Case Overview
The case of ADAPT PHARMA OPERATIONS LIMITED et al v. PERRIGO UK FINCO LIMITED PARTNERSHIP (Case No. 2:18-cv-16987) involves a patent infringement dispute in the pharmaceutical industry. Here is a detailed summary and analysis of the key points of this litigation.
Background
Adapt Pharma Operations Limited, along with other affiliated companies, filed an intellectual property lawsuit against Perrigo UK Finco Limited Partnership on October 25, 2018. The lawsuit was filed in the U.S. District Court for the District of New Jersey and pertains to the infringement of patents related to Adapt Pharma's product, Narcan® (naloxone HCl nasal spray)[4].
Patents-in-Suit
The patents at issue in this case include U.S. Patent Nos. 9,211,253, 9,468,747, 9,561,177, 9,629,965, 9,775,838, and 10,085,937. These patents cover methods of treating opioid overdose using intranasal administration of a naloxone formulation, as well as devices for such administration[1][3].
Claims and Defenses
Adapt Pharma alleged that Perrigo's submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Narcan® infringed the aforementioned patents. Perrigo's ANDA submission is considered a technical act of infringement under 35 U.S.C. § 271(e)(2)[3].
Court Rulings and Settlements
The court proceedings resulted in a significant ruling:
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Injunction: The court enjoined Perrigo from infringing the patents-in-suit. This means Perrigo was prohibited from manufacturing, using, or selling the generic version of Narcan® until the patents expire or are found invalid or unenforceable by a court decision from which no appeal has been taken[1].
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Dismissal of Claims: All claims, counterclaims, affirmative defenses, and demands were dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. This indicates a final resolution to the litigation aspects of the case, with no further appeals or motions allowed[1].
Validity and Enforceability
In a related case involving similar patents, the District Court for the District of New Jersey found that some of the asserted claims of the patents-in-suit would have been obvious in view of prior art. However, in the specific case against Perrigo, the court did not challenge the validity or enforceability of the patents. Instead, the parties stipulated to the enforceability and validity of the patents-in-suit[1][3].
Implications for Generic Drug Manufacturers
This case highlights the challenges generic drug manufacturers face when attempting to enter the market with products that may infringe existing patents. The injunction against Perrigo prevents them from launching their generic version of Narcan®, thereby maintaining Adapt Pharma's market exclusivity for the patented product until the patents expire.
Strategic Considerations
For companies like Perrigo, this outcome underscores the importance of thorough patent analysis and potential settlement negotiations before submitting an ANDA. It also emphasizes the need for generic manufacturers to be prepared for litigation and to have strategies in place to address patent infringement claims.
Key Takeaways
- Patent Infringement: The submission of an ANDA can be considered a technical act of patent infringement.
- Injunctions: Courts can enjoin generic manufacturers from infringing patents, protecting the innovator's market exclusivity.
- Validity and Enforceability: The validity and enforceability of patents can be crucial in determining the outcome of such litigation.
- Strategic Planning: Generic manufacturers must carefully evaluate patent landscapes and consider litigation risks before entering the market.
FAQs
Q: What was the main issue in the ADAPT PHARMA OPERATIONS LIMITED v. PERRIGO UK FINCO LIMITED PARTNERSHIP case?
A: The main issue was whether Perrigo's submission of an ANDA for a generic version of Narcan® infringed Adapt Pharma's patents.
Q: What was the outcome of the case?
A: The court enjoined Perrigo from infringing the patents, and all claims were dismissed with prejudice.
Q: What patents were involved in this case?
A: The patents involved included U.S. Patent Nos. 9,211,253, 9,468,747, 9,561,177, 9,629,965, 9,775,838, and 10,085,937.
Q: How does this case impact generic drug manufacturers?
A: It highlights the need for thorough patent analysis and the potential for litigation when submitting an ANDA.
Q: What is the significance of the court's ruling on the validity and enforceability of the patents?
A: The court's ruling ensured that the patents remained valid and enforceable, protecting Adapt Pharma's market exclusivity.
Cited Sources
- Robins Kaplan, "ANDA Litigation Settlements Spring 2020 | Hatch-Waxman"
- U.S. District Court for the Southern District of West Virginia, "MDL 2327 - Ethicon, Inc. Wave 8 Cases"
- U.S. Court of Appeals for the Federal Circuit, "ADAPT PHARMA OPERATIONS v. TEVA PHARMACEUTICALS"
- UniCourt, "ADAPT PHARMA OPERATIONS LIMITED et al v PERRIGO UK FINCO LIMITED PARTNERSHIP"
