A recent investigation into four breast cancer drugs produced by this multinational based in Basel, Switzerland, reveals that, 27 years after the start of their marketing, nearly 100 patents continue to protect them exclusively. Nothing less than a compact armoring instrument that has generated sales of more than 156 billion Swiss francs ($192 billion), thus ensuring a monopoly in this specialty until 2042.
Herceptin, one of Roche’s top sellers since its launch in the late 1990s — first in the United States and then in Europe — is prescribed for a particularly aggressive form of breast cancer that affects more than 400,000 people each year worldwide. In combination with three other derivative drugs (Perjeta, Kadcyla and Phesgo), Herceptin has assured Roche almost complete control of the market. The active ingredient of these drugs are trastuzumab and pertuzumab, two types of monoclonal antibodies that work by binding to the HER2 protein on cancer cells to stop their growth and help the immune system destroy them.
¿Medical quality or monopoly?
The report just published by the Swiss Non-Governmental Organization Public Eye (Citizen Look) tries to answer an essential question: How do we explain such longevity of this biological drug and its multimillion-dollar profitability in a highly competitive pharmaceutical market? Although Herceptin represented an advance for the treatment of this type of cancer, the main reason for its success, according to the report Public Eyeis because “it used and abused various tactics to extend its monopoly and delay [así] competition as much as possible.”
A drug is considered “biological” when it is manufactured from living cells or organisms, a more complex and expensive process than conventional drugs, made with inert substances. Hence the largest number of patents. The big problem with these production patents is that they make the development and marketing of generic or biosimilar drugs difficult. The study that has just been released Public Eye identifies 183 patents granted to Roche in the United States and 95 in Europe. At the end of September 2025, 100 of the former and 64 of the latter were still in force. On the other hand, another 20 patent applications from Roche, a giant among giants with more than 100,000 employees in a hundred countries, are already being processed on both sides of the Atlantic.
The investigation of Public Eye It was not easy because it lacked a prior inventory. To compile the list of patents related to trastuzumab and pertuzumab, its researchers relied on court documents, regulatory authorities, national patent offices and the World Intellectual Property Organization (WIPO) itself, as well as scientific articles and other publications. “Due to the difficulty of reconstructing such a complete view,” the final report admits, “it is possible that Roche’s actual list of patents for these treatments is even longer.”.
The diabolical mechanism of patents
A patent is an exclusive right granted to the owner or owner of an invention. Therefore, no one else can legally reproduce or market it in those countries where it has been granted. To be patentable, an invention must meet three requirements: be “novel”, in the sense of being the first of its kind; truly “inventive”, or of original creativity, and totally usable, that is, of industrial application for the purpose for which it was conceived and designed. In the pharmaceutical sector there are two types of patents: primary ones, which protect the molecular structure of a drug, and secondary ones, which protect modifications of that same already patented drug. In practice, the latter artificially prolong their period of exclusivity.
The extension of exclusivity is ensured and protected, fundamentally, through a “patent jungle”, that is, numerous patents at the same time. If these are registered gradually over time, the monopoly of a product can greatly exceed the 20 years stipulated by international law, as has happened and continues to happen with trastuzumab y pertuzumab.
Only 5% of Roche’s patents for these two molecules are primary. The remaining 95% has to do with secondary patents that protect a manufacturing process (40%); formulations, doses or methods of administration (30%); methods of use (13%), or combinations with other active substances (12%). Known in English as “evergreening”, this strategy of minor modifications to abusively accumulate secondary patents is common practice in the pharmaceutical industry. Roche in the United States, for example, has managed 16 secondary patents for trastuzumab and pertuzumab, all with identical titles. Thirteen of those patents were approved.
How it documents Public Eyeeven though these secondary patents do not protect the active substance, which remains unchanged, they nevertheless saturate the official patent registration offices, forcing them to carry out numerous examinations. Circumstances that extend the monopoly of a drug and also increase the risk of patents being granted too easily due to the backlog of applications.
Another strategy frequently used by pharmaceutical multinationals to prolong the monopoly of one of their products consists of launching a new version when its patent is about to expire. Just as has happened with Roche’s breast cancer drugs. Shortly before Herceptin’s patents expired, Roche changed the method of administration from intravenous to subcutaneous and thereby obtained several secondary licenses. While this new way of managing an existing product is more practical and perhaps less expensive, Public Eye The question arises: does this modification justify the extension of a high-price monopoly for another 20 years?
The introduction of Perjeta and Phesgo 14 and 22 years after Herceptin, respectively, allowed Roche – today the largest biotechnology company in the world— extend its monopoly until 2042 in the United States and 2039 in Europe. Considering that Roche’s first license for Herceptin dates back to 1992, the monopoly on this product has already been in place for 50 years in the United States and 47 in Europe. Much more than double the 20 years stipulated by the World Trade Organization (WTO) agreement on intellectual property rights for trade.
Thanks to these mechanisms, Roche has been able to impose exorbitant prices on its medicines. for the treatment of HER2 breast cancer. Even in Switzerland, its birthplace and corporate headquarters, Roche has not hesitated to pressure national authorities to impose its prices. In 2014, dissatisfied with the price set by the federal administration, Roche removed Perjeta from the list of medicines covered by compulsory health insurance, a blackmail that proved successful when a year later it reintroduced it with a higher price. In 2025, he points out Public EyeRoche repeated this strategy with another of its oncology drugs, Lunsumio. As of today, this drug is still not on the list of medications covered by health insurance.
Against this monopolistic mechanism
Criticism not only comes from non-governmental organizations, social movements, international networks and countries of the Global South (such as South Africa and India, among others), but also from the United Nations itself. In 2013, three organizations of the UN system published a first common document demanding health for all. There they recognized the right to access medicines, although they did not directly criticize the sensitive issue of patents because they knew that this would confront them directly against a great world power such as the pharmaceutical industry.
From then until the present, the issue of monopoly control of medicines has occupied a more important place on the United Nations agenda. The pandemic and access to vaccines and medications against COVID turned it into a debate of planetary proportions, also fueled by figures on the serious problem of exclusion from benefits. According to the WHO, almost 2 billion people in the world lack regular access to essential medicines.
This year, the United Nations High Commissioner for Human Rights produced a report on access to health for all. Discussed at the June-July meeting of the Human Rights Council, its report incorporates an analysis of good practices and key systemic challenges and affirms “a human rights-based approach to ensuring access to medicines, vaccines and other health products as part of realizing the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.”
His last recommendation, although sweetened by typically diplomatic vocabulary, typical of many official United Nations documents, is directed at pharmaceutical companies. It asks them to respect the right of all people to medicines, vaccines and other necessary health products and insists on the concept of due diligence, a mechanism that seeks to minimize the risk of poorly made decisions. In general terms, this is the business obligation to act with reasonable care necessary to avoid harm to third parties or comply with regulations, an obligation that extends to “business policies and practices regarding research and development, pricing, intellectual property management, distribution and technology transfer, among other things.”
In short: many speeches and proposals that try to resolve dramas, without achieving it. In several low-income countries in Africa and Asia, more than half of the population does not have access to essential medicines. In developing nations, where an estimated 42 million people suffer from HIV/AIDS, life-saving antiretroviral treatments are only available to 300,000 of the 5 to 6 million who need them today. This is an unanswered paradox of an international health system where the stratospheric profits of the pharmaceutical industry hide the reality of almost a third of the world’s population lacking essential medicines.
——————————–
To subscribe with $8,000/month to the Rocket click here
To subscribe with $10,000/month to the Rocket click here
To subscribe with $15,000/month to the Rocket click here
