Monday, November 16, 2015

The significance of Cubist Pharma v. Hospira (Fed. Cir. 2015)

Concerning the PatentlyO post on Cubist v. Hospira titled:
Correcting your Patent Based upon Later Advances in Science,

LBE has a quibble with the title of the PatentlyO post AND, more importantly, with the decision.

**As to the title of the post, the technology to identify optical isomers (enantiomers) was known BEFORE the filing of the Lilly patent applications. The issue in Cubist has nothing to do with a "later advances in science" but rather with
a later-obtained experimental result based upon earlier science.

**As to the decision, LBE has two comments on PatentlyO, which are reproduced below:


Interesting point about an inferred difference [referring to text: Dennis, compare a court’s equitable powers that will correct an error that is virtually self-evident. This shows that the PTO can go well beyond what a court can do using its equitable powers. ]. Here, there was no doubt that Lilly “possessed” the compound with the D-enantiomer. An issue in this case is the lack of focus on “what was claimed”, as distinct from what may have been disclosed. The problem was that Lilly claimed the compound with the L-enantiomer. In the past, one got what one claimed, whether intended or not:
Radio Steel v. MTD, 221 USPQ 657 (CAFC 1984) or the “baking
bread” case [ Chef America v. Lamb-Weston: “a nonsensical result does
not require the court to redraft the claims of the patent.”

In this case, Lilly intended to claim the L-enantiomer, even though that is not what Lilly possessed. If Lilly had claimed the fermentation product, rather than a chemical formula, there might not be a problem. The invention is defined by the claims, not by the disclosure.

A related issue arose “In re ‘639 patent” as to prior art, which recited a synthetic pathway to a claimed compound [nabumetone] but which pathway contained an error [ironically because of reliance on a Lilly publication that was in error]. As another twist, the prior art disclosure actually produced [some] nabumetone.




As to –later advances in science–, and the text — In this case, the original patent filing included a structural diagram of the claimed daptomycin compound that was inaccurate because it misidentified a stereoisomer of asparagine. It was only after the patent issued that researchers discovered that the compound contained the D-isomer rather than the L-isomer. To be clear, when the patent issued, scientists thought that the compound actually had the L-isomer but then later learned that it had the D-isomer. — it’s not clear “why” there was an inference that the L-enantiomer of asp was present in the daptomycin obtained from fermentation. Certainly, the identity of the enantiomer of asp could have been determined at the time of filing. If the Lilly scientists “guessed wrong” and intentionally selected what turned out to be wrong, is this the type of mistake that should be corrected by a certificate of correction? As a hypo, if the the daptomycin with L-enantiomer of asp (which exists) turned out to be more effective than that with the D-enantiomer, what would Cubist be arguing?

Lilly chose to claim the invention in terms of a formula. Even
though the specification may offer support for various claims, it is the issued claims that define the invention that may be enforced.
In re Zletz, 893 F.2d 319, 13 USPQ2d 1320 . There is no doubt that Lilly possessed the compound with the D-enantiomer, but they didn’t claim it, and didn’t bother to check which enantiomer they had. Is that a mistake that should be corrected by a certificate of correction?


As to enantiomer, from wikipedia:

In chemistry, an enantiomer is one of two stereoisomers that are mirror images of each other that are non-superposable (not identical),

See also


The court affirmed a district court's judgment that invalidated four longest lasting patents related to the drug, the last of which would have given Cubist coverage until 2020. However, only the oldest patent, which expires in June, was left intact


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