Introduction
The litigation between Almirall LLC and Taro Pharmaceutical Industries Ltd. (hereinafter referred to as Taro) is a significant case in the realm of patent law, particularly under the Hatch-Waxman Act. This dispute revolves around the infringement of United States Patent No. 9,517,219 ('219 patent), which pertains to topical dapsone and dapsone/adapalene compositions.
Background
Almirall LLC, the patent holder, filed a civil action against Taro on June 1, 2017, alleging patent infringement under the Hatch-Waxman Act. The '219 patent is associated with Allergan's (now Almirall's) ACZONE® Gel, 7.5%, which contains dapsone as its active pharmaceutical ingredient (API) and was approved by the FDA through New Drug Application (NDA) No. 207154[2].
Key Issues and Arguments
Polymeric Viscosity Builder (PVB) Claims
A central issue in this case is the interpretation of the claims related to the polymeric viscosity builder (PVB) in the '219 patent. The patent claims specify a PVB "comprising acrylamide/sodium acryloyldimethyl taurate copolymer" (A/SA). However, during the prosecution of the patent application, the claim language was modified from "consisting of" A/SA to "comprising" A/SA, which broadened the claim to include A/SA in combination with other ingredients[2].
Taro's ANDA Product
Taro's Abbreviated New Drug Application (ANDA) product does not contain A/SA but instead uses a multi-component PVB. Taro argued that their product does not literally infringe the '219 patent claims because it does not contain A/SA. However, Almirall pursued a theory of infringement under the doctrine of equivalents, arguing that Taro's multi-component PVB is equivalent to the claimed PVB[2][4].
Prosecution History Estoppel
Taro contended that Almirall surrendered the use of carbomer (such as Carbopol) as an equivalent to A/SA during the prosecution of the parent patent. The court found that Almirall's statements during prosecution clearly and unmistakably disclaimed carbomer as an equivalent, thus barring Almirall from asserting equivalents under the doctrine of argument-based prosecution history estoppel[4].
Expert Testimony and Discovery
Almirall moved to preclude Taro from eliciting expert opinion testimony from Dr. Amiji that was outside the scope of his expert report. The court denied this motion, finding that the testimony was a natural outgrowth of Dr. Amiji's previous testimony and that Almirall had notice of the gist of his testimony[1].
Motions in Limine
Taro filed motions in limine to exclude certain arguments and evidence. One such motion aimed to prevent Almirall from comparing Taro's ANDA product to Almirall's commercial ACZONE Gel 7.5% to prove infringement. The court considered these motions, ultimately ruling that comparisons between the products could be relevant to infringement but emphasized that the language of the patent claims, not the commercial product, defines the inquiry[1].
Request for Early Summary Judgment
Taro requested early summary judgment on the grounds of non-infringement, focusing on statements made during the prosecution of the '219 patent. The court denied this request, stating that the issues of equivalence between Taro's multi-component PVB and the claimed PVB, as well as claim construction, were proper subjects for fact and expert discovery[2].
Claim Construction and Equivalence
The court highlighted that the equivalence between Taro's multi-component PVB and the claimed PVB in the '219 patent is a matter for claim construction and expert discovery. This determination is crucial as it affects whether Taro's product infringes the patent under the doctrine of equivalents[2].
Conclusion of the Court
The court's denial of Taro's request for early summary judgment and its rulings on motions in limine set the stage for further discovery and claim construction. The case underscores the importance of prosecution history in interpreting patent claims and the limitations imposed by prosecution history estoppel on asserting equivalents[2].
Key Takeaways
- Prosecution History: Statements made during patent prosecution can significantly impact the interpretation of patent claims and the application of prosecution history estoppel.
- Doctrine of Equivalents: The doctrine of equivalents can be limited by clear and unmistakable disclaimers made during patent prosecution.
- Claim Construction: The interpretation of patent claims, especially in cases involving complex formulations, is critical and often requires extensive expert discovery and analysis.
- Comparative Analysis: Comparisons between the accused product and the patent holder's commercial product can be relevant to infringement but must align with the language of the patent claims.
Frequently Asked Questions (FAQs)
What is the central issue in the Almirall LLC v. Taro Pharmaceutical Industries Ltd. case?
The central issue revolves around the interpretation of the polymeric viscosity builder (PVB) claims in the '219 patent and whether Taro's ANDA product, which uses a different PVB, infringes these claims.
What is the significance of the change from "consisting of" to "comprising" in the patent claims?
The change broadened the claim to permit a PVB made of A/SA in combination with other ingredients, rather than limiting it to A/SA alone.
How did prosecution history estoppel impact the case?
Prosecution history estoppel barred Almirall from asserting equivalents for carbomer as a thickening agent because Almirall had clearly disclaimed carbomer during the prosecution of the parent patent.
What role did expert testimony play in this case?
Expert testimony was crucial, particularly in determining the equivalence between Taro's multi-component PVB and the claimed PVB. The court allowed Dr. Amiji's testimony despite Almirall's objections.
Why was Taro's request for early summary judgment denied?
Taro's request was denied because the court determined that the issues of equivalence and claim construction required further fact and expert discovery.
Cited Sources:
- Almirall LLC v. Taro Pharm. Indus. Ltd. - Casetext
- Case 1:17-cv-00663-JFB-SRF Document 39 Filed 11/28/17 - AWS
- Almirall, LLC v. Torrent Pharms., Ltd. - Robins Kaplan LLP
