Home Legal Advice Doctrine of Equivalents in Lilly v. Apotex

Doctrine of Equivalents in Lilly v. Apotex

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Eli Lilly and Co v. Apotex, Inc. (Fed. Cir. 2020)

You don’t see this typically — the district courtroom held on abstract judgment that Apotex infringes under the doctrine of equivalents.  On appeal, the Federal Circuit has affirmed – discovering no error. (Nonprecedential opinion)

Lilly’s US7772209 claims a selected therapy scheme for pemetrexed disodium that features a pre-treatment with folic-acid to keep away from the tough side-effects.  See, Crouch, Eligibility Cannot be Raised in IPR Appeal (2019).  Apotex’s product makes use of a barely completely different salt – pemetrexed dipotassium.  Apotex wants its model to be the equal with a view to obtain drug approval, however it could want to nonetheless keep away from infringement under the Doctrine of Equivalents.

Although Apotex (implicitly) admits that its model is an equal, the corporate argues that Lilly ought to be estopped from pursuing DoE infringement right here due to Prosecution History Estoppel (PHE).  In explicit, Lilly made a narrowing modification to the declare time period in query throughout patent prosecution to keep away from the prior artwork and now seeks to reclaim that floor through equivalents.

My simplistic drawing above does the trick.  Lilly’s unique patent submitting didn’t expressly declare the usage of “pemetrexed disodium,” however somewhat used the broader time period “an antifolate.”  During prosecution, Lilly narrowed its claims to keep away from some prior artwork — deleting the broader “antifolate” limitation and changing it with the narrower “pemetrexed disodium.”

None of the dependent claims expressly recited Pemetrexed Disodium.  However, one unique declare had restricted the antifolate to “ALIMTA,” which is Lilly’s kind of Pemetrexed Disodium.  In addition, the specification famous that the “most preferred” antifolate for the training the invention is “Pemetrexed Disodium (ALIMTA), as manufactured by Eli Lilly & Co.”  The declare to ALIMTA was additionally deleted throughout prosecution based mostly upon an indefiniteness rejection. MPEP 2173.05(u).

PHE: We know {that a} narrowing modification made throughout prosecution creates a presumption of Prosecution History Estoppel that may bar the patentee from asserting infringement-by-equivalents over the surrendered subject-matter.

The district courtroom discovered no give up, and the Federal Circuit affirmed.  The first bit right here is simple declare development — the unique (dependent) declare recited “ALIMTA” and now the declare recites “pemetrexed disodium.”  The district courtroom discovered these to be synonymous, and the federal circuit agreed.  Apotex had argued that ALIMTA ought to have been seen as encompassing all types of pemetrexed, and thus its deletion would function an extra narrowing modification. The courts, nevertheless, rejected that argument based mostly upon in intrinsic proof inside the patent paperwork.  This was the only real argument raised on appeal by Apotex and thus misplaced the case.

The courtroom doesn’t deal with PHE stemming from the larger modification (antifolate => pemetrexed disodium).  There was a continuation utility in-between, however you “can’t use continuations to avoid fact of narrowing amendment.” Robert A. Matthews, 2 Annotated Patent Digest § 14:82.

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