September 2, 2024 (Labor Day)

100 years ago today, US Patent No. 1,507,279, issued on Signaling Means for Toy Banks and for Other Purposes:

The patent explains that the invention relates primarily to improvements in signaling means capable of a variety of uses such as in connection with toy banks, show windows, advertising devices, light houses, etc.

August 8, 2024

On August 8, 1911, U.S. Patent No. 1,000,000,issued to Francis Holton for a vehicle tire

As of August 8, 2024, we are at U.S. Patent No. 12,058,943. In 113 years approximately 11,058,943 utility patents have issued averaging 97867 per year for 113 years or 8756 per month for 1356 months or 268 patents per day for 41, 274 days. That’s a lot of inventing!

August 3, 2024

On August 3, 1840, U.S. Patent No, 1711 issued to William Howe on a Truss Bridge.

This design was an improvement over his previous design, patented a month earlier on July 10, 1840, as U.S. Patent No. 1685:

Howe’s design was widely used through the middle and end of the 19th century, and was often used in the construction of covered bridges because the cover would protect the timbers in the truss, extending the life of the bridge. Howe patented (U.S. Patent No. 4726) a further improvement in 1846.

The Howe’s were a particular inventive family, with several members making inventions and getting, patents, the most notable is William’s nephew Elias, knows as the inventor of the sewing machine. Elias’ U.S. Patent No. 4750 was not the first patent on a sewing machine, but its lockstitch method was a substantial improvement. Meeting with limited commercial success, however, Elias turned to enforcement, and after many years of litigation, in 1856 formed the first American patent pool with Wheeler &Wilson, Grover & Baker, and another familiar name in sewing machines, I.M. Singer.

August 1, 2024

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.

July 16, 2024

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:

July 5, 2024

78 years ago today, on July 5, 1946, Louis Réard introduced his two-piece swimsuit design to the press and the public at the Piscine Molitor, a popular public pool in Paris. The swimsuit was modeled by Micheline Bernardini, an “exotic dancer” who worked at the Casino de Paris, because more reputable models refused to wear the suit, which consisted of just four triangles of fabric, totalling about 30 square inches.

There had been two-piece swimsuits before. Just a few months earlier, Ii May 1946, Jacques Heim produced a two-piece swimsuit that he named the “Atome.” Heim hired skywriters to fly above the Mediterranean coast advertising the Atome as “the world’s smallest bathing suit.” Réard’s swimsuit was more daring because it was smaller, and for the first time exposed the wearer’s navel.

Réard introduced his design four days after the first test of a nuclear weapon at the Bikini Atoll on July 1, 1946. The newspapers were full of news about it and Réard wanted to capitalize on the publicity so he named is suit the “bikini.” Réard, with an obvious flair for marketing, hired his own skywriters to fly over the French Riviera advertising his design as “smaller than the smallest bathing suit in the world.”  In the 1950’s Réard advertised that it wasn’t a true bikini “unless it could be pulled through a wedding ring.”

Less than two weeks from its introduction, Réard applied for French Design protection on his “Costume de bain 2 pièces.” The design was published as 31778 in Volume 374, pages 23-25, on December 17, 1946, and he received Reg. No. 35473-004.

It took a few years for society to catch up to Réard’s daring design, but by the 1960’s the bikini was mainstream. In August 1960, Brian Hyland famously sang about the “Itsy Bitsy Teenie Weenie Yellow Polka Dot Bikiini.”

Réard opened a bikini shop in Paris and sold swimsuits until he retired in 1980 and moved to Lausanne, Switzerland, where he died in 1984 at the age of 87.

An interesting side note is that Louis Réard was a mechanical engineer who took over his mother’s lingerie business in about 1940 and became a clothing designer.

July 1, 2024

45 years ago today, the Sony introduced the Walkman. Sony never pursued patent protection on the Walkman, believing it to be an innovation, not an invention. However, al little more than two years earlier, in March 1977 Andreas Pavel filed a patent application for his “Stereobelt” in Italy, followed by applications in Germany, United States, United Kingdom, and Japan.

Negotiations between Pavel and Sony began in 1980 and ended in 1986 with Sony agreed to pay Pavel limited royalties for the sales of certain Walkman models sold in Germany. The second round between Pavel and Sony began in 1990 in England and Wales, ending in 1993 with the court holding Pavel patent invalid for being “obvious and not significantly inventive,” leaving Pavel with a seven-figure attorney fee award to pay. On appeal Pavel tried to show non-obviousness through the commercial success of the Walkman, but the court rejected this, instead attributing the success to Walkman’s form factor, minimal operating power, and ability to reproduce high-quality sound at reasonable cost as key reasons for its appeal and popularity. The third and final round began in 2004, with Pavel threatening to file infringement proceedings in the remaining countries where he held patent, and Sony reportedly agreeing to a cash payment in the “low eight figures” and ongoing royalties of the sale of certain Walkman models.

Pavel told The New York times that he approached several electronics manufacturers but said he was met with rejection and ridicule. “They all said they didn’t think people would be so crazy as to run around with headphones, that this is just a gadget, a useless gadget of a crazy nut.” 45 years later, it’s hard to find someone running around without headphones. So it is with inventors — they see what the rest of us miss.

Website and Press Releases Created Plausible Claim of Inducement of Infringement by a Skinny Labelled Generic Product

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.

.

June 21, 2024

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.

Plaintiff Failed to Show It was Entitled to a Preliminary Injunction to Protect its Trade Secrets

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.