This week, the Initiative for Medicines, Access & Knowledge (I-MAK) released its latest edition of a report series titled “Overpatented, Overpriced.” The report demonstrates the fact that drug makers have filed hundreds of patent applications on the top 12 best-selling drugs in the United States in order to attain patent protection for an average of 38 years. The most recent report focuses on etanercept (Enbrel), which is indicated to treat rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and moderate-to-severe juvenile idiopathic arthritis.
The report found that Amgen, the developer of Enbrel, filed 72% of its total patent applications for the product after it had already received FDA approval. The primary patent on the reference product was filed in 1990 and expired in 2010. However, the report notes that, to date, there are at least 19 patent active patent applications and granted patents that protect the commercial exclusivity of the product until the last expires in 2029.
Additionally, the report found that Amgen filed nearly 3 times more patent applications in the United States than it did in either Europe or Japan. Specifically, in the United States, Amgen has 57 patents on Enbrel, whereas in Europe it has 20, and in Japan it has 18.
In fact, in Europe, the first biosimilar version of etanercept was launched in spring of 2016, and since then, “prices have dropped by nearly half and biosimilars have a 40% market share.”
Conversely, there have been no launches of biosimilar versions of etanercept in the United States due to ongoing patent litigation, though a biosimilar product, Erelzi, has been FDA-approved since 2016 (Erelzi is already launched in Canada).
The report goes on to discuss the impact that extensive patenting has on taxpayers, specifically through Medicare and Medicaid purchases. “Between 2012 and 2016, total Medicare and Medicaid spending on Enbrel increased 129% and a total of $7.7 billion of taxpayer funds were spent on the drug. During that time the average annual Medicare spending on Enbrel per person (the annual price of the drug) nearly doubled from $16,828 to $32,891,” says the report.
While drug pricing has taken center stage in American politics as of late, drug patenting remains minimally discussed. I-MAK stresses that “Until the US government starts to substantively address the overpatenting of medicines, American consumers and payers will continue to bear the side effects. The US cannot fix the drug pricing crisis until it solves the drug patent problem.”
The report goes a step further, and suggests specific policy changes that could address the problem, including the following:
- Modifying the “inventiveness” standard for issuing patents
- Eliminating continuation applications at the United States Patent and Trademark Office (USPTO) so that an applicant does not have unlimited attempts to obtain a patent on the same invention
- Maintaining and improving the existing patent challenge system, including inter partes review (IPR) proceedings
- Creating a pre-grant opposition system similar to the one USPTO uses for trademarks
- Allowing the removal of a patent from the FDA’s Orange Book if it is invalidated using the post-grant review or IPR processes, and improving quality and transparency of the Orange Book