AbbVie Vies for Claim Construction Leukemia Treatment Patent Case

On Friday a brief regarding claim construction was filed in a case filed by Abbvie Inc. and others against Dr. Reddy’s Laboratories LTD. The original case was for patent infringement under the Hatch-Waxman Act, and was filed in the District of Delaware.

The case is regarding violations of the patents for Venclexta. Venclexta is a “treatment of chronic lymphocytic leukemia (“CLL”), small lymphocytic lymphoma (“SLL”), and acute myeloid leukemia (“AML”)… CLL and SLL are blood cancers that progress until “morbidity is considerable, both from the disease and from complications of therapy.” 

AML, per the complaint, is “one of the most aggressive blood cancers, with a very low survival rate,” attacking with such speed that it affords few options for some patients to receive treatment before the introduction of Venclexta. 

The lawsuits involve three patent families:  (1) a family covering the active ingredient in Venclexta (a compound known as “venetoclax”) and methods of use thereof; (2) a family covering certain crystalline forms, or “polymorphs,” of venetoclax; and (3) a family covering administration of venetoclax.  This claim construction proceeding includes terms only from the three related patents within the second “polymorphs” family.”

The polymorph patents describe certain crystalline forms of the venetoclax compound which are identified by measuring the degree of angle of diffraction when the crystals are hit with X-rays. Due to the inherent variability of the crystallization process, no one set of crystals will have a perfect pattern, but should all have the unique diffraction pattern and percentages for that particular compound.

The patent claim has the format of: “a powder X-ray diffraction pattern having five  or more peaks selected from those at 6.3, 7.1, 9.0, 9.5,  12.5, 14.5, 14.7, 15.9, 16.9, and 18.9 degrees 2θ (pattern A)”   (’657 patent, claim 1)”. The plaintiff claims that the construction is sufficiently obvious, and accuse the defendants of wanting an additional step, namely a review of the crystals to see if they match a pattern, then a review of the angle of diffraction. The plaintiffs argue that this additional step adds vagueness as the means of determining if the crystal corresponds to the pattern is no defined or obvious from the claim.

Plaintiffs are represented by Saul Ewing Arnstein & Lehr and Paul Hastings. Defendants are represented by Smith, Katzenstein & Jenkins and Windels Marx Lane & Mittendorf