Tag Archives: en banc

Pending En Banc Petitions at the Federal Circuit

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by Dennis Crouch

The Federal Circuit recently decided the en banc design patent case of LKQ v. GM, but the court has not issued an en banc decision in a utility patent case since 2018.  There are currently four interesting petitions pending before the court.

Brumfield – Consistency and Proving International Damages: The Federal Circuit panel affirmed the district court’s grant of summary judgment that the asserted claims of the two asserted patents are invalid under 35 U.S.C. § 101. Brumfield v. IBG LLC, No. 2022-1630 (Fed. Cir. Mar. 27, 2024).  Although the Federal Circuit had previously held that the claimed invention was “technological,” the court here concluded that it was not bound by that prior non-precedential decision. In the petition for rehearing, Brumfield argues the improperly disregarded the Federal Circuit’s prior finding that the patents claim technological improvements.  The contention here is that “the interest of consistency would be ‘ill served'” by allowing different panels to make contradictory findings about the same patent claims.” See, Burke, Inc. v. Bruno Indep. Living Aids, Inc., 183 F.3d 1334 (Fed. Cir. 1999). Id.

The panel also affirmed the district court’s exclusion of Brumfield’s damages expert’s testimony on obtaining foreign damages based on IBG’s domestic making of the accused product. The panel held that although the Supreme Court’s WesternGeco  decision permits awarding damages based on foreign conduct in cases involving domestic infringement, the expert had failed to establish the required causal relationship between the domestic infringement and the foreign conduct. In the rehearing petition, Brumfield argues the improperly decided this fact-intensive causation issue sua sponte, depriving Brumfield of the opportunity to present evidence on an issue that IBG never disputed below or on appeal. [Note: I was involved in litigating patents from this patent family when owned by the predecessor-in-interest. I am no longer involved the litigation. DC]

Edwards Lifesciences – Expanded 271(e)(1) Safe Harbor: In Edwards Lifesciences Corp. v. Meril Life Sciences Pvt., a split Federal Circuit panel affirmed the district court’s summary judgment that Meril’s importation of its transcatheter heart valve fell within the safe harbor provision of 35 U.S.C. § 271(e)(1) and thus, did not infringe Edwards’ patent. No. 2022-1877 (Fed. Cir. Mar. 25, 2024). The majority held that the safe harbor applied because Meril’s importation was “reasonably related to submitting information to the FDA,” even though there was evidence of other commercial uses. The dissent argued that the majority perpetuated the court’s failure to give meaning to the word “solely” in the statute, which cabins the safe harbor to uses solely related to the federal regulatory process. Section 271(e)(1) states that it “shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention … solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”

Edwards has now petitioned for en banc rehearing, arguing that the panel decision vastly expands § 271(e)(1)’s safe harbor by reading the term “solely” out of the statute, in contravention of the provision’s plain text, history, and purpose. According to Edwards, any non-regulatory use is disqualifying under the correct reading of “solely.” Edwards contends the panel was bound by circuit precedent incorrectly holding that once a defendant identifies any use reasonably related to FDA approval, the safe harbor applies regardless of other non-regulatory uses. (citing AbTox, Inc. v. Exitron Corp., 122 F.3d 1019 (Fed. Cir. 1997)).

Edwards argues this precedent flouts the statutory text and history showing Congress struck a “careful balance” in § 271(e)(1) to allow infringement only for the singular purpose of seeking regulatory approval. By judicially rewriting this compromise to protect non-regulatory and commercial conduct, Edwards claims the Federal Circuit has distorted the market for patented products, undermined the patent bargain, and created a powerful statutory immunity ripe for abuse.

Salix Pharms – Improper Appellate Obviousness Fact Finding: The Federal Circuit recently affirmed the district court’s judgment that several claims of Salix’s patents covering methods of treating irritable bowel syndrome with diarrhea (IBS-D) using rifaximin were invalid as obvious. Salix Pharms., Ltd. v. Norwich Pharms. Inc., 2022-2153 (Fed. Cir. Apr. 11, 2024). Salix has petitioned for rehearing en banc, arguing that the panel majority improperly found facts in the first instance rather than reviewing and analyzing the district court’s fact-finding as required by precedent. See Icicle Seafoods, Inc. v. Worthington, 475 U.S. 709 (1986); Atl. Thermoplastics Co. v. Faytex Corp., 5 F.3d 1477 (Fed. Cir. 1993).

The petition contends that after correctly determining the district court erred in its obviousness analysis by misapplying the prior-art range precedent, the CAFC panel majority should have reversed or remanded for further fact-finding by the district court. Instead, Salix argues, the majority improperly made its own findings on key disputed factual issues never resolved by the district court, such as whether skilled artisans would have viewed small intestinal bacterial overgrowth (SIBO) as a cause of IBS-D or as a separate disorder. The majority relied on prior art references and made factual findings that the district court never made to conclude there was a reasonable expectation of success in using the claimed rifaximin dosage to treat IBS-D.

Additionally, Salix asserts the panel majority applied the wrong standard in determining that the district court’s erroneous reliance on a non-prior art reference (the “RFIB 2001 Press Release”) was harmless error. Rather than considering whether that reference induced the district court to make findings it otherwise would not have made, the majority simply concluded other evidence “established” the relevant fact. But as Judge Cunningham noted in dissent in the original panel decision, the district court heavily relied on the press release to discount evidence of skepticism in the art. The press release factored significantly into the court’s analysis.

Luv N’ Care – Scope of Unclean Hands Defense: The Federal Circuit affirmed the district court’s application of the unclean hands doctrine to bar Eazy-PZ’s patent and trade dress claims against Luv N’ Care due to Eazy-PZ’s litigation misconduct. Luv N’ Care, Ltd. v. Laurain, 2022-1905 (Fed. Cir. Apr. 12, 2024). In its petition for rehearing, Eazy-PZ argues that the panel majority departed from Supreme Court and Federal Circuit precedent requiring that unclean hands be based on misconduct having an “immediate and necessary relation to the equity that he seeks.” Keystone Driller Co. v. Gen. Excavator Co., 290 U.S. 240 (1933); see also Gilead Scis., Inc. v. Merck & Co., 888 F.3d 1231 (Fed. Cir. 2018).

The district court concluded that the patentee Eazy-PZ had engaged in litigation misconduct—all of which was associated with the asserted utility patent. However, the resulting unclean hands penalty was to dismiss the entire case, including the design patent and trade dress claims. The petition argues this was an improper extension without analyzing how the alleged misconduct related to or provided Eazy-PZ an unfair advantage regarding those claims. The petition asserts that withholding information relevant to utility claim construction could not have advantaged the design and trade dress claims. Eazy-PZ argues this expansive application of unclean hands, untethered to the specific relief sought, vitiates the Supreme Court’s “immediate and necessary” relation requirement.

Regarding the ‘903 utility patent itself, Eazy-PZ argues the panel affirmed based on factual findings the district court never made about how any false or evasive testimony impacted Luv N’ Care, violating the rule that appellate courts cannot make factual findings in the first instance.

Mishandled Disclosures: A Greek Tragedy in IP Law

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by Dennis Crouch

Neuropublic S.A., a Greek technology company, has filed a federal lawsuit against the law firm Ladas & Parry LLP, with several claims stemming from the firm’s alleged mishandling of Neuropublic’s confidential invention disclosure — sending it out to a third party (“PatentManiac”) for a preliminary novelty search which then (again allegedly) further leaked the disclosure. Although the case does not involve submission to AI algorithms, some of the questions here are similar to those many  IP attorneys are considering when onboarding new AI tools. (more…)

Goodbye Rosen references, hello Jennings references?

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Guest Post by Sarah Burstein, Professor of Law at Suffolk University Law School

LKQ Corp. v. GM Global Tech., 21-2348 (Fed. Cir. 2024) (en banc).

In its decision in LKQ v. GM, the en banc Federal Circuit may have raised as many questions as it answered. For now, I’d like to focus on one:  What counts as a proper primary reference under LKQ?

While the Federal Circuit overruled the Rosen requirement that a primary reference look “basically the same” as the claimed design, the court did not overrule the requirement that there be a primary reference.

According to the Federal Circuit “In applying Graham factor one, the scope and content of the prior art, a primary reference must be identified.” And, as required by Rosen, that primary reference must still be “something in existence,” not “something that might be brought into existence by selecting individual features from prior art and combining them, particularly where combining them would require modification of every individual feature.” But for this last point, the Federal Circuit doesn’t cite Rosen. Instead, it cites the decision that Rosen cited for that point, In re Jennings, 182 F.2d 207, 208 (CCPA 1950).

So what does Jennings tell us about references and § 103? Not much. Here is the entirety of the CCPA’s discussion of the issue:

In the instant case individual features seem to have been selected from different of the reference patents and compared with features shown in appellant’s drawings. In other words, it seems to have been held that by selecting features taken from five different patents, that is, none feature from one patent, another from another, etc., a device might be considered which would so closely resemble the drawings of appellant that his design would not be patentable over such possible construction.

We feel constrained to disagree with the concurring conclusions reached by the tribunals of the Patent Office.

In considering patentability of a proposed design the appearance of the design must be viewed as a whole, as shown by the drawing, or drawings, and compared with something in existence—not with something that might be brought into existence by selecting individual features from prior art and combining them, particularly where combining them would require modification of every individual feature, as would be required here.

182 F.2d 207 at 208. The Jennings court lists the cited references but does not say—let alone show—which “features seem to have been selected” from each or how they were “compared with features shown in appellant’s drawings.” Nonetheless, the CCPA did helpfully emphasize that, in analyzing whether a design is obvious, the design must be considered as a whole.

Going back to LKQ, the en banc Federal Circuit further tells us that “[t]he primary reference will likely be the closest prior art, i.e., the prior art design that is most visually similar to the claimed design” and that “[t]he primary reference will typically be in the same field of endeavor as the claimed ornamental design’s article of manufacture, but it need not be, so long as it is analogous art.”

So what to make of all of this?

First, and perhaps most importantly, the Federal Circuit’s decision in LKQ is a clear repudiation of the Frankenart approach to design patent obviousness. A challenger (or an examiner) can’t just slice and dice a design claim into “limitations,” find those in the prior art, and then stitch them together into an invalidating reference. That’s a good thing.

Second, we know that a proper primary reference no longer has to look “basically the same” as a claimed design, as that phrase was applied by the Federal Circuit. (For a few examples of the extremely high degree of visual similarity required by the Federal Circuit prior to LKQ, see here and here.)

Nonetheless, the court’s citation to and reaffirmation of the Jennings rule suggests that, even after LKQ, a primary reference must still have at least some quantum of overall visual similarity. If no reference looks at least somewhat similar to the claimed design, then are we not simply “selecting individual features from prior art and combining them” to invalidate the design?

So what about Whitman Saddle? The LKQ court tells us that it doesn’t matter that Whitman Saddle predated the enactment of § 103 and spoke about “invention,” not obviousness. They tell us, without any citation or explanation, that “[t]he reasoning of Whitman Saddle carries over to the modern § 103 standard of obviousness.” (I suspect that Judge Rich would have disagreed.) Perhaps some patent challengers will attempt to argue that, following LKQ, “half is enough”—i.e., that if half of the claimed design can be found in a piece of prior art, that constitutes a proper primary reference. I don’t think that’s right. Whitman Saddle was a case with unusual facts and, in its discussion, the Supreme Court expressly relied on the existence of a “mix and match” custom in the field of saddle design. In that case, the Supreme Court tells us, the issue wasn’t that the different parts of the claimed saddle design could be found in the prior art and hypothetically could have combined but rather because, the Supreme Court tells us, it was “customary” to do so. Without that custom, then the reference combining in Whitman Saddle would seem to be nothing more than the Frankenart approach rejected in Jennings—and now in LKQ. In cases without evidence of a similar type of custom, Whitman Saddle may have limited precedential value.

Third, the LKQ court left open the possibility that the primary reference could be both the “most visually similar to the claimed design” but not the type of reference that could anticipate the claimed design under § 102. That’s because the primary reference need not disclose a design for the same type of article, as required for anticipation. It merely needs to be “analogous art.” Thus, the Federal Circuit has indicated that, for designs, the universe of § 103 prior art is broader than the universe of § 102 prior art. That’s the opposite of how it works in utility patents. That’s not a problem, though. Or even a bad thing. (Indeed, I’ve argued that this is how it should be.) But it’s still notable.

One more point: The LKQ court justified its retention of a primary reference requirement as being necessary to avoid “hindsight.” That may be true in some sense. But, as I’ve written before, requiring a primary reference does more than that—it focuses the inquiry, quite properly and as required by Jennings, on the design as a whole. It recognizes that design patents are fundamentally different than utility patents. They protect fundamentally different innovations (visual designs) in a fundamentally different way (central claiming using images). The Frankenart approach rejected by Jennings—and now by the en banc Federal Circuit in LKQ—essentially asks whether it would have been technically possible to combine preexisting design elements. It tells us nothing about whether it would have been visually obvious to do so. Exactly how this new primary reference requirement will develop remains to be seen. But the Federal Circuit’s renewed and reemphasized focus on the fact that a design must be emphasized as a whole is extremely important and a point not to be missed.

* * *

For more on the history of § 103, design patents, and some thoughts about what types of modifications to a primary reference would be obvious (from a design perspective), see this article.

Speck v. Bates: Federal Circuit’s Two-Way Test for Pre-Critical Date Claims Limits Belated Interferences and Derivation Proceedings

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by Dennis Crouch

Speck v. Bates, No. 23-1147 (Fed. Cir. May 23, 2024)

In likely one of the last interference proceeding appeals, the Federal Circuit has applied a “two-way test” to determine whether pre-critical date claims and post-critical date claims are “materially different” under pre-AIA 35 U.S.C. § 135(b)(1). The court found that Bates’ post-critical date claims in its U.S. Patent Application No. 14/013,591 were time-barred because they were materially different from Bates’ pre-critical date claims.

Although the decision is based upon an interference proceeding, the same provision is found within the new version of 135(b) that covers (more…)

Decoding Patent Ownership beginning with Core Principles

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by Dennis Crouch

In a recent decision, the Federal Circuit vacated a district court’s grant of summary judgment that an inventor, Dr. Mark Core, had automatically assigned a patent associated with his PhD thesis to his then-employer and education funder TRW.  Core Optical Techs., LLC v. Nokia Corp., Nos. 23-1001 (Fed. Cir. May 21, 2024). The key issue was whether Dr. Core developed the patented invention “entirely on [his] own time” under his employment agreement. The majority opinion written by Judge Taranto and joined by Judge Dyk held the contract language was ambiguous on this point and remanded for further factual development to determine the parties’ intent.  Judge Mayer dissented.

Although not discussed in the court’s decision, the appellant brief includes a suggestion that the Federal Circuit should “narrow or overrule” the automatic assignment law seen in FilmTec Corp. v. Allied Signal, Inc., 939 F.2d 1568 (Fed. Cir. 1991), and its progeny (more…)

Federal Circuit Overrules Rosen-Durling Test for Design Patent Obviousness

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by Dennis Crouch

In a highly anticipated en banc decision, the Federal Circuit has overruled the longstanding Rosen-Durling test for assessing obviousness of design patents. LKQ Corp. v. GM Global Tech. Operations LLC, No. 21-2348, slip op. at 15 (Fed. Cir. May 21, 2024) (en banc). The court held that the two-part test’s requirements that 1) the primary reference must be “basically the same” as the claimed design, and 2) any secondary references must be “so related” to the primary reference that features from one would suggest application to the other, “impose[] limitations absent from § 103’s broad and flexible standard” and are “inconsistent with Supreme Court precedent” of both KSR (2007) and Whitman Saddle (1893). Rejecting the argument that KSR did not implicate design patent obviousness, the court reasoned that 35 U.S.C. § 103 “applies to all types of patents” and the text does not “differentiate” between design and utility patents.  Therefore, the same obviousness principles should govern.  This decision will generally make design patents harder (more…)

Cellect or Reject? SCOTUS Asked to Consider Fate of ODP Doctrine

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by Dennis Crouch

In its new petition for certiorari in Cellect LLC v. Vidal, No. __ (U.S. May 20, 2024), Cellect argues that the Federal Circuit erred in upholding the PTAB’s (PTAB) invalidation of Cellect’s four patents based on the judicially-created doctrine of obviousness-type double patenting (ODP). The key issue is whether ODP can cut short the patent term extension provided by the Patent Term Adjustment (PTA) statute, 35 U.S.C. § 154(b). Meanwhile, Dir. Vidal is looking to extend the power of ODP via rulemaking. This is an important case coming at an important time.  (more…)

Eolas Seeks Supreme Court Review of Federal Circuit’s Patent Eligibility Decision

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Eolas is seeking a writ of certiorari from the Supreme Court — hoping that the court will overturn the Federal Circuit’s decision invalidating its distributed computing (WWW) claims as ineligible under Alice Corp. and Mayo and ostensibly under 35 U.S.C. § 101. The petition presents three key questions: (more…)

Cycling Towards Confusion: Is there room for iFIT Fitness Services and iFIT Safety Glasses?

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by Dennis Crouch

In its initial decision, the TTAB dismissed iFIT’s opposition to ERB’s I-FIT FLEX registration — finding no likelihood of confusion because the goods were in separate markets.  iFIT is a major manufacturer of exercise equipment like treadmills and stationary bikes and holds several trademark registrations for IFIT marks covering fitness machines, online fitness training services and content, software, and some ancillary products like apparel.  ERB Industries applied to register I-FIT FLEX for protective and safety eyewear sold at hardware stores such as Home Depot.  Although the two brands are at-times sold in the same online store (Amazon.com and Walmart.com) this type of overlap was not sufficient for the TTAB. In its decision, the TTAB rejected iFIT’s relatedness argument using an analogy to racecar drivers and chemists. The TTAB reasoned that while some racecar drivers and chemists may use safety glasses, that doesn’t mean safety glasses are related to racecars or to chemicals like ammonia.

iFIT appealed the Federal Circuit, and most recently Federal Circuit granted (more…)

Post-Default Creditor’s Right to Assign, License and Enforce Patent does not Disturb Patentee’s Separate Right to Sue Infringers

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by Dennis Crouch

The Federal Circuit’s new decision in Intellectual Tech LLC v. Zebra Techs. Corp., No. 2022-2207 (Fed. Cir. May 1, 2024) offers some interesting insight into leveraged patent transactions, and the effect of a lender’s ability to license or assign a patent on the patent owner’s standing to sue for infringement, especially (more…)

Codifying Discretionary Denial of IPR Petitions

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by Dennis Crouch

The USPTO recently released yet another Notice of Proposed Rulemaking (NPRM) — this one focusing on codification of IPR/PGR rules associated with non-merits based “discretionary denials” of institution as well as termination due to settlement.  This is a controversial area because of that word ‘discretion.’  Unrestricted discretion by government officials is concerning because of the potential for arbitrary or biased decisions, lacking transparency and accountability.  In that frame, these rules are beneficial because they structure and limit discretion – hopefully making the outcomes more predictable and justifiable.  A key note – the rules here focus primarily on procedure (separate briefing for discretionary denials) and substantive issues relating to parallel, serial, and cumulative petitions. Although this is an important step, they do not address discretionary denials associated with parallel litigation (or other outside factors) under Fintiv and subsequent director guidance. This is likely the most controversial area of discretionary denials that is being left out for now.

Congress clearly intended the USPTO to have substantial discretion (more…)

The Use of Mandated Public Disclosures of Clinical Trials as Prior Art Against Study Sponsors

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By Chris Holman

Salix Pharms., Ltd. v. Norwich Pharms. Inc., 2024 WL 1561195 (Fed. Cir. Apr. 11, 2024)

Human clinical trials play an essential role in the discovery, development, and regulatory approval of innovative drugs, and federal law mandates the public disclosure of these trials. Pharmaceutical innovators are voicing concern that these disclosures are increasingly being used as prior art to invalidate patents arising out of, or otherwise relating to, these trials, in a manner that threatens to disincentivize investment in pharmaceutical innovation. A recent Federal Circuit decision, Salix Pharms., Ltd. v. Norwich Pharms. Inc., illustrates the concern.  In Salix, a divided panel upheld a district court decision to invalidate pharmaceutical method of treatment claims for obviousness based on a clinical study protocol published on the ClinicalTrials.gov. website. The case garnered amicus curiae briefs filed by several innovative pharmaceutical companies in support of the patent owner, Salix Pharmaceuticals. (more…)

Guest post by Prof. Holbrook: Extraterritoriality and Patent Damages Under § 271(a)

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Guest post by Tim Holbrook. Robert B. Yegge Endowed Distinguished Professor of Law and Provost’s Professor, University of Denver Sturm College of Law.

United States patents are generally territorial.  Their exclusive rights only operate within the United States and its territories.  Or so one may think reading the Patent Act.  Moreover, in a global marketplace, the territorial nature of intellectual property rights can create challenges. It would be simpler for a patent holder to just use the U.S. patent to cover foreign activity. This is especially true if a domestic act of infringement has spillover effects into other countries.

So, when – if ever – can a patent owner receive damages for foreign activity that may flow from acts of domestic infringement?

The Supreme Court answered that question   (more…)

Using AI in your Patent Practice

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By Dennis Crouch

Over the past year I’ve been investigating various generative Artificial Intelligence (GenAI) tools for assisting patent attorneys in their practice.  I have a strong belief that these tools and their progeny are now fixtures in our legal environment and are being used to both improve efficient delivery of legal services and to also improve the quality of those services.  Of course the generative creativity of our LLMs go hand in hand with hidden false narratives or hallucinations. Vendors are stepping up to thread the needle here: providing valuable GenAI tools while limiting false story telling.  As we move forward some of the struggle will be a focus on how much the attorney needs to know about how the GenAI works in order to use it responsibly.

Enter the USPTO and its Wet Blanket: The USPTO has released new guidance on the use of AI tools in practice before the USPTO. (more…)

Federal Circuit Affirms ITC Divided Opinion in Sonos v. ITC

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by Dennis Crouch

In a non-precedential opinion, the Federal Circuit has affirmed the US International Trade Commission’s (ITC) final determination in the patent infringement dispute between Sonos and Google involving smart speaker technology. Sonos, Inc. v. Int’l Trade Comm’n, Nos. 2022-1421, 2022-1573 (Fed. Cir. Apr. 8, 2024).  The ITC had issued a split opinion – finding that Google infringed a number of Sonos speaker patents, but concluded that Google’s proposed work-around was non-infringing.  Both sides appealed and the Federal Circuit’s deferential standard of review resulted in a full affirmance. The outcome then (more…)

De Forest Radio v. GE: A Landmark Supreme Court Decision on the Invention Requirement

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By Dennis Crouch

In 1931, the United States Supreme Court decided a landmark case on the patentability of inventions, De Forest Radio Co. v. General Electric Co., 283 U.S. 664 (1931), amended, 284 U.S. 571 (1931). The case involved a patent infringement suit over an improved vacuum tube used in radio communications. While the case predated the codification of the nonobviousness requirement in 35 U.S.C. § 103 as part of the Patent Act of 1952, it nonetheless applied a similar requirement for “invention.”

I wanted to review the case because it is one relied upon in the recent Vanda v. Teva petition, with the patentee arguing that the court’s standard from 1931 has been relaxed by the Federal Circuit’s “reasonable expectation of success” standard. The decision also provides an interesting case study in the way that the court seems to blend considerations of obviousness and (more…)

Shaping the Future of Patent Law: The Amgen v. Sanofi Decision and Bite-Sized Monopolies

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by Dennis Crouch

“The more one claims, the more one must enable.”

In a unanimous opinion delivered by Justice Gorsuch, the Supreme Court has affirmed the Federal Circuit’s decision invalidating Amgen’s functionally claimed genus of monoclonal antibodies. The Court held that Amgen’s patent claims were invalid due to a lack of enablement, as they failed to provide adequate guidance for making and using the claimed antibodies.

The case in question is Amgen Inc. v. Sanofi, 22-157, — U.S. — (2023) (21-757_k5g1).

Amgen’s patents cover monoclonal antibodies created by Amgen researchers which aid in reducing blood levels of low-density lipoprotein (LDL), also known as “bad cholesterol.” These antibodies inhibit the operation of a naturally occurring protein known as PCSK9, which degrades LDL receptors and contributes to high cholesterol levels. Amgen’s original patent covered antibodies having particular amino acid sequences, but later its competitor Sanofi patented another antibody with a different sequence from those disclosed and began competing.   Amgen was then able to obtain the broader patents at issue here that are not tied to any particular antibody structure or amino acid sequence. Rather, the claims cover an “entire genus” of antibodies capable of binding to specific amino acid residues on PCSK9 and consequently inhibit PCSK9 activity. Amgen subsequently sued Sanofi for infringement, prompting a defense from Sanofi challenging whether these broader claims were sufficiently enabled.

The Patent Act requires that patent applicant describes the invention in explicit terms to enable any person skilled in the art to make and use the invention. 35 U.S.C. 112. Sanofi characterized the methods Amgen provided for generating additional antibodies as merely a trial-and-error process, claiming that Amgen’s patents failed the enablement requirement as they sought exclusive use over potentially millions more antibodies than the company had taught how to produce. Although a jury sided with the patentee Amgen, the district court and the Federal Circuit agreed with Sanofi’s contention, ruling that Amgen did not meet the enablement requirement as a matter of law.

The enablement requirement is a crucial aspect of the patent “bargain”: an inventor is granted limited protection from competition in exchange for publicly disclosing their new technology. The Supreme Court, in its decision, referenced previous cases such as Morse, Incandescent Lamp, and Holland Furniture, as establishing the requirement that if a patent claims an entire class or genus of processes, machines, or compositions of matter, the specification must enable a person skilled in the field to make and use the entire class. In simpler terms, it follows the elementary school principle: If you bring cookies to share, bring enough for everyone.

If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class. In other words, the specification must enable the full scope of the invention as defined by its claims.

The more one claims, the more one must enable. See §112(a); see also Continental Paper Bag Co. v. Eastern Paper Bag Co., 210 U. S. 405 (1908) (“[T]he claims measure the invention.”).

Amgen v. Sanofi.

In this case, Amgen sought exclusivity for the entire class of functional antibodies, not just the 26 antibodies expressly disclosed.  Although Amgen also provided a “roadmap” for discovering more antibodies, the court found that those approaches were insufficient “research assignments” rather than a clear process for creating the additional antibodies. The Supreme Court ruled that these disclosures did not fulfill the enablement requirement as per the Patent Act, as they simply described Amgen’s trial-and-error method without providing sufficient information for skilled scientists to make the entire class of claimed antibodies.

The Supreme Court did agree with Amgen that functional/genus claims should not be held to a stricter standard of enablement. In other words, there is “one statutory enablement standard.” Nonetheless, the general principle remains that broader claims necessitate more enablement, and all claims must be enabled to their “full scope.”

The outcome of the Amgen v. Sanofi case, while significant, may not come as a surprise to those familiar with the evolution of patent law. In recent years, there has been a growing emphasis on promoting innovation and competition by limiting the scope of patent monopolies. This approach recognizes that patents should strike a balance between incentivizing inventors to disclose their inventions and ensuring that the public can freely build upon existing knowledge. Rather than granting broad and far-reaching patent rights, the trend has been towards encouraging more focused and narrowly tailored claims. This shift reflects a recognition that patents are more palatable when they offer bite-sized protection rather than providing a singular and overpowering monopoly. The ruling in the Amgen v. Sanofi case aligns with this approach, reinforcing the notion that patents should enable the creation and use of the claimed inventions while still allowing for competition and further advancements in the field.

Assessing Judicial Fitness: Judge Newman’s Alleged Cognitive Decline

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by Dennis Crouch

This week, the Federal Circuit disclosed further documents from a special committee established to evaluate the potential removal of Judge Pauline Newman from active duty due to a suspected mental or physical disability that could affect her judicial capabilities. The order, dated May 16, 2023, gives a more comprehensive discussion on concerns about Judge Newman’s performance, including signs of memory issues or confusion and diminished productivity. The document also outlines an investigation involving requested medical assessments and records, which Judge Newman has declined to provide.

The committee, formed on March 24, 2023, and comprising of Chief Judge Moore, Judge Prost, and Judge Taranto, is tasked to scrutinize the complaint, deliver their findings, and propose recommendations. Successive orders on April 7, April 17, and May 3, 2023, commanded Judge Newman to undertake a neurological evaluation and neuropsychological testing, backed unanimously by the council members based on noticeable changes in her mental sharpness.  Judge Newman opposed the mandated examinations, arguing that she should have the right to choose the medical professionals conducting them and that these examinations should have boundaries.

The May 16 order reiterates the need for these examinations in light of substantial evidence suggesting a possible disability that might inhibit Judge Newman’s judicial functions. The document then elaborates on the concerns expressed by court employees about Judge Newman’s competence. Reports from employees from various departments, including the Clerk’s Office, IT, HR, and Judge Newman’s chambers, highlight issues like memory lapses, confusion, paranoia, and inability to execute simple tasks. Notably, it details frequent accusations from Judge Newman about her email and computer being hacked, and her phones being bugged, as well as difficulty with everyday tasks such as logging into the court system, misplacing court documents, and forgetting information. The Judge has also shown confusion regarding court rules and struggled with mandatory security awareness training. These issues suggest significant cognitive impairment, according to the order, warranting a medical examination.

The document further mentions that “two out of five members of Judge Newman’s staff have recently resigned and have requested to have no further contact with Judge Newman.” It adds that “Judge Newman threatened to have a staff member arrested and removed from the building,” and another staff member “asserts her Fifth Amendment right to remain silent to avoid self-incrimination when asked about her role and responsibilities in the chambers, based on her lawyer’s advice.”

Judicial Disability and the “Great Dissenter”

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Guest Post by Paul R. Gugliuzza, Professor of Law, Temple University Beasley School of Law

The judicial disability proceedings instituted against Federal Circuit Judge Pauline Newman have now spilled into litigation. As Dennis reported yesterday, Judge Newman filed a complaint in D.C. federal district court seeking, among other things, to enjoin and terminate the proceedings.

Judge Newman’s complaint contains previously unreported details about the events giving rise to the disability proceedings against her. For instance, the complaint discloses an allegation, which was previously redacted from an order written by Chief Judge Moore in the disability proceedings, that, in the summer of 2021, Judge Newman had a heart attack and underwent coronary stent surgery.

Judge Newman’s complaint responds to that allegation by stating that “[d]uring the period (June 2021 through September 2021) when Chief Judge Moore claims that Judge Newman suffered a heart attack, Judge Newman sat on ten panels and issued at least eight (including majority, concurring, and dissenting) opinions.” Chief Judge Moore’s order, for its part, noted that Judge Newman wrote many fewer majority opinions than her colleagues over the past few years.

This dispute over Judge Newman’s ability to perform her judicial duties is an unfortunate tarnish on Judge Newman’s reputation and on the image of the Federal Circuit. And, because many of the relevant events occurred behind closed doors, we might never know for sure what’s been happening.

Is Judge Newman slowing down at age 95? Quite possibly. But is she “unable to discharge all the duties of office”—the standard set by law for instituting disability proceedings?

For some insight into Judge Newman’s workload as compared to her colleagues, I used Jason Rantanen’s Compendium of Federal Circuit decisions to collect and analyze data on the number of opinions written by individual Federal Circuit judges from June 2021 (the time of Judge Newman’s alleged heart attack) through the end of 2022. Those numbers tell a complicated story.

First off, Judge Newman’s assertion in her complaint that she wrote eight opinions from June 2021 through September 2021 is pretty much accurate. Over that time period, Judge Newman wrote one majority opinion (in a veterans case) and six dissenting opinions (either partial or full). In the eighth and final case that I was able to find, Judge Newman concurred in the result but didn’t write an opinion.

How does Judge Newman’s rate of opinion writing compare to her colleagues? The table below reports the number of opinions (precedential or not) written by each Federal Circuit judge who was in active service for the entire time period of June 1, 2021 through December 31, 2022—ten judges in total.

Opinions by Federal Circuit Judges (June 1, 2021 through December 31, 2022)

As the table makes clear, Judge Newman is an outlier, having written only nine majority opinions over that 19-month period. The judge with the next lowest number of majority opinions, Judge Chen, wrote three times as many as Judge Newman. In a group of ten active court of appeals judges, we would expect that, on average, each judge would write roughly 10% of the majority opinions. Yet Judge Newman wrote barely 2% (9 of 387).

Looking at concurring and dissenting opinions complicates things though. From June 2021 through the end of 2022, Judge Newman wrote 23 of those separate opinions. (And she concurred or dissented without opinion in four additional cases.) The two judges with the next most separate opinions, Judges Reyna and Dyk, wrote roughly half as many (13 and 11, respectively).

Overall, then, Judge Newman wrote 32 opinions from the time of her supposed heart attack through the end of 2022. That’s on the low side for an active Federal Circuit judge, but it’s worth noting that Judge Chen actually wrote fewer total opinions (30) over that same period.

Is a judge who writes, on average, more than one dissent or concurrence a month “unable” to discharge her duties? Arguably not. But, then again, there are underlying questions about Judge Newman’s physical and mental health that we can’t possibly know the answers to at this point.

And nothing is helped by the often-salacious framing of these disability proceedings as, essentially, a personal dispute between a famously headstrong—and female—Chief Judge quarreling with another female judge who, regardless of recent events, is indisputably a titan of the patent bar.

Rather, Judge Moore is acting in her official capacity as chief judge of a federal court of appeals and is proceeding in accordance with the framework set by statute and by the rules governing judicial disability proceedings. Judge Newman, for her part, is contesting both the process and merits of those proceedings, as she has every right to do. It’s not a judicial “cat fight.” It’s a legal dispute among judges—including other judges on the Federal Circuit—who genuinely disagree about what’s best for the court and the litigants who appear before it.

Turning back to the opinion numbers, the nub the conflict might be Judge Newman’s propensity to dissent. Each one of her 23 separate opinions reported on the table above dissented, at least in part. Because a dissenting judge, by definition, can’t write the majority opinion, a judge who dissents a lot creates a lot more work for her colleagues. And judges are, in the end, just people. A judge who does less work on majority opinions and who regularly refuses to compromise is unlikely to win many friends. Nor is a judge who constantly dissents likely to respond well to colleagues who suggest she take senior status or retire. Even if none of the Federal Circuit’s judges say so, frustration with Judge Newman as the court’s “great dissenter” is probably at least part of the reason for this sad saga.