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A court in Madrid has decreed precautionary measures that paralyze the planned launch in Spain by the pharmaceutical company Teva of the generic version of the drug apixaban, one of the most used oral anticoagulants and whose launch on the market was going to save public health 138 million euros. per year, as confirmed to EL PAÍS by three sources in the sector. Some 45,000 patients who pay for treatment out of pocket by taking it for indications not funded by the National Health System (SNS) would also benefit. Each box of the presentation of 60 2.5mg pills of Eliquis, which is the brand under which Bristol Myers Squibb (BMS) sells the drug, costs 81.96 euros in pharmacies. The entry of the generic into the market was going to mean a price decrease of 45% and this would stand at 45.08 euros.
The situation created is striking for several reasons, highlighted by all the sources consulted. Firstly, due to the importance and sales volume of the treatment. Apixaban—which can replace the historic sintrom in many patients—is the third medication sold in pharmacies that generates the highest expenditure for public health (307 million euros last year). Second, for the moment in which the precautionary measures arrive. Patent lawsuits are frequent between pharmaceutical companies, but in this case the court decision came when Teva had tens of thousands of boxes of the drug ready to be distributed to pharmacies.
And, finally, for the procedural situation. At the beginning of 2023, Teva began a legal process, called “patent nullity action”, before the Commercial Court 4 of Barcelona to question the protection enjoyed by Eliquis and won with a favorable ruling issued on December 15. January. BMS did what is usual in these cases: present an appeal before the Provincial Court of Barcelona. But, in addition, he asked another court in Madrid to declare precautionary measures so that the generic did not go on the market, something that he has finally achieved.
Lidia Casas, a patent expert with 20 years of experience in the sector, highlights how fierce the fights between pharmaceutical companies over patents can be. “We are talking about million-dollar business figures, so it is not strange that companies defend their interests at all levels and do so until the last moment. Furthermore, they must do it in several countries at the same time, because in this matter the jurisdictions are national,” she says.
César Hernández, general director of Pharmacy of the Ministry of Health, regrets the damage that the situation created is causing to Spanish public health. “If a company launches a generic and a judge rules that it has not infringed the patent, the health system benefits from day one. If a company infringes another's patent, and a judge rules against it, the company must compensate the injured party. The problem with precautionary measures [like these] is that, if the judge ultimately rules that the patent was not infringed, it is the public health system that assumes an expense that should not have occurred,” he explains.
After the precautionary measures, since last March 1, public health has been paying 380,000 euros per day more than it would have been doing if Teva's generic had been on the market, which brings to this Wednesday (48 days passed) the savings not achieved by the autonomous communities (which are the ones that pay for the medicines) to 18.2 million euros.
In other countries such as the United Kingdom, Portugal, Croatia and Romania, the generic has gone on the market, according to industry sources. In the United Kingdom by a final ruling - Teva has achieved the nullity of the patent in the first instance and on appeal - and in other countries "either because the judge, without having decided, understands that there are sufficient elements to consider that the patent may be null." or because Teva is allowed to launch the generic and, in the event that the ruling finally proves BMS right, compensation will then be set,” explain legal sources familiar with the case.
Teva has also won lawsuits against the patent in Ireland. On the other hand, courts in France, the Netherlands, Sweden and Norway have ruled in favor of BMS, according to the specialized magazine Juve Patent.
Rafael Borràs, director of Corporate Affairs and Market Access at Teva, declines to comment on the judicial procedure “while it is open”, although he reiterates “the company's commitment so that patients can have the greatest possible accessibility to the medicines they need and in help the health system to be more sustainable and incorporate all current treatments and those that emerge.”
A spokesperson for BMS, for its part, recalls that “the judicial resolution is not final” and that “the company's rights are valid and remain in force.” “At BMS we support the introduction of generics after the expiration of the relevant intellectual property rights. Intellectual property provides a limited period of exclusivity that helps foster innovation in our sector, which is why we defend our intellectual property and the value of our innovative science,” adds this spokesperson.
The “inventive activity”
The objection to the BMS Eliquis patent raised by Teva is based on the fact that the protection enjoyed by the medicine should be annulled because it lacks two basic characteristics: “sufficiency of description” and “inventive step”. “What is relevant in these cases is that the patent provides sufficient information for an expert (on the date of the application and with his general knowledge) to conclude that it was credible that the compound in question has a therapeutic effect and some advantage with respect to what already known. This can be controversial in patents that include several chemical compounds with therapeutic functions that, initially, may be rather speculative and in which the experimental results are provided later, as usually happens in the development of new medicines,” explains Lídia. Houses.
Manuel Anguita, spokesperson for the Spanish Society of Cardiology (SEC), clarifies that apixaban is a medication called direct-acting anticoagulants (DOACs). “It is a widely prescribed drug among older people. From 15% to 20% of the population over 80 years of age suffers from non-valvular atrial fibrillation, which is one of the indications for it. DOACs have undoubted advantages over older anticoagulants, such as sintrom, but they are also much more expensive. This has meant that public health does not finance all its indications or does so in a more restrictive way. The release of generics to the market, when it occurs, will be good news because it will make them more accessible,” he says.
Jaume Tura, a pharmacist with an office open in Santa Coloma de Cervelló (Barcelona), confirms that the current price can be an obstacle for some patients: “You notice it on the counter. In indications financed by public health, the patient pays a maximum of 4.27 euros per box because it is a chronic treatment. But there are others in which apixaban represents a notable improvement compared to sintrom, but they are not financed and it is the patient who must pay for it. And, of course, paying 82 euros [the box of 60 tablets lasts a month] is a significant effort for many people. And there are people you see who simply can't."
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