BIOCAD, a Russian biotech company, has won a dispute with Genentech, an American company and subsidiary Hoffmann – La Roche, a Swiss pharmaceutical giant, on invalidating a patent for the use of rituximab, a drug, to treat the rheumatoid arthritis.
On October 20, 2017, the Collegium of the Chamber for Patent Disputes announced the operative part of its ruling to recognize the patent as completely invalid. This ruling has tremendous implications both for developing the Russian pharmaceutical industry and increasing the availability of genetically engineered biological drugs to the patients.
Patent #2358762 was one of the so-called “secondary” or “evergreen” patents used by Western pharmaceutical companies to maintain their monopoly on the market. This led to artificial constraints on the development of technologies and production of new medicinal products. The fight against secondary patents is actively conducted in many countries. The decision made by the Collegium of the Chamber for Patent Disputes confirms that this process is also under way in the Russian Federation and allows the Russian manufacturers to further protect the interests of their fellow citizens.
The grounds for the patent invalidation was its inconsistency with the condition “presence of an inventive level”. In other words, Genentech tried to get an auxiliary patent on a method for the treatment of rheumatoid arthritis, which was already well known among experts since 2001.
For patients in Russia, this ruling is of critical importance because it opens the way for competition and makes the drug more affordable. The market protected by secondary patents amounts to billions of rubles. For example, the market of rituximab for the treatment of rheumatoid arthritis is worth about 1 billion rubles.