel Behrman, FDA: "How Do Biologic Drugs Differ from Small Molecule Drugs?"
• "Likely Market Effects of Follow-On Biologic Drug Competition," a panel discussion moderated by Michael Wroblewski and Elizabeth Jex, FTC
• "Likely Competitive Effects of Reference Product Regulatory Exclusivity," moderated by Michael Wroblewski and Christopher Garmon, FTC
• "Biotechnology Patent Issues," moderated by Suzanne Michel and Suzanne Drennon, FTC
• "Likely Competitive Effects of Follow-On Biologic Regulatory Incentives," moderated by Michael Wroblewski and Elizabeth Jex, FTC
• "Patent Dispute Resolution Processes," moderated by Michael Wroblewski and Suzanne Drennon, FTC

In advance of the roundtable, over a dozen organizations have submitted comments to the FTC, including BIO, GPhA, and PhRMA.

A live webcast of the event will be offered.  For more information, please visit the FTC website.

ACI "Paragraph IV On Trial" Conference, New York, November 19-20

American Conference Institute is presenting its first-ever "Paragraph IV On Trial" Conference, November 19-20 in New York.  This is a unique conference, with the format of a mock trial in a Hatch-Waxman case.

ACI states:  "Structured as an actual trial based on an ANDA filing involving a compound and a formulation patent, our experienced faculty of patent litigators will conduct live demonstrations of direct and cross examinations, as you witness an entire, detailed, Paragraph IV trial, beginning with the banging of the gavel and concluding with closing statements."

After each direct and cross examination, a panel of judges and in-house counsel will provide commentary.

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

Orange Book Blog readers can save $200 by using registration code "S".

BNA "Pharmaceutical Patent Laws" Conference, Arlington, VA, November 12

BNA Legal & Business Edge is presenting a conference entitled "Pharmaceutical Patent Laws:  A Prescription for Success in Challenging Times, November 12 in Arlington, VA.

According to BNA, this will be a "fast-paced conference on the latest developments and changes in pharmaceutical patent law."

Here's the agenda:

• Morning Keynote Address:  Inequitable Conduct
• "Pay for Delay" and Other Continuing Controversies in Pharmaceutical Patent Settlements
• Non-Patent Marketing Exclusivity
• Import and Export Issues
• Luncheon Keynote Address:  Two Legislative Currents Driving Biotech Patent Law Reform
• The Other Kind of Pharmaceutical IP:  Regulatory Life Cycle Management Strategies--Opportunities and Challenges
• Pharma Post-Election:  Predictions for the Future
• Trends in Declaratory Judgment Actions:  Where are the Courts Headed?

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

BNA is offering a special discount to Orange Book Blog readers:  40% off the registration fees; and, if you register two people at the discounted rate, a third registration will be free.  Enter code CONF40NE when registering, or email Nancy Erikson at NErickson@bna.com.

C5 "EU Pharma Law and Regulation" Conference, Geneva, November 4-5

C5 is presenting a conference next month entitled "EU Pharma Law and Regulation."  It will take place November 4-5 in Geneva, Switzerland.

According to C5, "From the EU Pharma Sector Inquiry to recent parallel trade cases, the continued growth of counterfeiting, multiple options for extending product exclusivity amidst dwindling product pipelines and blockbusters coming off-patent, C5's 'EU Pharma Law' is the only event covering the key topics shaping pharmaceutical law and practice today."

The following presentations sound particularly interesting:

• "Current and Pending Issues in EU Legislation, Regulation and Case Law"
• "Current State of Play and Legal Framework for Biosimilars"
• "Examination of the EU Pharmaceutical Sector Inquiry"
• "Examination of the Intersection Between Competition and Pharma Law:  The Inquiry, Anti-Trust and Parallel Trade"
• "Successful Patent Management and Patent Enforcement in the New EU Territories"
• "Weighing the Risks and Benefits of Expanding Into the Growing Asian Pharmaceutical Sector:  Key Considerations for European Pharma Companies"
• "Advanced Strategies for Patent and Product Life Cycle Management"
• "Choosing the Best Licensing Strategy for Every Stage of Drug Development"

In addition, two post-conference workshops are offered on November 6th:  "Developing an Effective FCPA Compliance Program in the Pharmaceutical Industry" and "A Practical Guide to Managing the PIP Approval Process and Successfully Achieving Paediatric Term Extension."

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

Orange Book Blog readers can save 10% by using registration code 800L09.ORANGE.

Non-Patent Exclusivity and 180-Day Exclusivity Forfeiture Slides Posted

Last week, I gave a talk about non-patent exclusivity at ACI's FDA Boot Camp conference in Boston.  The talk covered new chemical entity (5-year) exclusivity; new clinical trial (3-year) exclusivity; orphan drug exclusivity; pediatric exclusivity; and generic drug (180-day) exclusivity.  You can download a copy of my slides here.

In June, I gave a talk about forfeiture of 180-day exclusivity at IIR's Generic Drugs Summit conference in Washington.  The talk included a discussion of the "failure to market" forfeiture provisions, particularly the FDA's Acarbose and Granisetron decisions.  You can download a copy of those slides here.

CBI "Paragraph IV Disputes" Conference, Philadelphia, October 15-16

On October 15-16 in Philadelphia, the Center for Business Intelligence will hold a conference entitled "Pharmaceutical Congress on Paragraph IV Disputes:  Navigating Regulations and Enforcement Trends to Increase Preparedness and Optimize Paragraph IV Strategies."

CBI provides its top five reasons to attend:

• To hear the FTC's stance on antitrust and acceptable settlement strategies
• To learn to optimize cost savings in e-discovery
• To assess ANDA litigation after KSR
• To understand the "earlier of" - "later of" maze in forfeiture provisions
• To conduct an in-depth analysis of recent paragraph IV developments and their implications on industry

The conference will begin with a workshop, "Assess Litigation Strategies to Proactively Plan for Paragraph IV Disputes," on October 15 from 8:30 am to noon.

The main agenda then includes numerous talks that look interesting:

• "Strategies to Optimize Patent Lifecycle from Drafting to Maturity"
• "Preparing for Paragraph IV Challenges -- Generic Pre-suit Strategies"
• "Best Practices in E-Discovery -- Overcoming Obstacles, Controlling Costs and Maximizing Benefits"
• "The KSR Decision and ANDA Litigation"
• "Implications of Recent Developments and Trends in Litigating Paragraph IV Disputes" (I'll be speaking on this topic as one of the panelists)
• "Citizen Petitions and Their Impact on Generic Entry"
• "Interpreting Forfeiture Provisions -- An Analysis of Recent Cases to Increase Preparedness and Improve Product Strategy"
• "The FTC, Antitrust Law and Settling Paragraph IV Litigation," presented by Markus Meier, Assistant Director, FTC

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

Orange Book Blog readers can save $400 by using registration code SAQ782.

ACI "Maximizing Pharmaceutical Patent Life Cycles" Conference, New York, October 15-16

American Conference Institute is holding its ninth annual "Maximizing Pharmaceutical Patent Life Cycles" conference October 15-16 in New York.  According to ACI, this "definitive Hatch-Waxman event provides the crucial information for pharmaceutical patent counsel to cultivate, modify, and enhance a foundation for their life cycle strategies."

The agenda includes many topics covered on Orange Book Blog.  Selected talks include:

• "Constructing, Adjusting, and Executing a Pharmaceutical Patent Life Cycle Management Plan"
• "View from the FTC," presented by Saralisa Brau, Health Care Services and Products Division, FTC
• "Navigating the Complexity of Structuring Patent Settlement Options Between Brand Name and Generic Pharmaceutical Companies"
• "Eye on the Bench:  Identifying Judicial Trends in Pharmaceutical Patent Cases"
• "Mastering the Intricacies of the 180-Day Generic Market Exclusivity"
• "Plotting a Course Into Safe Harbor for Branded Pharma"
• "View from the FDA," presented by Elizabeth Dickinson, Office of Chief Counsel, FDA
• "Slicing Through the Complex Spectrum of Declaratory Judgment Actions in Pharmaceutical Patent Cases"
• "Factoring the Role, Challenges, and Impact of Orange Book Listings and Delistings in Patent Portfolio Management"

In addition, two optional post-conference workshops are offered on October 17th:  a brand name master class entitled "Overpowering the Challenges in Increasing the Pharmaceutical Patent Life Cycle Through Patent Extensions" and a generics master class entitled "Adding Value to Paragraph IV Certifications and Notice Letters."

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

Orange Book Blog readers can save $200 by using registration code S.

ACI "FDA Boot Camp" Conference, Boston, September 22-23

American Conference Institute will be holding another "FDA Boot Camp" in Boston, September 22-23.

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.

Talks on the agenda include:

• The Basics: Understanding and Working with the FDA -- Jurisdiction, Functions, Organization, and Operations
• The Nature of the Approval Process
• Understanding the Clinical Trial Process for Drugs and Biologics
• Patent and IP Overview: Hatch-Waxman, Trademark Protection, and More
• Non-Patent Exclusivity (I'll be presenting this one)
• Bioequivalence: What Lawyers Need to Know
• Follow-On (Comparable or Biosimilar) Biologics

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

Orange Book Blog readers can save $200 on registration with code SP1.

ACI "Biotech Patents" Conference, Boston, September 15-16

ACI's "Biotech Patents" conference will be held at the Royal Sonesta Hotel in Boston, September 15-16.  According to ACI, this is the "ONE place biotech patent practitioners come to learn and discuss the most recent and vital changes facing the industry today."

The agenda includes several talks that look interesting:

• "Navigating the Board of Patent Appeals and Interferences in Light of the KSR Decision"
• "They Are Coming:  Preparing Your Practice for the Inevitable Insurgence of Follow-On Biologics and Predicting the Future of the Biotech Industry"
• "The International Perspective:  Changing Patent Practices in the EU and India:
• "Practicing Biotechnology Arts:  Claim Drafting Strategies"
• "Ex Parte Kubin:  A Case Study"
• "Different But the Same:  The Unique Nature of Prosecuting Antibody Therapeutics Applications Under the Standard Patent Prosecution Process"

There is also a post-conference master class, "Drafting Successful Patent Applications for Biotechnology-Related Inventions."

Orange Book Blog readers can save $200 off registration by using code SP1.

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

C5 "Biotech Patenting" Conference, London, September 23-24

C5 will be bringing its popular "Biotech Patenting" conference to London on September 23-24.

According to C5, the conference "provides updates on the latest developments in biotech patenting, including recent case law and regulatory developments."  The conference is unique in offering an international perspective on biotechnology patent law:  experts from Europe, Asia and the United States will be speaking.  One of the highlights will be a keynote address by Judge Randall Rader of the U.S. Court of Appeals for the Federal Circuit.

The agenda includes numerous talks and panel discussions that should be of interest to Orange Book Blog readers, such as:

• "Critical Update on Legislative and Policy Developments at the UK-IPO and EPO," presented by officials from the UK-IPO and the EPO
• "Review of Recent EPO and EU National Court Biotech Decisions"
• "Impact of the EPC 2000 on Medical Use Claims"
• "Analysis of the Latest Decisions of the U.S. Courts and Their Implications"
• "Obviousness Determinations After KSR v. Teleflex"
• "How to Successfully Obtain and Enforce Your Biotech Patents in China and India"
• "Comparison of the U.S. and European Legal Issues Surrounding Biosimilars:  Legislation, Case Law and Approvals to Date"
• "Managing Your Biotech Patent Litigation: In-House and Outside Counsel Perspectives"

In addition, two pre-conference workshops are offered on September 22:  "How to Conduct Effective IP Due Diligence" and "Successfully Evaluating Freedom to Operate."

Orange Book Blog readers can receive a 10% discount off the registration fee with the following code:  789L09.OBB.

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