Lower Court Orders/Opinions

1320 933 FEDERAL REPORTER, 3d SERIES short of statutory patentable subject mat- drug application infringed the patent. ter. Competitor appealed. Holdings: The Court of Appeals, Lourie, CONCLUSION Circuit Judge, held that: We have considered the parties’ remain- ing arguments and find them unpersua- (1) competitor’s new drug application for sive. Accordingly, the Final Judgment of its pemetrexed product did not prac- the U.S. District Court for the Eastern tice the step of administration of peme- District of Virginia is trexed disodium, and thus could not literally infringe patent; AFFIRMED (2) patentee’s amendment, narrowing scope of claims from antifolate to , pemetrexed disodium, was merely tangential to pemetrexed ditromethamine, the accused compound, and ELI LILLY AND COMPANY, thus, prosecution history estoppel did Plaintiff-Appellee not bar patentee from asserting infringement under doctrine of equiva- v. lents; HOSPIRA, INC., Defendant-Appellant (3) patent did not disclose methods of Eli Lilly and Company, treatment using pemetrexed ditrome- Plaintiff-Appellee thamine, such that patentee could not v. have dedicated such method to the public, and thus, disclosure-dedication Dr. Reddy’s Laboratories, Ltd., Dr. rule did not bar patentee from assert- Reddy’s Laboratories, Inc., ing infringement under the doctrine of Defendants-Appellants equivalents; and 2018-2126 2018-2127 (4) District Court did not clearly err in 2018-2128 finding that competitor’s proposed product would be administered in in- United States Court of Appeals, substantially different way from Federal Circuit. claimed method in patent, such that Decided: August 9, 2019 product was equivalent to and infring- Background: Patentee brought action ed on patent. against competitor, alleging infringement Affirmed in part and reversed in part. of its patent claiming improved method for administering pemetrexed disodium to patient in need of chemotherapeutic treat- 1. Courts O96(7) ment. The United States District Court for The Court of Appeals for the Federal the Southern District of Indiana, Tanya Circuit reviews a district court’s grant of Walton Pratt, J., 2017 WL 6387316, denied summary judgment according to the law of competitor’s motion for summary judg- the regional circuit. ment of noninfringement, 2018 WL O 3008570, found literal infringement, and 2. Federal Courts 3604(4), 3675 following bench trial, 323 F.Supp.3d 1042, In the Seventh Circuit, summary found that competitor’s submission of new judgment is reviewed de novo, construing ELI LILLY AND CO. v. HOSPIRA, INC. 1321 Cite as 933 F.3d 1320 (Fed. Cir. 2019) all facts and drawing all inferences in favor the step of administration of pemetrexed of the non-movant. disodium, and thus could not literally in- 3. Federal Courts O3567, 3603(2) fringe patent claiming improved method On appeal from a bench trial, the for administering pemetrexed disodium to Court of Appeals reviews a district court’s patient in need of chemotherapeutic treat- conclusions of law de novo and its findings ment; competitor’s product was dissolved of fact for clear error. in saline before administration, pemetrexed disodium no longer existed once 4. Federal Courts O3603(7) dissolved in solution, and different salt of A factual finding is clearly erroneous pemetrexed dissolved in saline was not if, despite some supporting evidence, the pemetrexed disodium. Court of Appeals is left with the definite and firm conviction that a mistake has 11. Patents O1574(1) been made. A patentee is entitled in all cases to 5. Patents O1848, 1970(13) invoke to some extent the doctrine of Patent claim construction is ultimately equivalents without a judicial exploration an issue of law, which the Court of Appeals of the equities of a case beforehand. reviews de novo. 12. Patents O1555 6. Patents O1970(13) The Court of Appeals reviews de novo Patent infringement is principally de- the district court’s findings of fact on evi- termined by examining whether the ac- dence intrinsic to the patent, the patent cused subject matter falls within the scope claims and specification, along with the of the claims. patent’s prosecution history, and reviews for clear error extrinsic findings of fact 13. Patents O1338(2) related to claim construction. Prosecution history estoppel arises 7. Patents O1848, 1970(15) when a patent applicant narrows the scope While patent infringement is a ques- of his claims during prosecution for a rea- tion of fact, the Court of Appeals reviews son substantially relating to patentability. de novo the district court’s grant of sum- O mary judgment of noninfringement. 14. Patents 1819 A patent applicant’s narrowing the 8. Patents O1555, 1574(1) scope of his claims during prosecution is To prove infringement, a patentee presumed to be a surrender of all equiva- must supply sufficient evidence to prove lents within the territory between the orig- that the accused product or process con- tains, either literally or under the doctrine inal claim and the amended claim, but the of equivalents, every limitation of the prop- presumption is overcome if the patentee erly construed claim. can show the applicability of one of the few exceptions to prosecution history estoppel O 9. Patents 1824 identified by the Supreme Court. A patentee has the burden of proving infringement by a preponderance of the 15. Patents O1848, 1970(14) evidence. Whether prosecution history estoppel 10. Patents O1668 applies to bar a doctrine of equivalents Competitor’s new drug application for claim is a question of law, reviewed de its pemetrexed product did not practice novo. 1322 933 FEDERAL REPORTER, 3d SERIES 16. Patents O1819, 1848 disclosed in the patent and the prosecution Whether the tangential exception to history. prosecution history estoppel applies is a 21. Patents O839, 1668 question of law, and a patentee seeking to use the exception must base his arguments Patent claiming improved method for solely upon the public record of the pat- administering pemetrexed disodium to pa- ent’s prosecution. tient in need of chemotherapeutic treatment did not disclose methods of treat- 17. Patents O1574(5), 1668 ment using pemetrexed ditromethamine, Patentee’s amendment, narrowing such that patentee could not have dedicat- scope of claims from antifolate to peme- ed such method to the public, and thus trexed disodium, was merely tangential to disclosure-dedication rule did not bar pat- pemetrexed ditromethamine, the accused entee from asserting infringement under compound, and thus prosecution history the doctrine of equivalents; other patent, estoppel did not bar patentee from asserting infringement under doctrine of equiva- which was referenced in patent, contained lents of patent claiming improved method only generic reference to pemetrexed di- for administering pemetrexed disodium to tromethamine. patient in need of chemotherapeutic treat- 22. Patents O839 ment; reason for amendment was to nar- Under the disclosure-dedication rule, row claim to avoid Arsenyan, not to cede subject matter disclosed by a patentee, but other functionally identical pemetrexed not claimed, is considered dedicated to the salts, and relinquishment of other peme- public. trexed salts would render the patent worthless. 23. Patents O839 18. Patents O1819 The reason for the disclosure-dedica- In determining whether the tangential tion doctrine is that members of the public exception to prosecution history estoppel reading a disclosure of particular subject applies, amendments are not construed to matter are entitled, absent a claim to it, to cede only that which is necessary to over- assume that it is not patented and there- come the prior art, nor will the court spec- fore dedicated to the public, unless, for ulate whether an amendment was neces- example, claimed in a continuation or other sary. application based on the disclosure. O 19. Patents 1819 24. Patents O839 The reason for an amendment, where Under the disclosure-dedication rule, the tangential exception to prosecution his- subject matter is considered disclosed tory estoppel is invoked, cannot be deter- when a skilled artisan can understand the mined without reference to the context in unclaimed disclosed teaching upon reading which it was made, including the prior art the written description, but not any gener- that might have given rise to the amend- ic reference necessarily dedicates all mem- ment in the first place. bers of that particular genus. 20. Patents O1819 O In determining whether the tangential 25. Patents 1565, 1574(1) exception to prosecution history estoppel A component in an accused product or applies, whether an amendment was mere- process may be equivalent to a claim ele- ly tangential to an equivalent must be ment if the two are insubstantially differ- decided in the context of the invention ent with respect to the role played by the ELI LILLY AND CO. v. HOSPIRA, INC. 1323 Cite as 933 F.3d 1320 (Fed. Cir. 2019) element in the context of the specific pat- McCloud; James Patrick Leeds, Eli Lilly ent claim; relevant differences can include and Company, Indianapolis, IN. the function each serves, the way in which Bradford Peter Lyerla, Jenner & Block each works, and the result each obtains, LLP, Chicago, IL, argued for defendant- and especially in biochemical cases, struc- appellant in 2018-2126. Also represented tural or pharmacological characteristics. by Yusuf Esat, Sara Tonnies Horton; 26. Patents O1848, 1970(15) Adam G. Unikowsky, Washington, DC. The determination of equivalency vel John C. O’Quinn, Kirkland & Ellis LLP, non is a question of fact, which the Court Washington, DC, argued for defendants- of Appeals reviews for clear error in an appellants in 2018-2128. Also represented appeal from a bench trial. by William H. Burgess, Calvin Alexander 27. Patents O1668 Shank; Jeffery B. Arnold, Holland & District Court did not clearly err in Knight LLP, Atlanta, GA; Merri C. Mo- finding that competitor’s proposed peme- ken, Charles A. Weiss, Eric H. Yecies, trexed ditromethamine product would be New York, NY.

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