by Dennis Crouch
Eli Lilly and Co. v. Hospira, Inc. (Fed. Cir. 2019)
On summary judgment, the district court found for the patentee Eli Lilly — holding that the ANDA filings by Hospira & Dr. Reddy infringed Lilly’s U.S. Patent 7,772,209.
On appeal, the Federal Circuit found error’s in claim construction and consequently reversed the judgment of literal infringement. However, the court affirmed the alternative judgment of infringement under the doctrine of equivalents (DOE).
The drug at issue is pemetrexed (Lilly brand “Alimta”) approved for treatment of inoperable malignant pleural mesothelioma. The drug operates as an anti-folate (blocking folic acid from binding and being harnessed for cancer cell growth).
The ‘209 patent does not cover the drug itself, but instead covers an “improved method for administering pemetrexed disodium to a patient in need of chemotherapeutic treatment.” I previously wrote about the patent being challenged in separate IPRs and explained that “the claimed invention calls for a pre-treatment of a patient with folic acid and vitamin B12 in order to reduce the risk skin rashes, fatigue, etc.”
In the litigation here, Hospira argues that its proposal does not infringe because it calls for intravenous administration of pemetrexed ditromethamine dissolved in saline and other compounds — that solution makes it different than the “pemetrexed disodium” as claimed. Basically, a dissolved salt is not a salt.
The district court sided with the patentee writing that
Administration of pemetrexed disodium . . . refer[s] to a liquid administration of pemetrexed disodium. . . ., accomplished by dissolving the solid compound pemetrexed disodium into solution.
District Court Summary Judgment Decision. On appeal, the Federal Circuit reversed that decision — finding no literal infringement:
A solution of pemetrexed and chloride anions and tromethamine and sodium cations cannot be deemed pemetrexed disodium simply because some assortment of the ions in the solution consists of pemetrexed and two sodium cations. . . . Once diluted, the salt’s crystalline structure dissolves, and the individual ions dissociate. In other words, pemetrexed disodium no longer exists once dissolved in solution, and, as a corollary, a different salt of pemetrexed dissolved in saline is not pemetrexed disodium.
Thus, the appeallate panel found no literal infringement.
Doctrine of Equivalents. In yet another strong doctrine of equivalents decision, the Federal Circuit has held that the proposed generic solution of dissolved salts is the equivalent of the salt itself — and therefore infringes.
Few propositions of patent law have been so consistently sustained by the Supreme Court as the doctrine of equivalents. See Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushki Co., 535 U.S. 722, 733 (2002) (“Festo VIII”) (“[E]quivalents remain a firmly entrenched part of the settled rights protected by the patent.”); Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 40 (1997) (“[W]e adhere to the doctrine of equivalents.”); Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 608 (1950) (“Originating almost a century ago in the case of Winans v. Denmead, [56 U.S. 330 (1853)] . . . [the doctrine of equivalents] has been consistently applied by this Court and the lower federal courts, and continues today ready and available for utilization when the proper circumstances for its application arise.”). It is settled that a patentee is entitled “in all cases to invoke to some extent the doctrine of equivalents,” Seymour v. Osborne, 78 U.S. 516, 555 (1870), without a “judicial exploration of the equities of a case” beforehand.
Here, Lilly had narrowed its claims during prosecution, but the court found that the amendment was “tangential” to the equivalent in question — “touching lightly or in the most tenuous way.” Webster’s Third New International Dictionary (2002).
The reason for Lilly’s amendment, as the district court concluded, was to narrow original claim 2 to avoid Arsenyan, which only discloses treatments using methotrexate, a different antifolate.
The amendment was not intended to avoid dissolved pemetrexed disodium.
In summary, these cases are eminently suitable for application of the doctrine of equivalents, and we conclude that neither prosecution history estoppel nor the disclosure-dedication rule bars Lilly from asserting infringement through equivalence.
Thus, ultimately the judgment of infringement is affirmed despite the lack of literal infringement.
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Prosecutors: It makes sense to consider the prosecution history of this case to consider how to limit prosecution history estoppel.