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 MoreOn November 5, 2020, the Federal Circuit issued a precedential decision, Vaeleant Pharmaceuticals v. Mylan Pharmaceuticals, that is likely to have a significant impact on the litigation of Hatch-Waxman cases—including the possible development of “generic-friendly” districts. In short, if this decision stands, the future of patent pharma litigation against multiple generics for the same drug will likely be spread out, difficult to consolidate, subject to multiple forums determining in parallel common issues related to infringement and invalidity. Costs for brands are likely to go up along with settlement leverage for generics. Although, exactly who wins and who loses from this decision remains to be seen.
Read MoreWe previously blogged about the upcoming litigation trial between Amarin Pharmaceuticals ($AMRN) and Dr. Reddy’s and Hikma, which are two prospective generics for Amarin’s Vascepa®. While that blog post provided a general overview of the issues to be litigated at the upcoming trial, there are numerous other issues and questions around the upcoming trial. This post will focus on how the REDUCE-IT trial may impact Amarin’s fight with the existing generics, if at all.
Read MoreWe previously blogged about Teva’s ($TEVA) petition for post-grant review (PGR) of Corcept Therapeutics’ ($CORT) ‘214 patent. Since then, on November 20, 2019, the PTAB granted institution of Teva’s petition. The proceeding will now be litigated for another year before a final decision. On a recent earnings call, Corcept stated that it believes the standard for institution is “pretty low,” and not necessarily dispositive that Teva will prevail. Now that we have the institution decision, what can we glean from it, and how likely is that Corcept’s patent survives?
Read MoreAmarin Pharmaceuticals ($AMRN) will be going to trial soon to protect Vascepa® against generic competition. Amarin has asserted 15 claims from six patents against ANDAs filed by Hikma, Dr. Reddy’s and Teva. What are the issues to be addressed at trial?
Read MoreThe American University Law Review recently published a very timely and compelling article on the intersection between the Hatch-Waxman Act and the BPCIA, on the one hand, and post-grant proceedings at the PATB, on the other. The article, which is titled, Ships in the Night: Resolving Administrative Conflict Between FDA- and Patent-Related Legislation, American Univ. Law Review [Vol. 68:1111], (hereinafter, “Garcia & Stroud”), is authored by Carlos A. Garcia, Patent Counsel, Eli Lilly & Company, and Jonathan Stroud, Chief IP Counsel, Unified Patents Inc. The article is a comprehensive and thorough overview of how petitions for inter partes review and other post-grant proceedings may be impacting efficient resolution of patent issues for generic drugs.
Read MoreExelixis ($EXEL) recently received a Paragraph IV certification against its drug, Cabometyx, which is indicated for kidney cancer and as a second-line treatment for liver cancer. The certification was sent by MSN Pharmaceuticals. A lawsuit is likely to be filed by Exelixis against MSN within 45 days of the Paragraph IV certification. How well-positioned is Exelixis to fight this generic challenge?
Read MoreAnother generic has filed an ANDA with the FDA for a license to distribute a generic version of Korlym®. Teva is no longer the only company seeking to sell generic Korlym®, which therefore increases the likelihood that Corcept Therapeutics ($CORT) will face a generic competitor for its main drug at some point in the future.
Read MoreAnd just like that, it’s over. Boehringer Ingelheim has thrown in the towel in its patent fight with AbbVie over Boehringer’s proposed biosimliar for Humira®. Boehringer was a lone hold-out among a long line of proposed biosimilars for AbbVie’s blockbuster. Boehringer’s distinction was that it had raised a unique defense, namely, arguing that AbbVie had built an unfair “patent thicket” around Humira® that was unenforceable. We previously blogged about Boehringer’s “unclean hands” defense here and here and here. Now that Boehringer has settled, what are the larger lessons for future biosimilar patent fights?
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 MoreCelgene ($CELG) has announced plans to be acquired by Bristol Meyers Squibb ($BMY). A settlement conference is scheduled in the Hatch-Waxman patent case between Celgene and Dr. Reddy’s on January 10, 2019. Now that Bristol Meyers is at the table, will the parties be able to reach a settlement that couldn’t be reached before?
Read MoreMylan ($MYL) recently prevailed on a motion to dismiss for improper venue in a pending Hatch-Waxman case for the drug Eliquis®. Mylan successfully argued that Delaware was an improper venue under the recently test for venue in patent cases enunciated by the Supreme Court in TC Heartland. What are the implications of TC Heartland governing venue in all Hatch-Waxman cases? Will it lead to “generic friendly” judicial districts?
Read MoreWe previously wrote about Corcept’s ($CORT) amended complaint in its Hatch-Waxman patent litigation against Teva ($TEVA) regarding Korlym®. On July 27, Teva filed another motion to dismiss. Corcept opposed the motion on August 21, and Teva filed its reply on August 28. The motion is now fully briefed. Who will prevail?
Read MoreSenator Orrin Hatch (R-UT) recently proposed an amendment to the Hatch-Waxman Act that would significantly upset the availability of petitions for inter partes review (IPR) for generic pharmaceutical companies. Senator Hatch appears to believe that brand pharmaceutical companies deserve patents more than others.
Read MoreOn April 17, 2018, a new patent issued to Corcept Therapeutics ($CORT) that covers Korlym®. The patent is U.S. Patent No. 9,943,526 pursuant to U.S. Patent Application No. 15/133,791. The ‘526 patent has already been added to the Orange Book. Korlym® was already protected by two patents listed in the Orange Book, and Corcept recently commenced a Hatch-Waxman litigation against Teva asserting these two patents. How effective is the new ‘526 patent at keeping Teva at bay?
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