Strategic Patenting Stifles Antibiotic Innovation

By: Brian Wilmans

Antibiotics are one of humanity’s greatest discoveries. They’ve made it possible to eradicate instances where a cut on a finger could turn fatal due to bacterial infection.

However, today, antibiotics are losing their efficacy. The CDC tracked seven different strains of antibiotic-resistant bacteria from 2019-2022, and six out of the seven increased their prevalence by 20 percent.[1] Overprescription of antibiotics is certainly a contributing factor in the increase in resistance, but another factor is the decreased number of new antibiotic classes being brought to market. Since the first antibiotic, penicillin, was discovered in 1940, the largest gap between new types of antibiotics being invented had been 13 years.[2] We are now in year 15 since the last novel class of antibiotic was created. There are myriad reasons for that, from funding for R&D to decreased profit margin for pharmaceutical companies. However, another reason for it that may be more on the periphery: pharmaceutical companies’ practice of strategic patenting.

Strategic patenting is driven by pharmaceutical companies wanting to maximize their profit window while their patent is in effect. A patent term is 20 years, and the company which holds that patent will have exclusive rights to the drug and will use that to recoup on the massive R&D and production costs of bringing it to market.[3]

However, once the primary patent (the patent on the actual compound) expires, companies will try to patent other aspects of the drug that is secondary to its purpose.[4] This may include patents on its manufacturing processes, delivery, or any other elements that go into the final product for the consumers. Many of these patents are also for small, noncommercial aspects of the drug that do not enhance the performance, showing the profiteering nature of their creation.[5] This creates a massive web of protection via secondary patents that creates a bulletproof level of protection for the initial product and allows the pharmaceutical companies to extend the profit window of their drug.[6]

The question of whether strategic patenting is truly an issue must be asked. The costs for U.S. pharmaceutical companies to bring a drug from concept to market are tremendous. Due to the increase in consumer protectionism and regulation in the pharmaceutical development space, it is now estimated that the total cost to bring a new pharmaceutical to market is over a billion dollars.[7] However, strategic patenting does not seem to be about pharmaceutical companies not being able to recoup on their investment. If the drug is truly effective as the company believes, 20 years of exclusive use should be more than enough time to make back all of the input costs, with profit on top of that. This means that strategic patenting is not a necessity for “life-cycle management” of the patent as some of its proponents argue, but more a gross misuse of the good intentions of the patent system.[8]

So, how does secondary patenting create a deficiency in the pharmaceutical market for ample antibiotics? The answer is ironic, in that strategic patenting could be argued to hurt the pharmaceutical companies as much as it does the consumer. The extension of the patent life cycle shifts the focus of pharmaceutical companies from innovating new drugs to prolonging the life of old drugs, which actually takes away from the opportunity for them to create a new, groundbreaking drug from which to profit.[9] Instead of creating the next penicillin, companies such as Pfizer, AstraZeneca, and Johnson & Johnson are focusing on making incremental shifts in their current products, ones that they know can succeed in the marketplace and for which they already have patents in place that can be expanded upon with secondary patents. The practice has created a global issue: strategic patenting is stifling the innovation of the antibiotic marketplace by focusing attention on established products and trying to prolong their lifespan. This has created a gap in protection against bacterial infections that is not currently being met by the drugs at market.

The law of intellectual property and competition needs to come together to create a solution to this issue if we want antibiotics to continue to be globally effective. Let us consider, too, what disease treatment would look like if a solution is not found, and antibiotics continue to lose their efficacy. It will look like a much different world, one where we could once again be faced with dire health consequences from a simple cut on the finger.

 

[1] Antimicrobial Resistance Threats in the United States, 2021-2022, CDC (July 16, 2024), https://www.cdc.gov/antimicrobial-resistance/data-research/threats/update-2022.html.

[2]  C. Lee Ventola, The Antibiotic Resistance Crisis, 40 Pharmacy and Therapeutics 277, 278 (2015).

[3]  Olga Gurgula, Strategic Patenting by Pharmaceutical Companies – Should Competition Law Intervene?, 51 International Review of Intellectual Property and Competition Law 1062, 1067 (2020).

[4] Id.

[5] Id. at 1074.

[6]  Anti-competitive strategic patenting by pharmaceutical companies, Generics and Biosimilars Initiative (Dec. 2, 2021) https://gabionline.net/es/genericos/investigacion/Anti-competitive-strategic-patenting-by-pharmaceutical-companies.

[7] A new class of antibiotics is cause for cautious celebration — but the economics must be fixed, Nature (Jan. 3, 2024), https://www.nature.com/articles/d41586-023-04086-z#:~:text=A%20new%20antibiotic%20often%20costs,growing%20threat%20of%20antimicrobial%20resistance.

[8] Bhaven Sampat & Kenneth Shalden, Secondary pharmaceutical patenting: A global perspective, 46 Research Policy 693, 695 (2017).

[9] Dee Gill, $52.6 Billion: Extra Cost to Consumers of Add-On Drug Patents, UCLA Anderson Review (Apr. 24, 2024), https://anderson-review.ucla.edu/52-6-billion-extra-cost-to-consumers-of-add-on-drug-patents/.