A recent Supreme Court patent case involving Amarin and Hikma is a good reminder that patent protection is not always limited to the product itself.
The case involves what is known as a “skinny label.” A skinny label is when a generic drug company removes a patented use from its FDA label and seeks approval only for a non-patented use of the drug. Reuters reported that the Supreme Court agreed to hear the dispute after Amarin accused Hikma of encouraging doctors to prescribe a generic version of Vascepa in a way that allegedly violated Amarin’s patent rights, even though Hikma’s generic label had omitted certain patented uses.
That issue matters because many valuable inventions are not only about what a product is. Sometimes the value is in how the product is used.
This principle is not limited to pharmaceuticals. Method-of-use protection can also matter for biotechnology, medical devices, rehabilitation technology, exercise systems, wearable devices, software platforms, diagnostic systems, manufacturing systems, agricultural tools, energy systems, and consumer products. In many cases, the product itself may use known components, but the patentable value may come from a new way of operating it, applying it, integrating it into a workflow, or using it to produce a specific result.
For example, a compound may already be known. A formulation may use known ingredients. A medical device may include components that already exist. An exercise or rehabilitation device may use familiar straps, sensors, resistance elements, or support structures. A software platform may use known data inputs. But a new therapeutic use, dosing protocol, delivery route, patient population, diagnostic workflow, exercise protocol, rehabilitation method, software-guided process, monitoring technique, or treatment-adjustment workflow may still create protectable patent value.
This is where method-of-use claims can become important.
In healthcare, the person receiving the treatment is usually the patient. But the commercial actor is often an organization, such as a pharmaceutical company, hospital system, clinic, pharmacy, diagnostic laboratory, software platform, telehealth provider, rehabilitation provider, or medical-device company.
The same concept can apply outside of healthcare. The end user may benefit from the invention, but the organization may be the one supplying the product, setting the protocol, providing instructions, configuring the system, collecting data, monitoring performance, or controlling the workflow.
That distinction matters. A patient may take the medication or wear the device. An athlete may perform the exercise. A worker may operate the machine. A customer may use the software. But an organization may be the one directing the use, monetizing the workflow, or creating the commercial value.
For that reason, patent strategy should consider more than the end user. It should consider the full commercial pathway.
A strong patent application may need claims directed to the product itself, the method of using the product, the method of treatment, the method of administration, the clinical workflow, the software workflow, the system used to monitor performance, and the instructions or protocols that make the product commercially valuable.
For startups and growing companies, the takeaway is straightforward: if the value of the invention depends on how a product, device, system, or process is used, that use should be considered early in the patent strategy. Waiting until after clinical use, investor discussions, product launch, customer adoption, or partnership talks can limit the available options.
Good patent drafting is not just asking, “What is the product?”
It also asks who uses it, who directs the use, who provides the instructions, who controls the workflow, and where the commercial value is captured.
For biotech, pharmaceutical, medical-device, diagnostic, digital-health, rehabilitation, exercise, software, manufacturing, and product-based companies, those questions can make method-of-use claims an important part of a broader patent strategy.
Source: Reuters, “US Supreme Court to hear ‘skinny label’ patent fight involving Amarin.”
https://www.reuters.com/legal/litigation/us-supreme-court-hear-skinny-label-patent-fight-involving-amarin-2026-01-16/
