Understanding Biosimilar Patent Laws: A Comprehensive Guide
Introduction
Biosimilars, highly similar versions of FDA-approved biological products, have the potential to significantly reduce healthcare costs and increase access to life-saving treatments. However, their development and market entry are often hindered by complex patent laws. This article delves into the intricacies of biosimilar patent laws, the approval process, and the challenges faced by biosimilar manufacturers.
What are Biosimilars?
Biosimilars are biological products that are highly similar to and have no clinically meaningful differences from an FDA-approved reference biological product. Unlike generic drugs, which are chemically identical to their brand-name counterparts, biosimilars are produced through complex biological processes, making them more challenging to replicate.
The Approval Process for Biosimilars
The approval process for biosimilars involves several key steps:
Step 1: Reference Product Approval and Patenting
- Development and Testing: The Reference Product Sponsor (RPS) develops and tests a biological drug, performing clinical trials to demonstrate safety and efficacy.
- Patenting: The RPS may seek patents covering various aspects of the drug, including composition, manufacturing methods, and treatment methods. These patents grant the RPS the right to exclude others from making, selling, or offering to sell an infringing biosimilar.
- Biologics License Application (BLA): The RPS submits a Section 351(a) BLA to the FDA, providing clinical and non-clinical study data to show the drug is safe, pure, and potent.
Step 2: FDA Approval and Exclusivity
- FDA Approval: Upon FDA approval, the biological drug enters a market exclusivity period, typically 12 years, during which the FDA cannot approve a biosimilar version.
- Biosimilar Applicant Restrictions: A biosimilar applicant cannot submit a Section 351(k) BLA until 4 years after the FDA approves the reference biological drug.
Step 3: Biosimilar Development and Submission
- Biosimilar Development: The biosimilar applicant develops and tests a biosimilar drug, which may begin even before the reference product’s exclusivity period expires.
- Submission to FDA: The biosimilar applicant submits a Section 351(k) BLA, referencing the approved reference product.
The Patent Dance and Litigation
The Biologics Price Competition and Innovation Act (BPCIA) introduces a procedure known as the “patent dance” to resolve patent disputes between the RPS and the biosimilar applicant. This process involves several steps:
Initiation of Patent Dance
- Notice of Intent: The biosimilar applicant notifies the RPS of its intent to market the biosimilar, triggering the patent dance.
- List of Patents: The RPS provides a list of patents that it believes could be infringed by the biosimilar.
Litigation and Settlements
- Litigation: The biosimilar applicant may choose to engage in litigation to clear the RPS’s patent rights. This can involve multiple waves of litigation.
- Settlements: Many cases end in settlement agreements, which can delay the market launch of the biosimilar.
Types of Patents Impacting Biosimilar Market Launch
Contrary to popular belief, manufacturing patents are not the primary cause of delays in biosimilar market launches. Instead:
Composition of Matter and Treatment Patents
- Composition of Matter Patents: These patents cover the active pharmaceutical ingredients and have a significant impact on delays.
- Treatment Patents: Patents related to treatment methods also contribute to delays.
Impact on Market Launch
- Delays: Biosimilars that settle during litigation often face longer market launch delays compared to those that win or lose litigation.
- Number of Patents Asserted: A higher number of patents, particularly manufacturing, composition of matter, and treatment patents, are asserted in cases that settle during litigation.
Challenges and Implications
The complex patent landscape and litigation process pose significant challenges for biosimilar manufacturers:
Patent Thicket
- Extensive Patent Portfolios: Originator developers build extensive patent portfolios, leading to litigation and settlement outcomes that delay biosimilar market launches.
- Settlement Agreements: These agreements often result in delayed availability of biosimilars, undermining the intended benefits of the BPCIA.
Economic and Health Implications
- Financial Burdens: Delays in biosimilar market launches result in financial burdens on healthcare systems and delayed access to affordable biologic therapies for patients.
- Price Impact: Biosimilar entry is estimated to reduce the price of the relevant biologic by only about 4% to 10% per biosimilar entrant, raising questions about the balance between innovation and public benefit.
Expert Insights and Regulatory Considerations
Industry experts and regulatory bodies highlight the complexities and potential reforms:
Expert Views
“Biosimilar entry is estimated to depress the price of the relevant biologic by only about 4% to 10% per biosimilar entrant. This raises an important question—what is the length of time of the current, actual originator monopolies, and are they striking the right balance between incentivizing innovation and public benefit?”
Regulatory Considerations
- BPCIA vs. Hatch-Waxman: The BPCIA differs significantly from the Hatch-Waxman Act, which governs small-molecule generics. These differences impact patent litigation and antitrust considerations.
- Antitrust Implications: The smaller price difference between biologics and biosimilars compared to small-molecule drugs affects antitrust considerations and the likelihood of reverse payment settlements.
Conclusion
Biosimilar patent laws are intricate and often lead to significant delays in market launches. Understanding these laws is crucial for navigating the complex landscape of biologic and biosimilar development.
Key Takeaways
- Biosimilars are highly similar to FDA-approved reference biological products but are not structurally identical.
- The BPCIA introduces an abbreviated regulatory pathway and a patent dance procedure to resolve disputes.
- Patent Types: Composition of matter and treatment patents significantly impact biosimilar market launch delays.
- Litigation and Settlements: Many biosimilar cases end in settlement agreements, delaying market entry.
- Economic Impact: Delays result in financial burdens and limited access to affordable therapies.
Frequently Asked Questions (FAQs)
What is the “patent dance” in the context of biosimilars?
- The “patent dance” is a procedure under the BPCIA where the biosimilar applicant and the Reference Product Sponsor engage in a series of steps to resolve patent disputes before the biosimilar is marketed.
What types of patents are most commonly involved in biosimilar litigation?
- While manufacturing patents are common, composition of matter and treatment patents have a greater impact on market launch delays.
How do settlement agreements affect biosimilar market launches?
- Settlement agreements often result in delayed market launches, contributing to financial burdens on healthcare systems and delayed access to affordable therapies.
What is the exclusivity period for biologics under the BPCIA?
- Biologics enjoy a statutory exclusivity period of at least 12 years, during which the FDA cannot approve a biosimilar version.
Why do biosimilars face different antitrust considerations compared to small-molecule generics?
- The smaller price difference between biologics and biosimilars affects antitrust considerations, making reverse payment settlements less likely.
Cited Sources
- How Biosimilars Are Approved and Litigated: Patent Dance Timeline – JDSupra
- What Types of Patents Are to Blame for Biosimilar Market Delays? – Center for Biosimilars
- Biosimilars Enter the Courts: How Will Patent Infringement Settlements Be Tested for Validity Under Antitrust Laws? – Pillsbury Law
- The Characteristics of Patents Impacting Availability of Biosimilars – Springer Nature
- Pharmaceutical Patent Litigation and the Emerging Biosimilars – NCBI