Orange Book Blog

Momentum Events "IP Counsel Exchange for Biosimilar Applicants and Sponsors," New York, January 23-24

Momentum Event Group will be holding its inaugural "IP Counsel Exchange for Biosimilar Applicants and Sponsors" January 23-24 in New York City.  The effect of the recent Sandoz v. Amgen decision on biosimilar patent litigation strategy is expected to be a main topic of discussion.

The conference begins with an interactive working group, where participants can choose between:

• "Dissecting the European Biosimilars Experience: What Potential Sponsors and Applicants Can Learn From the Approval of the First Biosimilar Antibody in Europe" and
• "Navigating the Patent Application Process: Effective Strategies for Ensuring Your Application Obtains Approval and Can Withstand Challenges in the Emerging Biosimilar Market."

The conference continues with the following presentations:

• "Patent Caselaw Year in Review: Examining Recent Caselaw Developments Under Section 112 Addressing Written Description and Enablement and the Impact on Patent Strategies for Companies Within the Biosimilar Space"
• "Orange Book Withdrawal: How Sponsors and Applicants Can Conduct Effective IP Due Diligence and Patent Inventory Assessment in the Absence of an Established FDA Patent Listing Resource"
• "So You Think You Can Patent Dance: Effective Strategies for Best Posturing Your Product and Narrowing the Litigation Landscape"
• "Size Matters: Dissecting the Divergent Litigation Pathways of Small vs. Large Molecule Products and What Steps Your Company Should Take Now to Prepare Your Future Litigation Strategy"
• "Interactive Roundtable Discussion: Addressing the Top 5 Global IP Challenges Facing Current and Prospective Biosimilar Sponsors and Applicants"
• "Addressing the Potential Use of Trade Secrets (Or Not) in Connection with the FDA's Review of Biosimilar Applications Citing a Reference Product and BLA that Predates the BPCIA"
• "Case Study: To Collaborate or Not to Collaborate?  How Alliances Can Be Used to Strategically Bolster Your Patent Portfolio When Bringing a Biosimilar/Biobetter Product to Market"
• "Global IP Considerations, Challenges, Risks, and Opportunities for Biosimilar Applicants and Sponsors When Filing Patent Applications Abroad"

The conference concludes with your choice of one of three interative roundtable discussions:

• "Looking Beyond Year 12: How to Ensure Your Patent Strategies Are Adding Value Beyond the Statutory Period of Exclusivity"
• "Distinguishing Regulatory Pathways for Biosimilar Products: Biobetters vs. Biosimilars and Considering the Impact Your Regulatory Choice Will Have on Your IP Strategy"
• "Alternative Monetization Strategies for Your IP Portfolio: How to Drive Your Business When You Choose Not to Apply"

Orange Book Blog readers are entitled to a 10% discount on registration by using code OBB10.  For more information or to register, please visit the conference website.

ACI "Paragraph IV Disputes Master Symposium," Chicago, October 3-4

American Conference Institute will be holding its first-ever "Paragraph IV Disputes Master Symposium" next week, October 3-4, in Chicago.  McAndrews, Held & Malloy Partner Scott McBride will be speaking at the conference on claim construction strategies.  The rest of the agenda is as follows:

• Identifying patents which may be ripe for challenges of invalidity and noninfringement: offensive and defensive strategies for brand and generic companies
• Use of IPR and other PTO proceedings in a paragraph IV challenge: strategies for brand names and generics in navigating new proceedings in alternate and parallel forums which may change the rules of the Hatch-Waxman endgame
• The start of the paragraph IV litigation countdown: the paragraph IV certification and notice letter
• Obviousness in review: formulating assertions and defenses in view of new substantive and procedural developments in the federal courts and PTO
• Advanced strategies for drafting and perfecting pleadings and effectively using dispositive motions in paragraph IV disputes
• Of customs and courts: the importance of mastering the requirements of local patent rules in paragraph IV disputes
• A view from the bench (featuring Judge Davis of the E.D. Tex.; Judge Holderman of the N.D. Ill.; and judges Brown, Pisano, and Bongiovanni of the D.N.J.)
• The end of Roche v. Bolar? Understanding how new 271(e)(1) controversies may alter the course of brand name and generic strategies in paragraph IV litigation relative to safe harbor research exceptions
• Mastering regulatory maneuvers in paragraph IV disputes: seeking relief from the FDA in the course of Hatch-Waxman litigation
• New exclusivity challenges for brand names and generics
• Pay-for-delay and settlement drafting update
• Continuing claim construction conundrums impacting Markman strategies
• Evolving theories of inducement and divided infringement in paragraph IV litigation concerning method of treatment patents
• Protonix--case study of an at-risk launch: pros and cons of launching at risk and survey of new developments in seeking injunctive relief and damages
• Inequitable conduct: ethical considerations for paragraph IV matters before the PTO and district court

In addition, ACI is offering two pre-conference workshops on October 2: "Hatch-Waxman and BPCIA Master Class--Perfecting Your IP and Regulatory IQ of Small and Large Molecules"; and "Post-Grant Review and Inter Partes Review Boot Camp: Essential Considerations for Brand Names and Generics Regarding the Use of These PTO Procedures in Paragraph IV Scenarios."

Orange Book Blog readers receive discounted registration with code OBB 200.  For more information or to register, please visit the conference website.

41st IPO Annual Meeting, Boston, September 15-17

The Intellectual Property Owners Association will hold its 41st Annual Meeting on September 15-17 in Boston.  The keynote speakers include David Goulden, President and COO, EMC Corporation, and Hon. Kathleen O'Malley, Circuit Judge, U.S. Court of Appeals for the Federal Circuit.

In addition, McAndrews, Held & Malloy Shareholder Herbert D. Hart III will be a featured speaker.  Because of his significant experience litigating before the Patent Trial and Appeal Board (PTAB), Hart was invited to organize and participate in the session titled, "Back To The Future: Trial Practice of the PTAB."

Specifically, Hart will address current practice, decisions, and strategies in both litigating and managing PTAB trials, which are highly specialized, fast-paced, and unforgiving for those inexperienced in PTAB trial practice.  Hart will also provide trial practice tips directly applicable to today's post-grant trial proceedings.  Other long-time PTAB practitioners featured on the panel include:

• Bruce Stoner, Greenblum & Bernstein, P.L.C. (Former Chief Administrative Patent Judge, Board of Patent Appeals and Interferences)
• Oliver Ashe, Ashe, P.C.
• Mark A. Charles, The Procter & Gamble Company
• Danny Huntington, Rothwell, Figg, Ernst & Manbeck, P.C.

For more information or to register for the IPO Annual Meeting, please click here.

Momentum Events "International Congress on Paragraph IV Litigation," New York, September 23-24

Momentum Event Group will be holding its inaugural "International Congress on Paragraph IV Litigation" September 23-24 in New York City.  The conference will feature a panel discussion with Judge Plager of the Federal Circuit and Judges Salas and Schneider from the District of New Jersey.

Here is the complete agenda:

• Paragraph IV Caselaw Year in Review: An Examination of Recent Circuit and District Court Decisions and Trends in Paragraph IV Disputes
• FTC Keynote Address: The Use of Reverse Payment Settlements to "Pay for Delay"
• Regulatory Trends: Addressing Recent Trends in Citizens Petitions and Dissecting the Impact on Paragraph IV Litigation Strategies for Both Patentees and ANDA Filers
• In-House Roundtable: Corporate Views on the Costs, Benefits, and Strategies Behind Paragraph IV Litigation
• View from the Bench: Judicial Perspectives on Paragraph IV Litigation
• International Litigation Case Study: How to Manage, Oversee, and Coordinate Multi-Jurisdictional IP Litigation and Overcome Global Settlement Obstacles
• Focus on Biosimilars: Comparing and Contrasting the Divergent Litigation Pathways of Small- vs. Large-Molecule Products
• Impact of the AIA on Litigation Strategies for Branded and Generic Pharmaceutical Companies
• Label "Carve-Outs" and Listing Strategies: Practical Tips for Minimizing Downstream Exposure to Paragraph IV Challenges and Drafting Codes to Limit Carve-Out Opportunities
• Claim Construction and the Markman Hearing: Practical Tips for Ensuring the Best Interpretation of Key Patent Claims and Obtaining the Results You Want from the Markman Hearing
• Effective Motion Practice in Paragraph IV Disputes: When and How to Successfully Pursue and Respond to Motions for Summary Judgment and Preliminary Injunctions
• Special Litigation Considerations for Paragraph IV Disputes Involving Multiple ANDA Filers
• 180-Day Exclusivity and Forfeiture: A Dissection of Key Filing Benchmarks and Timing Considerations for Counsel on Both Sides
• "At Risk" Launches: Assessing the Pros and Cons of Launching During Litigation and Considering the Downstream Impact an "At Risk" Launch Can Have on Your Settlement Strategy
• Paragraph IV Appeals: A Litigators Guide to Effectively Preserving Issues for Appeal and Keeping Your Case Alive Post-District Court
• Litigation Strategies for Negotiating a Paragraph IV Settlement that Will Withstand Government Scrutiny

In addition, attendees can choose from two pre-conference workshops, which each begin at 8:30 am on September 23rd: "Preparing for and Anticipating a Paragraph IV Challenge: Assessing the Business Risks and Legal Costs of a PIV Challenge" and "Paragraph IV Mock Trial: Inside a Real-Time Examination of a Company Witness, Inventor, and Scientist."

You can receive a 15% discount off registration fees by using promo code SP15OK.  For more information or to register, please visit the conference website.

ACI "Legal and Regulatory Summit on Generic Drugs," New York City, July 17-18

ACI will be holding its first "Legal and Regulatory Summit on Generic Drugs" in New York City on July 17-18.  The conference co-chairs are Shashank Upadhye, formerly of Apotex, and Kurt Karst of FDA Law Blog.

Here's the agenda:

• The Politics and Policy of the Generic Drug Industry: Understanding the Role of the 113th Congress in Shaping the Future of Generic Pharma
• The Game Changer: Analyzing the Legal and Business Impact of the Generic Drug User Fee Amendments
• Breaking Developments in Hatch-Waxman Litigation: Paragraph IV Disputes and Beyond
• Examining Branded-Generic Alliances that Maximize the Potential of Biosimilars and Minimize Investment Risks
• Reverse Payments Update: Key Strategies to Bring to the Settlement Table
• The Evolution of Authorized Generics Agreements Including New Controversies Under Health Care Reform
• A View from the Bench: The Judges Speak on Major Developments in Case Law Impacting the Pharmaceutical Industry
• Developing Strategies for Bypassing Roadblocks to REMS-Controlled Drugs Access
• How Generic Companies Are Defending Against Evolving Theories of Products Liability Law Following Pliva v. Mensing
• Protecting Your Company From Price Erosion Through Improved Pricing Reimbursement Strategies Tailored to the Generics Industry
• Insights from the Office of Generic Drugs
• Eyes on the 180-Day Prize: Identifying Current and Future Trends to Successfully Position Your Generic Pipeline Strategy

In addition, ACI is offering two pre-conference workshops: "Industry Roundtable: Addressing the Day to Day Legal, Regulatory, and Business Challenges of Generic Manufacturers" and "Business Development Master Class: In-House Counsel Perspectives on Selecting and Evaluating Outside Counsel."

Orange Book Blog readers receive $200 off registration fees with discount code OBB 200.  For more information or to register, please visit the conference website.

ACI "Advanced Summit on Global Patenting Strategy & Practice," New York City, July 15-16

American Conference Institute will be holding its first "Global Patenting Strategy & Practice" conference July 15-16 in New York.  McAndrews, Held & Malloy Partner Scott McBride will be speaking on strategies for protecting trade secrets in multiple jurisdictions.

The rest of the agenda includes the following presentations:

• Understanding the Importance of Developing a Global Strategy for Your Patent Portfolio
• An Alignment of Interests: Determining the Impact of Patent Harmonization Efforts on IP Protection
• Devising Effective Strategies for Working with Inventors in Foreign Jurisdictions
• A Review of Guidelines for Patentability and Novelty in Different Patent Offices
• Comparing Claim Drafting and Construction Standards in important Jurisdictions
• Exploring Obviousness and Inventive Step Concepts Around the World
• Analyzing Written Description and Specification Requirements Across Different Patent Regimes
• Comparing and Contrasting Opposition Proceedings in the US and EU
• Navigating the "Ins" and "Outs" of Opposition Practice Across the World
• Managing Unique Challenges and Investigating Emerging Trends in Foreign Patent Litigation
• Using the International Trade Commission (ITC) as a Venue for Global Patent Conflicts
• Addressing the Challenges Presented by Compulsory Licensing Provisions Abroad

In addition, two post-conference workshops will be held on July 17:  "Mastering the Foreign Patent Law and Regulatory Requirements for Life Sciences Companies in a Global Context" and "Negotiating the Obstacles and Challenges Associated with Patenting a Product in Multiple Jurisdictions."

Orange Book Blog readers receive discounted registration by using code OBB 200.  For more information or to register, please visit the conference website.

ACI "4th Advanced Forum on Biosimilars," New York City, June 5-7

ACI will be holding its "4th Advanced Forum on Biosimilars" in New York City on June 5-7.  McAndrews, Held & Malloy partner Sandra Frantzen will be speaking on the written description and enablement requirements for biologics patents.  The full agenda includes the following presentations:

• The Biosimilars Pipeline: Evaluating the Commercial Opportunity and Viability of Follow-On Products
• Overcoming the Complicated Challenges to Establishing Biosimilarity
• The Next Fronteir of Biosimilars Challenges: Naming and Substitution at the Pharmacy Level
• Two Roads Diverged in a Wood: Evaluating Whether to Go Down the Biosimilars or BLA Pathway
• In-House Keynote: Interchange or "Out of Change"--the Changing World of Biosimilars
• In-House Roundtable Debate: Companies Weigh in on the Abbreviated Pathway
• The Reality of the Market: Lessons Learned So Far from Global Biosimilars Development and Litigation
• Preparing for the Impending Reality of Biosimilars Patent Litigation: Immediate Action Plans for the First Wave
• The Post-AIA World: Revolutionizing Biosimilars Litigation Strategies in Light of Validity Assessment at the PTO
• Practical Claim Drafting and Patent Prosecution Strategies for Biosimilars and Innovators
• Exploring Opportunities to Strengthen Your Patent Portfolio Through Licensing
• The Use of Citizen Petitions in the Biosimilars Context: A Case Study of AbbVie's Petition
• Evaluating the Benefit of Trade Secret Protection Versus Patent Protection: Alternative Ways to Protect Biologic and Biosimilar Technology
• Navigating Tricky Confidentiality and Conflicts Issues in the New Biosimilars Exchange Process

In addition, two pre-conference workshops will take place on June 5: "Biologics 101: Translating the Underlying Science into a Strong Biosimilars Patent Portfolio Strategy" in the morning; and "Monoclonal Antibodies: Successful and Practical Strategies for Developing and Commercializing Antibody Therapies" in the afternoon.

Orange Book Blog readers can receive discounted registration by using code OBB 200.  For additional information or to register, please visit the conference website.

ACI "Paragraph IV Disputes" Conference, New York City, May 7-8

ACI will be holding its always-popular "Paragraph IV Disputes" conference in New York City next week, on May 7-8.  This year's conference--the 7th annual--looks better than ever.  The agenda includes the following presentations:

• Anticipating a Paragraph IV Challenge: New Considerations in Light of AIA and the Patent Cliff
• Asserting Invalidity or Non-infringement Under Paragraph IV: Exploring the ANDA Applicant's Pre-litigation Obligations and Options
• Safe Harbor or Stormy Port?: Analyzing How New 271(e)(1) Controversies Will Impact Paragraph IV Disputes
• Throwing Down the Gauntlet: The Paragraph IV Notice Letter
• Obviousness in Retrospect: Making Sense of Prior Art, Obviousness-Type Double Patenting, Inherency and New AIA Controversies
• Let the Games Begin: The Start of the Paragraph IV Law Suit -- Pleadings and Other Considerations
• A View From the Bench -- with Hon. Paul R. Michel, Hon. Gregory M. Sleet, Hon. Stanley R. Chesler, Hon. Joel A. Pisano, Hon. Tonianne Bongiovvani, and Hon. Garrett E. Brown
• Pay-for-Delay Update -- presented by Markus H. Meier, Asst. Dir., Health Care Division, Bureau of Competition, Federal Trade Commission
• Settlement of Paragraph IV Law Suits: The Industry Perspective
• Parallel and Alternate Proceedings in Paragraph IV Disputes: Seeking Simultaneous or Sole Redress Before the PTO, ITC and Other Alternative Forums -- with Hon. Garrett E. Brown, Mon. Mary Pat Thynge, Hon. Joseph A. Dickson, Hon. James Donald Smith, and Hon. Robert K. Rogers
• FDA Proceedings and Regulatory Developments Impacting Paragraph IV Litigation
• New Exclusivity Challenges: Brand Names Take Notice -- It's Not Just a Concern for Generics Anymore
• Examining New Rulings in Inducement of Infringement and Divided Infringement and Their Application to Method Claims in Hatch-Waxman Litigation
• New Developments in Damages Theories and Injunctions Relative to At-Risk Launches: Legal and Economic Assessments
• Inequitable Conduct Developments in the Courts and at the PTO: Ethical Considerations for Paragraph IV Cases

In addition to the main conference, ACI is offering two pre-conference workshops on May 6.  In the morning will be Hatch-Waxman and BPCIA 101 -- A Primer on IP Basics and Regulatory Fundamentals; and in the afternoon, Working Group Session: Assessing the Impact of New PTO Procedures Under the AIA on Paragraph IV Litigation.  Finally, on May 9 ACI is offering a post-conference Master Class on Settling Paragraph IV Disputes: Drafting and Negotiating Strategies for Brand Names and Generics -- A Hands-On, Practical Approach.

Orange Book Blog readers are eligible for a discounted registration rate by using code OBB 200.  For additional information or to register, please visit the conference website.

Supreme Court to Hear Argument in Bowman v. Monsanto; Post-Argument Panel Discussion and Webinar to Follow

This morning, February 19, 2013, the Supreme Court will hear argument in one of the most important patent cases in recent years-–Bowman v. Monsanto.  The case specifically addresses patent exhaustion in the progeny of soybean seeds.  But the Court’s opinion in this case could impact the protection of some of the most innovative biotechnology inventions in the country--including those relating to progenitive or self-replicating technologies.  The opinion may also impact the viability of conditional sales of patented products.  And it could alter U.S. patent law in a way that would have significant consequences for biotech firms and other institutions involved in biotech research and development.

This afternoon, a CLE-eligible panel discussion is being hosted by the American University Washington College of Law and the Federal Circuit Bar Association.  The discussion will feature counsel for the parties and selected amici, and will be held at the American University Washington College of Law in Washington, DC.  For the in-person discussion, attendees will be asked to take their seats at around 4:15 pm EST.

The panel discussion may also be seen live on the internet.  The free webinar will be begin at 4:30 pm EST / 1:30 pm PST on the event website.  No log-in will be required.

Scott P. McBride, a partner at McAndrews Held & Malloy and contributor to Orange Book Blog, will be one of the panelists.  His team submitted an amicus brief on behalf of over twenty universities and university-related associations in the case, urging the Supreme Court to affirm the Federal Circuit's decision in favor of of the patent owner, Monsanto.

For additional information about the case and panel discussion, please visit the event website.

CPhI "Pharma IPR India 2013" Conference, Mumbai, India, April 10-12

CPhI will be holding its 2nd annual Pharma IPR India conference in Mumbai on April 10-12.  This was an outstanding conference last year, and it promises to be even better this year.

Pharma IPR India 2013 will take place over three days, focusing the first day on pharmaceutical intellectual-property rights in the United States, Canada, Brazil, and Mexico; the second day on Europe, Japan, and Australia; and the third day on India, China, South Africa, Russia, and Southeast Asia.

An early-bird registration rate is available through February 15th.  In addition, save an extra 10% by mentioning Orange Book Blog.

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