Loyola University Chicago School of Law, JD 2023
As you read this, you’re most likely using a phone or laptop that carries a few patents. A patent is awarded to a person or company in order to protect their intellectual property. Protection of intellectual property rests on the idea that one should be compensated for the time and effort required to produce the patented medium, while others should not be able to profit from the work of another. The patents awarded to your phone or laptop manufacturer allow them to recoup research and development expenses and remain competitive against competition. However, the patent system can be abused through patent evergreening and patent thicketing. Evergreening is the practice of obtaining a secondary patent on a slightly modified version of the original patented medium. Thicketing protects the patented medium by creating a web of overlapping or interdependent patents. Recent legislation aims to empower the FDA to decline patent extensions when the slightly modified version of a drug does not yield a clinical benefit.
May your prices be evergreen and your IP always protected
Evergreening can be accomplished by securing different types of patents such as a dose patent or an enantiomeric patent. These secondary patents protect something other than the actual pharmaceutical ingredient responsible for drug efficacy, which is protected by the primary patent. An enantiomer patent secures protection for an isolated compound, the enantiomer, that was previously part of a mixture or racemate. An enantiomer is the non-superimposable mirror image of a structure, similar to when one holds up their hand to a mirror. In terms of patent protection, this means a patent for the useful “right-handed” compound can be evergreened into protecting a “left-handed” version of the same compound that offers little benefit to the consumer while increasing drug prices. The utility of an enantiomer, measured in terms of clinical efficacy, may not be greater than the original compound. In some cases, an enantiomer can be harmful to consumers, as was the case with thalidomide, where the S-enantiomer caused severe birth defects following use during pregnancy. Illustrating the important role of the FDA in safeguarding consumers, the FDA denied approval at the urging of Dr. Francis Oldham Kelsey, saving millions of children from suffering the effects of thalidomide.
Evergreening’s impact on drug prices
Patent evergreening is a significant factor in the increased costs of care. Between 2005 and 2015, approximately seventy-eight percent of patents awarded to drugs were awarded based on an existing drug. For example, AstraZeneca held a patent on Prilosec, a drug used to treat heartburn, ulcers, and GERD. When AstraZeneca’s patent on Prilosec was due to expire they filed for a patent on Nexium. The only difference between Prilosec and Nexium is that Prilosec contains both the R-enantiomer and S-enantiomer, while Nexium contains only the S-enantiomer.
Nexium contains the same active agent as Prilosec, however a non-beneficial mirror-image version of that active agent, the R-enantiomer has been removed. A review of the drug concluded that “there was no significant difference in the therapeutic success” between Prilosec and Nexium, and suggested the efficacy of Nexium is due in part to a change in dosage. The Nexium patent is a secondary chiral switch patent and therefore does not protect novel research or a distinct compound. From an economic perspective, the Nexium patent isn’t necessary to help AstraZeneca recoup research expenses they would otherwise be unable to recoup. Each time a company extends a patent by evergreening, it prevents other companies from introducing a lower-cost generic form of the medication.
Patent legislation and FDA power
Empower the FDA to decline granting patents and patent extensions is vitally important, as patent abuse is unlikely to be resolved through antitrust lawsuits due to a 2020 ruling that a patent thicket was not an abuse of intellectual property. The court held that despite a dense thicket of patents held by the pharmaceutical company AbbVie on their drug Humira, the patents were not a cause of action for an antitrust case, which weakens the ability of the Department of Justice and Patent and Trademark Office to combat patent abuse.
In response to rising drug prices and abuse of the patent system by secondary patents, Senator Tina Smith (D-MN) and Senator Bill Cassidy (R-LA) introduced a Bill targeting evergreening called the Ensuring Innovation Act. The Act was signed into law by President Biden on April 23, 2021. The Act is a response to a ruling that enantiomers were an adequate reason for extending a drug patent. Under that ruling, a company may extend a patent by obtaining an enantiomeric secondary patent, such as the Prilosec to Nexium example. The Act effectively overturns this ruling, allowing the FDA to decline approval for enantiomers and increase federal oversight of pharmaceutical patents. With legislation that enables the FDA to combat patent abuse through the FDA’s drug approval power, consumers are likely to see decreased drug prices due to increased competition and the introduction of lower cost generics. The Act is also likely to encourage the development of truly innovative new drugs by reassuring companies that secondary patents will not block their efforts to deliver new drugs.