Biosimilars and Originator Biologics

Registration and Breakfast

Opening Remarks from the Conference Co-Chairs

The Unitary Patent and the Unified Patent Court: A Guide to Ratification, Implementation, and Strategies for Biosimilars and Originator Biologics

The Unitary Patent and the Unitary Patent Court were designed to achieve a simpler, cost-effective means of protecting and enforcing patents in Europe. While it is certain that the UPC’s decisions will have pan-European effect, it is less clear how the UPC could impact biosimilar medicines. This session will analyze the changes under the UPC and UP and provide attendees with a handbook for the future. Topics of discussion will include:

• Considering the costs and benefits of the system for biologic patent applications
• Weighing the decision to opt out
• Monitoring competitor patents toward launching UPC revocation actions
• Strategically using divisional applications during the transition period
• Understanding the territorial scope of protection and the role protocols play in the biologics space
• Predicting the impact to litigation and legal certainty
• Detailing the non-exclusive jurisdiction for all national validations of European patents and biologics patents in particular

THE INTERNATIONAREGULATORY THINK TANK

Part I: Anticipating the Impact of EU Regulatory Change on Life Sciences Companies

Recent and ongoing European regulatory changes will affect every originator and biosimilar company that currently sells or sponsors products in the European Union and the UK. The regulatory landscape is transforming so rapidly that that companies must track and monitor these developments or risk the license-to-operate.

While timelines continue to waver, manufacturers, distributors, providers, and counsel must consider the implications of these regulations and take a proactive approach to dealing with regulatory change.

Topics of discussion will help you:

• Understand legislative reforms that will impact biosimilar regulation within Europe
• Learn how companies can adapt their processes and systems to these new systems in order to comply
• Appreciate which innovative process and technology solutions can help you achieve readiness success

Morning Networking Break

Part II: Comparing Global Biosimilar Regulation, the EMA, FDA and Their Approval Processes

There are fundamental differences in both the regulatory processes and the market dynamics of the U.S. and the EU that account for much of the discrepancy in the uptake of biosimilars.
As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U.S. and European markets in the coming years.

This session will dissect the BPCIA, compare it with the European approach, and consider near and medium scenarios for biosimilars in the United States.

Topics of discussion will include:

• Exploring the basics of the BPCIA
• Comparing the European and American approaches
• Considering near and medium scenarios for biosimilars in the United States

European Supplementary Protection Certificates: What Every Regulatory and IP Attorney Needs to Know About the Evolving Framework Governing SPCs

The introduction of the SPC manufacturing waiver which went into effect on 2 July 2022 addressed a significant disadvantage that European producers of biosimilars had compared to non- European rivals. Under the new system, the UPC will have jurisdiction over SPCs unless the opt-out provision is invoked or if they originate from an already opted out European patent. This session will detail the rights conferred by the SPC.

Topics of discussion will include:

• Whether an SPC under the current national SPC laws can be based on a unitary patent
• Outlining the implications of the rules of origin on the biopharmaceutical industry
• Detailing the scope, relevant marketing authorization, and which patents can be used to obtain an SPC
• Considering areas where clarification from CJEU may still be required
• Preparing for the EU Commission’s prospect of introducing a unitary SPC

Medical Uses of Known Biological Products and Drug Repurposing: Reconciling Infringement and Enforcement

As originators become more active in the business of biosimilars, and biosimilar manufacturers have entered the arena of creating their own new biologics, the importance of second medical uses for individual companies as well as the global industry is of growing importance.

Topics of discussion will include:

• Understanding second medical use patents & carve out strategies
  • Clarifying the patentability of further medical use inventions
• Whether eliminating an indication claimed by a second medical use patent from the product label does or does not alone save the generic from a finding of infringement and a consequent injunction
• Assessing the implications of second use patents for:
  • Regulatory
  • Market Access
  • Legal
• Outlining the implications
• What form can second medical use claims take?
• What must be established for a second medical use patent to be infringed?
• How do you enforce a second medical use patent?
• Can you prevent off-label use?

Networking Luncheon

Plausibility, Sufficiency, and Inventive Step: Deliberations for Formulation and Combination Patents

Plausibility in the context of the inventive step and sufficiency requirements can be a contentious issue. To discern whether an invention is purely speculative, the Boards of Appeal of the EPO developed the doctrine of plausibility in the context of sufficiency of disclosure as well as inventive step.

As we await the Board of Appeal to issue the written decision, this session will consider in what situations post-published evidence can be considered to support the effect of the invention.

Topics of discussion will include:

• Understanding in what situations post-published evidence can be considered to support the effect of the invention
• Overcoming the key challenges and hurdles currently being faced in obtaining formulation, combination and second medical use patents in Europe (as related to showing plausibility, sufficiency and inventive step)
• Incorporating the latest EPO and national case law into your strategies for procuring, maintaining and enforcing these types of patents
• Striking the balance between securing an early filing date and overcoming the plausibility hurdle

Proportionality, Preliminary Injunctions & Damages: The Ability to Deny, Grant or Tailor Injunctive Relief

• Considering the Boards of Appeal’s decision in Amgen v. Sanofi, how great an influence is potential invalidity when it comes to a preliminary injunction application?
• Assessing when may preliminary injunctions be denied, regardless of if a patent is valid or infringed upon
• How important is the role of an infringement assessment in preliminary proceedings?
• Analyzing Article 3(2) of the IP Enforcement Directive 2004/48
  

Alternative Dispute Resolution: The Shift from Ordinary Proceedings Towards ADR

• Understanding how BoA and the EUIPO helps with ADR
• ADRs in the EUIPO Boards of Appeal
• Assisted Negotiation and Expert Determination
• Effective Dispute Resolution (EDR)
• Co-mediation mechanisms
• ADR Cooperation Initiatives
• Detailing why parties should consider using EUIPO ADR mechanisms
• Combining parallel disputes at national and international levels into one resolution
• Avoiding complex litigation proceedings
• Achieving quicker, more efficient outcomes in a cost-effective way

Day One Adjourns

Co-Chair’s Recap of Day One and Opening Remarks

THE IMPACT OF BIOSIMILAR COMPETITION IN EUROPE

Special Keynote: Tracking Changes in Competition Law

Balancing Innovation and Competition: Patent Thickets, Continued Litigation, and New Economic Considerations for Settlements

This session will consider the economic implications of biosimilar reverse payment litigation globally, the competitive effects, and economic damages.

Topics of discussion will include:

• Understanding settlement strategies between innovator biologic companies and biosimilar applicants
• Whether developing a patent thicket is an antitrust violation
  • UFCW Local 1500 Welfare Fund v. AbbVie Inc. (7th Cir. Dec. 28, 2020)
    • Reviewing what is deemed anti-competitive activities
• Whether you need to prove that all the patents in the thicket around a drug are invalid
• Highlighting the state legislation directly addressing reverse payment patent settlements
  • When biologic manufacturers should expect antitrust scrutiny
• Reviewing the proper standards of antitrust review and the rising call for a legislative response
  • Analyzing the current legislative and regulatory framework
  • Mergers, acquisitions and exclusive licenses
  • Anticompetitive agreements
  • Abuse of dominance
  • Life cycle management and contracting
  • Pricing strategies
• Avoiding costly litigation and associated penalties by effectively complying with the law

Morning Networking Break

COMMERCIAL STRATEGIES FOR THE ORIGINATOR AND BIOSIMILARS MARKETPLACE

The Economics of Biosimilars: Improving Market Access and Sustainable Pricing Across Europe

• Evaluating the clinical pipeline by company, indication and phase
  • Analyzing the market share for biosimilars in various regions
  • Target drugs with highest spending
  • Current market dynamics and considerations for biosimilar adoption
  • Comparing the European Union biosimilar experience
• Considering the implications of insurers placing biosimilars on “primary tiers” and what that means for the future
• Incentivizing providers to adopt biosimilars

Networking Luncheon

GLOBAL STRATEGIES: From Patent Protection to Cost and Market Access in The U.S., the EU, and Asia

Our panelists of global thought leaders will contemplate where the EU fits in the global biosimilars
marketplace.

• Assessing regulatory and legislative developments impacting the biopharmaceutical industries in each region
• Understanding the economics and market influences
  • Considerations for market access, sustainable pricing and reimbursement policies
  • Market uptake of biosimilar products
  • Biosimilar v. biosimilar litigation in a crowded market

The Business of Biologics: Calling Attention to Products Coming Off-Patent and Devising Forward-Thinking Portfolio Strategies for Maximizing Global Success

• Identifying approved and marketed biologics coming off patent while looking ahead and considering clinical insights, pricing and dosages
• Predicting what problems future competitors may run into with respect to their IP profiles
• Forecasting which segments or regions will drive market growth
• Reviewing key sustainability tactics adopted by leading market players
• Evaluating the impact of off-patent drugs on competition and growth strategies
• Developing techniques for an accurate assessment of the current value of your portfolio while

Artificial Intelligence, Data and Drug Development: Accelerating Biopharmaceutical Discovery and Development

• Understanding how AI and data mining can accelerate drug discovery and development
• Analyzing the extent to which data might be mined from previous clinical trials toward finding new uses for known drugs
• Taking stock of the role of artificial intelligence in this process
• Preparing for the challenges that exist for patents

Conference Concludes