Even if most of the time on the primary patent is taken up by development, secondary patents secure market secureness for more time!

[Dee, 4-24-24, UCLA Anderson Review, “$52.6 Billion: Extra Cost to Consumers of Add-On Drug Patents”, , accessed: 7-10-24, AngH]

In the $485 billion pharmaceutical industry, the 20-year primary patent on a drug starts with the discovery of a single new molecule that will, if all goes well, become the active ingredient in a new drug. Unlike tech inventions, molecules have specific structures that are easily differentiated.

While tech patents are often successfully challenged by holders of previous patents, primary drug patents are almost always enforced, Gupta explains in a phone interview. The near certainty of at least 20-year monopoly protections made the drug industry a particularly good subject, she says, for isolating effects of secondary patents from those of successful challenges to the core discovery.

Because much of a drug’s 20-year exclusivity period is eaten up by development, testing and regulatory approvals, branded drugs average about 10.9 years on the market with monopoly rights with the primary patent intact.

Gupta finds that secondary patents extend the average selling monopoly to about 13.4 years in her sample, or by about 22%. Generic competitors spend considerable additional time and money developing ways around the secondary restrictions — for example, formulating it into a capsule instead of the protected tablet — or fighting the protections with lawyers.

If all of the secondary patents are enforced, the time from the branded launch to generic protection would extend even further, to 17.6 years, the study finds. But in many cases, Gupta notes, generic manufacturers overcome secondary patent restrictions in litigation, especially on strong-selling brands they really want to copy. Blockbuster drugs saw generic competition much earlier than less popular drugs, the study finds.