Case Overview
The case of BioDelivery Sciences International, Inc. v. Actavis Laboratories UT, Inc., filed as 1:16-cv-00175 in the United States District Court for the District of Delaware, involves a patent infringement dispute related to the pharmaceutical drug product Bunavail®. Here is a detailed summary and analysis of the key aspects of this litigation.
Parties Involved
- Plaintiffs: BioDelivery Sciences International, Inc. (BDSI) and its wholly owned subsidiary, Arius Two, Inc.
- Defendant: Actavis Laboratories UT, Inc. (Actavis Labs), a pharmaceutical company involved in the formulation, manufacture, packaging, and marketing of generic drug products[2].
Jurisdiction and Venue
The case was filed in the District of Delaware, a common venue for patent litigation due to its expertise in handling complex intellectual property cases. The plaintiffs argued that the court had jurisdiction over Actavis Labs based on several factors, including the defendant's purposeful availment of the forum and its previous litigations in Delaware[2].
Patent and Drug Product at Issue
The patent in question is related to Bunavail®, a buprenorphine/naloxone buccal film used in the maintenance treatment of opioid dependence. The FDA approved the New Drug Application (NDA) No. 205637 for Bunavail® on June 6, 2014, and the relevant patent was listed in the Orange Book shortly after[2].
Claims and Allegations
BDSI and Arius Two, Inc. filed an amended complaint alleging patent infringement by Actavis Labs under 35 U.S.C. §§ 271(e)(2), (a), (b), and (c). The complaint stated that Actavis Labs had filed an Abbreviated New Drug Application (ANDA) with the FDA, seeking approval to manufacture, use, and sell a generic version of the buprenorphine/naloxone buccal film before the expiration of the patent[2].
Defendant's Actions and Motions
Actavis Labs filed an ANDA No. 208806 with the FDA, which prompted the plaintiffs to allege infringement. Actavis Labs did not dispute the infringement if the patent was found valid but argued that the patent was invalid[2].
Trial and Rulings
The case involved a detailed analysis of the patent's validity. The court considered various arguments, including those related to anticipation and obviousness. However, the specific rulings and outcomes in this case are not as detailed in the available sources as those in similar Hatch-Waxman litigations.
Similarities with Other Hatch-Waxman Cases
In Hatch-Waxman litigations, the validity of patents is often a central issue. For example, in UCB, Inc. v. Actavis Laboratories UT, Inc., the court found the asserted claims of a patent invalid for anticipation and obviousness, similar to the potential arguments in the BioDelivery Sciences case. The court in such cases typically examines whether the prior art would have led a person of ordinary skill in the art to anticipate or find the claimed invention obvious[1][3].
Strategic Implications
The outcome of this case would have significant implications for both the plaintiffs and the defendant. For BDSI and Arius Two, Inc., a favorable ruling would protect their exclusive rights to Bunavail® until the patent expires. For Actavis Labs, a successful challenge to the patent's validity would allow them to enter the market with a generic version sooner.
Conclusion
The litigation between BioDelivery Sciences International, Inc. and Actavis Laboratories UT, Inc. highlights the complex and often contentious nature of patent disputes in the pharmaceutical industry. The case underscores the importance of thorough patent validity assessments and the strategic maneuvering involved in Hatch-Waxman litigations.
Key Takeaways
- Patent Validity: The central issue in such cases often revolves around the validity of the patent, with arguments focusing on anticipation and obviousness.
- Jurisdiction: The District of Delaware is a preferred venue for patent litigation due to its expertise.
- Strategic Implications: The outcome can significantly impact the market entry of generic drugs and the exclusive rights of the patent holders.
- Hatch-Waxman Litigation: These cases involve intricate legal and technical analyses, often requiring detailed expert testimony and thorough review of prior art.
Frequently Asked Questions (FAQs)
What is the main issue in the BioDelivery Sciences International, Inc. v. Actavis Laboratories UT, Inc. case?
The main issue is whether Actavis Laboratories UT, Inc.'s filing of an Abbreviated New Drug Application (ANDA) for a generic version of Bunavail® infringes the patent held by BioDelivery Sciences International, Inc.
What is Bunavail®, and what is it used for?
Bunavail® is a buprenorphine/naloxone buccal film used in the maintenance treatment of opioid dependence.
Why is the District of Delaware a common venue for patent litigation?
The District of Delaware is known for its expertise in handling complex intellectual property cases, making it a preferred venue for patent litigation.
What are the key arguments in Hatch-Waxman litigations?
Key arguments often focus on the validity of the patent, particularly whether the claimed invention is anticipated or obvious based on prior art.
How do the outcomes of these cases impact the pharmaceutical industry?
The outcomes can significantly affect the timing of generic drug market entry and the exclusive rights of patent holders, influencing competition and pricing in the pharmaceutical market.
Cited Sources:
- UCB, INC. v. ACTAVIS LABORATORIES UT, INC. - U.S. Court of Appeals for the Federal Circuit[1].
- BioDelivery Sciences International, Inc. v. Actavis Laboratories UT, Inc. - United States District Court for the District of Delaware[2].
- UCB, Inc. v. Actavis Labs. UT, Inc. - Casetext[3].
