Andrulis Pharmaceuticals Corp. v. Celgene Corp.

DC Delaware Case 1:13-cv-01644-RGA
Affirmed by FC panel 7/14/16 (Docket No. 2015-1962)
PROST, SCHALL, CHEN
July 14, 2016

Brief Summary: FC affirmed DC DE finding of invalidity of US 6,140,346 due to the indefiniteness of the term “enhanced” in e.g., “enhanced therapeutically-effective amounts of thalidomide”.

Summary: FC affirmed DC DE finding of invalidity of US 6,140,346 for indefiniteness of the term “enhanced”, “enhanced combination”, “enhanced therapeutically-effective amounts of thalidomide”, and “said neoplastic diseases are sensitive to said enhanced combination”. The DC first construed the term “administering” and concluded it did not include prescribing but only “delivering the drug into or onto a [mammal’s] body.” Andrulis argued that “enhanced” (alone and in “enhanced combination”) means “synergistic”. The opinion explains that “[t]he term ‘enhance’ in common usage means to ‘improve,’ ‘increase’ or ‘intensify.’” “The central issue” here “is whether enhanced means greater than additive or whether it renders the claim indefinite.” It explained that “[t]he patent itself does not provide much guidance on the meaning of enhanced”, “show[ing] up in the specification only twice”, and that “[i]t is not self-evidence from this usage…that the use of ‘enhance’ is consistent with how it was used in the claimed to modify ‘combination’ or ‘amount of thalidomide.” The prosection history was not found to support Andrulis’s position because, in part, “the examiner told the applicant during prosecution that claims showing a ‘greater than additive effect’ would overcome a particular piece of prior art” and the applicant responded by “add[ing] ‘enhanced’ to the patent claims, implying that term would overcome the…prior art-but that does not mean enhanced is the same as ‘greater than additive” (“The fact that the applicant used ‘enhanced’ rather than ‘greater than additive’ suggests that the applicant chose not to expressly adopt the examiner’s position, as the applicant could have easily used the examiner’s suggested language…[o]r…used some variation of ‘synergistic,’ which appears to the be therm of art for ‘greater than additive.’”) The inventor’s testimony as to the meaning of “enhanced” was not accepted (“It does not matter, however, what he believes….it is not unusual for there to be a significant difference between what an inventor thinks his patented invention is and what the ultimate scopy of the claims is after allowance by the PTO” (Howmedica, FC 2008)). The opinion also discussed the grammatical problems with the use of the term “enhanced” in “enhanced therapeutically-effective amounts of thalidomide” (“Because ‘enhanced’ in this phrase must modify ‘amount of thalidomide,’ this term must be indefinite because it is unclear what an ‘enhanced’ amount of thalidomide (or an ‘enhanced’ therapeutically-effective amounts of thalidomide) would be.”) And “neoplastic diseases” was construed to mean “cancers”.

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