By: Connor Christensen
The prices of insulin have risen to unconscionable levels in just a little over two decades. What used to be a relatively minor expense for Americans with diabetes has, for some, become an insurmountable obstacle to living a normal life, or, in some cases living at all. The purpose of this brief commentary is to address just one of the many issues attributed to the stark increase in insulin prices: patent evergreening.
People with Type I and Type II diabetes constantly depend on insulin injections to supplement their insufficient natural production of the blood-sugar regulating hormone in their pancreas.[1] Without this hormone, a diabetic person’s life expectancy is short and riddled with many serious health complications.[2] For many decades insulin was readily accessible and affordable for those who needed it. Recently, however, things have changed.
In 1996, the list price of a single vial of insulin manufactured by Eli Lilly, a pharmaceutical firm, was only $25.[3] Since then, the formula for the same bottle of insulin hasn’t changed, but the list price has gone up to around $275 per vial.[4] This price increase alone is shocking, but it becomes even more unthinkable when you consider the fact that the average diabetic person uses between one and three vials per month.[5] Presently, a diabetic person without insurance requiring three vials per month could expect to pay at a minimum of $825 a month for just insulin alone.[6] Some people have even reported paying as much as $2880 for a month’s supply of insulin.[7] The exact reason for this stark increase in price is not uniformly agreed upon. Still, it’s speculated that it is a result of multiple “opaque” transactions among wholesalers, pharmacies, and manufacturers.[8] With figures this high, it is unsurprising that 27% of diabetics report that affording insulin has impacted their daily life.[9]
The financially vulnerable are particularly put at risk by these exorbitant list prices. Being economically vulnerable and diabetic requires people to make sacrifices in other parts of their lives to keep affording insulin.[10] These sacrifices include staying at undesirable jobs, maintaining unhealthy relationships, foregoing higher education, selling valuables, and rationing food.[11] However, sometimes, even these sacrifices aren’t enough. In 2017, after aging out of his mother’s health insurance and despite making above minimum wage, Alec Smith, a 26-year-old diabetic man, died because he wasn’t able to afford enough insulin to live.[12]
Tragic losses of life, like Alec’s, are entirely preventable, and there are a number of potential solutions that can fix or at least ameliorate the situation. Finding methods to prevent “patent evergreening ” is one of the possible solutions to the insulin crisis.[13] Evergreening occurs when brand-name companies patent “new inventions” that, in actuality, are simply old drugs with slight modifications.[14] Evergreening a patent can be done in various ways such as by “stacking patents,” (covering one drug with multiple patents) or by making small improvements to the drug and then pulling the old drug from the market.[15] Insulin, like many other drugs, has fallen prey to such evergreening.[16]
Traditionally, patent monopolies on drugs eventually give way to generic competition after the patent expires. Upon expiration of the original patent other entities are allowed to produce the drug.[17] Evergreening, however, delays this process. The generic competition of once patented drugs is critical for consumers, consistently reducing the price of the drug by over 50%.[18] However, the unique development of insulin has allowed its formula and delivery to be continually improved upon since its discovery and first isolation.[19]
Evergreening can essentially re-patent a drug, thus substantially extending the life of the monopoly granted to drug companies for their product.[20] As a consequence, by “evergreening” a patent, drug companies can effectively prevent biosimilar, or generic versions of that drug from being sold for far longer than the twenty years of a standard patent. Although there may be no protections remaining on the original formula, the “stacked” patents around that formula may cause it to be economically impossible to produce the original formula.[21] For example, Sanofi’s insulin, Lantus, has 74 patents associated with it, which will work together to protect it from generic competition for 37 years into the future.[22] Stacked patents not only discourage competition, but they also are incredibly effective at squashing potential patent infringers. Unsurprisingly, drug companies with multiple patents on their drugs are able to win 65% of the infringement cases against their drug.[23]
Closing the loopholes that allow evergreening patents is a bipartisan issue. President Trump has even stated, “[o]ur patent system will reward innovation, but it will not be used as a shield to protect unfair monopolies.”[24] There is no question as to whether modern insulin is better than what we had in 1921; its formula, dosage, and administration improved beyond belief.[25] What used to be riddled with impurities is now a work-horse of a drug. However, it is highly questionable whether each small step in the lineage is deserving of patent protection.[26]
A potential solution to prevent patent evergreening would be to modify the “inventiveness” standard required to obtain a new patent on drugs.[27] By modifying this standard, the goal would be to stop non-inventive and commonly practiced pharmaceutical techniques from receiving patent protection.[28] Moreover, each incremental improvement must be worth the burden on the consumer, especially in a country where the price of insulin has reached unconscionable levels.[29] Therefore, to be considered inventive, the newer formula or methodology should be demonstratively safer or clearly more efficacious.[30] Increasing the scrutiny would help control drug companies receiving patents on non-inventive, incremental improvements on insulin while still rewarding them for making sizable leaps forward.[31] Further, increasing the “inventiveness” standard would also encourage generic drug companies to enter the market. Previously, generic companies were precluded from producing generic insulins because patents protected the original formulas for such long periods of time that they were obsolete when it became possible to make a generic version.[32] These obsolete versions of insulin were not viewed as a worthwhile investment to generic drug companies, so the market has been mostly devoid of generic versions.[33] However, generic drug companies have shown some interest in creating generic versions of the next-generation of insulin. Reducing evergreening by raising the inventiveness standard required for new insulin patents could be enough to make manufacturing generics a worthwhile investment.[34]
Affording greater scrutiny to the issue of whether an incremental improvement is truly “inventive” is just one piece of the solution to reducing the price of insulin to affordable levels. Evergreens are a symbol of vitality; the irony is tangible that something of the same name can be depriving people of life.
[1] The History of a Wonderful Thing We Call Insulin, American Diabetes Association (July 1, 2019), https://www.diabetes.org/blog/history-wonderful-thing-we-call-insulin.
[2] Id.; Press Release, CDC, New CDC report: More than 100 million Americans have diabetes or prediabetes (July 18, 2017), https://www.cdc.gov/media/releases/2017/p0718-diabetes-report.html.
[3] Ritu Prasad, The Human Cost of Insulin in America, BBC (Mar. 14, 2019), https://www.bbc.com/news/world-us-canada-47491964.
[8] Ginger Vieira, Why is the Cost of Insulin Rising and What Can People Do About It?, Healthline (Oct. 2, 2018), https://www.healthline.com/health-news/why-is-the-cost-of-insulin-rising-and-what-can-people-do-about-it.
[13] Serena Gordon, Why isn’t there Any Cheap, Generic Insulin?, WebMD (Mar. 18, 2015), https://www.webmd.com/diabetes/news/20150318/why-isnt-there-any-cheap-generic-insulin#1.
[14] Roger Collier, Drug Patents: the evergreening problem, 185 CMAJ JAMC 385, 385–86 (2013).
[15] Janet Freilich, The Paradox of Legal Equivalents and Scientific Equivalence: Reconciling Patent Law’s Doctrine of Equivalents with the FDA’s Bioequivalence Requirement, 66 SMH L. Rev. 59, 86 (2013).
[17] Jeremy A. Greene & Kevin R. Riggs, Why Is There No Generic Insulin? Historical Origins of a Modern Problem, 372 New Eng. J. Med. 1171, 1174 (2015).
[18] Overpatented, Overpriced: How Excessive Pharmaceutical Patenting is Extending Monopolies and Driving up Drug Prices, I-MAK, http://www.i-mak.org/wp-content/uploads/2018/08/I-MAK-Overpatented-Overpriced-Report.pdf (last visited Sept. 13, 2020) [hereinafter I-MAK Report 1].
[20] Id.
[21] Freilich, supra note 15, at 86.
[22] I-MAK, Sanofi’s Lantus is Overpatented and Overpriced, T1International (Nov. 1, 2018, 4:21 PM), https://www.t1international.com/blog/2018/11/01/sanofis-lantus-overpatented-and-overpriced/.
[23] Freilich, supra note 15, at 87.
[25] See Gordon, supra note 13.
[26] See Greene, supra note 17, at 1173.
[27] Patent Policy Prescriptions, I-MAK, http://www.i-mak.org/wp-content/uploads/2018/11/I-MAK-Policy-Prescriptions.pdf (last visited Sept. 13, 2020) [hereinafter I-MAK Report 2].
[29] Greene, supra note 17, at 1173.
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