Case Overview
The litigation between Allergan, Inc. and Sandoz, Inc. involves a series of patent infringement disputes, particularly focusing on Allergan's patents related to the drug Latisse® (bimatoprost) and other pharmaceutical products. Here is a detailed summary and analysis of the key aspects of the case.
Patents-in-Suit and Drug Products
The case revolves around several patents held by Allergan, including U.S. Patents Nos. 7,388,029 ('029 patent), 7,351,404 ('404 patent), 8,263,054 ('054 patent), 8,038,988 ('988 patent), 8,101,161 ('161 patent), and 8,926,953 ('953 patent). These patents pertain to a topical solution using bimatoprost to treat hair loss or reduction[1].
Nature of the Case and Issues Presented
Allergan initiated the litigation by suing Sandoz for infringement of the '029 and '404 patents. Sandoz countered by arguing that these patents were invalid. The District Court initially found in favor of Allergan, but the Federal Circuit reversed this decision, finding the '029 and '404 patents obvious[1].
First Litigation: Allergan I
- District Court Ruling: The District Court found in favor of Allergan, ruling that the patents were valid.
- Federal Circuit Appeal: Sandoz appealed, and the Federal Circuit reversed the decision, declaring the '029 and '404 patents obvious.
- Subsequent Actions: During the appeal, Allergan filed a second suit alleging infringement of the '054, '988, and '161 patents. This case was stayed pending the resolution of the first appeal[1].
Second Litigation: Involving the '953 Patent
- Patent Issuance: After the '404 patent was invalidated, Allergan submitted ex parte declarations to the USPTO to address prior-art references. The '953 patent was subsequently issued.
- New Litigation: Allergan filed complaints asserting the '953 patent against Sandoz and other defendants.
- District Court Ruling: Sandoz filed a motion to dismiss based on collateral estoppel, which the District Court granted.
- Federal Circuit Appeal: The Federal Circuit reversed-in-part and affirmed-in-part, agreeing that collateral estoppel applied to some claims but not others[1].
Collateral Estoppel Analysis
The Federal Circuit applied a five-part test to determine if collateral estoppel was applicable:
- Identical Issue: The issue sought to be precluded must be identical to one previously litigated.
- Actual Determination: The issue must have been actually determined in the prior proceeding.
- Critical and Necessary Part: The issue’s determination must have been a critical and necessary part of the decision in the prior proceeding.
- Final and Valid Judgment: The prior judgment must be final and valid.
- Full and Fair Opportunity: The party against whom collateral estoppel is asserted must have had a full and fair opportunity to litigate the issue in the previous forum.
The Federal Circuit found that these criteria were met, particularly regarding the issue of invalidity due to obviousness, which was central to the previous litigations[1].
Claim Construction and Invalidity
- Claim Similarity: The Federal Circuit determined that the claims of the '953 patent were substantially similar to those of the invalidated '404, '054, '161, and '988 patents.
- Eyelash Darkness Limitation: The issue of eyelash darkness, a key attribute of the bimatoprost solution, was found to be identical across all litigations.
- Prior Art References: Allergan's attempt to use ex parte declarations to alter the status of prior-art references was not considered by the District Court, which the Federal Circuit upheld[1].
District Court’s Jurisdiction Over Unasserted Claims
Allergan argued that the District Court had no jurisdiction over unasserted claims of the '953 patent, as it had narrowed its assertion of infringement to only three claims. The Federal Circuit agreed, stating that Sandoz had not shown a continuing case or controversy regarding the withdrawn claims[1].
Key Takeaways
- Collateral Estoppel: The Federal Circuit's application of collateral estoppel highlights the importance of ensuring that issues are fully and fairly litigated in the first instance to avoid preclusion in subsequent cases.
- Claim Construction: The case emphasizes the critical role of claim construction in determining patent validity and infringement.
- Patent Strategy: Allergan's strategy of filing multiple patents and litigations underscores the complexities and challenges in protecting pharmaceutical patents.
FAQs
What were the main patents involved in the Allergan v. Sandoz litigation?
The main patents involved were U.S. Patents Nos. 7,388,029 ('029 patent), 7,351,404 ('404 patent), 8,263,054 ('054 patent), 8,038,988 ('988 patent), 8,101,161 ('161 patent), and 8,926,953 ('953 patent)[1].
Why did the Federal Circuit reverse the District Court's decision in Allergan I?
The Federal Circuit reversed the decision because it found the '029 and '404 patents obvious, thus invalidating them[1].
What is collateral estoppel, and how was it applied in this case?
Collateral estoppel is a doctrine that prevents a party from relitigating an issue that has already been decided in a previous case. In this case, it was applied to prevent Sandoz from challenging the validity of claims that were substantially similar to those previously invalidated[1].
How did the ex parte declarations affect the '953 patent litigation?
The ex parte declarations submitted by Allergan to the USPTO were intended to alter the status of prior-art references but were not considered by the District Court, which the Federal Circuit upheld[1].
What was the outcome regarding the unasserted claims of the '953 patent?
The Federal Circuit agreed that the District Court had no jurisdiction over the unasserted claims of the '953 patent, as Allergan had narrowed its assertion of infringement to only three claims[1].
Sources Cited
- Robins Kaplan LLP Law Firm, "Allergan, Inc. v. Sandoz, Inc.", April 26, 2017.
- Robins Kaplan LLP Law Firm, "Allergan Sales, LLC v. Sandoz, Inc.", October 25, 2016.
- Casetext, "Allergan, Inc. v. Sandoz Inc., Case No. 6:11-cv-441".
- United States Court of Appeals for the Federal Circuit, "ALLERGAN SALES, LLC v. SANDOZ, INC.", August 29, 2019.
- Casetext, "Allergan Sales, LLC v. Sandoz, Inc."
