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By Kevin E. Noonan –
The provisions of U.S. regulatory law regarding FDA approval for less than all the indications for which an innovator drug was approved under 21 U.S.C. § 355(j)(2)(A)(viii) (the so-called "skinny label) has in the recent past raised something of a kerfuffle before the Federal Circuit (see "GlaxoSmithKline LLC v. Teva Pharmaceuticals USA (Fed. Cir. 2022)"). In contrast, the patency of skinny label approvals under the patent statute was affirmed by the Federal Circuit in a December 7th decision in H. Lundbeck A/S v. Lupin Ltd.The case arose in ANDA litigation in which Lundbeck and assorted plaintiffs asserted U.S. Patent No. 9,278,096, directed to use of the antidepressant vortioxetine (Trintellix®) for treating patients who discontinued or reduced treatment with other antidepressants due to "sexually related adverse effects," and U.S. Patent No. 9,125,910 for treating patients with vortioxetine for cognitive impairment against all defendants, and U.S. Patent No. 9,101,626, directed to methods for making vortioxetine against defendant Lupin. Takeda is the NDA holder for Trintellix® and the opinion notes that two patents not in suit, U.S. Patent No. 7,144,884 and 8,476,297 (on the drug compound) expire on June 17, 2026 and expired on October 2, 2022, respectively. In contrast, the patents in suit expire on March 21, 2032 (the '096 patent) and June 15, 2027 (the '910 patent). Defendants filed "Paragraph III" ANDAs on the '884 and '297 patents, which ANDAs are limited to treatment of major depressive disorder; this indication is not claimed in the '096 or '910 patents-in-suit.
Claims 1 and 7 of the '096 patent are representative of claims for treating depression without or with reduced adverse sexual side effects with vortioxetine:
1. A method for the treatment of a disease selected from the group consisting of depression, anxiety, abuse and chronic pain, comprising the administration of a therapeutically effective amount of [vortioxetine] or a pharmaceutically acceptable salt thereof to a patient in need thereof, wherein said patient has previously received medication or is still receiving medication for the treatment of said disease, the medication is ceased or reduced or has to be ceased or reduced due to sexually related adverse events, and the medication is selected from the group consisting of selective serotonin reuptake inhibitors, selective noradrenaline reuptake inhibitors, noradrenaline/serotonin reuptake inhibitors, and tri-cyclics.
6. The method according to claim 1, wherein Compound I or a pharmaceutically acceptable salt thereof is administered to the patient in unit doses of about 1–50 mg.
7. The method according to claim 6, wherein the patient is administered between about 1 and 20 mg per day of the hydrobromic acid salt of Compound I orally.
Claims 1, 3, and 6 of the '096 patent are representative of claims for treating cognitive impairment with vortioxetine:
1. A method of treating cognitive impairment involving decline in speed of processing, executive function, attention, or verbal learning and memory in a patient diagnosed with depression, the method comprising administering a therapeutically effective amount of [vortioxetine] or a pharmaceutically acceptable salt thereof to the patient, wherein . . . the method alleviates a symptom or complication of the cognitive impairment or delays the progression of the cognitive impairment.
3. The method of claim 1, wherein the depression is major depressive disorder.
6. The method of claim 3, wherein the method comprises administering a hydrobromide salt of [vortioxetine] to the patient.
Plaintiffs asserted induced or contributory infringement against defendants, asking the District Court for an injunction until the '096 and '910 patents expired. The District Court held that defendants' ANDAs "neither induced infringement of nor contributorily infringed" the '096 nor '910 patents, and denied the injunction. Plaintiffs appealed this judgment.
In addition, plaintiffs asserted the '626 patent against defendant Lupin, the opinion stating that claims 1 and 11 were representative; claim 1 recites:
1. A process for the preparation of [vortioxetine] or a pharmaceutically salt thereof, the process comprising reacting compound II . . ., with a compound of formula III . . ., and a compound [IV] . . ., in the presence of a solvent, a base and a palladium catalyst consisting of a palladium source and a phosphine ligand at a temperature between 60° C. and 130° C.
The District Court construed the claims consistent with plaintiffs' interpretation of the word "reacting" and held Lupin's method of producing vortioxetine would infringe. Lupin cross-appealed this judgment.
The Federal Circuit affirmed, in an opinion by Judge Dyk joined by Judges Prost and Hughes. Plaintiffs argued that an infringement action under § 271(e)(2)(A) "creates a separate cause of action that does not require a showing of direct, induced, or contributory infringement by the ANDA filer"; in other words filing an ANDA by itself is an act of infringement. In the context of this lawsuit, Plaintiffs also asserted that "it makes no difference that the drug is proposed to be sold for a use not covered by the '096 and '910 patents because the drug could be prescribed for those patented uses." The panel rejected this argument, stating that "'the use . . . claimed in a patent' under section 271(e)(2)(A) must be the use for which an applicant is seeking marketing approval" under their case law.** The opinion cites Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1365 (Fed. Cir. 2003), in support of this determination, the opinion stating that how a drug was used was a necessary factor in determining infringement. This is because otherwise the NDA holder for a particular drug could extend its exclusivity "by regularly filing a new patent application claiming a narrow method of use not covered by its NDA, [which] would confer substantial additional rights on pioneer drug patent owners that Congress quite clearly did not intend to confer," citing Warner Lambert. Despite the possibility of off-label use, that possibility does not override the basis in § 271(e)(2)(A) to be limited to preventing an ANDA filer from approval for uses subject to patent protection; here, defendants do not seek approval for the uses claimed in the '096 and '910 patents. Such uses do not raise infringement liability under §§ 271(a), 271(b), or 271(c) and § 271(e)(2)(A) does not create infringement liability independently of these statutory bases for finding infringement, according to the Federal Circuit.
Turning to the District Court's findings that defendants' ANDAs did not constitute infringement of claim 7 under § 271(b), the opinion cites that "instructions may not merely describe an infringing mode; they must 'evidence intent to encourage infringement,'" citing Takeda Pharms. U.S.A., Inc. v. West-Ward Pharm. Corp., 785 F.3d 625, 630–31 (Fed. Cir. 2015). Plaintiffs' sole evidence for inducing infringement liability was the FDA-approved label, which does not induce infringement of the asserted claims of the '096 patent because it is limited to the indication for treating major depressive disorder (which indication the opinion notes predates the '096 patent). The opinion expressly distinguishes this situation with that in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 7 F.4th 1320, 1333 (Fed. Cir. 2021), where there was evidence of the existence of advertising or promotional activities and materials that encouraged infringement inter alia by off-label use stratagems. The panel reiterates their interpretation of § 271(e)(2)(A) that "a patentee can[not] bar the sale of a drug for a use covered only by patents that will have expired simply by securing a new patent for an additional, narrower use," citing Warner-Lambert. Further, the Court opined:
[W]e do not see how, in the normal course, a label required to market the drug for a use covered by expired patents could demonstrate the required specific intent to encourage infringement of new patents covering different uses.
The panel notes that there may be circumstances (related to safety, for example) where FDA requires a new patented method of use to be included on the label due to such safety concerns, citing for example AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1060– 61 (Fed. Cir. 2010) (instructions to lower a dose for safety reasons); Vanda Pharms. Inc. v. West-Ward Pharms. Int'l Ltd., 887 F.3d 1117, 1131 (Fed. Cir. 2018) (requiring a test and adjustment of drug dose accordingly); and Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., 845 F.3d 1357, 1365, 1368–69 (Fed. Cir. 2017) (taking a supplement to reduce "potentially life-threatening toxicities"). That is not the case here according to the opinion. Rather, these defendants had properly under the statute "carved out" the indications encompassed by the '096 patent claims, and accordingly the Court held that "[t]he district court correctly determined that, under these circumstances and consistent with our cases," the proposed ANDA labels "will not encourage, recommend, or promote an infringing use."
The opinion concludes its considerations of the induced infringement issue by rejecting plaintiffs' argument that physicians could prescribe the approved drug based on their own "background knowledge together with information in the carved-out label," stating that "mere knowledge of possible infringement by others does not amount to inducement; specific intent and action to induce infringement must be proven," again based on the Warner=Lambert opinion. Also rejected was plaintiffs' assertion of error by the District Court in "ignoring the lower doses recited in the '096 patent claims, while at the same time arguing with regard to claim validity that the skilled worker would have recognized the lower incidence of adverse sexual events that resulted at any of the approved dosages, the panel stating that "Plaintiffs cannot now fault the district court for crediting their own argument."
With regard to contributory infringement, the panel likewise rejected plaintiffs' arguments, here because there is no liability for contributory infringement for selling an article that is "suitable for substantial noninfringing use" under the statute, 35 U.S.C. § 271(c). The opinion states that the District Court properly found that vortioxetine had such substantial noninfringing uses over the claims of the '096 patent, for example, by prescribing the drug to "patients with no prior treatment, patients with prior treatment other than with the drugs referenced in the '096 patent, and in cases where the prior antidepressant was ceased or reduced for reasons other than sexually related adverse events (for example, due to poor efficacy)." Similarly for the '910 patent, substantial noninfringing uses found sufficient to avoid contributory infringement include "prescription for treating MDD, prescription to patients without cognitive impairment, and prescription for purposes unrelated to cognition." And plaintiffs' assertion that these uses may infringe other Lundbeck patents is not relevant, according to the Court, because the determination under § 271(c) relates and is limited to substantial noninfringing uses of the asserted patents.
In Lupin's cross-appeal regarding the District Court's infringement determination of the '626 patent, the Court found no basis to adopt Lupin's narrow interpretation of the term "reacting" based on the term's plain meaning and rejected Lupin's assertion of the prosecution history for its contrary construction. The Court found no error by the District Court either for its claim construction nor its infringement determination.
The Court apportioned costs to the defendants in plaintiffs' appeal of the judgment of non-infringement of the '096 and '910 patents and to plaintiffs in defendant Lupin's appeal of the District Court's judgment of infringement of the '626 patent.
Lundbeck A/S v. Lupin Ltd. (Fed. Cir. 2023)
Panel: Circuit Judges Dyk, Prost, and Hughes
Opinion by Circuit Judge Dyk* The caption in full reads as follows:
H. LUNDBECK A/S, TAKEDA PHARMACEUTICAL COMPANY LIMITED, TAKEDA PHARMACEUTICALS U.S.A., INC., TAKEDA PHARMACEUTICALS INTERNATIONAL AG, TAKEDA PHARMACEUTICALS AMERICA, INC., Plaintiffs-Appellants
v.
LUPIN LTD., LUPIN PHARMACEUTICALS, INC., MACLEODS PHARMA USA, INC., MACLEODS PHARMACEUTICALS LTD., SANDOZ INC., SIGMAPHARM LABORATORIES, LLC, ZYDUS PHARMACEUTICALS (USA) INC., ALEMBIC GLOBAL HOLDING S.A., ALEMBIC PHARMACEUTICALS INC., ALEMBIC PHARMACEUTICALS LIMITED, CADILA HEALTHCARELTD., LEK PHARMACEUTICLS D.D.
** Defendants contended that this argument was waived by it not having been asserted at the district court.
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By Kevin E. Noonan –
In the shadow of its recent, precedent-challenging In re Cellect decision, the Federal Circuit illustrated the pedestrian application of its obviousness-type double patenting jurisprudence in affirming the Patent Trial and Appeal Board's rejection on ODP grounds in In re Institut Pasteur.The case arose in an appeal during ex parte prosecution of rejections on ODP grounds of claims directed to methods for treating pain using opiorphin, one of a number of preparations of peptides derived from human Basic Proline-rich Lacrimal Protein (BPLP) in Application No. 14/730,396 ("'396 Application"). Claim 17 is representative:
17. A method for treating pain comprising administering a dose of 10-300 mg/day of a peptide consisting of the sequence Gln-Arg-Phe-Ser-Arg (SEQ ID NO:2) or Glp-Arg-Phe-Ser-Arg (SEQ ID NO:55) for 7 days.
The claims in the '396 patent were rejected over several claims of related U.S. Patent No. 9,403,871, claims 1 and 6 being representative:
1. A method for treating pain comprising administering an effective amount of an isolated peptide consisting of up to 15 amino acids to a human subject,
wherein the peptide comprises the sequence Glu-Arg-Phe-Ser-Arg (SEQ ID NO: 3) or Glp-Arg-Phe-Ser-Arg (SEQ ID NO: 7),
wherein the peptide exhibits an inhibitory property against a neutral endopeptidase or an aminopeptidase and
wherein the peptide has the same amino acid sequence as that found within human Basic Proline-rich Lacrimal Protein (SEQ ID NO:2) or differs from the amino acid sequence found within SEQ ID NO:2 by two or less amino acid substitutions. . . .6. The method of claim 1, comprising administering a dose of 10-100 mg of the peptide.
(where for the biochemically curious the abbreviation "Glp" stands for pyroglutamate).
The co-owned '871 patent was filed a little more than one year before the '396 application. The basis for the ODP rejection asserted by the Examiner was that "it would have been 'obvious for one of ordinary skill in the art to treat chronic pain by the methods of claims [of the '871 patent] which would require treatment for several days, 7 included.'" In Pasteur's earlier appeal to the PTAB, the Board agreed with the Examiner that "pain" as recited in the '871 patent includes "acute pain" and "chronic pain such as arthritis or inflammatory bowel disease." It is important to note in view of this reasoning that there is a fine line to be drawn between assessing ODP based on the claims of a related patent having patentably indistinct claims and considering the teachings of the specification of such a related patent. Here, the significance of the disclosure of such a related patent is in how the terms recited in the claims are interpreted (e.g., with regard to claims reciting "pain" to include "chronic pain" in view of how "pain" is construed in view of the specification).
In addition, in the Board's view, the '871 recited a claim term for an "effective amount" of the peptide used in the claimed method that encompassed within its scope the 10-100 mg dosage recited in claim 6 of the '396 application. Finally, with regard to the "7 day" limitation the Board held that chronic or persistent pain would be understood by the skilled worker to be subject to a 7-day course of treatment.
Applicant's response to the Board's affirmance of this rejection in the earlier appeal was to continue prosecution by filing an amendment, exemplified in the opinion as follows:
17.[] A method for treating pain in a human patient comprising administering a dose of 1 mg/kg to 2mg/kg at 10-300 mg/day of a peptide consisting of the sequence Gln-Arg-Phe-Ser-Arg (SEQ ID NO:2) or Glp-Arg-Phe-Ser-Arg (SEQ ID NO:55) to the patient for 7 days without inducing pharmacodependence or tolerance in the patient.
These amendments were of no avail, the Examiner asserting an ODP rejection to these claims. According to the Examiner, simple math yielded a daily dosage of 80-160mg for an average-sized patient (80kg), which daily dosages were within the scope of the '871 patent claims used to support the earlier ODP rejection previously affirmed by the Board (and not appealed to the Federal Circuit). As for the limitation to avoid pharmacodependence or tolerance to the drug, the Board held that this limitation simply reflected "[t]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, [that] does not render the old composition patentably new to the discovered," citing Atlas Powder Co. v. Ireco, Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999).
Not deterred, applicants filed a declaration by one of the inventors, who attested that "'opioid receptor agonists, such as morphine' are the 'most efficient drugs to alleviate severe pain' but their 'clinical usefulness has been limited by the development of tolerance and dependence that occurs after long-term treatment.'" Further, the declarant attested that "'it was expected that opiorphin could induce tolerance and dependence – just as morphine does' and 'opiorphin's lack of the detrimental side effects of opioids – tolerance and dependence – was surprising and unexpected.'" Thus, the declarant attested that the invention claimed in the '396 application "fulfill[ed] a long-felt need for efficient pain-controlling compounds without the detrimental side effects of opioids – tolerance and dependence."
The Examiner was unimpressed, finding in the declaration admissions that the analgesic properties of opiorphin were known in the art at the recited dosages, despite acknowledging the declarant to attest that "further research found opirphin [sic] to have a minimal adverse morphine-associated effect and to produce analgesic potency, and concludes that this effect was surprising and unexpected." For the Examiner, the declaration admits that "the instant method of treatment of pain uses the same drug and the same dose as taught by the '871 patent," and so "[t]he only remaining disputed difference between the scope of the instant claims and the claims of the '871 patent is the duration of the treatment." The latter distinction had been before the Board previously and although further research had adduced evidence of the mechanism of pharmacodependence this was just an instance of discovery of new properties of the drug which knowledge did not render the claims patentable, according to the Examiner in maintaining the ODP rejection. Finally, regarding the assertion that the claimed invention satisfied the objective indicia of non-obviousness, the Examiner's position was that these claims recited "an identical process of administering the same drug to treat the same pathology, which is expected to produce identical results" and the recited adjustments in dose and treatment time were "a finite number of identified, predictable solutions, and one of ordinary skill in the art would have recognized that the results of this adjustment are predictable."
The Board affirmed, based on the inclusion of chronic pain in the methods claimed in the'871 patent and that "there is no dispute here that the '871 patent's claims teach treating chronic pain with the same drug, at the same dose, for the same duration as presently claimed." Under these circumstances if this treatment regimen did not induce tolerance or pharmacodependence that was an inherent property of the treatment and did not render the '396 claims patentably distinct sufficient to overcome the ODP rejection.
The Federal Circuit affirmed, in an opinion by Judge Clevenger, joined by Judges Taranto and Stoll. The opinion notes that the Board had relied on its decision in the first appeal of these claims that addressed the limitations argued by Pasteur in this second appeal to be wanting. The Federal Circuit considered the Board's decision to be supported by substantial evidence as a consequence, including "concessions" by Pasteur at oral argument regarding the identity of the drug and the dosage between the '871 patent claims and the '396 application claims. The panel also held that the Board's conclusion that the lack of tolerance or pharmacodependence in the '396 application claims was an inherent property of the claimed method also was supported by substantial evidence. With regard to the objective indicia, the opinion also finds substantial evidence supported the Board's conclusions of obviousness under the ODP doctrine. In particular, the Federal Circuit agreed that the '396 application claims did not satisfy a long-felt need over the '871 patent claims because practice of the method claimed in the '871 patent would satisfy that need.
Unlike the patentee in Cellect, of course, Pasteur will be able to bring these claims to grant by filing a terminal disclaimer. However, this will result in a patent expiration date for these claims to be March 18, 2025 instead of (at a minimum) May 26, 2029 (subject to patent term adjustment for the time spent appealing the rejection before the Board and Federal Circuit). These calculations provide ample explanation for Pasteur's efforts in overcoming the asserted ODP rejections without filing a terminal disclaimer.
In re Institut Pasteur (Fed. Cir. 2023)
Nonprecedential disposition
Panel: Circuit Judges Taranto, Clevenger, and Stoll
Opinion by Circuit Judge Clevenger -
By Michael Borella —
After two-and-a-half years of negotiation disrupted by the rise of generative models, the European Parliament and the European Council have reached a provisional understanding of how artificial intelligence (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.As was the case for earlier proposals, AI systems are categorized based on the level of risk that they pose. High risk AI will be more strictly governed than low risk AI. For example, a high-risk AI system must undergo a fundamental rights impact assessment before being put into the market, and may also be subject to enhanced transparency requirements.
AI capabilities viewed as unacceptable will be banned from the EU. The latter include "cognitive behavioural manipulation, the untargeted scrapping of facial images from the internet or CCTV footage, emotion recognition in the workplace and educational institutions, social scoring, biometric categorization to infer sensitive data, such as sexual orientation or religious beliefs, and some cases of predictive policing for individuals."
New in this agreement are a set of provisions addressing large, foundational models that can be used for multiple purposes (this includes the current wave of generative AI chatbots capable of producing text, images, and code), as well as where these models are integrated into other high-risk systems.
Nonetheless, there are exceptions. Member states are not prevented from using AI for military, defense, or national security purposes. Also, the regulations will not affect AI systems used solely for research or non-professional reasons.
Penalties for violation of the regulations would be based on a percentage of a company's annual revenue or a fixed amount, whichever is higher. These quantities would vary based on the severity of the offense, from 7% or €35 million down to 1.5% or €7.5 million. Lesser fines may be set forth for small and medium-sized businesses.
The details of the regulations are yet to be finalized. It may be weeks or months before the text of the regulations is completed, and even longer before it is ratified.
The proposed legislation establishes the EU's lead in AI regulation. The U.S. is currently nowhere near federal legislation setting forth restrictions on AI development or use. While the Biden administration's recent executive order expressed many of the same concerns, it is questionable whether this directive will have any power if President Biden is not re-elected in November of 2024.
Regardless, the EU's stance (and to some extent, that of the Biden administration) is that technology companies cannot be trusted to self-regulate in this space. The dangers are too impactful and the field is too dynamic to leave much room for error. This is in contrast to the "effective accelerationist" movement embraced by some in Silicon Valley, a rather oddball amateur philosophy (backed by an enormous amount of capital) that calls for unrestricted advancement in AI and can be summarized as "Don't regulate us, bro!"
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By Kevin E. Noonan –
Proper construction of claim limitations reciting the chemical property of pH (which denotes the concentration of hydrogen ions in a solution as an indication of acidity) has arisen several times in district court and Federal Circuit opinions, perhaps the most notable being in Warner-Jenkinson v. Hilton Davis Chemical (1997), which revitalized the doctrine of equivalents. The issue arose recently before the Federal Circuit in Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., with the Court vacating and remanding the District Court's claim construction for failure to consider extrinsic evidence. The opinion illustrates the difficulties posed and considerations considered by the Court when addressing claim constriction for terms comprising pH.The case arose in ANDA litigation related to Actelion's Flolan® (epoprostenol) product, used for treatment of cardiovascular disease. As described in the opinion, the compound is unstable in water and prepared by Actelion as a freeze-dried or lyophilized power for reconstitution in commercially available IV fluids prior to use (intravenous administration to a patient) without needing refrigeration (sold by Actelion as Veletri®). The patents-in-suit were U.S. Patent Nos. 8,318,802 and 8,598,227, with claim 11 of the '802 patent being set forth as representative:
11. A lyophilisate formed from a bulk solution comprising:
(a) epoprostenol or a salt thereof;
(b) arginine;
(c) sodium hydroxide; and
(d) water,
wherein the bulk solution has a pH of 13 or higher, and wherein said lyophilisate is capable of being reconstituted for intravenous administration with an intravenous fluid.(wherein the italicized limitation was at issue in the case). The opinion also notes that the inventor's discovery that epoprostenol formulations "in the presence of an alkalinizing agent, and high pH (>11) is very stable compared to Flolan" was unexpected. Litigation ensued when Mylan sent Actelion a Paragraph IV letter under 21 U.S.C. § 355(j)(2)(A)(vii)(IV), with Actelion asserting claims 1, 6, 8, 10, 11, 16, 18, 20, and 22 of the '802 patent and claims 1–3, 8, 10, 12, 14, 16, 18–22, and 24–42 of the '227 patent under 35 U.S.C. § 271(e)(2).
Both parties argued that the pH limitation should be construed by its ordinary and customary meaning but differed as to what that meaning was. Actelion argued that the term "a pH of 13 or higher" should be construed as giving the acidity value of the solution as an order of magnitude subject to conventional rounding rules, wherein the term would include a pH of 12.5 (which would be rounded up to 13). Mylan, on the other hand, argued that the term cannot properly be construed to include any pH value less than 13 and if interpreted as a range must be between pH 12.995 and 13.004 based on the concept of significant figures (or digits) in view of the logarithmic nature of pH values. Both parties asserted chemical textbooks to support their claim construction arguments.
The District Court declined the parties' invitations to consider the proffered textbook definitions as extrinsic evidence and construed the limitation according to Actelion's plain meaning definition based solely on the intrinsic evidence. According to the District Court, the plain meaning of a numerical value included two significant figures and thus "a pH of 13" would ordinarily encompass values from 12.5 to 13.4. Neither the specification nor the prosecution history contained any disclosure that would implicate any "increased degree of precision" according to the District Court. The parties stipulated infringement in favor of Actelion, the District Court entered judgment, and this appeal followed.
The Federal Circuit vacated the judgment and remanded to the District Court for further claim construction in light of extrinsic evidence, in an opinion by Judge Stoll joined by Judges Reyna and Stark. After reciting the standard of review (de novo for claim construction relying solely on intrinsic evidence, clear error for claim construction relying on extrinsic evidence, and de novo on the "ultimate interpretation of the claim"), the panel turned to the "narrow question" of the proper meaning of "a pH of 13" in the context of the '802 and 227 patents. Put simply, the Court found the intrinsic evidence to be "equivocal" and the extrinsic evidence asserted by the parties and not considered by the District Court to be "highly relevant to how a person of ordinary skill would understand the [disputed claim] language." The opinion then reviewed the conventional sources of claim construction (the "plain and ordinary meaning" of the claim language, the specification and the prosecution history) to explicate their conclusion that the intrinsic evidence was equivocal. Regarding the "plain and ordinary meaning" of the claim language, the panel disagreed with Mylan's construction involving the range from pH 13 to the upper range of pH 14, stating that such cases are "not of great significance to our analysis here" and "there is no blanket rule that ranges, or specifically open-ended ranges, must foreclose rounding." The opinion also notes that while the claims lack any conventional "approximation language" such as "about" the panel did not agree with Mylan's argument that as a consequence the term "a pH of 13" must be construed to mean exactly pH 13. The opinion states that this absence of approximation language is not dispositive and that the Court is not interested in promulgating a "bright line rule" on this question (and the opinion notes the panel finds both parties' arguments to be "equally plausible").
Regarding the specification, the panel finds the language therein to be inconsistent. In some sections the pH of the "bulk solution" are described as being "adjusted to about 12.5-13.5, most preferably 13" (and also distinguished pH 12.5 from pH 13 and the range of pH 12.5-13.5 from pH 13) while elsewhere pH 13 is described as "pH 13.0," which would indicate a more restricted scope for this limitation. Mylan argued (unsuccessfully before the district court as well as the panel) that these disclosures precluded the claim term "pH 13" from encompassing a range and in particular pH 12.5. These arguments, and Actelion's responses, convinced the panel that "the specification supplies the same clarity as to the desired level of precision as muddied water" and thus could not be relied upon to provide intrinsic evidence of the meaning of pH 13 in the claims. Further, while the significance of the pH term was in the stability of the drug compound epoprostenol in the formulation, the opinion finds no evidence in the specification that stability was tested in the range of pH 12-pH 13 upon which the claim term could be definitively construed.
And regarding the prosecution history, the Court considered several amendments to the claims involving the pH limitation, and statements by the Examiner that evidence regarding formulations at pH 12 did not distinguish over the prior art but those at pH 13 did so (the amendments resulting in the claim language in the granted patents were included in the Reasons for Allowance).
Under these circumstances the panel decided that:
We find that this case is one where the proper claim construction cannot be reached without the aid of extrinsic evidence, and that the district court should have considered, at minimum, the textbook excerpts offered and addressed by the parties.
This decision was supported by Supreme Court precedent (Teva Pharms. USA, Inc. v. Sandoz, Inc., 574 U.S. 318, 331 (2015), and Federal Circuit case law (Pickholtz v. Rainbow Techs., Inc., 284 F.3d 1365, 1372–73 (Fed. Cir. 2002)) cited in the opinion.
Accordingly, the panel decided to vacate and remand, because:
It is not for this court to make those findings [regarding extrinsic evidence] in the first instance. We decline to decide, for example, how many significant figures "a pH of 13" has or what it would mean for a number—either for a pH value or for the concentration of hydrogen ions—to have zero significant figures. Instead, we leave those and other relevant factual questions that might arise based on the extrinsic evidence, including the three textbooks, for the district court to address in the first instance.
Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2023)
Panel: Circuit Judges Reyna, Stoll, and Stark
Opinion by Circuit Judge Stoll -
By Kevin E. Noonan –
Although merely exemplifying the burden imposed on an appellant by the Federal Circuit's substantial evidence standard of review over decisions by the U.S. Patent and Trademark Office regarding the facts underlying legal decisions on obvious, an inter partes review of patents directed to capturing feral pigs provides enough of a curiosity to provoke a post, in Jager Pro, Inc. v. W-W Manufacturing Co.The case arose over two decisions by the Patent Trial and Appeal Board (PTAB) where all challenged claims of U.S. Patent Nos. 9,814,228 and 10,098,339 were held unpatentable as obvious. These claims were directed to apparatus and methods for capturing feral pigs. Claim 1 of the '228 patent was set forth in the opinion as representative:
1. A method for capturing a plurality of feral pigs, comprising:
[a] moving at least one portion of an enclosure from an open position that permits passage of a plurality of feral pigs into the enclosure to a closed position that restricts passage of the plurality of feral pigs out of the enclosure, [b] wherein in the closed position, the enclosure cooperates with a ground surface to define an enclosure area in which the plurality of feral pigs are trapped, [c] and wherein the ground surface extends continuously from within the enclosure area to areas surrounding the enclosure,
[d] wherein the enclosure comprises a release mechanism that effects movement of the at least one portion of the enclosure from the open position to the closed position,
[e] wherein the release mechanism effects movement of the at least one portion of the enclosure from the open position to the closed position upon receipt of a release signal from a control mechanism that is in communication with a display device, [f] wherein the display device is in communication with a camera assembly and configured to:
receive a wireless detection signal from the camera assembly; and
[g] transmit a wireless control signal upon receipt of the wireless detection signal from the camera assembly, wherein the wireless control signal corresponds to an instruction to the control mechanism to generate the release signal, and
[h] wherein, upon detection of a presence of the plurality of feral pigs within the enclosure by the camera assembly, the camera assembly transmits the wireless detection signal to the display device.Challenger W-W Manufacturing asserted the combination of an archived webpage to Texas Boars which included teachings regarding the preamble of claim 1 and bracketed limitations 1[a]–1[e] and Korean Patent No. 10-0688143 which contained this figure which taught or at least suggested "wireless transmission of signals from a camera assembly to a display device as well as from the display device to a control mechanism":
The Board also considered Jager Pro's assertion of certain objective indicia of non-obviousness to be inadequate because the patentee did not provide any evidence of there being a nexus between the evidence adduced and the objective indicia, nor was their argument entitled to a presumption that such a nexus existed.The Federal Circuit affirmed, in an opinion by Judge Chen joined by Judges Lourie and Reyna. The panel rejected patentee's arguments that the Board's obviousness determinations were not supported by substantial evidence, that the Board did not articulate a basis for there to have been a motivation to combine the cited references, nor that the skilled worker would have had a reasonable expectation of success. On the contrary, the Federal Circuit relied on there being a "simple substitution" of an animal-instigated closure (through a trip wire) and human-instigated closure (pushing a button in response to received images of the animals), which in the Board's opinion was motivated by the advantages resulting from this substitution. Such advantages of the substitution that the skilled worker would have recognized include increased control and chance for success in trapping the animals. These considerations were supported by substantial evidence on the record in the Board's opinion, unrebutted by patentee.
The panel also rejected Jager Pro's arguments regarding deficiencies in the asserted references because (in the Court's view) the references were argued individually rather than the asserted combination of the references. Specifically, the opinion takes issue with the purported absence of wireless connection embodiments in the '134 patent because the panel interpreted broken lines in the Figure above to indicate such wireless embodiments.
With regard to the objective indicia and the nexus vel non with the claims, Jager Pro argued entitlement to this presumption due to the display device of their commercial product "transmit[ting] a wireless signal directly to the release mechanism, which then releases the gate" (emphasis in opinion). The Federal Circuit agreed with the Board that this feature was not a requirement of the claims, which had the complication that the wireless signal was sent from the display to a controller which then sent another signal to a mechanism that opens the gate. The Board had found Jager Pro's instruction manual regarding use of the apparatus to be inconclusive because it contained no explanation of how the control box was controlled according to limitation 1[e]. This Board finding was also supported by substantial evidence according to the panel opinion.
The panel held that the substantial evidence standard was satisfied by the Board for the factual questions at issue supporting its obviousness determination of the challenged claims and thus affirmed the Board determination that the challenged claims were obvious.
Jager Pro, Inc. v. W-W Manufacturing Co. (Fed. Cir. 2023)
Nonprecedential disposition
Panel: Circuit Judges Lourie, Reyna, and Chen
Opinion by Circuit Judge Chen -
By Aaron Gin —
Today, the U.S. Patent and Trademark Office announced a new, no-cost, pilot program that accelerates the examination process for U.S. patent applications related to semiconductor manufacturing. Starting tomorrow Friday, December 1, 2023, applicants can file a petition to participate in the pilot program. Petitions that correspond to qualifying non-provisional utility patent applications, directed to "certain processes and apparatuses for manufacturing semiconductor devices," will be advanced out of turn for examination (accorded special status) until a first action.• Qualifying applications must be "non-continuing original utility non-provisional applications" that may optionally claim priority to a prior provisional application or one or more foreign priority applications.
• At least one claim of the qualifying application must cover a process or an apparatus for manufacturing a semiconductor device and correspond to one or more of the technical concepts within H10 (Semiconductor Devices; Electric Solid-State Devices Not Otherwise Provided For) or H01L (Semiconductor Devices Not Covered by Class H10) in the Cooperative Patent Classification (CPC) system.
• Applicants must file the petition to make special with the application or entry into the national stage under 35 U.S.C. § 371 or within 30 days of the filing date or entry date of the application.
• The fee for the petition to make special under 37 C.F.R. § 1.102(d) has been waived for this program.
In a related news release, the Secretary of Commerce Gina Raimondo stated that "[t]his new USPTO program will ensure we are prioritizing critical intellectual property protections to incentivize investments in domestic semiconductor manufacturing." The Director of the USPTO, Kathi Vidal said of the new pilot program: "Fast tracking examination of patent applications related to semiconductor device manufacturing speeds bringing key innovations to market and strengthens our nation's supply chain."
The pilot program aims to support the Creating Helpful Incentives to Produce Semiconductors (CHIPS) Act of 2022, which allocates investments designed to increase semiconductor manufacturing capacity and improve the resilience of the semiconductor supply chain. The Semiconductor Technology Pilot Program supports the CHIPS Act by "encouraging research, development, and innovation in the semiconductor manufacturing space and providing equitable intellectual property protection to incentivize investments in the semiconductor manufacturing area." The USPTO stated that the new pilot program can help achieve the goals of the CHIPS Act by expediting and encouraging innovations relating to semiconductor devices and their manufacture.
The petition (Form PTO/SB/467) will be available starting December 1, 2023. The pilot program will be available until December 2, 2024 or until the USPTO accepts 1,000 grantable petitions, whichever is reached first.
For additional information, please see:
• USPTO Semiconductor Technology Pilot Program
• Pre-publication of the Federal Register 2023-26340 -
By Kevin E. Noonan –
The Federal Circuit dismissed an appeal from an unsuccessful challenger in an inter partes review (IPR) proceeding based on failure to satisfy the standing requirements for appeal in Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, Inc.The case arose in an IPR over U.S. Patent No. 10,149,820, directed to compositions and methods for treating pterygium, "an eye condition in which a tumor-like growth extends from the nasal or temporal side of the eye to the cornea." Surgery was the recognized treatment, and also recognized was the likelihood of tumor recurrence. The '820 patent claims use of multikinase inhibitors including nintedanib, pazopanib, and sunitinib.
Nintedanib
Claims 4 and 5 were the only claims remaining after the IPR; claim 4 was set forth as representative:1. [disclaimed] A method for reducing hyperemia or symptoms thereof in pterygium in an affected eye of a subject in need of such treatment, without surgically excising a pterygium, comprising administering to the affected eye of the subject a therapeutically effective amount of a multikinase inhibitor.
3. [disclaimed] The method of claim 1, wherein the multikinase inhibitor is administered to the affected eye in the form of topical ocular formulation or ocular implant.
4. The method of claim 3, wherein the multikinase inhibitor is nintedanib and the nintedanib is administered to the affected eye in the form of a topical ocular formulation and is administered topically to the affected eye.
Relevant to the issues on appeal, the Board held that Allgenesis had not shown the remaining (not disclaimed) claims of the '820 patent were invalid for anticipation or obviousness over its own PCT application because the earliest priority date for the '820 patent (June 5, 2015) was earlier than the priority date of the PCT application (June 22, 2015) and Cloudbreak's provisional application provided sufficient written description support for claims 4 and 5 of the '820 patent. The Board also determined that the '820 claims were not obvious in view of the combination of two other references because of the '820 patent's disclosure of unexpected results of improved efficacy and safety. Allgenesis appealed both grounds of the Board's determination of non-obviousness.
The Federal Circuit dismissed the appeal based on Allgenesis' failure to satisfy Article III requirements, in a decision by Chief Judge Moore joined by Judges Stoll and Cunningham. The opinion sets forth the basis for Allgenesis' deficiency as being rooted in the requirement for standing of injury in fact under Spokeo, Inc. v. Robins, 578 U.S. 330, 338 (2016). This requirement, while not arising for standing to file an IPR petition, Cuozzo Speed Techs., LLC v. Lee, 579 U.S. 261, 279 (2016), is required to appeal the Board's decision under Consumer Watchdog v. Wis. Alumni Rsch. Found., 753 F.3d 1258, 1261 (Fed. Cir. 2014). Allgenesis asserted standing based on "(1) its potential infringement liability and (2) the Board's priority determination." Neither assertion was sufficient, according to the opinion, because Allgenesis' allegations of injury were speculative and insufficiently concrete to establish injury in fact. With regard to potential liability for infringement, the opinion states that the evidence, a declaration from Allgenesis' Vice President of Finance, relied on a Phase II clinical trial in 2020 and vague assertions of future plans to produce a nintedanib commercial product. The opinion found these assertions to be unconvincing, saying that they "fail[] to identify any specific, concrete plans for Allgenesis to develop a nintedanib product that might implicate claims 4 and 5 of the '820 patent." Nor did Allgenesis provide testimony regarding plans for further development such as a Phase III trial. Instead, according to the panel, Allgenesis provided "generic" statements that it had not abandoned plans for a commercial product. However, according to the opinion, "[s]uch conclusory testimony is insufficient to establish that Allgenesis has any concrete plans to develop and bring to market a nintedanib treatment for pterygium." Nor did Allgenesis assert any threat from Cloudbreak to file suit for infringement. The panel concludes that "Allgenesis has failed to establish it has nonspeculative, concrete plans for future activity that creates a substantial risk of future infringement."
Allgenesis was no more successful in its second assertion of injury in fact, that the Board's decision on priority of invention in favor of Cloudbreak would impair its ability to obtain its own patent on using nintedanib to treat pterygium. Once again, the Federal Circuit found Allgenesis' evidence and argument to be insufficient to support its injury in fact claim. The opinion analogizes the circumstances with the Court's earlier decision in Best Medical International, Inc. v. Elekta Inc., 46 F.4th 1346 (Fed. Cir. 2022) (despite significant distinctions between the factual circumstances, recognized by the Court). What the cases had in common, in the Federal Circuit's view, was reliance on collateral estoppel as the basis for the injury and, as the Court notes, "[c]ollateral estoppel will not attach to the Board's non-appealable priority determination," citing SkyHawke Techs., LLC v. Deca Int'l Corp., 828 F.3d 1373, 1376 (Fed. Cir. 2016). And again the Court states that "Allgenesis has, based on these quite vague allegations, failed to establish a concrete injury." Even when eschewing estoppel arguments Allgenesis "failed to articulate with any specificity how the Board's priority determination will impact its issued patents or pending continuation applications which claim priority to its PCT application," those articulations being found in "a single paragraph containing only vague allegations in its opening brief and reply brief, respectively."
Having decided that Allgenesis failed to establish injury in fact as required for standing the Federal Circuit dismissed the appeal without reaching the merits.
Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, Inc. (Fed. Cir. 2023)
Panel: Chief Judge Moore and Circuit Judges Stoll and Cunningham
Opinion by Chief Judge Moore -
By Joshua Rich —
Aside from the actual games on the field, the college football press has been fixated on one story over the past several weeks: the Michigan "sign stealing" controversy. Michigan head coach (and former Chicago Bears quarterback) Jim Harbaugh has been suspended from appearing at the field for the last three games of the season — including the critical game against Ohio State — by the Big Ten conference, and may see further punishment when the NCAA completes its investigation. But the entire process could have been prevented by a more innovative approach to technology, which could have brought even greater opportunities to forecast opposing teams' plays.
The existence of "signs", let alone stealing them, is a relatively recent innovation in the history of college football. For decades, coaches chose a play and told it to a player on the sidelines, who would then run onto the field and convey it to the entire team in a huddle.[1] As offensive coaches decided in 1980s and 1990s that they wanted to speed up the pace of play and limit defensive substitutions, they realized the biggest delay between plays was huddling. So they started signaling plays to the team with hand signals. However, those hand signals were not only clearly visible to the other team (and therefore readable and decipherable), but also limited to a relatively small number of plays that could be communicated by gestures. Then came an innovation that allowed a wider variety of signals — large placards or signs that could be held up by student assistants in numerous permutations and various orders to indicate different plays, as well as different formations.[2] However, the problem of visibility of the signs remained.
The NCAA became concerned that the visibility of signs could create even greater inequality between college football teams because large, well-funded programs would be able to scout or "steal" signs at an opponent's games earlier in the season. It therefore put in a rule in place in 1994 that bears some resemblance to trade secret rules. Trade secret laws, such as the Federal Defend Trade Secrets Act ("DTSA"), define protectable trade secrets as any type of information if "(A) the owner thereof has taken reasonable measures to keep such information secret; and (B) the information derives independent economic value, actual or potential, from not being generally known to, and not being readily ascertainable through proper means by, another person who can obtain economic value from the disclosure or use of the information."[3] Similarly, NCAA Bylaw 11.6.1 provides that "[o]ff-campus, in-person scouting of future opponents (in the same season) is prohibited."
The NCAA rule protects only information that is not known to the general public without a license (such as a game ticket). For example, if a coach shouts the play from the sidelines so that it is audible to players on the field, there is no protection against the other team using that information; that is why the placards with seemingly random symbols have been adopted as "reasonable measures" of keeping the information secret. But in this case, there are two "proper means" of scouting that avoid a complete ban. First, in-game sign stealing (that, deciphering the signs while the game is being played) is permissible. Second, reading signs from the television broadcast of an earlier game — an activity that can be performed on campus — is acceptable. Furthermore, like trade secret laws, a team is allowed to use reverse engineering to determine the play from the publicly-visible signs.[4]
Michigan's problems with the NCAA's sign stealing rule arose out of a mysterious private investigation[5] of a Michigan staffer with the colorful name of Connor Stalions. Stalions came to the Michigan football program from the Navy rather than the traditional route of playing the sport. He appears to have started his scouting work in compliance with the rules, by watching recorded television broadcasts of games. He allegedly eventually crossed far over the line, however, by buying tickets to opponents' earlier games and having associates record the sideline signals throughout the game with smartphones. Allegedly, the complete-game videos were then synched to the on-field action to allow a correlation of the signs to the plays. Stalions then would stand near the coaches during Michigan games, allegedly to communicate the upcoming play to them from the signs shown on the far sideline.
While such a scheme would clearly run afoul of the NCAA sign stealing rule — if the allegations are true — a crowdsourcing, big data approach might very well avoid any rule violation. Many college football programs have rabid fanbases that would be willing to do almost anything to support their chosen team.[6] If fans learned that a team would benefit from having recordings of the sidelines of upcoming opponents, many likely would be willing to make and provide such a recording. They could then post the recoding on the internet (for example, hosted on YouTube) and coaches would be able to review and decipher the signs from on campus after the games. So long as the fans were not employed or directed by the school, such a crowdsourcing approach would appear to be legal.[7]
In addition, crowdsourcing a future opponent's signs from several sources so that the correlation to plays could be made would allow deeper analysis of the data. For example, once such a correlation is identified, an AI-based approach could not only allow prediction of which plays an opponent would like run in a given situation (with stolen signs providing a failsafe for the prediction) and identify the best players, formations, and plays to combat the opponent's plays. Essentially, rather than relying on a coach's "gut instinct", an AI could serve as a predictive tool that would suggest the best approach — essentially serving as a replacement for an existing coach. Thus, one of the first jobs that could be replaced with AI would be one of the jobs that nobody has suggested would be vulnerable: football coach.
[1] In fact, as Michigan has simplified its playbook and started calling more running plays — 32 in a row against then sixth-ranked Penn State! — it has reverted to huddling much more frequently and communicating plays to the huddle without signs.
[2] An example of such signs used by the Michigan football team last week are shown here:
[3] See 18 U.S.C. § 1839(3).
[4] 18 U.S.C. § 1839(6) provides that "the term 'improper means' . . . does not include reverse engineering, independent derivation, or any other lawful means of acquisition."
[5] It is not clear who retained and paid the private investigator who uncovered the information at the heart of the controversy.
[6] As one notorious example, in order to "punish" Auburn for a victory over Alabama, one Alabama fan poisoned the oak trees standing at Toomer's Corner by the Auburn campus merely because Auburn fans would celebrate victories by wrapping those trees in toilet paper. The trees had otherwise played no part in the game.
[7] Other Big Ten teams, including Ohio State, are alleged to have done something similar by providing their in-game sign stealing to other teams playing against Michigan.
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