Beyond Curiosity: Practical Guidance on the Research Exemption and Hatch-Waxman Safe Harbor

In several previous articles (1, 2a, 2b), we reviewed key cases on the common law experimental use exemption and the statutory safe harbor under the Hatch Waxman Act. In this last installment, we  will provide practical advice on what it takes to successfully invoke the exemptions during litigation or (where possible) avoid litigation entirely. We thus conclude our series of with some practical tips for both patentees and defendants dealing with (A) the common law research exemption and (B) activities “reasonably related” to the development and submission of information under the Hatch-Waxman Act, including an update from the Federal Circuit’s § 271(e)(1) safe harbor jurisprudence.

The Common Law Research Exemption:  Practical Guidance

1. Research Supporting Institutional or Commercial Goals Is Not Protected

Modern research rarely happens in a vacuum. Whether conducted in a lab, university, startup, or R&D division, scientific work is almost always performed with a purpose beyond simple intellectual curiosity. That broader purpose—whether it’s product development, competitive benchmarking, publication, or technology transfer—takes the research outside the bounds of the common law exemption.

The exemption is only available when the research is conducted solely for philosophical inquiry or idle curiosity, without any connection, even indirectly, to commercial interests or organizational goals. This is an extraordinarily narrow standard. Activities such as validating a prototype, running comparative studies, refining experimental methods, or conducting feasibility testing typically do not qualify, even if they occur at an early stage or relate to products that never reach the market.

Importantly, courts do not require that revenue be generated or that a product be sold in order to find infringement. Instead, they look at the intent and function of the research. If the work supports internal decision-making, investor readiness, future marketing, or strategic positioning, it is likely to be viewed as commercial in nature. Even basic feasibility testing or bench research can trigger liability if it aligns with business objectives.

This means that startups engaging in proof-of-concept work, companies testing patented alternatives, and research organizations developing new applications must treat patent clearance as a front-end issue—not an afterthought. Simply calling the work “experimental” is not enough.

2. Academic and Nonprofit Institutions Are Not Immune

There is a persistent but incorrect belief that academic or nonprofit institutions are insulated from infringement risk because they are not profit-driven. However, the legal test focuses on purpose, not status. Courts consistently analyze whether the activity furthers a legitimate business or institutional goal, even in a university or non-profit setting.

In practice, this means that university labs, research hospitals, and other nonprofit entities are not categorically protected. If research is performed to advance educational goals, attract grants, build institutional reputation, publish results, or support future commercialization—all of which are typical in academic research environments—the activity is considered commercial for purposes of the exemption.

Publicly funded research projects are not immune, either. Even when a study is part of a national initiative or collaborative scientific effort, it may still fall outside the exemption if it serves institutional priorities or involves patented technologies used in a way that advances organizational interests.

This has serious implications for university tech transfer offices, sponsored research programs, and joint development agreements. It also affects collaborations with industry, where the line between academic and commercial work can quickly blur. Universities and nonprofits need to treat third-party patent rights as a real and present concern and build compliance and licensing into their research planning—especially when external funding, potential IP generation, or commercialization is involved.

3. Proactive Risk Management Is Essential

Because it is so narrowly defined, the exemption cannot reasonably be relied upon to excuse infringement.  Rather, if an entity wishes to pursue work that is likely to infringe the patent rights of another, they face few choices: stop the work until the patent expires; design around the patent; invalidate the patent claims; conduct the work outside of the United States (where the patent is not enforceable); take a license from the patent owner; or risk costly litigation.

None of these are desirable choices, and each divert time and money away from critical work. As a result, companies engaging in conduct that is likely to infringe but unlikely to fall within the exemption must proactively manage the risks that accompany such conduct.  To do so they must first fully understand the patent rights of others in the industry, including what the relevant patents cover, when the patents expire, and who owns the patents.

At a minimum, companies should conduct freedom-to-operate analysis before beginning research to stay one step ahead of potential infringement risks, avoid costly litigation, and ensure compliance with relevant patent laws.  Companies may also proactively wish to secure licenses, if not prohibitively expensive, or enter joint development agreements for patented technologies that will be used in their research activities.  Companies may wish to avoid publicizing their work if it would otherwise be difficult for the patent owner to discover the early-stage research or justify a costly infringement suit, particularly where there is no commercial product.

Above all, companies conducting research should manage their expectations and not rely upon the uncertainty of the common law exception to excuse their potentially infringing activities.  Where possible, companies should consider alternative protections, including for research involving drug development or medical devices under the statutory safe harbor provisions of 35 U.S.C. § 271(e)(1), which has been recognized as a valid defense to patent infringement.

Hatch-Waxman Act Safe Harbor

The Latest Word from the Federal Circuit: Jazz Pharms. v. Avadel CNS Pharms.

The Federal Circuit in Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, 136 F.4th 1075 (Fed. Cir. 2025) assessed the propriety of a permanent injunction that enjoined Avadel from: (1) initiating new clinical trials for Lumryz, (2) offering open-label extensions (“OLE”) in ongoing clinical trials, and (3) applying for Food and Drug Administration (FDA) approval of Lumryz for idiopathic hypersomnia (“IH”). For additional background, see our previous article.

1. Initiating New Clinical Trials is Protected

The court reversed the injunction against initiating new clinical trials, holding that such conduct is non-infringing under the § 271(e)(1) safe harbor and, instead, is explicitly protected by 35 U.S.C. §271(e)(3). Accordingly, the court found that the injunction was “over-broad as a matter of law.” Id. at 1083.

“The plain language and purposes of the Hatch-Waxman Act make it clear that enjoining Avadel from initiating new clinical trials for Lumryz (for IH or otherwise) until expiration of the ’782 patent is unlawful and, therefore, an abuse of discretion. . . . As the Supreme Court has explained, it is ‘apparent from the statutory text” that § 271(e)(1) “exempt[s] from infringement … all uses of patented inventions that are reasonably related to the development and submission of any information under the FDCA … necessarily includ[ing] preclinical studies of patented compounds that are appropriate for submission to the FDA.’”

Id. (internal citation omitted).

2. Offering Open-Label Extensions (OLEs) May Be Protected, But Requires Factfinding

The court also reversed the injunction to the extent it enjoined Avadel from offering OLE periods to current clinical trial participants finding that (i) Jazz never alleged the OLE activities were infringing and (ii) no factfinding had occurred. Specifically, the Court remarked that:

“[W]hether Avadel’s use of an OLE period is a safe-harbor activity is a question of fact that has not yet been accused, let alone adjudicated. Accordingly, because this activity has never been accused of infringement, and because ‘[t]he statute clearly requires that the § 271(e)(1) issue be decided prior to the grant of injunctive relief,’ we reverse the injunction insofar as it enjoins Avadel from offering OLEs to patients in clinical trials. Only if and when that activity is adjudicated to fall outside the protection of the safe harbor, and only if and when the district court finds the eBay factors to favor an injunction, may it be permanently enjoined.”

136 F.4th at 1085 (internal citation omitted). Thus, blanket prohibitions are improper if the activities have not been shown to infringe and courts must determine whether or not the § 271(e)(1) safe harbor applies before enjoining clinical activities like OLEs.

3. Submitting an NDA for a New Indication: Unsettled

The court vacated the injunction to the extent it enjoined Avadel from seeking new FDA approval for new indications of Lumryz and remanded. In doing so, the Court held that:

• Submitting an ANDA or §505(b)(2) application (a so-called “paper NDA”) is not infringing under 25 U.S.C. §271(a), but it can be “artificial infringement” under §271(e)(2) if it seeks approval for a patented drug or use.
• If submitting an ANDA/paper NDA falls under §271(e)(2), then remedies are limited by §271(e)(4), and an adjudicated infringer cannot be enjoined from applying for additional FDA approvals of a patented drug.
• If submitting an ANDA/paper NDA does not fall under §271(e)(2), the district court must re-evaluate under the eBay factors for injunctive relief.

Practical Tip

Focus on Objective Use

When asserting or challenging the safe harbor, focus on demonstrating whether or not the use is reasonably related to regulatory approval.  Evidence related to the objective nature of the actions of the defendant in the context of the regulatory process—instead of the actual or subjective intent of the defendant—should be determinative (e.g., the Federal Circuit in both Jazz and Meril confirmed that subjective intent or commercial motive of the defendant does not determine the boundaries of the § 271(e)(1) safe harbor). 

Additional Practical Tip: For Patentees

Patentees facing potential competition from ANDA or 505(b)(2) applicants should:

Stay Informed

As the cases discussed in our most recent article show, the safe harbor is not static and each new court ruling can shift its boundaries.  As new fact patterns are assessed by the trial courts and the Federal Circuit, the activities of competitors falling in and outside of the safe harbor should be tracked.  Understanding evolving caselaw (e.g., the significance of the word “solely” in § 271(e)(1)) and monitoring the activities of competitors that parallel the fact patterns of new caselaw can determine whether (i) relief is available or (ii) more evidence is needed for a complaint (e.g., to avoid an early dismissal or summary judgment) or to counter the merits of a safe harbor defense at trial.

Additional Practical Tips: For Potential Defendants

Life science clients whose business model includes seeking FDA approval of ANDA or 505(b)(2) applications should:

Educate Your Team and Keep Thorough Documentation

Make sure legal, R&D, and regulatory groups understand the likely boundaries of the safe harbor, including what qualifies as FDA-related research and what does not (e.g., commercial manufacturing), and how to document activities falling inside the safe harbor.  Use recent cases as practical examples in training and revisit policies when new court decisions emerge.

Preserve documents “reasonably related” to seeking such approval—such as work project timelines, correspondence with the FDA, trial protocols—as evidence of concrete actions (e.g., pre-submissions, protocol development and design, interactions with the FDA) supporting whether the activity is “reasonably related” to an FDA submission.

Assert Safe Harbor Early and Clearly

 To fully leverage the protective scope of the safe harbor, it is essential to assert it as a central, well-supported, and initial part of a litigation strategy. Proactively and substantively plead the defense. As cases we discussed in our earlier article (previous article) show, a successful safe harbor defense may allow early resolution of litigation.

Evaluate and Stay Up to Date

The common law exemption and the Hatch Waxman safe harbor, when considered early and invoked properly, can be valid defenses to patent infringement. To navigate the risks of patent infringement when engaging in research, companies should carefully evaluate the implications and purpose of their activities and consider alternative strategies like licensing where necessary. Staying informed about ongoing legal developments is essential for avoiding costly litigation and ensuring compliance with patent laws.

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