Introduction
The litigation between Bristol-Myers Squibb Company (BMS) and Mylan Pharmaceuticals Inc. (MPI) is a significant case in the realm of patent infringement, particularly under the Hatch-Waxman Act. This article delves into the key aspects of the case, including the background, legal arguments, court decisions, and the broader implications for patent litigation.
Background
Bristol-Myers Squibb Company and Pfizer Inc. (collectively, BMS or Plaintiffs) initiated a patent infringement action against Mylan Pharmaceuticals Inc. (MPI) in the United States District Court for the District of Delaware. The case, Bristol-Myers Squibb Co. v. Mylan Pharms. Inc., involves MPI's submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of BMS's branded drug Eliquis® (apixaban)[1].
The Hatch-Waxman Act and Patent Infringement
The Hatch-Waxman Act allows generic drug manufacturers to submit ANDAs to the FDA, which can lead to patent infringement claims by the brand-name drug manufacturers. In this case, BMS alleged that MPI's ANDA submission and the subsequent planned commercial activities would infringe BMS's patents, specifically U.S. Patent Nos. 6,967,208 and 9,326,945[1].
Venue and Jurisdiction
A critical aspect of the case was the determination of proper venue. Following the Supreme Court's decision in TC Heartland LLC v. Kraft Foods Group Brands LLC, which narrowed the definition of proper venue in patent cases, MPI moved to dismiss the complaint for improper venue. The court, however, denied this motion without prejudice, allowing for expedited venue-related discovery to determine if MPI had a "regular and established place of business" in Delaware[1].
Federal Circuit Ruling on Venue
The Federal Circuit's decision in a related case, Valeant Pharmaceuticals N. Am. LLC v. Mylan Pharmaceuticals Inc., provided significant guidance on venue in Hatch-Waxman litigation. The Federal Circuit clarified that for Hatch-Waxman cases, venue is proper only in districts where the acts related to the submission of the ANDA occurred, not in districts where future distribution of the generic product may be contemplated. This ruling restricted the interpretation of "acts of infringement" under 28 U.S.C. § 1400(b) to the actual submission of the ANDA, rather than future planned acts[4].
Implications of the Federal Circuit's Decision
The Federal Circuit's decision has several key implications:
- Narrow Definition of Acts of Infringement: The court held that the act of submitting an ANDA is the sole "act of infringement" for venue purposes, rejecting the argument that future planned acts of infringement should be considered[4].
- Venue Restrictions: This decision limits the venues where brand-name drug companies can sue generic manufacturers, potentially reducing the number of lawsuits and inconsistencies in judgments[4].
- Foreign Entities: The Federal Circuit also clarified that foreign entities, like Mylan Laboratories Ltd. (MLL), are subject to venue in any judicial district, provided the complaint sufficiently alleges their involvement in the ANDA submission[4].
Court Proceedings and Outcomes
In the Bristol-Myers Squibb Co. v. Mylan Pharms. Inc. case, Judge Leonard P. Stark of the District of Delaware allowed the case to proceed on the merits while permitting expedited venue-related discovery. This approach ensured that the court could later determine if venue was proper based on the discovery findings[1].
Broader Implications for Patent Litigation
The decisions in these cases have significant implications for patent litigation under the Hatch-Waxman Act:
- Venue Clarity: The Federal Circuit's ruling provides clarity on where patent infringement actions can be brought, reducing the complexity and potential for forum shopping.
- Efficiency in Litigation: By limiting the venues to those where the ANDA was submitted, the court aims to reduce the time and expense associated with multiple lawsuits in different districts.
- Consistency in Judgments: The narrowed definition of "acts of infringement" helps in achieving consistent judgments across different cases, which is crucial for the integrity of the patent system[4].
Industry Impact
For pharmaceutical companies, these decisions mean:
- Strategic Considerations: Generic manufacturers must consider the venue implications when submitting ANDAs, as the submission location can determine where they can be sued.
- Litigation Strategy: Brand-name drug companies need to be precise in their venue allegations, focusing on the specific acts related to the ANDA submission rather than future distribution plans[4].
Key Takeaways
- The submission of an ANDA is considered the sole "act of infringement" for determining proper venue in Hatch-Waxman cases.
- Venue is limited to the district where the ANDA was submitted.
- Foreign entities involved in ANDA submissions can be subject to venue in any judicial district.
- The decisions aim to reduce complexity, time, and expense in patent litigation.
Frequently Asked Questions (FAQs)
Q: What is the Hatch-Waxman Act, and how does it relate to patent infringement?
A: The Hatch-Waxman Act allows generic drug manufacturers to submit ANDAs to the FDA, which can lead to patent infringement claims by brand-name drug manufacturers.
Q: How did the TC Heartland decision impact venue in patent cases?
A: The TC Heartland decision narrowed the definition of proper venue in patent cases, requiring that the defendant have a "regular and established place of business" in the district or where the defendant has committed acts of infringement.
Q: What was the Federal Circuit's ruling on venue in Valeant Pharmaceuticals N. Am. LLC v. Mylan Pharmaceuticals Inc.?
A: The Federal Circuit ruled that venue in Hatch-Waxman cases is proper only in districts where the ANDA was submitted, not in districts where future distribution is planned.
Q: How do these decisions affect foreign entities involved in ANDA submissions?
A: Foreign entities can be subject to venue in any judicial district if the complaint sufficiently alleges their involvement in the ANDA submission.
Q: What are the broader implications of these decisions for patent litigation?
A: These decisions aim to reduce complexity, time, and expense in patent litigation by limiting venues and ensuring consistency in judgments.
Cited Sources:
- Bristol-Myers Squibb Co. v. Mylan Pharms. Inc., C.A. No. 17-379-LPS (D. Del. Sep. 11, 2017).
- Bristol-Myers Squibb Company et al v. Aurobindo Pharma USA Inc., Docket Report, Justia.
- Bristol-Myers Squibb Co. v. Mylan Pharms., Inc., Casetext Analysis.
- Valeant Pharmaceuticals N. Am. LLC v. Mylan Pharmaceuticals Inc., Mintz Insights Center.
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE, Case 1:17-cv-00379-LPS Document 36 Filed 09/11/2017.
