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BY Howard J. Shire
December 20, 2010

Federal Circuit Reverses District of Delaware on Prosecution Laches and
Inequitable Conduct

On Nov. 9, 2010, the Federal Circuit delivered its opinion in Cancer Research Labs. v. Barr Labs., Civ. No. 10-1204. The case involved a single patent, 5,260,291, titled “Tetrazine derivatives” (the '291 patent). The patent claims a genus of tetrazine derivative compounds and methods for treating cancer by administering those compounds. One claimed compound, temozolomide, is the active ingredient in the drug Temodar', approved by the Food and Drug Administration (“FDA”) for the treatment of two types of brain cancer, refractory anaplastic astrocytoma and glioblastoma multiforme.

The specification of the '291 patent discloses data from animal tests, specifically mouse tumor models, that demonstrate the efficacy of the tetrazine derivatives. In the first substantive office action, the Examiner rejected the original method claim for lack of utility. Instead of responding to the office action, the applicants filed a continuation application and abandoned the original application. This rejection-continuation-abandonment pattern repeated itself nine more times before the Examiner rejected all pending claims for lack of utility.

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