Introduction
The litigation between Allergan Sales, LLC and Teva Pharmaceuticals USA, Inc. is a complex and multifaceted case that involves patent infringement, the submission of Abbreviated New Drug Applications (ANDAs), and the nuances of subject-matter jurisdiction. Here, we will delve into the key aspects of this case, analyzing the legal arguments, court decisions, and the implications of each.
Background of the Case
The case, filed in the United States District Court for the District of Delaware (C.A. No. 16-1114-RGA), involves Allergan Sales, LLC, Forest Laboratories Holdings, Ltd., Allergan USA, Inc., and Ironwood Pharmaceuticals, Inc. (collectively, "Plaintiffs") against Teva Pharmaceuticals USA, Inc. and other generic pharmaceutical companies[3].
Patent Infringement Allegations
The Plaintiffs alleged that Teva's submission of its ANDA to the FDA for a generic version of their drug infringed multiple patents. Specifically, the allegations included infringement of various claims under several patents, including the '036, '727, '947, '409, '526, '553, and '030 patents[3].
Subject-Matter Jurisdiction and Mootness
A critical issue in the case was whether the court had subject-matter jurisdiction over the original lawsuit against Teva. Allergan argued that the case was moot because Teva had reformulated the accused product and abandoned the original formulation. However, the court rejected this argument, stating that jurisdiction was not based on any certification (such as a PIV certification) but rather on § 271(e)(2)(A) and § 1338(a) of the U.S. Code. Since Teva's original ANDA remained on file and the alleged infringement had not been reversed, the court found continuing subject-matter jurisdiction[1][4].
Effect of Product Reformulation
Teva's reformulation of the product raised questions about its impact on the subject-matter jurisdiction. The court determined that the composition of Teva's reformulated product was insignificantly different from the original, aside from the dosage form. This meant that the infringement allegations in the new suit were substantively identical to those in the original complaint, supporting the continuation of the original lawsuit[1][4].
Claim Construction and Summary Judgment
In a related aspect of the case, the parties disputed the construction of the term "gelling agent" in one of the patents. The magistrate judge construed "gelling agent" as a substance that gels the film composition and concluded that water could not act as a gelling agent. Based on this construction and persuasive expert evidence from Teva, the court granted Teva's motion for summary judgment for non-infringement. Allergan's objections were overruled, and the court adopted the magistrate's conclusions[5].
Additional Legal Arguments and Counterclaims
Allergan also argued that Teva's counterclaims were moot, but the court found that as long as Allergan's original infringement claim was not moot, Teva's declaratory judgment counterclaims were not moot either[1][4].
Implications and Outcomes
The court's decisions had significant implications for both parties. The denial of Allergan's motion to dismiss and the continuation of subject-matter jurisdiction meant that the original lawsuit against Teva could proceed. However, the grant of summary judgment for non-infringement on the "gelling agent" issue was a significant victory for Teva, narrowing the scope of potential infringement claims.
Key Takeaways
- Subject-Matter Jurisdiction: The court's jurisdiction in ANDA lawsuits is based on § 271(e)(2)(A) and § 1338(a), not on any certification.
- Mootness: The reformulation of a product does not necessarily render the original lawsuit moot if the alleged infringement remains.
- Claim Construction: The plain and ordinary meaning of patent terms can be crucial in determining infringement, as seen in the "gelling agent" dispute.
- Counterclaims: Declaratory judgment counterclaims can remain viable as long as the original infringement claim is not moot.
FAQs
Q: What was the main issue regarding subject-matter jurisdiction in Allergan Sales, LLC v. Teva Pharmaceuticals USA, Inc.?
A: The main issue was whether the court had continued subject-matter jurisdiction over the original lawsuit against Teva after Teva reformulated the accused product.
Q: How did the court determine the effect of Teva's product reformulation on the lawsuit?
A: The court found that the reformulated product was insignificantly different from the original, aside from dosage form, and thus the infringement allegations remained substantively identical.
Q: What was the outcome of the claim construction dispute over the term "gelling agent"?
A: The court granted Teva's motion for summary judgment for non-infringement, concluding that water could not act as a gelling agent.
Q: Why were Teva's counterclaims not considered moot?
A: Because Allergan's original infringement claim was not moot, Teva's declaratory judgment counterclaims were also not considered moot.
Q: What are the implications of this case for future ANDA lawsuits?
A: The case clarifies that jurisdiction in ANDA lawsuits is not based on certifications and that product reformulations do not automatically render original lawsuits moot.
Sources
- Robins Kaplan LLP, "Allergan Sales, LLC v. Teva Pharms. USA, Inc."
- Bespc.com, "Case 2:15-cv-00551-GAM Document 105 Filed 07/13/15"
- Insight.rpxcorp.com, "in the united states district court for the district of delaware allergan sales, llc, forest laboratories holdings, ltd., allergan usa, inc., and ironwood pharmaceuticals, inc., plaintiffs, v. teva pharmaceuticals usa, inc., mylan pharmaceuticals inc., sandoz inc., aurobindo pharma ltd., and aurobindo pharma usa, inc., defendants."
- Robins Kaplan LLP, "Allergan Sales, LLC v. Teva Pharms. USA, Inc."
- Robins Kaplan LLP, "Allergan Sales, LLC v. Teva Pharms. USA, Inc. - Generically Speaking Winter 2017"
