Am I a Genus? The Amgen case and its impact on genus patenting for biologics
Amgen, a biotechnology company, brought suit against Sanofi for alleged infringement of its two patents on antibodies used to decrease low-density lipoprotein (LDL) cholesterol or ‘bad’ cholesterol.[1] Amgen discovered that it could reduce the amount of bad cholesterol in the body through antibodies that inhibited a specific protein called PCSK9, thus creating an effective cholesterol treatment.[2] Amgen patented this antibody, known as Repatha, and the broader genus that Repatha belonged to, which included “any antibody that binds to a specific region of PCSK9 and inhibits PCSK9 from binding to LDL receptors.”[3] Amgen included a list of 26 illustrative antibody embodiments and two methods for identifying antibodies within the scope of its specification.[4]
Amgen claimed that Sanofi’s drug, Praluent, infringed on its genus patent. Even though Praluent was a different antibody to Repatha and not listed in the 26 examples provided, Amgen claimed that it was covered by the genus patent as it fell within its scope.[5] Sanofi contended, however, that Amgen’s patent had not been properly enabled.[6]
The enablement requirement under the U.S. Patent Act mandates that a patent describe “the manner and process of making and using [the invention] in such full, clear, concise, and exact terms as to enable any person skilled in the art…to make and use.”[7] That is, a patent needs to adequately describe the invention to the degree that it could be recreated by another expert in the field. The threshold for enablement is even higher for genus patents as “the more a party claims…the more it must enable.”[8]
The question before the Supreme Court was thus: did Amgen sufficiently enable their genus patent?
The court unanimously found that it had not.[9] Justice Gorsuch writing for the Court stated that Amgen’s patents were effectively “two research assignments” rather than fleshed-out claims to the genus.[10] The Court was satisfied that the two methods presented could theoretically create all of the antibodies within the genus. However, the “unpredictable” nature of antibody science and the vague nature of the methods made them more akin to “trial and error processes” as opposed to enabled methods for discovery.[11]
The Court relied heavily on established precedent in its decision. Pointing first to O’Reilly v Morse, the court emphasized that while Morse could patent the telegraphic system he invented he could not patent “all means of using electric current for communication at a distance.”[12] This was because “he had not described how to make and use them all.”[13] Similarly, in Incandescent Lamp Patent the Court pointed to the fact that the patent had been invalidated because it claimed “any” carbonized fibrous or textile material without disclosing a “common quality.”[14]
The Court in applying this precedent was satisfied that Repatha was sufficiently enabled as were the other 26 examples, as their exact amino acid sequences were provided.[15] However, the genus patents lacked specificity. They were so broad in their methodology that they failed to provide a sufficiently certain roadmap to creation, instead relying on “painstaking experimentation” that was akin to de novo discovery.[16] Therefore, the Court held that Amgen’s patent was invalid and its suit against Sanofi unsuccessful. [17]
The implication of the Amgen decision is to limit the success of genus patents to broad claims. The Court while following precedent strictly, and thus not necessarily changing the test for genus claims, applied the test in the space of biologics thereby importing the strict traditional test into this field of research. [18] The Court was clear that patent law is not adaptable to the field but will be applied in a uniform manner, with adherence to the test rather than the technology. [19]
Criticism of the Amgen decision has focused on its potential to disincentivize innovation and stunt progress in the field of biomedical research.[20] The major concern is that if genus patents become more difficult to enable then “fundamental breakthroughs” will no longer be as commercially attractive, with minor tweakings on established innovations being pursued as opposed to ground-breaking discoveries in the field of biomedicine.[21]
The Amgen decision has, however, also been viewed positively on the very point of innovation. The decision goes some way to putting a bar on patent monopolies that hinder innovation by allowing individuals to claim patents disproportionate to their actual discoveries.[22] The fact that the majority of antibodies remain within the public domain, rather than a genus patent, provides competitive conditions to see these antibodies researched and innovated on to provide more treatment options for the public.[23]
The major take-away from Amgen is that the Court is not going to change the principles of patent law simply because it is in a novel setting. If you want to enable a genus patent, you will have to do more than create “research assignments” in your application.[24]
Footnotes
