Introduction
The litigation between Duke University and Alcon Laboratories, Inc. revolves around patent infringement claims related to the popular eyelash growth treatment, LATISSE®. Here, we delve into the key aspects of this legal battle, examining the claims, defenses, and outcomes.
Background of the Litigation
Duke University, in collaboration with Allergan Sales, LLC, initiated a patent infringement lawsuit against Sandoz Inc. and Alcon Laboratories, Inc. The dispute centers on U.S. Patent No. 9,579,270 (the ’270 Patent), which pertains to the formulation and use of bimatoprost, the active ingredient in LATISSE®[1][3][5].
Claims of Infringement
Duke University and Allergan Sales, LLC alleged that Alcon Laboratories, Inc. and Sandoz Inc. infringed claims 22 and 30 of the ’270 Patent by manufacturing and selling a generic version of LATISSE®. The plaintiffs argued that the defendants' actions were deliberate and malicious, as they continued to sell the product despite being aware of the patent infringement[1].
Defendants' Response
Alcon Laboratories, Inc. and Sandoz Inc. responded with a declaratory judgment action, seeking to resolve the controversy over the infringement and validity of the ’270 Patent. They argued that the patent claims were substantially similar to those previously adjudged as invalid due to obviousness and that Duke University and Allergan were collaterally estopped from asserting these claims again[3].
Legal Arguments and Proceedings
Literal Infringement
The plaintiffs claimed that the defendants' generic product literally infringed the ’270 Patent. However, the defendants argued that there was no literal infringement, and the court ultimately granted summary judgment of no literal infringement for all asserted claims[2].
Doctrine of Equivalents
Alcon Laboratories, Inc. also argued that there was a factual dispute regarding infringement under the doctrine of equivalents. However, the court denied this argument, stating that Alcon had not met its burden of directing the court to evidence that would support a verdict of infringement under the doctrine of equivalents[2].
Collateral Estoppel
The defendants argued that Duke University and Allergan were precluded from asserting the patent claims due to collateral estoppel, given that similar claims had been previously found invalid. This argument was part of their declaratory judgment action to clear the uncertainty created by the plaintiffs' assertions[3].
Court Decisions and Outcomes
Summary Judgment
The court granted summary judgment of no literal infringement for all asserted claims, finding that Alcon had not provided sufficient evidence to support a verdict of literal infringement. Additionally, the court denied Alcon's arguments under the doctrine of equivalents[2].
Declaratory Judgment
The declaratory judgment action by Sandoz and Alcon aimed to resolve the controversy over the infringement and validity of the ’270 Patent. The court's decision on summary judgment supported the defendants' position that there was no infringement, which aligns with their declaratory judgment claims[3].
Impact and Implications
The outcome of this litigation has significant implications for both the pharmaceutical industry and patent law. It highlights the importance of thorough patent analysis and the challenges of asserting patent claims that have been previously invalidated.
Key Takeaways
- Patent Infringement Claims: Duke University and Allergan alleged infringement of the ’270 Patent by Alcon and Sandoz.
- Summary Judgment: The court granted summary judgment of no literal infringement for all asserted claims.
- Doctrine of Equivalents: The court denied Alcon's arguments under the doctrine of equivalents.
- Collateral Estoppel: The defendants argued that the plaintiffs were precluded from asserting the patent claims due to collateral estoppel.
- Declaratory Judgment: The court's decision supported the defendants' declaratory judgment claims.
FAQs
What is the ’270 Patent, and what does it cover?
The ’270 Patent covers the formulation and use of bimatoprost, the active ingredient in LATISSE®, a treatment for eyelash growth.
Why did Duke University and Allergan file a lawsuit against Alcon and Sandoz?
Duke University and Allergan filed a lawsuit alleging that Alcon and Sandoz infringed claims 22 and 30 of the ’270 Patent by manufacturing and selling a generic version of LATISSE®.
What was the outcome of the summary judgment motion?
The court granted summary judgment of no literal infringement for all asserted claims, finding that Alcon had not provided sufficient evidence to support a verdict of literal infringement.
What is the doctrine of equivalents, and how did it apply in this case?
The doctrine of equivalents allows for infringement claims when a product does not literally infringe a patent but is substantially equivalent. In this case, the court denied Alcon's arguments under the doctrine of equivalents.
What is collateral estoppel, and how did it impact the case?
Collateral estoppel is a legal principle that prevents a party from relitigating an issue that has already been decided. The defendants argued that Duke University and Allergan were precluded from asserting the patent claims due to collateral estoppel, given that similar claims had been previously found invalid.
Cited Sources:
- United States District Court for the Eastern District of Texas. Duke University and Allergan Sales, LLC v. Sandoz Inc. and Alcon Laboratories, Inc. Civil Action No. 2:17-cv-528.
- United States District Court for the District of Delaware. Alcon Inc., Alcon Vision, LLC, and Alcon Laboratories, Inc. v. Padagis Israel Pharmaceuticals Ltd., Padagis US LLC, and Padagis LLC. Civil Action No. 22-1422-WCB.
- United States District Court for the Middle District of North Carolina. Sandoz Inc. and Alcon Laboratories, Inc. v. Duke University, Allergan Sales, LLC, and Allergan, Inc. Civil Action No. 1:17-cv-823.
- United States District Court for the Central District of California. Femto-Sec Tech, Inc. v. Alcon Laboratories, Inc. and WaveLight, GmbH. Case 8:15-cv-01551.
- Casetext. Duke Univ. v. Sandoz, Inc.
