A legal battle is unfolding within the walls of the US Supreme Court that in the coming years could change the cost of medications in pharmacies and the rules of competition in many industries. At the center of the conflict are two pharmaceutical companies, Amarin and Hikma, and the subject of the dispute is the fine line between the legal sale of cheap generic analogues and the hidden theft of others’ intellectual achievements.
It all started with a drug named Vascepa from the Amarin company. Initially, this medication was used to combat high levels of fats in the blood (triglycerides), and this method of treatment has long since become universally available. However, Amarin later invested billions of dollars in research and proved that this same drug effectively reduces the risk of cardiovascular problems, such as heart attacks or strokes. The company received a fresh patent for this new “cardiovascular” indication, guaranteeing it a monopoly in the market.
When the protection term for the first “triglyceride” use expired, Hikma company entered the market with its significantly cheaper generic. To avoid infringing on Amarin’s new patent for heart treatment, Hikma utilized a legal mechanism known as “skinny labeling” or “narrow labeling.” This means that in the prescribing information for their drug, they honestly crossed out any mention of cardiovascular diseases, leaving only the authorization to treat fat levels. It seemed that the law was upheld, and consumers gained access to a cheap drug.
However, Amarin filed a lawsuit, leveling a serious accusation: “active inducement of patent infringement.” Their logic is that Hikma, despite changing the label, was actually actively prodding doctors to prescribe their cheap product specifically “for the heart.” Evidence presented includes press releases for investors and promotional materials where Hikma called its product a “generic version of Vascepa” and bragged about its market potential. Since the brand name Vascepa is associated in doctors’ minds primarily with saving lives in heart disease, Amarin argues that Hikma intentionally “winked” at the market, suggesting how to bypass the patent.
This case has caused considerable concern in the Supreme Court, as the judges understand that more than just the profits of two firms are at stake. If the Court allows the punishment of generic drug manufacturers for simple statements like “our product is an analogue of the brand,” it could paralyze the entire industry of cheap medications. Pharmaceutical companies would simply be afraid to enter the market to avoid spending millions on court cases over every word in their advertisements. This means that expensive drugs would remain monopolists for much longer than the law intended.
On the other hand, the judges fear creating a “safe harbor” for cunning infringers. If manufacturers are permitted to imply the use of patented technologies with impunity, it will devalue the billions invested in science. The US government has already intervened in the process, taking the side of the cheap drug manufacturer. The government’s position is simple: the mere knowledge that doctors may use a drug off-label cannot be considered a crime. As long as a company does not directly command patent infringement, it should not bear responsibility for it.
Currently, the Supreme Court is trying to find the golden mean. The judges emphasize that their decision will resonate far beyond medicine. It concerns any product—from software to car parts—that can be used in different ways. The outcome of this case will show whether the American system can maintain the delicate balance between rewarding inventors and the people’s right to accessible goods. Although the legal proceedings will last much longer, it has already become a powerful signal for all business: the era of simple disclaimers on labels may be ending, and every word in a press release will have to be answered for in court.
Founder of Research & Patent group Intectica, author of patent algorithms for solving problems in the pharmaceutical industry, patent attorney certified in all intellectual property objects (Patents, Design, TM), with education in chemistry and law, chief expert of the patent institution of Ukraine UKRPATENT (1997-2004). Member of international organizations, including ECTA, PTMG, UAM, lecturer and blogger.
