Pharma Symposium- 2025

AI is revolutionising drug discovery, while the pharmaceutical sector braces for a patent cliff from 2025 to 2030, when several blockbuster drugs will lose exclusivity. In this context, patents are not just protective tools but strategic assets. A deep understanding of the patent lifecycle and legal framework is essential for innovation and long-term growth.

The emergence of biosimilars raises urgent questions for innovators: how to protect biologics, navigate biosimilar entry, and manage litigation effectively. The “patent dance,” FTO assessments, and the impact of these on cost and market access must now be central to every IP strategy.

PHARMA SYMPOSIUM 2025 Timely updates on the Hatch-Waxman Act and recent case laws are also crucial to staying compliant and competitive. These developments directly affect regulatory pathways and the ability to defend or challenge exclusivity. This two-day symposium gathers global experts to discuss the latest in patent protection, litigation trends, and the role of AI in shaping IP strategy.

With focused sessions for R&D professionals, legal teams, and business leaders, it aims to enable smarter, future-ready IP decisions. The Symposium would also offer strong networking opportunities for the attendees to interact with the speakers and fellow delegates through a combination of roundtable discussions, networking lunches, Q&A with speakers so as to maximize the learning from the event.

This Symposium features presentation of all important patent issues as mentioned in this brochure. The speakers are a unique gathering of Patent Attorneys, Litigators and Legal Counsels who have extensive years of experience in their professional fields and are well acquainted with the Industry’s need. These speakers will put across to the delegates the real insight of Patent Laws, Practices and Commercial perspectives as prevalent and practiced in United States, Europe, India. The Workshop will provide an opportunity to receive firsthand information including recent Judgment on various issues from the experts in the fields. The speakers are selected such that R&D Scientists, In-House Counsels, Patent Attorneys, and IP Practitioners can get to know real insights and nitty-gritties followed in the United States, Europe, India Patent Domain. The speakers would share real-life cases and experiences that can help attendees in following best practices for building their respective patent portfolios so as to best commercialize.

In-house Counsels, Life Science Companies, IP Management Teams, Research & Development Scientists, Patent Agents & Attorneys in the field of Practice, Patent Litigators, Professionals in Legal-Business domain related to Pharma, Biotech and Chemical Industry.

IIPRD is a premier IP Consulting and Licensing Firm with a diversified business practice providing services in the domain of Commercialization, Valuation, Licensing, Transfer of Technology and Due-Diligence of Intellectual Property Assets along with providing complete IP and Patent Analytics, Transactional, and Litigation Support Services to Indian and International Corporates, Licensing Firms, and Global Law Firms. IIPRD has been established precisely to assist business houses in strategizing their growth by leveraging their IPR’s through effective Creation, Promotion, Protection, and Commercialization of IP. IIPRD has a legacy of over 17 years of existence, and is among the first Indian IP Firms to have core focus on Commercialization, Technology Transfer, and Licensing. IIPRD as strong team of over 330 professionals focus in complete Patent Support and Technology Consulting Matters ranging from conducting all types of Patent Searches, Research and Analytics, Preparation/Prosecution Support, Landscape Analysis, and Claim Charts/Infringement Analysis/Litigation Support.

Khurana & Khurana, Advocates and IP Attorneys (K&K) is more than a full service Intellectual Property and Commercial Law firm. K&K was formed in the year 2007 with a very firm focus of providing end-to-end IP Prosecution/ Litigation and Commercial Law services in a manner that is Corporate centric and follows stringent delivery practices that are consistent and are above defined quality standards. K&K works closely with its sister concern IIPRD, both of which supplement each other in order to provide end-to-end IP Legal and Commercialization/Licensing services to over 3000 Corporates. K&K is a team of over 330 professionals spread across 7 Offices in India, and has strong rankings from Legal 500, MIP, IAM, Chambers, Asia IP, among others. Our team of IP Attorneys/Practitioners, having high level of technical and legal competence, gives us the right competitive edge and positioning, as a law firm focused on creating immense IP value for our clients. K&K through its experienced and qualified team of Attorneys/ Practitioners, across Technology and Legal Domains, gives a rare synergy of legal opinion, out-of-box thinking for protection of ideas/IP’s and entrepreneurial spirits to its client base.

Carlson Caspers is a premier intellectual property law firm known for its deep expertise in patent law and strong litigation capabilities. Established in 2003 by leading IP attorneys, the firm has earned a reputation for representing clients in life sciences, technology, and manufacturing sectors. The team includes attorneys with backgrounds in science, engineering, and pharmacy, offering clients a unique blend of technical and legal knowledge. With a client-centered approach, Carlson Caspers provides a full range of IP services, including litigation, patent prosecution, portfolio development, licensing, and strategic counseling. The firm is consistently recognized for its excellence by leading legal rankings and publications.

A German based IP Law firm, as a team of chemists and biochemists with many years of experience, Hamm & Wittkopp represents its clients in all areas of intellectual property. A major focus of our activities lies in the fields of chemistry and pharmaceutics – with particular emphasis on generic pharmaceuticals and biosimilars. We offer a comprehensive service of the highest level, from analyzing and clarifying the IP situation, for example via oppositions and nullity actions against troublesome patents, to securing your own innovations via patent applications and defending your interests in litigation proceedings. Our structure allows us to provide tailor-made support in all patent and trademark matters, whereby we are able to act flexibly and efficiently, whilst adapting to the specific needs of each individual case.

09:00 AM TO 9:30 AM – REGISTRATION

09:30 AM TO 11:00 AM – Speaker: Jennell Bilek (US Attorney)

SESSION-1: Latest on Hatch-Waxman

Explore current litigation strategies under Hatch-Waxman and BPCIA, and understand what they mean for generic and biosimilar companies

Key Takeaways:

• Paragraph IV litigation landscape and trends
• Recent court rulings
• Antitrust lawsuits

11:00 A.M. TO 11:15 A.M. TEA BREAK

11:30 A.M. TO 1:00 P.M. Speaker: Peter Kohlhepp (US Attorney)

SESSION-2: Grant Strategy for Biosimilars

Strategic use of Post-Grant Proceedings for Biosimilars. An overview of how IPRs, PGRs, and oppositions can be tactically used to challenge or defend biologic patents, and manage litigation risks.

Key Takeaways:

• Choosing IPR vs GPR
• PTAB Litigation Trends
• Real-world invalidation case studies

01:00 P.M. TO 02:00 P.M. NETWORKING LUNCH

02:00 P.M. TO 03:30 P.M. Speakers: Jennell Bilek and Gary Speier (US Attorneys)

SESSION-3: Biosimilars: Strategy from Selection to Launch

Explore the strategic lifecycle of biosimilars from a scientific, regulatory, and commercial lens.

Key Takeaways:

• Reference product selection
• Regulatory harmonization
• Clinical, pricing, and launch strategy

03:30 P.M. TO 04:00 P.M. TEA BREAK

SESSION-4: AI Tools for FTO Clearances

Discover how software and AI tools are currently providing data-driven insights and streamlining FTO reviews and risk assessments.

Key Takeaways:

• AI tools in patent landscape analytics
• Automating clustering & risk scoring
• Use cases in pharma R&D

09:00 AM TO 9:30 AM – REGISTRATION

09:30 AM TO 11:00 AM – Speaker: Gary Speier (US Attorney)

SESSION-5: Valuation of Pharma Intangible Assets.

Learn advanced valuation techniques critical for licensing, M&A, and internal decision-making. Pharma intangible assets include patents, trademarks, ANDAs, and NDAs.

Key Takeaways:

• Pharma-specific value drivers
• Cost, market, and income valuation models
• Legal defensibility of valuation

11:00 A.M. TO 11:15 A.M. TEA BREAK

11:30 A.M. TO 1:00 P.M. Speakers: Dr. Alexander Wittkopp (Patent Attorney & European Patent Litigator)

SESSION-6: Trends, latest decisions and recent developments in European Court Cases

How the national courts and the Court of Justice shape the landscape of pharmaceutical patents in Europe.

Key Takeaways:

• Recent patent case laws in major EU jurisdictions, consistent and inconsistent decisions
• Latest national and central decisions around Supplementary Protection Certificates.
• Practical use of the Manufacturing and Export-Waiver – and its constraints

01:00 P.M. TO 02:00 P.M. NETWORKING LUNCH

02:00 P.M. TO 03:30 P.M. Speaker: Dr. Nils Kahlcke (Patent Attorney & European Patent Litigator)

SESSION-7: : Introduction into the Unitary Patent System and its impact to Europe’s pharmaceutical patent legal system.

Key Takeaways:

• Unified Patent Court – Streamlined litigation process
• Unitary Patent System – Latest Case Laws at the UPC Courts in the Pharma/Bio domains
• Recent decisions in Pharma domains issued by the EPO’s Boards of Appeal

03:30 P.M. TO 04:00 P.M. TEA BREAK

04:00 P.M. TO 05:30 P.M. Tarun Khurana & Tapan Shah

SESSION-8: Indian Patent Prosecution Strategies and Litigation Trends.

An update on latest Pharma/Biotech Litigation/Opposition Cases in Indian Courts with key learnings.

Key Takeaways:

• Latest Relevant Case Laws in the Pharma/Bio domains
• Key outcomes from said cases and tests/standards laid out
• Major Patent Litigation Cases

Gary is a registered U.S. patent attorney with a focus on issues facing companies in the life sciences sectors. He is a patent litigator who provides counsel on a broad range of patentrelated matters and regularly conducts pre-suit investigations, intellectual property valuations and IP due diligence. Gary provides freedom-to-operate clearance reviews and opinions relating to infringement and validity, and develops patent procurement and patent prosecution strategies for domestic, international, and foreign jurisdictions. He has been involved in numerous post-grant proceedings (e.g., ex parte reexaminations and inter partes reviews) in front of the U.S. Patent and Trademark Office (USPTO). The post-grant proceedings have involved patents across diverse technology areas (e.g., medical devices, drug delivery systems, polymers, pharmaceuticals, new chemical entities, and process manufacturing).

Peter Kohlhepp practices intellectual property law focusing on high-stakes patent litigation and post-grant proceedings. His work spans a variety of technologies, including medical devices, automotive technology, pharmaceuticals and nutraceuticals, medical diagnostics, telecommunications, and energy. Peter has extensive experience representing clients before the US Patent Trial and Appeal Board (USPTO), including frequently delivering successful oral arguments before Board panels.

Jennell advises clients on a wide range of intellectual property and legal matters. She is a strong advocate for clients in and out of court. She takes pride in developing a deep understanding of the disputed technology and the business needs of her clients to achieve favorable outcomes. For instance, in a notable win from the District of Delaware, the Judge found six patents invalid for indefiniteness after the Markman hearing, which saved the client the expense of trial for six of the seven patents-in-suit. With strong briefs and argument, the decision was affirmed at Forest Labs., Inc. v. Teva Pharms. USA, Inc., 716 Fed. Appx. 987 (Fed. Cir. 2017). She represents plaintiffs and defendants in a variety of industries with experience in many forums such as Delaware, Minnesota, New Jersey, Southern District of New York, Connecticut, and the USPTO.

Alexander is a partner at Hamm & Wittkopp Patent Attorneys, based in Hamburg (Germany). He represents his international clients in the areas of German, European, and US intellectual property law, including patent prosecution, oppositions, nullity and infringement proceedings, as well as preparing freedom-to-operate and validity opinions in the field of chemistry, biochemistry, and pharmaceuticals. Alexander is a qualified German and European Patent Attorney and a European Patent Litigator, as well as a US Patent Agent. He regularly provides complete FTO-analyses for generic products and biosimilars, conducts detailed assessments of the relevance and validity of crucial proprietary rights, and represents his clients in oppositions and revocation actions.

Nils is an Associate at Hamm&Wittkopp Patent Attorneys, based in Hamburg (Germany). He represents national and international clients before the EPO and the UPC patent with a focus on oppositions, appeals as well as nullity and infringement proceedings in the field of organic chemistry and pharmaceuticals. Nils is a qualified German and European Patent Attorney, as well as a European Patent Litigator. He regularly provides complete FTO-analyses for generic products, conducts detailed assessments of the relevance and validity of crucial proprietary rights.

Tarun has over 20 years of experience in a broad range of Intellectual Property (IP) subject matters, and is the Co-Founding Partner and Patent Attorney of Khurana & Khurana (K&K) and of its Patent Research and IP Asset Management Firm, IIPRD, both of which are among the Leading IP and Commercial Law Practices with 10 Offices in India, and over 220 Professionals. The firms also have regional offices in US, GCC/UAE, Thailand, Indonesia, Vietnam, Myanmar, Bangladesh, Malaysia, Sri Lanka, and Nepal. Tarun is ranked among the top Patent Prosecution Practitioners in India by IAM 1000 (and also by IAM 300 Strategists), and focuses on Patent Portfolio Management, Litigation, Valuation and IP Commercialization mandates for numerous Indian and International Corporates ranging from Small Start-ups to Fortune 5 companies.

With more than 12 years of experience in providing specialized services in Patents and related Intellectual Property Rights, Tapan holds expertise in the technical domains of Organic Chemistry, Medicinal Chemistry, Pharmaceuticals, Biotechnological products and Medical Devices. He holds Master’s Degree with specialization in Medicinal Chemistry from National Institute of Pharmaceutical Education and Research (NIPER, Mohali) Tapan has diverse experience in devising and assisting Fortune 500 Pharmaceutical and Chemical companies, US and European Law firms, independent patent attorneys and In-house patent counsels towards development and commercialization of products and processes.