Patent thickets – good, bad or simply ugly?
Patent thickets have long been a point of controversy in the life sciences industry. By design, patents are intended to incentivize the R&D innovation and capital investment needed to bring new drugs to market with the promise of exclusive rewards downstream. But a wave of patent legislation passed in the US in the 80s broadened the scope of patentable subject matter and strengthened patent rights significantly, opening the door for a new, arguably anticompetitive practice often employed by bigger pharmaceutical companies to protect their R&D investments by preventing generics or biosimilars from entering the market for years beyond the original drugs’ initial patent coverage period.
Ethicists claim that patent thickets drive up drug prices, slow down research and ultimately impact patients’ ability to access care. IP advocates assert that patent thickets are simply a natural product of the competition required to drive the innovation that makes treatments available in the first place. But how do patent thickets really impact R&D in the life sciences?
What is a patent thicket?
A patent thicket is a dense knot of often overlapping patents carefully constructed to protect a particular product or technology by inhibiting or preventing generics or biosimilars produced by competitors from entering the market. Patent thickets often include patents which cover similar or the same subject matter. To quote one patent researchers, branded pharmaceutical companies’ patent portfolios often look like the “many-headed hydra from Greek mythology”.
In order to develop generic or biosimilar drugs, competitor pharmaceutical companies need to either wait for the patents which cover the original drug to expire, or they need to challenge each patent by arguing that the subject matter they cover is not novel or obvious.
The denser the patent thicket surrounding a drug, the more difficult and costly it is to break through it. As a result, patent thickets are an effective deterrent against the development of competitor generics or biosimilars.
Humira approaches the patent cliff
Patent thickets have re-entered the conversation this year as one of the most famous patent thicket cases – the blockbuster drug Humira – approaches key patent expiration in 2023. Humira, made by AbbVie, is the world’s top drug by sales, and it has long been surrounded by controversy due to the sheer number of overlapping patents that protect it – 257 in total, with protections that will run into the next decade, including a patent that covers the “firing button” of the Humira pen device.
To give you an idea of the density of the patent thickets which surround America’s top drugs, 584 additional patent applications were filed for the top five drugs in the US (Humira, Enbrel, Keytruda, Revlimid and Imbruvica) after initial FDA approval, gaining in one case, an additional 28 years of patent protection beyond the key patent expiration.
Thickets like these have come under increasing scrutiny, particularly in the US, where the public pays higher prices for drugs than anywhere else in the world. Last year, a bipartisan group of US Senators formally requested that the US Patent and Trademark Office make decisive moves to clear out patent thickets they believe inflate drug prices and stifle healthy competition, and combating high drug prices has been firmly on the agenda for the Biden administration. In 2021, the President passed an Executive Order that clearly pointed to the misuse of patents to “inhibit or delay generic drugs and biosimilars” as a key driver of drug price inflation.
The problem with upstream patents
One of the primary concerns around patent thickets is that many are constructed around basic upstream research technologies, making it increasingly difficult to conduct effective biomedical research without risking patent infringement.
One famous case of upstream patents restricting research was the “golden rice” development process. Scientists developing the vitamin A-elevated genetically modified crop apparenetly came up against over 70 different patents hindering their ability to conduct the foundational research required to take the project to completion. In this case, the relevant patent holders agreed to license the technology needed for free (primarily because the project was in aid of a humanitarian cause, not for-profit).
However, while upstream patents covering basic research technologies are troubling in principle, there is no clear evidence to suggest that upstream patents have any major impact on biomedical R&D efforts, specifically in academia.
Avoiding patent thickets with Similari
For researchers and R&D teams, patent thickets present an expensive dead end to R&D efforts. But due to their complexity, they can be difficult to avoid without a clear overview of the patent landscape for the field of research you’re working in. As a result, many researchers spend hours every week manually monitoring data for patent news and competitor intelligence to ensure that resources aren’t being directed toward protected targets.
The AI-enabled Similari insights management platform allows researchers and R&D teams to offload up to 90% of this manual data monitoring time, providing you with a moment-by-moment crystal-clear picture of your defined arena of inquiry. By monitoring millions of deep data points across your field, Similari is able to deliver actionable insights and the latest patent and clinical trial news, much of which is invisible to traditional search methods.
Find out how Similari can help you navigate and avoid patent thickets by trying a free demo today.