Partner Aydin Harston is quoted in a Law360 article discussing the implications of the Federal Circuit's recent ruling that only patents covering a drug's active ingredient should be listed in the FDA's Orange Book. The decision, which arose from a dispute between Teva Pharmaceuticals and Amneal Pharmaceuticals over the listing of an inhaler device patent, raises questions about the fate of possible improperly listed patents and the potential impact on the generic drug market. The article, "What's Next After Fed. Circ. Limits Orange Book Listings?" by Ryan Davis, explores these issues.
"On its own, the decision 'probably doesn't make a huge impact because there are still not enough teeth,'" Aydin told Law360. "You could let it ride, essentially, if you're the branded [company] and … wait for some kind of antitrust action, or some enforcement action under the FTC Act. Otherwise, it's just a list on the internet."
The Federal Circuit rarely rehears decisions, but Teva has indicated that it intends to request a rehearing due to the substantial implications of this decision on the pharmaceutical industry.
"If appeals of the Teva ruling itself are exhausted, 'I could see some in-house attorney saying, 'Enough is enough. I see that this is clear enough now that we should remove some of these patents,'" Aydin told Law360. "However, Orange Book listings often have significant business implications, so drugmakers may need a stronger rationale than the ruling to start removing them, [Aydin] said. That might include a finding of antitrust liability that is upheld on appeal, and 'I think if that happened, that's when you'll probably see more of a change in behavior.'"
Read the full article, "What's Next After Fed. Circ. Limits Orange Book Listings?" by Ryan Davis on Law360 here, or by clicking on the article title below.
