Novartis Opposes Supreme Court Petition Targeting “After-Developed” Technology in Patent Validity Analyses, Arguing No Split at the Federal Circuit
Executive Summary
Recently, we posted about MSN Pharmaceuticals Inc.’s petition for certiorari and the several amicus briefs in support of that petition. On November 7, Novartis Pharmaceuticals Corp. filed its brief in opposition.
The case squarely presents the long-simmering doctrinal tension over how patent law treats “after-developed” or “after‑arising” technology—innovations not known at a patent’s filing but later alleged to fall within a claim’s scope. Petitioners (“MSN”) urge the Court to resolve what they characterize as conflicting Federal Circuit lines on whether such later technology can “reach back” to invalidate claims under § 112(a). Novartis’s opposition argues the case involves no true “after‑arising technology” claim and reflects settled law: patents must enable and describe the full scope of the invention they claim, but need not enable or describe later improvements that add features beyond the claimed invention. The petition thus asks the Court to reconcile enablement/written description doctrine with claim scope symmetry across infringement and validity in the specific posture of later-developing embodiments.
Procedural Posture and Case Context
The dispute centers on Novartis’s U.S. Patent No. 8,101,659, filed in 2002, claiming a pharmaceutical composition comprising valsartan and sacubitril “administered in combination in about a 1:1 ratio,” to treat hypertension or heart failure. Years after filing, Novartis’s scientists developed LCZ696, a non‑covalent complex of valsartan and sacubitril (marketed as Entresto®). In the MDL, the district court construed “administered in combination” to include both physical mixtures and complexes, noted “non-frivolous” § 112 issues under that construction, and after trial invalidated the ’659 claims for lack of written description while rejecting enablement and obviousness challenges. On appeal, the Federal Circuit reversed the written description ruling and affirmed non‑enablement and non‑obviousness determinations, emphasizing that the asserted claims do not “claim” complexes and that the specification adequately describes and enables the claimed composition of valsartan and sacubitril administered together.[1] MSN stipulated to infringement after the district court’s claim construction to streamline trial, a litigation choice that notably shapes the briefing before the Supreme Court.
Petitioners’ Position (“MSN”)
MSN frames a clear question: whether courts may consider after‑arising technology to hold a patent invalid under § 112(a) when a patentee secures a claim construction that ensnares later-developed embodiments for infringement. Its argument has three principal strands:
Doctrinal incoherence. MSN catalogs what it calls four divergent Federal Circuit approaches:
Cases like Idenix, Plant Genetic Systems, and Chiron[2] where broad claim constructions embracing later-developed embodiments led to § 112 invalidity for lack of written description or enablement.
Cases like Hogan (C.C.P.A.)[3] and the decision below that, in MSN’s view, carve out after‑arising technology from the validity analysis, barring it from “reach back” invalidation.
Cases such as Schering[4] that narrowly construe claims to exclude later-developed technology and find no infringement.
Cases such as SuperGuide[5] that allow later-developed technology within literal claim scope and uphold infringement.
MSN argues this patchwork produces claim scope asymmetry and allows patentees a “double standard:” broad scope for infringement, narrow scope for validity.
Patent bargain and claim scope symmetry. MSN contends the Federal Circuit’s approach below violates the principle that claims must be construed the same for infringement and validity. In its view, once a patentee secures a broad construction to capture an accused product with a later-developed feature, § 112 requires the specification to describe and enable the full scope of the claim—including the later-developed embodiments.
Otherwise, patentees reap exclusionary rights without the quid of enabling disclosure.
Historical and Supreme Court precedent. MSN leans on The Incandescent Lamp Patent[6] to argue that later-developed embodiments (Edison’s bamboo filament) can expose overclaiming and consequent § 112 invalidity, and it invokes recent enablement doctrine (Amgen[7]) requiring that claims covering classes of compositions enable their full scope. It urges the Court to embrace the Idenix line and close the “Hogan‑Entresto loophole,” aligning after‑arising technology with ordinary § 112 rules.
Respondent’s Position (Novartis)
Novartis responds that the petition mischaracterizes both the patent and the law:
No “after‑arising technology” claim. The ’659 patent claims A + B (valsartan + sacubitril administered together), not A + B + C (the later-developed complex with a non‑covalent bonding feature). The specification, it argues, plainly describes and enables the claimed composition. Later improvements that add features to the original invention may infringe because they include A + B, but the additional features are not part of “what is claimed” for § 112. On this view, the Federal Circuit applied the same “full scope” rule reaffirmed in Amgen: enable and describe the full scope of the claimed invention—not unclaimed later additions.
Doctrinal consistency and proper focus on claims. Novartis maintains that the cases MSN assembles turn on differences in what was claimed and the nature of the disclosure, not conflicting legal standards. Idenix, Plant Genetic Systems, and Chiron[i] involved claims defined by function over vast classes and were invalid when the disclosure failed to teach the full claimed class. By contrast, Hogan addressed enablement judged at filing based on state of the art and cautioned against using later developments in methods to invalidate earlier claims that were enabled at filing—an application of the same “full scope” rule.
Settled infringement/validity framework for improvements. Novartis invokes longstanding principles recognizing that later improvements can both infringe earlier patents and be separately patentable, without invalidating the original patent for failing to describe or enable the improvement. The Supreme Court’s decisions (including Temco[8] and Cantrell [9]) underscore that an improver cannot appropriate the basic patent, and the original patent need not have described the later improvement to remain valid.
Vehicle problems. Novartis points to MSN’s stipulation to infringement and post‑judgment strategy as foreclosing the interwoven issues MSN seeks to present (claim construction symmetry, infringement, validity), making this a poor case to address the academic debate over “after‑arising technology.”
Key Legal Tensions
Two core tensions emerge in the briefing:
Claim scope symmetry vs. time-of-filing enablement. MSN presses that when claim construction embraces later-developed embodiments for infringement, § 112 must hold the patentee to the same scope for validity. Novartis answers that enablement and written description are judged against “what is claimed” at filing; later-added features in an accused product are irrelevant to whether the specification enabled or described the claimed invention’s full scope at that time. The Federal Circuit below emphasized precisely that distinction.
Functional genus claims vs. discrete compositions. The Supreme Court’s recent enablement doctrine (Amgen) and Federal Circuit cases like Idenix and Plant Genetic Systems impose strict requirements when claims sweep functionally across broad classes. By contrast, the ’659 claims recite specific active agents administered together, and the court of appeals found the specification “plainly” described that invention. MSN argues that once “combination” is construed broadly to include complexes, the claim covers embodiments unknown at filing; Novartis responds the claims still do not “claim” the added complex feature and must be assessed as of the claimed invention’s scope.
Practical Implications
The outcome of this petition could shape strategies in drafting and enforcing claims where technology evolves after filing:
If the Court grants and adopts MSN’s approach, patentees who argue for broad constructions capturing later-developed embodiments may face heightened § 112 exposure even when later features are not claimed. Litigators would need to calibrate claim construction positions carefully to avoid “ensnare and invalidate” risks.
If the Court denies cert or endorses Novartis’s framing, the existing practice remains: assess enablement and written description against “what is claimed” as of filing; later-added features in accused products do not expand the disclosure obligation. Claims to discrete compositions are less likely to be destabilized by later advancements, though functional genus claims remain vulnerable under Amgen.
In either scenario, the briefing underscores the importance of claim drafting that delineates scope clearly and anticipates potential construction of terms like “combination,” along with thoughtful litigation choices to avoid asymmetry arguments.
Takeaways for Clients
For composition claims, drafting that anchors “what is claimed” to discrete, identified constituents reduces § 112 exposure if technology later introduces additional features or forms.
In litigation, seeking broad constructions to capture later-developed embodiments requires a parallel strategy for § 112: ensure the specification plausibly teaches the breadth of embodiments within the claim scope, or be prepared for narrowing constructions or invalidity risk.
Functional genus claims remain susceptible after Amgen and related Federal Circuit decisions. Where the art is evolving quickly, consider layered claim sets: specific compositions and methods alongside more general claims with robust disclosure and exemplification.
Patent-term extension representations and prosecution statements can play into claim construction and litigation considerations; ensure consistency with the intrinsic record and future litigation strategy.
If you have questions about this Client Alert or are interested in additional details or guidance, please reach out to Greg Chopskie (greg.chopskie@pierferd.com) or your regular PierFerd contact for assistance.
This publication and/or any linked publications herein do not constitute legal, accounting, or other professional advice or opinions on specific facts or matters and, accordingly, the author(s) and PierFerd assume no liability whatsoever in connection with its use. Pursuant to applicable rules of professional conduct, this publication may constitute Attorney Advertising. © 2025 Pierson Ferdinand LLP.
[1] In re Entresto, 125 F.4th 1090 (Fed. Cir. 2025).
[2] Idenix Pharms. LLC v. Gilead Scis. Inc., 941 F.3d 1149 (Fed. Cir. 2019).
Plant Genetic Sys., N.V. v. DeKalb Genetics Corp., 315 F.3d 1335 (Fed. Cir. 2003).
Chiron Corp. v. Genentech, Inc., 363 F.3d 1247 (Fed. Cir. 2004).
[3] In re Hogan, 559 F.2d 595 (C.C.P.A. 1977).
[4] Schering Corp. v. Amgen Inc., 222 F.3d 1347 (Fed. Cir. 2000).
[5] SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870 (Fed. Cir. 2004).
[6] The Incandescent Lamp Patent, 159 U.S. 465 (1895).
[7] Amgen Inc. v. Sanofi, 598 U.S. 594 (2023).
[8] Temco Elec. Motor Co. v. Apco Mfg. Co., 275 U.S. 319 (1928).
[9] Cantrell v. Wallick, 117 U.S. 689 (1886).
