Image via Yahoo
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In January of 2024, a 22-year-old Wisconsin man visited his local Walgreens pharmacy to fill his usual inhaler prescription. Upon arrival, he was informed that his typical $66 bill would now cost him about $540. Leaving the pharmacy without his medication, Cole Scmidtknecht died less than two weeks later from a severe asthma attack. His parents took action against the pharmacy benefits manager, Optum Rx, for failing to inform Scmidtknecht of the price change or offering any more-affordable alternatives.
Unfortunately, this is just one of many examples demonstrating the current epidemic of rising drug prices. Currently, the total U.S. spending on prescription drugs amounts to an estimated $800 million. While low-cost generic drugs make up around 91% of all prescriptions, the remaining 9% of prescriptions that are filled with big-name brands account for over 80% of total drug spending. The pharmaceutical industry has become an oligopoly, in which big companies have gained full control over setting drug prices. This is due to an abuse of the current U.S. patent system, which has allowed Big Pharma to hike prices on both existing drugs and new products, all while preventing new drug manufacturers from entering the market.
How do we find the balance between intellectual property protections and medical innovation? The modern patent system dates back to the 17th century, and has since become the main form of protection for intellectual property. Patents provide innovators with the exclusive right to manufacture and sell their invention. They can, however, have detrimental effects on consumers.
Pharmaceutical patents typically offer 20 years of protection. In the absence of this protection, drug developers would likely be hesitant to invest in new treatments, as they would make minimal return on their investments. Developing new treatments can be extremely costly, but patents allow manufacturers to protect their products, and make back the money they put into their work. Pharmaceutical company Eli Lilly invested $10 billion into research and product development for Donanemab, one of the first FDA-approved medications for slowing Alzheimer’s development.
This patent system, however, allows drug manufacturers to set their prices at artificially high costs for extended periods of time, straining the budget of patients for whom these drugs are essential. Donanemab treatment has an annual cost of $32,000. Director of Medicines at the National Institute for Health and Care Excellence (NICE), Helen Knight, said that “the cost effectiveness estimate for donanimhaber is five to six times above” what is acceptable.
As mentioned, standard drug patents provide drug developers with a standard 20 years of protection. To extend this lifespan, big companies can employ a number of methods, with the two most common being evergreening and patent thickets. Evergreening refers to the practice where companies make minor changes to their products, allowing them to file new patents for virtually the same product. Examples of these minute changes include alterations in dosage and method of administration. This allows companies to maintain their control of the drug market by delaying the entry of cheaper, more generic drug manufacturers. One 2018 research paper found that 78% of drug patents in the United States between 2005 and 2015 were not for new drugs, but rather existing ones that had been altered in some way.
Patent thickets are another common practice, with which companies hold multiple patents for products and processes related to their drugs, creating a web of patents around a single product. This makes it much more difficult for generic brands to enter the market. Johnson and Johnson’s Xarelto is a prime example of a patent thicket, for which the company filed over 45 patents over the span of a decade.
The increasing exclusivity of drugs, paired with the current state of inflation, has made the need for action more evident than ever. In July of 2024, the Senate passed the Affordable Prescriptions for Patients Act. This bill limits the number of patents a drug/health-product manufacturer can assert in an infringement lawsuit against a company seeking to sell a similar product. Essentially, it restricts big pharma companies from using their excessive number of patents to take down smaller manufacturers.
As with any proposed legislation, there were some who strongly opposed the bill on the grounds that weakening patent protections would reduce incentives for investment into drug development. Vice President for Intellectual Property at the Biotechnology Innovation Organization (BIO) provided testimony before the Senate Subcommittee on Intellectual Property, during which he emphasized the importance of patents in relation to technological innovation. He argues that invalidating patents, or denying applications, could deter manufacturers from investing in research and development, delaying new cures and treatments for patients.
Many also believe that terms like “evergreening” and “patent thickets” are simply buzzwords that oversimplify the issue at hand. The Council for Innovation Promotion claims that the number of patents on a product is not indicative of market exclusivity, as the claims of each individual patent can vary. They also note that any additional patents filed on a product only protect the specific improvement being made, and original patents expire as they were originally scheduled to.
The debate over pharmaceutical patent law touches on issues of public health, economic fairness, and the rights of innovators. While patents are essential in promoting the development of new drugs and health care products, there must be a balance in order to protect the public’s need for affordable access to essential medications. The challenge lies in creating a system that both rewards innovation while ensuring that life-saving treatments are available to those who need them at an affordable price.
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This article was edited by Cameron Ma.
Renee Agostini 
John Virgil Aton 
Nia Cruz