Part 2: 2024 Hatch-Waxman Year in Review

Today, we're zooming in on key cases decided this past year and unpacking their broader implications for the pharmaceutical industry. We’ll look at decisions that refined safe harbor provisions, imposed stricter scrutiny on certain patents, tackled Orange Book listings, and much more. 

And before we close, we’ll share some insights into what the industry may encounter in 2025, so stick around to the end to hear what to expect in the coming year. 

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2024 Hatch-Waxman Year in Review

About the authors
Ben Bourke
Alexander P. Wharton

Transcript

Welcome to Womble Perspectives, where we explore a wide range of topics, from the latest legal updates to industry trends to the business of law. Our team of lawyers, professionals and occasional outside guests will take you through the most pressing issues facing businesses today and provide practical and actionable advice to help you navigate the ever changing legal landscape.

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Welcome to today’s episode of Womble Perspectives, part two of a two part series looking back at significant legal and regulatory developments in the pharmaceutical and biotech sectors in 2024. 

Today, we're zooming in on key cases decided this past year and unpacking their broader implications for the pharmaceutical industry. We’ll look at decisions that refined safe harbor provisions, imposed stricter scrutiny on certain patents, tackled Orange Book listings, and much more. 

And before we close, we’ll share some insights into what the industry may encounter in 2025, so stick around to the end to hear what to expect in the coming year.  

First up, Edwards Lifesciences v. Meril Life Sciences—a pivotal case that further clarified the broad applicability of the Hatch-Waxman safe harbor provisions.  

Here, the Federal Circuit ruled that the importation of two demonstration-only transcatheter heart valves during the FDA's pre-approval process was protected by the safe harbor provision. Interestingly, the ruling reaffirms that this protection isn’t limited to purely regulatory activities but can extend to certain promotional actions, so long as they’re “reasonably related” to FDA submissions.  

The takeaway? Innovator companies operating in crowded commercial spaces now have greater confidence that early development-stage activities—yes, even those potentially bordering on promotional efforts—might qualify for safe harbor protection. However, this benefit weakens considerably post-FDA approval. For legal teams supporting innovator companies, ensuring appropriate documentation during FDA-driven activities is absolutely critical moving forward.  

But safe harbor wasn’t the only area of interest this year. Next, we’ll shift our focus to polymorph patents and post-trial ANDA amendments.  

In an intriguing decision that impacts polymorph patents. Salix Pharmaceuticals v. Norwich Pharmaceuticals emphasized that while polymorph patents often benefit from strong nonobviousness protections, these protections are not guaranteed if the prior art presents detailed methods that predictably yield the polymorph in question.  

Another significant aspect of this case? Norwich’s attempt to file a post-trial ANDA amendment to remove an infringing indication and enter the market earlier. Both the Federal Circuit and the district court shut this down. The court held firm that infringement arises at the time of ANDA filing, making last-minute modifications highly inequitable.  

Key takeaway? Innovator companies should remain proactive in defending polymorph patents against unexpected challenges. For generics, the futility of post-trial modifications signals the need for sharper pre-litigation strategies.  

And now,  Teva v. Amneal Pharmaceuticals. The Federal Circuit ruled that patents directed specifically at inhaler devices were improperly listed in the Orange Book.

Why? Because the court clarified that Orange Book listings must explicitly "claim the drug" as opposed to supporting devices that facilitate its use. This ruling aligns with broader industry concerns, especially given the Federal Trade Commission’s mounting pressure against improper Orange Book listings.  

What does this mean for innovator companies? Ensuring compliance with Orange Book requirements is more critical than ever. Incorrect listings could attract regulatory scrutiny, leading to both reputational damage and potential FTC action.

While those three cases took center stage, there were other noteworthy decisions across areas like skinny labels, experimental-use defenses, and patent eligibility. For example, Amarin Pharma v. Hikma Pharmaceuticals addressed label-related induced infringement, reinforcing how even public statements can influence liability under Hatch-Waxman litigation.  

We also saw steps toward legislative codifications of experimental-use exceptions, with mixed feedback received by the USPTO. While 2025 may not bring sweeping changes, legal professionals must prepare for incremental shifts amplifying protections for innovators while striving for a balance with generic accessibility.  

To wrap up today, what can we expect in 2025?  

Here are three possible developments for the Hatch-Waxman landscape next year:

Legislative action is gaining momentum with proposals like the "Skinny Labels, Big Savings Act," which are expected to fuel further debates and possibly lead to regulatory codification. At the same time, the FTC is taking a tougher stance on Orange Book misuse, which could prompt NDA holders to either ensure compliance upfront or mount legal challenges. Additionally, as AI patents become increasingly prevalent, patent eligibility issues under Section 101 are likely to grow, impacting both innovative and generic drugmakers alike. 

The pharmaceutical patent landscape is becoming increasingly complex but full of opportunities for both legal and regulatory advancements. Staying informed will be the key to navigating what’s ahead.  

Thank you for listening to Womble Perspectives. If you want to learn more about the topics discussed in this episode, please visit The Show Notes, where you can find links to related resources mentioned today. The Show Notes also have more information about our attorneys who provided today's insights, including ways to reach out to them.

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