Pirfenidone – USA

Pirfenidone – USA

Claim Construction (District of Delaware): Oct. 20, 2020

Civil Action No.: 19-cv-78 -RGA

Plaintiff: Genentech, Inc. et al.

Defendants: Aurobindo Pharma Limited, et al.

Court issued claim construction of a single term in US 7,566,729, US 7,635,707 and US 8,592,462. The Court heard oral argument on September 23, 2020. Plaintiffs Genentech and InterMune brought cases against Defendants, alleging Hatch-Waxman Act patent infringement. The cases have been consolidated. Defendants argued that the term “Grade 2 abnormality in one or more biomarkers of liver function” as recited in various asserted claims of the three patents should be construed as indefinite.


“Grade 2 abnormality in one or more biomarkers of liver function”

Plaintiffs’ proposed construction: A value obtained from a blood chemistry test of abnormal liver function that meets the grading criteria for a ‘Grade 2 adverse effect’ set forth in the Common Terminology Criteria for Adverse Events v3.0 (CTCAE) published Aug. 9, 2006 by the National Cancer Institute, as also presented in Table 1 of each of the ’729, ’707, and ’462 patents, and incorporated by reference therein.

Defendants’ proposed construction: The term is indefinite.

Court’s construction: The term is not indefinite. Plaintiffs’ proposed construction is adopted.


Plaintiffs argued that “one or more biomarkers of liver function” is defined in the specification as the five biomarkers alanine transaminase (ALT), aspartate transaminase (AST), bilirubin, alkaline phosphatase (ALP), and gamma-glutamyltransferase (GGT). Plaintiffs contended that the specification consistently identifies “Grade 2 abnormalities” with respect only to these five biomarkers, which are listed in Table 1. Defendants contended that a person of ordinary skill in the art (POSITA) would be unable to determine which liver function tests are in fact “biomarkers of liver function.” Defendants pointed to several instances in the specification where, they argued, “biomarkers of liver function” is not clearly defined. For example, defendants note an instance in the specification which states, “Examples of biomarkers of liver function include, but are not limited to” ALT, AST, bilirubin, ALP, and GGT. Defendants have also identified other tests that can be used to assess liver function, but which are not mentioned in the specification.

Court, however, agreed with Plaintiff and said that the disputed claim term can be construed with reasonable certainty. Court said that the specifications of all three patents use the term “biomarkers of liver function” to refer to the five tests—ALT, AST, bilirubin, ALP, and GGT—on a basis sufficient to inform a POSITA as to the scope of the term.  All three patents contain two tables which only list the toxicity criteria for the five tests, ALT, AST, bilirubin, ALP, and GGT. The patent claims require a “Grade 2 abnormality” and only the five tests—ALT, AST, bilirubin, ALP, and GGT—are defined in terms of the requisite elevation levels that would constitute such a “Grade 2 abnormality.” Consequently, a POSITA seeking to understand the term “Grade 2 abnormality in one or more biomarkers of liver function” would look to the specification and find that only the five tests—ALT, AST, bilirubin, ALP, and GGT—are defined in terms of a “Grade 2 abnormality.” As a result, a POSITA would be able to determine with “reasonable certainty” which tests constitute “biomarkers of liver function.”

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