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Mandy H. Kim focuses her practice on intellectual property litigation. Mandy has significant experience managing complex litigations across a wide range of technologies, including in the life sciences, biotechnology, medical devices, computer hardware and software, and consumer electronics industries. Mandy routinely handles motion practice, fact and expert discovery matters, and has litigated a number of cases from pleadings through trial and/or settlement. She has represented clients in federal and state courts, and before the International Trade Commission. Read Mandy H. Kim's full bio.

Addressing the issue of Article III standing and obviousness in an appeal of an inter partes review (IPR) decision, the US Court of Appeals for the Federal Circuit found that the petitioner had standing to appeal because past activities created a controversy between the parties. Grit Energy Solutions, LLC v. Oren Techs., LLC, Case No. 19-1063 (Fed. Cir. Apr. 30, 2020) (Prost, CJ) (Newman, J., concurring in part, dissenting in part).

Continue Reading “Non-Limiting” Prior Art Claims Support Obviousness After Standing Is Established

Addressing the issue of Article III standing in an appeal of an inter partes review (IPR) decision, the US Court of Appeals for the Federal Circuit dismissed the appeal because the party appealing failed to establish an injury sufficient to confer standing. Argentum Pharms. LLC v. Novartis Pharms. Corp., Case No. 18-2273 (Fed. Cir. Apr. 23, 2020) (Moore, J.).

Continue Reading Article III Standing Required to Appeal Final Decisions by the PTAB

The US Court of Appeals for the Federal Circuit reversed a district court’s summary judgment that found a patent was not obvious because the claimed pH range would not have been obvious-to-try despite overlapping ranges between the claimed pH range and the pH range for similar prior art compounds. Valeant Pharms. Intl. v. Mylan Pharms. Inc., Case No. 18-2097 (Fed. Cir. Apr. 8, 2020) (Lourie, J.).

Continue Reading Prima Facie Obviousness Established Where Claimed pH Range Overlaps with Prior Art Range for Similar Compounds

Addressing the issue of patent eligibility under §101, the US Court of Appeals for the Federal Circuit reversed a district court, explaining that the method of preparation claims at issue are not directed to a patent-ineligible natural phenomenon. Illumina, Inc. v. Ariosa Diagnostics, Inc., Case No. 19-1419 (Fed. Cir. Mar. 17, 2020) (Lourie, J.) (Reyna, J., dissenting).

Continue Reading “Method of Preparation” Claims Found Patent-Eligible Under §101

Addressing the issue of obviousness, the US Court of Appeals for the Federal Circuit affirmed the district court’s finding that a patent was invalid based on inherency because the claim limitation was necessarily present in the prior art. Hospira, Inc. v. Fresenius Kabi USA, LLC, Case Nos. 19-1329, -1367 (Fed. Cir. Jan. 9, 2020) (Lourie, J).

The patent at-issue is directed to premixed pharmaceutical compositions of dexmedetomidine that do not require reconstitution or dilution prior to administration and remains stable and active after prolonged storage. Hospira makes and sells dexmedetomidine products, including a ready-to-use product called Precedex Premix covered by the patent at-issue. Fresenius filed an Abbreviated New Drug Application (ANDA) seeking approval by the Food and Drug Administration (FDA) to market a generic ready-to-use dexmedetomidine product. Hospira brought suit alleging infringement under the Hatch-Waxman Act.


Continue Reading Inherent Claim Limitation Necessarily Present in the Prior Art Invalidates Patent