Bad facts make bad law. The case of GlaxoSmithKline’s lawsuit over Teva’s generic Coreg® drug is a case-in-point. I previously blogged about the case here and here. Given that the Supreme Court declined to grant certiorari, we’re now stuck with Federal Circuit precedent holding that a generic can still face liability for induced infringement of a method-of-use patent covering a section viii carved-out indication. What will be the consequences of this?
Read MoreThe debate around whether patents are unnecessarily propping up drug prices has been simmering for years. A recent policy memo from the Hudson Institute has thoughtfully raised concerns about the data underlying this debate, and the memo made its way up to the U.S. Senate Judiciary Subcommittee on Intellectual Property. While the memo may have successfully poked holes in some of the data, it draws questionable conclusions regarding what those holes might mean. Unpacking this debate is therefore necessary to guide the correct policy on the intersection of patents and drug prices. Read the full article at IPWatchdog.
Read MoreI previously blogged about the surprising case, GlaxoKlineSmith v. Teva (GSK), where the Federal Circuit held that a generic pharmaceutical company can, under the right circumstances, be liable for inducing infringement of a method-of-use pharmaceutical patent despite carving out the patented indication from its label. The decision at first spooked the generic pharmaceutical industry, but was then followed by two additional opinions—one related to a panel rehearing, followed by another one, which issued on February 11, 2022, denying a hearing en banc, which included a fiery dissent. These decisions show clear disagreements among the Judges at the Federal Circuit. What is at the heart of this dispute?
Read MoreI previously blogged (here and here) about the pending Hatch-Waxman lawsuit between Exelixis ($EXEL) and MSN Pharmaceuticals in connection with MSN’s prospective generic for Cabometyx®. The case has been barreling towards trial in May of this year, which would theoretically provide insight into how soon Cabometyx® may face generic competition. This trial date is important because the 30-month stay is scheduled to expire in November 2022. However, a current dispute over scheduling has called into doubt if the trial in May will proceed, and even if it does, if it will provide certainty on MSN’s entry.
Read MoreWe previously blogged about the upcoming litigation trial between Amarin Pharmaceuticals ($AMRN) and Dr. Reddy’s and Hikma, which are two prospective generics for Amarin’s Vascepa®. While that blog post provided a general overview of the issues to be litigated at the upcoming trial, there are numerous other issues and questions around the upcoming trial. This post will focus on how the REDUCE-IT trial may impact Amarin’s fight with the existing generics, if at all.
Read MoreThe Federal Circuit has issued a precedential decision addressing whether a patent covering a given polymorph was invalid as obvious, Grunenthal GmbH v. Alkem Laboratories Ltd. Though the Court explained that it was not establishing a categorical rule that polymorph patents can never be obvious, the case nonetheless provides important guidelines for when a polymorph patents are likely to be invalid. For those following Revlimid®’s patent cases, the immediate question is—does the Grunenthal case have read-through to Celgene’s polymorph patents?
Read MoreCorcept Therapeutics ($CORT) recently filed a new lawsuit against Teva ($TEVA) related to Teva’s proposed generic for Korlym®. The new suit asserts three new patents that were recently listed in the Orange Book. Are the three new patents a game-changer?
Read MoreEarlier this year, Teva ($TEVA) filed an ANDA to distribute a generic version of Korlym®, and soon thereafter, Corcept Therapeutics ($CORT) commenced a Hatch-Waxman patent suit in federal court in New Jersey. On June 15, 2018, Teva moved to dismiss the case. What is this motion all about? And will Teva’s motion prevail?
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