Hi Monesh, fascinating read! As someone with a grandmother suffering from Alzheimer's, and also having taken Professor Heller's property class this semester, I was interested in the overlap between these topics. The momentary component preventing medical advancements from being used by those who need them is heartbreaking. Another component of Alzheimer's that makes combatting it such a challenge is how often the disease is accompanied by Parkinson's and dementia. It's been really hard watching someone I love battle these degenerative conditions, and I am hopeful that Leqembi will provide a reasonably-priced solution in the future. It is unfortunate that current intellectual property rules and strategies place families between a rock and a hard place. While I try to remain hopeful, I feel this is the type of issue that may not be addressed without massive outcry. Those intent on keeping existing practices in place have massive amounts of money to lose if mechanisms such as evergreening are taken away. As a result, I worry they will remain in place until there is an even larger force pushing against them to oppose the ones supporting them. Thanks for sharing.

-Michael

An Illustration of the Problem

Alzheimer's, a debilitating neurodegenerative disease, affects up to one in nine Americans aged 65 and older.¹ While most are aware of the condition’s effects on cognitive functioning, many aren’t aware that Alzeimer’s kills one third of the affected population. With these staggering statistics, one would reasonably expect that a vulnerable population such as the elderly would have adequate means to combat the devastating effects of the relatively common disease. But a closer inspection would reveal the bleak circumstances for an individual with this disease; treatment costs are incredible, with the latest treatment (a drug called Leqembi) costing patients $26,500 annually.² As there exists very little Medicare coverage for the drug, treatment is prohibitively expensive for most Alzeimer’s sufferers.² Families that decide to shoulder treatment costs end up spending an enormous $340,000 over the lifetime of the afflicted individual.³

The Anticommons

How can one explain the incredible burden placed on individuals with Alzheimer's and their families with the fact that pharmaceutical companies such as Eisai (manufacturer of Leqembi) boast remarkable revenues off of their overpriced drugs, often reaching into the multi-billions of dollars?² The answer can be found in what Professor Michael Heller terms the anticommons: a calamitous phenomenon that occurs when property (including intellectual property) is excessively privatized and fragmented such that the resource ends up underutilized, imposing costs on society.⁴

For example, excessively partitioning a plot of land may lead to inefficient land uses since large scale machinery cannot be used by any individual owner to farm his plot without infringing on other owners’ property. However, as we have seen in our discussion of Alzheimer's, the anticommons has even more disastrous implications on society in the biomedical context, going beyond economic waste to leading to the deaths of millions of Americans directly – by imposing insurmountable costs on individual healthcare – and indirectly – by restricting research tools/knowledge so that future research initiatives are hindered.⁵ In this way, patent protection deviates from the purported rationale of ensuring fair compensation for research and development efforts to a system which solidifies wealth inequalities by validating corporate greed at the expense of victims of diseases.

Evergreening

Evergreening is one particular way in which the anticommons rears its ugly head in the field of biomedicine. In essence, evergreening is the manipulative strategy employed by drug companies to artificially extend patent protections through techniques such as developing new formulations of a drug, changing the dosage schedule, or applying for patents on different production/manufacturing techniques.⁶ This strategy allows the companies to extend their monopolistic advantage over the market by keeping out competitors from introducing biochemically similar products that would reduce drug prices. The dearth of legislative regulation on this issue is mind-boggling considering its prevalence – studies show that 78% of drugs that are associated with patents are existing drugs as opposed to novel drugs, and that 70% of the 100 best selling drugs have artificially extended patent protection in this manner.⁶

The existence of evergreening shows the ironic flaw of patent law. In purporting to encourage intellectual exploration to allow for technological advances for society to enjoy, the patent system goes well beyond just compensation for R&D and allows drug monopolies to be locked in for decades on end with arbitrary manipulations to drug formulations, preventing open-source research so that existing drugs can be improved.

A solution to this issue would be to strengthen the criteria of patent eligibility so that minor modifications to patents would not meet the bar of extending protection. Another solution, as Professor Moglen discussed in class, would be challenging bogus patents to expropriate them. This approach could be pursued through legislative means such as reversing the Patent and Trademark Office’s discretionary denial policy which would allow more patents to be reevaluated and struck down without incurring litigation costs.⁷

Negative Innovation

Another problematic manifestation of the anticommons in the field of biomedicine that completely contradicts intellectual property law’s goal of promoting innovation and useful technology is “negative innovation.” Negative innovation occurs when the protective incentives created by patent law actually encourages companies to bring their drug to the marketplace in a way that presents adverse health consequences to patients.⁸ This phenomenon can be observed in the case of ibrutinib, a drug used to treat lymphocytic leukemia discovered by the company Pharmacyclic.⁸ In ibrutinib’s case, the USPTO granted patents on the drug at several dosages based on the findings of early clinical trials, though the FDA suggested that Pharmacyclic explore the efficacy of lower doses in future developmental programs, as there were indications that such lower doses may be just as effective for treatment while mitigating the toxic side effects of the drug that is found in all cancer agents.8 However, since patents were only granted for the high doses, Pharmacyclic was effectively discouraged from exploring lower doses as a showing of efficacy at lower doses would undermine the current patent which was narrowly obtained and predicated on the fact that only higher dosages met the threshold of “non-obvious” which is required for a patent.⁸

Like evergreening, negative innovation flies in the face of what patent law purports to provide. Instead of providing a structure to encourage productive innovation for the benefit of society, companies are effectively gridlocked to not pursue improvements to their drugs so that they do not forfeit the protection they obtained. It is harrowing to consider that companies in such a position are likely to opt to continue providing unsafe products to vulnerable victims instead of risking other entrants in the market, but that is the unfortunate reality. Significant revisions must be made to our patent system to prevent gaming in this way. As it stands, patent law in biomedicine goes well beyond rewarding R&D by providing a grossly disproportionate benefit to IP owners to the degree that they are willing to risk human lives for profit.

Linked Bibliography

[1] Alzheimer’s Association. 2023 Alzheimer’s Disease Facts and Figures. Alzheimers & Dementia 2023;19(4). DOI 10.1002/alz.13016.

[2] Kimball, Spencer. “Most Alzheimer’s Patients Would Pay up to $26,500 per Year for New Treatment Leqembi.” CNBC, 10 Jan. 2023, www.cnbc.com/2023/01/09/most-alzheimers-patients-would-pay-up-to-26500-per-year-for-leqembi.html.

[3] Henry, Carly. “Alzheimer’s Disease Also Upends the Finances and Lives of Those Caring for Patients.” Cronkite News - Arizona PBS, 14 Dec. 2018, cronkitenews.azpbs.org/2018/12/13/alzheimers-impacts-caregivers-lives-and-finances/#:~:text=The%20Alzheimer%27s%20Association%20estimates%20the,the%20value%20of%20unpaid%20care.

[4] ​​Michael Heller, The Tragedy of the Anticommons: A Concise Introduction and Lexicon, 76 Mod. L. Rev. 6 (2013).

[5] Heller MA, Eisenberg RS. Can patents deter innovation? The anticommons in biomedical research. Science. 1998 May 1;280(5364):698-701. doi: 10.1126/science.280.5364.698. PMID: 9563938.

[6] ​​Robin Feldman, May your drug price be evergreen, Journal of Law and the Biosciences, Volume 5, Issue 3, December 2018, Pages 590–647, https://doi.org/10.1093/jlb/lsy022

[7] Kristi Martin, “Policymakers’ Attention Turns to Drug Patents in the Debate on Prices,” To the Point (blog), Commonwealth Fund, Oct. 7, 2021. https://doi.org/10.26099/NJXV-MB86

[8] Feldman, R.C., Hyman, D.A., Price, W.N. et al. Negative innovation: when patents are bad for patients. Nat Biotechnol 39, 914–916 (2021). https://doi.org/10.1038/s41587-021-00999-0