'; Jennifer Richie Discusses Balancing of FDA Compliance and Patent Infringement for Biological Products

Jennifer Richie Discusses Balancing of FDA Compliance and Patent Infringement for Biological Products

August 14, 2023

By Jennifer A. Richie

In evaluating the safety and efficacy of a new biological product, the FDA will often consider evidence in the form of comparisons to previously approved products of the same class. [1], [2] Comparing a new product to an approved product is an appealing strategy for biotech companies as it can accelerate the approval process and reduce costs associated with clinical trials. [1], [2]

However, statements made in pursuit of regulatory approval may be used to establish one or more elements of patent infringement. [3] Statements construed as “admissions” can have significant consequences, potentially exposing the company to infringement claims and other legal challenges from patent holders. Many biotech companies therefore face a unique challenge in navigating the intricacies of regulatory compliance while simultaneously avoiding admissions of patent infringement.

A comparative statement made to demonstrate safety and efficacy is typically not recognized as an admission of infringement per se. [4] In spite of this, specific element-by-element comparisons to a patented product may be used as evidence in an infringement analysis, including claim construction (i.e., the meaning and scope of a patent claim). [5] For example, in Intendis GMBH v. Glenmark Pharmaceuitcals Inc., Glenmark could not avoid infringement based on technical characterizations provided in its FDA submission. [3] When describing its drug formulation to the FDA, Glenmark stated that isopropyl myristate was selected as a penetration enhancer in place of the triglyceride and lecithin which were disclosed in the referenced patented formulation. Based on this explicit comparison of function, the Federal Circuit held that Glenmark had forfeited the right to argue that isopropyl myristate was not legally equivalent to the triglyceride and lecithin. Since all other elements of the two formulations were identical, the plaintiff successfully argued that Glenmark’s product met each and every element of the patented formulation. In its finding of infringement, the Federal Circuit Court reasoned that “[Glenmark] should not be permitted to liken their product to the claimed composition to support their bid for FDA approval, yet avoid the consequences of such a comparison for purposes of infringement” [3].

Accordingly, comparisons to patented products or technologies should be crafted carefully. For biotech companies pursuing this regulatory strategy, it may be beneficial to highlight the strengths of their new products. Since all statements made in pursuit of regulatory approval may be available in an infringement analysis, factual assertions in an FDA application, if in evidence, may similarly be used to proactively support non-infringement positions. [6] Biotech companies may use these communications as an opportunity to emphasize the new product’s unique features, advantages, and innovations. By highlighting distinctive aspects and addressing unmet needs in the market, companies can position their product effectively while mitigating the risk of infringement allegations.

The biotech industry is highly competitive, highly regulated, and ever-evolving. Comparing a new product to an approved one in FDA submissions helps companies address these challenges by supporting faster routes to market entry. It is important, however, that biotech companies are familiar with the risks associated with this regulatory strategy. By adopting a proactive approach to patent infringement concerns, biotech companies may be in a better position to commercialize their innovative technologies by mitigating legal setbacks – thereby striking a balance between regulatory compliance strategies and intellectual property considerations.


[1] “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products: Guidance for Industry” Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Dec. 2019,

[2] “Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA?” CDER Small Business and Industry Assistance Chronicles, 19 Sept. 2019,

[3] Intendis GMBH v. Glenmark Pharmaceuticals Inc., 822 F. 3d 1355, 1361-63 (Fed. Cir. 2016).

[4] Abbott Laboratories v. Sandoz, Inc., 566 F.3d 1282, 1298 (2009).

[5] U.S. Surgical Corp. v. Hospital Products International Ply. Ltd., 701 F.Supp. 314, 347 (D. Conn. 1988).

[6] University of Florida v. Orthovita, Inc., No. 1:96-CV-82-MMP, 1998 WL 34007129 (N.D. Fla. Apr. 20, 2008).