Litigation Details for Forest Laboratories LLC v. Amneal Pharmaceuticals LLC (D. Del. 2015)

Forest Laboratories LLC v. Amneal Pharmaceuticals LLC (D. Del. 2015)

Docket		Date Filed	2015-08-27
Court	District Court, D. Delaware	Date Terminated	2016-09-02
Cause	35:271 Patent Infringement	Assigned To	Leonard Philip Stark
Jury Demand	None	Referred To
Parties	FOREST LABORATORIES LLC
Patents	8,058,291; 8,168,209; 8,173,708; 8,283,379; 8,293,794; 8,329,752; 8,338,485; 8,338,486; 8,362,085; 8,580,858; 8,598,233
Attorneys	Ricardo Rodriguez
Firms	Young, Conaway, Stargatt & Taylor LLP
Link to Docket	External link to docket

Details for Forest Laboratories LLC v. Amneal Pharmaceuticals LLC (D. Del. 2015)

Date Filed	Document No.	Description	Snippet	Link To Document
2015-08-27				External link to document
2015-08-27	1		quot;the '009 patent"); 8,058,291 ("the '291 patent"); 8,168,209, as corrected …009 patent, the '291 patent, the '209 patent, the '708 patent, the '379 patent, the…794 patent, the '752 patent, the '485 patent, the '486 patent, the '085 patent, the…379 patent, the '794 patent, the '752 patent, the '485 patent, the '486 patent, the…379 patent, the '794 patent, the '752 patent, the '485 patent, the '486 patent, the	External link to document
2015-08-27	5		Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 8,039,009 B2; 8,058,291 B2; 8,168,209… 2 September 2016 1:15-cv-00756 830 Patent None District Court, D. Delaware	External link to document
2015-08-27	23		of, U.S. Patent Nos. 8,168,209, as corrected (“the ‘209 patent”); 8,173,708 (“the ‘708 patent”); 8,283,379…,379 (“the ‘379 patent”); 8,329,752 (“the ‘752 patent”); 8,362,085 (“the ‘085 patent”); 8,598,233 (“the…“the ‘233 patent”) and 8,039,009 (“the ‘009 patent”). These patents are also at issue in Civil Action… Judge Stark’s Revised Procedures for Managing Patent Cases (which is posted at http://www.ded.uscourts.gov…www.ded.uscourts.gov.; see Chambers, Judge Leonard P. Stark, Patent Cases) on , 2015, and	External link to document
2015-08-27	102		infringement of U.S. Patent Nos. 8,039,009 ("the '009 Patent"), 8,058,291 ("the '…379 Patent, the '794 Patent, the '752 Patent, the '485 Patent, the '486 Patent, the…379 Patent, the '794 Patent, the '752 Patent, the '485 Patent, the '486 Patent, the… Patent, the '209 Patent, the '708 Patent, the '379 Patent, the '794 Patent, the…379 Patent, the '794 Patent, the '752 Patent, the '485 Patent, the '486 Patent, the	External link to document

Forest Laboratories LLC v. Amneal Pharmaceuticals LLC: A Comprehensive Litigation Summary and Analysis

Background and Procedural Posture

The litigation between Forest Laboratories LLC and Amneal Pharmaceuticals LLC is a significant example of a Hatch-Waxman patent infringement case. This case, filed in the United States District Court for the District of Delaware, involves Forest Laboratories LLC and its affiliates suing Amneal Pharmaceuticals LLC and other related entities for alleged patent infringement related to Forest's pharmaceutical products.

Patent Infringement Claims

Forest Laboratories LLC filed the lawsuit on April 21, 2014, alleging that Amneal's submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Forest's Namenda XR® (memantine hydrochloride extended release capsules) and Namzaric (a combination of memantine and donepezil) infringed several of Forest's patents[1][3].

Personal Jurisdiction Disputes

A key aspect of this litigation involves disputes over personal jurisdiction. Amneal argued that the court lacked personal jurisdiction over it, citing the Supreme Court's decision in Daimler AG v. Bauman (2014). However, the court ultimately found that it had general jurisdiction over Amneal based on the consent theory, where Mylan (another defendant in related cases) had consented to general jurisdiction in Delaware[1].

General vs. Specific Jurisdiction

The Supreme Court recognizes two types of personal jurisdiction: general and specific. General jurisdiction applies when a defendant's contacts with the forum state are so extensive that they are "at home" in the state, while specific jurisdiction is based on the connection between the defendant's forum-state contacts and the plaintiff's claim. In this case, the court focused on whether Amneal's activities constituted sufficient contacts to establish general jurisdiction[1].

Consent to General Jurisdiction

The court's decision hinged on the argument that Mylan, and by extension Amneal, had consented to general jurisdiction in Delaware. This consent was inferred from Mylan's previous actions and agreements, which the court deemed sufficient to establish jurisdiction over Amneal as well[1].

Patent Infringement Allegations

Forest Laboratories alleged that Amneal's ANDA filing infringed multiple patents related to Namenda XR® and Namzaric. These allegations were based on Section 271(e)(2)(A) of the Patent Act, which allows for infringement claims against ANDA filers who seek to market a generic version of a patented drug before the patent expires[1][3].

Section 271(e)(2)(A) and Section 271(g) Infringement

Section 271(e)(2)(A) specifically addresses the infringement by ANDA filers, while Section 271(g) pertains to the infringement by importing, offering to sell, or selling a product made by a process patented in the United States. Amneal's actions were alleged to infringe under both sections, given their role in manufacturing and marketing the generic drugs[1][4].

Judicial Efficiency and Overlapping Actions

Similar to other cases involving biosimilar and generic drugs, the issue of judicial efficiency was raised. Amgen's arguments in a related case highlighted the importance of considering future acts of infringement in determining jurisdiction. This approach aims to avoid redundant litigation and promote judicial economy by addressing all related infringement claims in a single action[4].

Commercial Relationships and Venue Considerations

The close commercial relationship between the ANDA submitter and the future distributor (in this case, Amneal) is a crucial factor. Decisions like Acorda Therapeutics, Inc. v. Mylan Pharms. Inc. emphasize that the future acts of the distributor should be considered in determining venue and jurisdiction, as these parties often act in a cooperative or partnership-like manner[1][4].

Key Takeaways

• Personal Jurisdiction: The court's decision to assert general jurisdiction over Amneal based on consent highlights the importance of understanding the scope of a defendant's contacts with the forum state.
• Patent Infringement: The case underscores the application of Sections 271(e)(2)(A) and 271(g) in Hatch-Waxman litigation, particularly in cases involving generic and biosimilar drugs.
• Judicial Efficiency: Considering future acts of infringement can enhance judicial efficiency by consolidating related claims into a single action.
• Commercial Relationships: The close relationship between ANDA submitters and future distributors is a significant factor in determining venue and jurisdiction.

FAQs

Q: What is the Hatch-Waxman Act, and how does it apply to this case?

The Hatch-Waxman Act is a federal law that allows generic drug manufacturers to file ANDAs with the FDA, which can lead to patent infringement lawsuits. In this case, Forest Laboratories sued Amneal for infringement based on Amneal's ANDA filing for a generic version of Forest's patented drugs.

Q: How did the court determine personal jurisdiction over Amneal?

The court determined personal jurisdiction over Amneal based on the consent theory, where Mylan's previous actions and agreements were deemed to extend to Amneal, establishing general jurisdiction in Delaware.

Q: What sections of the Patent Act were relevant to the infringement claims?

Sections 271(e)(2)(A) and 271(g) of the Patent Act were relevant. Section 271(e)(2)(A) addresses infringement by ANDA filers, while Section 271(g) pertains to infringement by importing, offering to sell, or selling a product made by a patented process.

Q: Why is judicial efficiency important in these types of cases?

Judicial efficiency is crucial as it helps avoid redundant litigation by consolidating related claims into a single action, thereby reducing the burden on the court and the parties involved.

Q: How do commercial relationships impact venue and jurisdiction in Hatch-Waxman cases?

The close commercial relationship between the ANDA submitter and the future distributor is significant. It can influence the determination of venue and jurisdiction, as these parties often act in a cooperative manner, making it necessary to consider their future acts in the jurisdiction analysis.

Cited Sources

1. Forest Labs., Inc. v. Amneal Pharms. LLC - Casetext
2. Forest Laboratories LLC et al v. Sigmapharm - Justia Law
3. Michael J. Freno - K&L Gates
4. Who Can Be A Defendant In Biosimilar Patent Litigation? - Fish & Richardson LLP