Understanding what to patent versus what to keep as a trade secret is an increasingly important and challenging decision facing companies developing biologics products, such as cell and gene therapies, where technologies are complex and rapidly evolving. Careful consideration of the risks and benefits of each, along with their distinct enforcement considerations, are essential to developing an overall IP strategy to provide robust protection of cell and gene therapy products.

What to Patent

The core protection for a biologic typically lies in composition of matter patents that cover the product itself. Additional patent applications can be filed to cover improvements as they are discovered, which can add years of exclusivity. Common types of improvement patents for cell and gene therapies include sequence modifications, delivery methods, formulations, patient populations, and manufacturing methods.

Patent vs. Trade Secret Protection

While patents offer strong exclusionary protection, it is important to weigh whether keeping certain information as a trade secret is more valuable. A number of factors may impact this decision:

Reverse-engineering: If the public-facing product is easily reverse-engineered, trade secret protection will offer little value. However, a trade secret may offer complementary protection in instances where the key innovation is not easily derived from the product. Examples may include AI methods to identify or refine product candidates, which are not themselves public facing.Patent eligibility: Certain biologic technologies may face challenges with patent eligibility, especially those derived from natural products or those directed to measuring a natural correlation. However, there are strategies to mitigate these challenges. For example, natural receptors isolated from humans are not patent eligible by themselves but may be patent eligible when introduced into a new cell type or when modified for therapeutic uses.Business model: If the business model relies on licensing the technology to others, patents are critical to providing value. Filing patent applications may also be beneficial to demonstrate innovation and secure investment.Detecting infringement: If infringement would be difficult to identify, a trade secret might serve as a better option. Assays used in screening or product development and aspects of manufacturing may fall within this category. However, given the importance of manufacturing for cell and gene therapies, manufacturing patents can also provide meaningful coverage against both biosimilars and innovators.

Considerations for Patent Infringement vs. Trade Secret Enforcement

Developing an effective IP protection strategy for cell and gene therapy products also requires understanding and anticipating the complexities of enforcement mechanisms for both patents and trade secrets, including advantages and challenges of each approach. Biologics innovators often use patent infringement litigation and trade secret misappropriation litigation, separately or in combination, to safeguard their proprietary technologies, secure market exclusivity, or prevent competitors from undermining their market position. When planning to enforce a cell and gene therapy patent portfolio or assert trade secret claims, there are several considerations that can guide planning:

Goals of enforcement: Defining the business and legal objectives of any enforcement campaign is crucial in determining whether (and when) to pursue a patent infringement litigation or trade secret misappropriation suit. Depending on the forum the lawsuit is brought in, enforcement of patents or trade secrets may allow the intellectual property owner to seek a court order for defendants to stop using confidential information or infringing a patent (“injunctive relief”), financial compensation (“damages”), an exclusion order preventing importation of a product into the U.S., or other forms of relief. The desired outcome – whether it is market exclusion, financial compensation, settlement leverage, or another goal – is likely to meaningfully shape the enforcement strategy and forum.Relationship to the competitor: As a threshold matter, trade secret cases typically originate from a relationship between the parties where confidential trade secret information was shared, often under an agreement (e.g., under a non-disclosure agreement during collaborations or licensing discussions) or during the course of employment. Patents may be enforced, however, even if the patent owner did not have any prior relationship with the defendant, allowing for potentially broader enforcement.§ 271(e)(1), which exempts certain activities relating to FDA regulatory approval from infringement liability, potentially delaying the patent owner’s ability to enforce a patent until after FDA approval of the infringing product.Pleadings and discovery: The logistics and early-stage burden on the plaintiff may differ significantly between patent infringement and trade secret misappropriation suits. While asserted patents (and possibly exemplary claims) must be identified when filing a patent infringement case, depending on the jurisdiction, plaintiffs retain the flexibility to identify the specific asserted patent claims later when the facts of the case are more well developed. By contrast, trade secret litigation requires the trade secret owner to identify the trade secrets with reasonable particularity up front, often before the case is allowed to proceed to discovery and with a limited ability to modify the results. This requires plaintiffs involved in trade secret misappropriation litigation to carefully and strategically balance how broadly or narrowly the trade secrets will be defined early on in the litigation before they have the benefit of all of the underlying facts from the other side.

Conclusion

For more information, please join our presentation on November 19, 2024, titled “Protecting and Enforcing Biologics IP,” that will be offered both online and in person in Cambridge, Massachusetts.

We will discuss how to develop a comprehensive patent and trade secret IP strategy with examples including evaluating patents versus trade secrets and how to overcome common obstacles to securing patent protection, with specific examples relevant to cell and gene therapies. We will also discuss strategies and considerations for protecting biologics IP, including best practices for preparing for effective patent and trade secret litigation.

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