(Health Korea News / Changyong Lee) Israeli pharmaceutical company Teva lost a patent lawsuit for an asthma inhaler in the United States. Due to this defeat, Teva’s asthma inhaler ‘ProAir HFA’ is in danger of being removed from the Orange Book of the FDA (Food and Drug Administration).
On the 20th, the United States Court of Appeals for the Federal Circuit (CAFC) ordered the U.S. District Court of New Jersey to delete several of Teva’s ‘ProAir HFA’ patents listed in the U.S. FDA’s Orange Book. The order of the District Court for the District of New Jersey was confirmed.
This patent lawsuit originated when the American pharmaceutical company Amneal sought FDA approval to launch a generic version of Teva’s asthma inhaler ‘ProAir HFA’ on the market, and Teva filed a lawsuit against Amneal.
Teva’s ‘Proair HFA’ is an asthma inhaler that contains the drug ‘albuterol sulfate’. Teva has registered 9 patents related to ProAir HFA in the FDA Orange Book, of which 5 patents are related to asthma inhaler parts. In other words, it is not related to albuterol sulfate, an ingredient in the inhaler drug.
Amnil argued that these five patents were not a type of patent eligible for patent listing. Amnil argued that these patents should not be listed in the Orange Book and requested that the patents be removed from the Orange Book.
This is not the only claim Amnil made. Amnil filed a counterclaim, claiming antitrust liability, claiming that the patent registration of ‘ProAir HFA’ unreasonably delayed the approval of its generic asthma inhaler product.
The New Jersey District Court agreed with Amneel. On the 20th, the Federal Circuit Court of Appeals also ruled that these patents listed in the Orange Book were not eligible for listing in the Orange Book because they did not contain active ingredients.
The Federal Circuit Court of Appeals said, “The fact that the FDA has approved Teva’s ProAir HFA product as a drug does not make the inhaler device components a drug.” It was only approved through the new drug approval application) route. Therefore, claiming a patent only for the function of a device such as an inhaler’s dose counter (a device that tells you how much medication is left) does not qualify for registration in the Orange Book,” he explained.
“For a patent to be listed in the Orange Book, it must claim an active ingredient or formulation, or an approved method of using the drug,” he said. “This is because the regulatory approval path for drugs focuses on the active ingredient. “Devices follow a separate approval path,” he emphasized.
“We are pleased that the court agreed that these inappropriate inhaler patent lists should be removed from the Orange Book,” the Federal Trade Commission (FTC) said in a press release. “Removing the junk patent list will help pharmaceutical companies better serve consumers.” “This is important to enable fair competition to provide generic medicines at low prices.” Junk patents refer to patents that do not actually produce technological innovation or that can simply be abused for the purpose of legal action.
The FTC has challenged more than 300 Orange Book patents on products from 20 brands last year and this year. This is because the patent was improperly or inaccurately listed in the Orange Book.
The Orange Book is a list of medications approved by the FDA as safe and effective. A pharmaceutical company’s listing of a patent in the Orange Book can usually lead to a statutory moratorium that blocks the introduction of competing drugs, including lower-cost generic alternatives, for 30 months.
Meanwhile, the Korea Biotechnology Association commented on this ruling, saying, “As domestic bio companies advance overseas and expand their presence, patent dispute lawsuits from foreign big pharma companies have recently increased, so domestic companies need to be thoroughly prepared.”
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