Activists affiliated with the Initiative for Medicines, Access & Knowledge (I-MAK) and R Street Institute have propagated false narratives about how patents stifle competition in the drug industry and keep generic drugs from coming to market. These erroneous arguments include the ideas that drug developers ‘game’ the FDA’s Orange Book, that they file unnecessary patents to extend their market exclusivity, and that these practices deprive U.S. patients of accessible generic medicines. The allegations being made by I-MAK and R Street Institute reflect commonly cited myths that do not stand up to scrutiny.
A close examination of the arguments made by these organizations reveals that they fundamentally misrepresent the vital role patents play in promoting drug innovation without inhibiting generic entry:
| Claim: Drugmakers prevent competitors from entering the market by creating “thickets” of numerous patents. |
| In reality: There are several reasons that the alleged phenomenon of “patent thickets” is a myth. First, the number of patents on a product by itself is not indicative of the length of market exclusivity. As the USPTO’s recent study states, “simple counts of patents can be misleading when every patent is counted equally” because the actual claims in each patent will vary. The patent counts published by I-MAK are especially misleading because they include abandoned and pending patent applications as well as non-Orange Book patents, which do not affect the timeline of generic drug approval. The USPTO’s own data, which focuses on only patents listed in the Orange Book, shows no correlation between the total number of patents and the length of exclusivity. Second, the practice of filing multiple patents to protect a product is not nefarious — or unique to the drug industry. Complex technologies like drugs and electronics work by combining multiple inventions, which must each be patented in order to prevent illicit copying. In fact, tech companies regularly file far more patents than drug companies. According to the Intellectual Property Owners’ Association’s 2023 report of top U.S. patentees, nearly a third of the largest patent-owning companies belong to the tech sector, while just 2% are in the biopharma sector. |
| Claim: By filing extraneous “junk patents” on a drug, drugmakers extend their period of exclusivity and delay the arrival of generic competition. |
| In reality: There are several inaccurate components to this claim. First, as explained above, all granted patents have been examined by the USPTO and found to satisfy all legal requirements, such as being novel and non-obvious. Therefore, these patents are not “junk” patents, but represent legitimate innovations. Second, the idea that companies can extend one patent by filing additional patents — also known as “evergreening” — is false. When additional patents are filed, they only protect the specific improvement being made. The original patents on the drug will still expire on schedule, making anything covered only by the original version of the product fair game for generic manufacturers. Lastly, there is no evidence that patent protections are delaying the market entry of generic drugs. A recent USPTO study found that the average exclusivity period for 13 recently approved drugs was just 11.4 years, significantly less than the 20-year duration of a patent. This is largely consistent with prior research demonstrating that the median exclusivity period lasts about 12.5 years. The study also found that there was no correlation between the number of patents on a drug and the length of exclusivity — exposing flaws in the research published by I-MAK, which claimed to have found such a correlation. |
| Claim: Abuses of the patent system by drugmakers are restricting patients’ access to generic medicines. |
| In reality: The practices that I-MAK and R Street cite as abuses, which include “patent thickets” and “product hopping,” have previously been debunked as myths by C4IP. But beyond that, the claim that U.S. patients lack access to generic drugs is not based in reality. 90% of all U.S. prescriptions are currently filled with generic drugs. Our use of generic medicines dwarfs that of other developed nations, which prescribe generic drugs only 41% of the time on average. Because of our strong patent system, the United States experiences the best of both worlds: we get innovative new medicines first, and we also have a plethora of generic options available for most conditions. If lawmakers respond to activist pressure by weakening our patent system in order to address these fictitious “abuses,” they will upset the competition that makes America’s pharmaceutical market the most robust and innovative in the world. |