On August 1, 1893, Henry D. Perky and William H. Ford were issued U.S. Patent No. 502378 on a Machines for the Preparation of Cereals for Food, which forms the boiled, steamed, steeped, or soaked grain into the familiar “pillow” shape of shredded wheat. He introduced the product at the Chicago World’s Fair in 1893.

In 1895 Perky was issued U.S. Patent No. 548,086, as well as U.S. Patent No. D24688 on the shape of the biscuit itself:

After the patents expired, Kellogg Company saw that as an opportunity for Kellogg’s to sell its own version of the product. Kellogg obtained a patent on the biscuit in 1916, and Kellogg’s Shredded Wheat was born. Kellogg obtained its own patents on the shredded wheat biscuit (U.S. Patent No. 1,168,888), numerous patents on the method of prepare shredded wheat biscuits (U.S. Patent Nos. 1,102,614, 1,124,363, 1,159,045, 1,170,162, and 1,197,297), on the package for the shredded wheat biscuits (U.S. Patent No. 1,914,336), and entered the market.

This provoked Perky’s successor National Biscuit Company to sue Kellogg for trademark infringement, attempting to enjoin it from using Shredded Wheat as a trademark and from manufacturing the cereal in its pillow-shaped form. The case eventually made it to the United States Supreme Court case Kellogg Co. v. National Biscuit Co., 305 U.S. 111, 59 S.Ct. 109, 83 L.Ed. 73 (1938). The Supreme Court held that the term “shredded wheat” was generic and not trademarkable — it was a term in public use for the product, and was how the product was described in the expired patents. Further, the court held that when the patent for the shredded wheat machinery expired in 1912, the right to make the shredded wheat “pillows” and apply the name “shredded wheat” to the resulting product, passed into the public domain along with that patent. This has been an important limitation of trade dress rights ever since.

A side lesson to learn is that St. Louis (the ice cream cone) handily beats Chicago (shredded wheat) as far as World’s Fair Food is concerned.

On July 16, 1969, Apollo XI launched, carrying Neil A. Armstrong, Edwin E. Aldrin, Jr., and Michael Collins, to the moon. It should be no surprise that a lot of patented technology contributed to the success of the mission.

U.S. Patent No. 3,576,298 covers variant of the Command Module:

U.S. Patent No. D219690 protects the appearance of a variant of the Lunar Module:

U.S. Patent No. 3,751,727 protected a space suit:

U.S. Patent No. 3,534,406 also protected a space suit:

In Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA, Inc., [2023-1169] (June 25, 2024), the Federal Circuit reversed the dismissal of Amarin’s complaint for failure to state a claim for induced infringement.

Less than a month after Hikma launched its generic icosapent ethyl product, Amarin sued
under 35 U.S.C. § 271(b), alleging that Hikma had induced infringement of U.S. Patent Nos. 9,700,537 and 10,568,861. through the content of Hikma’s press releases, website, and product label evidence Hikma’s specific intent to actively encourage physicians to directly
infringe the asserted patents by prescribing its generic icosapent ethyl product for the off-label CV indication, an indication for which Hikma did not get FDA approval. Hikma moved to dismiss under Federal Rule of Civil Procedure 12(b)(6), arguing that Amarin had failed, as a matter of law, to allege facts that Hikma had taken active steps to specifically encourage infringement.

The district court referred the case to a magistrate judge, who recommended denying the motion. The magistrate judge concluded that, based on the totality of the allegations, which relied not only on the content of the skinny label but also Hikma’s press releases and website, Amarin had “pleaded an inducement claim . . . that is at least plausible.” Specifically, she noted that, “notwithstanding the lack of an express instruction regarding the CV indication in the ‘Indications and Usage’ section of Hikma’s label, several other portions
of Hikma’s label, taken together with Hikma’s public statements, instruct physicians to use Hikma’s product in a way that infringes the asserted patents.” On de novo review, the district court declined to adopt the magistrate judge’s recommendation and granted
Hikma’s motion to dismiss.

The Federal Circuit said that although this case has underlying features of a traditional Hatch-Waxman case, at bottom, it is nothing more than a run-of-the-mill induced infringement case arising under 35 U.S.C. § 271(b).

The Federal Circuit said that although this case has underlying features of a traditional Hatch-Waxman case, at bottom, it is nothing more than a run-of-the-mill induced infringement case arising under 35 U.S.C. § 271(b). Accepting all well-pleaded facts as true and drawing all reasonable inferences in Amarin’s favor, the Federal Circuit concluded that Amarin’s complaint plausibly plead that Hikma actively induced healthcare providers’ direct infringement, i.e., that Hikma encouraged, recommended, or promoted infringement.

Amarin alleged that the clinical studies section, which describes statin-treated patients
with the same cardiovascular event history and lipid levels covered by the asserted patents, would be understood by physicians as a teaching that the product could be prescribed to treat cardiovascular risk. Amarin further alleged that Hikma’s removal of the CV Limitation of Use language and the warning of potential side effects for patients with cardiovascular disease, communicate to physicians that Hikma’s generic product could be used for the off-label CV indication — particularly since other drugs contain the CV Limitation.

The Federal Circuit said that taken on its own, it might have agreed with the district court
(and Hikma) that the label does not, as a matter of law, recommend, encourage, or promote an infringing use. But, as the magistrate judge correctly observed, Amarin’s theory of induced infringement is not based solely on the label. Counsel for Amarin explained that “our case is not about the label standing alone, but to be clear, we do rely on portions of the
label”). Rather, it is based on the label in combination with Hikma’s public statements and marketing materials.

The Federal Circuit noted that Hikima’s website promoted its product as broad enough to encompass both infringing and non-infringing uses, and its press releases, consistently referred to Hikma’s product as a “generic equivalent to Vascepa®” or “generic Vascepa®.”

Hikma’s press releases broadly refer to the product as a “generic version” of Vascepa and provide usage information and sales data for the brand-name drug from which it is plausible
that a physician could discern an encouragement to use the generic for purposes beyond the approved indication. The Federal Circuit found that the allegations in the Complaint plausibly state a claim for induced infringement.

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236 years ago today, New Hampshire became the ninth state to ratify the Constitution, and the U.S. Government was off and running. During the Constitutional Convention of 1787, both James Madison of Virginia and Charles C. Pinckney of South Carolina submitted proposals that would allow Congress the power to grant copyright for a limited time. (Pinckney’s South Carolina was the first state to enact its own patent law). James Madison wrote in the Federalist, “the States cannot separately make effectual provision” for the protection of invention and so in drafting the Constitution of the United States, responsibility for providing such protection was entrusted to the Congress of the United States. Madison’s and Pinckney’s proposals resulted in Article I, Section 8, Clause 8, which provides:

“The Congress shall have Power … To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.”

The First Congress in 1789 considered patent and copyright legislation. On January 8, 1790, during his first State of the Union, President Washington called on Congress to establish act on the Constitutional authorization, urging Congress to pass legislation designed for “the promotion of Science and Literature” “so as to better educate the public.”

On April 10, 1790, Washington signed into law the first Patent Act, and Samual Hopkins must have been waiting in the lobby because the first United States patent issued to him a few months later on July 31, 1790. The Patent Action of 1790 did not establish a Patent Office, and instead the submissions were examined by a committee, including Thomas Jefferson, that not only decided whether to issue a patent, but for how long (the Patent Act set the maximum term at 14 years). A grand total of three U.S. patents issued in 1790, and a total of 57 patents were issued under the Patent Act of 1790, before it was replaced with the Patent Act of 1793, which among other things, eliminated examination!

On May 31, 1790, Washington signed into law the first Copyright Act. Prior to the passage of the Constitution, several states passed their own copyright laws between 1783 and 1787, the first being Connecticut. This Copyright Act of 1790 granted authors the exclusive right to publish and vend “maps, charts and books” for a term of 14 years, renewable for one additional 14-year term, if the author was alive at the end of the first time. The Copyright Action of 1790 had a longer run than the Patent Act of 1790, being amended in 1802 and 1819, and replaced by the Copyright Act of 1831.

In Insulet Corp. v. Eoflow, Co, Ltd., [2024-1137] (June 17, 2024), the Federal Circuit reversed a preliminary injunction against manufacturing, marketing, or selling any
product that was designed, developed, or manufactured, in whole or in part, using or relying on alleged trade secrets of Insulet.

Insulet and EOFlow are medical device manufacturers that make insulin pump patches. Insulet began developing the wearable insulin pump OmniPod® in the early 2000s. The FDA approved the first OmniPod product in 2005, and a next-generation product, the OPI-2, came onto the market soon thereafter in 2007. Insulet then began work on its next-generation Eros product, which obtained FDA approval in 2012 and commercially launched in 2013.

EOFlow began developing its own flagship product, an insulin pump patch called the EOPatch®, soon after the company’s founding in 2011. The EOPatch received regulatory approval in South Korea in 2017, after which EOFlow began developing its next-generation
EOPatch 2. Around that time, four former Insulet employees joined EOFlow. In 2019 and 2022, respectively, the EOFlow 2 received regulatory approval in South Korea and
Europe, after which it began commercial distribution in those select geographic markets.

After reports surfaced that Medtronic had started a diligence process to acquire EOFlow. Insulet sued EOFlow for violations of the Defend Trade Secrets Act. (“DTSA”), seeking to enjoin all technical communications between EOFlow and Medtronic in view of its trade secrets claims. The district court temporarily restrained EOFlow from “disclosing products or manufacturing technical information related to the EOPatch or Omni[P]od products,” and then granted Insulet’s request for a preliminary injunction.

The Federal Circuit began by noting that trade secrets are an important form of intellectual property that both Congress and the states have deemed worthy of protection. The Founders also recognized the value, as well as the volatility, of an idea kept as a secret. However in evaluating Insulet’s likelihood of confusion, the Federal Circuit noted that the court did not assess the statute of limitations in the context of evaluating Insulet’s likelihood
of success on the merits, the court thus ignored a material factor deserving significant weight, which constitutes an abuse of discretion. If the three-year statute of limitations for filing a DTSA claim had expired, Insulet’s claims would be timebarred and therefore would have no chance of success.

Further, even if the district court had adequately dealt with the statute of limitations issue, that would have been insufficient to support the October 24, 2023 order. As EOFlow further contends, the district court also abused its discretion in its consideration of what constitutes a trade secret. The Federal Circuit quoted the definition of trade secret in the DTSA, and noted that the definition used in the district court’s order was severely overbroad, including “any and all Confidential Information of Insulet” and “any information that contains, derives from, or incorporates such Confidential Information.”

The Federal Circuit also disagreed with the district court’s assessment that “it would be unfair to require at this stage perfection as to the precise number and contours of the trade secrets at issue.”

In order to secure a preliminary injunction, Insulet had to establish the likelihood of its success on the merits for at least one, specifically defined, trade secret. It did not do so. Rather, it advanced a hazy grouping of information that the court did not probe with particularity to determine what, if anything, was deserving of trade secret protection.

Finding that Insulet took measures to protect some unidentified “set of information” is not the same as finding that Insulet took reasonable measures to protect specific information alleged to be a trade secret, such as particular “design drawings and specifications for each physical component and subassembly,” as the DTSA requires.

The Federal Circuit found that because the district court failed to identify any trade secret with sufficient particularity, its analysis of misappropriation necessarily also fails as well.

The Federal Circuit concluded that in view of the failure to address the statute of limitations,
the lack of a tailored analysis as to what specific information actually constituted a trade secret, as well as the finding that it was “hard to tell” what subset of that information
was likely to have been misappropriated by EOFlow, we find that the district court abused its discretion in granting the preliminary injunction.

The Federal Circuit also agreed with EOFlow that the district court’s analysis of irreparable harm and public interest were flawed. The Federal Circuit made a point of stating that it was not deciding that Insulet has failed to adequately allege misappropriation of trade secrets or that it cannot succeed on the merits of its claims, only that Insulet has not proven it was entitled to a preliminary injunction.

In Ecofactor, Inc. v. Google LLC, [2023-1101] (June 3, 2023), the Federal Circuit affirmed the the denial of Google’s motion for summary judgment that claim 5 of U.S. Patent No. 8,738,327 was invalid under 35 U.S.C. § 101; the denial of Google’s motion for judgment
as a matter of law of non-infringement of the ’327 patent; and the denial of Google’s motion for a new trial on damages.

The ‘327 patent relates to the operation of smart thermostats in computer networked
heating and cooling systems to reduce strain on the electricity grid during a period of expected high demand through adjustments to the user’s thermostat settings. The district court denied Google’s motion for summary judgment on Section 101, and submitted step two of the Alice inquiry to the jury, which found Google failed to meet its burden. Google filed a post-trial JMOL motion repeating its § 101 arguments, which the district court denied.

Google appealed the order denying summary judgment but not the jury verdict of ineligibility. The Federal Circuit said that the denial of Google’s motion for Summary Judgment was not appealable, disposing of the eligibility issue.

On the issue of infringement, the claims required a thermostat “that receives temperature
measurements from inside the structure.” Google argues that because metal, plastic, and/or glass housings, they cannot directly measure the surrounding ambient temperature “inside the structure” like other thermostats. Google argues that its thermostats can only derive an estimate of the ambient temperature by measuring only the temperature within the thermostat housing itself, which is not “inside the structure.” As a result, Google argues that the jury’s verdict of infringement is unsupported by substantial evidence.

EcoFactor’s infringement expert testified that the accused thermostat products meet
the claimed limitation because the thermostats measured temperature of the structure and not just the temperature within the thermostat housing. 26:20–327:6). EcoFactor’s expert supported his conclusion with several forms of evidence. EcoFactor’s expert relied on website guides maintained Google for the benefit of software engineers who develop applications for use with Nest thermostats. One website page states that the Nest thermostats measure the “[a]mbient temperature,” defined as the “temperature measured near the thermostat”—not just within the thermostat. Another website page explains that the temperature sensors of certain Nest products measure ambient room temperature.

The Federal Circuit concluded that the jury’s infringement verdict that the accused Nest thermostat products satisfy the claim language of “receives temperature measurements from inside the structure” is supported by substantial evidence.

On the issue of damages, Google argued for a new trial because EcocFactor’s damages expert should have been excluded. Among other things, Google asserted that his proposed royalty rate was “plucked . . .out of no where.” However the Federal Circuit said that far from plucking the $X royalty rate from nowhere, Mr. Kennedy based this rate on the following admissible evidence: three license agreements and the testimony of
EcoFactor’s CEO, Mr. Habib. Ultimately, the Federal Circuit noted, the jury returned a verdict of $20,019,300, which represents significantly less than Mr. Kennedy’s proposed damages amount of $Y that would have resulted from applying the $X royalty rate to Google’s past sales.

Google also attacked the lack of apportionment, since the licenses relied upon were for EcoFactor’s entire patent portfolio. The Federal Circuit explained that damages owed to the patentee must reflect the value of only the patented improvement—called apportionment. If a sufficiently comparable license is used for determining the appropriate reasonable royalty rate, further apportionment may not be required because the comparable license has built-in apportionment. Built-in apportionment effectively assumes that the negotiators of a comparable license settled on a royalty rate and royalty base combination embodying the value of the asserted patent.” Id. (citation omitted). For built-in apportionment to apply, the license must be sufficiently comparable in that principles of apportionment were effectively
baked into the purportedly comparable license. The Federal Circuit found that Mr. Kennedy sufficiently showed, for purposes of admissibility, that the three license agreements were economically comparable to the hypothetically negotiated agreement.

Judge Prost dissented from the damages portion of the opinion, stating that Google argues that (1) Mr. Kennedy, EcoFactor’s damages expert, calculated an $X royalty rate2 from the Schneider, Daikin, and Johnson lump-sum licenses in an unreliable way; and (2) the $X rate in any event did not reflect the value of the ’327 patent (as distinct from that of other patents covered by those licenses). Google is right on both counts. The district court therefore, in my view, abused its discretion by not granting a new damages trial given Mr. Kennedy’s flawed testimony.

In Purdue Pharma L.P., v. Collegium Pharmaceutical, Inc., [2022-1482] (November 21, 2023), the Federal Circuit affirmed the Final Written Decision of the PTAB that claims 1–17 of U.S. Patent No. 9,693,961 were unpatentable for lack of written description and anticipation.  The patent is titled “Pharmaceutical Formulation Containing Gelling Agent” and is meant to prevent or deter the abuse of opioid analgesics by the inclusion of at least one aversive agent.

Deadline for Final Written Decision

At the outset, the Federal Circuit rejected Purdue’s argument that the Board lacked authority to issue a Final Written Decision once the deadline established by 35 U.S.C. § 326(a)(11) and 37 C.F.R. § 42.200(c) (one year plus the six-month extension) passed.

Written Description

On written description, the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.  The Federal Circuit said it has required that the specification provide sufficient blaze marks to “guide a reader through the forest of disclosed possibilities toward the claimed compound.”  The issue was whether the ’961 specification adequately disclosed the claimed polyglycolyzed glycerides (“PGGs”) as an aversive agent. The Board found the claimed formulation was not disclosed, and the Federal Circuit concluded that substantial evidence supported the Board’s finding.

Although the ’961 claims on their face do not require an aversive agent, the specification makes clear that the claims require “inclusion of at least one aversive agent” and the parties agree that the claims require the use of an aversive agent.  PGGs are identified as a possible surfactant “useful in accordance with the present invention.”  While the specification discloses that some surfactants can be gelling agents and that gelling agents can satisfy the aversive agent requirement, the parties agree that not all surfactants are gelling agents.  The specification does not say that PGGs are gelling agents.  The only time PGGs are mentioned in the specification, they are described as a surfactant, and not as a gelling agent, and surfactants generally are described as “useful in accordance with the present invention.”  In other parts of the specification, the patent recognizes that surfactants can be used completely separate from and in addition to the gelling agent.

The Federal Circuit said that “[j]ust because the specification states PGGs are useful for the invention does not suggest how PGGs are gelling agents. The disclosure of the application does not reasonably convey to those skilled in the art that the inventor had possession of the claimed drug formula containing PGGs as a gelling agent (aversive agent). In other words, there are insufficient blaze marks.” Because the anticipation finding flowed from the lack of written description in the claimed priority application, the finding of anticipation was affirmed.