Patent is held unenforceable due to laches and/or inequitable conduct
Cancer Research Technology, et al. v. Barr Laboratories, Inc., et al., Civ. No.07-457-SLR, January 26, 2010.
Robinson, J. After trial, the court makes findings of fact and conclusions of law. It finds in favor of the defendants on the defenses of prosecution laches and/or inequitable conduct.
This is an ANDA case involving the generic version of the brain cancer drug Temodar©. A bench trial took place between March 30, 2009 and April 2, 2009 on the prosecution laches and inequitable conduct defenses. As for laches, the court found that CRCT also did nothing "to further the prosecution of [its] application toward the issuance of any claims" for nearly a decade and, instead, preserved its rights through a series of continuations and abandonments. The court concluded that the "ends" - commercialization of a very successful cancer drug - do not justify the "means" employed by CRCT in this case. Taken in the totality, this case involves eleven patent applications, ten abandonments, and no substantive prosecution for a decade. The court further concluded with respect to the inequitable conduct claim that the withheld information directly contradicts statements made in the '291 patent's specification regarding the utility of the claimed compounds, and directly contravenes the patentability of (broadly-written) claim. For these reasons, the withheld inactivity data is highly material. Finally, the court notes that plaintiff's assertions that certain (nondisclosed) positive studies are “cumulative to the disclosure in the specification” are misplaced. Materiality is not adjudged by whether the withheld information is "positive" or "negative;" to the extent CRCT had positive phase II data (regarding malignant melanoma and/or small cell carcinoma of the lung), it was also information that "may have influenced the patent examiner in the course of prosecution." As for intent, the court determined that the information withheld from the PTO was highly material, and that (at least) the inventor knew of the information. He should have appreciated the materiality of the data and his conclusions as they expressly contradicted the disclosure of the pending applications. Under these circumstances, the court finds the inventor’s publications to the scientific community a sufficient basis upon which to infer intent to deceive.
