Inter Partes Review (IPR) Archives | Page 10 of 19

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

by Paul Devinsky | Aug 26, 2021 | 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The US Court of Appeals for the Federal Circuit issued three separate but related rulings (two precedential, one non-precedential) affirming decisions by the Patent Trial & Appeal Board (Board) regarding the validity of nine US patents and addressing the limitations of preamble language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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As Due Process Recognizes, it’s Hard to Shoot at a Moving Claim Construction Target

by McDermott Will & Schulte | Aug 5, 2021 | Patents

The US Court of Appeals for the Federal Circuit vacated several Patent Trial & Appeal Board (PTAB) decisions as violating due process and the Administrative Procedure Act (APA), referencing the parties’ inability to respond to the PTAB’s sua sponte construction of a term on which the parties had previously agreed. Qualcomm Inc. v. Intel Corp., Case Nos. 20-1589; -1594 (Fed. Cir. July 27, 2021) (Moore, C.J.)

After Qualcomm sued Intel over a patent directed to techniques for generating a power tracking supply voltage for a circuit that processes multiple radio frequency signals simultaneously, Intel filed six inter partes review (IPR) petitions challenging the validity of Qualcomm’s patents. In each petition, Intel proposed that the claim term “a plurality of carrier aggregated transmit signals” meant “signals for transmission on multiple carriers at the same time to increase the bandwidth for a user.” Qualcomm proposed a different construction: “signals from a single terminal utilizing multiple component carriers which provide extended transmission bandwidth for a user transmission from the single terminal.” Neither party disputed that the signals were required to increase user bandwidth, either at the PTAB or in a parallel proceeding before the US International Trade Commission (USITC) where the USITC adopted a construction—including the increased bandwidth requirement.

However, during the oral hearing, one of the administrative patent judges (APJs) asked Intel counsel about the inclusion of the bandwidth limitation in the claim construction. No other APJ raised, or asked Qualcomm, any questions about the increased bandwidth requirement in the claim construction. The day after the hearing, the PTAB sua sponte ordered additional briefing on the meaning of other claim terms that had been extensively discussed at the hearing.

The PTAB ultimately issued six final written decisions concluding that all challenged claims were unpatentable. In doing so, the PTAB omitted any requirement that the signals increase or extend bandwidth in construing the term “a plurality of carrier aggregated transmit signals” to mean “signals for transmission on multiple carriers.” The PTAB also held that “means for determining a single power tracking signal” (power tracker limitation) was a means-plus-function limitation and that an integrated circuit (IC) board, the “power tracker 582,” was the corresponding structure.

Qualcomm timely appealed, arguing that 1) it was not afforded notice of, or an adequate opportunity to respond to, the PTAB’s construction of “a plurality of carrier aggregated transmit signals” and 2) that the PTAB’s construction of the power tracker limitation was erroneous for failing to include an algorithm in the corresponding structure.

NOTICE AND OPPORTUNITY TO RESPOND TO THE PTAB’S CONSTRUCTION

The Federal Circuit has discussed the administrative and notice requirements provided by the APA and due process in IPR proceedings: “[a] patent owner in [an IPR] is undoubtedly entitled to notice of and a fair opportunity to meet the grounds of rejection” (Belden v. Berk-Tek). The Court observed that for IPRs, the PTAB must “timely inform” the patent owner of “the matters of fact and law asserted” and, in terms of notice, “must provide ‘all interested [...]

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Even Judges Have a Boss: PTAB Must Sufficiently Articulate its Obviousness Reasoning

by Paul Devinsky | Jul 29, 2021 | Patents

Addressing the sufficiency of the Patent Trial & Appeal Board’s (PTAB) justification of its inter partes review (IPR) determination, the US Court of Appeals for the Federal Circuit reversed the PTAB’s obviousness determinations, concluding that the PTAB’s findings regarding motivation to combine were not supported by substantial evidence. Chemours Company FC, LLC v. Daikin Industries, Ltd., Daikin America, Inc., Case No. 20-1289, -1290 (Fed. Cir., July 21, 2021) (Reyna, J.) (Dyk, J., concurring in part and dissenting in part).

Chemours, owner of the challenged patents, appealed the PTAB’s final written decisions in two IPRs initiated by Daikin. The challenged claims relate to a unique polymer for insulating communication cables formed by pulling wires through melted polymer to coat and insulate the wires, a process known as “extrusion.” The challenged claims of the patents recite that the polymer has a specific melt flow range of about 30+/- g/10 mins. The polymer’s melt flow range correlates with how fast the melted polymer can flow under pressure during extrusion. A higher melt flow rate means a faster coating of the polymer onto a wire. During the IPRs, the PTAB found all challenged claims unpatentable as obvious.

The Federal Circuit reviews the PTAB’s legal determinations de novo and its factual findings for substantial evidence, which “requires more than a ‘mere scintilla’ and must be enough such that a reasonable mind could accept the evidence as adequate to support the conclusion.” Obviousness is a question of law necessarily made on underlying findings of fact, and in making factual findings, the PTAB “must have both an adequate evidentiary basis for its findings and articulate a satisfactory explanation for those findings.”

In this instance, the Federal Circuit found that the PTAB’s obviousness findings were not supported by substantial evidence. According to the Court, while the PTAB may rely on prior art other than the references being applied or combined to inform itself of the state of the art at the time of the invention, the scope of the relevant prior art encompasses only that which is “’reasonably pertinent to the particular problem with which the inventor was involved.”’ Here, the Court explained that the only prior art reference relied on was not appropriate because it expressly taught away from the claimed invention and relied on teachings from other references that were not concerned with the particular problems the prior art sought to solve. As the Court noted, the PTAB “did not adequately grapple with why a skilled artisan would find it obvious to increase [the reference’s] melt flow rate to [the] claimed range while retaining its critical ‘very narrow molecular-weight distribution.’” To support its obviousness conclusion, the PTAB needed “competent proof showing a skilled artisan would have been motivated to, and reasonably expected to be able to, increase the melt flow rate of [the reference’s] polymer to the claimed range when all known methods for doing so would go against [the reference’s] invention by broadening molecular weight distribution.” By failing to provide its reasoning, the PTAB relied [...]

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Emmy Award to the Rescue – Secondary Considerations Overcome Prior Art

by McDermott Will & Schulte | Apr 30, 2020 | 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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