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IP UPDATE
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Results for "Patent precedent"
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Knowledge of Patent, Evidence of Infringement Are Necessary, but Not Sufficient, to Establish Willfulness

by | Mar 11, 2021 |

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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PTAB Designates Two Precedential Opinions for Evaluating Impact of District Court Litigations on Discretionary Denial under § 314(a)

by | Jan 7, 2021 |

In the wake of its May 13, 2020, precedential decision in Apple v. Fintiv, Inc., the Patent Trial and Appeal Board designated as precedential two additional decisions that weigh the Fintiv factors. In Fintiv, the Board articulated six factors for consideration when determining to exercise discretion to deny institution of an inter partes review (IPR) petition under § 314(a) in view of a parallel district court proceeding:

  • Existence of a stay pending IPR
  • Proximity of the court’s trial date to the Board’s deadline for issuing a final written decision
  • Expended investment in the parallel proceeding
  • Overlap between issues raised each proceeding
  • Whether the petitioner and the defendant are the same party
  • Other circumstances.

The two new precedential decisions provide further insight as to what circumstances may tip the balance for each factor. In each decision, the Board found that the circumstances of the parallel district court proceeding did not weigh in favor of a discretionary denial of institution.

In Sotera Wireless, Inc. v. Masimo Corp., Case No. IPR2020-01019, Paper 12 (USPTO Dec. 1, 2020 (Chagnon, APJ) (designated precedential as to § II.A on Dec. 17, 2020), the Board weighed the Fintiv factors and declined to deny institution based on the parallel district proceeding. In particular, the PTAB found that the already granted stay weighed strongly against exercising discretion to deny institution under the first factor. The Board rejected speculative arguments that if it declined review, the district court would lift the already granted stay and would set a trial date to pre-date the timeframe for issuing a final written decision in the IPR proceeding. The Board concluded that the second factor also weighed against denial because discovery was not complete and the district court had not issued a claim construction order or any other significant rulings. The Board also found that the fourth factor (issue overlap) weighed against denial because materially different invalidity grounds had been raised in the district court contentions as compared to the grounds at issue in the IPR petition.

In Snap, Inc. v. SRK Technology, LLC, Case No. IPR2020-00820, Paper 15 (USPTO Oct. 21, 2020 (Droesch, APJ) (designated precedential as to § II.A on Dec. 17, 2020), the Board again weighed the Fintiv factors and declined to deny institution based on the parallel district proceeding. Because the district court had not yet ruled on the motion to stay pending the outcome of the IPR, the Board found that the “stay factor” did not weigh for or against denying institution. As for the issue overlap factor, the Board found that a stipulation by the defendant to not pursue in district court any ground raised, or that could have reasonably been raised, in the IPR weighed strongly in favor of not exercising discretion to deny institution.



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PTAB Designates Three Opinions as Precedential

by | Dec 17, 2020 | ,

In RPX Corp. v. Applications in Internet Time, LLC, Case Nos. IPR2015-01750, -01751, -01752 (Oct. 2, 2020) (Boalick, CAPJ) (designated precedential on Dec. 4, 2020), the Patent Trial and Appeal Board (Board) terminated institution of RPX’s petitions for inter partes review (IPR) because Salesforce—served with a complaint more than one year before—should have been named as a real party-in-interest (RPI) to the proceedings. As a result, RPX’s petition was time-barred under § 315(b).

The Board’s determination came after remand from the Federal Circuit, which vacated the Board’s prior finding that Salesforce was not an RPI. (IP Update, Vol. 21, No. 8). The Federal Circuit instructed the Board to use the common law understanding of “real party-in-interest” and a “flexible approach that takes into account both equitable and practical considerations, with an eye toward determining whether the non-party is a clear beneficiary that has a pre-existing, established relationship with the petitioner.” On remand, the Board took additional discovery to examine the relationship between RPX and Salesforce, including RPX’s business model, Salesforce’s relationship with RPX, whether RPX represents Salesforce’s interests in invalidating the patents, and the significance of the fact that Salesforce and RPX had overlapping Board members. After considering the relationship, the Board found the evidence pointed clearly toward a common interest—between RPX and its members—in invalidating the patents in IPR proceedings. It found RPX could not avoid the time bar under § 315(b), or estoppel under § 315(e) for its members, by creating the appearance that RPX acts independently of its members’ interests when filing IPR petitions.

In SharkNinja Operating LLC v. iRobot Corp., Case No. IPR2020-00734 (Oct. 6, 2020) (Melvin, APJ) (designated precedential on Dec. 4, 2020), the Board declined to address—for purposes of institution—the patent owner’s claim that the IPR petition failed to name an alleged RPI under § 312(a)(2)’s requirement that a petition “identif[y] all real parties-in-interest.” iRobot alleged that JS Global was an unnamed RPI because it was intertwined with SharkNinja’s business and was in a position to fund and exercise control over the IPR petition. The Board declined to reach a determination on the issue because it would have no impact on the proceeding, absent evidence that (1) JS Global was a time-barred or an otherwise estopped entity whose addition to the petition would result in its dismissal under § 315 or (2) SharkNinja’s omission of JS Global was done in bad faith. Even if SharkNinja was mistaken in its decision not to name JS Global as an RPI, the Board’s precedent would allow SharkNinja to correct the mistake during the proceeding.

In Apple Inc. v. Uniloc 2017 LLC, Case No. IPR2020-00854 (Oct. 28, 2020) (Quinn, APJ) (designated precedential on Dec. 4, 2020), the Board exercised its discretion to deny Apple’s motion for joinder because it would have resulted in a “serial attack” on Uniloc’s patent. Apple had previously filed an IPR petition on the same patent, alleging various grounds of invalidity. The Board denied institution because it failed to show a reasonable likelihood [...]

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PTO Seeks Comments on Proposed Rulemaking for Denying Patent Reviews

by | Oct 29, 2020 | ,

The US Patent and Trademark Office (PTO) requested public comments on considerations for instituting trials under the Leahy-Smith America Invents Act (AIA). Comments are due by November 19, 2020.

Patent practitioners have grown accustomed to reviewing the PTO Patent Trial and Appeal Board (Board) administrative guide, precedential or informative opinions, and other published filings and decisions to discern best practices for filing petitions for and defending against inter partes review, post-grant review, covered business method and derivation proceedings before the Board. For example, the latest Board Consolidated Trial Practice Guide (Nov. 2019) (CTPG) is available here. The PTO is considering codifying or modifying its current policies and practices through formal rulemaking and wishes to gather public comments on its current approach and other approaches suggested by stakeholders.

PTO policies and Board decisions such as General Plastic, Valve Corp. I, Valve Corp. II, NHK Spring and Fintiv set forth factors for analyzing whether to institute an AIA proceeding (and particularly a follow-on or serial petition) or issue a discretionary denial due to the timeline for parallel district court proceedings. Many of these policies and cases are also discussed in the CTPG. The PTO already has received input from stakeholders on these policies that expand on the PTO director’s discretionary authority to institute an AIA trial. Most stakeholder comments suggested that the case-specific analysis outlined in precedential opinions and the CTPG achieves the appropriate balance and reduces gamesmanship—for example, by ensuring that AIA proceedings do not create excessive costs and uncertainty for the patent owner or the system, while allowing meritorious challenges to patents to be heard. However, some stakeholders have proposed that the PTO adopt brightline rules, regardless of the case-specific circumstances, to:

  • Use its discretion to preclude claims from being subject to more than one AIA proceeding
  • Permit more than one AIA proceeding only if the follow-on petitioner is unrelated to the prior petitioner
  • Place no limits on the number of petitions that can be filed or the number of AIA trials that can be instituted against the claims of a patent, so long as the petition complies with statutory timing requirements and the institution threshold of showing that at least one claim of the patent is unpatentable
  • Preclude institution of an AIA trial against challenged claims if the patent owner opposes institution and a related district court or US International Trade Commission (ITC) action (in which any of the challenged claims are or have been asserted against the petitioner, the petitioner’s real-party-in-interest or a privy of the petitioner) is unlikely to be stayed
  • Eliminate any consideration of the status of any district court or ITC actions involving the challenged patent, so long as the petition complies with statutory timing requirements and the institution threshold.

These contrasting views prompted the PTO to issue a request for comments on the factors that should be considered as part of a balanced assessment of the relevant circumstances when exercising its discretion to institute an AIA trial. The PTO [...]

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“Method of Preparation” Claims Still Patent Eligible Under § 101 in Modified Opinion

by | Aug 13, 2020 |

The US Court of Appeals for the Federal Circuit denied an accused infringer’s petition for rehearing en banc and issued a modified opinion with additional analysis maintaining its prior finding that patent claims directed to a method of preparation were patent eligible. Illumina, Inc. v. Ariosa Diagnostics, Inc., Case No. 19-1419 (Fed. Cir. Aug. 3, 2020) (Lourie, J.) (Reyna, J., dissenting).

In its original decision in Illumina v. Ariosa, the Federal Circuit found that claims directed to methods of preparing a fraction of cell-free DNA that is enriched in fetal DNA were not directed to a patent-ineligible natural phenomenon. In its modified opinion, the Court again concluded that the claims were patent eligible under § 101 because they were not directed to a natural phenomenon, but to an exploitation of that natural phenomenon, by inventing a method for preparing a mixture enriched in fetal DNA that selectively removed maternal DNA. In the modified opinion, the majority further explained that the claimed size thresholds were not dictated by any natural phenomenon, but were “human-engineered parameters that optimize the amount of maternal DNA that is removed from the mixture and the amount of fetal DNA that remains in the mixture in order to create an improved end product that is more useful for genetic testing than the original natural extracted blood sample.” The Court emphasized that the claimed methods achieve more than an observation or detection of a natural phenomenon because the claims include “physical process steps that change the composition of the mixture, resulting in a DNA fraction that is different from the naturally occurring fraction in the mother’s blood.” The Court distinguished Myriad by stating that the claims were ineligible in that case because they covered a gene that the inventors isolated but did not invent, whereas in this case, the inventors claimed an innovative method using human-engineered size parameters to perform the separation—not the separated DNA itself. The Court concluded that the claimed methods were patent eligible under § 101 because they “utilize the natural phenomenon that the inventors discovered by employing physical process steps and human-engineered size parameters to selectively remove larger fragments of cell-free DNA and thus enrich a mixture in cell-free fetal DNA.”

Judge Reyna again dissented, arguing that the claims were patent ineligible under § 101 because they were directed to an undisputed natural phenomenon (i.e., the “surprising” discovery of size discrepancy of cff-DNA in a mother’s blood), and the application of the natural phenomenon used routine steps and conventional procedures that are well known in the art. He explained that “[l]ike in Alice, the claims here are directed to a natural phenomenon because they involve a fundamental natural phenomenon, that cff-DNA tends to be shorter than cell-free maternal DNA in a mother’s blood, to produce a ‘mixture’ of naturally-occurring substances.” Judge Reyna argued that the majority ignored the Court’s “claimed advance precedent” by reasoning that the claims belong in a distinct category of “method of preparation” claims, but such characterization should be treated [...]

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Hooked on Precedent or Something New

by | Aug 13, 2020 |

Highlighting internal disagreement regarding patent eligibility under § 101, a divided panel of the US Court of Appeals for the Federal Circuit issued a series of opinions revising and reissuing a previous opinion on § 101 patent eligibility for a mechanical invention and, in an even split, denied a petition for en banc review. American Axle & Manufacturing, Inc. v. Neapco Holdings LLC, Case No. 18-1763 D.I. 134 (Fed. Cir. Oct. 3, 2019) (Dyk, J.) (Moore, J., dissenting); id. D.I. 133 (denying en banc by a 6–6 vote).

In October 2019, a divided Federal Circuit panel in American Axle v. Neapco affirmed a district court finding that method claims for a mechanical invention were invalid under 35 U.S.C. § 101. The majority specifically found that the claimed invention was nothing more than a recitation of Hooke’s law, which undoubtedly is a law of nature. Judge Moore dissented, arguing that the majority improperly expanded the § 101 eligibility inquiry beyond its statutory gatekeeping function and distorted patent eligibility under § 101 and enablement under § 112.

Neapco filed a petition for rehearing and a petition for rehearing en banc. Several amicus briefs were also filed. Notably, retired Judge Paul R. Michel, formerly the chief judge of the Federal Circuit, filed an amicus brief in support of the en banc petition because he believed the panel’s original decision “conflicts with the Supreme Court’s and [Federal Circuit’s] precedent.”

In view of the petition for rehearing, the original panel modified and reissued its opinion. The Court affirmed its original decision that two of the three independent claims were invalid under § 101 (patent claims 22 and 36); however, the Court reversed its original decision invalidating claim 1. Regarding claims 22 and 36, the majority reiterated that the claims were merely an application of Hooke’s law and that it was simply applying Supreme Court and Federal Circuit precedent, analogizing this case to the Supreme Court’s 1853 O’Reilly v. Morse decision where the Supreme Court determined the patentability of claims directed to a natural law of using electromagnetic force to transmit messages. When responding to the dissent, the majority reiterated that it was not departing from prior precedent, and that its “holding is limited to the situation where a patent claim on its face and as construed clearly invokes a natural law, and nothing else, to accomplish a desired result.”

Regarding claim 1, the majority reversed its original decision because the claim had an additional limitation that could cause the claim to not merely be an application of Hooke’s law. Because the district court did not address this limitation, the majority remanded the case so the district court could address this issue in the first instance.

Judge Moore maintained her dissent, arguing that the majority was announcing a new patentability test: the “Nothing More” test. She argued that the decision created a new test for instances when claims are directed to a natural law even though no natural law is specifically recited in the claims. Judge Moore further reiterated [...]

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Stick to Your Guns: PTAB Should Rarely Issue New Grounds of Unpatentability

by | Jul 15, 2020 |

The Patent Trial and Appeal Board (PTAB) Precedential Opinion Panel (POP) issued a precedential opinion in an inter partes review (IPR) to resolve two questions:

  • May the PTAB raise a ground of unpatentability not developed by the petitioner?
  • If it does so, must the PTAB provide the parties notice and an opportunity to respond to the new ground of unpatentability?

Hunting Titan, Inc. v. DynaEnergetics Europe GmbH, Case No. IPR2018-00600 (USPTO July 6, 2020) (Boalick, CAPJ) (granting request for POP rehearing). The POP held that while the PTAB may raise new grounds of unpatentability, it should refrain from doing so except in rare instances. If it does raise new grounds of unpatentability, the PTAB must provide the parties notice and an opportunity to respond to the new grounds.

Titan filed a petition requesting IPR of a patent owned by DynaEnergetics directed to a perforating gun assembly for wellbore tools. One of the grounds alleged anticipation by a prior art reference (Schacherer). The PTAB instituted review, and DynaEnergetics timely moved to amend the claims. Opposing the motion to amend, Titan argued that the substitute claims were obvious over various prior art references, including the Schacherer reference. Titan did not argue anticipation as to the substitute claims. In its final written decision, the PTAB held that the amended claims were unpatentable because they were anticipated by Schacherer. DynaEnergetics moved for reconsideration and POP review.

The POP granted review to provide precedential guidance on new grounds of unpatentability. Citing to the recent US Court of Appeals for the Federal Circuit decision in Nike, Inc. v. Adidas AG, the POP determined that the PTAB may raise new grounds of unpatentability in certain cases, but those cases should be exceedingly rare. The POP reasoned that the adversarial nature of an IPR proceeding puts the competing parties in a better position to identify and argue the strongest grounds. The POP rejected the notion that the PTAB should independently examine the patentability of every proposed substitute claim, as if it were a reexamination proceeding, by culling through the prior art to determine if better unpatentability arguments could have been presented. Only in rare cases that are no longer adversarial, such as when a petitioner does not oppose a motion to amend or when a petitioner ceases to participate in an instituted IPR that proceeds to a final judgment, would it be reasonable for the PTAB to consider new grounds of unpatentability. Although the POP did not articulate every exceptional scenario, it suggested that when the record “readily and persuasively” establishes that substitute claims are unpatentable, it would be reasonable for the PTAB to rely on a new ground of unpatentability. Titan’s IPR was not an exceptional case, so the POP reversed the panel’s decision as to the substitute claims.

The POP also explained that the parties must be given notice and an opportunity to respond to any new grounds the PTAB may raise. With respect to substitute claims, notice cannot come from the grounds [...]

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“Waive” Goodbye to Belated Argument that Administrative Patent Judges’ Appointment is Unconstitutional

by | May 14, 2020 | ,

Addressing whether a party can waive a challenge to the constitutionality of Administrative Patent Judges’ (APJs’) appointment, the US Court of Appeals for the Federal Circuit found that the issue is non-jurisdictional and therefore waivable. Ciena Corp. v. Oyster Optics, LLC, Case No. 19-2117 (Fed. Cir. Jan. 28, 2020) (O’Malley, J.) (reissued as precedential May 5, 2020).

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Patent’s Explicit Description of Claimed Advantages Defeats § 101 Challenge

by | Apr 30, 2020 |

Reversing a district court’s motion to dismiss, the US Court of Appeals for the Federal Circuit found patent claims directed to cardiac monitoring devices patent eligible under 35 USC § 101 because the claims were directed to a technical improvement to the function of such devices. CardioNet, LLC v. InfoBionic, Inc., Case No. 19-1149 (Fed. Cir. Apr. 17, 2020) (Stoll, J.) (Dyk, J., dissenting in part, concurring in the result).

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With Notice and Opportunity to Respond, PTAB May Raise New Patentability Issues Based on Art of Record

by | Apr 23, 2020 | ,

In an opinion concerning the notice provisions of the Administrative Procedure Act (APA), the US Court of Appeals for the Federal Circuit held that the Patent Trial and Appeal Board (PTAB) may identify a new patentability issue regarding proposed substitute claims based on prior art of record—but must first notify the parties and provide an opportunity to respond. Nike, Inc. v. Adidas AG, Case No. 20-1262 (Fed. Cir. Apr. 9, 2020) (Stoll, J.).

The decision is part of a long-running battle between Nike and Adidas that began in 2012, when Adidas filed a petition for inter partes review (IPR) of a patent owned by Nike. Nike subsequently filed a motion to cancel the existing claims and substitute new claims. Particularly relevant is a new claim that recites a knit textile upper element of a shoe containing “apertures” that can be used to receive laces and that are “formed by omitting stitches” in the knit textile.

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