Do Pharmaceutical Patents Do More Harm Than Good?

Pharmaceutical patents are the backbone of the modern pharmaceutical industry. They allow drug developers to possess exclusive rights in their inventions for a limited period of time. That exclusivity drives innovation and is critically important to a pharmaceutical company’s return on investment.
Developing a new drug is risky and costly, with recent estimates ranging from $314 million to $2.8 billion. With so much at stake, it is imperative for pharmaceutical companies to secure patents on their drug products to prevent competitors from copying or selling them without permission. A patent safeguards a company’s goal of recouping substantial costs associated with the research, development, and clinical trials of new drugs.
Despite the obvious benefits of pharmaceutical patents, they are also a source of contentious debate concerning issues of unaffordable drug pricing, accessibility to medication, and unfair competition. Many argue that pharmaceutical patents cause more harm than good. For example, given that a patent effectively grants a monopoly over a drug for the life of the patent, patent owners may charge higher prices to secure higher profit, knowing a competing drug or generic version is unable to enter the market during that time. This can be problematic if it causes life-saving medications to become unaffordable.
This article discusses how a pharmaceutical patent works, its role in drug development, and the polarizing impact it has on global health care.

What Is a Pharmaceutical Patent?

A U.S. patent is a legal right granted by the government to an inventor “to exclude others from making, using, offering for sale, or selling the invention throughout the United States” for a limited time — usually 20 years from the patent’s filing date — in exchange for public disclosure of the invention. See, 35 USCS Section 154.
Pharmaceutical patents are granted for newly invented drugs that are: directed to patentable subject matter; novel or new; useful; nonobvious; and clearly described to enable a person of ordinary skill in the art to make and use the invention.
The process of obtaining a pharmaceutical patent is complex, rigorous and time-consuming. Pharmaceutical companies begin by performing research and development to discover new compounds and therapeutic agents in potential drug formulations. The R&D process generally involves years of laboratory work, animal testing and clinical studies.
Once a new drug or pharmaceutical agent is identified, the inventor can file a patent application with a patent office. The application must include specific details about the invention, such as its chemical structure, the method of production, and the intended therapeutic use. The U.S. Patent and Trademark Office (USPTO) offers guidance and tools to assist with filing patent applications.