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

By Kevin E. Noonan --

After more than two decades of being the red-headed stepchild of patent infringement before the Federal Circuit, infringement under the doctrine of equivalents has made a dramatic comeback in the past few years, the Court affirming plaintiffs asserting their patents under the doctrine six times (versus denying DOE infringement on the basis of prosecution history estoppel twice, on the basis of the dedication-disclaimer estoppel twice, and finding no equivalents twice).  One of those affirmances was in Eli Lilly & Co. v. Hospira, Inc., directed to the same patent and with assertion of infringement under the doctrine of equivalents as in the most recent case decided by the Federal Circuit, Eli Lilly & Co. v. Apotex, Inc.

This case arose in ANDA litigation over Apotex's generic version of Eli Lilly's ALIMTA® (premetrexed disodium) drug product for treating mesothelioma and certain lung cancers.  Lilly asserted Orange Book-listed U.S. Patent No. 7,772,209 against Apotex for infringement under the doctrine of equivalents pursuant to 35 U.S.C. § 271(e)(2); claims 1 and 12 are representative:

1.  A method for administering pemetrexed disodium to a patient in need thereof comprising administering an effective amount of folic acid and an effective amount of a methylmalonic acid lowering agent followed by administering an effective amount of pemetrexed disodium, wherein
    the methylmalonic acid lowering agent is selected from the group consisting of vitamin B12, hydroxycobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-cobalamin perchlorate, azidocobalamin, cobalamin, cyanocobalamin, or chlorocobalamin. . . .

12.  An improved method for administering pemetrexed disodium to a patient in need of chemotherapeutic treatment, wherein the improvement comprises:
    a) administration of between about 350 μg and about 1000 μg of folic acid prior to the first administration of pemetrexed disodium;
    b) administration of about 500 μg to about 1500 μg of vitamin B12, prior to the first administration of pemetrexed disodium; and
    c) administration of pemetrexed disodium.

The accused infringing article, Apotex's generic version of ALIMTA®, comprised pemetrexed dipotassium (instead of the disodium salt).  As explained in this opinion, while the District Court was considering the parties' cross-motions for summary judgment, the Federal Circuit handed down its decision in Eli Lilly v Hospira for infringing generic versions of ALIMTA® comprising pemetrexed ditromenthamine.  In applying this decision, the District Court considered whether, in the face of rejection, Lilly's change from ALIMTA to "pemetrexed disodium" raised an estoppel sufficient for the Court to find infringement under the doctrine of equivalents for dipotassium species.  Neither this substitution nor expressly reciting "pemetrexed disodium" in the claim was sufficient to raise prosecution estoppel in the District Court's opinion.  The District Court having granted summary judgment against Apotex for infringement under the doctrine of equivalents, this appeal followed.

The Federal Circuit affirmed, in an opinion by Judge Stoll joined by Chief Judge Prost and Judge Bryson.  In the panel's view, Lilly's substitution of "ALIMTA" with "pemetrexed disodium" was not a narrowing amendment that raises prosecution history estoppel, the Court expressly relying on its earlier Eli Lilly v. Hospira precedent.  One basis for this conclusion was that the '209 specification expressly equated ALIMTA with pemetrexed disodium, thereby introducing no narrowing amendment (being in the panel's view merely a change in nomenclature).  This equivalence was supported by the Examiner's rejection of claims reciting ALIMTA for indefiniteness, the opinion quoting MPEP § 2173.05(u) (2004) for the proposition that "[i]f the trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112, second paragraph," that "claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product," and that the "value of a trademark would be lost to the extent that it became descriptive of a product, rather than used as an identification of a source or origin of a product."  In response Lilly swapped "ALIMTA" with "pemetrexed disodium" in its claims, which in due course passed to issue in the '209 patent.  In the Court's view "[n]othing in the prosecution history suggests that Lilly's amendment narrowed the claims, that the Examiner understood Lilly to be narrowing the claims, or that either Lilly or the Examiner understood "ALIMTA" to mean anything other than pemetrexed disodium."

The Court considered Apotex's reading of the District Court's reasoning, that the Examiner's indefiniteness rejection rested on ALIMTA meaning either pemetrexed disodium or pemetrexed alone, to be a "misread[ing] of the prosecution history."  It was not the case that the Examiner rejected claims reciting ALIMTA for being indefinite and for reciting a trade name; rather, in the Court's view the rejection was raised that such claims were indefinite because they recited the ALIMTA trade name.

And finally, the panel also did not credit Apotex's argument that in a corresponding European Patent Convention application the Applicant had substituted pemetrexed disodium for pemetrexed per se, saying "[i]n light of the European prosecution history as a whole, we do not read Lilly's statement that it was "refocus[ing]" the claims in its application to suggest that Lilly equated "ALIMTA" with "pemetrexed."

Eli Lilly & Co. v. Apotex, Inc. (Fed. Cir. 2020)
Nonprecedential disposition
Panel: Chief Judge Prost and Circuit Judges Bryson and Stoll
Opinion by Circuit Judge Stoll

Comments

[James Scott Elmer]

The DOE gives patent applicants some comfort that their claims will be afforded a reasonable scope of protection beyond their literal scope if that is needed to adequately cover their invention. To the extent that this helps avoid messy disputes with the examiner about the outer boundaries of an invention and streamlines prosecution it is a good thing. This is especially true in the world we live in where a vast majority of patents are commercially unsuccessful and the actual scope of most claims is unimportant. Best to leave those difficult scope issues for the courts to resolve in the tiny minority of cases where it matters.

[Kevin E. Noonan]

Agreed, James. The issue has been that the CAFC didn't believe in the DOE and made it difficult for inventors to rely on it. That has changed somewhat recently; we'll see if inventors feel the beneficial effects you rightly mention.

Thanks for the comment. Happy New Year

[MaxDrei]

Yes, of course, James and Kevin. This is exactly the reason why (inspired by the USA) a DoE was written into the European Patent Convention from the outset, in 1973. It is all set out in the Protocol to Art 69, EPC.

But here, Applicant's claim recites "pemetrexed disodium". In the application as filed (if I understand the case correctly) there is no claim at all that is expressed at the next up level of generality, namely, "pemetrexed". How can such a thing happen????

Using the DoE, patentee recaptured a claim to territory not even announced in their patent application as filed.

I cant help thinking that there comes a point where the courts should decline to grace negligent drafting, that point being where the courts start giving encouragement to those who want to reduce respect for the value of patents as promoters of technical progress (by defining with precision the metes and bounds of the protected area). We all of us benefit when patents are adjudicated strictly, for then patents will tend to be drafted more thoughtfully and carefully.

[skeptical]

" We all of us benefit when patents are adjudicated strictly,"

That is most definitely a loaded statement- as made clear for probably a decade now of other positions supported by MaxDrei that just do not stand up to scrutiny.

One man's "strictly" is another's Efficient Infringer's wet dream.