Case Overview
The litigation between Shire Development LLC and SpecGx LLC, filed as Case No. 1:18-cv-00800 in the U.S. District Court for the District of Delaware, revolves around patent infringement claims related to several pharmaceutical patents held by Shire Development LLC.
Parties Involved
- Plaintiffs: Shire Development LLC, Shire LLC, and Shire US Inc.
- Defendant: SpecGx LLC, a Delaware limited-liability company.
Nature of the Action
This civil action arises under the patent laws of the United States, specifically Title 35, United States Code. The lawsuit alleges patent infringement by SpecGx LLC related to its Abbreviated New Drug Application (ANDA) for a generic version of a drug product covered by Shire's patents[3].
Patents-in-Suit
The patents at issue include:
- U.S. Patent No. 6,913,768 (the '768 patent)
- U.S. Patent No. 8,846,100 (the '100 patent)
- U.S. Patent No. 9,173,857 (the '857 patent)
These patents pertain to methods of treatment and drug delivery systems for certain pharmaceutical products.
Claims and Allegations
Shire Development LLC and its affiliated companies allege that SpecGx LLC's ANDA Product, for which SpecGx has submitted ANDA No. 211546 to the FDA, infringes on the methods of treatment claimed in the '768, '100, and '857 patents. Here are the key allegations:
- Infringement of Patent Claims: SpecGx's ANDA Product is claimed to constitute a material part of the methods of treatment covered by the patents in suit. Shire argues that SpecGx knows or should know that its product will be made for uses that directly infringe the patented methods[3].
- Irreparable Harm: Shire contends that SpecGx's infringement will cause irreparable harm and that there is no adequate remedy at law. Therefore, Shire seeks preliminary and permanent injunctions to prevent SpecGx from manufacturing, using, selling, or importing the infringing product[3].
Jurisdiction and Venue
Shire argues that the court has personal jurisdiction over SpecGx because:
- SpecGx is a Delaware limited-liability company.
- SpecGx has purposefully directed its activities towards residents and corporate entities within the State of Delaware.
- The claims arise out of or relate to these activities.
- SpecGx’s contacts with Delaware are continuous and systematic, making it reasonable and fair for the court to exercise personal jurisdiction[3].
Legal Arguments and Relief Sought
Shire seeks several forms of relief, including:
- Injunctive Relief: To prevent SpecGx from manufacturing, using, selling, offering to sell, or importing the ANDA Product prior to the expiration dates of the patents in suit, including any regulatory extensions.
- Delayed FDA Approval: An order that the effective date of any approval of SpecGx’s ANDA Product shall be no earlier than the expiration dates of the patents in suit[3].
Similar Litigations and Context
This case is part of a broader pattern of patent litigation involving Shire Development LLC. For instance, Shire has also been involved in similar disputes with other pharmaceutical companies, such as Watson Pharmaceuticals and Teva Pharmaceuticals, over patent infringement related to their drug products[1][5].
Key Takeaways
- Patent Infringement Claims: The lawsuit centers on Shire's allegations that SpecGx's ANDA Product infringes on its patented methods of treatment.
- Jurisdiction and Venue: The court's jurisdiction over SpecGx is based on its Delaware incorporation and systematic contacts with the state.
- Relief Sought: Shire seeks injunctive relief and delayed FDA approval for SpecGx’s ANDA Product to protect its patent rights.
- Broader Context: This case is one of several patent infringement lawsuits involving Shire Development LLC, highlighting the company's proactive approach to protecting its intellectual property.
FAQs
Q: What are the patents at issue in the Shire Development LLC v. SpecGx LLC case?
A: The patents include U.S. Patent No. 6,913,768, U.S. Patent No. 8,846,100, and U.S. Patent No. 9,173,857.
Q: Why is Shire Development LLC suing SpecGx LLC?
A: Shire is suing SpecGx for alleged patent infringement related to SpecGx’s ANDA Product, which Shire claims infringes on its patented methods of treatment.
Q: What relief is Shire seeking in the lawsuit?
A: Shire is seeking injunctive relief to prevent SpecGx from manufacturing, using, or selling the infringing product, as well as an order to delay FDA approval of SpecGx’s ANDA Product until the patents expire.
Q: What is the basis for the court’s jurisdiction over SpecGx LLC?
A: The court’s jurisdiction is based on SpecGx being a Delaware limited-liability company and its systematic contacts with the state.
Q: Are there similar cases involving Shire Development LLC?
A: Yes, Shire has been involved in similar patent infringement disputes with other pharmaceutical companies, such as Watson Pharmaceuticals and Teva Pharmaceuticals.
Cited Sources
- Robins Kaplan LLP - Shire Development, LLC v. Watson Pharms., Inc.
- Unified Patents - US-9173857-B2 - Controlled Dose Drug Delivery System
- PharmaCompass - mydayisamphetamine-shire-development-v-specgx-1527500733.pdf
- FindLaw - SHIRE DEVELOPMENT LLC v. WATSON PHARMACEUTICALS INC.
- Justia - Shire Development LLC et al v. Teva Pharmaceuticals USA, Inc. et al
