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Exploring the Latest in Intellectual Property Law
IP UPDATE
Exploring the Latest in Intellectual Property Law
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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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Apportionment Unnecessary When Royalty Is Based on Comparable License

by | Dec 3, 2020 |

Rejecting a defendant’s request for a new trial on a variety of grounds, the US Court of Appeals for the Federal Circuit affirmed a damages award and explained that apportionment was unnecessary because a sufficiently comparable license was used to determine the appropriate royalty. Vectura Ltd. v. GlaxoSmithKline LLC et al., Case No. 20-1054 (Fed. Cir. Nov. 19, 2020) (Prost, C.J.)

Vectura owns a patent directed to the production of composite active particles for use in pulmonary administration, such as in dry-powder inhalers. Vectura filed a lawsuit against GlaxoSmithKline (GSK) alleging infringement of the patent by GSK’s Ellipta-brand inhalers. At trial, a jury found the patent valid and infringed, and awarded $90 million in damages. After GSK’s motion for judgment as a matter of law (JMOL) on infringement was denied, GSK appealed.

The Federal Circuit affirmed, rejecting all of GSK’s arguments. The Court rejected GSK’s argument that, based on a claim construction issue, it was entitled to JMOL of non-infringement. The asserted claims of the patent related to “composite active particles” made up of particulate additive material (magnesium stearate) on the surface of a particle of active material, used to promote the dispersion of these particles (in, e.g., inhalers). GSK argued that there was no substantial evidence of improved dispersion because Vectura’s scientific test was technically defective. The Court concluded that this test “generally supported” Vectura’s view and that, in any event, Vectura had provided other evidence—including GSK’s own documents—that the accused inhalers demonstrated improved dispersion.

The Federal Circuit also rejected GSK’s argument that the district court had erroneously construed the claim term “composite active particles” to mean “[a] single particulate entit[y/ies] made up of a particle of active material to which one or more particles of additive material are fixed such that the active and additive particles do not separate in the airstream.” GSK argued that this term required use of the “high energy milling” process referred to in the specification of the patent, but the Federal Circuit disagreed, stating that “[a]lthough the [asserted] patent contains a few statements suggesting that its high-energy milling is required . . . those statements are outweighed by the numerous statements indicating that high-energy milling is merely a preferred process.”

The Federal Circuit further rejected GSK’s argument that Vectura’s damages theory was deficient. Vectura’s damages theory was based on a 2010 license between the parties relating to highly comparable technology. GSK argued that Vectura’s damages theory simply adopted the royalty rate from this prior license wholesale and failed to “show that the patented . . . mixtures drove consumer demand for the accused inhalers before presenting a damages theory based on the entire market value of the accused inhalers.” The Court noted that the case presented a “rather unusual circumstance” in that, while apportionment is ordinarily required where an entire-market-value royalty base is inappropriate, “when a sufficiently comparable license is used as the basis for determining the appropriate royalty, further apportionment may not necessarily be required.” The Court concluded that this was “one [...]

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Too Good to Be True? Federal Circuit Demands Evidence of Reliance on Favorable Ruling, Stipulation

by | Nov 4, 2020 |

The US Court of Appeals for the Federal Circuit held that notwithstanding a stipulation on claim construction, a party may still induce infringement absent proof that it actually relied on the stipulation, and that mere inaction, absent an affirmative act to encourage infringement, cannot be the basis for a claim of inducement. The Federal Circuit also affirmed the district court’s reduction of the jury’s damages award to $0 despite a finding of direct infringement because the plaintiff failed to prove damages. TecSec, Inc. v. Adobe Inc., Case Nos. 19-2192, -2258 (Fed. Cir. Oct. 23, 2020) (Taranto, J.).

TecSec owns several patents on systems and methods for multi-level security for network-distributed files. TecSec sued Adobe (among other defendants) in this now-10-year-old-case, which the Federal Circuit has considered several times. As relevant here, the district court entered a claim construction in 2011 that led to a stipulation of non-infringement, and the Federal Circuit reversed that claim construction in 2013. On remand, the district court barred TecSec from introducing evidence of inducement in the 2011–2013 period on the grounds that it was reasonable for Adobe to have relied on the district court’s ruling and the stipulation. On the new claim construction, Adobe stipulated to one act of direct infringement. Adobe also moved for summary judgment of patent ineligibility, which the district court denied, stating that its rationale supported judgment for TecSec that the patents claimed eligible subject matter. At trial, the jury found that the claims were valid and that Adobe directly infringed but did not induce infringement. The jury awarded TecSec $1.75 million in damages. On Adobe’s post-trial motion, the district court reduced the damages award to $0 because TecSec had not proved inducement and had proved no damages associated with the single act of direct infringement. Both parties appealed.

Inducement

The Federal Circuit reversed the district court’s decision on Adobe’s motion in limine barring inducement evidence for the 2011–2013 period. The district court’s primary rationale for granting the motion had been the reasonableness of Adobe’s reliance on the claim construction order and stipulation of non-infringement. However, the Federal Circuit reasoned that the intent prong of inducement is a subjective inquiry, and that inducement could still be found upon a showing that Adobe subjectively believed that the claim construction order was wrong and would subsequently be reversed.

Jury Instructions

The Federal Circuit next addressed two challenges by TecSec to jury instructions. The first instruction was predicated on three facts: (i) that Adobe had admitted that a certain sequence of steps constituted direct infringement, (ii) that Adobe had performed the steps on at least one occasion, and (iii) that “the parties agree that the one time for which Adobe had admitted infringement . . . occurred before TecSec filed its lawsuit.” The Court found that this instruction was factually accurate and therefore not erroneous. The second instruction explained that inducement required “an affirmative act to encourage infringement,” and that “[e]vidence of mere inaction, or a failure to stop or prevent infringement, does not [...]

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Trade Secret Misappropriators Fail to Launch in Rocket Facility

by | May 14, 2020 |

Addressing a variety of challenges to a judgment against defendants in a trade secret misappropriation action, the US Court of Appeals for the Third Circuit found that the plaintiff had standing on the basis of lawful possession (as opposed to ownership) of the trade secret materials and that the damages awarded, including punitives, was supported by sufficient evidence. Advanced Fluid Systems, Inc. v. Huber, Case Nos. 19-1722; -1752 (3d Cir. Apr. 30, 2020) (Jordan, J.).

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Failure to Mark Can Put Damages Underwater

by | Mar 12, 2020 |

The US Court of Appeals for the Federal Circuit affirmed that patented articles must be marked in order for the patentee to recover pre-notification or pre-complaint damages. Arctic Cat Inc. v. Bombardier Recreational Products Inc., Case No. 19-1080 (Fed. Cir. Feb. 19, 2020) (Lourie, J).

In 2002, Arctic Cat entered into a licensing agreement with Honda for patents related to personal watercraft. The license agreement contained no provisions requiring Honda, as a licensee, to mark all licensed products with the applicable patent numbers. Honda began selling unmarked watercraft, and Arctic Cat made no attempt to ensure that the products were marked. Approximately a decade later, Honda stopped selling the unmarked products.

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Failure to Mitigate Not a Complete Defense to Statutory Damages Under Copyright or DMCA

by | Jan 29, 2020 |

On an issue of first impression in a copyright infringement dispute out of the Southern District of Texas, the US Court of Appeals for the Fifth Circuit confirmed that failure to mitigate is not a complete defense to copyright or Digital Millennium Copyright Act (DMCA) claims for statutory damages. Energy Intelligence Grp., Inc. et. al., v. Kayne Anderson Capital Advisors, LP, et. al., Case No. 18-20350 (5th Cir., January 15, 2020) (Higginson, J.).

In 2014, energy industry publisher Energy Intelligence Group, Inc. and its affiliated entity in the United Kingdom (together, EIG) filed suit against energy securities investment firm Kayne Anderson Capital Advisers (KA), alleging copyright infringement and abuses of the DMCA based on a KA partner’s violation of US copyright law and violation of his subscription agreement for EIG’s Oil Daily newsletter, which provides news and analysis about the North America petroleum industry. The jury in the district court proceeding found that EIG could have reasonably avoided almost all of the alleged copyright and DMCA violations through real-time investigations and enforcement efforts, and thus awarded EIG just over $500,000 in statutory damages for the infringement of 39 works of authorship. The district court, however, still applied the Copyright Act’s fee shifting provisions and awarded EIG over $2.6 million in attorney’s fees and costs. The parties’ consolidated appeals to the Fifth Circuit thus presented an issue of first impression: namely, whether the failure to mitigate copyright infringement is a complete defense to liability for statutory damages under the Copyright Act and the DMCA.

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No Statutory Damages Even When Post-Registration Acts Violate a Different Exclusive Right from Pre-Registration Acts

by | Jan 29, 2020 |

The US Court of Appeals for the Fifth Circuit has reversed a district court ruling awarding statutory copyright damages for pre-registration infringements, explaining that the statute bars such an award even when the post-registration infringement of exclusive rights of the copyright holder is different from the pre-registration act(s). Southern Credentialing Support Services, LLC v. Hammond Surgical Hospital, LLC, Case No. 18-31160 (5th Cir. Jan. 9, 2020) (Costa, J.). This case analyzes § 412 of the US Copyright Act, which bars an award of statutory damages for infringements commenced prior to registration of a copyright.

Credentialing is a process doctors must complete to practice at hospitals, and credentialing service providers verify the information doctors provide. Southern Credentialing Support Services (SCSS) began providing credentialing services to Hammond in 2010, and designed two packets of custom forms for credentialing uses by Hammond. After SCSS stopped providing services to Hammond in 2013, Hammond contracted with another provider for credentialing services and continued to use some of the forms developed by SCSS. By 2017, the new provider for Hammond had also made the SCSS forms available online. SCSS did not obtain copyright registration for its forms until 2014, after learning that Hammond was still using some of the SCSS forms. After the parties failed to resolve the dispute amicably, SCSS sued Hammond for copyright infringement.

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Slipping Through the Cracks of the § 271(e)(1) Safe Harbor

by | Jan 8, 2020 | ,

The US Court of Appeals for the Federal Circuit affirmed that the majority of the batches of an accused biosimilar manufactured by Hospira were not protected by the Safe Harbor exemption of § 271(e)(1), and that patent infringement damages were not unreasonable, notwithstanding that none of the accused product had been sold. Amgen Inc. v. Hospira, Inc., Case Nos. 19-1067; -1102 (Fed. Cir., Dec. 16, 2019)(Moore, J.).

EPO is a glycoprotein that regulates red blood cell development. Recombinant versions of EPO are used to treat anemia. One example is Amgen’s product Epogen. In 2014, Hospira submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) requesting approval for its EPO biosimilar. Amgen then sued Hospira for infringement of its patent directed to methods of producing EPO isoforms and its patent directed to recombinant cells producing EPO at certain rates. Specifically, Amgen asserted that 21 pre-approval batches of EPO manufactured by Hospira infringed various claims of these patents.

Hospira appealed.

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