Introduction
The case of Warner Chilcott Co., LLC v. Teva Pharmaceuticals USA, Inc. is a significant patent infringement dispute that highlights the complexities and challenges in pharmaceutical patent litigation, particularly under the Hatch-Waxman Act. This article delves into the key aspects of the case, including the patents in question, the legal proceedings, and the final outcomes.
Background and Patents-in-Suit
Warner Chilcott Co., LLC, and its subsidiary, Warner Chilcott (US), LLC, owned several patents related to the drug Atelvia®, which is used for treating osteoporosis. The primary patents at issue were U.S. Patent Nos. 7,645,459 and 7,645,460, both of which describe a delayed-release formulation of risedronate in combination with ethylene diamine tetraacetic acid (EDTA)[2][4].
The Drug Product: Atelvia®
Atelvia® is a specific formulation containing 35 mg of risedronate sodium and 100 mg of disodium EDTA. This formulation was approved by the FDA on October 8, 2010, and is marketed for the treatment of osteoporosis[4].
The Litigation
Teva Pharmaceuticals USA, Inc., filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval for a generic version of Atelvia®. This action triggered a patent infringement lawsuit by Warner Chilcott under the Hatch-Waxman Act. Warner Chilcott asserted that Teva's ANDA infringed the '459 and '460 patents[4].
Proceedings in the District Court
The case was heard in the United States District Court for the District of New Jersey. Before the trial, Warner Chilcott dropped all asserted claims related to U.S. Patent No. 8,246,989 and all but two claims (claim 16 of the '459 patent and claim 20 of the '460 patent) of the '459 and '460 patents. Teva stipulated to infringement of these remaining claims, and the trial focused on the validity of these claims[2][4].
Prior Art and Obviousness
The district court considered Teva's argument that a prior art reference, known as the Brazilian Application, anticipated the asserted claims. The Brazilian Application disclosed an enterically coated formulation containing a combination of a bisphosphonate and a chelating agent, including the specific ingredients and dosages claimed in the '459 and '460 patents. The court found that this prior art did not teach away from using disodium EDTA and did not suggest that using the claimed amount of EDTA would be dangerous[2].
Objective Considerations
The district court also evaluated Warner Chilcott's evidence of objective considerations, such as long-felt need, unexpected results, and skepticism by skilled artisans. However, the court concluded that this evidence did not demonstrate nonobviousness. There was no proof of improved patient compliance as an unexpected result of the claimed invention, and other factors such as simultaneous invention by a third party and Teva's alleged failures or copying did not establish a nexus with the claimed invention[1].
District Court Decision
The district court held that claims 16 of the '459 patent and claim 20 of the '460 patent were invalid as obvious in view of the prior art. This decision was based on the court's analysis of the Brazilian Application and the lack of sufficient evidence supporting the nonobviousness of the claimed inventions[1][2].
Appeal to the Federal Circuit
Warner Chilcott appealed the district court's decision to the U.S. Court of Appeals for the Federal Circuit. The Federal Circuit reviewed the district court's findings and affirmed the decision, concluding that the district court did not err in finding the asserted claims invalid as obvious[1].
Key Takeaways
- Patent Validity: The case underscores the importance of prior art in determining patent validity. The Brazilian Application played a crucial role in establishing that the claimed inventions were obvious.
- Objective Considerations: The lack of strong objective considerations, such as unexpected results or long-felt need, can significantly weaken a patent holder's case for nonobviousness.
- Hatch-Waxman Act: This case illustrates the legal framework under which generic drug manufacturers can challenge the validity of patents listed in the FDA's Orange Book.
FAQs
Q: What was the main issue in the Warner Chilcott v. Teva Pharmaceuticals case?
A: The main issue was whether the claims of U.S. Patent Nos. 7,645,459 and 7,645,460, related to the drug Atelvia®, were valid or obvious in view of prior art.
Q: What is Atelvia®, and what is its significance in this case?
A: Atelvia® is a delayed-release formulation of risedronate and EDTA used to treat osteoporosis. It was the drug product at the center of the patent infringement dispute.
Q: What role did the Brazilian Application play in the case?
A: The Brazilian Application was a prior art reference that disclosed a formulation similar to that claimed in the '459 and '460 patents, which the court found anticipated the asserted claims.
Q: What were the objective considerations evaluated by the district court?
A: The court evaluated factors such as long-felt need, unexpected results, skepticism by skilled artisans, and nexus between the claimed invention and Teva's alleged failures or copying.
Q: What was the final outcome of the case?
A: The Federal Circuit affirmed the district court's decision, holding that claims 16 of the '459 patent and claim 20 of the '460 patent were invalid as obvious.
Sources
- Warner Chilcott Co. v. Teva Pharms. United States, Inc., 2015-1588 (March 18, 2016 Fed. Cir.).
- Warner Chilcott Co., LLC v. Teva Pharms. USA, Inc., Civ. No. 11-6936 (FSH), 2015 U.S. Dist. LEXIS 26207 (D.N.J. Mar. 4, 2015).
- ANDA Update - McDermott Will & Emery, July 5, 2016.
- Warner Chilcott Co. v. Teva Pharmaceuticals USA, Inc., Casetext.
- Warner Chilcott Co., LLC v. Teva Pharms. USA, Inc., Robins Kaplan.
