For more than two decades, generic drugs, these copies of original chemical drugs, and their biological counterparts, biosimilars, have become commonplace in our medicine cabinets. However, their arrival on the market is not going smoothly. Reluctant to give up monopolies on products that bring them billions, Big Pharma deploys a whole legal arsenal, exploiting the slightest loopholes in legislative and regulatory texts to keep competition at bay for as long as possible.
Because if, in theory, the commercial exclusivity conceded to an innovative medicine ends after twenty years, period at the end of which the patent falls into the public domain, in practice, a multitude of tricks allow laboratories pharmaceutical companies to prolong this monopoly. Even if it means sometimes tackling the gray areas of competition law.
This is particularly the case of deferred entry agreements, a practice imported from the United States, and which proliferated in Europe for a long time, until an investigation by the European Commission in 2009 took an interest in it. closer. For fear of seeing their patents invalidated before the courts by manufacturers of procedural generics, the laboratories concluded amicable agreements with the generic manufacturers: in return for a large sum of money, the latter undertook not to market their competing drugs before the expiry of the patent. “Resolving a dispute by agreement is possible. The problem is that the patents attacked in these cases are often secondary patents, which relate to a method of manufacturing the drug or its galenic form, and not the primary ones, which protect the innovative molecule. However, secondaries are more easily circumvented by generics, which makes these agreements much more contentious”explains Walid Chaiehloudj, associate professor of law faculties at the University of Perpignan.
Agreement between competitors
The Danish laboratory Lundbeck, which had concluded an arrangement of this type in 2002 with generic manufacturers to rule out rivals to its antidepressant, Seropram, paid the price. Believing that this was an agreement between competitors, the European Commission sanctioned the laboratory and the generic manufacturers in 2013. Total amount of fines: nearly 146 million euros. If, since then, this practice has declined in Europe, it is still very widespread across the Atlantic.
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