“Writing Decisions in the Dark”: Ages of American Intellectual Property Law

“If the Court had not done so in Incandescent Lamp, it might have been writing decisions like Holland Furniture in the dark” [1]. — Neil Gorsuch

Such were Supreme Court Justice Gorsuch’s concluding words in the unanimous opinion in Amgen Inc. v. Sanofi on the infringement of cholesterol drugs. Affirming the decision of the United States Court of Appeals for the Federal Circuit in 2021, the Supreme Court rejected Amgen’s broad claim that its two patent applications cover all 26 antibodies that block the PCSK9, an enzyme that leads to higher cholesterol levels.

This recent patent case is a timely reminder of the fundamental legal principle in the history of intellectual property law dispute — the enablement rule in 35 U.S. Code § 112 (a) which states that “the specification [of the patent] shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use” [2].

From the first U.S. patent of Samuel Hopkins’ potash-making process to the 12 millionth patent of Pacific Biosciences of California, Inc. in DNA sequencing, the enablement rule has defined centuries of the evolution of intellectual property [3]. Instead of being just a profitable bargain for the inventor, patents are becoming a means to promote general welfare as the power of Congress to enact patent reform and the Supreme Court to adjudicate patent disputes expand. While Amgen v. Sanofi is not revolutionary per se, it is a modern test of Congress and the Supreme Court’s historical precedents and scientific judgment which they have passed.

I. Promoting the Progress of Science: Historical Roots of Patents

Beginning in the Age of Enlightenment and the Industrial Revolution and culminating in the Berne Convention, Congress has gained awareness and diversified its ways of protecting intellectual property, extending it beyond just the privilege of the inventor. Legislation and institutional reforms leading up to the rapid growth and almost doubling in patent filings and grants in the late 20th century shed light on the definition of works protected as well as the scope and conditions of rights guaranteed by the government.

The concept of intellectual property was first introduced in the U.S. Constitution Article I, Section 8, Clause 8 as a means within the powers of Congress “[t]o 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” [4]. The reasoning underlying this clause is 1) the protection of patents and copyrights maximizes the utility for the inventor who enjoys monetary compensations for the use of their invention and the state that seeks to build a strong industry and economy, 2) the continuation of the solemn adjudgment of copyright as a right by the British common law, and 3) the creation of a limit of the intellectual property in terms of the timeframe works are protected until entering public domain and the scope of works protected as defined by originality [5][6]. This clause marks the U.S. government’s first attempt at protecting creative rights and applying a federal standard rather than leaving it to the states’ discretion. The product of this trial period that spanned decades after the clause was first written was the need and subsequent establishment of a center for intellectual property filing, the United States Patent and Trademark Office (USPTO) in 1836, during the height of the Industrial Revolution. This system drove down the costs of patents for the inventor, facilitating the invention process and increasing the chances of economic returns. By 1850, the cost of a patent in the U.S. was only 13 GBP (17.4 dollars) compared to its British counterpart of 375 GBP (501.4 dollars) [7].

Having benefited from the first instance where an effective mechanism for patents opened up the opportunity for innovation, the U.S. later participated as a contracting state in the Berne Convention in 1866. The Convention outlined several minimum standards of protection and introduced the concept of “moral right” — the right to claim authorship of the work and the right to object to any modification independent of the inventor’s economic rights — that underlies the spirit of the enablement rule today [8][9]. The limitation placed on the exclusive rights of authorization of the inventor to make adaptations and productions creates room for further development of the discoveries without violating the basic legitimate interests of the author.

II. From Incandescent Lamp to Holland Furniture: Risks of Broad Claims

The essence of the enablement rule is that the more one claims, the more one must enable. Like the Supreme Court’s rejection of Amgen’s claim to the full class of antibody inhibitors, Courts have noticed and responded to the gap between inventor claims and the use of patents since The Incandescent Lamp Patent (1895) concerning the claims of the inventors of an incandescent conductor made out of carbonized paper that Thomas Edison infringed their patent by using bamboo as a conductor [10]. The problem at stake is the validity of the patent’s monopoly of all fibrous and textile materials for production. While broad claims as such could be considered valid if there exists a discovery and disclosure of a common quality of fibrous and textile substances adapted to incandescent lighting, the claims of this patent did not and are therefore too indefinite [11].

The similar holding in Holland Furniture Co. v. Perkins Glue Co. (1928) reinforces the validity of patent claims conditional upon enablement. Perkins’ claim that instructed gluemakers to mix any starch ingredient with “three parts of water and with alkali” to produce a product as effective as animal glue for wood veneering exceeded the product itself [12]. Allowing the claim would imply excluding others from all types of starch ingredients, discouraging, rather than promoting, innovation [13]. Here and in Incandescent Lamp, the Court successfully avoided an expansion of patentability by redefining that 1) the process of using a patent is inseparable from the patent itself and that 2) enabling others to use and build upon one’s work is equally important, if not more, as the material value it brings to the inventor.

III. Enablement is Empowerment, Innovative and Non-Innovative Work Alike

A counterintuitive fact of the function of intellectual property law is that it encourages not only original inventions but also the further use and development of them. Discovery is not the same as development, and innovative and non-innovative work always go together. Issuing patents with broad claims places too much emphasis on early discovery and limits subsequent stages of development, the latter of which is often the most time-consuming and risky [14]. The enablement rule takes into account this fact well. Whether it is fibrous and textile materials, starch, or modern antibodies, it ensures that there is not just one solution available to lighting, construction, or high cholesterol levels, thereby preserving the liberty of a free market economy and empowering the public in their intellectual pursuits for the progress of science and society. Ultimately, proactive responses to change depend on judicial and legislative decisions that acknowledge the limited scope of every patent. In the current ever-changing legal and technological landscape, the goal of patent reform and adjudication is to recognize originality but also leave room for competition and incentivize further innovation.

Conclusion

Gorsuch mentions at the end of his opinion that it is the Supreme Court’s duty to apply the mandate of enablement and achieve the “balance” that it wishes [15]. Whether that is the balance between the amount of existing knowledge and originality in a patent, the discovery and development processes, or the inventor’s profitability and the users’ convenience, with an enablement rule that stood the test of new technologies and kept its intent to promote public welfare intact, it is safe to say that this balance is clearer and more dynamic than ever before.

Bibliography

[1] Amgen Inc. v. Sanofi, 598 U.S. 594 (2023).

[2] Patent Laws, 35 U.S.C. § 112 (2012). Note that the enactment of the Leahy-Smith America Invents Act (AIA) — applicable to any patent application filed on or after September 16, 2012 — did not change the enablement rule. It simply named the first designated paragraph in the pre-AIA code on specification as “(a) IN GENERAL,” making it easier to locate the enablement rule in 35 U.S.C. § 112 (a).

[3] “Milestones in U.S. Patenting.” Text. Accessed October 10, 2024. https://www.uspto.gov/patents/milestones.

[4] U.S. Constitution, art. 1, sec. 8, cl. 3.

[5] Madison, James. Federalist No. 43.

[6] “ArtI.S8.C8.1 Overview of Congress's Power Over Intellectual Property.” Constitution Annotated. https://constitution.congress.gov/browse/essay/artI-S8-C8-1/ALDE_00013060/

[7] Hancock, William Neilson. On the Cost of Patents of Invention in Different Countries: A Paper Read Before the Statistical Section of the British Association, at Edinburgh, August 2nd 1850.

[8] Berne Convention for the Protection of Literary and Artistic Works of September 9, 1886, art. 6bis, cl. 8.

[9] Note that although the Convention is named as “for the Protection of Literary and Artistic Works,” the expression “literary and artistic works” includes every production in the literary, scientific, and artistic domain regardless of mode of expression according to art. 2, cl. 1.

[10] The Incandescent Lamp Patent, 159 U.S. 465 (1895).

[11] Ibid.

[12] Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245 (1928).

[13] Ibid.

[14] Balthasar, Joseph P. Amgen v. Sanofi: Critical Impact on the Value of Innovative Science in Antibody Discovery. The AAPS Journal 25, no. 3 (May 12, 2023): 51. https://doi.org/10.1208/s12248-023-00816-3.

[15] Amgen Inc. v. Sanofi, 598 U.S. 594 (2023).