Patents On Delivery Devices Can Extend Drug Patent Protection For Years, Study Finds

The number of patents for drug delivery devices has shot up in recent years, and has had the effect of significantly extending the protection enjoyed by patented pharmaceuticals, delaying cheaper versions of the drugs and leading to higher prices, a recent paper found. And in a Q&A below, one of the authors raises an issue for policymakers.

The study looked at patents on drug delivery services, such as inhalers or injector pens (like EpiPen), and found that such patents have tripled since 2000. This contributes a media of 5 years of additional market exclusivity to such products, it said.

The paper, entitled, “Tertiary patenting on drug–device combination products in the United States,” was published in the February edition of Nature Biotechnology, and is available here.

The authors, Reed F. Beall and Aaron S. Kesselheim, are at the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School, Boston.

The study also identified a subset of 31 products that only had patents pertaining to the delivery device listed with the US Food and Drug Administration – not the drug it delivered. The patents had expired a median of 17 years after FDA approval.

Tertiary patents are a form of patenting that can carry patent protection on for many years after the expiration of all secondary and primary patents. The study was also reported about here.

Below is a short prepared Q&A with author Reed Beall.

1)      What was the most surprising finding within this research?

Beall: I was surprised at the large number of tertiary patents added to the Orange Book each year, which appears to be outpacing the addition of all other kinds of patents. These modifications can keep delay generic entry for years, even when there is no measurable clinical benefit from these updates.

2)      What implications do your findings have for drug manufacturers?

Beall: Addressing the issue of tertiary patents and the extent to which they cause unavailability of low-cost generics should be a priority. I believe it would be better if drug manufacturers had to show compelling clinical evidence that a new patented feature of its delivery device actually added clinical value before that patent could be listed in the Orange Book.

3)   How do your findings compare or contrast with the existing conventional wisdom about combination products within the industry?

Beall: I think the conventional wisdom is that combination products can be innovative and very useful for patients, and certainly that’s true in many cases. But I don’t think many people – or policymakers – realize that the current Orange Book patent listing system for these products can also be gamed to unduly delay generic entry.

[Note from the FDA website: “The publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act) and related patent and exclusivity information.”]