The Intellectual Property (IP) landscape in China as it relates to the pharmaceutical industry is undergoing dramatic changes. Along with the changes come challenges and opportunities. On the one hand, this y ear has witnessed an emerging trend of regulatory approvals of generic drug applications while the underlying patents protecting the active pharmaceutical ingredients (APIs) are still in force. This trend, coupled with the high rate of invalidating pharmaceutical patents and limited judicial remedies, presents new challenges to the innovative pharmaceutical companies. On the other hand, a more refined IP system is widely anticipated that promotes pharmaceutical innovation and balances varied industrial and public interests. It remains uncertain, as well as fascinating, to what extent such a system should or will ultimately be shaped, if at all, by certain time-proved components, notably patent linkage, patent term extension (P TE) and regulatory data protection (RDP). Furthermore, the rise of the Chinese pharmaceutical industry as whole, with increased international reach and R&D capabilities, represents a new, game-changing reality that international companies operating in China must respond to. How pharmaceutical companies choose to navigate the rapidly evolving IP landscape, manage the challenges and leverages the opportunities may eventually determine their survival or success in China.

With the development of China's economy in recent years, the patent applications in the biotechnology field have shown a significant growth trend, and biological sequences are one of the important parts, involving DNA sequences, RNA sequences, protein sequences (including antibodies, enzymes, etc.). Correspondingly, disputes in the biotechnology field have gradually become heated. In particular, the expiration of major pharmaceutical variants of foreign original pharmaceutical companies such as “Humira” will usher in a flash point of relevant surrounding patents invalidation and litigation. Therefore, the patent protection in the biotechnology field will increasingly become a concern. This keynote speech will combine five invalid cases of the “ glucoamylase” series represented by the speaker (one of which is the 2018 Patent Reexamination Board 's top ten cases), to discuss some of the hot issues in patent protection for biological sequences, such as supportive and creative issues.

In the context of China's biomedical inno vation, intellectual property protection is a top priority. Among them, the compound patents are the basis of pharmaceutical patent pr otection, but the eff ectiveness of pharmaceutical compound patents are often challenged in practice. How to grasp the inventiveness of pharmaceutical compound in ventions, including the Markush claims and specific compound claims, is of paramount importance. The rules f or inventiveness judgment of pharmaceutical compound in ventions are being formed in patent in validation and administrative litigation cases. The panel discussion will discuss v arious aspects of pharmaceutical compound patents in conjunction with specific cases, such as the thr ee-step approach and unintended technical effects considerations, technical effects and technical issues identifications, whether changes to the existing Markush-style ring structure and fixed parts are obvious, whether jumping out of the definition scopes of the existing Markush-type variables will mean that it is ob vious, the identification of supplementary experimental data in diff erent stages of the trial, and so on.

• Patenting in US
• Introduction of US Post-Grant Review (IPR,PGR,CBM,EPR) and Latest Developments
• Rules and Principles in IPR Procedures
• IPR Cases Study

• The LoE date • Factors that can increase term: PTA and PTE • Factors that can reduce term: obviousness-type double patenting and terminal disclaimers • Interplay with FDA regulatory exclusivities • Assessing LoE in a complex pharmaceutical patent portfolio

• Developing Your IP Portfolio to Maximize Value
• U.S. Specific Issues – Don’t let them trip you up!
• Ownership and Inventorship
• CROs, Foreign filing licenses, and the On-Sale Bar
• Partnering and Due Diligence – Best Practices

• Why – if at all – is Brexit a problem for the UPC/UPS.
• Determining whether the UK can still participate in the UPC after its exit from EU?
• How does this affect pharma companies seeking patent protection in the U.K?
• How will this impact patent prosecution strategies for pharmaceutical companies looking to obtain Unitary Patents?
• How are we targeting the new Courts – how will Bayer use it?
• Why is Bayer in favour of the new system?

• The potential impact of Brexit on SPCs
• Regulatory data protection rules in the UK

• Developing a systematic approach to successful patent Licensing
• Portfolio evaluation & management.
• How do you value IP?
• Enforcement & monetization
• Creating a strategic licensing plan

• PD-1/PD-L1 patent landscape in the U.S., Europe and China – what are the main freedom-to-operate risks?
• Challenges of obtaining global patent protection over antibody inventions – what are the common issues?
• Enhancing the value of antibody inventions – what are the successful claim strategies in different jurisdictions?
• Life cycle management of therapeutic antibody products – how to protect later arising inventions?

• Regulatory pathways for biosimilars in China,EU and US
• Regulatory data exclusivity – will it be available for biologics and would it matter?
• Biosimilars vs. me-toos and biobetters – what is the trend?
• What is the future of a crowded market for me-toos – is there enough space for biosimilars?
• Domestic and global players – (when) will global biosimilar players enter China?
• Will domestic me-too/biosimilars players go global? and Competitive advantage of domestic biosimilars

• Introduction of Japanese patent examination guidelines on medical field, focused on “patent subject matter eligibility of medical invention” and “novelty and inventive step of medical invention” with case examples.
• Patent term extension system in Japan
• Recent IP issues in JPO

How Indian pharm industry evolved, refined strategy and re-oriented business model to embrace new challenges and stay ahead of the game.

• Tips for obtaining a pharmaceutical patent in Korea
• Patent term extension in Korea since 1987
• Patent-approval linkage system in Korea since 2015
• Recent key decisions rendered by the Korean Supreme Court

• Preparations prior to beginning litigation.
• Assembling a team both in house and outside counsel - key considerations and best practices.
• Best practices for managing outside counsel teams - the in-house perspective.
• Coordination of IP litigation with the business - Strategies for collaboration of business and legal teams.
• Global strategies for managing worldwide patent disputes - best practices for developing and executing a unified strategy.

• Status of patent applications of Traditional Chinese Medicine
• The problem of low quality of patent application documents
• Novelty,Inventiveness and Practical applicability issues
• Studies from invalidation cases
• Practical advises for patent applicant