As the U.S. Supreme Court considers a case involving a cholesterol lowering drug, a West Virginia University College of Law professor said he believes pharmaceutical companies manipulate the patent system to maintain monopoly rights.

Sean Tu, who studies patents and how they influence drug prices and innovation, is available to explain why the outcome of Amgen v. Sanofi, which he wrote about in JAMA, may have far-reaching effects on the pharmaceutical industry, patient welfare and treatment options.

A ruling is expected in June.


“Biologics are a class of drugs that represent only about 2% of U.S. prescriptions but account for 37% of the net drug spending. For example, adalimumab or Humira costs patients approximately $78,000 per year and has made the drug manufacturer, AbbVie, over $20 billion in 2021 alone. Manufacturers use the patent system to help protect these drugs from competition, allowing them to charge monopoly prices.

“In order to get broad protection to stop competitors from entering the market, biologic manufacturers have previously attempted to receive ‘functional genus’ patents. These patents can run afoul of patent law’s ‘enablement’ requirement.

“The enablement requirement is fundamental to patent law’s quid pro quo bargain. The enablement requirement demands that the patentee disclose how to make and use the invention without ‘undue experimentation.’ In exchange for this disclosure, the patentee gets the exclusive right to make, use and sell the claimed invention for about 20 years. The broader the claims, the more difficult it is to satisfy the enablement requirement. For example, the claim ‘a method of treating all cancers using drug X’ would be extremely broad. If I had only one example showing that drug X can be used to treat pancreatic cancer, then there will likely be undue experimentation to show that drug X can be used to cure all cancers. Currently, manufacturers would only be able to get a narrower patent for the use of drug X to treat pancreatic cancer.

“The Supreme Court has taken up the first patent enablement case in about 100 years. In the Amgen v. Sanofi case, Amgen received one of these broad functional genus claims from the U.S. Patent and Trademark Office. However, the lower court invalidated the patent as failing to enable the full scope of the claims. Now, the Supreme Court will determine if these broad functional claims will survive.

“This case will have a profound impact on patient welfare. If the Supreme Court allows these broad functional genus claims, then manufacturers will be prevented from creating new drugs to the same target. In essence, the first drug manufacturer who comes up with a new drug for a known target will be able to prevent all subsequent drugs to the same target. Patients will have fewer choices, leading to adverse outcomes. For example, some patients may not respond to the first drug, but would respond to a second drug, thereby leaving patients with no treatment options. Additionally, sometimes the first drug is pulled due to adverse side effects. If there are no alternative therapies, patients will again be left with no treatment options. Finally, patients may need a different drug if they become refractory to treatment with the original drug.” — Sean Tu, Professor, WVU College of Law