Orange Book Blog

ACI "Summit on U.S. Biosimilars," Munich, Germany, April 20-21

McAndrews Shareholder Sandra Frantzen will be one of the featured speakers at American Conference Institute's "Summit on U.S. Biosimilars" conference in Munich, Germany, April 20-21.  Ms. Frantzen will be speaking on "Incorporating Inter-Partes Review and New USPTO Procedures into Branded and Biosimilar Litigation Strategies."

Other speakers include in-house counsel and executives from AbbVie, Boehringer Ingelheim, IPM Biotech, PAREXEL, Sandoz, and Sanofi, as well as outside counsel from U.S. and European firms.

The complete agenda is as follows:

• "Diving into the Science of Biologics and Biosimilars: What Counsel Needs to Know to Formulate a Regulatory and Patent Strategy"
• "Understanding the Structure of the USFDA and Its Role in Approving and Regulating Biosimilars"
• "Delving into the Mechanics of the USFDA Biosimilars Approval Process and Section 351(k) Applications Under the Pathway"
• "Mastering the Essentials of New USPTO Post-Grant Proceedings for Effective Use in the Biosimilars Space"
• "Obtaining Adequate Patent Protection in the U.S.: Factoring Key Cases into Your Biosimilars Patent Strategy"
• "U.S. Federal Trade Commission and State Law Updates: Understanding the Controversy Surrounding Competition, Substitution, and Naming in the Biosimilars Arena"
• "Minimizing the Uncertainty Surrounding the Pathway: Insights Into USFDA's Current Initiatives Regarding the First Wave of Biosimilars Applications"
• "Evaluating the Risk and Commercial Opportunity in the Emerging U.S. Biosimilars Landscape"
• "In-House Keynote Address" by Julia Pike, Head Global IP Litigation for Sandoz
• "Timing is Everything: A Cheat Sheet for Managing the Logistics of the BPCIA Exchange Process"
• "Biosimilars Litigation Spotlight: Immediate Action Plans for Innovators and Biosimilars to Prepare for the Battles to Come"
• "Incorporating Inter-Partes Review and New USPTO Procedures Into Branded and Biosimilar Litigation Strategies"
• "Open Floor Session: Lessons Learned So Far: Comparing and Contrasting the U.S. and E.U. Biosimilars Experience"

Orange Book Blog readers can save €100 with discount code OBB100.  For more information or to register, please visit the conference website.

ACI "Paragraph IV Disputes Master Symposium," Chicago, September 30-October 1

ACI's "Paragraph IV Disputes Master Symposium" returns to Chicago next week, September 30 to October 1.  According to ACI, this is an "advanced forum for brand name and generic counsel on the intricacies of Hatch-Waxman litigation."

The agenda includes the following presentations:

• Review of Key Supreme Court Cases that May Alter the Course of Paragraph IV Litigation
• Identifying New Due Diligence Concerns Relative to ANDA Drug Targets and Anticipating New Paragraph IV Challenges
• It's All About Timing:  Exploring the Surge in Premature Paragraph IV Notice Filings and Its Consequences
• Teva v. Sandoz--A Debate on the Standard of Review for Claim Construction: De Novo vs. Deferential
• Exploring the Use of Reissue Applications to Amend Invalidity Findings in the District Courts
• Analyzing the Evolving Utilization of IPR and Other PTO Proceedings in Paragraph IV Litigation
• Understanding the Importance of Abiding by Local Rules: A Magistrate's Perspective
• A View from the Bench: The Judges Speak
• Exploring New Developments in Double-Patenting Type Obviousness and Federal Circuit and PTO Discord on Obviousness
• Experts, Problems of Proof, Dispositive Motions and Markman Hearings: Addressing Common Dilemmas Encountered in a Paragraph IV Trial
• Understanding How the Supreme Court's Decision in Limelight v. Akamai Will Impact ANDA Litigation Involving Method of Treatment Patents
• FTC Keynote: Reverse Payment Settlements and Other Antitrust Concerns Impacting Paragraph IV Litigation in the Wake of Actavis
• The Ever Shifting Boundaries of the Safe Harbor: Determining the Scope of 271(e)(1) Protections Relative to Paragraph IV Litigation After Classen and Momenta
• New Exclusivity Challenges for Brand Names and Generics: Exploring Their Implications for Paragraph IV Challenges
• The Uncertain Future of At-Risk Launches: A Study of Injunctive Relief, Damages, and the Impact of the Protonix Case
• Ethical Considerations for Paragraph IV Matters Before the PTO and District Courts

ACI is also offering two pre-conference workshops on Monday, September 29:  "PTO Procedures Practice Boot Camp for Paragraph IV Litigators" and "A Judge's Perspective on Effectively and Ethically Communicating with the Court in Paragraph IV Matters," which will feature four former federal judges.

Mention discount code OBB200 to save $200 on registration.  For more information, please visit the conference website.

ACI "Women Leaders in Life Sciences Law" Conference, Boston, MA, July 28-29

We are proud that McAndrews Shareholder Nabeela Rasheed will be one of the featured speakers at American Conference Institute's inaugural "Women Leaders in Life Sciences Law" conference in Boston, July 28-29.  Dr. Rasheed will be speaking on "Thinking Like a Leader: Updates on the Substantive Legal Developments Affecting Life Sciences Companies in 2014 and Beyond."

The conference will also include these presentations:

• "Breaking Through the Glass Ceiling: Increasing the Prominence of Women in Leadership Positions in Life Sciences Law"
• "Being a Successful GC--How to Keep All the Balls in the Air Without Losing Your Mind"
• "Owning It: Recognizing the Distinct Communication Styles Between Women and Men and Cultivating the Traits That Stand Out in a Leader"
• "Spotlight on Women Power Players Shaping the Future of Life Sciences Law in the Government"
• "I Don't Know How She Does It: How Women Leaders in the Increasingly Demanding Life Sciences Legal Space Can Make the Most Out of Both Life and Career"
• "Interactive Open Floor Discussion on the Challenges and Opportunities Facing Women in Life Sciences Law"

In addition, ACI will be hosting two post-conference working groups on July 29: "I Wish Someone Had Told Me: Advice from Life Sciences General Counsel on Embracing Influence and Power and Running a Successful Legal Department" and "Combating Gender Sterotypes in the Life Sciences Legal Community: Open Forum and Working Group on Overcoming Implicit Bias."

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

Meet Us at BIO 2014 in San Diego!

A group of twelve attorneys from McAndrews, Held & Malloy will be attending BIO 2014 in San Diego this week, and we're hosting a cocktail reception on Tuesday night.  Please join us if you'll be attending BIO!

 

 

ACI "Legal and Regulatory Summit on Generic Drugs," New York City, July 24-25

American Conference Institute will be holding its 2nd annual "Legal and Regulatory Summit on Generic Drugs" in New York on July 24-25.  The conference promises to present "comprehensive strategies for the generic pharmaceutical industry's present and future challenges."

Here is the complete agenda:

• Unearthing Changes at the Office of Generic Drugs and Understanding Their Impact on the Future Growth and Evolution of the Generic Drug Industry
• Deciphering GDUFA and Its Impact on ANDA Approvals, Profit Margins, and Performance Metrics
• Demystifying the FDA's Rulemaking Authority: Exploring How FDA's Proposed Labeling Rule and Other Proposed Rules and Guidances Will Affect the Dynamics of the Generic Pharmaceutical Industry
• The Changing Paradigm of the Generic Drug Market Entry: Assessing Brand Name Drug Vulnerabilities and New Targets for Generic Drug Manufacturers
• Operating in the Post-Bartlett Landscape in Light of New Decisions and FDA Rulemaking
• The Case for Generic Drug Quality: Understanding How Quality Initiatives in Congress and FDA, and DOJ Enforcement Activity Have Impacted the Generic Drug Industry
• Mitigating the Effects of New Stability Data Requirements to Ensure the Integrity of Generic Drugs
• Exploring Strategies for Biosimilar Development in the United States: Regulatory, IP & Commercial Considerations Gleaned from the Global Framework
• Exploring New Developments and Related Tactics in Hatch-Waxman Litigation That Are Impacting the Strategies of Generic Drug Manufacturers
• Developing Settlement and Negotiation Methods Post-Actavis to Minimize Chances of Costly Government Enforcement Actions
• View from the Bench: The Judges Speak on Major Developments Affecting the Generic Drug Industry
• Comprehending How Mergers and Acquisition Activity and Collaborative Partnerships Are Impacting and Changing the Dynamics of the Generic Pharmaceutical Industry
• Examining Provisions of the Affordable Care Act Impacting Generic Drug Pricing and Reimbursement

ACI is also offering two pre-conference workshops on July 23: "Understanding and Working with the FDA's Office of Generic Drugs: Jurisdiction, Organization, and Operations" and "OGD Roundtable: Gaining Priceless Insights on the Inner Workings of the FDA's OGD from Former OGD Officials."

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

ACI "Biosimilars" Conference, New York, June 5-6

American Conference Institute is holding their 5th annual "Biosimilars" conference in New York on June 5-6.  Speakers include in-house counsel from Eli Lilly, Mylan, Sandoz, Amgen, AbbVie, Momenta, J&J, and Actavis.  Also speaking will be representatives of the Federal Trade Commission, GPhA, and PhRMA.

The agenda includes the following presentations:

• Minimizing the Uncertainty Surrounding the Untested Pathway: Insight Into FDA's Current Position and Initiatives Regarding Biosimilars
• Predicting Follow-On Entry and Evaluating the Risk and Commercial Opportunity in the Emerging Biosimilar Landscape
• New Kid No More: Evolution in Biosimilars Science and Regulations
• The Holy Grail for Biosimilars: Meeting FDA's Requirements for Biosimilarity and the Heightened Standard of Interchangeability
• FTC Keynote: Revisiting Competition Issues in the Follow-On Biologics Arena: Substitution and Naming Conventions
• The Importance of Biologic Manufacturer Accountability: Key Policies for Biologic Substitution and Nonproprietary Names
• Industry Round Table: Weighing in on the Emerging Controversy on Biosimilars Naming and State Substitution Laws
• The EU Experience: Regulatory and IP Lessons Learned So Far from the First Biosimilar Antibody Approval in Europe
• Analyzing the Arguments in the First BPCIA Case, Sandoz v. Amgen: Immediate Action Plans for Innovators and Biosimilars to Prepare Before the First Application is Public
• The Most Powerful Tool in Your Arsenal: Using Inter-Partes Reveiw at the PTO to Revamp Branded and Biosimilar Litigation Strategies
• Going Beyond the Hatch-Waxman Comparisons: Delving into Pre-Suit Due Diligence and Pre-Litigation Tactics for Evaluating Patent Strength and Assertion Strategies
• Platform Patents and Antibodies: Specific Action Plans to Protect or Defend Patents Most Ripe for a Biosimilars First Wave Challenge
• Key IP Case Law Through the Biosimilars Lens: Top 5 Patent Battles to Consider When Updating Your Biosimilars Prosecution and Litigation Strategies
• Case Spotlight: Momenta v. Amphastar and Bioequivalence: Understanding the Implications for the Future of Biosimilars
• Timing is Everything: Managing the Logistics of the BPCIA Exchange Process and Preparing for "Early" and "Late" Phase Litigation
• Ethics in the Biosimilars Realm: Avoiding Conflicts and Maintaining Confidentiality in the Brave New World

ACI is also offering a pre-conference primer on June 4 that includes two sessions:  "Biosimilars 101: Comprehensive Deep Dive Into the Relevant Legal, Regulatory, and Scientific Factors Companies Must Now" in the morning and "Biosimilars Around the World: A Regulatory and Patent Cheat Sheet to Maximize Global Biosimilars Market Share and Minimize Risk" in the afternoon.

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

ACI "Paragraph IV Disputes" Conference, New York, April 28-28

American Conference Institute will be holding their 8th annual "Paragraph IV Disputes" conference on April 28-29 in New York.  Highlights of the conference include a district court judges panel, a magistrate judges panel, and an FTC keynote address.  Here is the complete agenda:

• On the 30th Anniversary of the Drug Price Competition and Patent Term Restoration Act: Understanding Hatch-Waxman's Transformative Impact on the Pharmaceutical Industry
• Assessing Pharmaceutical Patent Sustainability and Vulnerability: Strategies and Considerations for Brand Names and Generics in Anticipating, Identifying and Determining Which Patents Will be Ripe for Challenges of Invalidity and Non-Infringement
• Use of IPR and Other PTO Proceedings in a Paragraph IV Challenge: Strategies for Brand Names and Generics in Navigating PTO Proceedings in ANDA Litigation
• The Gauntlet Rethrown: The Paragraph IV Certification and Notice Letter
• Of Prior Art and Double Patenting: Exploring the Dichotomy Between the Federal Circuit and PTO on Obviousness Findings and Potential Impact of the Goodlatte Bill on Obviousness-Type Double Patenting
• Let the Games Begin: Advanced Strategies for Drafting and Perfecting Pleadings and Effectively Using Dispositive Motions in Paragraph IV Disputes
• Working With Local Counsel and Within Local Rules: Magistrate and Local Counsel Roundtable
• A View From the Bench: District Court Judges Panel
• Claim Construction and Markman Hearings: Standards, Jurisprudential Splits and Strategies for Paragraph IV Litigation
• FTC Keynote: Reverse Payment Settlements and Other Antitrust Concerns Impacting Paragraph IV Litigation in the Wake of Actavis
• Perils of the Safe Harbor: Understanding How the Resetting of the Boundaries of 271(e)(1) in the Aftermath of Classen and Momenta is Impacting Paragraph IV Litigation Strategies
• In the Limelight: Strategies and Theories of Inducement, Contributory, and Divided Infringement in Paragraph IV Litigation Concerning Method of Treatment Patents
• Assessing GDUFA Implementation and Additional Regulatory Developments of FDA Which Impact Paragraph IV Litigation
• Looking Beyond 180 Days: New Exclusivity Challenges for Brand Names and Generics and Related Implications for Paragraph IV Challenges
• A Pros and Cons Analysis of Launching At Risk and Survey of New Developments in Seeking Injunctive Relief and Damages
• Ethical Considerations for Paragraph IV Matters Before the PTO and District Courts: Inequitable Conduct and More

In addition to the main conference, ACI is offering a post-conference workshop on pharmaceutical patent settlements.

Orange Book Blog readers can receive discounted registration with code OBB200.  For more information or to register, please visit the conference website.

Bloomberg BNA "AIA Post-Grant Patent Practice Conference," Arlington, VA, February 19-20

Bloomberg BNA's upcoming "AIA Post-Grant Patent Practice Conference" presents a unique opportunity to hear from present and former PTAB judges--as well as keynote speakers Hon. Pauline Newman and Hon. Randall Rader.  This two-day conference is based on the Bloomberg BNA treatise Post-Grant Patent Practice, which was authored by four former Administrative Patent Judges and which will be distributed to each conference attendee as part of the materials.

The first day of the conference will provide an overview of the statutory and regulatory basis for post-grant practice and will discuss how post-grant practice has evolved over its first year.  The second day will feature mock demonstrations of the various hearings that occur during post-grant trials, including inter partes review, post-grant review, and covered business method patent review.  These demonstrations will feature prominent attorneys who have significant experience before the Patent Trial and Appeal Board.

Here's the complete agenda:

Day One:  The Law Governing Post-Grant Practice, Including the Fresenius USA v. Baxter Int'l case, and Real-World Experience Practicing Before the PTAB

• The Fundamentals of Post-AIA Post-Grant Patent Procedures--a panel discussion that includes McAndrews shareholder Herbert D. Hart III
• Luncheon Address by the Honorable Pauline Newman, Circuit Judge, Federal Circuit
• Inter Partes and Post-Grant Reviews (including CBM Patent Reviews)
• Derivation and Interference Procedures
• Fresenius USA v. Baxter Int'l and its Impact on Post-Grant Practice

Day Two:  Mock Hearings/Conferences with APJs and Insights from Lawyers "In the Trenches"

• Motions Based on Estoppel/Privity and Mock Conference
• Motions for Joinder and Mock Conference
• Discovery Motions and Mock Conference
• Luncheon Address by the Honorable Randall Rader, Chief Judge, Federal Circuit
• Motions to Amend Claims and Mock Hearing on Amendment
• Final Briefing and Mock Final Hearing

An advance registration discount is available until Friday, January 31 with the code EARLYBIRD.  For more information or to register, please visit the conference website.

CPhI "Pharma IPR India 2014" Conference, Mumbai, India, February 26-28

CPhI will be presenting its 3rd annual "Pharma IPR India" conference in Mumbai on February 26-28.  The conference features speakers from more than a dozen different countries across the world.  The complete agenda is as follows:

Day 1: USA, Canada, and Mexico

• Analysing the scope and implications of Inter Partes Review (IPR) in the United States after one year
• Evaluating reverse payment settlement cases and decisions after Actavis
• Determining patent eligibility for a US patent and ascertaining ways to use attorney fees/cost shifting for the benefit of pharmaceutical companies
• Formulating the best litigation strategies in the US to optimise costs for pharma and biopharma companies
• Biosimilars status in the USA
• Evaluating the current regime ofthe Canadian Patent Act
• Mapping the current patent regime and patent linkage by tracking recent patent infringement cases in Mexico

Day 2: Europe, South Africa, Brazil, GCC countries, and Australia/New Zealand

• Overview of current implementation of the Unitary Patent System in Europe, including its coming into force, structure, competence, language, and particularities
• Ascertaining data exclusivity in Europe and understanding implications of SPCs on pharma companies
• Formulating strategies to introduce generic products in the European market if there are unavoidable patents not yet invalidated
• Understanding application of the Doctrine of Equivalents in European patent cases
• Understanding recent changes in patent legislature in South Africa and analysing current IP infrastructure
• Understanding the scope of patent law in Brazil and determining reforms therein impacting pharma and biopharma companies
• Examining patent regimes in GCC countries and basic laws of the market and guidance on how to develop a product for these markets
• Defining devised changes affecting patentability in Australia/New Zealand by updating recent trends to standards of applications and litigation in the industry

Day 3: India, South Korea, Taiwan, China, and Japan

• Determining the current position of post-grant oppositions filed by pharmaceutical companies in India
• Determining grounds for invoking compulsory licenses in India, to determine new growth strategies for generic and multi-national companies
• Understanding patent law and the IP regime in South Korea as they apply to pharmaceuticals
• Highlighting amendments related to the dual invention/utility model system in Taiwan, and enforcement of patent rights and damages under the Taiwan Patent Act of 2013
• Understanding the revised version of "Measures for Compulsory Licensing for Patent Implementation" that came into effect in the Chinese patent law
• Understanding techno-legal aspects involved in the patent system of Japan to facilitate breaking the barriers for the entry of generic companies

The early bird discounted registration rate for the conference is still available, but only until January 31st.  For more information or to register, please visit the conference website.

ACI "Patent Reform" Conference, New York City, January 22-23

ACI is holding its 3rd annual "Patent Reform" conference in New York City next month, on January 22-23.  This is the "critical industry forum on the Leahy-Smith America Invents Act."

The conference includes the following presentations:

• USPTO Keynote Address I: The USPTO's Efforts to Implement AIA Provisions Impacting Patent Prosecution
• Straddling the First-to-Invent/First-to-File Gap: Changing Company Protocols, Cautiously Approaching Amendments, and Strategies for Promoting Likelihood of Issuance
• Through the AIA Prior Art Looking Glass--Understanding the Global Wonderland of Prior Art, and Utilizing Preissuance Submissions, Suppleental Examination, Ex parte Reexamination, and Reissue
• USPTO Keynote Address II: Detailing How the New Post-Grant Opposition Procedures Have Impacted Patenting, and Updating on the Implementation of the Post-Grant Review Proceedings
• Innovative Practice Resources for Meeting with Success During Inter Partes Review
• Red Skies on the Horizon--Tracking Developments of Covered Business Method Proceedings and Preparing for the Era of the Post-Grant Review
• Examining the Impact of Patent Reform on Hatch-Waxman Litigation and the Brand/Generic Wars
• Interactive Open Floor Discussion on Proposed Legislation on Non-Practicing Entities
• The Showdown Over Diagnostic Methods--Obtaining Patent Protection from the PTO Under the AIA Despite the Supreme Court's Nebulous View of a "Product of Nature"

In addition, a pre-conference workshop is offered in the morning on January 22, "Patent Reform 101: A Primer on the Fundamental Provisions of the America Invents Act."  And a post-conference workshop is offered in the morning on January 24, "Interactive Working Group Session: A Hypothetical Invention Being Patented Under the AIA."

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