On June 15, 2020, the Supreme Court docket denied a petition for certiorari from the Federal Circuit’s 2019 Eli Lilly & Co. v. Hospira, Inc. opinion affirming infringement underneath the doctrine of equivalents (DOE). In doing so, the Supreme Court docket put to relaxation a greater than decade-long dispute over makes an attempt to market a generic model of Lilly’s Alimta®.
At challenge on this newest iteration of Alimta ANDA litigation was Lilly’s U.S. Patent No. 7,772,209 (the ’209 patent) claiming an “improved technique” for treating sufferers by administering pemetrexed disodium together with folic acid and vitamin B12. As initially filed, nonetheless, the asserted claims recited an “antifoliate,” not pemetrexed disodium (itself a species of antifolate). To beat a previous artwork rejection throughout prosecution, Lilly narrowed that declare from administering an “antifoliate” to administering “pemetrexed disodium.” The generic candidates—Hospira and Dr. Reddy’s Laboratories (“DRL”)—developed an alternate salt: pemetrexed ditromethamine.
Lilly filed go well with, arguing partially that Hospira’s and DRL’s pemetrexed ditromethamine product infringed underneath DOE. Hospira and DRL countered, arguing that prosecution historical past estoppel (PHE) utilized to Lilly’s narrowing modification, thus barring Lilly’s DOE declare, and in any occasion DOE was restricted by the “disclosure-dedication” rule. The district courtroom disagreed, concluding that PHE didn’t apply as a result of the “purpose for Lilly’s modification was to differentiate different antifolates and was subsequently solely tangential to pemetrexed ditromethamine.”
In affirming, the Federal Circuit supplied an in-depth evaluation of the appliance of DOE, PHE, the “tangential relation” exception to the presumption of PHE, and the disclosure-dedication rule.
The Lilly determination shouldn’t be the one life sciences opinion with such expansive remedies of DOE and its exceptions. Within the final two years the Federal Circuit has handed down quite a few related choices. See Eagle Pharms. Inc. v. Slayback Pharma LLC (DOE and disclosure-dedication); Galderma Labs., L.P. v. Amneal Pharms. LLC (DOE and argument-based PHE, amendment-based PHE, and vitiation); UCB, Inc. v. Watson Labs. Inc. (DOE and PHE, slim claiming, vitiation, and ensnarement); Amgen Inc. v. Coherus Biosciences Inc. (DOE and argument-based PHE); Pharma Tech Options, Inc. v. LifeScan, Inc. (DOE and amendment-based PHE); Indivior Inc. v. Dr. Reddy’s Labs, S.A. (DOE and disclosure-dedication).
However essentially the most fascinating could also be but to return: DOE in compound declare instances. Simply such an argument was made in Acerta Pharma B.V. v. Pharmacyclics LLC.[1]
There, Acerta argued that its U.S. Patent No. 7,459,554 (the ’554 patent) coated Pharmacyclics’s Imbruvica® product. Declare 16 of the ’554 patent covers a compound differing from Pharmacyclics’ in two positions of the “core.” Missing literal infringement, Acerta claimed infringement underneath DOE. Pictorially, Acerta alleged that its claimed molecule (under left) was equal to Pharmacyclics’ (under proper):
Sadly for the curious, that litigation was dismissed with prejudice in October 2019. However there’s not less than one case involving DOE of compound claims: ViiV Heathcare Co. v. Gilead Sciences, Inc.[2] Given the exercise of DOE in life sciences, there’ll possible be extra.
With the shut scrutiny rivals and courts are giving DOE in life science instances, life science patent practitioners might want to stay conscious of evolving arguments when engaged in prosecution, due diligence, and freedom-to-operate analyses.
[1] Acerta Pharma BV v. Pharmacyclics LLC, Civil Motion No. 18-cv-00581 (D. Del.).
[2] ViiV Heathcare Co. v. Gilead Sciences, Inc., Civil Motion No. 18-cv-00224 (D. Del.).
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