The Supreme Court will hear oral argument on March 27, 2023, in a critically important patent case that has profound implications for biomedical innovation. In Amgen v. Sanofi, the Court is reviewing a new rule created by the Federal Circuit that effectively eliminates genus claims under the enablement doctrine.
This new enablement rule ignores the longstanding use of genus claims in patent law, which have incentivized inventors to create and commercialize pioneering innovations from nineteenth-century telephones and lightbulbs to today's life-saving medical tests and drugs that have turned fatal and devastating diseases like AIDS and COVID-19 into manageable and treatable conditions.
Unfortunately, as with many issues in patent law and policy today,1there is much confusion and misunderstanding about genus claims. This is due in part to misinformation from activists and policy organizations, many of whom propagated fear-mongering myths in their amicus briefs filed in the Amgen case.
Similar to the "Patents Kill" posters that appeared in major cities during the COVID-19 pandemic, these amici are promoting anti-innovation rhetoric about genus claims, contrary to the law and evidence of how the patent system has promoted innumerable life-saving medical innovations.2This is confirmed by the fact that the U.S. has been the birthplace for the majority of new medicines over the past half-century.3The Supreme Court should not be misled to killing the golden goose responsible for these life-saving golden eggs.
Genus claims are as old as the U.S. patent system
We must first clear the ground of legal confusion about genus claims given the assertions that these are a novel feature of the patent system. To the contrary, a genus claim is a longstanding feature of U.S. patents by which inventors define their new inventions disclosed to the public. Genus claims have been around for as long as patent claims, arising out of the requirement in the first patent statutes that inventors must describe "the principle" of their inventions.4
In essence, a genus claim is nothing more than a claim covering multiple embodiments, or "species" in patent parlance. A genus, by definition, includes multiple species (similar to Carl Linnaeus's canonical 18th-century taxonomy for biological species). For example, the term "fastener" is a genus that includes innumerable species, such as screws, nails, tacks, staples, etc. Another example of a genus is a "nucleic acid." Within the genus of "nucleic acid" are many species, such as DNA, RNA, eukaryotic DNA, mammalian DNA, human DNA, etc.
As modern "peripheral" claiming practices evolved following the 1870 Patent Act, the Commissioner of Patents affirmed the validity of genus claims in the 1924 Ex parte Markush decision.5The Patent Commissioner concluded that Eugene Markush rightly claimed his novel process of manufacturing dyes in a very broadly framed genus of "aniline, homologues of aniline and halogen substitutes of aniline." Although genus claims can take various forms, almost a hundred years later, patent lawyers and judges still refer to genus claims written in this form as "Markush claims."
Genus claims have driven every technological revolution
Given the ubiquity of genus claims in the U.S. patent system over the past two hundred years, it should be unsurprising that innovators regularly disclose their inventions as genus claims. They have relied on their genus claims to secure their pioneering inventions, enabling follow-on innovations and commercialization of their life-enhancing inventions throughout the U.S. — and ultimately the world.
The groundbreaking inventions we all know — such as the Wright Brothers' airplane or Charles Goodyear's vulcanized rubber — were all secured in patents by what we now call genus claims. Their patent claims were tested through litigation, many by the Supreme Court itself.
Although often forgotten today, the Supreme Court affirmed Morse's first genus claim to his telegraph, in which Morse broadly claimed the "use of the motive power of magnetism when developed by the action of such [galvanic] current or currents, as a means of operating or giving motion to machinery … [which was] the first recording or printing telegraph by means of electro-magnetism."6
Recognizing how commonplace such claims were by 1854, the Court affirmed this broad genus claim (and the next six dependent claims) in a single sentence: "We perceive no well-founded objection … to his right to a patent for the first seven inventions set forth in the specification of his claims."7
Almost sixty years later, Judge Learned Hand similarly affirmed the Wright Brothers' broad genus claims for their "flying machine" invention. The defendant argued that he did not infringe their patent because "the means [he used in his airplane] must be the means specified" by the Wright Brothers in their claims.8The defendant's airplane used a human operator to directly "warp" the wings in combination with the turning of the tail rudder, whereas the Wright Brothers described and claimed a rope and pulley system.
Judge Hand rejected this argument, recognizing that "an intelligent understanding of the invention" by the Wright Brothers covered the defendant's "obvious modification" in creating a new embodiment that "any skilled operator" of airplanes could easily deduce from the Wright Brothers' invention, as claimed and described in their 1906 patent.9
Relying on Judge Hand's reasoning, the Second Circuit later reinforced the validity of the Wright Brothers' genus claim and its application to the (un)described embodiment in the defendant's airplane by recognizing that the Wright Brothers were "pioneers in the practical art of flying" and thus their broad genus "claims should have a liberal interpretation."10(As an aside, NASA's Ingenuity drone flying on Mars carries a small swatch from the wing of the Wright Brothers Flyer 1, and the location of the drone's first flight on Mars is now called Wright Field.11
Genus claims launched the biotech revolution
Of course, genus claims were the launching pad of the biotech revolution. In the early 1970s, Stanley Cohen and Herbert Boyer developed recombinant DNA technology, which pioneered new, life-saving drugs, such as human growth hormone and synthetic insulin (the first real-world applications of their invention in healthcare in the 1980s).
Their innovation was protected in "the Cohen-Boyer patents," which broadly claimed methods of making genetically engineered living cells and the engineered bacteria made by those methods. The Cohen-Boyer patents had broad genus claims, not limited to specific microorganisms or specific genes being engineered into the microorganisms.
Contrary to the fearmongering of activists and professors of so-called "stifled" drug development, the Cohen-Boyer patents prompted widespread commercialization efforts and new healthcare treatments. More than 450 companies licensed the Cohen-Boyer patents, leading to over 2,400 commercialized products developed through their genetic engineering techniques.
Examples include drugs for treating heart disease, cancer, and HIV. Commercial sales of recombinant DNA products over the life of their patents exceeded $35 billion.12Scientists developed an untold number of new inventions from the Cohen-Boyer patents, and many of those follow-on innovations were themselves protected by genus claims.
In 1980, the Supreme Court affirmed (again) another broad genus claim in the then-nascent field of biotechnology. In the famous case of Diamond v. Chakrabarty, 13the Court reversed the Patent Office's rejection of Dr. Amand Chakrabarty's patent application with a broad genus claim for man-made bacteria that could breakdown oil, and which covered multiple species of the genetically engineered bacteria. The Court held that this is a patentable invention that was properly claimed and described by Dr. Chakrabarty in his patent.
The Chakrabarty decision is famous and rightly so. First, it represented the then-unique approach in the U.S. patent system in securing the innovations in next-generation technological revolutions, even when other countries hesitated to secure the same fruits of inventors' labors. Second, in affirming that reliable and effective patent protections would be secured in the fruits of biotech research, Chakrabarty spawned the biotech revolution, which continues to this day. As a result of Chakrabarty, a majority of all new drugs have been invented in the U.S.
Those examples underscore the purpose of allowing broad, pioneering claims — rewarding inventors for their fundamental breakthrough technologies while instructing other researchers how to engage in follow-on innovation. Genus claims have been the foundation of essentially every technological revolution and their subsequent advances. Genus claims continue to promote innovation and encourage inventors to disclose the details of their continued research and development.
Genus claims secured and promoted biotech-based diagnostic tests
Genus claims have been particularly important for the invention and development of biotech-based diagnostic tests using cloned antibodies produced from genetically engineered organisms (called hybridomas). The development of "monoclonal antibodies" is the basis for all modern diagnostics, from easy-to-use pregnancy tests, COVID tests, hepatitis tests and cancer screenings, among many other life-saving tests. The benefits to patients are incalculable, as people receive faster and more efficient diagnoses of a vast array of conditions and maladies, and thus faster and better treatment.
Enablement doctrine today is based on an eight-factor test set forth in the 1988 Federal Circuit decision In re Wands, 14which affirmed as sufficiently enabled a broad genus claim to a method of using monoclonal antibodies for use in diagnostic tests.
In this case, the Patent Office rejected Wands' patent application for lack of enablement, arguing that the four successful uses of the hybridomas to produce the monoclonal antibodies were insufficiently enabling of the innumerable diagnostic tests using these antibodies. Following longstanding precedent, the Federal Circuit held that the four antibody embodiments disclosed in the patent specification were sufficiently enabling.
The nature of monoclonal antibodies is such that genus claims with functional limitations are the only practical way to fully describe the inventions and to reward inventors for their work. Thus, a genus claim in an invention in the field of biotechnology is valid as long as the patent enables specialists to recreate the invention. It is unnecessary, if not practically impossible, to identify all conceivable embodiments.
In sum, if the rule recently crafted by the Federal Circuit had been applied in the 1970s and 1980s to the foundational innovations at the birth of the biotech revolution, then there would have been no biotech revolution. The Patent Office would have rejected the patent applications, and courts would have invalidated issued patents. There would have been no property rights serving as a basis for the venture capital investments that created companies like Genentech, spurring the invention, development and commercialization of the unprecedented drugs and medical tests that many take for granted today.
Amici for Sanofi are fearmongering
Despite the long historical use of genus claims and the demonstrated benefit of genus claims for all innovators, Sanofi's amici conjure a parade of horribles divorced from evidence. As the history and law have shown, especially in the biotech revolution, if genus claims were as terrible as amici assert, then innovation would have been stifled. But the flaw in their argument is easily revealed: they can't identify any instance where genus claims have in fact stifled innovation.
Professor Robin Feldman's amicus brief, for example, asserts that genus claims would have prevented the development of HIV anti-viral cocktails.15The historical evidence shows this claim is false. Patents with genus claims that disclosed key HIV discoveries and inventions advanced the development of HIV treatments: in the early days of HIV research, scientists at Harvard University were awarded a patent on a key HIV protein.16
Later, Dr. Anthony Fauci and colleagues at the National Institutes of Health obtained a broad genus patent on another key HIV protein fused to an antibody protein.17These broad patents contributed to the understanding and development of antiviral medicines. There are many other examples. The point is that there is no evidence that genus claims impeded the research and development of HIV therapies; in fact, the evidence is to the contrary.
Let's return to the historical, statutory test for enablement
Hopefully, the Court in Amgen v. Sanofi will not be led down a garden path by fear-mongering hypothetical scenarios that ignore or outright misrepresent the key role of genus claims in advancing innovation. Genus claims are necessary for pioneering inventions to produce technological, industrial and medical revolutions, and they are particularly important for developing monoclonal antibody therapeutics.
The Court should recognize that the Federal Circuit's new enablement rule is contrary to law and to the function of the patent system in promoting innovation and spurring its disclosure and commercialization throughout the world.