Case Overview
The litigation between Sandoz, Inc., a subsidiary of Novartis, and Duke University, along with Allergan (now part of AbbVie), revolves around the infringement of a patent related to the eyelash growth drug Latisse (bimatoprost). Here is a detailed summary and analysis of the case.
Background of the Patent and Drug
- Latisse, a variation of Allergan’s glaucoma therapy Lumigan, was approved in 2008 to treat hypotrichosis of the eyelashes by increasing their length, thickness, and darkness. It was the first drug of its kind for this condition and one of only a few to stimulate hair growth, alongside Merck’s Propecia and Johnson & Johnson’s Rogaine[3].
The Patent in Question
- The patent at the center of the dispute is the ’270 patent, which dates back to 2017 and pertains to the method of applying Latisse to promote eyelash growth. Specifically, the method involves a once-nightly drop of bimatoprost on a disposable sterile applicator, applied evenly along the skin of the upper eyelid margin at the base of the eyelashes[3].
Infringement Allegations
- Duke University, the owner of the patent, and Allergan, which licensed its use, alleged that Sandoz’s generic version of Latisse, introduced in 2016, infringed on their patent. They argued that Sandoz’s generic label provided evidence of the company’s intent to encourage direct infringement by instructing users to perform the patented methods[3].
Trial and Verdict
- In March 2023, a Colorado federal jury found Sandoz liable for $39 million for infringing the patent. This verdict came after Duke University and Allergan dropped their allegation that Sandoz willfully infringed the patent, as it was deemed to be a less critical aspect of the case[3][5].
Legal Arguments and Defense
- Sandoz attempted to invalidate the patent, but the US Patent and Trademark Office had already examined and rejected Sandoz’s invalidity arguments. The plaintiffs argued that Sandoz’s attempts to use hindsight to invalidate the patent were unfounded, and the patent office’s decision was correct[1].
Post-Verdict Developments
- Following the jury’s verdict, Sandoz expressed disappointment and indicated that it would consider all available options, including appeals. Despite this, a Colorado federal judge later denied Sandoz’s bid for a new trial, rejecting the argument that the court erred in applying Federal Circuit precedent[5].
Financial Implications
- The $39 million verdict significantly impacts Sandoz, particularly given that Allergan’s revenues from Latisse had declined steeply since Sandoz began selling its generic version in 2016. Allergan, now part of AbbVie, was set to receive the bulk of the $39 million award[3][5].
Historical Context and Previous Litigation
- This is not the first time Sandoz and Duke University/Allergan have been in court over Latisse. Nearly a decade ago, Sandoz was successful in getting two Allergan patents invalidated. However, in this instance, the court upheld the validity of the ’270 patent[3].
Industry Impact
- The outcome of this case highlights the importance of patent protection in the pharmaceutical industry. It underscores the financial and competitive implications of patent infringement and the lengths to which companies will go to protect their intellectual property.
Key Takeaways
- Patent Protection: The case emphasizes the critical role of patent protection in the pharmaceutical industry.
- Infringement Consequences: The $39 million verdict demonstrates the significant financial consequences of patent infringement.
- Legal Battles: The history of litigation between Sandoz and Duke University/Allergan shows the ongoing and complex nature of patent disputes.
- Market Impact: The introduction of generic versions can significantly affect the market share and revenues of brand-name drugs.
FAQs
Q: What is the drug at the center of the litigation between Sandoz and Duke University?
A: The drug is Latisse (bimatoprost), used for promoting eyelash growth.
Q: What is the ’270 patent related to?
A: The ’270 patent pertains to the method of applying Latisse to promote eyelash growth.
Q: How much did the jury order Sandoz to pay for patent infringement?
A: The jury ordered Sandoz to pay $39 million.
Q: Did Sandoz attempt to appeal the verdict?
A: Yes, Sandoz expressed its intention to consider all available options, including appeals, but a new trial bid was denied.
Q: Who received the bulk of the $39 million award?
A: Allergan, now part of AbbVie, was set to receive the bulk of the award.
Cited Sources:
- Law360: "Jury Says Sandoz Owes US$39M For Eyelash Drug Infringement"
- FiercePharma: "Sandoz must cough up $39M after losing Allergan patent fight"
- Law360: "Duke University et al v. Sandoz Inc."
