Biden Administration report debunks myths around patent “evergreening” and “thickets”

You may have missed that earlier this summer the Biden administration’s U.S. Patent and Trademark Office (USPTO) released a report on its long-awaited Drug Patent and Exclusivity Study. The study was conducted in response to a 2022 request from Congress to fact-check the outlandish claims made by patent critic groups like the Arnold Ventures-funded Initiative for Medicines, Access, and Knowledge (I-MAK).

The USPTO conducted an independent analysis of data associated with 25 New Drug Applications (NDAs) listed in the Food and Drug Administration’s (FDA) Orange Book between 2005-2018 and mapped the scope and duration of patent protection and regulatory exclusivities associated with those small molecule products.

In doing so, the report discredits I-MAK’s false claims about patent system abuse, which have been repeated ad nauseum by members of Congress and the media and found what innovators across industries have known since the country was founded: intellectual property (IP) protections are the lifeblood of American innovation and fuel our global leadership. Notably, the study specifically confirms that strong IP protections foster innovation across industries, debunks patent critic assertions in regard to “evergreening” and “patent thickets,” and corrects the record on patent exclusivity periods.

Here are five of the study’s key findings:

1. The study states how IP fuels innovation across industries. “In the cycle of innovation, inventors build upon the knowledge and advancements of those that came before them. The patent system helps accelerate this cycle through disclosure of these innovations and in incentivizing research and development. Using the patent system to protect these later innovations that build upon earlier patented inventions is a common business practice in many, if not all, industries.”

2. The study debunks claims that allege biopharmaceutical companies engage in “evergreening” when obtaining patents at different points in a product’s life cycle. “[A] patent applicant cannot be granted two patents for identical inventions. Once a patent term ends, the claimed inventions are in the public domain, regardless of whether any continuation applications were filed.”

3. The USPTO’s analysis also puts to rest the misguided claims of “patent thickets,” concluding that simply counting the number of patents on a product is not a reliable way to determine a drug’s exclusivity period and “can be misleading.” “The results illustrate that simply quantifying raw numbers of patents and exclusivities is an imprecise way to measure the intellectual property landscape of a drug product because not every patent or exclusivity has the same scope. For example, one patent could contain different sets of claims directed to: (1) a pharmaceutical product, (2) a method of using the product, and (3) a process for manufacturing the product.”

4. The study also highlights that simply “counting the number of patents on a product is not a reliable way” to determine exclusivity and the entry of generic products. “The study observes that patent expiration dates, like the number of patents, may not be predictive of the timing of actual launch of competing products... because not all listed patents may be infringed by a generic product or the patent owner and generic drug applicant agree upon a launch date before patent expiration.”

5. The study also discredits patent critics’ calculations of the duration of time a medication has exclusivity, including the use of abandoned and pending applications in the calculation of product exclusivity periods, because such data does not provide a “meaningful metric” in this calculation. “As a general matter, mapping the scope and duration of patent protections and [FDA regulatory] exclusivities associated with a particular FDA-approved drug product can be complex and may inform but not fully reflect the time it took (or can be expected to take) for a generic version of that product to come to market. In some cases, however, the timing of the entry of generic products is not fully reflected by a computation of patents and exclusivities and competition could be affected by other factors.”

USPTO’s findings confirm that assertions touted by patent critic groups that the patent system is broken and rampant with abuse are baseless. Attacking our IP system runs counter to the goal of getting the benefits of innovation, competition and lower costs to patients.

It's time for the Biden administration, Arnold Ventures-funded researchers and others to stop misguided attacks on the IP system and instead focus on those who are truly responsible for increasing costs and barriers for Americans at the pharmacy, like insurers and their PBMs.