The FTC recently challenged scores of pharmaceutical patents as improperly listed in the Orange Book. This was an important because, among the many ways that BigPharma has been accused of abusing the patent system to block lower-cost generic formulations, attacking Orange Book listings has had limited success in the past. In 2020, the First Circuit endorsed antitrust allegations against Sanofi for improperly listed patents. More recently, the Federal Circuit issued a precedential decision limiting the scope of patents that can be permissibly listed in the Orange Book. This is also an important decision because it is one of the few precedential decisions from the Federal Circuit to address this issue. What are the policy implications of the Federal Circuit’s recent ruling regarding Orange Book patent listings?
Read MoreCorcept Therapeutics has been battling for years to halt Teva’s generic for Korlym®. Although Corcept started off with only two patents, it has been adding patents to the Orange Book ever since Teva’s ANDA was filed. By periodically litigating those patents in piecemeal fashion, Corcept has delayed generic Korlym®’s availability to consumers at lower-cost prices. Yet, in a recent order, the court finally called out Corcept’s delay tactics and indicated it would award attorneys’ fees. What happened?
Read MoreMylan ($MYL) recently prevailed on a motion to dismiss for improper venue in a pending Hatch-Waxman case for the drug Eliquis®. Mylan successfully argued that Delaware was an improper venue under the recently test for venue in patent cases enunciated by the Supreme Court in TC Heartland. What are the implications of TC Heartland governing venue in all Hatch-Waxman cases? Will it lead to “generic friendly” judicial districts?
Read MoreSenator Orrin Hatch (R-UT) recently proposed an amendment to the Hatch-Waxman Act that would significantly upset the availability of petitions for inter partes review (IPR) for generic pharmaceutical companies. Senator Hatch appears to believe that brand pharmaceutical companies deserve patents more than others.
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