Jornadas de estudio y actualización en materia de patentes «Los lunes de patentes»

10:00 - 13:00. Pharmaceutical patent strategies and generic entry in Asia: Litigation, exclusivity and market access across Korea, Taiwan, China, Japan and ASEAN (Association of Southeast Asian Nations)

PONENTES: Javier Torrejón y Arianna Bartolini

This session will explore pharmaceutical IP and generic entry strategies across key Asian markets, with a particular focus on Taiwan, South Korea, Singapore, Thailand, Vietnam and the Philippines, together with selected references to China and Japan.

From a pharmaceutical industry perspective, the session will analyse how different Asian IP and regulatory systems influence generic launches, exclusivity periods, litigation strategies, lifecycle management and biosimilar competition. The discussion will focus on the practical interaction between patents, regulatory frameworks, and commercial decision-making, rather than on purely legal doctrine.

Topics to be discussed include patent linkage systems, data exclusivity, Bolar exemptions, patent term extensions, manufacturing-for-export waivers, launch-at-risk strategies, first generic exclusivity opportunities, secondary patent protection and biosimilar IP considerations. The session will also review how differences in enforcement, litigation timelines, and regulatory practices across Asian jurisdictions can affect launch timing and market access strategies for both innovative and generic pharmaceutical companies. Particular emphasis will be placed on:

• differences between linkage-driven and access-driven markets
• practical enforcement realities in Asia
• secondary patent vulnerability in ASEAN countries
• litigation and invalidation strategies
• regulatory exclusivity mechanisms
• the strategic implications of local market dynamics for pharmaceutical companies operating in the region.

The session will include practical frameworks and selected case studies involving pharmaceutical patent disputes, generic entry strategies and biosimilar competition in Asian markets, illustrating how companies approach exclusivity protection and market entry under different regional systems. The objective of the session is to provide a practical overview of the current pharmaceutical IP landscape in Asia and its impact on pharmaceutical development, lifecycle management and generic or biosimilar launch strategies.

(The presentation will be given in either Spanish or English, with materials in English) 

15:00 - 16:50. Stardard essential patents (SEPs) and FRAND: Legal foundations, market dynamics and global challenges

PONENTE: Alessandro Orsi

1.Why SEPs and FRAND matter

- Why standards matter in modern technology ecosystems
          Interoperability, scale, network effects
          Examples: telecoms, Wi-Fi, video codecs, IoT, automotive
- Why IP lawyers must care about SEPs
          SEPs sit at the intersection of patent law, competition law, contract law and policy
- What makes SEPs different from "ordinary" patents
          Market power created by standardisation
          Inability to "design around" once a standard is adopted

2. What is a standard? What is a SEP?

2.1 Standards and standard-setting

- What a technical standard is
- Role of standard development organisations (SDOs)
           ETSI, ITU-T, IEEE, ANSI (high-level)
- Voluntary vs de facto standards

2.2 Standard essential patents

- Definition of a standard essential patent
- "Essentiality": technical and legal meaning
- Self-declaration of essentiality (and its limits)
- Over-declaration and under-declaration risks

3. Why FRAND exists: The grand bargain

- The core tension:
         Innovators need returns on R&D
         Implementers need access to standards
- The FRAND commitment:
         Fair
         Reasonable
         Non‑Discriminatory
- FRAND as a private-law commitment with public-law implications
- FRAND’s dual role:
         Enabling widespread adoption of standards
         Preventing abuse of standard-conferred market power

4. Anatomy of FRAND: What do the terms mean in practice?

4.1 "Fair" and "Reasonable"

- Ex ante vs ex post valuation
- Incremental value vs standard value
- Royalty base debates (SSPPU vs end‑product)
- Portfolio licensing logic

4.2 "Non-Discriminatory"

- What ND does not mean (identical prices for all)
- Comparable licenses and objective justification
- Volume, geography, cross-licenses

4.3 Procedural FRAND

- Good-faith negotiation
- Information exchange
- Timing, offers, counteroffers

5. Enforcement and remedies: The injunction debate

- Can a SEP holder seek an injunction?
- Hold-up vs hold-out narratives
- Competition law overlay
- Balancing patent exclusivity and access to standards

6. The global FRAND landscape: Key jurisdictions

6.1 Europe

- CJEU framework (Huawei v ZTE)
- Emphasis on negotiation conduct
- Emerging role of the UPC
- Ongoing EU policy and regulatory initiatives

6.2 United Kingdom

- Courts setting global FRAND rates
- Willingness to enjoin implementers refusing global licenses
- Strong procedural focus and economic analysis

6.3 United States

- FRAND largely framed through contract and antitrust law
- Injunction scepticism
- Jury trials and damages focus

6.4 China

- Anti-suit injunctions
- Increasing role in global FRAND disputes
- State interests and industrial policy considerations

7. Current challenges and open questions

- Fragmentation vs globalisation of FRAND adjudication
- Parallel litigation and forum shopping
- Transparency and predictability of licensing
- SEP licensing in new verticals (automotive, IoT, Industry 4.0)
- The role of regulators vs courts vs SDOs

(The presentation will be given mostly in Spanish, with materials in English)

17:10 - 18:00. El informe pericial en litigios de patentes: la perspectiva judicial

PONENTE: Florencio Molina López

La ponencia abordará, desde una perspectiva eminentemente práctica y judicial, cuáles son los elementos que aportan auténtico valor probatorio a un informe pericial en litigios de patentes. Se analizarán las principales fortalezas y debilidades que suelen apreciarse en la práctica forense y la importancia de la claridad expositiva y de la solidez metodológica. También se explicará la forma en la que los tribunales valoran cuestiones como la interpretación de reivindicaciones, la infracción, la actividad inventiva, los experimentos técnicos o la credibilidad e independencia del experto. Asimismo, se ofrecerán algunas reflexiones sobre la evolución reciente de la litigación de patentes y el creciente grado de sofisticación procesal y técnica de este tipo de procedimientos. En particular, se tratarán los siguientes aspectos:

• Función y centralidad de la prueba pericial en el litigio de patentes
• El juez como destinatario real del informe pericial: qué espera encontrar y qué no
• Claridad, estructura y pedagogía técnica del informe
• La correcta delimitación del conocimiento general común y del experto en la materia
• La interpretación de las reivindicaciones y su aplicación al análisis pericial
• El análisis de infracción: errores frecuentes y aspectos especialmente relevantes
• La actividad inventiva: construcción del razonamiento técnico y principales debilidades observadas en la práctica
• Experimentos, ensayos comparativos y documentación técnica
• Coordinación entre informe escrito, documentación técnica y declaración oral en juicio
• Independencia, objetividad y credibilidad del perito
• Interrogatorio y contrainterrogatorio del perito en la sala
• Qué convierte un informe técnicamente correcto en un informe judicialmente convincente
• Tendencias actuales y creciente sofisticación procesal y técnica de los litigios de patentes