Between 2005 and 2015, nearly three-fourths of issued drug patents were for already existing drugs. A common argument in favor of the current patent approval process for drugmakers is that it promotes innovation through competition and leads to the creation of novel, lifesaving drugs. This statistic is proof that the result of exclusivity is stagnation, not innovation.The pharmaceutical industry is more focused on preserving the quality of their cash-cow drugs rather than developing new ones, which is indicative of the broader profit-focused goal of the medical industry.
Name-brand drug makers often abuse the patent system in order to prevent other companies from selling off-brand or generic versions of the same drug. When a manufacturer creates a new medication, the company applies for a product patent, which gives them ownership over the product for 20 years. For those two decades, it is prohibited by law for other companies to produce the same product, which allows the initial drugmaker to generate enough profit to cover the development costs of the drug. When the patent expires, other pharmaceutical companies are free to mass produce the drug and sell it at a lower cost once they’re able to prove the bioequivalence of the two products.
The current medical patent system incentivizes hoarding intellectual property and doesn’t allow for true competition among companies. Large pharmaceutical companies leverage their power to keep their drugs exclusive for longer than allowed by an initial patent. Since new name brand drugs are the only version of their kind on the market, big pharmaceutical companies can continue pricing their name brand drugs as high as possible due to the lack of competition. More than half of respondents who have insurance are afraid they won’t be able to afford their drugs either, while approximately 60% of Black adults as well as nearly 70% of Hispanic adults have the same fear. This is not indicative of a healthy system focused on affordable health care.
However, many companies use loopholes to extend the life of their patents beyond 20 years in order to make it impossible for competitors to sell their drug at a more affordable cost — a process called evergreening. Biosimilars are drugs that are chemically near identical to brand name drugs, but are significantly cheaper than name-brand options, usually by at least 30%. Generics like these are the real backbone of medical care in the United States, providing affordable treatment to the sick and needy who aren’t able to afford expensive brand name drugs.
Though these affordable options can save lives, they threaten profits for manufacturers. There are various methods routinely employed in the health care industry to ensure that brand name drugs and goods continue to turn a profit for the foreseeable future. Many companies, like AstraZeneca, add secondary patents to the original, known as a patent thicket, to extend the duration of a drug’s exclusivity by patenting different, unrelated aspects of it — like the cap for an inhaler. These additions often add little of substance to the drug’s quality or treatment capability, serving instead to make sure the original drug stays exclusive and profitable for just a little while longer.
Other methods for restricting patent proliferation include Big Pharma companies settling legal challenges to their patents in court. Less successful companies sue pharmaceutical companies to challenge their drug patent, seeking to produce a generic drug themselves. Big Pharma will offer cash settlements to drop the challenge, and as a result these powerful pharmaceutical industries can keep generic drugs off the market for a little bit longer. Most insidiously, these companies will actually prevent generic companies from accessing drug samples and therefore prevent them from recreating said drugs and putting them on the market even after the patent expires. As of March 2016, the FDA has received roughly 150 complaints about this exact behavior from generic companies.
Though it’s unlikely that there will be any major action taken towards the healthcare industry given the current administration’s sentiments against regulation, addressing these abuses is the U.S. government’s responsibility.
High drug prices are a direct result of these strategies used to delay the availability of generic options in a timely manner. There are several regulations policymakers should implement to prevent patent abuse. The Patent Thickets Act of 2024 would prevent duplicate patents, by limiting the number of patents pharmaceutical companies can use in court cases, preventing them from suing competitors that develop biosimilar or generic drugs. The bipartisan bill will drive down drug prices, but has yet to pass the House. The Medication Affordability and Patent Integrity Act of 2023 requires that brand name drug makers disclose information pertaining to their drugs’ design to the United States Patent and Trademark Office, which gives the USPTO the information they need to determine whether further patents requested by the manufacturers are legitimate, or unnecessary.
To put a stop to the abuse of patent regulations in the United States, regulators need to take a firmer stance against large pharma companies taking advantage of the rules. The USPTO has a clear, unfulfilled responsibility to strike down flimsy secondary patents from drugmakers. The decision to do so would forego the revolving door of opportunities and positions that result from cutting these large corporations so much slack, but it would be the right decision to ensure the affordability of medication in the United States.
WSN’s Opinion section strives to publish ideas worth discussing. The views presented in the Opinion section are solely the views of the writer.
Contact Noah Zaldivar at [email protected].
