Patent Docs

RegenxBio Inc. v. Sarepta Therapeutics, Inc. (D. Del. 2024)

February 18, 2024

By Kevin E. Noonan –

A consequence (predominantly negative) of the Supreme Court's recent foray into defining (however inadequately) the contours of patent-eligible subject matter is to give the district courts (and to a somewhat lesser extent, the Patent and Trademark Office) free rein to apply any Supreme Court precedent (no matter how archaic, ill-defined or incoherently reasoned) in invalidating claims on Section 101 grounds. This tendency was exhibited in the district court invalidation of the Sequenom patent portfolio (Ariosa Inc. v. Sequenom, Inc.), and has arisen, phoenix-like in a decision in the District Court of Delaware, based on of all things, Funk Bros. Seed Co. v. Kalo Inoculant Co. (see RegenexBio Inc. v. Sarepta Therapeutics Inc., Civil Action No. 20-1226 RGA).

The case arose over Sarepta's use of an adeno-associated virus variant disclosed and claimed in RegenxBio's U.S. Patent No. 10,526,617* to make a gene therapy product to treat Duchenne's muscular dystrophy. The '617 patent considered claim 1 to be representative:

1. A cultured host cell containing a recombinant nucleic acid molecule encoding an AAV vp1 capsid protein having a sequence comprising amino acids 1 to 738 of SEQ ID NO: 81 (AAVrh.10) or a sequence at least 95% identical to the full length of amino acids 1 to 738 of SEQ ID NO: 81, wherein the recombinant nucleic acid molecule further comprises a heterologous non-AAV sequence.

The District Court considered the parties' arguments regarding subject matter eligibility by applying the tests enunciated in Mayo Collaborative Services v. Prometheus Laboratories, Inc. as further explicated in Alice Corp. v. CLS Bank International. According to the District Court, Defendants asserted that the claims were directed to "naturally occurring rh.10 sequences," which were not patent eligible thereby, and further that the claims "monopolize" the use of these sequences in cultured host cells "for any research or commercial application" (perhaps supplying all the motivation the court needed for invalidating them). Having "established" satisfaction of step 1 of the Mayo/Alice test as being directed to naturally occurring sequences, the District Court accepted that under step 2 of that test, the skilled worker would have had "all the tools needed to make and use cultured host cells containing nucleic acids encoding the full scope of the claimed capsid proteins." (This argument echoes the rationale enunciated successfully in In re Kubin, and unsuccessfully in In re Bell and In re Deuel, that having a method for making something was equivalent to having the composition itself, in the obviousness context.) Generically, Defendants argued that "cultured host cells, recombinant nucleic acid molecules, heterologous non-AAV sequences" and other components were all well-known and hence fail step 2 of the test, illustrating the lessons of Sequenom and other instances where broad claiming and disclosure are used against a patentee in the eligibility context. Defendants concluded their argument (and the District Court seemed to accept it) by asserting that the combination of the elements do not add an "inventive concept" that amounts to the requisite (and undefined) "significantly more" needed to confer eligibility in the face of the naturally occurring rh.10 sequences themselves.

Plaintiffs argued that the proper test was the "markedly different" test, satisfied here by the claim elements considered as a whole, i.e., the recombinant host cells that was not naturally occurring and indeed were "structurally and functionally different." Defendants limited their counter argument, according to the opinion, on the straw man that the rh.10 sequences were not themselves markedly different, rather than the recombinant cell that is the proper subject of the claim.

The District Court's rationale centered on whether the resulting cell represented a "change" from what occurred in nature, concluding it did not. Relying on Funk Bros., the District Court opined that "taking 'two sequences from two different organisms and put[ting] them together' is no different than taking two strains of bacteria and mixing them together." According to the opinion, the inventors here "have not changed any of the claimed invention's naturally occurring components" and "[w]ithout some change, the mere fact that the '617 patent's inventors combined natural products and put them in a host cell does not make the invention patentable [(sic, patent eligible)] under §101" (ignoring that the combination is itself a change in the properties of the cell transformed into a recombinant cell).

The remainder of the District Court's analysis under step 2 followed the familiar regimen of selecting statements in the '617 patent specification relating to ways of producing the components of the claimed invention to illustrate the "well-known, routine, and conventional" nature thereof in support of the District Court's non-eligibility conclusion (as well as a short detour regarding whether use of the claimed invention for gene therapy, as used by Defendants, would make a difference, the District Court concluding that it would not).

The analysis applied by the District Court exemplifies how the complicated "framework" set forth under the Supreme Court tests in Mayo and Alice can (and in this case did) encourage courts to lose the forest for the trees. This is illustrated by the District Court's reliance on Funk Bros., wherein the combination of two naturally occurring species of bacteria was held to be ineligible for patenting. The difference, of course, is there was no change in either species of bacteria in that case. In this case, the cells have been transformed by introduction of the AAV vector ("a recombinant nucleic acid molecule," per se non-naturally occurring) that further comprises "a heterologous non-AAV sequence," which combination does not occur in nature and is "a non-naturally occurring manufacture or composition of matter and a product of human ingenuity 'having a distinctive name, character and use'" under Chakrabarty. The District Court founders on the specifically recited AAV sequence (encoding AAV vp1 capsid protein) being itself naturally occurring, another example of a court cherry-picking the elements of a claim despite avowing to be considering the claim "as a whole," as the District Court does here (Defendants encouraging such foundering by their arguments set forth in the opinion.)

Ironically, the District Court's decision is contrary to Justice Thomas's opinion in AMP v. Myriad Genetics, which it purports to apply. Specifically the opinion states:

[T]his case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. Judge Bryson aptly noted that, "[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position to claim applications of that knowledge. Many of its unchallenged claims are limited to such applications" [emphasis in opinion].

The meaning of Funk Bros. is similarly misunderstood (albeit a misunderstanding shared by most in view of the sparse nature of Justice Douglas's language in the Court's opinion). As explained by Justice Frankfurter's concurring opinion:

Insofar as the court below concluded that the packaging of a particular mixture of compatible strains is an invention and as such patentable, I agree, provided not only that a new and useful property results from their combination, but also that the particular strains are identifiable and adequately identified. I do not find that Bond's combination of strains satisfies these requirements. The strains by which Bond secured compatibility are not identified and are identifiable only by their compatibility. . . . [The patentee] appears to claim that since he was the originator of the idea that there might be mutually compatible strains and had practically demonstrated that some such strains exist, everyone else is forbidden to use a combination of strains whether they are or are not identical with the combinations that Bond selected and packaged together. It was this claim that, as I understand it, the District Court found not to be patentable, but which, if valid, had been infringed. . . . The consequences of such a conclusion call for its rejection. Its acceptance would require, for instance in the field of alloys, that if one discovered a particular mixture of metals, which when alloyed had some particular desirable properties, he could patent not merely this particular mixture but the idea of alloying metals for this purpose, and thus exclude everyone else from contriving some other combination of metals which, when alloyed, had the same desirable properties. In patenting an alloy, I assume that both the qualities of the product and its specific composition would need to be specified. The strains that Bond put together in the product which he patented can be specified only by the properties of the mixture.

The careless, improvident, and unnecessary resurrection of Funk Bros. in the Supreme Court's Myriad decision, indicating the Court's desire to re-impose its own jurisprudence over that developed by the Federal Circuit, thus bears fruit here. As noted by a former Solicitor General, the Federal Circuit spent 30 years "quietly walking away from" Supreme Court decisions it found to have been wrongly reasoned or decided, but the consequence of the correction is shown in this case, where such a decision is used in the broader context of subject matter eligibility to invalidate heretofore conventionally eligible claims.

It should also be noted that co-plaintiff in this case is the University of Pennsylvania, which along with the Biden administration's equally ill-considered effort to warp the march-in rights provisions of the Bayh-Dole Act into a basis for the government to set drug prices threatens to throw a spanner into the engine of innovation (at least for biotechnology and pharmaceuticals). The Twentieth Century gave us all an object lesson in governmental overreach in managing an economy and those whose inventive efforts provide the basis for real-world advances in technology, the economy, and citizens' lives. One would think (incorrectly, it would seem) that lesson having been learned the hard way would inform governmental actions in the Twenty-First century.

* The '617 patent had an earliest priority date of November 12, 2002 and thus expired on November 12, 2022.
USPTO Issues Guidance about Inventorship of AI-assisted Inventions

February 12, 2024

By Aaron Gin and Michael Borella –

On February 12, 2024, the U.S. Patent and Trademark Office released detailed guidance regarding inventorship of inventions created with the assistance of artificial intelligence (AI). The guidance, signed by Kathi Vidal, Under Secretary of Commerce for Intellectual Property and Director of the USPTO, is scheduled to be published in the Federal Register on February 13, 2024. The guidance focuses on how inventorship should be determined in U.S. patents and patent applications when AI, including generative AI, plays a role in the conception and/or reduction to practice of a given invention.

The 27-page document demonstrates the Patent Office's effort to navigate the challenges AI poses to traditional notions of inventorship and creativity, and comes in response to AI-specific requests for public comment, public listening sessions, and President Joe Biden's "Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence."

At the heart of the USPTO's guidance is the principle that AI systems, even when they have a role in facilitating or contributing to the creation of inventions, cannot themselves be named as inventors on patent applications. Instead, only natural persons—humans—are capable of inventing under U.S. law, consistent with Thaler v. Vidal, 43 F.4th 1207 (Fed. Cir. 2022). Thaler makes clear that "the AI system's contribution is not inventorship, even if the AI system's contributions were instrumental in the creation of the invention." Id.

Accordingly, the guidance firmly states that inventors as well as joint inventors named on U.S. patents and patent applications must be natural persons. Specifically, the guidance provides that "based on the holding in Thaler that an 'individual' must mean a natural person, it is clear that a 'joint inventor' or 'coinventor' must also be a natural person." Furthermore, patent applications that name a machine (e.g., an AI) on an Application Data Sheet, an inventor's oath or declaration, or a substitute statement as either an inventor or a joint inventor will be considered to have improper inventorship.

Interestingly, the guidance acknowledges that AI systems could perform acts that, if performed by a human, could constitute inventorship under existing U.S. patent law. Furthermore, in the scenario where an AI could otherwise be considered an inventor, the inability to list the AI as an inventor or joint inventor does not inherently render the invention unpatentable.

Detailed principles and examples are provided to assist in determining when a human's contribution to an AI-assisted invention is significant enough to warrant inventorship. Namely, the guidance reiterates the factors of Pannu v. Iolab Corp., 155 F.3d 1344 (Fed. Cir. 1998), which include that each inventor must:

(1) contribute in some significant manner to the conception of the invention;

(2) make a contribution to the claimed invention that is not insignificant in quality, when that contribution is measured against the dimension of the full invention; and

(3) do more than merely explain to the real inventors well-known concepts and/or the current state of the art.

The guidance also delves into the public policy of the U.S. patent system. Specifically, it outlines the importance of a human contribution in the innovation process, because "the patent system is designed to encourage human ingenuity," citing the IP Clause of the Constitution and the legislative history of the 1952 Patent Act ("Inventions eligible for patenting 'include anything under the sun made by man.'") Graham v. John Deere Co., 383 U.S. 1, 9 (1966).

The USPTO highlights some "guiding principles" in determining AI-assisted inventorship, which include:

(1) A natural person's use of an AI system in creating an AI-assisted invention does not negate the person's contributions as an inventor. Rather, the natural person can be listed as the inventor or joint inventor if the natural person contributes significantly to the AI-assisted invention;

(2) Merely recognizing a problem or having a general goal or research plan to pursue does not rise to the level of conception. A natural person who only presents a problem to an AI system may not be a proper inventor or joint inventor of an invention identified from the output of the AI system. However, a significant contribution could be shown by the way the person constructs the prompt in view of a specific problem to elicit a particular solution from the AI system;

(3) Reducing an invention to practice alone is not a significant contribution that rises to the level of inventorship. Therefore, a natural person who merely recognizes and appreciates the output of an AI system as an invention, particularly when the properties and utility of the output are apparent to those of ordinary skill, is not necessarily an inventor. However, a person who takes the output of an AI system and makes a significant contribution to the output to create an invention may be a proper inventor. Alternatively, in certain situations, a person who conducts a successful experiment using the AI system's output could demonstrate that the person provided a significant contribution to the invention even if that person is unable to establish conception until the invention has been reduced to practice;

(4) A natural person who develops an essential building block from which the claimed invention is derived may be considered to have provided a significant contribution to the conception of the claimed invention even though the person was not present for or a participant in each activity that led to the conception of the claimed invention. In some situations, the natural person(s) who designs, builds, or trains an AI system in view of a specific problem to elicit a particular solution could be an inventor, where the designing, building, or training of the AI system is a significant contribution to the invention created with the AI system; and

(5) Maintaining "intellectual domination" over an AI system does not, on its own, make a person an inventor of any inventions created through the use of the AI system. Therefore, a person simply owning or overseeing an AI system that is used in the creation of an invention, without providing a significant contribution to the conception of the invention, does not make that person an inventor.

The guidance applies to utility patents, plant patents, design patents, and corresponding applications.

The guidance also states that the duty of disclosure and the duty of reasonable inquiry both apply to the question of proper inventorship. This will incentivize inventors and their representatives to be forthcoming about the contributions that humans and/or AI systems may have had with respect to the conception of inventions. Moreover, the guidance notes that examiners and other USPTO employees may make requests for information regarding inventorship when such an individual "has a reasonable basis to conclude that one or more named inventors may not have contributed significantly to the claimed subject matter."

Nonetheless, further rounds of USPTO guidance may be released "as appropriate." These may discuss the impact of AI on other aspects of patent practice, including subject matter eligibility, obviousness, and enablement.

By emphasizing human contribution and providing specific principles and examples, the guidance gives the clearest picture yet available from the USPTO regarding its policies and practices at the intersection between AI and inventorship.

For additional information, please see:

• Unpublished Version of USPTO Inventorship Guidance
• Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence
United Therapeutics Corp. v. Liquidia Technologies, Inc. (Fed. Cir. 2023)

February 8, 2024

By Kevin E. Noonan –

One of the most notable consequences (intended or not, for good or ill) of the Leahy-Smith America Invents Act (AIA) has been the possibility (now likelihood, if only in frequency) that the decisions of the Patent Trial and Appeal Board and district courts will be different (typically to the detriment of patent holders). This outcome Is at least in part the result of differences in the burdens of proof between the two fora, specifically the preponderance of the evidence before the Board and the clear and convincing evidence in court. These circumstances have raised concerns (most notably by now-suspended, Federal Circuit Judge Pauline Newman) regarding the constitutional propriety of an Article I court being able to overrule an Article III court on separation of powers grounds (see "XY, LLC v. Trans Ova Generics, L.C. (Fed. Cir. 2018)"). Another example of such an outcome arose in the Federal Circuit's affirmance of the PTAB decision that the claims of an asserted patent that had already been held not invalid in litigation were invalidated by the Board, in United Therapeutics Corp. v. Liquidia Technologies, Inc.

The case arose in litigation between NDA holder United Therapeutics Corp. ("UTC") and Liquidia, who filed its own NDA (under § 505(b)(2) of the Food, Drug, and Cosmetic Act). Both regulatory approval applications were directed towards inhaled formulations of treprostinil for treating pulmonary hypertension (UTC's Tyvaso®, Liquidia's Yutrepia™). UTC asserted two Orange Book-listed patents, U.S. Patent Nos. 9,593,066 and 10,716,793 in the litigation. The District Court found that the '066 patent claims were invalid albeit infringed and are not at issue here. For the '793 patent, the District Court found the asserted claims not to be invalid and that Liquidia's competing product would infringe (having not yet obtained FDA approval), and enjoined Liquidia from marketing its version of the drug until after expiration of the '793 patent (expected on May 14, 2027). However the District Court noted that Liquidia had challenged the validity of the '793 patent in an ongoing IPR (No. IPR2021-00406) and that, should the PTAB hold the asserted claims of this patent to be invalid Liquidia would be able to seek having the injunction lifted (for further details, see "United Therapeutics Corp. v. Liquidia Technologies, Inc. (Fed. Cir. 2023)").

All claims of the '793 patent were challenged in the IPR, with claim 1 being representative:

1. A method of treating pulmonary hypertension comprising administering by inhalation to a human suffering from pulmonary hypertension a therapeutically effective single event dose of a formulation comprising treprostinil or a pharmaceutically acceptable salt thereof with an inhalation device, wherein the therapeutically effective single event dose comprises from 15 micrograms to 90 micrograms of treprostinil or a pharmaceutically acceptable salt thereof delivered in 1 to 3 breaths.

The opinion also sets forth relevant dependent claims 4, 6, and 7:

4. The method of claim 1, wherein the inhalation device is a dry powder inhaler.

6. The method of claim 4, wherein the formulation is a powder.

7. The method of claim 6, wherein the powder comprises particles less than 5 micrometers in diameter.

Liquidia's IPR petition asserted obviousness of all '793 claims based on U.S. Patent No. 6,521,212 ("the '212 patent") in combination with two scientific abstracts to Voswinckle (termed "JESC" and "JAHA"). The '212 patent described methods for delivering benzindene prostaglandins (of which treprostinil sodium is one) by inhalation to treat pulmonary hypertension, while the Voswinckle references described studies using various amounts of treprostinil (16, 32, 48, and 64 μg/mL) (JESC) and wherein patients in the study were administered the drug in three breaths (JAHA). UTC responded to Liquidia's obviousness allegation by challenging the status of the Voswinckle references as prior art. The basis for this assertion was that Liquidia had not established that the Voswinckle references were printed publications under pre-AIA 35 U.S.C. § 102(b). Liquidia relied upon the Voswinckle references having been stored in libraries but it had not (according to UTC) shown that "both [had] been available at the library and sufficiently indexed or categorized by priority date" (see In re Hall, 781 F.3d 897, 898–99 (Fed. Cir. 1986)). In rejecting this challenge, the Board noted that each of the Voswinckle references were presented at a public conference attended by 20,000 people (including "scientists, physicians, and nurses, as well as journalists") (emphasis in opinion). In addition, the Board recognized that the Voswinckle references were cited in other documents available to the public prior to the '793 priority date. On these bases the Board concluded that the combination of the Voswinckle references and the '212 patent rendered obvious the invention claimed in the '793 patent. The Board also held that the objective indicia asserted by UTC ("unexpected results, copying, and long-felt and unmet need") did not overcome their prima facie obviousness determination.

UTC petitioned for rehearing (including an appeal to the PTO's Precedential Opinion Panel) on the question of whether the Voswinckle references were prior art. While the Panel did not deign to review the decision, it did direct the Board to reconsider because in its judgment the Board had failed to determine whether the "other publications" (identified as "research aids") that purportedly disclosed the Voswinckle references had themselves had been available to the public before the critical date. In addition, the Panel determined that the Board had not "adequately addressed" whether the Voswinckle references "were publicly accessible by way of their presentation and/or inclusion in distributed materials, such as at a conference or library." The Board dutifully reconsidered the evidence and maintained its decision that the references were prior art. Admitting it had not recognized that the research aids had not been publicly available before the priority date, the Board nevertheless found that the Voswinckle references had been distributed at conferences prior to that date (including in an "abstract book" provided to attendees). Having dispensed with any deficiencies in its reasoning on this issue, the Board held the asserted claims of the '793 patent to be invalid for obviousness and UTC appealed.

The Federal Circuit affirmed in an opinion by Judge Lourie joined by Judges Prost and Reyna. With regard to the prior art status of the Voswinckle references, the Court first addressed whether the Board's analysis "improperly exceeded the prior art theories set forth in Liquidia's petition" under 35 U.S.C. § 312(a)(3) as interpreted by the Supreme Court in SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1357 (2018). UTC argued that the Board's reasoning regarding the prior art patency of the Voswinckle references that depended on their inclusion of the abstract books at conferences exceeded Liquidia's arguments in its petition. The panel held that Liquidia's position in its petition was that the Voswinckle references were prior art because they had been publicly disclosed, and that the Board properly found Liquidia's later arguments in its Reply to be timely under the statute because they were asserted "in direct response" to UTC's contrary arguments first raised in its Response. This reasoning was not an abuse of discretion, according to the panel, under inter alia Anacor Pharms., Inc. v. Iancu, 889 F.3d 1372, 1380–82 (Fed. Cir. 2018), because Liquidia's arguments in its Reply were not inconsistent with its position in its Petition (i.e., that the Voswinckle references were prior art under pre-AIA 35 U.S.C. § 102(b)).

The panel also agreed with the Board's substantive determination that the Voswinckle references were prior art. UTC argued that the Board's reasoning regarding the references was entirely "hypothetical" and only supported by "conclusory expert testimony." In this regard, the Court rejected UTC's assertion that "evidence of actual existence or dissemination" was required, saying this was "not the proper standard" (emphasis in brief). Rather, the opinion asserts that "[o]ur cases have consistently held that the standard for public accessibility is whether a person of ordinary skill in the art could, after exercising reasonable diligence, access a reference," citing Samsung Elecs. Co. v. Infobridge Pte. Ltd., 929 F.3d 1363, 1374 (Fed. Cir. 2019) (emphasis in brief). But once such public accessibility has been established "there is no requirement to show that particular members of the public actually received the information," according to the opinion citing Jazz Pharms., Inc. v. Amneal Pharms., LLC, 895 F.3d 1347, 1356 (Fed. Cir. 2018), quoting Constant v. Adv. Micro-Devices, Inc., 848 F.2d 1560, 1569 (Fed. Cir. 1988) (emphasis added). On this basis, the panel held that the Board relied on substantial evidence that the Voswinckle references were prior art.

Turning to the ultimate question of obvious for sole independent claim 1, the Court held that the Board had relied on substantial evidence in concluding that, while no one reference explicitly taught the recited administered range of a therapeutically effective single event dose that comprises from 15 micrograms to 90 micrograms of treprostinil, the skilled worker would have understood that the JESC reference disclosed solutions within this range. This reference taught administration of treprostinil in various concentrations (16, 32, 48, and 64 μg/mL) but did not disclose explicitly recited administered dosage volumes. However, according to the Federal Circuit the Board properly relied on expert testimony regarding such volumes (ranging from at least 1 mL and up to 5 mL of solution), which would deliver 16–80, 32–160, 48–240, or 64–320 μg, each of which contained a value falling within the dose recited in claim 1. The panel considered UTC's challenges to these calculations on technical grounds, finding that the Board had heard and rejected these same arguments. Accordingly, the panel accepted the Board's conclusions to be supported by substantial evidence on the obviousness question.

Regarding the objective indicia of non-obviousness, the panel found that the Board's rejection of UTC's arguments was also supported by substantial evidence (noting that UTC's assertions regarding unexpected results were included in "only a single paragraph in UTC's opening brief, [which] borders on waiver"). On the merits the Court held that UTC provided assertions but not evidence of any such unexpected results.

Finally, the Federal Circuit upheld the Board's obviousness determination of dependent claims 4, 6, and 7. UTC's arguments regarding these claims were that the recitation therein of dry power administration of treprostinil was a "separated invention" not disclosed in any of the asserted prior art references. Thus, UTC argued that the Board failed to explain how the ordinarily skilled worker would have had any reasonable expectation of success in administering treprostinil as a dry powder. The panel first held that UTC had waived this argument because it had not raised it (at least in this form) before the Board. And on the merits, the panel held that as with independent claim 1 the Board's decision on these dependent claims was supported by substantial evidence (including the unrebutted testimony of Liquidia's experts) and thus affirmed.

United Therapeutics Corp. v. Liquidia Technologies, Inc. (Fed. Cir. 2023)
Nonprecedential disposition
Panel: Circuit Judges Lourie, Prost, and Reyna
Opinion by Circuit Judge Lourie
FDA Approves Yet Another Interchangeable Biosimilar and Another Biosimilar

January 28, 2024

By Kevin E. Noonan –

On October 3, 2023, the U.S. Food and Drug Administration (FDA) announced approval of Biogen's Byooviz (ranibizumab-nuna) as an interchangeable biosimilar to Genentech's Lucentis (ranibizumab injection). The drug was approved for intravitreal injection for the following indications:

• Neovascular (Wet) Age-Related Macular Degeneration (AMD),
• Macular Edema Following Retinal Vein Occlusion (RVO), and
• Myopic Choroidal Neovascularization (mCNV).

Byooviz and Lucentis share administration route, dose (0.5 mg), and formulation (10 mg/mL). Byooviz had been previously approved as a biosimilar on September 20, 2021.

On December 6, 2023, the FDA approved Bio-Thera Solution's Avzivi (bevacizumab-tnjn) as a biosimilar to Genentech's Avastin (bevacizumab). This drug was approved for treatment of colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer. The biosimilar is available as 100 mg/4 mL (25 mg/mL) or 400 mg/16 mL (25 mg/mL) injections in a single-dose vial.

These approvals bring to 45 the number of approved biosimilar products of which seven are interchangeable.
Malvern Panalytical Inc. v. TA Instruments-Waters LLC (Fed. Cir. 2023)

January 25, 2024

By Kevin E. Noonan –

One of the characteristics of patent infringement litigation in the aftermath of the Supreme Court's decision in Markman v. Westview Instruments, Inc. (holding that claim construction was a matter of law to be reviewed de novo by the Federal Circuit; but see Teva Pharma. USA, Inc. v. Sandoz, Inc.) was that an inordinate proportion of claim construction decisions were overturned in whole or part. Those proclivities have been attenuated in the years following the Cybor v. FAS Technologies* opinion, but the Court's recent decision in Malvern Panalytical Inc. v. TA Instruments-Waters LLC is reminiscent of those bygone days of Federal Circuit preeminence.

The case arose in patent infringement litigation when Malvern sued Waters for infringement of U.S. Patent Nos. 8,827,549 and 8,827,549. The claims of each patent asserted by Malvern were directed to isothermal titration microcalorimeters, used to measure energy absorbed or released during chemical reactions between two compounds. The claimed microcalorimeters comprise an automatic pipette assembly 220 illustrated in the opinion by this diagram:

The limitation at issue was another component, the pipette guiding mechanism that guides the pipette assembly "between and into at least two positions of operation." Disclosed are two embodiments, one being "a pipette arm 520 that supports the pipette assembly 220, and an essentially vertical guide rod 530," illustrated by this Figure 5a:

The operation of this structure is described in the specification to be:

"The pipette arm 520 is moveably attached by a sleeve 540 to the guide rod 530, but its motion about the guide rod is restricted by a guide grove 550 in the guide rod 530 and a guide pin 560 that protrudes from the inner surface of the sleeve 540 and which fits into the guide groove 550" wherein the "movement of the pipette assembly 220 in the vertical direction is restricted to the angular positions of the positions of operation," and "rotational movement of the pipette assembly 220 between the angular positions only is permitted when the titration needle 260 is fully retracted from respective positions of operation."

The second embodiment of this claimed element is illustrated by this Figure 6:

In this embodiment, the guide groove in the guide rod 530 is replaced by a coaxial external guide sleeve 610 with corresponding guide paths 620 for the guide arm 520."

Claim 1 of the '549 patent and claim 9 of the '175 patent are set forth as representative:

1. A micro titration calorimetry system comprising:
    an automatic pipette assembly comprising a titration needle arranged to be inserted into a sample cell for supplying titrant, a syringe for supplying titrant to the titration needle, a stirring paddle for stirring fluid in the sample cell, and a stirring motor for rotating the stirring paddle, and
    a pipette guiding mechanism arranged to restrict the movement of the pipette assembly along safe paths to ensure that the titration needle cannot be damaged during movement thereof between different positions of operation.

9. A micro titration calorimetry system comprising:
    an automatic pipette assembly comprising a titration needle arranged to be inserted into a sample cell for supplying titrant, a syringe for supplying titrant to the titration needle, a stirring paddle for stirring fluid in the sample cell, and a stirring motor
    for rotating the stirring paddle, and
    a pipette guiding mechanism arranged to guide the pipette assembly between and into at least two positions of operation, wherein a first position of operation is a pipette washing position wherein the titration needle is inserted in a washing apparatus, and a second position of operation is a titration position wherein the titration needle is inserted into the sample cell for calorimetric measurements.

The opinion states as being "relevant to this appeal" prosecution of an unrelated patent, U.S. Patent No. 9,103,782 owned by Malvern. In that case, applicants were able to overcome an anticipation rejection over U.S. Patent Application Publication No. 2010/0238968 based on common ownership. Also relevant was a supplemental examination request under 35 U.S.C. § 257 that Malvern filed upon acquisition of the '175 patent. As part of that effort, Malvern filed an Information Disclosure Statement including references cited against the '782 patent, including the '968 application (although as noted in the opinion Malvern did not characterize the references). During supplemental examination, the Examiner cited an owner's manual for a prior art microcalorimeter disclosing a manually operated pipette guiding mechanism, which Malvern overcame by affidavit that this manual was the inventors' own work.

Turning to claim construction, the opinion recites the parties' proposed constructions of the term "pipette guiding mechanism," wherein Malvern argued the term meant a "mechanism that guides the pipette assembly," while Waters argued that it should mean a "mechanism that manually guides the pipette assembly"; the District Court adopted Waters' construction. In ruling on this decision, the District Court characterized the phrase "pipette guiding mechanism" to be a "coined term" that required an examination of the intrinsic evidence to determine the "objective boundaries to the scope of the term," citing Iridescent Networks, Inc. v. AT&T Mobility, LLC, 933 F.3d 1345, 1353 (Fed. Cir. 2019). In doing so, the District Court relied on statements on the meaning of the term made during prosecution of the '782 patent and that applicants had limited the meaning of the term to manual embodiments. These arguments were attributed to Malvern as the common assignee of the '782, '549, and '175 patents and because statements made during prosecution of the '782 patent were incorporated into the intrinsic record during supplemental examination. The parties consented to a stipulated judgment of infringement based on the disputed claim construction and this appeal followed.

The Federal Circuit vacated the stipulated judgment in an opinion by Judge Prost, joined by Judges Hughes and Cunningham. The panel agreed with Malvern that the term "pipette guiding mechanism" encompassed both manual and automated embodiments based on the intrinsic evidence, specifically the plain meaning of the claims, the specification, and the prosecution history. Regarding the claim language, the panel considered the plain meaning of the words individually, citing Littelfuse, Inc. v. Mersen USA EP Corp., 29 F.4th 1376, 1381 (Fed. Cir. 2022), and 3M Innovative Props. Co. v. Tredegar Corp., 725 F.3d 1315, 1329 (Fed. Cir. 2013), and found no basis for limiting the pipette guide mechanism to only manual embodiments ("Instead, the broad claim language supports the conclusion that the 'pipette guiding mechanism' encompasses both manual and automatic embodiments.") Interpreting the claim broadly is consistent, in the panel's view, with how the Court construed the claims in Hill-Rom Services, Inc. v. Stryker Corp., 755 F.3d 1367 (Fed. Cir. 2014), wherein broad claim language supported broad claim interpretation. And the Court found that the remaining language of the claims similarly supported this interpretation. According to the opinion, while "[t]he claims clarify and restrict what the guiding mechanism does, . . . they provide no language suggesting the restriction to manual embodiments Waters advocates."

The specification supports this interpretation according to the Court, based on disclosure of two embodiments neither of which is limited to manual pipette guiding mechanisms. "In fact," the Court says, "the specification states nothing about whether the guiding mechanism is manual or automatic," and cites Hill-Rom Services, Inc. v. Stryker Corp., 755 F.3d 1367, 1373 (Fed. Cir. 2014), for the principle that "[t]here are no magic words that must be used, but to deviate from the plain and ordinary meaning of a claim term to one of skill in the art, the patentee must, with some language, indicate a clear intent to do so in the patent" and, as in Hill-Rom, "there is no such language here." The Court dismissed Waters' arguments to the contrary because they were based on portions of the disclosure that "say nothing about whether the guiding mechanism is manually or automatically operated." Nor was the Court persuaded by the fact that other components were described as automatic (and thus not describing the pipette guiding mechanism as being automatic implied the term should be limited to manual embodiments).

Finally, regarding the prosecution history, the Court was not persuaded to Waters' construction by the supplemental examination of the '175 patent, wherein the inventors testified that a manual for a prior art microcalorimeter comprising a manual pipette guide mechanism was their own work and thus not prior art. Waters argued that this testimony should be interpreted to mean the claimed microcalorimeters of the '175 patent were themselves limited to manual embodiments of the pipette guide mechanisms. (In a footnote the panel explains that they found the statements to be "too vague or ambiguous to qualify as a disavowal of claim scope.")

Turning to the "coined term" issue which provided one basis for the district court's decision, the opinion notes the District Court's reliance on Indacon, Inc. v. Facebook, Inc., 824 F.3d 1352, 1357–58 (Fed. Cir. 2016), in construing the claims. While recognizing that their Indacon decision involved the question of construing a claim that did not have an established meaning in the art, the panel maintained that what the District Court had needed to do was "answer the question of what plain and ordinary meaning a term has in the context of a patent," which the District Court here did not do, in the Federal Circuit's opinion.

Finally, the panel considered what weight (if any) to give the prosecution history of the '782 patent. The Court concluded that the '782 prosecution was not relevant to claim construction of the '175 and '549 patents-in-suit merely because that history had been submitted in an IDS during the supplemental examination of the '175 patent. The Court relied on its precedent in Goldenberg v. Cytogen, Inc., 373 F.3d 1158, 1167 (Fed. Cir. 2004), that "[i]n the absence of an incorporation into the intrinsic evidence, this court's precedent takes a narrow view on when a related patent or its prosecution history is available to construe the claims of a patent at issue and draws a distinct line between patents that have a familial relationship and those that do not." And the opinion further asserts that citing the prosecution history in an IDS is at most an admission that "'references in the disclosure may be material to prosecution of the pending claims,' but [] "does not admit materiality," citing Abbott Labs. v. Baxter Pharm. Prods., Inc., 334 F.3d 1274, 1279 (Fed. Cir. 2003) (emphasis added). The Court concluded here that there was no such admission by Malvern's "bare listing" of the IDS. And even if considered to be so, the opinion further states that this disclosure was insufficient to amount to disclaimer of automatic pipette guiding mechanisms, because the applicant of the '782 patent had abandoned arguments having to do with scope of claims reciting pipette guiding mechanisms. Reaching this conclusion was supported by their decision in Ecolab, Inc. v. FMC Corp., 569 F.3d 1335, 1343 (Fed. Cir. 2009), in the Court' view.

For these reasons the panel vacated the District Court's claim construction and remanded, where questions of infringement and claim invalidity will be assessed under the Federal Circuit's construction of the "pipette guiding mechanism" term. The Court also awarded costs to Malvern.

* In his dissent from this en banc decision upon which de novo review of claim construction by the Federal Circuit was established until partially overturned by the Supreme Court in Teva Pharma v. Sandoz, Judge Rader cited statistics that in 1997, the Federal Circuit reversed 53% of the cases decided (27% reversed completely, 26% reversed in part) and for 246 cases decided by the Federal Circuit after Markman, 141 explicitly reviewed the District Court's claim construction, and reversed, in whole or part, in 54 of these cases (about 38%). He identified eight problem areas caused by Markman: multiple trials, bias towards summary judgment, new evidence, the "learning curve problem," and a propensity for every decision to be appealed to the CAFC for de novo review.

Malvern Panalytical Inc. v. TA Instruments-Waters LLC (Fed. Cir. 2023)
Panel: Circuit Judges Prosy, Hughes, and Cunningham
Opinion by Circuit Judge Prost
USPTO Contributes Patent and Trademark Data to Help Launch National AI Research Resource Pilot Program

January 25, 2024

By Aaron Gin —

This week, the U.S. National Science Foundation (NSF) alongside public and private sector collaborators launched the National Artificial Intelligence Research Resource (NAIRR) pilot program. NAIRR seeks to advance AI discovery and innovation by making resources available from 11 different federal agencies and over 25 private companies. The pilot program was formed as a direct reaction to President Biden's 2023 AI Executive Order (specifically section 5.2(a)(i)) and targets several of the EO's broad topics including "Ensuring Responsible and Effective Government Use of AI" and "Promoting Innovation and Competition."

With an estimated six-year budget of $2.6 billion, NAIRR seeks to provide researchers with access to AI-relevant data and compute resources, which are being made available by agencies including the NSF, Defense Advanced Research Projects Agency (DARPA), National Aeronautics and Space Administration (NASA), National Institutes of Health (NIH), and National Institute of Standards and Technology (NIST) to name a few.

The contribution of the U.S. Patent and Trademark Office (USPTO) is expected to include provision of its "bulk datasets," which include U.S. patents and trademarks in a structured format. Such data offers a "rich and diverse" dataset of complex language, which may be used for the development of robust language models. The USPTO is also making available "research datasets," which include patent and trademark information relating more generally to "intellectual property, entrepreneurship, and innovation topics." The datasets and related documentation is specifically formatted for academic researchers. The patent and trademark information is provided for NAIRR users in a variety of different formats, including the official gazette, multi-page PDFs, full text/XML version, and others.

Kathi Vidal, Under Secretary of Commerce for Intellectual Property and Director, USPTO commented with respect to the NAIRR Pilot: "The USPTO is committed to advancing US innovation including AI innovation and AI-assisted innovation. We are focused on maximizing AI's benefits and distributing them broadly across society, confining the risks through technical mitigations and human governance and empowering a diversity of individuals and organizations to participate in AI innovation."

Broadly speaking, the information and resources provided by the USPTO through the NAIRR pilot program may help democratize access to AI resources and assist researchers in areas related to intellectual property, data governance, and patent data.

For additional information, please see:

• NSF NAIRR Pilot News Release
• NAIRR Pilot
Top Four Stories of 2023

January 21, 2024

By Donald Zuhn –-

After reflecting upon the events of the past twelve months, Patent Docs presents its 17th annual list of top patent stories. For 2023, we identified ten stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and applicants. On Monday and Wednesday last week, we counted down stories #10 to #8 and stories #7 to #5, and today we count down the top four stories of 2023. As with our other lists (2022, 2021, 2020, 2019, 2018, 2017, 2016, 2015, 2014, 2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look. As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know. In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2023" on January 23, 2024 from 10:00 am to 11:15 am (CT). Details regarding the webinar, which will focus on a few of the most important stories on this year's list, can be found here.

4. Federal Circuit Decides In re Cellect

At the end of August, in In re Cellect, the Federal Circuit decided a question left open during a recent spate of opinions involving the judicially created doctrine of obviousness-type double patenting (ODP): the effect patent term adjustment (PTA) can (or should) have on creating circumstances where ODP will operate to find a patent invalid in the absence of a timely filed terminal disclaimer. The Patent Trial and Appeal Board had issued four Decisions affirming the USPTO reexamination division's invalidation of four Cellect patents, all on the grounds that the provisions of 35 U.S.C. § 154(b)(2)(B) mandated that a terminal disclaimer be filed under circumstances where ODP arose due to extension of patent term as PTA, i.e., that ODP must be determined after application of PTA. The Federal Circuit affirmed the Board's judgment in the re-examinations. As we noted at the time of the decision, there are stratagems existing and to be developed to adapt to the regime established by the Federal Circuit's decision in In re Cellect, which only reinforces the value of the clever draftsman in protecting important technologies under creative applications of the law as the Federal Circuit construed it in In re Cellect.

(On Friday, the Federal Circuit issued an Order denying Cellect's petition for rehearing en banc.)

For information regarding this and other related topics, please see:

• "In re Institut Pasteur (Fed. Cir. 2023)," December 13, 2023
• "Overcoming the Consequences of In re Cellect," October 5, 2023
• "In re Cellect (Fed. Cir. 2023)," August 30, 2023

3. Unified Patent Court Agreement Enters into Force

The Unitary Patent (UP) and Unified Patent Court (UPC) finally arrived in 2023, with the Agreement on a Unified Patent Court (UPCA) coming into force on June 1. Unitary Patents confer uniform patent protection in participating EU member states (i.e., EU member states that have ratified the UPCA), of which there are currently seventeen: Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Portugal, Slovenia, and Sweden. The UPC is a supranational court where proprietors of Unitary Patents and certain European patents (i.e., those that have not been opted out of the UPC) can seek enforcement and third parties can seek revocation of patents in the above EU member states. Prior to the entry into force of the UPCA, proprietors and applicants were able to file requests to opt out of the UPC for European patents that had already granted and European applications that had published. These requests could be filed beginning on March 1, 2023 during the UPC Sunrise Period. The three-month Sunrise Period was a busy time for proprietors, applicants, and representatives as opt out decisions needed to be made, and in many cases opt out requests had to be filed. Moving forward, proprietors, applicants, and representatives will have to continue to make opt out decisions (at least during the seven year transitional period, which may be extended further) and decide whether to request unitary effect for newly granted European patents.

For information regarding this and other related topics, please see:

• "UPC Postpones Start of Sunrise Period to March 1, 2023," December 12, 2022

2. Supreme Court Decides Amgen v. Sanofi — Maintains Status Quo on Enablement

In May, The Supreme Court handed down its decision in Amgen v. Sanofi, affirming the Federal Circuit's decision below in a unanimous opinion written by Justice Gorsuch. The opinion relies heavily on its own precedent that was heavily cited by both parties in their briefs and arguments, including O'Reilly v. Morse, 15 How. 62; The Incandescent Lamp Patent, 159 U. S. 465; and Holland Furniture Co. v. Perkins Glue Co., 277 U. S. 245. In the Court's view, the statute plainly requires that "[i]f 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." The Court does state, however, that "[a]ll this is not to say a specification always must describe with particularity how to make and use every single embodiment within a claimed class." But the enablement requirement specifies, for example, that the specification discloses "some general quality . . . running through" the class that gives it "a peculiar fitness for the particular purpose," as in Incandescent Lamp, and situations where there is some adaptation or testing is needed does not make the disclosure "necessarily inadequate," as in Wood v. Underhill, 5 How. 1, 4– 5. Under Minerals Separation, Ltd. v. Hyde, 242 U. S. 261, 270–271, the opinion states that "[a] specification may call for a reasonable amount of experimentation to make and use a claimed invention, and reasonableness in any case will depend on the nature of the invention and the underlying art."

For information regarding this and other related topics, please see:

• "In the Wake of the Supreme Court's Amgen v. Sanofi decision: What’s Next for Biotechnology Claims?" October 2, 2023
• "Baxalta Inc. v. Genentech, Inc. (Fed. Cir. 2023)," September 24, 2023
• "Medytox, Inc. v. Galderma S.A. (Fed. Cir. 2023)," July 9, 2023
• "Supreme Court Decides Amgen v. Sanofi; Status Quo Extended," May 18, 2023
• "Amicus Briefing in Amgen v. Sanofi: The Rest of the Story – Part III," May 14, 2023
• "Amicus Briefing in Amgen v. Sanofi: The Rest of the Story – Part II," May 11, 2023
• "Amicus Briefing in Amgen v. Sanofi: The Rest of the Story," May 8, 2023
• "The Supreme Court Grapples with Patent Enablement," April 3, 2023
• "Esteemed Scientists File Amicus Brief in Amgen v. Sanofi on Respondents' Behalf," March 29, 2023
• "Another Group of Law Professors File Amicus Brief in Amgen v. Sanofi," March 27, 2023
• "U.S. Government Files Amicus Brief in Amgen v. Sanofi," March 26, 2023
• "AbbVie Files Amicus Brief in Amgen v. Sanofi," March 21, 2023
• "GlaxoSmithKline Files Amicus Brief in Amgen v. Sanofi," March 19, 2023
• "Patent Law Academics File Amicus Brief in Amgen v. Sanofi," March 14, 2023
• "Amgen Files Reply Brief in Amgen v. Sanofi," March 12, 2023
• "Sanofi and Regeneron File Respondents' Brief on Amgen v. Sanofi," February 19, 2023
• "Amgen Files Its Principal Brief in Amgen v. Sanofi," February 5, 2023

1. Legal and Patent Communities (Along with Everyone Else) Navigate Rapid Advancements in Artificial Intelligence

The 2023 story of the year — and not just in patent law or even in the law in general, but in almost every industry and sector of the economy — was the rise of Artificial Intelligence (AI). Numerous publications have tabbed AI as the top story of 2023, so Patent Docs joins quite a large group. In patent law, practitioners investigated how large language models like OpenAI's ChatGPT can impact patent prosecution in the near future. And in February, the U.S. Patent and Trademark Office published a Federal Register notice requesting public comments regarding the current state of AI and Emerging Technologies (ET), and associated inventorship issues that may arise with the advance of such technologies. The latter request concerned a request from Dr. Stephen Thaler, a computer scientist and inventor, that the Supreme Court consider the question of whether the Patent Act restricts the definition of an "inventor" to human beings.

With regard to the impact of AI in the law in general, a New York personal injury case rocketed into infamy in 2023, when two lawyers filed a brief in the Southern District of New York that had been written at least in part by ChatGPT. After opposing counsel and the judge determined that the brief cited to case law that did not exist and the quotes from these fictitious cases were fabrications by ChatGPT, the court imposed sanctions under Rule 11 for purposes of deterrence. Perhaps in response to this case, we reported on a number of judges who issued standing orders last year on how AI can and cannot be used in proceedings before them.

In other AI developments, President Biden signed an executive order in October governing the development, testing, and use of AI. Formally titled, "Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence," the order sets forth guiding principles and actions to be taken by federal agencies. These actions include research, coordination with industry, academia, and the international community, promulgation of regulations, publication of reference materials, and establishment of a White House Artificial Intelligence Council to assist the administration with all of the above. And in December, after two-and-a-half years of negotiation, the European Parliament and the European Council reached a provisional understanding of how AI should be regulated within the European Union (EU). The goal is to promote the investment in and use of safe AI that honors fundamental human rights.

For information regarding this and other related topics, please see:

• "European Union Agrees to Terms of Artificial Intelligence Act," December 10, 2023
• "College Football's Latest Controversy: NCAA IP-Like "Sign Stealing" Rules Not Ready for Big Data or AI," November 24, 2023
• "An Analogy for the Current Wave of AI Copyright Lawsuits," November 12, 2023
• "Early Responses to Proposed AI Regulation," November 5, 2023
• "Biden Administration Signs Executive Order on Artificial Intelligence," October 31, 2023
• "Judges Issue Standing Orders Regarding the Use of Artificial Intelligence," August 13, 2023
• "The Quest for an 'Artificial Intelligence' Inventor," May 23, 2023
• "ChatGPT Throws Wrench into Europe's Attempts to Regulate AI," April 30, 2023
• "The Copyright Office Issues Guidance Regarding Works Produced by Generative AI," April 16, 2023
• "Will Artificial Intelligence Force Us to be Less Dumb about How We Evaluate Humans?" April 9, 2023
• "Petition for Writ of Certiorari filed in DABUS AI-as-Inventor Case," April 6, 2023
• "The AI-Assisted Patent Attorney," February 27, 2023
• "USPTO Requests Public Comments on Artificial Intelligence and Inventorship," February 14, 2023
• "Can ChatGPT Draft Patent Applications?" February 6, 2023
• "The Existence of ChatGPT Does Not Justify Attempts to Equate Human and Machine Cognition," January 11, 2023
Top Stories of 2023: #5 to #7

January 17, 2024

By Donald Zuhn –-

After reflecting upon the events of the past twelve months, Patent Docs presents its 17th annual list of top patent stories. For 2023, we identified ten stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and applicants. On Monday, we counted down stories #10 to #8, and today we count down stories #7 to #5, as we work our way towards the top four stories of 2023. As with our other lists (2022, 2021, 2020, 2019, 2018, 2017, 2016, 2015, 2014, 2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look. As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know. In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2023" on January 23, 2024 from 10:00 am to 11:15 am (CT). Details regarding the webinar, which will focus on a few of the most important stories on this year's list, can be found here.

7. University of California/Berkeley Appeals PTAB Ruling in CRISPR Interference; FDA Approves CRISPR Gene Editing Treatment

In December 2022, the Patent Trial and Appeal Board rendered its decision on Preliminary Motions in Interference No. 106,133 between Senior Party Sigma-Aldrich and Junior Party The Broad Institute, Harvard University, and MIT (collectively, "Broad"). As with the priority phase in co-pending Interference Nos. 106,126, No. 106,127, and No. 106,132, the Board suspended the priority phase in Interference No. 106,133 until the appeal in Interference No. 106,115 has been decided by the Federal Circuit. 2022 and 2023 saw briefing in that appeal.

Meanwhile, the significance of the final outcome in the CRISPR interferences was demonstrated last fall, when the U.S. Food and Drug Administration's Cellular, Tissue, and Gene Therapies Advisory Committee announced on October 27 that exagamglogene autotemcel (exa-cel), which was the subject of biologics license application (BLA) 125787 from Vertex Pharmaceuticals, Inc. in collaboration with CRISPR Therapeutics (Zug, Switzerland) and provides for the first time gene therapy for sickle cell anemia, was shown to be effective, having 29 of 30 patients stay pain-free for 18 months. On October 31, the Advisory Committee issued its recommendation that exa-cel is safe for clinical use, and the FDA then approved the treatment on December 8. The treatment, being marketed as CASGEVY, is the first CRISPR-based gene-editing therapy to be approved in the U.S.

For information regarding this and other related topics, please see:

• "FDA Signals Willingness to Approve CRISPR-Based Treatment for Sickle Cell Anemia," November 2, 2023
• "Broad Files Reply Brief in Interference No. 106,115 Cross-Appeal," September 7, 2023
• "CVC Files Response and Reply Brief in Interference No. 106,115 Appeal," August 27, 2023
• "Amici Support Reversal of PTAB Decision in CRISPR Interference," July 25, 2023
• "Broad Files Opening Brief and Cross-Appeal in CRISPR Interference," July 23, 2023
• "CVC Appeals PTAB Decision in CRISPR Interference," July 12, 2023
• "PTAB Rules on Preliminary Motions in Interference No. 106,133," January 22, 2023

6. Judicial Council of Federal Circuit Suspends Judge Newman

Efforts to have Judge Pauline Newman, Circuit Judge on the Court of Appeals for the Federal Circuit, removed from the Federal Circuit for being unfit or guilty of misconduct were the subject of several reports in mid-2023. In September, the Judicial Council of the Federal Circuit ordered Judge Newman to be suspended from the court for one year. The Judicial Council's Order repeated allegations made previously against Judge Newman, supplemented with 16 (sometimes) heavily redacted Exhibits and notations and other supporting exhibits that were redacted in their entirety for confidentiality purposes. The arguments and supporting exhibits were apparently provided to justify the grounds for the decision, which were Judge Newman's purported refusal to cooperate with the Special Committee's investigation into her competency (despite the Judge having provided medical and psychological results from her own doctors rather than the Committee's hand-picked ones). The suspension remains subject to Judge Newman's on-going lawsuit in the D.C. District Court asserting that the Council's suspension is unconstitutional and a violation of Judge Newman's due process rights.

For information regarding this and other related topics, please see:

• "Judge Newman Suspended for One Year by Federal Circuit," September 20, 2023
• "Federal Circuit Special Committee Recommends One-Year Suspension of Judge Newman," August 6, 2023
• "Federal Circuit Special Committee Responds to Judge Newman's Counsel's Request for Clarification Regarding Misconduct Hearing," June 21, 2023
• "Judge Newman Matter Continues," June 20, 2023
• "Judge Newman and the On-Going Attempts to Remove Her from the Federal Circuit," May 21, 2023

5. Supreme Court Denies CareDx Petition; Senators Coon & Tillis Try to Fix Patent Eligibility (Again)

In May, CareDx and Stanford University filed a petition for certiorari in CareDX, Inc. v. Natera, Inc. and CareDx, Inc. v. Eurofins Viracor, Inc. At the time, we noted that the arguments in the petition threaded a very narrow needle in giving the Court a reason to grant certiorari and emphasize (as has been emphasized before) the need to do so. In particular, the petition directed the Court's attention to the "heav[y] investment CareDx made in bringing this technology to market" and infringing behavior of both Natera and Eurofin in bringing their own "copycat" products to market. Those hoping for a certiorari grant (and positive outcome), however, were frustrated (yet again) when the Court denied the patentees' petition in October.

Given the refusal of the Supreme Court to wade back into the subject matter eligibility waters, Senators Coons and Tillis, who chaired a series of Congressional hearings on patent eligibility in 2019, who have asked the U.S. Patent and Trademark Office for its statistics and other information on patent eligibility, and who have proposed several bills providing various iterations of legislative solutions, proposed their latest attempt to provide a legislative solution in June when they introduced "The Patent Eligibility Restoration Act of 2023." As we noted at the time, this proposal marks the third time that one or both of the Senators have proposed or introduced a bill to revise § 101. The first two attempts garnered discussion but little tangible progress, leaving the patent community feeling like Charlie Brown repeatedly getting the football yanked away.

In one bit of good news on the subject matter eligibility front, the storied case of American Axle v. Neapco Holdings entered a new chapter in July — not the final chapter, but the plot thickened considerably. We provided a recap at the time, noting that Judge Stark, then of the District Court for the District of Delaware, had found all asserted claims of U.S. Patent No. 7,774,911 invalid under 35 U.S.C. § 101 as being directed to a law of nature implemented by well-understood, routine, and conventional means, a decision that was affirmed by the Federal Circuit, with the majority subsequently withdrawing its original opinion and handing down a revised opinion (finding claim 22 still ineligible but vacating and remanding the District Court's decision on claim 1) in response to a petition for en banc rehearing, and the Supreme ultimately denying American Axle's petition for certiorari. On remand, Judge Williams (who had taken on the case given Judge Stark's promotion to the Federal Circuit), denied Neapco's motion for summary judgment of invalidity pursuant to § 101 and granted American Axle's motion for summary judgment of no invalidity.

For information regarding this and other related topics, please see:

• "American Axle's Claims Found Eligible on Remand," August 1, 2023
• "Senators Tillis and Coons Once More Attempt to Fix Patent Eligibility," June 25, 2023
• "Senate Bill Proposed to Provide Subject Matter Eligibility Solution," June 22, 2023
• "Can Judge Michel and John Duffy Convince the Supreme Court to Revisit Subject Matter Eligibility?" May 31, 2023
• "Stanford Asks Supreme Court to Revisit Subject Matter Eligibility on Diagnostic Claims," May 3, 2023
• "Sequoia Technology LLC v. Dell Inc. (Fed. Cir. 2023)," April 23, 2023
• "On Alice Rejections per USPTO Technical Center," March 6, 2023
• "ITC Takes Section 101 to Its Illogical Extreme," March 1, 2023
• "Chromadex, Inc. v. Elysium Health, Inc. (Fed. Cir. 2023)," February 15, 2023
• "PTAB Remains Hostile to Section 101 Appeals," January 31, 2023
• "The Mental Process Exception to Patent Eligibility is Remarkably Brainless," January 9, 2023
USPTO Further Transitions to DOCX Format

January 16, 2024

By Donald Zuhn —

In an email News Brief distributed today, the U.S. Patent and Trademark Office reminded stakeholders that starting at 12:01 am (ET) on January 17, the filing of new, non-provisional utility patent applications with specification, claims, and abstract in a non-DOCX filing format will incur a surcharge of up to $400. The Office noted that an Applicant will still have the option of providing a backup (or auxiliary) PDF version of a newly filed application with the DOCX version, and that there would be no fee associated with providing the backup PDF.

The Office indicated that the transition to the DOCX format is intended "to modernize [the Office's] patent application systems to improve user experience, provide applicants a more streamlined process, harmonize across country borders, and strengthen [the Office's] ability to examine applications quickly and effectively." The Office stated that it had "worked carefully with stakeholders to shape both the transition to DOCX as well as the timing," and that the Office's systems will "provide[] pre-prosecution checks that improve the robustness and reliability of patents."

Further information regarding the DOCX format can be found on the Office's DOCX webpage, and a video explaining "How to file your patent application documents in DOCX" can be found here. Questions regarding DOCX filing can be directed to the Patent Electronic Business Center at ebc@uspto.gov or 866-217-9197.
Top Stories of 2023: #8 to #10

January 15, 2024

By Donald Zuhn –-

After reflecting upon the events of the past twelve months, Patent Docs presents its 17th annual list of top patent stories. For 2023, we identified ten stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and applicants. Today, we count down stories #10 to #8, and later this week we will count down the remaining top stories of 2023. As with our other lists (2022, 2021, 2020, 2019, 2018, 2017, 2016, 2015, 2014, 2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look. As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know. In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2023" on January 23, 2024 from 10:00 am to 11:15 am (CT). Details regarding the webinar, which will focus on a few of the most important stories on this year's list, can be found here.

10. Debate on Expansion of COVID Waiver Continues; WHO Releases Draft Agreement on Pandemic Prevention, Preparedness, and Response

The year began with the World Health Organization (WHO) releasing a draft agreement on pandemic prevention, preparedness, and response in February for consideration by the Intergovernmental Negotiating Body (INB), which is comprised of the 194 Member States of the WHO, and which was established in December 2021 at a special session of the WHO's World Health Assembly to draft and negotiate an agreement to strengthen global pandemic prevention, preparedness, and response. The draft includes a 49-clause preamble, with at least ten of the clauses concerning intellectual property. The agreement is expected to be agreed upon by the World Health Assembly in 2024.

And the year ended with the International Trade Commission (ITC) issuing a Report, in response to a request by the U.S. Trade Representative, Ambassador Katherine Tai, in anticipation of negotiations over expansion of the World Trade Organization (WTO) IP waiver that applies to COVID-19 vaccines (but not yet to COVID-19 diagnostics and therapeutic drugs). The mandate from the Trade Representative was that the ITC Report be a product of market and other research within the Commission's expertise and also reflect the views of stakeholders and the public, and that the Report would not have as a goal to "draw any policy conclusions." Despite not drawing any policy conclusions, however, the ITC Report has renewed discussions in some quarters over expansion of the COVID-19 waiver, the deadline of which was extended indefinitely in December 2022 (see "Nine Countries Seek Extension of WTO Waiver to COVID-19 Therapeutics and Diagnostics" and "Top Four Stories of 2022").

For information regarding this and other related topics, please see:

• "International Trade Commission Issues Report of COVID-19 IP Waiver," November 8, 2023
• ""Zero Draft" of WHO CA+ Released," February 7, 2023

9. Supreme Court Declines to Hear Teva Pharmaceuticals v. GlaxoSmithKline

In May, the Supreme Court declined to grant certiorari in Teva Pharmaceuticals USA v. GlaxoSmithKline LLC, disregarding the views of the Solicitor General regarding whether to grant cert. Perhaps the Justices felt that the Federal Circuit's backtracking in its second panel decision on the breadth of infringement inducement set forth in its first decision, in light of then Chief Judge Prost's strong dissent and the firestorm of protest (public and through amicus briefing regarding Teva's petition for rehearing), was enough to cabin the decision to the somewhat unique facts in the case. The petition for cert. involved the Federal Circuit's decisions in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2020) and GlaxoSmithKline LLC v. Teva Pharmaceuticals USA (Fed. Cir. 2021), in both of which former Chief Judge Prost issued strong dissents, and which concerned whether a generic applicant filing a "skinny label" ANDA could properly be found liable for inducing infringement under 35 U.S.C. § 271(b). The Court issued an Order to the Solicitor General soliciting the government's views and that brief advocated that the Court grant cert.

For information regarding this and other related topics, please see:

• "H. Lundbeck A/S v. Lupin Ltd. (Fed. Cir. 2023)*," December 18, 2023
• "Solicitor General Files Brief Advocating Certiorari Grant in Teva Pharmaceuticals v. GlaxoSmithKline; Court Declines Invitation," May 15, 2023

8. Patent Law under Attack (Again)

The New York Times is (in)famous in this space for its attacks on the patent system (see "Top Stories of 2022: #8 to #10"; #9. New York Times Reopens Attack on U.S. Patent System). And last year at this time, the Times was at it again in a front page piece on Humira, a drug used for a variety of ailments that has brought relief to millions of patients who otherwise suffered with earlier, less effective drugs. The "problem" seems to be that Humira has made a pharma company a lot of money (purportedly $116 billion), that the drug is expensive (said to cost upwards of $50,000/year) and that the drug company has amassed a large number of patents to protect its intellectual property. But as we noted in response to the Times article, the bigger problem is that the Times failed to recognize several important facts relating to the circumstances under which Humira's makers made this money and amassed its patent estate (or "thicket" as the anti-patent crowd likes to call it).

In May, the U.S. Senate's Health, Education, Labor & Pensions (HELP) Committee passed out of committee five bills that attempted to address high drug prices: the Ensuring Timely Access to Generics Act of 2023 (S. 1067); the Expanding Access to Low-Cost Generics Act of 2023 (S. 1114); the Retaining Access and Restoring Exclusivity Act (S. 1214); and the Increasing Transparency in Generic Drug Applications Act (S. 775). And in September, a letter from 25 scholars, former judges, and former government officials sent to the Senate Health, Education, Labor and Pensions Committee, the Chair and Ranking Member of the House Ways and Means Committee, and the Secretary of Health and Human Services, Xavier Becerra, intended to "correct[] false claims that the federal government can use [the "march-in rights" provisions of] the Bayh-Dole Act . . . to impose price controls on prescription drugs."

Attacks on the patent system are not confined to an asserted impact of patents on drug pricing, however. Some attacking the patent system are also opposed to software patents, with such opposition seemingly being based on one or more of the false assumptions that all software patents are too broad, that it is obvious to invent software based processes, programming is an administrative activity that does not warrant patent protection, or that the patent system should not protect non-physical inventions. As we noted in July, none of these positions have any legal or technical credibility.

For information regarding this and other related topics, please see:

• "Patent Luminaries Try to Set Congress Straight on Drug Price Controls," September 26, 2023
• "FTC Announces Efforts to Police Pharmaceutical Companies' Patent Behavior," September 19, 2023
• "Drugs May Cost Too Much, But Patents Are Not the Cause," July 18, 2023
• "You Are Going to Hear A Lot More FUD about Patent Law, So Here Are Some Facts," July 5, 2023
• "Senate Once Again Tries to Address Drug Pricing," May 16, 2023
• "The New York Times Is at It Again Regarding Patents," January 29, 2023

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