Schwarz Pharma, Inc. and Schwarz Pharma Ag v. Paddock Laboratories,Inc.
Schwarz Pharma, Inc. v. Paddock Laboratories, Inc., F.3d , (2007).
Briefed by: Andrea Berg
Facts: Paddock filed an Abbreviated New Drug Application (ANDA) at the FDA for approval to market generic tablets containing moexipril hydrochloride (MH) and magnesium oxide (MgO).
Warner-Lambert Co., LLC (Warner-Lambert) owns the ’450 patent, and Schwarz held an exclusive license under it with respect to the Angiotensin Converting Enzyme (ACE) inhibitor moexipril. MH is the hydrochloric acid salt of moexipril and the active ingredient in Schwarz’s branded drug. The patent relates to pharmaceutical compositions containing ACE inhibitors combined with stabilizers to prevent certain types of degradation. ACE inhibitors are prescribed for the treatment of high blood pressure. Without the stabilizers, the ACE inhibitors may degrade through cyclization, discoloration, and hydrolysis. The ’450 patent generally teaches use of an alkali or alkaline earth metal carbonate to inhibit cyclization and discoloration. Schwarz has alleged that Paddock infringed claims 1, 5-8, 12, and 16 of the ’450 patent by filing the ANDA.
Claim 1, one of the independent claims (the other is claim 16, which relates to the process), follows:
A pharmaceutical composition which contains:
(a) a drug component which comprises a suitable amount of an ACE inhibitor which is susceptible to cyclization, hydrolysis, and discoloration,
(b) a suitable amount of an alkali or alkaline earth metal carbonate to inhibit cyclization and discoloration, and
(c) a suitable amount of a saccharide to inhibit hydrolysis.
Originally, a “metal containing stabilizer†and “an alkali or alkaline earth-metal salt,â€was claimed but following a rejection, each was amended to instead recite “an alkali or alkaline earth metal carbonate.†MgO is an alkaline earth metal carbonate.
Procedural Posture: Schwarz and Warner Lambert sued Paddock for infringement of patent ‘450. The lower court found no literal infringement, so the plaintiffs relied on the doctrine of equivalents. The lower court found no infringement on this basis either because Schwarz was estopped from claiming that the MgO used by Paddock was the equivalent of an alkali or alkaline earth metal carbonate. The court held that Schwarz did not rebut the presumption of surrender of the patent because MgO was a foreseeable equivalent of magnesium carbonate. Schwarz appealed; however, Warner Lambert was not party to the appeal though it was the owner of the patent. Schwarz argues that it never claimed MgO, was it could not have surrendered it. Paddock argues that MgO is both a metal containing stabilizer and an alkaline earth metal salt within the plain meaning of those terms. It contains a metal, and it is a stabilizer, thus it was exactly what was surrendered when Schwarz amended the original claim.
Issues: 1. Does Schwarz have standing in this appeal without joining Warner Lambert since Schwarz does not possess “all substantial rights†of the patent?
2. Did the court err in allowing prosecution history estoppel to narrow the claim of ‘450 and exclude MgO from what was covered by the patent?
Holding: 1. The court held that Schwarz did have standing. Even if Warner Lambert is not part of the appeal, it is part of the infringement action and will be bound by a decision of this court.
2. No. The district court did not err in finding that prosecution history estoppel existed in this case. MgO was clearly within what was surrendered in the amendment. In addition, it was foreseeable and was very much related to the patentability of the claim, as it amended the claim to narrow it and overcome a rejection by the examiner.
Critical Analysis: This seemed like a very “easy†prosecution history estoppel case. I’m not sure why Schwarz decided to appeal. Perhaps that is why Warner Lambert decided not to join in on appeal.
Schwarz Pharma, Inc. v. Paddock Laboratories, Inc., F.3d , (2007).
Briefed by: Andrea Berg
Facts: Paddock filed an Abbreviated New Drug Application (ANDA) at the FDA for approval to market generic tablets containing moexipril hydrochloride (MH) and magnesium oxide (MgO).
Warner-Lambert Co., LLC (Warner-Lambert) owns the ’450 patent, and Schwarz held an exclusive license under it with respect to the Angiotensin Converting Enzyme (ACE) inhibitor moexipril. MH is the hydrochloric acid salt of moexipril and the active ingredient in Schwarz’s branded drug. The patent relates to pharmaceutical compositions containing ACE inhibitors combined with stabilizers to prevent certain types of degradation. ACE inhibitors are prescribed for the treatment of high blood pressure. Without the stabilizers, the ACE inhibitors may degrade through cyclization, discoloration, and hydrolysis. The ’450 patent generally teaches use of an alkali or alkaline earth metal carbonate to inhibit cyclization and discoloration. Schwarz has alleged that Paddock infringed claims 1, 5-8, 12, and 16 of the ’450 patent by filing the ANDA.
Claim 1, one of the independent claims (the other is claim 16, which relates to the process), follows:
A pharmaceutical composition which contains:
(a) a drug component which comprises a suitable amount of an ACE inhibitor which is susceptible to cyclization, hydrolysis, and discoloration,
(b) a suitable amount of an alkali or alkaline earth metal carbonate to inhibit cyclization and discoloration, and
(c) a suitable amount of a saccharide to inhibit hydrolysis.
Originally, a “metal containing stabilizer†and “an alkali or alkaline earth-metal salt,â€was claimed but following a rejection, each was amended to instead recite “an alkali or alkaline earth metal carbonate.†MgO is an alkaline earth metal carbonate.
Procedural Posture: Schwarz and Warner Lambert sued Paddock for infringement of patent ‘450. The lower court found no literal infringement, so the plaintiffs relied on the doctrine of equivalents. The lower court found no infringement on this basis either because Schwarz was estopped from claiming that the MgO used by Paddock was the equivalent of an alkali or alkaline earth metal carbonate. The court held that Schwarz did not rebut the presumption of surrender of the patent because MgO was a foreseeable equivalent of magnesium carbonate. Schwarz appealed; however, Warner Lambert was not party to the appeal though it was the owner of the patent. Schwarz argues that it never claimed MgO, was it could not have surrendered it. Paddock argues that MgO is both a metal containing stabilizer and an alkaline earth metal salt within the plain meaning of those terms. It contains a metal, and it is a stabilizer, thus it was exactly what was surrendered when Schwarz amended the original claim.
Issues: 1. Does Schwarz have standing in this appeal without joining Warner Lambert since Schwarz does not possess “all substantial rights†of the patent?
2. Did the court err in allowing prosecution history estoppel to narrow the claim of ‘450 and exclude MgO from what was covered by the patent?
Holding: 1. The court held that Schwarz did have standing. Even if Warner Lambert is not part of the appeal, it is part of the infringement action and will be bound by a decision of this court.
2. No. The district court did not err in finding that prosecution history estoppel existed in this case. MgO was clearly within what was surrendered in the amendment. In addition, it was foreseeable and was very much related to the patentability of the claim, as it amended the claim to narrow it and overcome a rejection by the examiner.
Critical Analysis: This seemed like a very “easy†prosecution history estoppel case. I’m not sure why Schwarz decided to appeal. Perhaps that is why Warner Lambert decided not to join in on appeal.