My New Book: Unfettered Invention - How the X Patents Sparked Early American Technology

 Alas, I haven't posted much lately. I hoped to regain the pace I had before becoming an administrator, but it has not happened yet. However, I figured the release of my new book was worthy of a post. 

Along with co-authors Scott Guthery and Julie Burke, we have published Unfettered Invention: How the X Patents Sparked Early American Technology.

Here is the description from the sales page, which is pretty complete:

Between 1790 and 1835, inventors simply described their ideas in an application form, sent with a $30 fee to Washington, DC. Almost 10,000 applications streamed into the newly created Patent Office, describing looms, water wheels, printing presses, pumps, bridges, and all the other technologies that powered early American industry. The ideas ranged from breakthroughs to small improvements to dead ends. Taken together, they offered an extraordinary window into the technological imagination of the founding era.

Then they were all destroyed in a catastrophic 1836 Patent Office fire. That same year, Congress passed a new patent act, setting more stringent requirements and restarting the patent numbering system. As a few thousand of the early applications were recreated over time, they were designated as “X Patents.”

The authors analyzed almost two hundred years of patent recovery attempts, and then went searching for more. They combed through scattered archival records, auction catalogs, courthouse filings, local museums, private collections, and US records repositories. A deep dive into the pages of The Franklin Journal, whose editor, Dr. Thomas Pascal Jones, tracked patent filings during the X patent era, revealed previously untapped records.

The result is a fascinating, eye-opening story of how the X patents ignited and shaped America’s appetite for innovation in everything from butter churns, washing machines, pumps, plows, spinning machinery, and printing presses to the most demanding engineering problems of the age: steam engines, locomotives, suspension bridges, automated mills, hydraulic machinery, and the transformation of the traditional water wheel into the modern water turbine.

Unfettered Invention starts by describing the chaotic early years of the Patent Office, followed by the rapid evolution of America's intellectual property law from twenty-seven words in the US Constitution to the writing of the Patent Act of 1836, the foundation of today's patent system. These chapters reveal how thinking about patents and a patent system matured over time, and describe key court cases addressing the thorny issues that the patent system underpinning an industrializing nation needed to address.

In the Notables chapter, the authors review high-impact X-patent inventions and the innovators who created them. These include commercially successful breakthroughs such as Cyrus McCormick's reaper. Other inventions had an impact despite being too far ahead of their time for mass production, for example, Samuel Morey's internal combustion engine.

The core of Unfettered Invention is the seven specific technical domains: bridges, water wheels, mathematical instruments, looms, printing presses, pumps, and railroads, describing the evolution of each technology as it adapted to the emerging needs of an industrializing nation. Bridges had to go over broader rivers, looms had to weave new kinds of fabric and do it faster, railroads had to get over the Appalachian Mountains, pumps had to drive city water systems, and water wheels had to be more efficient. These chapters document attempts to make technology work faster, cheaper, safer, more reliably, and, most importantly, at scale.

The book concludes with an appendix that describes in more detail the data that the authors used to build the story of the X patents.

For patent attorneys and IP professionals, the book offers a rare look at what American patent practice looked like before examination existed. For readers of technology and industrial history, the book is a fascinating account of a nation teaching itself to invent,

Part legal history, part technological archaeology, part detective story: Unfettered Invention captures early American industrial history.

It is available in hardback and paper - I hope you give it a look!

 

Hikma v. Amarin Argument Preview

Guest post by Kaidi (KD) Zhang, Stanford Law School J.D. expected 2027; UC Berkeley Ph.D. in Chemistry 2024

The Supreme Court will hear arguments in Hikma v. Amarin on April 29. The core question before the Court is seemingly straightforward but carries massive industry implications: Should a patent infringement claim based on inducement survive a 12(b)(6) motion to dismiss if the alleged infringer uses a statutorily permitted “skinny label,” but markets its generic drug as the “therapeutically equivalent” of the patented drug? 

In the decision below, the Federal Circuit held that pleading “the totality of the allegations of inducement” as “a whole” was sufficient for an induced infringement case to proceed. This ruling continued to narrow the viability of skinny labels, following the court’s earlier decision in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. (GSK), where it upheld a jury verdict of induced infringement based on a skinny label. 

In a recent Stanford Law Review article, Professors Jacob Sherkow and Paul Gugliuzza criticized the GSK decision for “turn[ing] two decades of Federal Circuit jurisprudence on drug labels and inducement on its head.” The Supreme Court declined to intervene then, but has granted certiorari in this case, which may have profound implications for the pharmaceutical industry. A brand-name drug is often approved to treat multiple different conditions (known as “indications”). Over time, the patent for the original drug compound may expire, but the brand-name company might still hold active “method-of-use” patents for specific indications. In many cases, companies pursue these additional indications after the drug is already on the market, which can extend their exclusivity.

Section viii (21 U.S.C. § 355(j)(2)(A)(viii)) of the Hatch-Waxman Act provides a statutory pathway for generic companies to enter the market before all method-of-use patents have expired. It allows a generic manufacturer to submit a statement to the FDA essentially saying: “We only want approval to sell this drug for older, unpatented uses; we are not seeking approval for the use that is still under patent.” To legally utilize the Section viii pathway, the generic manufacturer must remove—or “carve out”—all instructions, marketing, and references related to the patented use from their product’s packaging and informational inserts.

This specific dispute centers on Vascepa, a brand-name drug developed by the respondent, Amarin. Vascepa was initially approved in 2012 for a small group of patients suffering from severe hypertriglyceridemia (SH). In 2019, following a five-year study involving 8,000 patients, the drug received approval for a second indication for reducing the risks of cardiovascular events (CV). The petitioner, Hikma, subsequently developed a generic version of Vascepa (icosapent ethyl) and obtained FDA approval to sell the drug exclusively for the SH indication using the Section viii pathway. 

Notably, there are 11 companies with generic versions of icosapent ethyl approved for SH, and many of these generics (seven at the time the respondent’s brief was filed) are already on the market. Even though all generic pharmaceuticals are legally required to have the same labels carving out the CV indication, Amarin only sued Hikma because, according to Amarin, “[Hikma] alone chose to publish statements that healthcare providers would interpret as encouraging prescriptions that infringe respondents’ patents.”

Under 35 U.S.C. § 271(b), inducement liability requires that a party “actively induce[d]” a direct infringer to take specific action that suffices for “infringement of a patent.” Hikma contends it can be liable only if it actively encourages medical professionals to prescribe its generic icosapent ethyl specifically for the CV indication, and that none of its actions rise to this level. It argues that its skinny label encourages only non-infringing use, and that its external statements do not actively induce specific conduct. Hikma emphasizes that the only time the patented CV indication was mentioned on the label was to warn of the drug’s potential side effects “in people who have heart (cardiovascular) disease.” This warning, Hikma argues, cannot plausibly establish active inducement of the CV treatment method. Therefore, the case should be dismissed for failure to state a claim under the rigorous Iqbal-Twombly pleading standard.