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US government warns pharma over drug patents

Updated: Sep 20

Words by GOLD newsdesk

a book, a lock, a lightbulb, a gavel, and a diploma

The Federal Trade Commission (FTC) has issued a statement cautioning US pharmaceutical companies against engaging in “improper” listings in the agency’s Orange Book – a register containing patents for approved drugs.

The move, made on 14 September 2023, was in response to requests by lawmakers who are concerned that companies are creating new patent listings to delay the entry of new generics into the market.

The statement from the FTC said that “improperly listing patents in the Orange Book may harm competition from less expensive generic alternatives and keep prices artificially high”.

In addition, if a generic company is sued by the originator company over a patent listed in the Orange Book, the FDA cannot approve a generic version of the drug for 30 months.

However, a spokesman from industry body PhRMA has come to the industry's defense and told FiercePharma that of the thousands of patents listed in the Orange Book since 2017, only 21 disputes have resulted in an update. PhRMA said that more guidance is needed from the FDA on these listings, and that the industry has been seeking this for some time.

As a result of this latest development, companies should be prepared for more aggressive patent enforcement by the FTC and should therefore exercise caution when listing new Orange Book decisions and when contemplating new M&A transactions.

The FTC statement is another in a series of blows to the US pharma sector, which is still reeling from the announcement of the first 10 drugs to be negotiated by Medicare under the Inflation Reduction Act, showing the country's increasing scrutiny of the industry's activities.

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