Litigation Details for Genentech, Inc. v. Aurobindo Pharma Limited (D. Del. 2019)

Genentech, Inc. v. Aurobindo Pharma Limited (D. Del. 2019)

Docket		Date Filed	2019-01-17
Court	District Court, D. Delaware	Date Terminated	2021-10-20
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To
Parties	INTERMUNE, INC.
Patents	7,566,729; 7,635,707; 7,696,236; 7,767,225; 7,767,700; 7,816,383; 7,910,610; 7,988,994; 8,013,002; 8,084,475; 8,318,780; 8,383,150; 8,420,674; 8,592,462; 8,609,701; 8,648,098; 8,753,679; 8,754,109; 8,778,947
Attorneys	Mark E. Waddell
Firms	Morris, Nichols, Arsht & Tunnell
Link to Docket	External link to docket

Details for Genentech, Inc. v. Aurobindo Pharma Limited (D. Del. 2019)

Date Filed	Document No.	Description	Snippet	Link To Document
2019-01-17				External link to document
2019-01-16	1		U.S. Patent No. 7,566,729 25. U.S. Patent No. 7,566,729 (“the ‘729 patent”), entitled… U.S. Patent No. 7,767,700 29. U.S. Patent No. 7,767,700 (“the ‘700 patent”), entitled… U.S. Patent No. 8,013,002 35. U.S. Patent No. 8,013,002 (“the ‘002 patent”), entitled… U.S. Patent No. 8,383,150 41. U.S. Patent No. 8,383,150 (“the ‘150 patent”), entitled… U.S. Patent No. 8,609,701 47. U.S. Patent No. 8,609,701 (“the ‘701 patent”), entitled	External link to document
2019-01-16	18	Patent/Trademark Report to Commissioner of Patents	B2; 7,696,236 B2; 7,767,700 B2; 8,420,674 B2; 7,566,729 B1; 7,635,707 B1; 8,592,462 B2; 8,609,701 B2; … Report to the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 7,767,225 B2; …2019 20 October 2021 1:19-cv-00103 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Genentech, Inc. v. Aurobindo Pharma Limited: A Comprehensive Litigation Summary and Analysis

Case Overview

The case of Genentech, Inc. v. Aurobindo Pharma Limited (Case Number: 1:19-cv-00103) is a significant patent infringement litigation that unfolded in the United States District Court for the District of Delaware. Here, we delve into the key aspects of this case, including the background, claim construction, legal arguments, and the court's decisions.

Background

Genentech, Inc. and InterMune, Inc. (now part of Roche) filed a lawsuit against Aurobindo Pharma Limited and other pharmaceutical companies, alleging patent infringement under the Hatch-Waxman Act. The lawsuit involved several patents related to pharmaceutical products, specifically U.S. Patent Nos. 7,566,729, 7,635,707, and 8,592,462[4].

Claim Construction

A central issue in this case was the construction of the claim term "Grade 2 abnormality in one or more biomarkers of liver function." The plaintiffs argued that this term is defined in the specification as referring to specific biomarkers: alanine transaminase (ALT), aspartate transaminase (AST), bilirubin, alkaline phosphatase (ALP), and gamma-glutamyltransferase (GGT)[1][4].

Plaintiffs' Argument

Genentech and InterMune contended that the specification consistently identifies "Grade 2 abnormalities" with respect to these five biomarkers. They pointed to tables in the patents that list these biomarkers and their corresponding elevation levels, which constitute a "Grade 2 abnormality"[1][4].

Defendants' Argument

Aurobindo Pharma Limited and the other defendants argued that the term "Grade 2 abnormality in one or more biomarkers of liver function" is indefinite. They claimed that the phrase lacks a plain and ordinary meaning and that neither the claim language nor the specification provides a clear boundary for the term. The defendants highlighted several instances in the specification where the term "biomarkers of liver function" is allegedly unclear or self-contradictory[1][4].

Court's Decision

The court heard oral arguments on September 23, 2020, and subsequently issued a memorandum order. The court disagreed with the defendants' argument of indefiniteness, ruling that the specification clearly defines the term "Grade 2 abnormality" in relation to the five specified biomarkers. The court held that a person of ordinary skill in the art would understand which liver function tests are referred to by the term "biomarkers of liver function"[1][4].

Implications of the Decision

The court's decision underscores the importance of clear and specific language in patent specifications. It reinforces the principle that patent claims must be definite and that the specification plays a crucial role in defining claim terms. This ruling is consistent with other cases where courts have emphasized that the specification is as important as, if not more important than, the claims themselves[1].

Litigation Outcomes and Statistics

While the specific outcome of this case in terms of infringement and damages is not detailed here, it is part of a broader trend in patent litigation. In many cases, patentees prevail in a significant percentage of cases, especially when the claims and specifications are well-defined. For instance, in a study on patent litigation outcomes, it was noted that patentees win approximately 67% of cases terminated by consent judgment[2].

Key Takeaways

• Clear Specification: The case highlights the critical importance of clear and specific language in patent specifications to avoid claims of indefiniteness.
• Claim Construction: The court's decision emphasizes that claim terms must be defined clearly within the specification to ensure that they are not indefinite.
• Patent Litigation Trends: The outcome is consistent with broader trends in patent litigation where well-defined claims and specifications often lead to favorable outcomes for patentees.

Frequently Asked Questions

What was the main issue in the Genentech v. Aurobindo Pharma case?

The main issue was the construction of the claim term "Grade 2 abnormality in one or more biomarkers of liver function" and whether it was definite.

How did the court define the term "Grade 2 abnormality in one or more biomarkers of liver function"?

The court defined this term as referring specifically to the biomarkers ALT, AST, bilirubin, ALP, and GGT, as consistently identified in the patent specification.

What was the defendants' argument regarding the claim term?

The defendants argued that the term was indefinite because it lacked a plain and ordinary meaning and the specification did not provide a clear boundary for the term.

What is the significance of the court's decision in this case?

The decision emphasizes the importance of clear and specific language in patent specifications and reinforces that the specification is crucial in defining claim terms.

How common is it for patentees to win in patent litigation cases?

In many cases, patentees win a significant percentage of cases, especially when the claims and specifications are well-defined, with a win rate of around 67% in cases terminated by consent judgment.

Cited Sources:

1. Myers Bigel, "Courts continue to remind patent owners and patent practitioners that when it comes to patent drafting, the specification is just as important as the claims, if not more," https://www.myersbigel.com/courts-continue-to-remind-patent-owners-and-patent-practitioners-that-when-it-comes-to-patent-drafting-the-specification-is-just-as-important-as-the-claims-if-not-more/.
2. LegalMetric, "Individual Judge Report," https://www.legalmetric.com/samples/sample_ijr_patent.pdf.
3. United States District Court for the District of Delaware, "AstraZeneca AB, Plaintiff, v. Aurobindo Pharma Ltd., et al. Defendants," https://www.ded.uscourts.gov/sites/ded/files/opinions/14-664.pdf.
4. United States District Court for the District of Delaware, "Genentech, Inc. and InterMune, Inc., Plaintiff, v. Aurobindo Pharma Limited, et al., Defendants," https://www.ded.uscourts.gov/sites/ded/files/opinions/19-78_0.pdf.