The hidden IP problem holding innovators back
People in life sciences companies understand how patents are crucial to their business, by setting competitive boundaries, protecting long development cycles, and shaping market trajectories. Yet, an aspect of patent practice is often quiet in the background: how a company signals that its products are protected.
In the United States, this is known as patent marking (and in the UK as webmarking.) For organisations active in the US market, the impact of patent marking is financial, not administrative.
Why patent marking matters more than many teams realise
Under US law, an alleged infringer is exposed to pre-suit damages after receiving “notice”. Actual notice occurs with a detailed letter or the filing of a complaint. The good news is that something known as “constructive notice” can occur much earlier with patent marking. Before 2011, this meant fixing patent numbers directly onto products. The America Invents Act introduced virtual patent marking, by marking a patented product with “patent” or “pat.” followed by an internet address (URL) to a patent marking webpage listing the patents associated with the product. (Note: patent claims to methods are treated differently in some cases.) The webpage must remain substantially consistent and continuous.
With proper marking and an accurate patent marking webpage listing, “constructive notice” begins when a patent appears in the listing, and infringers are exposed to pre-suit damages accruing up to six years, from the time they begin to make, use, sell, or import a covered product into the United States. In the life sciences sector, where products often remain on the market for years, the accrual of pre-suit damages can be significant. When in-house counsel begins to consider the quantum available for a relatively strong patent position, the impact becomes clear.
Where a simple rule meets a complex reality
While the law may appear straightforward, modern product portfolios are not. A therapy may involve a device, a cartridge, consumables, software components, and regional packaging. Diagnostics evolve even faster. Minor feature changes may generate new SKUs. Market access requirements may create others. Packaging and labelling can often shift independently of device updates.
Those responsible for these changes can sit across regulatory, marketing, packaging, digital, product, and manufacturing teams. With tight deadlines and delivery pressures, legal teams are sometimes not informed of each variation. Maintaining correct patent marking across all versions, and ensuring that the virtual patent marking webpage reflects each one, is more complex than many appreciate.
A single unmarked version of a successful patented product can terminate an earlier constructive notice date for a patent covering an entire, otherwise properly marked product family. One outdated patent marking webpage listing without detailing a successful (and properly marked) product can do the same. These gaps are sometimes discovered only during damages analysis in legal proceedings later on, when retroactive changes are not available. That alone should encourage patent-savvy companies to examine their processes carefully.
What a 2025 review revealed about the sector
We reviewed a small sample of US life sciences companies, to see where patent marking obligations showed up in regulatory filings with the US Securities and Exchange Commission. These obligations rarely appeared in risk or compliance sections of these filings, even though license agreements (and others) in accompanying exhibits turned up with obligations for a licensee to mark licensed products.
Regulatory submissions like this can be hundreds of pages long, with license agreements appearing some years or incorporated by reference in others. They may not be indexed for ease of discovery. Teams responsible for packaging updates, digital maintenance, or regulatory submissions may never encounter them. While the obligations exist, visibility may be limited even to these teams, leaving them prone to “constructive notice” failures.
Variations in patent marking webpages reflect the same issue. Some are posted listing only patent numbers, without associated patented products, thus failing statutory compliance requirements. Others are outdated. Some companies appear to publish no webpage at all, while a noticeable number focus their patent marking webpages on US patents alone, reflecting an understanding of the monetary leverage of constructive notice under US law.
The building blocks exist, but they are not connected
Inside most life sciences companies, the ingredients for proper constructive notice already exist. These include license agreements that assign patent marking obligations, regulatory systems with detailed product identifiers, packaging workflows that govern label updates, and corporate websites serving as public notice endpoints. Yet, these components sit within different groups that operate on different timelines. Constructive notice remains at the intersection and may often be fully owned by none of them.
This fragmented structure creates a quiet vulnerability. It arises because no single team has visibility across the full process.
A hidden failure scenario that many companies would recognise
Many constructive notice failures begin with something routine: a regional packaging change, a new vial size for a hospital channel, a diagnostic workflow updated through a minor software patch. Each update can be correct within its own team, but the patent marking webpage is not updated because no one realises that the change might create a new variation of a patented article. The unmarked version ships. Months pass. When the company later prepares its damages analysis, counsel discovers that “constructive notice” was severed when the new version entered and dominated the market. Years of accrued potential damages are lost. The lapse was invisible while it occurred, yet, by the time it was discovered there was no way to recover the lost years.
Few IP professionals forget a scenario like this once they hear it. It is simple, plausible, and costly. It also reflects the type of operational gap that is hard to detect without a structured approach.
Why automation has become a practical necessity
As product portfolios expand, maintaining “constructive notice” manually becomes unrealistic. Automation helps synchronise updates across teams, reduce the time between internal changes and patent marking website updates, and maintain alignment across SKUs and regional variations. It can surface patent marking obligations buried within agreements and create audit trails that survive staff turnover.
Automation provides more than efficiency. It offers governance, strengthens litigation posture, improves licensing leverage, and reduces likelihoods of discovering problems later on.
A forward look at what this means for the life sciences sector
The ability to establish constructive notice with virtual patent marking has been in place since 2011, yet, everything around it has changed. Products evolve frequently. Manufacturing networks are global. Digital components shift regularly. Regulatory expectations continue to rise. Yet, many companies still manage patent marking much as they did a decade ago.
For companies active in the US market, this creates both risk and opportunity. The risk is discovering too late that valuable years of accrued damages cannot be recovered. The opportunity lies in creating more reliable and structured approaches to virtual patent marking that strengthen enforcement and higher monetary settlements. Companies that review their processes often find issues they did not expect. Companies that wait often find issues when they cannot be fixed.
In an industry defined by long development cycles and high stakes intellectual property assets, bringing automation to virtual patent marking is one of the most practical and protective steps a company can take. The impact lasts, and so does the cost of overlooking it.
Disclaimer: This article does not constitute legal advice or a legal opinion on any specific facts or circumstances. The views expressed are the author’s own. For clarity around your patent strategy or to better understand how these issues apply to your organisation, speak with a qualified patent professional practicing in virtual patent marking and patent-product mapping.
About the author
Jim Gastle is a CA / US patent agent and professional engineer, with 40 years of experience in advising clients across various scientific fields. As a co-founder of Terrifio, he focuses on automating virtual patent marking compliance and AI-powered patent-product mapping to reduce internal burdens and maintain enforcement readiness. Recognised as a thought leader, Gastle has shared his insights through media and professional appearances across the UK, Europe, and the US. His client work centers on addressing marking compliance gaps and quantifying enhanced value outcomes through comprehensive modelling.
