The United States Food and Drug Administration allows companies to list patents covering approved drug products in its "Orange Book." The presence of listed patents covering a product can delay marketing approval of generic versions of that product, so the Orange Book serves as an important tool for maintaining market exclusivity. In Teva v. Amneal, the United States Court of Appeals for the Federal Circuit considered whether Teva complied with patent statutes when it listed patents claiming inhalers for delivering aerosolized medication based on the FDA approval of ProAir HFA Inhalation Aerosol, which combines the active ingredient albuterol sulfate with other ingredients and an inhaler device. The court found it did not. Rather, the court held that patents listed in the Orange Book must claim the active ingredient of a drug. It was not sufficient that Teva's FDA-approved product was a combination of the inhaler and drug, because the claims of the patent focused on the device rather than the drug delivered by that device. The court therefore ordered Teva to delist the patents.
In light of this decision, owners of life science patents that do not claim active ingredients may need to rely on strategies other than Orange Book listing to fully protect their assets. Companies should also consider adding dependent claims reciting compounds where possible even in device patent applications, and they should scrutinize existing device patents to see if any patents may benefit from reissue to add claims listing active agents used with the patented devices.
Patent Term Extension: Merck v. Aurobindo
Another tool to protect life science assets in the United States is patent term extension. Patent term extension is similar to a supplementary patent certificate in Europe. It provides up to five years of extra patent protection to compensate patent owners for time lost during the drug approval process. This extra patent term is calculated based on the length of the regulatory review period occurring after the date on which the subject patent issued. In Merck v. Aurobindo, the question was whether reissuing a patent to add narrower dependent claims (along the lines mentioned above as a practice tip in light of the Teva decision), should reduce the period of time eligible for PTE. In Merck, the challenger argued that reissuing a patent should prevent a patentee from acquiring PTE for the period between the original patent issue date and the date the reissue patent granted.The court disagreed, holding that patent term extension is calculated from the date the original patent issued, not the issue date of the reissued patent.
With this decision, patent owners can take comfort that they will not lose patent term extension if they choose to seek reissue of their patents, which is a common practice as companies prepare for potential litigation with generic challengers.But care should be taken to design claims for the reissue that retain original claim scope while also adding claims that read on the approved product.
Other Tools for Protecting Exclusivity
To maximize protection for key assets, patent owners should consider all of these tools, while keeping recent cases in mind.
Scott, Laura, Jeffrey and Lauren are attorneys at Finnegan. Finnegan is one of the world's largest intellectual property (IP) firms, with offices across the U.S., Europe, and Asia. In Israel alone, Finnegan has helped over 250 companies develop patent strategies to outmaneuver competitors, enhance valuation, and protect their innovations in the U.S. and Europe. The firm assists Israel's most promising startups and leading enterprises. Notably, four of Calcalist's most valuable Israeli companies in 2024 trust Finnegan for critical IP matters, including patent strategy, defense, enforcement, portfolio development, trademarks, and privacy issues.
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