Washington, D.C. (October 4, 2024) – Sterne, Kessler, Goldstein & Fox secured decisive wins in two inter partes review (IPR) proceedings before the U.S. Patent Trial and Appeal Board (PTAB), representing Hopewell Pharma Ventures in cases against Merck Serono. The PTAB recently issued final written decisions invalidating all challenged claims of two key patents, U.S. Patent No. 7,713,947 and U.S. Patent No. 8,377,903, which relate to the treatment of multiple sclerosis using the drug cladribine, marketed under the brand name MAVENCLAD®.
The PTAB’s rulings confirmed that the prior art presented by Hopewell Pharma Ventures rendered the challenged claims obvious, dealing a significant blow to Merck Serono’s patent portfolio for cladribine-based therapies. In addition to addressing the substantive patentability issues, the PTAB provided detailed guidance on the criteria for disqualifying prior art based on inventorship.
Dr. Jonathan Embleton, co-founder, President & CEO of Hopewell Pharma Ventures, stated “This ruling from the PTAB provides an example of invalid patents interfering with patient access to lower-cost generic alternatives for important medications used to treat a serious and disabling disease. The strategic guidance and sophisticated legal analysis provided by the team at Sterne Kessler was critical in our effort to challenge the validity of the MAVENCLAD® patents. We are also grateful for the financial support provided by GLS Capital and its extensive experience in pharmaceutical patent matters, which we believe added substantial value.”
These IPR victories are part of an ongoing dispute between the parties, which includes parallel Abbreviated New Drug Application (ANDA) litigation in the case Merck KGaA et al. v. Hopewell Pharma Ventures, Inc., currently pending in the U.S. District Court for the District of Delaware.
Sterne Kessler’s team in the IPR proceedings included Directors Eldora Ellison, Ph.D., Olga Partington, Ph.D., Chandrika Vira, and J.C. Rozendaal, alongside attorneys Christina Dashe, Tyler Liu, Pratibha Khanduri, Ph.D., and Madeleine Bond, and Patent Agent Sarah Leesman.
Hopewell Pharma Ventures is a U.S. pharmaceutical company that develops generic drugs to ensure that patients have the earliest possible access to lower-cost alternatives. Hopewell’s financial partner, GLS Capital, supported them in this legal battle.
GLS Capital is a commercial litigation finance firm with more than $500 million under management. Having a broad investment mandate and fully discretionary capital, all investment decisions are made internally by the GLS investment committee.
The cases are IPR2023-00480 and IPR2023-00481.
About Sterne, Kessler, Goldstein & Fox
Based in Washington, D.C. and renowned for more than four decades for dedication to the protection, enhancement, and enforcement of intellectual property rights, Sterne, Kessler, Goldstein & Fox is one of the most highly regarded intellectual property specialty law firms in the world. Its team of attorneys, registered patent agents, technical specialists, specialized trademark paralegals, and law clerks include some of the country’s most respected practitioners of IP law, tackling innovations across a broad spectrum of industries. The firm’s practitioners represent Fortune 500 companies, entrepreneurs, start-ups, inventors, venture capital firms, and universities in a client service driven environment that is welcoming, inclusive, and intellectually stimulating. Visit the firm online at sternekessler.com.
Receive insights from the most respected practitioners of IP law, straight to your inbox.
Subscribe for Updates