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Lily Prevails in Alimta Obvious Double Patenting Challenge

By Robyn Hagan Cain on August 29, 2012 | Last updated on March 21, 2019

For those of you wondering what David Bowie and Eli Lilly could possibly have in common, the answer is five years.

The Federal Circuit Court of Appeals upheld the validity of Alimta, Lilly's lung cancer drug, on Friday. That means the company won't face generic competition until 2017, reports Bloomberg.

The dispute in this case centered around abbreviated new drug applications (ANDAs) filed by several generic pharmaceutical manufacturers seeking approval to market generic formulations of the chemotherapy agent pemetrexed, (which Lilly markets as Alimta). The companies' ANDAs each included a Paragraph IV certification asserting that the '932 patent was invalid, unenforceable, or would not be infringed by the proposed generic products.

(Teva Parenteral Medicines, Inc. specifically conceded infringement, but maintained that the asserted claims of the '932 patent were invalid for obviousness-type double patenting over two earlier-issued claims.)

A district court ruled against the generic companies in 2011, holding that Lilly's U.S. Patent 5,344,932 ('932 patent) was not invalid. Teva, Barr Laboratories, Inc., and APP Pharmaceuticals, LLC appealed.

The doctrine of obviousness-type double patenting is intended to "prevent the extension of the term of a patent ... by prohibiting the issuance of the claims in a second patent not patentably distinct from the claims of the first patent." A later patent claim is not patentably distinct from an earlier claim if the later claim is obvious over, or anticipated by, the earlier claim.

As with statutory obviousness under 35 U.S.C. § 103, obviousness-type double patenting is an issue of law premised on underlying factual inquiries. Here, the Federal Circuit Court of Appeals found that, based on the evidence presented at trial, the district court did not err in its findings or its conclusion that the asserted '932 claims was patentably distinct from Lilly's other patents.

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