Intellectual property (IP) plays a vital role in technology and innovation, including in the pharmaceutical industry. Patents grant exclusive rights to inventors, driving research and development of new drugs. However, patent infringement occurs when a patented drug is used, made, sold, or imported without authorization, often leading to costly litigation, market restrictions, and competitive challenges. Effective patent protection in this regulated sector balances innovation rewards with affordable access to medicines. This article explores the patent infringement case study of Plexxikon vs. Novartis.
Background
The Plexxikon vs. Novartis case is about Plexxikon accusing Novartis of using its cancer treatment patents without permission for the drug Tafinlar. The court sided with Plexxikon, awarding damages and stressing the importance of protecting patent rights in drug development.
Plaintiff-Appellee: Plexxikon (member of the Daiichi Sankyo Group since April 2011), a leader in structure-guided discovery and development of novel small molecule pharmaceuticals.
Patents infringed – US9469640 & US9844539
Zelboraf® (Vemurafenib/PLX4032) – Filed in 2005, approved by the FDA in 2011
Turalio® (Pexidartinib/PLX3397) – approved by the FDA in 2019
Defendant-Appellant: Novartis (acquired GlaxoSmithKline’s oncology business for $16+ billion in 2015)
- Tafinlar (developed by GSK) patent applied in 2008, approved in 2013
Court proceedings
- In the suit, Plexxikon alleged that Novartis owed the company substantial royalties on its drug Tafinlar®, which infringes two Plexxikon patents.
- In a jury trial at the U.S. District Court for the Northern District of California, Novartis conceded infringement and sought to invalidate Plexxikon’s patents covering Tafinlar® on the grounds of anticipation, written description and enablement.
- Plexxikon argued that more than a decade ago, GSK scientists acquired knowledge to develop Tafinlar after consulting with Plexxikon in potential partnership talks, which never materialized into a deal.
- Evidence came in at trial that the GSK inventor had looked at Plexxikon patent applications disclosing the core structure of the molecule before shifting the program focus in a way that ultimately led to the infringement.
Decision
- The jury rejected Novartis’s arguments, upheld the validity of Plexxikon’s patents, and found Novartis’s infringement was willful.
- Plexxikon was awarded damages of $178 million for past infringement of its patents and will receive royalty payments for future sales of Tafinlar.
Settlement
- As announced on December 2023, Plexxikon will receive a lump sum payment from Novartis of approximately 182 Million USD.
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