Secondary Considerations Archives

Secondary Considerations

Under High Pressure: New Mechanism of Action Can’t Save Drug Administration Claims

By Katherine Pappas on Jun 22, 2023
Posted In Patents

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board ruling that method claims reciting a mechanism of action triggered by the co-administration of two known antihypertensive agents were obvious over the cited prior art. In re Couvaras, Case No. 22-1489 (Fed. Cir. June 14, 2023) (Lourie, Dyk, Stoll, JJ.)

This case arose out of applicant John Couvaras’s prosecution of patent claims reciting a method of increasing prostacyclin release in the systemic blood vessels to improve vasodilation in a human with essential hypertension by co-administering two therapeutic agents. During prosecution, Couvaras conceded that the two claimed therapeutic agents had been known as essential hypertension treatments for many decades. The examiner agreed, citing 10 references as confirmation. The examiner further found that the physiological results of co-administering the two therapeutic agents were not patentable because they naturally flowed from the claimed administration of the known antihypertensive agents.

Couvaras appealed to the Board, arguing that the increased prostacyclin release was unexpected and that objective indicia overcame any existing prima facie case of obviousness. The Board disagreed, ruling that the increased prostacyclin release was inherent in the obvious administration of the two known antihypertensive agents and that no evidence existed to support a finding of any objective indicia. Couvaras appealed.

Couvaras raised three arguments on appeal:

The Board erred in affirming that a skilled artisan would have had motivation to combine the art.
The claimed mechanism of action was unexpected, and the Board erred in discounting its patentable weight by deeming it inherent in the claimed method.
The Board erred in weighing objective indicia of non-obviousness.

With respect to motivation to combine, the Federal Circuit agreed with the Board that the art supplied sufficient motivation to combine because the claimed therapeutic agents were known for decades to treat hypertension, finding the Board’s conclusion supported by substantial evidence. The Court found that Couvaras had forfeited a related argument for no reasonable expectation of success by failing to first raise that challenge to the Board.

The Federal Circuit also rejected Couvaras’s argument that the claimed mechanism of action was unexpected and therefore entitled to patentable weight. Couvaras argued that the Board downgraded the patentable weight of limitations drawn to the antihypertensive agents’ mechanism of action by deeming them to be merely inherent. According to Couvaras, even if the recited mechanism of action was inherent in the claimed administration of the two agents, that mechanism was unexpected because the increased prostacyclin release was unexpected and could not be dismissed as having no patentable weight due to inherency.

The Federal Circuit disagreed, explaining that Couvaras was attempting to claim a mechanism of action that naturally flows from the co-administration of two known antihypertensive agents and that “[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.” The Court allowed that while mechanisms of action may not always meet the most rigid standards for inherency, “[r]eciting the mechanism for known compounds [...]

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Absent Nexus Secondary Considerations Come in Second

By Courtney Seams and Gaylon C. Hollis on Jun 15, 2023
Posted In Patents

Addressing the nexus between a secondary consideration and the claimed invention in assessing obviousness, the US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board finding of nonobviousness because the Board erred in its nexus analysis regarding secondary considerations. Yita LLC v. MacNeil IP LLC, Case Nos. 22-1373; -1374 (Fed. Cir. June 6, 2023) (Taranto, Chen, Stoll, JJ.)

Yita petitioned for inter partes review (IPR) of all claims of two patents. The patents share a common specification and cover vehicle floor trays that are theraformed from a polymer sheet of substantially uniform thickness. These trays (illustrated below) were designed to closely conform to the walls of the vehicle foot well so that the trays would stay in place once installed.

The Board found that the claims of one of the patents were not obvious even though an artisan would have been motivated to combine the prior art asserted (which disclosed the “close conformance” limitation) and would have had a reasonable expectation of success because the evidence of secondary considerations was overpowering and included a nexus between the evidence of success and the patented invention. The Board also found that the claims of the other patent were not obvious because the “1/8 inch limitation” regarding the thickness of the foot well was not disclosed in the prior art. The Board declined to consider Yita’s argument, which was raised for the first time in its reply brief. Yita appealed.

Yita argued that the Board committed a legal error in its analysis of the secondary consideration evidence for the first patent and abused its discretion by not considering the argument Yita raised in its reply brief regarding the other patent.

On the secondary considerations issue, the Federal Circuit explained that the Board erred in finding a nexus between the secondary consideration evidence of success and the claimed invention because the Board exclusively related to a feature that was well-known in the prior art (i.e., the close conformance between the tray and the vehicle floor). The Court explained that where the prior art teaches a well-known feature and an artisan would have been motivated to combine such prior art with an expectation of success, any secondary consideration that is exclusively related to the well-known feature will not rescue the claim from obviousness. The Court noted that while secondary considerations can be linked to an individual element of the claimed invention or to an inventive combination of elements, here the Board relied on secondary consideration evidence that was related entirely to the already well-known close conformance of the tray and vehicle floor.

The Federal Circuit next addressed Yita’s argument that the Board should have considered an argument raised in Yita’s reply brief regarding the 1/8-inch limitation. Yita failed to raise the argument that it would have been obvious to modify a prior art reference to arrive at the “1/8 inch limitation” [...]

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Long-Felt Need Not Felt Long Enough to Overcome Obviousness

By Tessa Kroll on Feb 24, 2022
Posted In Patents

The US Court of Appeals for the Federal Circuit upheld a finding that patents covering Narcan, a naloxone-based intranasal opioid overdose treatment, were obvious despite evidence of long-felt need. Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., Case No. 20-2106 (Fed. Cir. Feb. 10, 2022) (Prost, Stoll, JJ.) (Newman, J., dissenting).

In 2012, during the growing opioid crisis, the US Food & Drug Administration (FDA) identified a need for an improved intranasal naloxone treatment that could be FDA-approved and deliver the same amount of naloxone to the blood as an injectable formulation. In 2015, Adapt filed a patent application for Narcan, a method of nasally administering naloxone using about 4 mg of naloxone, benzalkonium chloride (BZK) and three other excipients. After Teva submitted an abbreviated new drug application (ANDA) to sell a generic version of Narcan, Adapt sued Teva for infringement. After a two-week bench trial, the district court determined that Adapt’s patents were obvious in view of prior art. Adapt appealed.

The Federal Circuit found no error in the district court’s conclusions that a skilled artisan would have been motivated to combine the prior art, that the prior art did not teach away from the claimed combination and that Adapt’s evidence regarding unexpected results, copying and industry skepticism was not probative of nonobviousness. The Court noted that a skilled artisan would have been motivated to improve on existing treatments because their shortcomings were well known, and the FDA had explicitly identified a need for an improved intranasal product. The claimed excipients also were separately taught in the prior art within the claimed concentration ranges. The Court agreed that a skilled artisan would have been motivated to combine these components to achieve the tonicity and pH required for a drug to be tolerable in the nose and to preserve and stabilize the formulation. While the prior art suggested that BZK causes naloxone degradation, the Court found that this did not teach away from its use because BZK was commonly used in intranasal formulations.

Turning to secondary considerations of nonobviousness, the Federal Circuit affirmed the following:

Narcan’s 56% increase in bioavailability was not “evidence of unexpected results” because BZK was a known permeation enhancer expected to increase bioavailability.
“[C]opying in the ANDA context is not probative of nonobviousness because . . . bioequivalence is required for FDA approval.”
The FDA’s recommendation to increase naloxone dosage in intranasal formulations negated any alleged industry skepticism regarding the higher dosage.

While the Federal Circuit found that the district court erred in finding there was no long-felt but unmet need for an effective intranasal naloxone product, the Court concluded that this error was harmless because the long-felt need began just three years before the patents’ priority date, which was not long enough to overcome the “strong case of obviousness . . . in view of the plethora of prior art.” The Court further agreed that competitors’ alleged failure to obtain FDA approval was not probative of nonobviousness and ultimately affirmed the district [...]

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When it Comes to Method of Use Claims, Preamble Language Regarding Intended Use is Limiting

By Paul Devinsky on Aug 26, 2021
Posted In Patents

The US Court of Appeals for the Federal Circuit issued three separate but related rulings (two precedential, one non-precedential) affirming decisions by the Patent Trial & Appeal Board (Board) regarding the validity of nine US patents and addressing the limitations of preamble language and motivation to combine. Eli Lilly Co. v. Teva Pharmaceuticals, Case Nos. 20-1876, -1877, -1878 (Fed. Cir. August 16, 2021) (Lourie, J.); Teva Pharmaceuticals v. Eli Lilly Co., Case Nos. 20-1747, -1748, -1750 (Fed. Cir. August 16, 2021) (Lourie, J.); Teva Pharmaceuticals v. Eli Lilly Co., Case Nos. 20-1749, -1751, -1752 (Fed. Cir. August 16, 2021) (Lourie, J.). These decisions come as the latest events in a dispute between Teva and Eli Lilly Company over competing products for the treatment of migraine headaches.

Teva owns nine patents directed to humanized antagonist antibodies that target calcitonin gene-related peptide. In 2018, the Food and Drug Administration (FDA) first approved Teva’s version of the biologic fremanezumab (Ajovy®) and then approved Lilly’s biologics license application for galcanezumab (Emgality®) eight days later. Both drugs are part of a new class of migraine therapeutic agents called calcitonin gene-related peptide antagonists.

Lilly challenged the validity of Teva’s nine patents covering Ajovy® in a series of inter partes review (IPR) petitions, arguing that the claims were obvious. The Board instituted IPR for all nine Teva patents. The similarity of subject matter and arguments led to three separate written opinions, each addressing three of the patents. In these decisions, the Board upheld the validity of three of the patents at issue (which covered methods of treating migraines with the antibodies) but found the claims of the six other patents directed to the antibodies themselves invalid.

Lilly appealed the first Board ruling covering methods of treating migraines to the Court. Lilly argued that the Board erred by (1) “reading a result into the constructions of the preambles and the term ‘effective amount,’” which led the Board to erroneously require Lilly to prove that a skilled artisan would have had “a reasonable expectation of achieving a result that was not claimed,” and (2) applying a too-high standard when weighing evidence to determine whether a skilled artisan would have a reasonable expectation of success. Lilly contended that a claim preamble containing only a statement of purpose cannot be a claim limitation and that no weight should have been given to the preambles. Teva argued that Lilly was basing its analysis on a false dichotomy between “limiting preambles” and preambles that are mere statements of purpose.

The Federal Circuit found the claim preambles to be limiting, reasoning that claims directed to methods of using compositions “are not directed to what the method ‘is’” but rather to “what the method ‘does,’” which usually is recited in the preamble. The preambles provided the only metric by which one practicing the claim could determine whether the amount administered is an “effective amount” and provided the antecedent basis for at least one later claim term in the independent claims.

After finding the preambles to [...]

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It’s Highlighted and Verified: Reversal of PTAB Non-Obviousness Decision

By Cecilia Choy, Ph.D. on Jun 3, 2021
Posted In Patents

In a relatively unusual outcome, the US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board (Board) decision finding non-obviousness in an inter partes review (IPR). Becton, Dickinson, and Co. v. Baxter Corp. Englewood, Case No. 20-1937 (Fed. Cir. May 28, 2021) (Dyk, J.)

Becton petitioned the Board for IPR of Baxter’s pre-America Invents Act (AIA) patent, directed to a system for preparing patient-specific doses and a method for telepharmacy. The Board decided that the patent claims were not shown to be invalid as obvious, but also found that Baxter’s secondary considerations evidence was “weak.” Becton appealed based on two contested limitations: a verification limitation and a highlighting limitation. The Federal Circuit reversed the Board, concluding that the challenged claims were obvious and explained that weak evidence of secondary considerations could not overcome the strong showing of obviousness.

First, the Federal Circuit decided that the Board erred in finding that a prior art reference that taught a remote pharmacist may verify a dose preparation did not render obvious a claimed method where a remote pharmacist must verify. The reference made clear that a non-pharmacist could not further process work without the verification step. Baxter’s own expert witness conceded that, in accordance with the teachings of the prior art, a non-pharmacist would be disciplined for continuing to process dose preparation without authorization. The Court concluded there was no significant difference between the teaching in the prior art reference and Baxter’s verification requirement.

Second, the Federal Circuit decided that the Board erred in finding that the “highlighting” limitation as it relates to a set of drug preparation steps on a computer was non-obvious. In what it characterized as a “close case,” the Board decided that a prior art reference’s teachings highlighting patient characteristics when dispensing repackaged medication did not make obvious highlighting, in a drug formulation context, prompts for additional information. Citing KSR v. Teleflex, the Court explained that the “combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” The reference taught highlighting in terms of various inputs and information delivered. Becton’s expert testified that one of ordinary skill would understand from the reference that other information, such as prescription order information, could be displayed on the user interface. Baxter’s expert did not contradict Becton’s expert. Because “a person of ordinary skill is also a person of ordinary creativity, not an automaton,” the Board erred in using that one reference as the only source for what one of ordinary skill would consider.

Lastly, Baxter unsuccessfully argued that under pre-AIA 35 U.S.C. § 102(e)(2), one of the patent references was ineligible as prior art. Sec. 102(e)(2) provides that a prior art reference may be a “patent granted” on another’s application filed in the United States before the invention by the applicant. Baxter argued that since the claims of the reference were cancelled after a 2018 IPR, the reference no longer qualified as a “patent granted” [...]

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Emmy Award to the Rescue – Secondary Considerations Overcome Prior Art

By McDermott Will & Emery on Apr 30, 2020
Posted In America Invents Act

The Patent Trial and Appeal Board (Board), in a decision designated as precedential, found that a Patent Owner’s substitute claims were patentable in view of evidence of secondary considerations even though the prior art weighed in favor of obviousness. Lectronics, Inc. v. Zaxcom, Inc., Case No. IPR2018-01129 (PTAB Jan. 24, 2020) (Deshpande, APJ.) (designated precedential on Apr. 14, 2020).

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