FTC to scrutinize patent strategies impacting inhaler costs

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The strategies under scrutiny involve patenting various aspects of drug products and listing those patents in a federal registry known as the Orange Book. By doing so, companies can potentially deter rivals from introducing competing generic products. In some cases, such listings can prevent federal regulators from approving a competitor’s generic product for over two years.

The FTC’s focus is on the inappropriate listing of patents in the Orange Book, which may be inhibiting generic competition. Some companies have listed patents on inhalers, injector pens, and other devices that don’t directly pertain to the medication they deliver. For instance, patents have been found for containers, rubber straps, and dose counters tracking the number of remaining puffs for a patient.

While no specific products were singled out in the policy statement, an FTC official disclosed that agency staff had identified numerous inhaler patents potentially violating federal law.

This issue is significant as it might contribute to unaffordable medical and drug products. A crackdown on improperly listed patents in the Orange Book wouldn’t immediately impact inhaler product prices. However, it could expedite the availability of lower-priced generics.

Drugs used to treat asthma and chronic obstructive pulmonary disease are generally decades old and have lost patent protection long ago. Despite this, pharmaceutical companies have managed to maintain revenue streams by introducing new patent-protected devices to deliver these drugs.

An example is Boehringer Ingelheim’s Combivent Respimat, an inhaler product introduced in 2011. It combines two drugs first approved in the 1980s, with patents listed in the Orange Book only covering aspects of the inhaler device, not the drugs themselves. The inhaler, costing hundreds of dollars, currently faces no generic competition. The FTC’s new policy could potentially change this situation, paving the way for more affordable alternatives in the future.

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