Litigation Details for Boehringer Ingelheim Pharmaceuticals Inc. v. Mankind Pharma Ltd. (D. Del. 2018)

Boehringer Ingelheim Pharmaceuticals Inc. v. Mankind Pharma Ltd. (D. Del. 2018)

Docket		Date Filed	2018-10-26
Court	District Court, D. Delaware	Date Terminated
Cause	35:271 Patent Infringement	Assigned To	Colm Felix Connolly
Jury Demand	None	Referred To	Sherry R. Fallon
Parties	DR. REDDY'S LABORATORIES, INC.
Patents	10,258,637; 7,713,938; 8,551,957; 9,949,998
Attorneys	Serena S. Gopal
Firms	Blank Rome LLP
Link to Docket	External link to docket

Details for Boehringer Ingelheim Pharmaceuticals Inc. v. Mankind Pharma Ltd. (D. Del. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-10-26	63	Notice of Service	Associated with ANDA No. 212322 for U.S. Patent Nos. 8,551,957 and 9,949,998 filed by Boehringer Ingelheim… 26 October 2018 1:18-cv-01689 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2018-10-26	64	Notice of Service	Associated with ANDA No. 212394 for U.S. Patent No. 7,713,938, filed by Boehringer Ingelheim Corporation…Products Associated with ANDA No. 212354 for U.S. Patent No. 9,949,998; (2) Plaintiffs' Preliminary Infringement…Product Associated with ANDA No. 212355 for U.S. Patent No. 9,949,998; and (3) Plaintiffs' Preliminary … 26 October 2018 1:18-cv-01689 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2018-10-26	65	Notice of Service	Associated with ANDA No. 212366 for U.S. Patent Nos. 7,713,938; 8,551,957 and 9,949,998; and (2) Plaintiffs…Associated with ANDA No. 212382 for U.S. Patent Nos. 7,713,938; 8,551,957 and 9,949,998, filed by Boehringer… 26 October 2018 1:18-cv-01689 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2018-10-26	67	Notice of Service	Associated with ANDA No. 212370 for U.S. Patent Nos. 7,713,938; 8,551,957 and 9,949,998; (2) Plaintiffs…Associated with ANDA No. 212371 for U.S. Patent Nos. 7,713,938 and 9,949,998; (3) Plaintiffs' Preliminary…Associated with ANDA No. 212349 for U.S. Patents No. 7,713,938 & 9,949,998; and (4) Plaintiffs' Preliminary…Associated with ANDA No. 212374 for U.S. Patent No. 7,713,938, filed by Boehringer Ingelheim Corporation… 26 October 2018 1:18-cv-01689 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2018-10-26	69	Notice of Service	Associated with ANDA No. 212336 for U.S. Patent Nos. 7,713,938 and 9,949,998, filed by Boehringer Ingelheim… 26 October 2018 1:18-cv-01689 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2018-10-26	113	Patent/Trademark Report to Commissioner of Patents	;7,713,938 B2 ;8,551,957 B2 ;9,949,998 B2 ;10,258,637 B2 ;9,949,997 B2 . (Dellinger, Megan) (Entered:… Report to the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 7,579,449 B2 ;… 26 October 2018 1:18-cv-01689 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2018-10-26	132	Claim Construction Chart	to the identified claim terms of U.S. Patents Nos. 8,551,957 and 7,713,938. Agreed-upon constructions… U.S Patent No. 8,551,957 Claim(s) Term/Phrase …Pharmaceuticals Inc.. (Attachments: # 1 Exhibit 1 - '938 Patent, # 2 Exhibit 2 - '938 Notice of Allowance)(Dellinger… U.S. Patent No. 7,713,938 Claim(s) Term/Phrase … 26 October 2018 1:18-cv-01689 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Boehringer Ingelheim Pharmaceuticals Inc. v. Mankind Pharma Ltd.: A Comprehensive Litigation Summary and Analysis

Introduction

The litigation between Boehringer Ingelheim Pharmaceuticals Inc. and Mankind Pharma Ltd. is a significant case in the pharmaceutical industry, involving patent infringement and the complexities of generic drug approvals. Here, we will delve into the key aspects of this case, including the background, the claims made by the parties, the legal arguments, and the potential implications.

Background

Boehringer Ingelheim Pharmaceuticals Inc. (Boehringer Ingelheim) is a global pharmaceutical company known for its innovative drugs. Mankind Pharma Ltd. (Mankind Pharma) is an Indian pharmaceutical company that develops, manufactures, and distributes generic drugs. The dispute arose when Mankind Pharma submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for generic versions of Boehringer Ingelheim’s patented drugs, specifically those related to the patents US 8,551,957 and US 8,598,998[3][4].

Claims and Allegations

Boehringer Ingelheim alleged that Mankind Pharma’s ANDA products would infringe on their patents. The plaintiffs sought several forms of relief, including:

• A judgment that Mankind Pharma had infringed at least one claim of the patents in question.
• A declaration that the case is exceptional, entitling Boehringer Ingelheim to reasonable attorney fees.
• Preliminary and permanent injunctions against Mankind Pharma to prevent the manufacture, use, offer to sell, or sale of the infringing drugs.
• An order that the effective date of any FDA approval for Mankind Pharma’s ANDA products should not be earlier than the expiration dates of the patents in question[3].

Legal Arguments

Boehringer Ingelheim argued that Mankind Pharma’s actions would cause substantial and irreparable harm if not enjoined. They contended that Mankind Pharma’s generic drug products would directly infringe on their patented inventions. The plaintiffs also argued that this case is exceptional under 35 U.S.C. § 285, which warrants reimbursement of their reasonable attorney fees due to the alleged willful infringement by Mankind Pharma[3].

Personal Jurisdiction

Boehringer Ingelheim also argued that the court has personal jurisdiction over Mankind Pharma. They claimed that Mankind Pharma is organized under the laws of the State of Delaware, intends to market and distribute its generic drug products in the United States, and enjoys substantial income from sales in this jurisdiction[3].

Potential Impact

The outcome of this case could have significant implications for both companies and the broader pharmaceutical industry. If Boehringer Ingelheim succeeds, it would prevent Mankind Pharma from entering the market with generic versions of the patented drugs until the patents expire. This would maintain Boehringer Ingelheim’s market exclusivity and protect their intellectual property. Conversely, if Mankind Pharma prevails, it could lead to earlier market entry for generic drugs, potentially reducing drug prices and increasing competition[3][4].

Comparison with Other Litigations

This case highlights the ongoing battles between brand-name pharmaceutical companies and generic drug manufacturers over patent rights. Similar to other cases, such as those involving the Inflation Reduction Act and Medicare drug negotiations, the focus is on the balance between protecting intellectual property and ensuring affordable healthcare[1].

Key Takeaways

• Patent Infringement Claims: Boehringer Ingelheim alleged that Mankind Pharma’s ANDA products would infringe on their patents.
• Relief Sought: Boehringer Ingelheim sought injunctions, declarations of infringement, and attorney fees.
• Personal Jurisdiction: The court was argued to have jurisdiction over Mankind Pharma due to its business activities in the U.S.
• Implications: The case affects market exclusivity, drug prices, and competition in the pharmaceutical industry.

FAQs

What is the main issue in the Boehringer Ingelheim v. Mankind Pharma litigation?

The main issue is whether Mankind Pharma’s generic drug products infringe on Boehringer Ingelheim’s patents.

What relief is Boehringer Ingelheim seeking in this case?

Boehringer Ingelheim is seeking a judgment of infringement, injunctions against Mankind Pharma, and reimbursement of attorney fees.

Why is personal jurisdiction important in this case?

Personal jurisdiction is crucial because it determines whether the U.S. court has the authority to hear the case against Mankind Pharma, a company based in India.

How could the outcome of this case impact the pharmaceutical industry?

The outcome could affect drug prices, market competition, and the balance between protecting intellectual property and ensuring affordable healthcare.

What are the potential financial implications for Boehringer Ingelheim if they lose the case?

If Boehringer Ingelheim loses, they could face significant financial losses due to the early entry of generic competitors, which could reduce their market share and revenue.

Sources

1. Boehringer Ingelheim Pharmaceuticals, Inc. v. U.S. Department of Health and Human Services et al. - Litigation Tracker, Georgetown University Law.
2. Limon v. Circle K Stores Inc. - Casetext.
3. Boehringer Ingelheim Pharmaceuticals Inc. v. Mankind Pharma Ltd. - Insight, RPX Corporation.
4. Boehringer Ingelheim Pharmaceuticals Inc. v. Mankind Pharma Ltd. - Insight, RPX Corporation.