Case Overview
The litigation between Boehringer Ingelheim Pharmaceuticals Inc. and Cadila Healthcare Limited, case number 1:19-cv-01295, revolves around patent infringement allegations related to generic versions of Boehringer Ingelheim's medications.
Parties Involved
- Plaintiffs: Boehringer Ingelheim Pharmaceuticals Inc., Boehringer Ingelheim International GmbH, and Boehringer Ingelheim Corporation.
- Defendants: Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Limited, with Zydus USA being a wholly-owned subsidiary of Cadila Healthcare Limited[1][4].
Nature of the Action
This is a patent infringement case filed under the Food and Drug Laws and Patent Laws of the United States. The plaintiffs allege that the defendants infringed on their patents by submitting Abbreviated New Drug Applications (ANDAs) to the FDA for generic versions of JARDIANCE® (empagliflozin) and SYNJARDY® (empagliflozin/metformin) tablets before the expiration of the relevant patents[1].
Patents in Question
The patents at issue include United States Patent Nos. 7,579,449, 9,949,998, and 7,713,938. These patents cover the composition and use of empagliflozin and the combination of empagliflozin with metformin[1].
Allegations of Infringement
Boehringer Ingelheim alleges that Zydus Pharmaceuticals' submission of ANDAs to the FDA constitutes an act of infringement under 35 U.S.C. § 271(e)(2)(A). This section of the law prohibits the submission of an ANDA if it would result in the manufacture, use, offer to sell, sale, or importation of a drug before the expiration of the relevant patent[1].
Legal Proceedings
The complaint was filed in the District Court of Delaware, and it outlines the plaintiffs' claims of patent infringement. The plaintiffs seek to prevent the defendants from manufacturing, selling, and distributing the generic versions of their patented drugs until the patents expire[1].
Defendants' Actions
The defendants, Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Limited, had submitted ANDAs to the FDA, which the plaintiffs argue is an infringement of their patent rights. The defendants' actions are seen as a direct challenge to the exclusivity period granted by the patents[1].
Court Rulings and Appeals
While the specific rulings in this case are not detailed in the provided sources, the general process involves the court evaluating whether the submission of the ANDAs constitutes infringement. If the court finds infringement, it may grant an injunction to prevent the defendants from proceeding with their generic drug applications until the patents expire.
Similar Cases and Precedents
In similar patent infringement cases, such as GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., the courts have emphasized the importance of proving causation in induced infringement claims. For instance, in the GSK case, the court ruled that the defendant's actions must be shown to have directly caused the infringement, and that other factors such as medical guidelines and physician experience could also influence prescribing decisions[3].
Implications and Consequences
The outcome of this case can have significant implications for both the pharmaceutical industry and the generic drug market. If Boehringer Ingelheim prevails, it could extend the exclusivity period for their patented drugs, delaying the entry of generic competitors. Conversely, if the court rules in favor of the defendants, it could expedite the availability of generic versions, potentially reducing drug costs for consumers[1].
Key Takeaways
- Patent Infringement Claims: Boehringer Ingelheim alleges that Zydus Pharmaceuticals' ANDA submissions infringe on their patents.
- Legal Basis: The case is grounded in 35 U.S.C. § 271(e)(2)(A), which prohibits ANDA submissions that would result in pre-patent expiration use of patented drugs.
- Court Proceedings: The case is ongoing in the District Court of Delaware.
- Industry Implications: The outcome can affect the timing of generic drug entry and the exclusivity period for patented medications.
FAQs
What is the main issue in the Boehringer Ingelheim v. Cadila Healthcare litigation?
The main issue is whether the submission of ANDAs by Zydus Pharmaceuticals for generic versions of Boehringer Ingelheim's patented drugs constitutes patent infringement.
Which patents are involved in this litigation?
The patents involved include United States Patent Nos. 7,579,449, 9,949,998, and 7,713,938, covering empagliflozin and its combination with metformin.
What is the significance of 35 U.S.C. § 271(e)(2)(A) in this case?
This section of the law prohibits the submission of an ANDA if it would result in the manufacture, use, offer to sell, sale, or importation of a drug before the expiration of the relevant patent.
How could the outcome of this case impact the pharmaceutical industry?
The outcome could either extend the exclusivity period for Boehringer Ingelheim's patented drugs or expedite the entry of generic competitors, affecting drug prices and market dynamics.
Are there any similar cases that provide precedent for this litigation?
Yes, cases like GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. provide precedent on issues such as proving causation in induced infringement claims.
Cited Sources:
- Boehringer Ingelheim Pharmaceuticals Inc. et al v. Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Limited, Complaint, Case 1:18-cv-01763-UNA.
- Mallory v. Comm'r of Soc. Sec., No. 1:19-cv-01295-EPG.
- GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., Case 18-1976.
- Boehringer Ingelheim Pharmaceuticals Inc. et al v. Cadila Healthcare Limited, Case 1:19-cv-01295.
- Boehringer Ingelheim Pharmaceuticals Inc. et al v. Cadila Healthcare Limited, Summary, Patexia.
