I. Patentability Requirements
A. Inventorship/Invention and Priority Dates
1. Reduction to Practice
a. Actual
"Sufficiency of the testing required to show an invention worked for its intended purpose is a question of fact reviewed for substantial evidence." Medtronic, Inc. v. Teleflex Innovations S.ÀR.L., 2021-2356, 5/24/23.
i. Intended Purpose
"Similar to claim construction, a determination of an invention's intended purposes is a legal issue, reviewed de novo." Medtronic, Inc. v. Teleflex Innovations S.ÀR.L., 2021- 2356, 5/24/23.
"[A]lthough the patents themselves are the most important and, indeed, most persuasive evidence of the patents' intended purpose, we find it is appropriate to consider extrinsic evidence, particularly when it does not contradict the patents themselves." Medtronic, Inc. v. Teleflex Innovations S.ÀR.L., 2021-2356, 5/24/23.
Rejecting intended purpose of crossing tough or chronic occlusions in favor of merely providing increased backup support as compared with a guide catheter alone. "Although the challenged patents do mention crossing "tough" or "chronic" occlusions, we find that to be a specific example within a broader general purpose. Indeed, as the Board found, the challenged patent specification itself recognizes a broader purpose when discussing the field and background of the invention." Medtronic, Inc. v. Teleflex Innovations S.ÀR.L., 2021-2356, 5/24/23.
"The very title of the patents themselves, "Coaxial Guide Catheter for Interventional Cardiology Procedures," describes the purpose of the claimed inventions, and it is undisputed that the claim language does not impose a further purpose than this." Medtronic, Inc. v. Teleflex Innovations S.ÀR.L., 2021-2356, 5/24/23.
2. Coinventorship/Joint Inventors
Coinventorship determination reversed based on insufficient contribution "under the second Pannu factor" where the "alleged contribution . . is mentioned only once in the [] specification as an alternative [and] is recited only once in a single claim of the [] patent." HIP, Inc. v. Hormel Foods Corp., 2022-1696, 5/2/23.
a. Significant Contribution
Court could find a significant contribution to four different utility patents and two design patents without construing any of the claims. "In other words, the court is not required to prospectively address hypothetical claim construction disputes. That is as true for inventorship analyses as it is for invalidity and infringement analyses." "[T]hese three elements, taken together, were a significant contribution to at least one claim of each asserted patent." Blue Gentian, LLC v. Tristar Prods., Inc., 2021-2316, 6/9/23.
"Key features that the patent owner itself acknowledges distinguish the invention of the asserted patents from the prior art are necessarily tied to the claims." Blue Gentian, LLC v. Tristar Prods., Inc., 2021-2316, 6/9/23 (emphasis in original).
3. Corroboration
"Nor must every individual aspect of reduction to practice be corroborated. Rather, the corroborative evidence simply needs to be sufficient to support the credibility of the inventors' story." Medtronic, Inc. v. Teleflex Innovations S.ÀR.L., 2021-2356, 5/24/23 (citation omitted).
a. Inventor's Documents
"[C]ertain documents could only be connected to the rapid exchange prototype through inventor testimony, which carries little to no weight in the context of corroboration; one cannot corroborate oneself, after all." Medtronic, Inc. v. Teleflex Innovations S.ÀR.L., 2021-2356, 5/24/23.
b. Joint Inventor Communication
"The district court properly evaluated whether Mr. Ragner's account, including both what he knew about expandable hoses going into the meeting and what he conveyed to Mr. Berardi at the meeting, was corroborated." Blue Gentian, LLC v. Tristar Prods., Inc., 2021- 2316, 6/9/23.
"[E]ven if the statement in Price were fully apt, it does not preclude an analysis of corroboration that considers conception and communication together." Blue Gentian, LLC v. Tristar Prods., Inc., 2021-2316, 6/9/23 (referring to Price v. Symsek, 988 F.2d 1187, 1190 (Fed. Cir. 1993)).
B. Prior Art Invalidity
1. Reference Disclosure
a. Inherency
"Demonstrating inherent disclosure requires meeting a stringent standard." Amgen Inc. v. Sandoz Inc., 2022-1147, 4/19/23.
i. Evidence of Necessarily Present
"[T]he inherent anticipation analysis involves understanding whether, by making the formulations (1:57 or 1:62) by the DDM process, which are similarly disclosed in both the [challenged] and [prior art] patents with the disclosures of the incorporated references, would naturally result in a composition having the Morphology Limitation." "To anticipate, the prior art need only meet the inherently disclosed limitation to the same extent as the patented invention." Arbutus Biopharma Corp. v. ModernaTX, Inc., 2020-1183, 4/11/23.
ii. Apparent Arrangement or Combination
"The district court's use of the "immediately envisage" line of cases to convert this case into a point-within-a-range case constitutes an improper application of our precedent governing overlapping ranges." UCB, Inc. v. Actavis Labs. UT, Inc., 2021-1924, 4/12/23.
b. Disclosure to POSITA
i. Context of Challenged Patent
"The district court did not err in not holding Amgen to the statements set forth in the specification regarding isolating apremilast. In PharmaStem, we held that it was not unfair to hold the inventors to the consequences of their admissions because their characterization of the prior art references was not unreasonable, and the prior art references themselves strongly supported the interpretation. In contrast, here, the district court found that Sandoz's own expert conceded that the formation of chiral salts was not a viable method for separating the Example 12 enantiomers contrary to the statement in the specification." Amgen Inc. v. Sandoz Inc., 2022-1147, 4/19/23 (emphasis added) (citation to PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1362 (Fed. Cir. 2007) omitted)
2. Obviousness (§ 103)
a. Differences Between the Prior Art and the Claims at Issue
i. Prior Art Overlaps with Claimed Range
"Here, it is undisputed that the range claimed in the '589 patent overlaps with the ranges taught by the Muller patents. Thus, Actavis established a prima facie case of obviousness." UCB, Inc. v. Actavis Labs. UT, Inc., 2021-1924, 4/12/23.
ii. Inherent Properties
"Reciting the mechanism for known compounds to yield a known result cannot overcome a prima facie case of obviousness, even if the nature of that mechanism is unexpected." In re Couvaras, 2022-1489, 6/14/23.
b. Analogous Prior Art
"Because Mylan argued that de Gennes is analogous to another prior art reference and not the challenged patent, Mylan did not meet its burden to establish obviousness premised on de Gennes and the Board's factual findings regarding analogousness are not supported by substantial evidence." Sanofi-Aventis Deutschland GmbH v. Mylan Pharms. Inc., 2021- 1981, 5/9/23.
To view the full article, click here.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.