Memo to the Supreme Court: The Enablement Requirement Needs Your Guidance—Again

A petition for certiorari is currently pending before the United States Supreme Court which raises serious concerns as to fundamental principles of patent law, especially relating to the enablement requirement of 35 U.S.C. §112.  In the decision by the U.S. Court of Appeals for the Federal Circuit which gave rise to the petition in question, an “after-arising technology” exception was carved out from the requirement that a patent claim as construed must be enabled as to its full scope. The ruling did violence to other important rules, but it also has potential far-reaching consequences that have not been explored. It is essential that the Supreme Court grant certiorari to steer the law in the right direction.

On January 10, 2025, the Federal Circuit issued its precedential decision in Novartis Pharms. Corp. v. Torrent Pharma Inc., 125 F. 4^th 1090 (Fed. Cir. 2025). It held that a claim which had been construed to cover first and second species for infringement purposes, and which was enabled only as to the first species, was excused from needing enabling support as to the second species because it constituted “after-arising technology” that was patented long after the filing date of the patent in suit.

Efforts by the accused infringer, MSN Pharmaceuticals, Inc., to obtain rehearing at the Federal Circuit were unavailing. Thus, MSN has now filed a petition for certiorari which raises questions about whether and in what types of cases after-arising technology can impact an enablement analysis.

That petition, however, does not fully explore the ramifications of allowing after-arising technology to effectively validate a patent that might otherwise be invalid for lack of enablement. Nor does any amicus brief that has been filed so far to my knowledge. Those ramifications could be far-reaching and the Supreme Court would do well to consider them. Although the Court seemed to sort out the enablement puzzle just two years ago in its Amgen decision, the patent community needs the Court’s guidance—again.

Accordingly, if a friend of the Court was inclined to chime in, here is a possible amicus brief urging the Supreme Court to grant certiorari and decide the case on the merits. I do not plan to file this brief, but hope it might inspire someone else to officially address these issues.

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INTRODUCTION AND SUMMARY OF THE ARGUMENT

The question Petitioners MSN Pharmaceuticals, Inc. et al. (“MSN”) present in their petition most assuredly merits review by this Court. And it tracks the issue as the Federal Circuit apparently perceived it: “Whether, in a patent-infringement suit, a court may consider after-arising technology to hold that the patent is invalid under §112(a) of the Patent Act?”

MSN has demonstrated that the gyrations that were necessary for the Federal Circuit to reach its decision do violence to several fundamental principles of patent law, including: that enablement is measured as of the effective filing date of the patent at issue; that patent claims must be construed the same for infringement and validity purposes; as well as this Court’s crystal clear holding—just two years ago—that, without exceptions,  “the specification [of a patent] must enable the full scope of the invention as defined by its claims. The more one claims, the more one must enable.” Amgen Inc. v. Sanofi, 598 U.S. 594, 609 (2023).

But beyond the foregoing, as will be demonstrated herein, the Federal Circuit’s decision validating Novartis’s ‘659 patent has unexplored ramifications and raises questions that further merit this Court’s attention.

First, in this case, notwithstanding MSN’s and the Federal Circuit’s framing of the issue, the after-arising technology at issue in this case was actually advanced by Respondent Novartis, and utilized by the Federal Circuit, to validate a patent that was otherwise manifestly invalid for want of an enabling disclosure of the full scope of the patent’s broadly construed claims. Thus, we are—in reality—facing another question: whether or not after-arising technology may  be used to invalidate a patent, can after-arising technology now be used to validate an otherwise invalid patent?

Second, for a significant period after the ‘659 patent issued on January 14, 2012, and before the so-called after-arising technology was patented, the ‘659 patent was manifestly invalid for failing to enable the full scope of the claims as Novartis itself and the district court construed them. But after-arising technology in the form of separate patents which issued in 2014 and 2016 provided a vehicle for disregarding the absence of enablement as to a key sector of the claims’ scope. So, one might fairly ask: when exactly did the ‘659 patent go from invalid to valid? Was the validation retroactive? And what are the consequences of such an invalid-to-valid transition?

Third, the after-arising technology in this case did not occur through happenstance. It was in the form of two later patents obtained by Novartis itself. It is one thing to accept the notion that a United States patent could be invalid for lack of enabling disclosure upon issuance, but could become valid as a result of events that occur years after issuance; but can such later events consist, as here, of self-help in the form of the patent owner obtaining new patents belatedly disclosing the portion of the original invention that was not sufficiently disclosed in its own original patent? Even worse, might an accused infringer sign its own death warrant by inventing the after-arising technology that ends up validating an otherwise invalid patent?

As will be discussed below, the Federal Circuit’s decision in this case opens a Pandora’s Box of complications—all of which have the potential of destabilizing the patent system and undermining the patent system’s constitutional objective to “promote the Progress of Science and useful Arts….” This Court’s guidance is sorely needed—again.

 ARGUMENT

I. From Bad to Worse: While Using After-Arising Technology to Invalidate a Patent Is Problematic, Using After-Arising Technology to Validate an Otherwise Invalid Patent Is Even More Troublesome

The essential facts of this case are largely undisputed. Novartis’s ‘659 patent claimed an effective filing date of January 17, 2002, and (as a result of a patent term extension) expired on January 15, 2025. The patent claims at issue call for two components—valsartan and sacubitril—administered “in combination.” The specification of the ‘659 patent disclosed valsartan and sacubitril administered only as two separate components. In contrast, Novartis’s commercial product ENTRESTO, as well as MSN’s accused product, each feature a complex of non-covalently bonded valsartan and sacubitril.

Novartis sued MSN for infringement of the ‘659 patent. During claim construction, over MSN’s objection, Novartis sought a construction which encompassed both separate and bonded combinations, so as to cover MSN’s product. The District Court agreed, though it warned Novartis that such construction would create “a non-frivolous issue” of, inter alia, lack of enablement.

Nonetheless, the District Court ultimately rejected MSN’s enablement defense. That court first flatly concluded, “It is not disputed that the specification neither discloses nor suggests a complex of valsartan and sacubitril.”. That should have been the end of the enablement inquiry. But the District Court went on to address Novartis’s contention that such a complex is “an after-arising invention that the patent need not enable.”  Id. It gleaned this legal proposition from a group of cases, beginning with In re Hogan, 559 F. 2d 595 (C.C.P.A. 1977), which it cited for the proposition “that a later-existing state of the art cannot be used to invalidate a patent for lack of enablement.” (Emphasis added).

The Federal Circuit affirmed on the issue of enablement, and its analysis got off on the wrong foot at the very start, when the court stated that the ‘659 patent “does not claim as its invention valsartan-sacubitril complexes.” In fact, it does. As the District Court noted, “The parties do not dispute that the claims at issue are directed to a genus of combinations of sacubitril and valsartan, which includes complexes of sacubitril and valsartan.” (Quotation marks omitted). It is well settled that where a claim is broadly construed—as was true here—the question is whether the claim is enabled under the court’s broad construction. See, e.g. Identix Pharms. LLC v. Gilead Scis., Inc. 941 F.3d 1149, 1156 n. 3 (Fed. Cir. 2019).

The Federal Circuit then stated that after filing its application that became the ‘659 patent, Novartis developed a novel compound comprising non-covalently bound valsartan and sacubitril salts, which were disclosed in Novartis’s U.S. Patents 8,877,938 and 9,388,134. The Federal Circuit went on to endorse the District Court’s recognition that valsartan- sacubitril complexes are part of a later-existing state of the art which may not properly be considered in an enablement analysis, citing Hogan as well as Plant Genetic Sys., N.V. v. DeKalb Genetics Corp., 315 F. 3d 1335, 1340 (Fed. Cir. 2003) (“[O]ne [can]not use a later-existing  state of the art to invalidate a patent that was enabled for what it claimed at the time of filing.”(Emphasis added.)) The Federal Circuit added that the later-discovered complexes “cannot be used to ‘reach back’ and invalidate the asserted claims. (Emphasis added.)

This was the Federal Circuit’s entire enablement analysis. And it rests on an incorrect premise.

No one was asserting that Novartis’s ‘938 and ‘134 patents invalidate the Novartis’s ‘659 patent. While MSN had the burden of proving the absence of enablement by clear and convincing evidence, it did so in spades, with the unchallenged fact that the ‘659 patent neither discloses nor suggests valsartan-sacubitril complexes.. This meant that there could not possibly be enablement as to the full scope of the ‘659 patent under the broad claim construction that Novartis championed and received.

To the contrary, as the District Court pointed out, it was Novartis that relied on the later ‘938 and ‘134 patents: “I agree with [Novartis] that complexes are later-existing technology that need not be enabled.” It was Novartis that artfully used this theory to surgically reconstrue and narrow the ‘659 patent claims, for validity purposes only, so that they no longer covered complexes. And it was Novartis that did so while resting on the original broad construction under which MSN was adjudged an infringer.

All patents enjoy a presumption of validity. Some patents are held invalid. The ‘659 patent, construed as Novartis would advocate, was invalid on the day it issued for containing no disclosure of valsartan- sacubitril complexes. It was validated by events that occurred long after issuance.

Prohibiting the use of after-arising technology to invalidate a patent makes sense, because—in effect—it requires one to conclude that information that existed and was enabling as of the filing date either no longer exists or is no longer enabling. But allowing after-arising technology to validate an otherwise deficient specification is much worse: it invites information from any and all sources, which multiply every day, to fill any and all gaps in a patent specification that existed as of the filing date.

II. INVALID TODAY/VALID TOMORROW: THIS CANNOT AND WILL NOT END WELL

The ‘659 patent issued in January 2012. Novartis’s ‘938 patent did not issue until November 2014 and the ‘134 patent did not issue until July 2016. Thus, had the present case been litigated in, say, 2013, Novartis could not have made the argument it eventually used to save the ‘659 patent. Thus, given the admitted absence of anything in the ‘659 specification that discloses or suggests complexes, the ‘659 patent should have and presumably would have been invalidated.

But no such litigation took place. Instead, we now confront a patent which stood manifestly invalid when it first issued, but which was resurrected by new technology which had not been patented as of 2012, when the ‘659 patent issued.

What if the date upon which after-arising technology can alter an enablement analysis need not await the issuance of a patent, but might instead be deemed to occur on the date of invention? In this case, Novartis might have argued that the ‘659 patent was already cured of its manifest enablement deficiency by 2012 because the applications that became the ‘938 and ‘134 patents had been filed in 2006 and 2005 respectively.

To appreciate more fully the mischief created by the Federal Circuit’s decision, it is helpful to use a cleaner hypothetical. Suppose the ‘659 patent was first filed in 2010 and issued in 2012, with a projected term that would run until 2030. Suppose further that the first disclosure of valsartan- sacubitril complexes was in the imaginary ‘000 patent which was filed in 2015 and issued in 2020. And suppose an infringer began sales in 2013.

Under the Federal Circuit’s analysis, the ‘659 patent would be deemed valid at least from 2020 forward, and Novartis could presumably collect damages for that time interval and seek an injunction. The next question that a future court might have to answer, if the Federal Circuit’s decision is allowed to stand, is whether the post-issuance validation is retroactive to the issue date of the ‘659 patent.

But is retroactivity even necessary? We could expect a patent owner in Novartis’s position to argue that the invention of the ‘000 patent is legally deemed to have been completed as of its filing date. See Hyatt v. Boone, 146 F. 3d 1348, 1352 (Fed. Cir. 1998) (“The filing of a patent application serves as conception and constructive reduction to practice of the subject matter described in the application.”) So, perhaps Novartis could claim that the ‘659 patent’s enablement deficiency was cured and that damages started accruing when the accused infringer began its sales in 2013.

And then there is this to consider: what happens if our hypothetical ‘000 patent is itself held invalid for lack of invention under 35 U.S.C. §§102 and/or 103? This might occur in a separate litigation, or perhaps a PTO proceeding, or perhaps even in the ‘659 infringement litigation. Is the ‘659 patent now invalid again? Or perhaps after-arising technology need not be patentable at all to play the role it played in this case.

How might District Courts decide such questions? The Federal Circuit in this case provides no clue whatsoever.

This is uncharted territory for the U.S patent system. Competitors who study issued patents and conclude that they are invalid have expectations that can now be dashed unexpectedly. In the pharmaceutical industry, planning and expenditures for generic substitutes can be scuttled when a manifestly invalid patent is suddenly rendered enforceable. While the after-arising technology in this case arose relatively early in the ‘659 patent’s term, it could just as well have arisen years later, potentially scuttling generic substitutes that have been on the market for years. The purchasing public, which might have become accustomed to the availability of low-cost generic substitutes, might see prices skyrocket back to where they were before any generics became available.

III. WHODUNIT? DOES THE FEDERAL CIRCUIT’S RATIONALE DEPEND ON WHO INVENTED THE AFTER-ARISING TECHNOLOGY? 

In the present case, the entity that—for all intents and purposes—filled the enablement gap in Novartis’s ‘659 specification was Novartis itself. So perhaps the lower courts viewed this as a no harm/no foul situation in which Novartis inventors collectively and eventually disclosed and enabled all sectors of Novartis’s broadly construed claims. Indeed, the District Court made a finding  that Novartis’s  scientists, not knowing if it was even possible to make a complex of valsartan and sacubitril, ”first synthesized LCZ696 [the active ingredient in Novartis’s commercial product ENTRESTO] in January 2006, after conducting over one thousand separate experiments between March 2005 and January 2006.”

But nothing in the Federal Circuit’s decision suggests that its holding is limited to situations in which the same company that failed to adequately disclose the ‘659 invention also stepped in later to fill the gap. Thus, hypothetically, a disinterested third party might have obtained a later patent on after-arising technology. Would the same result obtain?

And what if MSN itself had been the company that invented and patented the after-acquired technology? This could lead to the spectacle of an accused infringer which invented an improvement over the ‘659 patent effectively engineering its own defeat by providing a vehicle for narrowing the scope of the ‘659 patent (for validity purposes only) to compensate for a glaring deficiency of enabling disclosure.

Should this Court elect not to review this case, questions like these will inevitably arise. The Federal Circuit has given no hint as to how these questions would be addressed. This Court’s guidance is badly needed—again.

 CONCLUSION

For the reasons set forth in MSN’s petition, and for the additional reasons set forth herein, this Court should grant certiorari.