Amid debate over competition in the pharmaceutical industry, a new analysis found just 6% of patents covered key ingredients — or innovative new molecules — in pricey biologic medicines, underscoring concerns that drug makers abuse the patent system when they go to court to thwart rivals.
The researchers examined 21 patent infringement lawsuits filed by pharmaceutical companies against other drug makers and identified 179 patents that were allegedly infringed. But most were for so-called secondary uses, or less critical than uses listed in primary patents. For instance, 42% covered manufacturing processes, 35% covered other ways to use a medicine, and 34% covered formulations.
Moreover, the time between regulatory approval of a biologic and when a patent was issued for a secondary use was generally about a decade later. This is just two years before marketing exclusivity would end and a drug maker could face competition from biosimilar versions, which are lower-priced variants that are expected to produce the same health outcomes.
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