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Sleep Better: Amendments Proposed during IPR Deemed Proper and Valid

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s (Board) finding that proposed amendments made during an inter partes review (IPR) are valid and proper despite the inclusion of changes not related to patentability issues raised in the petition. Nat’l Mfg., Inc. v. Sleep No. Corp., Case No. 21-1321 (Fed. Cir. Nov. 14, 2022) (Stoll, Schall, Cunningham, JJ.)

We’ve likely all seen the commercials promising a proven quality of sleep. Sleep Number is the owner of numerous patents, including several directed to methods for adjusting “the pressure in an air mattress ‘in less time and with greater accuracy’ than previously known.” The patents state this is achieved by taking pressure measurements at the valve enclosure and applying a pressure adjustment factor that is iteratively revised using an “adjustment factor error.” The patent states that this method allows for monitoring the pressure of the air mattress without the need to turn off the pumps.

American National Manufacturing challenged the validity of the patents in an IPR proceeding, claiming that most were rendered obvious by the prior art of Gifft in view of Mittal and Pillsbury and that six of the dependent claims requiring a “multiplicative pressure adjustment factor” would have been obvious in further view of Ebel. Gifft disclosed an air-bed system using valve assembly pressure to approximate the air chamber pressure and Mittal and Pillsbury both disclosed using additive offsets to improve accuracy. Ebel disclosed using both additive and multiplicative components to accurately measure the actual pressure in an inflating or deflating air bag.

The Board agreed with American National that it would have been obvious to combine Gifft, Mittal and Pillsbury and that the resulting combination rendered most of the claims obvious, but it also noted that the combination failed to show that a “skilled artisan would have applied Ebel’s multiplicative factors” to the prior art. However, in each proceeding Sleep Number filed a motion to amend the claims contingent on a finding that the challenged claims were unpatentable. The proposed claims included the “multiplicative pressure adjustment factor” that the Board had determined was not unpatentable along with other non-substantive changes.

American National took issue with these amendments, arguing they were legally inappropriate, non-enabled because of an error in the specification and lacked written description support. The Board disagreed. American National appealed. Sleep Number cross-appealed the Board’s finding of obviousness.

The Federal Circuit found that the proposed amendments were not improper even though some of the changes were non-substantive changes to address consistency issues. The Court pointed out that “once a proposed claim includes amendments to address a prior art ground in the trial, a patent owner also may include additional limitations to address potential § 101 or § 112 issues, if necessary.” The Court rejected American National’s argument that permitting such amendments creates an “asymmetrical” and “unfair” proceeding “by allowing the patent owner and the Board to address concerns that may be proper for [an] examination or reexamination proceeding, but that [...]

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Another Genus Claim Bites the Dust for Lack of Written Description

Addressing the issue of written description in the context of antibody-related genus claims, the US Court of Appeals for the Federal Circuit reversed a $1.2 billion jury verdict and found genus claims using functional language invalid for lack of written description. Juno Therapeutics, Inc. v. Kite Pharma, Inc., Case No. 20-1758 (Fed. Cir. Aug. 26, 2021) (Moore, J.)

Kite’s YESCARTA® is a therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19. Juno sued Kite, alleging infringement of a patent relating to a nucleic acid polymer encoding a three-part CAR for a T cell. The three-part CAR comprises:

  1. An intracellular domain of the CD3 ζ (zeta) chain, a signaling domain that is activated to create an initial immune response
  2. A costimulatory region comprising of a specific amino acid sequence (here, a specific CD28 sequence) that, when activated, directs the T cells to multiply
  3. A binding element that determines what target molecule or antigen the CAR can bind to, such as a single-chain antibody variable fragment (scFV).

Juno’s patent disclosed two scFVs (one that binds CD19 and another that binds PSMA) but did not disclose the amino acid sequence of either scFV.

After a two-week trial, the jury reached a verdict in Juno’s favor, finding in relevant part that Kite failed to prove that any of the asserted claims were invalid for lack of written description or enablement. The jury awarded damages amounting to a $585 million upfront payment and an almost 28% running royalty. The district court denied Kite’s motions for judgment as a matter of law and enhanced the total award to approximately $1.2 billion in addition to the 28% running royalty. Kite appealed.

The Federal Circuit reversed, concluding that no reasonable jury could find adequate written description because the patent disclosed neither representative species nor common structural features of the claimed scFV genus to identify which of the millions of billions of scFVs would function as claimed. Turning first to lack of representative species, the Court explained that the broadest asserted claims cover any scFV that binds to any target of clinical interest but fails to provide a representative sample of species within, or defining characteristics for, that expansive genus. The Court also disagreed that the two working embodiments in the patent were representative of the entire genus of vast number of possible scFVs that bind to an undetermined number of targets without more in the disclosure (such as the characteristics of the exemplary scFVs that allow them to bind to particular targets or nucleotide sequences). The Court stated that even if such scFVs were known as Juno argued, the specification provided no means of distinguishing which scFVs would bind to which targets.

Turning next to lack of structural features common to the claimed genus, the Federal Circuit held that general assertions that scFVs generally have a common structure in the context of the technology in this case were insufficient because an scFV with the [...]

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Knowledge of Patent, Evidence of Infringement Are Necessary, but Not Sufficient, to Establish Willfulness

Addressing claim construction, enablement, damages and willfulness, the US Court of Appeals for the Federal Circuit found that evidence of a defendant’s knowledge of the asserted patent and proof of infringement were, by themselves, legally insufficient to support a finding of willfulness. Bayer Healthcare LLC v. Baxalta Inc., Case No. 19-2418 (Fed. Cir. Mar. 1, 2021) (Stoll, J.)

Bayer owns a patent on certain recombinant forms of human factor VII (FVIII), a protein that is critical for blood coagulation. Recombinant FVIII is useful as a treatment for coagulation disorders, primarily Hemophilia A. Natural FVIII has a short half-life, making therapeutic administration expensive and inconvenient. Adding polyethylene glycol (a process known as PEGylating) to FVIII at random sites was found to increase the protein’s half-life but reduce its function. Bayer invented FVIII that is PEGylated in a specific region (the B-domain) so that it retains its function and maintains the longer half-life.

After Baxalta developed a PEGylated FVIII therapeutic, Adynovate®, Bayer sued Baxalta for infringement of its patent. During claim construction, the district court construed the claim preamble “an isolated polypeptide conjugate” to mean “a polypeptide conjugate where conjugation was not random,” finding that Bayer had disclaimed conjugates with random PEGylation. The district court also construed “at the B-domain” to mean “attachment at the B-domain such that the resulting conjugate retains functional FVIII activity,” rejecting Baxalta’s proposal of “at a site that is not any amine or carboxy site in FVIII and is in the B-domain” because Bayer had not disclaimed PEGylation at amine or carboxy sites. Before trial, Baxalta moved for clarification of the term “random” in the construction of the preamble, but the district court “again” rejected Baxalta’s argument that Bayer defined “random” conjugation as “any conjugation at amines or carboxy sites.”

Before trial, Baxalta moved to exclude the testimony of Bayer’s damages expert regarding his proposed reasonable-royalty rate. The expert had defined a bargaining range and proposed to testify that the royalty rate should be the midpoint of the range based on the Nash Bargaining Solution. The district court permitted the expert to testify as to the bargaining range but excluded the opinions regarding the midpoint as insufficiently tied to the facts of the case.

After trial, the district court granted Baxalta’s pre-verdict motion for judgment as a matter of law (JMOL) of no willful infringement. Subsequently, the jury returned a verdict that the claims were infringed and not invalid for non-enablement, and awarded damages based on an approximately 18% royalty rate for the period for which the parties had presented sales information. Baxalta moved for JMOL or a new trial on infringement, enablement and damages. Bayer moved for pre-verdict supplemental damages for the period between the presented sales data and the date of judgment, and for a new trial on the issue of willfulness. The district court denied all of Baxalta’s motions and Bayer’s motion for new trial, but granted Bayer’s motion for supplemental damages, applying the jury’s ~18% rate to sales data for the later period. [...]

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