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In the rapidly evolving landscape of biosimilars, intellectual property (IP) strategy is paramount. Biosimilar manufacturers face unique challenges, including navigating complex patent thickets, ensuring regulatory compliance, and maintaining competitive pricing. A robust three-pronged IP strategy encompassing patent challenges, strategic partnerships, and innovation in manufacturing can provide a competitive edge. This article delves into how such a strategy can be effectively implemented, drawing insights from industry experts and real-world examples.
Table of Contents
The Importance of a Three-Pronged IP Strategy
1. Patent Challenges: Navigating the Patent Thicket
One of the primary hurdles for biosimilar manufacturers is the dense web of patents protecting originator biologics. These patents, often referred to as “patent thickets,” can be difficult to identify and navigate. Challenging these patents through inter partes review (IPR) and other legal mechanisms is a critical component of a successful IP strategy.
For instance, Samsung Bioepis has been proactive in filing IPRs to challenge patents held by originator companies. In 2023, Samsung Bioepis filed five IPRs against Alexion Pharmaceuticals’ patents related to eculizumab, a monoclonal antibody used to treat rare blood disorders. The Patent Trial and Appeal Board (PTAB) instituted all five challenges, with final decisions expected by the end of 2024[1]. Such actions not only pave the way for biosimilar entry but also set precedents for future patent disputes.
2. Strategic Partnerships: Leveraging Collaborations
Forming strategic partnerships is another vital aspect of a comprehensive IP strategy. Collaborations with other biosimilar developers, research institutions, and even originator companies can provide access to essential technologies, shared resources, and market entry opportunities.
A notable example is the settlement between Samsung Bioepis and Janssen regarding the biosimilar of Stelara® (ustekinumab). The settlement allowed Samsung Bioepis to market its biosimilar, SB17, in the U.S. starting February 2025[1]. Such agreements can expedite market entry and reduce litigation costs, benefiting both parties involved.
3. Innovation in Manufacturing: Enhancing Competitiveness
Innovation in the manufacturing process is crucial for biosimilar manufacturers to maintain competitiveness. This includes developing cost-effective and efficient production methods, ensuring high-quality standards, and protecting these innovations through patents.
The FDA’s guidance documents emphasize a stepwise approach to demonstrating biosimilarity, which includes extensive structural and functional characterization of both the proposed biosimilar and the reference product[4]. By innovating in these areas, biosimilar manufacturers can not only meet regulatory requirements but also create additional layers of IP protection.
Industry Insights and Expert Opinions
Amit Munshi, CEO of Epirus Biopharmaceuticals, highlights the significant market potential for biosimilars, with over $80 billion worth of drugs expected to go off-patent in the next seven years[2]. “The biosimilar market will soon be booming,” Munshi notes, emphasizing the need for robust IP strategies to capitalize on this opportunity.
Legal experts also underscore the importance of addressing patent thickets. A study published in Nature points out that patents protecting originator biologics are a major obstacle for biosimilar developers, often leading to unnecessary business uncertainties[3]. The study suggests that greater transparency and regulatory reforms could help mitigate these challenges.
Real-World Examples
Several real-world cases illustrate the effectiveness of a three-pronged IP strategy:
- Samsung Bioepis vs. Alexion Pharmaceuticals: By challenging multiple patents through IPRs, Samsung Bioepis has positioned itself to potentially enter the market with a biosimilar for eculizumab, pending PTAB decisions[1].
- Samsung Bioepis and Janssen Settlement: The strategic partnership allowed Samsung Bioepis to secure market entry for its biosimilar of Stelara® ahead of potential litigation outcomes[1].
- Innovation in Manufacturing: Companies like Amgen have leveraged innovative manufacturing techniques to produce biosimilars at a lower cost, enhancing their competitive edge in the market[4].
Conclusion
A three-pronged IP strategy that includes patent challenges, strategic partnerships, and innovation in manufacturing can significantly benefit biosimilar manufacturers. By navigating patent thickets, leveraging collaborations, and continuously innovating, these companies can secure market entry, reduce costs, and ultimately provide more affordable biologic treatments to patients.
Pullquote
“The biosimilar market will soon be booming as over $80 billion worth of drugs go off patent in the next seven years.” — Amit Munshi, CEO, Epirus Biopharmaceuticals
Cited Sources
- Biologics and Biosimilars Landscape: IP, Policy, and Market Developments
- Biosimilar litigation and its impact on IP strategy – IAM
- A qualitative study of biosimilar manufacturer and regulator – Nature
- Implications of the BPCIA on the IP Strategies of Brand Companies – Sterne Kessler
Citations:
[1] https://www.fr.com/insights/thought-leadership/blogs/biologics-and-biosimilars-landscape-ip-policy-and-market-developments
[2] https://www.iam-media.com/article/biosimilar-litigation-and-its-impact-ip-strategy
[3] https://www.nature.com/articles/s41587-020-0717-7
[4] https://www.sternekessler.com/news-insights/publications/implications-bpcia-ip-strategies-brand-companies-and-biosimilar/
[5] https://www.analysisgroup.com/Insights/ag-feature/analysis-group-forum/spring-2019/similar-but-not-the-same-charting-the-course-of-biosimilar-ip-litigation-in-the-us/
[6] https://www.mitla.org.mt/how-three-pronged-ip-strategy-help-biosimilar-manufacturers/
[7] https://assets.kpmg.com/content/dam/kpmg/pdf/2015/10/world-of-biosimilars.pdf
[8] https://www.foxrothschild.com/publications/key-considerations-for-your-life-sciences-ip-strategy
[9] https://www.mckinsey.com/industries/life-sciences/our-insights/three-imperatives-for-r-and-d-in-biosimilars
[10] https://www2.deloitte.com/content/dam/Deloitte/us/Documents/life-sciences-health-care/us-lshc-biosimilars-whitepaper-final.pdf
[11] https://www.mckinsey.com/industries/life-sciences/our-insights/an-inflection-point-for-biosimilars
[12] https://www.pinsentmasons.com/out-law/analysis/how-three-pronged-ip-strategy-help-biosimilar-manufacturers
[13] https://www.ashpfoundation.org/-/media/REF/Research/PDFs/ASHPF-Biosimilars-Implementation-Strategies-Report.pdf
[14] https://www.biopharmadive.com/news/amgen-enbrel-patent-thicket-monopoly-biosimilar/609042/
[15] https://www.centerforbiosimilars.com/view/patent-shifts-predictions-legal-landscapes-of-biosimilars-with-ha-kung-wong
