Introduction
The litigation between Bracco Diagnostics Inc. and Maia Pharmaceuticals, Inc. revolves around a patent infringement dispute involving the drug sincalide, a synthetic peptide hormone. Here is a detailed summary and analysis of the case.
Background of the Case
Bracco Diagnostics Inc. filed a complaint against Maia Pharmaceuticals, Inc. in the United States District Court for the District of New Jersey, alleging patent infringement of United States Patent No. 6,803,046 (the ’046 Patent). The ’046 Patent covers Bracco’s drug sincalide, sold under the trade name Kinevac, which is used to stimulate gallbladder contraction, pancreatic secretion, and to accelerate the transit of a barium meal through the small bowel[4].
Maia’s New Drug Application (NDA)
Maia filed a New Drug Application (NDA) under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (FDCA) for a drug product containing sincalide, referencing Bracco’s sincalide formulation. This NDA included a paragraph IV certification, challenging the validity of the ’046 Patent[1].
Claims of Infringement
Bracco alleged that Maia’s NDA and the associated paragraph IV certification constituted an act of infringement of the ’046 Patent. Bracco argued that Maia had no factual or legal basis for its certification and that the filing of the NDA was done with the intent to infringe the patent. Bracco also claimed that Maia’s product had no substantial non-infringing uses other than as the pharmaceutical claimed in the ’046 Patent[1].
District Court Proceedings
The district court constructed the claims of the ’046 Patent, particularly focusing on the terms "buffer," "surfactant/solubilizer," and "surfactant." The court defined a buffer as "an excipient that: stabilizes the pH of sincalide formulations of the invention, and consequently, reduces the risk of chemical instability at extreme pH values." The court also included amino acids in its definition of buffer and surfactant/solubilizer, which was crucial as Maia’s product contained amino acid excipients[2][4].
Claim Construction Disputes
Maia appealed the district court’s claim constructions to the Federal Circuit Court, arguing that the court erred in including amino acids in the definitions and in listing compounds from the Markush groups in the claim construction order. However, the Federal Circuit Court affirmed the district court’s judgment, noting that the technical error of listing compounds was harmless and did not frustrate the task of claim construction. The court emphasized that claim construction is to provide definitional meaning to claim language, not to list specific compounds[2][4].
Stipulation of Infringement
Based on the district court’s claim constructions, the parties stipulated to infringement of certain claims (claims 1-3, 6, 10-17, 19, 21-23, 26, 30-37, 40-41, 44, and 48-55) and dismissed the remaining claims and defenses without prejudice. Maia argued that it had no choice but to stipulate to infringement due to the court’s construction, but the Federal Circuit Court rejected this argument, holding that Maia had stipulated to infringement based on the clear language of the stipulation[2][4].
Federal Circuit Court Decision
The Federal Circuit Court upheld the district court’s judgment, affirming the claim constructions and the stipulation of infringement. The court noted that the Markush groups in the dependent claims were closed, meaning they excluded any elements not specified in the claim, and thus the scope of the dependent claims was clear and definite. The court also rejected Maia’s proposal to adopt different constructions for the terms "buffer," "surfactant/solubilizer," and "surfactant," finding that the district court’s constructions were correct and did not invalidate the functional construction of the claim terms[2][4].
Key Takeaways
- Patent Infringement: Bracco successfully alleged that Maia’s NDA and product infringed the ’046 Patent.
- Claim Construction: The district court’s constructions of the terms "buffer," "surfactant/solubilizer," and "surfactant" were upheld by the Federal Circuit Court.
- Stipulation: The parties stipulated to infringement based on the district court’s claim constructions.
- Federal Circuit Decision: The Federal Circuit Court affirmed the district court’s judgment, rejecting Maia’s appeals.
FAQs
What was the basis of the patent infringement claim by Bracco Diagnostics Inc.?
Bracco Diagnostics Inc. claimed that Maia Pharmaceuticals, Inc. infringed the ’046 Patent by filing an NDA for a drug product containing sincalide, which referenced Bracco’s sincalide formulation.
What were the key terms in dispute during the claim construction?
The key terms in dispute were "buffer," "surfactant/solubilizer," and "surfactant," particularly whether amino acids could be included in these definitions.
Why did Maia appeal the district court’s claim constructions?
Maia appealed because it argued that the district court erred in including amino acids in the definitions and in listing compounds from the Markush groups.
What was the outcome of the Federal Circuit Court’s decision?
The Federal Circuit Court affirmed the district court’s judgment, upholding the claim constructions and the stipulation of infringement.
What is the significance of the Markush groups in this case?
The Markush groups in the dependent claims were closed, meaning they excluded any elements not specified in the claim, making the scope of the dependent claims clear and definite.
Cited Sources
- PharmaCompass.com - BRACCO DIAGNOSTICS INC - PharmaCompass.com
- Casetext - Bracco Diagnostics Inc. v. Maia Pharm., Inc., No. 2020-1387
- Law360 - BRACCO DIAGNOSTICS INC. v. MAIA PHARMACEUTICALS, INC.
- Robins Kaplan LLP - Bracco Diagnostics Inc. v. Maia Pharms., Inc.
- Law360 - BRACCO DIAGNOSTICS INC. v. MAIA PHARMACEUTICALS, INC.
